DDrare: Database of Drug Development for Rare Diseases

Searched query = "Ulcerative colitis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Drug = (-)-3-(4-Aminophenyl)-2-methoxypropionic acid; (R)-3-(1-oxo-propoxy)-4-(N,N,N-trimethyl amonium chloride)-butanoic acid; (S)-(-)-3-(4-Aminophenyl)-2-methoxypropionic Acid; (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxyben; (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride; -aminosalicylic acid; 0.25 mg RPC1063; 0.25mg RPC103; 0.25mg RPC1063; 0.5 mg RPC1063; 1 mg RPC1063; 1.0 mg RPC103; 1.0 mg RPC1063; 1.Remicade; 10 mg Natura-alpha capsule; 100; 100 mg; 150 mg; 1500mg mesalazine pellets; 15N2-tofacitinib; 2 x 10 mg Natura-alpha capsules; 2'-Fucosyllactose; 2-Hydroxybenzoic acid; 20 mg; 225mg SHP647 (PF-00547659); 23-valent polysaccharide pneumococcal vaccine (Pneumovax TM); 25 mg Ontamalimab; 250mg mesalazine pellets; 2L polyethylene glycol/ascorbic acid; 3-hydroxy-2-methyl-4H-pyrane-4-one iron (III) complex (3:1), Ferric (3-hydroxy-2-methyl-4-pyrone), Tris-maltol-iron (III), Tri=maltol-iron (III); 331731-18-1; 40 mg MSB11022; 42942019; 450 mg; 5 ASA, enemas, suppositories, corticosteroids; 5-ASA; 5-ASA (5-Aminosalicylate); 5-ASA MMx; 5-AminoSalicylic Acid; 5-Aminosalicyclic acid; 5-Aminosalicylic Acid; 5-Aminosalicylic acid; 5-Aminosalicylic acid (5-ASA); 5-Aminosalicylic acid(5-ASA) and/or Prednisone; 5-HTP; 5-amino salicylic acid; 5-amino salicylic acid (5-ASA); 5-amino-2-hydroxybenzoic acid; 5-aminosalicylate (Pentasa, Ferring); 5-aminosalicylic acid; 5-aminosalicylic acid (5-ASA); 50 mg; 500mg mesalazine pellets; 549-0261/F02-01; 6 mercaptopurine; 6-MP; 6-[2-(3,4-diethoxyphenyl)thiazol-4-yl] pyridine-2-carboxylic acid; 6-mercaptopurine; 75 mg Ontamalimab; 750mg mesalazine pellets; 75mg SHP647 (PF-00547659); 90 mg hydrocortisone acetate suppository with Sephure suppository applicator; A multistrain probiotic product (DSF); A07DA03; A: 1 dosis; AB (antibiotics); ABBV-006; ABBV-066; ABBV-323; ABBV-323 Dose A; ABBV-323 Dose B; ABI-M201; ABT-494; ABT-Humira; ABX464; ABX464 100mg; ABX464 25mg; ABX464 50mg; ADALIMUMAB; AEB071; AEB071A; AG011; AG011 - Capsules; AG011 - Enema; AJG501; AJG511; AJM300; ALLOPURINOL; ALTH12-1:4; ALTH12-2:4; AMG 181; AMG181; AMGEVITA; AMGEVITA (Adalimumab biosimilar ); AMGEVITA®; AMT; AMT-101; AMT-101 (oral); AND (Andrographolide); ANDROGRAPHIS PANICULATA; ANDROGRAPHIS PANICULATA (ethanol extract); AODG (Apigenin-7-O-glucuronide); APD334; APREMILAST; APRISO 375 mg extended-release capsules; APVO210; AR401959 L-arginine; AS; AS INN; ASA; ASACOL; ASC; ASP015K; ASP3291; AST-120; ATL-2502; AVONEX; AVX 470; AZA; AZAFOR 50mg; AZATHIOPRINE; AZATIOPRINA; AbGn-168H; Abalimumab; Abatacept; Abatacept (ABA); Abrilumab; Accelerated 1 hour-infusion; Accelerated 30 minutes-infusion; Acetate; Acetic acid; Acidophilus; Active group; Adalimumab; Adipate; Adipose derived, autologous mesenchymal stem cells; Adipose tissue-derived mesenchymal stem cells; Adipose-cord mesenchymal stromal cells (A-MSCs); Air; Aldesleukin; Alicaforsen; Alkaline Phosphatase; Allogeneic adipose tissue-derived mesenchymal stem cells; Allopurinol; AloASC; Aloe; Aloe Barbadensis Miller; Amg 181; Amgevita; Amgevita 40 mg Injektionslösung im Fertigpen; Amgevita 40 mg Injektionslösung in einer Fertigspritze; Amgevita 40Mg Solution for Injection; Aminosalicylic acid; Amitriptyline; Amitriptyline hydrochloride; Amoxicillin; Amoxicillin and tetracycline; Amoxicillin, metronidazole and tetracycline; Anakinra; Andecaliximab; AndoSan; Andrographolide; Anrukinzumab; Anti Beta7; Anti CD3 monoclonal antibody; Anti TNF therapy including infliximab; Anti-CD3; Anti-CD3 monoclonal antibody; Anti-IP-10 Antibody; Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human; Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; Anti-MAdCAM antibody; Anti-TL1A; Anti-TNF Drug; Anti-TNF Therapy; Anti-TNF discontinuation: Physiological saline solution; Anti-TNF: Infliximab (Infusion); Anti-TNF:Adalimumab (Subcutaneus); Antibiotic cocktail; Apigenin; Apixaban; Apixaban 2.5 milligram; Apremilast; Apriso 0.375G ER CAP; Aquamin®; Arginine; Asacol; Asacol (mesalamine); Asacol (mesalamine) Delayed-release Tablets; Asacol 400 mg; Asacol 400 mg (mesalamine); Asacol 400 mg tablet; Asacol 400mg tablet; Asacol 800 mg (mesalamine); Asacol 800 mg tablet; Asacol 800mg tablet; Asacol Delayed Release Tablets; Asacol Delayed-Release Tablets; Asacol tablet; Asacol®; Asacol® 400 mg; Ascorbic Acid; Ascorbic acid; Aspergillus oryzae; Avonex; Azathioprine; Azathioprine (AZA); Azathioprine (AZA) or 6-mercaptopurine (6-MP); Azathioprine (Imuran) 50 mg Overencapsulated Tablet; Azathioprine and Allopurinol; Azathioprine or 6-mercaptopurine; Azatioprina; B2-ASmedic; B: 2 dosis; BBT-401-1S; BBT-401-1S, Multiple doses; BBT-401-1S, Single dose; BECLOMETASONE DIPROPIONATE; BG9418 (Interferon beta-1a); BG9924; BI 655130; BIAP; BITTER CANDYTUFT FRESH PLANT EXTRACT; BL-7040; BMS-188667; BMS-936557; BMS-986165; BMS-986165 Dose 1; BMS-986165 Dose 2; BMS-986166; BMS-986184; BMS986165; BRAZIKUMAB; BT-11; BT-11 (1000 mg); BT-11 (500 mg); BT-11 1000mg; BT-11 500 mg; BT-11 Active; BUDESONIDE; Bacteriotherapy; Balsalazide; Balsalazide Disodium; Balsalazide disodium; Baminercept; Band; Bascial prescription plus or minus herbs depend on symptoms; Basiliximab; Beclometasone; Beclometasone dipropionate; Beclomethasone dipropionate; Beclomethasone diproprionate; Behavioral: AbbVie Care 2.0; Behavioral: Administration of probiotic (L. rhamnosus and L. acidophilus); Behavioral: Increased dietary intake of salmon or cod; Behavioral: TIP / IMPACT Plus Care Coordination; Berberine; Berberine Chloride; Bertilimumab; Beta-1,3/1,6-D-Glucan; Bezlotoxumab; Bifidobacterium breve; Bifidobacterium infantis; Bifidobacterium infantis 35624; Bimekizumab; Bio-enhanced Curcumin Soft Gelatin Capsule; Biologically active human fecal microbiota; Biopsies; Biosimilar; Biosimilar infliximab; Bitterschleifenblume-ganzpflanze 1,5ml/10ml; Blood sample; Blood samples; Boulardii; Bovine intestinal alkaline phosphatase (BIAP); Bovine-Calf Alkaline Phosphatase (BIAP); Bovine-Calf Alkaline Phosphatase BIAP; Brazikumab; Broccoli; Budenofalk 2mg rectal foam; Budenofalk 3mg; Budenofalk rectal foam; Budenofalk® suppositories; Budenofalk® suppositories (BUS); Budesonide; Budesonide (6 mg); Budesonide (9 mg); Budesonide 6 mg capsules, hard (BUX-PVII prototype); Budesonide 6 mg prolonged-release capsule, hard (BUX-PVII prototype); Budesonide 6 mg prolonged-release capsules, hard (BUX-PVII prototype); Budesonide 9 mg capsules, hard (BUX-PV); Budesonide 9 mg capsules, hard (BUX-PVII prototype); Budesonide 9 mg prolonged-release capsule, hard (BUX-PVII prototype); Budesonide 9 mg prolonged-release capsules, hard (BUX-PVII prototype); Budesonide MMX; Budesonide MMX 6 mg Tablet; Budesonide MMX®; Budesonide MMX® 6 mg; Budesonide MMX® 9 mg; Budesonide-MMX; Budesonide-MMX®; Budesonide-MMX® 6 mg; Budesonide-MMX® 9 mg; Budesonide-MMX™; Butanoic acid; Butyrate; By demand; CANNABIDIOL; CARVI EXTRACTUM FLUIDUM; CAT-354; CB-01-02; CB-01-05-MMX; CC; CC-10004; CD; CGMP protein; CICLOSPORIN; CLA; CLA (Chlorogenic acid); CLIPPER*30CPR 5MG R.M.; CNTO 148; CNTO-148; CNTO1275; CNTO148; CNTO1959; CNTO312; COFFEE COAL; COLAL PRED; COLAL-PRED; COLAL-PRED®; CP; CP- 690 550; CP-690,500 5 mg; CP-690,550; CP-690,550 10 mg; CP-690,550-10; CP690,550; CS (corticosteroids) Only; CT-P13; CT-P13 SC (Infliximab); CYCLOSPORIN; CYCLOSPORINE VS INFLIXIMAB; Caffeine; Caffeine 100 mg; Calcitonin nasal spray (salmon); Calcium; Caltrate Pill; Cannabidiol; Cannabis; Cannabis, Medical; Carbon; Carbon dioxide; Carnitine; Carrageenan; Casein; Casein glycomacropeptide (CGMP); Catridecacog; Ceftriaxone; Cefuroxime; Certolizumab pegol; Chloride; Chlorogenic Acid; Cholecalciferol; Ciclosporin; Ciclosporina; Cimzia; Ciprofloxacin; Clarithromycin; Clipper; Clipper 30 cpr 5mg R.M.; Clotrimazole; Coamoxiclav; Cobitolimod; Coffee; Colal-Pred; Colazide; Coltect; Combination Oral Budesonide and Rectal Hydrocortisone; Combination Product: Beclomethasone dipropionate in addition to MC-EVOO; Combination Product: Beclomethasone dipropionate in addition to refined oil; Combination Product: Twice daily 90 mg hydrocortisone acetate suppository administered with Sephure applicator; Corticosteroid; Corticosteroids; Corticosteroids only; CortimentMMX 9 mg; CosmoFer; CosmoFer 50mg/ml solution for infusion or injection; Cotrimoxazole; Curcumin; CyCol; CyCol™; Cyclosporin; Cyclosporine; Cyclosporine (USAN); Cytochrome P450 (CYP) Substrates; D-Proline; DACORTIN; DAND (14-Deoxyandrographolide); DDAND (14-deoxy-11,12-didehydroandrographolide); DELTACORTENE FORTE*10CPR 25MG; DELTACORTENE*20CPR 5MG; DEXTRAN 1 FOR INJECTION; DIMS0150; DIMs0150; Daclizumab; Dacortin; Decortin H; Decortin H 1 mg; Decortin H 10mg; Decortin H 20mg; Decortin H 50 mg; Decortin H 5mg; Dekavil; Dekristol; Delayed and extended release mesalazine; Deligoparin; Delmitide acetate; Deltacortene; Deltacortene 10 cpr 25mg; Deltacortene 20 cpr 5mg; Dersalazina sodica; Dersalazine; Dersalazine sodium; Device: The Colonic Transendoscopic enteral Tubing.; Dexamethasone; Dexamethasone 21-phosphate; Dextran; Dextromethorphan; Dextromethorphan 30 mg; Diagnostic Test: Antibodies to golimumab; Diagnostic Test: Calprotectin; Diagnostic Test: Colonoscopy; Diagnostic Test: Golimumab trough levels; Diagnostic Test: Histology; Diagnostic Test: Rectosigmoidoscopy; Diagnostic Test: parasitological diagnostics (coproscopy); Diagnostic Test: serum leucine-rich alpha-2 glycoprotein (LRG) levels; Diet; Doxycycline; Dukoral; E. coli Nissle; E6007; EGF enema; EMEA/H/C/000240; EMEA/H/C/000481; EN; ENTOCORT CR; ENTYVIO; ETROLIZUMAB; Ecologic 825; Eicosapentaenoic Acid; Eicosapentaenoic acid; Encapsulated Mesalamine Granules (eMG); Encapsulated faecal microbiota; Encapsulated faecal microbiota filtrate; Entecavir; Entocort EC® 3 mg; Entocort® CR; Entyvio; Entyvio 300 mg; Entyvio 300mg; Epaxal Berna (virosomal hepatitis A vaccine); Epidermal growth factor; Epidermal growth factor enema; Ergocalciferol; Ethanol; Etrasimod; Etrasimod L-arginine; Etrolizumab; Etrozulimab; Exposure to golimumab; F8IL10; FE 999301; FILGOTINIB; FITC-ADALIMUMAB; FITC-Adalimumab; FMT; FMT enema; FMT infusions; FMT oral; FP-110; FP-CYA-050; FP-CYA-053; Factor XIII; Faecal Microbiota Transplant; Faecal Microbiota Transplantation; Faecal matter; Fecal Microbial Transplant; Fecal Microbial Transplantation; Fecal Microbiota; Fecal Microbiota Enema; Fecal Microbiota Transplant; Fecal Microbiota Transplant (FMT); Fecal Microbiota Transplantation; Fecal Microbiota Transplantation (FMT); Fecal Microbiota Transplantation (FMT), OpenBiome; Fecal microbiota; Fecal microbiota capsule; Fecal microbiota transplantation; Ferric carboxymaltose; Ferrous sulphate; Filgotinib; Film-coated tablet; Flagyl; Flaxseed; Flaxseed lignan-enriched complex (FLC); Flixabi; Fluorescein; Flupentixol; Fosfomycin; Freeze-dried black raspberry powder; G321605; GB004; GED-0301; GED-0507-34-LEVO; GED-0507-34-Levo; GED-0507-34-Levo 160 mg; GED-0507-34-Levo 80 mg; GED0507; GI-270384; GLPG0974; GLPG1205; GLPG3970; GLYCYRRHIZA GLABRA ROOT; GOLIMUMAB; GS-4875; GS-5745; GS-5745 IV; GS-5745 SC; GS-6034; GSK1399686; GSK1605786; GSK1605786A; GSK2586184 400mg; GSK2831781; GSK2831781 IV infusion; GSK2831781 SC injection; GSK2982772; GSK2982772A, where A denotes the free base; GUSELKUMAB; GWP42003; Ganciclovir; Gastro-resistant phosphatidylcholine granules; Gelatin; Genetic: TPMT genotyping; Gliolan; Glutamine; Glycyrrhiza; Glycyrrhiza glabra; Gold; Golimumab; Golimumab (GLM); Golimumab (Optimization); Golimumab 1 mg per kg; Golimumab 100 mg; Golimumab 2 mg per kg; Golimumab 200 mg; Golimumab 4 mg per kg; Golimumab 400 mg; Golimumab 50 mg; Golimumab 50 mg in patients <80 kg and Golimumab 100 mg in patients >80 kg; Golimumab Dose 1; Golimumab Dose 2; Golimumab Liquid in Vial; Golimumab Liquid in prefilled syringe; Golimumab Prefilled Syringe; Golimumab treatment optimization.; Gralise; Granulated mesalamine; Grapefruit; Group 1- Control Diet; Group 2- UCD Diet; Guaiazulene; Guselkum; Guselkumab; Guselkumab Dose 1; Guselkumab Dose 2; H02AB; HE3286; HF2; HGS1025; HMPL-004; HMPL-004 1800 mg/day; HMPL-004 2400 mg/day; HMPL-004 high dose; HMPL-004 low dose; HMPL004-6599; HUMIRA; HUMIRA 40Mg Solution for Injection; HUMIRA ®; HYDROCORTISONE ACETATE; Hemay007; Hepatitis A Vaccine; Herbal treatment (SA100); Hextend; Hgd40; High Dose Budesonide; High dose; HuM291; HuM291); Hulio; Human Anti-TNF IgG1 Monoclonal Antibody; Human Anti-TNFalfa; Human anti-IP10 monoclonal antibody; Human anti-TNF-alpha monoclonal antibody; Humanized recombinant IgG4 monoclonal antibody against CD-127; Humira; Humira (adalimumab original); Humira 40 mg solution for injection in pre-filled syringe; Humira 40 mg solution for injection in pre-filled syringes; Humira 40 mg/0.8 ml solution for injection; Humira 40 mg/0.8 ml solution for injection for paediatric use; Humira®; Hyaluronate; Hydrocortisone; Hydrocortisone acetate; Hydrocortisone sodium succinate; Hydrogen; Hydroxide; Hydroxocobalamin; Hydroxocobalamin with Butyrate; IBD98-M; IBD98-M Delayed-release Capsules; IDOFORM®Travel; IM90838; IMU-838; INCB039110; INFLIXIMAB; INTERLEUKIN 2; INTERLEUKIN-2; ITACITINIB ADIPATE; IV Corticosteroid; Iberogast N; Imolope; Impact; Imuran; Imurek; Imurek 25mg Filmtabletten; Imurek 50mg Filmtabletten; Imurel; Inflectra; Inflectra 100 mg; Inflectra 100 mg powder for concentrate for solution for infusion; Infliximab; Infliximab (IFX); Infliximab 10 mg/kg; Infliximab 5 mg/kg; Infliximab [infliximab biosimilar 3]; Infliximab and adalimumab; Infliximab or adalimumab or golimumab or vedolizumab or ustekinumab; Infliximab, adalimumab, certolizumab pegol; Innovator infliximab; Inositol; Interferon beta; Interferon beta-1a; Interferon-beta; Interferon-beta-1a; Interferon-beta-1a, 44 microgram; Interferon-beta-1a, 66 microgram; Interleukin 2; Interleukin-2 (aldesleukin).; Iron; Iron Sucrose; Iron sucrose; Iron sulphate; Iron sulphate 200mg coated tablets; Iron supplement 300-600 mg/day; Iron(III)- hydroxide dextran complex; Itacitinib; JNJ-54781532 150 mg once daily; JNJ-54781532 25 mg once daily; JNJ-54781532 75 mg once daily; JNJ-54781532 75 mg twice daily; JNJ-54781532-AAD-10 mg; JNJ-54781532-AAD-30 mg; JNJ-54781532-AAD-5 mg; JNJ-66525433; K(D)PT; KHK4083; KRP203; KRP203A; Kamillenblüten 3ml/10ml; Kappaproct; KdPT; Kremezin; Kremezin®, Spherical Adsorptive Carbon; Kyo-Dophilus; Kümmel 2ml/10ml; L-Carnitine; L-Lysyl-D-Prolyl-L-Threonine Acetate; L-Lysyl-D-Prolyl-LThreonine acetate, lyophilisate; LC51-0255; LDP-02; LIXACOL; LOPERAMIDE; LT-02; LT-02 (modified-release PC pellets); LX1606; LY3074828; LYC-30937; LYC-30937-EC; LYS006; Lactated Ringers; Lactobacillus GG; Lactobacillus casei DG; Lactobacillus plantarum; Lactobacillus reuteri; Lactobacillus rhamnosus GG ATCC 53103; Lactobacillus salivarius UCC118; Lactobacilus acidophilus & bifidobacterium animalis/lactis; Lactose; Lactose in water; Leucine; Levocarnitine; Levocarnitine propyl hydrochloride; Linaclotide; Lixacol; Loperamide; Loperamide hydrochloride; Losartan; Low Dose Budesonide; Low FODMAP; Low dose; Low dose naltrexone; Lumbar puncture; Lysine; Lysine-D-Proline-Threonine; Lysine-D-proline-threonine; MATRICARIA FLOWER; MATRICARIA RECUTITA L. FLOS; MD-0901; MDX-1100; MDX-1100 (anti-CXCL10 human monoclonal antibody); MEDI7183 high dose; MEDI7183 low dose; MEDI7183 medium dose; MELISSAE FOLII DRY AQUEOUS EXTRACT; MENTHA × PIPERITA L. FOLIUM; MERCAPTOPURINE; MESALAZINA; MESALAZINE; MESENCHYMAL CELLS; MET-2; METHOTREXATE; METHOTREXATE DISODIUM; METHYLENE BLUE; METHYLPREDNISOLONE SODIUM HEMISUCCINATE; MEZAVANT; MIRIKIZUMAB; MK-8259; MLN0002; MLN0002 (Vedolizumab); MLN0002 SC; MLN002; MMX Mesalamine; MMX Mesalamine/Mesalazine; MMX Mesalamine/Mesalazine (High Dose); MMX Mesalamine/Mesalazine (Low Dose); MMX mesalamine/ mesalazine; MONOCLONAL ANTIBODY ANTI-IGG1; MSC; MTX; MTX 12.5; MTX 25; MYRRH; Magnesium; Magnesium citrate; Maltodextrin; Maltose; Mango; Mango polyphenolics; Mare´s milk; Matricaria Flower; Maximal oral 5ASA; Melatonin; Melissenblätter 15ml/10ml; Melitracen; Mercaptopurine; Mercaptopurine (Puri-Nethol); Mercaptopurine (Purinethol); Mesalamin; Mesalamine; Mesalamine Delayed Release Tablets 400mg; Mesalamine Enema; Mesalamine Granules; Mesalamine Once-Daily; Mesalamine Twice-Daily; Mesalamine granules; Mesalamine, 5-ASA; Mesalamine, 5-aminosalicylic acid [5-ASA]; Mesalazina; Mesalazine; Mesalazine (3,600 mg); Mesalazine (Asacol®); Mesalazine - TID 1000 mg; Mesalazine - TID 2x 500 mg; Mesalazine 1000 mg gastro-resistant tablets; Mesalazine 250Mg; Mesalazine 250Mg Tablet and nitazoxanide 500Mg Oral Tablet; Mesalazine 4G Enema; Mesalazine 500 mg gastro-resistant tablets (Salofa; Mesalazine 500 mg gastro-resistant tablets (Salofalk® 500 mg); Mesalazine Enema; Mesalazine enema; Mesalazine liquid enema; Mesalazine slow-release granules; Mesalazine tablet; Mesalazine with hydrocortisone sodium succinate; Mesalazinum; Mesenchymal Stromal Cells; Mesenchymal stromal cells; Methotrexate; Methotrexate bellon; Methotrexate bellon 25mg/ml; Methotrexate injection; Methylene blue; Methylene blue 25mg tablets; Methylprednisolone; Metoject; Metronidazole; Metronidazole capsule 50 mg; Mezavant; Mezavant 1200 mg magensaftresistente Retardtabletten; Mezavant Gastro-resistant, prolonged release tablets; Mezavant XL; Mezavant XL 1200 mg gastro-resistant prolonged release tablets; Mezavant XL 1200 mg gastro-resistant, prolonged release tablets; Mezavant XL 1200 mg gastro-resistant, prolonged release tablets.; Mezavant XL 1200mg gastro-resistant, prolonged release tablets; Mezavant XL Gastro-resistant, prolonged release tablets; Midazolam; Midazolam 2 mg; Mirikizumab; Mirikizumab IV; Mirikizumab SC; MitoQ; Modified Gegen Qinlian Decoction; Modified-release phosphatidylcholine; Mongersen; MultiStem; MultiStem high dose; MultiStem low dose; Multiple dose- Group B; Multiple dose-Group B; Multistem; Mycodigest supplement; Myrrh; Myrrhinil-Intest®; N.a.; NAND (Neoandrographolide); ND; NEORAL; NX-13 250 mg; Naltrexone; Nanocort; Neomycin; Neoral Soft Gelatin Capsules; Niclosamide; Nicolon; Nitazoxanide; Nitazoxanide 500Mg Oral Tablet; Nivolumab; Nolpitantium Besylate; Nolpitantium besylate; Non as of yet; None; None given; Normal Saline Enema; Null; Nutrition supplement; Nutritional dietary intervention; Nuvion®); OPC-6535; OPC-6535 Tablets (drug); OPC-6535(Tetomilast); OPRX-106; OPRX-106 (plant cells expressing TNFR-Fc) 2mg; OPRX-106 (plant cells expressing TNFR-Fc) 8mg; ORE1001; OSE-127; OST-122; Oats; Omeprazole; Omeprazole 20 mg; Ondansetron; Ondansetron hydrochloride dihydrate; Ontamalimab; Oral 5-ASA+/-topical 5-ASA+IV corticosteroids / PO Methylprednisolone; Oral Corticosteroids; Oral OKT3; Orencia; Originator (legacy) drug; Oseltamivir; Other: 0 mg; Other: 100% pomegranate juice; Other: Additional Therapies; Other: Control; Other: Control group(Normal saline); Other: Conventional drugs; Other: Faecal bacterial transplantation; Other: Fast Mimicking Diet; Other: Hyperbaric Oxygen Therapy; Other: Impact of biotherapy on postoperative morbidity in ulcerative colitis; Other: Intensify treatment with the existing drug; Other: Laboratory Biomarker Analysis; Other: Measurement of drug (Adalimumab/Infliximab); Other: Mesalazine; Other: Other Biologic Agents; Other: PENTASA (mesalamine/ 5-Aminosalicylic acid (5-ASA); Other: Saline; Other: Therapy Education; Other: Threonine; Other: Ulcerative Colitis Diet; Other: dietary intervention with no-carrageenan diet; Other: e-Monitoring; Other: pretreatment antibiotics; Overencapsulated Azathioprine (Imuran) 50 mg Tablet; Overencapsulated mesalazine tablets; Oxygen; Ozanimod; Ozanimod hydrochloride; PARNAPARIN SODIUM; PBF-677; PCT (PureCell Technologies Complex); PEG; PEG-liposomal prednisolone sodium phosphate; PF 06687234; PF-00547659; PF-00547659 SC Injection; PF-05230917; PF-05285401; PF-06480605; PF-06480605 100 mg/ml; PF-06651600; PF-06651600 10 mg; PF-06651600 50 mg; PF-06651600-15; PF-06687234; PF-06700841; PF-06700841 25 mg; PF-06700841 5 mg; PF-06700841-15; PF-06826647; PF-06826647 100 mg QD; PF-06826647 300 mg QD; PF-06826647 600 mg QD; PF-6826647 400 mg QD; PN-10884A; PN-943; PRD5973697; PREDNISOLONE; PREDNISOLONE SODIUM PHOSPHATE; PREDNISONE; PRIM-DJ2727; PRO145223; PRO145223 (RO5490261); PROPIONYL L-CARNITINE; PROPIONYL L-CARNITINE HYDROCHLORIDE; PRV-300; PS; PS-QD; PS-SP; PTG-100; PUR 0110; PUR 0110 Rectal Enema; PUR 0110 Rectal Enema 1000 mg; PUR 0110 Rectal Enema 250 mg; PUR 0110 Rectal Enema 500 mg; PV; Palmitoleic Acid; Palmitoleic acid; Parnaparin; Pending; Pentasa; Pentasa 2g sachet prolonged release granules (95%); Pentasa 500 mg Retardtabletten; Pentasa Compact 2g, granulate with prolonged release; Pentasa Compact 4g, granulate with prolonged release; Pentasa Sachet; Pentasa Sachet 1 g; Pentasa Sachet 1g; Pentasa Sachet 2 g; Pentasa enema; Pentasa prolonged release granules 2g; Pentasa sachet 1g; Pfefferminzblätter 1ml/10ml; Phosphate; Phosphatidylcholine; Photodynamic therapy with Gliolan; Picosulfate; Placebo; Polaprezinc; Polyethylene glycol; Polyphenon E®; Pomegranate; Prednisolon; Prednisolon Jenapharm; Prednisolone; Prednisolone Sodium Phosphate; Prednisolone Tablets B.P. 5mg; Prednisolone sodium metasulphobenzoate; Prednisone; Prefilled Syringe delivery of Golimumab; Previously referred to as MEDI2070 and AMG 139; Probiotic; Probiotic Formula Capsule; Probiotic Mixture; Probiotics; Procedure: Biopsies; Procedure: Blood sampling, endoscopy; Procedure: Colectomy; Procedure: Colonoscopy; Procedure: Colorectal biopsies; Procedure: Enema; Procedure: FMT; Procedure: Fecal microbiota transplantation; Procedure: Gastroscopy; Procedure: Hyperbaric oxygen; Procedure: Infusion of Saline; Procedure: Narrow Band Imaging; Procedure: Rectal dialysis; Procedure: Sham Hyperbaric Air; Procedure: Standardized FMT; Procedure: Stool samples; Procedure: colonoscopy; Procedure: lumbar puncture; Procedure: rectosigmoidoscopy; Procedure: sigmoidoscopy; Products containing aminosalicylate; Products containing azathioprine or 6-mercaptopurine; Proline; Promiten; Propionyl-L-Carnitine; Propionyl-L-carnitine; Propionylcarnitinhydrochlorid; Psyllium; Psyllium Husk Powder; Psyllium husk; Puri-Nethol; QBECO SSI; RAVAGALIMAB; RDP58; RECTABUL2mg rectal form; REMICADE; REMSIMA - 100 MG POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLANCONCINO (VETRO) - 1 FLACONCINO; RIBOFLAVIN; RISANKIZUMAB; RO5490261 / F02; RO5490261/F02; RO5490261/F04-02; RO7049665; RO7246311; ROSUVASTATIN CALCIUM; RPC1063; RTNV148B IgG; Raspberry; Ravagalimab; Rebamipide; Recombinant Factor XIII (rFXIII); Rectal dialysis; Rectal tacrolimus; Regular treatment; Remestemcel-L; Remicade; Remicade (infliximab); Remicade 100 mg infuusiokuiva-aine, konsentraattiliuosta varten; Remicade 100 mg powder for concentrate for solution for infusion.; Remicade 100 mg pulver til konsentrat til infusjonsvæske, oppløsning; Remsima; Remsima (CT-P13); Remsima (infliximab); Remsima 100 mg pulver til konsentrat til infusjonsvæske, oppløsning; Remsima and Inflectra; Retarded Release Phosphatidylcholine (rPC); Retarded release phosphatidylcholine; RhIL-11; RhuMAb Beta7; RhuMAb Beta7, Anti Beta 7, PRO145223; RhuMAb Beta7, Anti Beta7, PRO145223; RhuMab Beta7, Anti Beta7, PRO145223; Riboflavin; Rifaximin; Risankizumab; Risankizumab (Genetical Recombination); Risankizumab IV; Risankizumab SC; Rituximab; Rivenprost; Rivenprost (drug); Ro 549-0261/F04; Rosiglitazone; Rosuvastatin; Rosuvastatine EG; SANDINUM; SAR339658; SB-656933; SB-656933 Tablets; SB012; SB5; SC12267; SC12267 (4SC-101); SCH 900050; SER-287; SF257 C59; SHINGRIX; SHP647; SHR0302; SIMPONI; SODIUM HYALURONATE; SOYBEAN PHOSPHATIDYLCHOLINE; SPD476; SPD476 (mesalazine); SPD476 is a polymeric matrix formulation that displays both delayed- and extended-release of mesalazine; SPESOLIMAB; SR140333B; SRT2104; ST 261; ST-0529; ST10-021; ST261; STELARA®; STNM01; STNM01 1.84 mg; STW5-II; STW5-II (Iberogast N, BAY98-7410); SUSPENSION CONTAINING 7500 EMBRYONATED VIABLE TRICHURIS SUIS OVA/15ML; Salicylic acid; Saline; Salmon; Salofalk; Salofalk 1000mg Granu-Stix; Salofalk 1000mg Granu-Stix®; Salofalk 1000mg Granu-stix®; Salofalk 3g gastro-resistant prolonged-release granules; Salofalk 4g/60ml Klysma; Salofalk Granu-Stix 500 mg; Salofalk® 1000mg Granu-Stix®; Salofalk® 500 mg gastro-resistant tablet; Salofalk® 500 mg tablets; Salofalk® 500mg; Salofalk® 500mg Granu-Stix®; Sandimmum; Sandimmun; Sandimmun 50 mg/ml, infuusiokonsentraatti; Sandimmun Neoral; Semi-vegetarian diet; Serum bovine immunoglobulin; Shingrix; Simponi; Simponi (Golimumab); Simponi®; Simponi® (Golimumab); Simulect; Single dose-group A; Smartject Device delivery of Golimumab; Smoking cigarettes; Smoking of cannabis; Sodium Picosulfate/Magnesium Citrate Laxative; Solu-Medrol; Solu-medrol; Sotrastaurin; Sotrastaurin (INN) acetate; Soybean; Spesolimab; Spesolimab IV infusion; Spesolimab SC solution for injection; Standard 2 hours-infusion; Standard Therapy; Standardized FODMAP; Standardized anthocyanin-rich extract; Stasis; Stelara; Sterile saline for injection; Steroids; Sucrose; Sugar Extract; Sulphsalazine, Pentasa, Asacol, Colazide, Depentum; Suspension de microbiote fécal; Synergy-1; Synergy1; Sübetaholzwurzel 1ml/10ml; Süßholzwurzel 1ml/10ml; TA-650; TA-650 (Infliximab); TD-1473; TD-1473 Dose A; TD-1473 Dose B; TD-1473 Dose C; TD-3504; THRX-139060; TJ301 300mg; TJ301 600mg; TOFACITINIB; TOP1288; TOP1288 Rectal solution; TOP1288 rectal solution; TP05; TP05 Coating A; TP05 Coating B; TP05 Coating D; TP05 Coating E; TP05 Coating H; TREMFYA®; TSO; Tacrolimus; Tauroursoursodeoxycholic acid, brand name Tudcabil; Telotristat; Telotristat Etiprate; Telotristat etiprate; Terbinafine; Tetomilast; Tetracycline; Thalidomide; Thalidomide Pharmion; Threonine; To be confirmed; To be requested; Tofacitinib; Tofacitinib citrate; Tofacitinib citrate (Phase III Formulation); Tofacitinib citrate (Proposed commercial formulation - debossed); Tofacitinib citrate (Proposed commercial formulation – debossed); Tofacitinib citrate (Proposed commercialFormulation - debossed); Tofacitinib citrate (clinical trial image); Traditional treatments; Tralokinumab; Treatment Algorithm A; Treatment Algorithm B; Treatment Algorithm C; Tremfya; Trexan; Trexan inj 25 mg/ml; Trichuris suis eggs; Trichuris suis ova; Trichuris suis ova (TSO); Tris; UCB4940; UCMSC group; UDCA; UR-12746-S; USTEKINUMAB; UTTR1147A; UTTR1147A, IL22-Fc, IL-22Fc; UTTR1147A/RO7021610 (Active); Umbilical Cord Mesenchymal Stem Cells; Unknown; Upadacitinib; Upadacitinib (ABT-494); Upadacitinib - Direct compression-yellow; Upadacitinib - Wet Granulation-Yellow; Upadacitinib -Direct compression-yellow; Updacitinib (ABT-494); Urbason; Ursodeoxycholic acid; Ursodiol; Ursodiol (ursodeoxycholic acid, UDCA); Ursofalk; Ustekinumab; Ustekinumab Dose Based on BSA and Body Weight; Ustekinumab IV; Ustekinumab IV Infusion; Ustekinumab SC; Ustekinumab SC Injection; Usual current care; V565; VB-201; VB-201 160mg; VEDOLIZUMAB; VSL#3; VSL#3 (Original De Simone formulation); VSL#3®; Vaccine Vivotif + Vaccine Dukoral; Vaccine Vivotif + Vaccine Dukoral + oats; Valganciclovir; Vaminolac; Vaminolac, komb.; Vamorolone; Vamorolone 4% suspension for oral dosing; Vancomycin; Vancomycin Pre-Treat; Vancomycin Pre-Treatment; Vatelizumab; Vedolizumab; Vedolizumab 108 mg SC; Vedolizumab 300 mg; Vedolizumab 300 mg IV; Vedolizumab IV; Vedolizumab IV, Placebo IV, Placebo SC; Vedolizumab IV, Placebo SC; Vedolizumab Injection; Vedolizumab Intravenous (IV), Vedolizumab Subcutaneous (SC), Placebo IV; Vedolizumab SC; Vedolizumab SC 108 mg; Vedolizumab intravenous injection; Vedolizumab subcutaneous injection; Vidofludimus; Vidofludimus calcium; Vidofludimus calcium dihydrate; Vigantol; Vigantol Oel; Vigantol Oel TM; Visilizumab; Visilizumab (HuM291; Visilizumab (Nuvion); Visilizumab (Nuvion®; Vitamin B2; Vitamin D; Vitamin D drops; Vitamin D3; Vitamin E; Vitamin E 800IU; Vitamin K; Vitamin K 10 mg; Vivotif; Warfarin; Warfarin 10 mg; Water; Wharton Jelly Mesenchymal stem cells; XELJANZ; Xeljanz; Xeljanz 5 mg film-coated tablets; Xeljanz 5mg film-coated tablets; Z-206; Zessly; Zoenasa-1:4; [124I]IB PF 06687234; [14C]-RPC1063 Solution (0.1 mg/mL) for Oral Administration; [18F]FSPG; [BI 655130]; [CC-10004]; [N/A]

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	EUCTR2019-004224-38-HU (EUCTR)	30/12/2020	22/10/2020	A Clinical Study of the Efficacy, Safety and Pharmacokinetics of Ustekinumab as Intravenous Induction Treatment Followed by Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis	A Phase 3 Study of the Efficacy, Safety and Pharmacokinetics of Ustekinumab as Open-label Intravenous Induction Treatment Followed by Randomized Double-blind Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis - UNIFI-Jr	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: STELARA ® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB Trade Name: STELARA ® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB Trade Name: STELARA ® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB	Janssen-Cilag International NV	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	90	Phase 3	United States;Hungary;Poland;Belgium;Russian Federation;Germany;United Kingdom;Japan
2	EUCTR2020-001398-59-HR (EUCTR)	02/12/2020	07/12/2020	Clinical trial to evaluate the efficacy and the safety of OSE-127 versus placebo in subjects with ulcerative colitis who have failed or are intolerant to previous treatment(s)	Randomized, double-blind, Phase 2 study to evaluate the efficacy and the safety of OSE-127 versus placebo in subjects with moderate to severe active ulcerative colitis who have failed or are intolerant to previous treatment(s)	Moderate to severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: OSE-127 Product Code: OSE-127 INN or Proposed INN: AS INN Other descriptive name: humanized recombinant IgG4 monoclonal antibody against CD-127	OSE Immunotherapeutics	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	150	Phase 2	Belarus;Serbia;Ukraine;Lithuania;Russian Federation;France;Hungary;Belgium;Poland;Croatia;Bulgaria;Georgia;Latvia
3	EUCTR2019-002698-74-GB (EUCTR)	17/11/2020	30/03/2020	A study to evaluate the efficacy and safety of PF 06480605 in adult participants with moderate to severe ulcerative colitis	A PHASE 2B, MULTICENTER, RANDOMIZED, DOUBLEBLIND,PLACEBO CONTROLLED DOSE-RANGINGSTUDY TO EVALUATE THE EFFICACY, SAFETY, ANDPHARMACOKINETICS OF PF-06480605 IN ADULTPARTICIPANTS WITH MODERATE TO SEVEREULCERATIVE COLITIS - Tuscany 2	A phase 2b randomised, double-blind, placebo controlled dose-ranging study in Adults with Moderate to Severe Ulcerative Colitis MedDRA version: 20.0;Level: HLT;Classification code 10009888;Term: Colitis (excl infective);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: PF-06480605 Product Code: PF-06480605 INN or Proposed INN: PF-06480605 Other descriptive name: Anti-TL1A	Pfizer Inc	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	240	Phase 2	United States;Serbia;Slovakia;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;India;France;Hungary;Mexico;Canada;Poland;Belgium;Romania;Australia;South Africa;Bulgaria;Germany;China;Japan
4	EUCTR2020-004391-18-FR (EUCTR)	28/10/2020	14/09/2020	IMPACT OF ANTI-TNF, VEDOLIZUMAB AND TOFACITINIB ON AORTIC STIFFNESS, CAROTID INTIMA-MEDIA THICKNESS AND CARDIOVASCULAR RISK OF PATIENTS WITH ULCERATIVE COLITIS	IMPACT OF ANTI-TNF, VEDOLIZUMAB AND TOFACITINIB ON AORTIC STIFFNESS, CAROTID INTIMA-MEDIA THICKNESS AND CARDIOVASCULAR RISK OF PATIENTS WITH ULCERATIVE COLITIS - VASC-UC	ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Inflectra 100 mg Product Name: Inflectra 100 mg Trade Name: AMGEVITA Product Name: AMGEVITA Trade Name: Simponi Product Name: Simponi Trade Name: Entyvio 300 mg Product Name: Entyvio 300 mg Trade Name: XELJANZ Product Name: XELJANZ	CHU Amiens-Picardie	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	100	Phase 4	France
5	EUCTR2020-002695-12-NL (EUCTR)	14/10/2020	02/09/2020	Treatment of refractory pouchitis with tofacitinib	Tofacitinib in the treatment of chronic, recurrent and/or antibiotic refractory pouchitis: a multi-omics approach - TOFA-Pouchitis	Chronic, recurrent and/or antibiotic refractory pouchitis in patients with ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Xeljanz 5mg film-coated tablets	Amsterdam UMC, location AMC	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	12	Phase 2	Netherlands
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
6	EUCTR2020-001398-59-BG (EUCTR)	13/10/2020	18/09/2020	Clinical trial to evaluate the efficacy and the safety of OSE-127 versus placebo in subjects with ulcerative colitis who have failed or are intolerant to previous treatment(s)	Randomized, double-blind, Phase 2 study to evaluate the efficacy and the safety of OSE-127 versus placebo in subjects with moderate to severe active ulcerative colitis who have failed or are intolerant to previous treatment(s)	Moderate to severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: OSE-127 Product Code: OSE-127 INN or Proposed INN: OSE-127 Other descriptive name: humanized recombinant IgG4 monoclonal antibody against CD-127	OSE Immunotherapeutics	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	150	Phase 2	Belarus;Serbia;Ukraine;Lithuania;Russian Federation;France;Hungary;Belgium;Poland;Croatia;Bulgaria;Georgia;Latvia
7	EUCTR2020-000047-31-FR (EUCTR)	07/10/2020	13/05/2020	A study of AMT-101 in patients with Ulcerative Colitis.	A Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter, Phase 2a Study of the Efficacy and Safety of Oral AMT-101 in Subjects with Moderate to Severe Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: AMT -101 INN or Proposed INN: Not yet assigned Other descriptive name: AMT -101	Applied Molecular Transport Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	102	Phase 2	United States;Serbia;Belarus;Spain;Ukraine;Russian Federation;United Kingdom;Switzerland;Italy;India;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Kazakhstan;Bulgaria;Georgia;Netherlands;Germany;Moldova, Republic of
8	NCT04535882 (ClinicalTrials.gov)	October 1, 2020	28/8/2020	Effectiveness of Serum Leucine-rich Alpha-2 Glycoprotein Levels on IBD	Association Between Serum Leucine-rich Alpha-2 Glycoprotein Levels and Endoscopic Activity of Ulcerative Colitis or Crohn's Disease Colitis	LRG Levels	Diagnostic Test: serum leucine-rich alpha-2 glycoprotein (LRG) levels	Showa Inan General Hospital	NULL	Recruiting	N/A	N/A	All	100		Japan
9	EUCTR2020-001398-59-LV (EUCTR)	21/09/2020	28/07/2020	Clinical trial to evaluate the efficacy and the safety of OSE-127 versus placebo in subjects with ulcerative colitis who have failed or are intolerant to previous treatment(s)	Randomized, double-blind, Phase 2 study to evaluate the efficacy and the safety of OSE-127 versus placebo in subjects with moderate to severe active ulcerative colitis who have failed or are intolerant to previous treatment(s)	Moderate to severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: OSE-127 Product Code: OSE-127 Other descriptive name: humanized recombinant IgG4 monoclonal antibody against CD-127	OSE Immunotherapeutics	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	150	Phase 2	Belarus;Serbia;Ukraine;Lithuania;Russian Federation;France;Hungary;Belgium;Poland;Croatia;Bulgaria;Georgia;Latvia
10	EUCTR2020-000047-31-HU (EUCTR)	09/09/2020	07/07/2020	A study of AMT-101 in patients with Ulcerative Colitis.	A Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter, Phase 2a Study of the Efficacy and Safety of Oral AMT-101 in Subjects with Moderate to Severe Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: AMT -101 INN or Proposed INN: Not yet assigned Other descriptive name: AMT -101	Applied Molecular Transport Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	102	Phase 2	United States;Serbia;Belarus;Spain;Ukraine;Russian Federation;United Kingdom;Switzerland;Italy;India;France;Hungary;Canada;Poland;Belgium;Romania;Kazakhstan;Bulgaria;Georgia;Germany;Netherlands;Moldova, Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
11	EUCTR2019-002698-74-DE (EUCTR)	08/09/2020	21/02/2020	A study to evaluate the efficacy and safety of PF 06480605 in adult participants with moderate to severe ulcerative colitis	A PHASE 2B, MULTICENTER, RANDOMIZED, DOUBLEBLIND,PLACEBO CONTROLLED DOSE-RANGINGSTUDY TO EVALUATE THE EFFICACY, SAFETY, ANDPHARMACOKINETICS OF PF-06480605 IN ADULTPARTICIPANTS WITH MODERATE TO SEVEREULCERATIVE COLITIS - Tuscany 2	A phase 2b randomised, double-blind, placebo controlled dose-ranging study in Adults with Moderate to Severe Ulcerative Colitis MedDRA version: 20.0;Level: HLT;Classification code 10009888;Term: Colitis (excl infective);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: PF-06480605 Product Code: PF-06480605 INN or Proposed INN: PF-06480605 Other descriptive name: Anti-TL1A	Pfizer Inc	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	240	Phase 2	United States;Serbia;Slovakia;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;India;France;Hungary;Mexico;Canada;Poland;Belgium;Romania;Australia;South Africa;Bulgaria;Germany;China;Japan
12	EUCTR2019-004652-11-SI (EUCTR)	28/08/2020	31/08/2020	A Study of Etrolizumab-Based Induction Therapy Combinations Followed by Etrolizumab Maintenance Therapy in Patients with Moderate-To-Severe Ulcerative Colitis	RANDOMIZED, OPEN-LABEL PHASE 3B STUDY OF ETROLIZUMAB BASED INDUCTION THERAPY COMBINATIONS FOLLOWED BY ETROLIZUMAB MAINTENANCE THERAPY IN PATIENTS WITH MODERATE-TO-SEVERE ULCERATIVE COLITIS - Lantana	Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrolizumab Product Code: RO5490261/F04-02 INN or Proposed INN: Etrolizumab Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223 Trade Name: Remicade INN or Proposed INN: INFLIXIMAB Other descriptive name: INFLIXIMAB Trade Name: Xeljanz INN or Proposed INN: TOFACITINIB Other descriptive name: TOFACITINIB Trade Name: Xeljanz INN or Proposed INN: TOFACITINIB Other descriptive name: TOFACITINIB Trade Name: Stelara INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB Trade Name: Stelara INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	372	Phase 3	Serbia;United States;Slovakia;Spain;Ukraine;Ireland;Israel;Russian Federation;Italy;Switzerland;France;Latvia;Netherlands;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Brazil;Belgium;Poland;Germany
13	NCT04576000 (ClinicalTrials.gov)	August 25, 2020	17/9/2020	Identification of Biomarkers of Tofacitinib Therapy in Patients With Ulcerative Colitis	PhaRmacOkinetics and PHarmacodynamic BiomarkErs of TofacItinib Therapy in Patients With Ulcerative Colitis (PROPHETIC)	Ulcerative Colitis	Drug: Tofacitinib	Robarts Clinical Trials Inc.	NULL	Recruiting	18 Years	N/A	All	100		United States;Belgium;Canada;Italy;Netherlands;Spain
14	EUCTR2018-000930-37-HU (EUCTR)	17/08/2020	24/06/2020	A Study to Investigate safety and how well Ravagalimab (ABBV-323) works and how safe it is in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy	A Multicenter, Single-Arm, Open-Label Study to Investigate the Efficacy and Safety of Ravagalimab (ABBV-323) in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Ravagalimab Product Code: ABBV-323 Other descriptive name: ABBV-323	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	40	Phase 2	United States;France;Hungary;Canada;Spain;Netherlands;Germany;United Kingdom;Italy;Korea, Republic of
15	EUCTR2019-003999-39-NO (EUCTR)	17/08/2020	29/04/2020	A placebo-controlled study followed by an open label treatment to evaluate the safety and efficacy of PF-06826647 in participants with moderate to severe ulcerative colitis	A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP, PLACEBO-CONTROLLED STUDY WITH AN OPEN LABEL EXTENSION TO EVALUATE THE SAFETY AND EFFICACY OF PF-06826647 IN PARTICIPANTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	moderate to severe ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: PF-06826647 Product Code: PF-06826647 INN or Proposed INN: PF-06826647	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	202	Phase 2	United States;United Arab Emirates;Qatar;Saudi Arabia;Hong Kong;Slovakia;Morocco;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Italy;India;France;Macedonia, the former Yugoslav Republic of;Puerto Rico;Jordan;Malaysia;Australia;Tunisia;China;Bosnia and Herzegovina;Oman;Turkey;United Kingdom;Czech Republic;Armenia;Mexico;Brazil;Belgium;Poland;Romania;Croatia;Georgia;Germany;Norway
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
16	EUCTR2019-004469-41-DE (EUCTR)	11/08/2020	26/03/2020	A trial to investigate the safety and efficacy of PN-943 in patients with moderate or severe Ulcerative Colitis (a long-term condition where the colon and rectum become inflamed)	A Phase 2 Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center Study to Evaluate the Safety and Efficacy of Oral PN-943 in Subjects with Moderate to Severe Active Ulcerative Colitis	Ulcerative colitis (US) is a chronic relapsing inflammatory bowel disease of the large intestine characterized by bloody diarrhoea, abdominal cramps and fatigue. UC is characterized by inflammation and ulceration of mainly the mucosal and occasionally submucosal intestinal layers. MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: PN-943 Other descriptive name: PN-943 Product Code: PN-943 Other descriptive name: PN-943	Protagonist Therapeutics, Inc	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	150	Phase 2	Serbia;United States;Ukraine;Austria;Russian Federation;Italy;Hungary;Canada;Poland;Bulgaria;Georgia;Germany;Korea, Republic of
17	EUCTR2019-004469-41-BG (EUCTR)	11/08/2020	27/04/2020	A trial to investigate the safety and efficacy of PN-943 in patients with moderate or severe Ulcerative Colitis (a long-term condition where the colon and rectum become inflamed)	A Phase 2 Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center Study to Evaluate the Safety and Efficacy of Oral PN-943 in Subjects with Moderate to Severe Active Ulcerative Colitis	Ulcerative colitis (US) is a chronic relapsing inflammatory bowel disease of the large intestine characterized by bloody diarrhoea, abdominal cramps and fatigue. UC is characterized by inflammation and ulceration of mainly the mucosal and occasionally submucosal intestinal layers. MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: PN-943 Other descriptive name: PN-943 Product Code: PN-943 Other descriptive name: PN-943	Protagonist Therapeutics, Inc	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	150	Phase 2	Serbia;United States;Ukraine;Austria;Russian Federation;Italy;Hungary;Canada;Poland;Bulgaria;Georgia;Germany;Korea, Republic of
18	EUCTR2020-000047-31-GB (EUCTR)	03/08/2020	20/04/2020	A study of AMT-101 in patients with Ulcerative Colitis.	A Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter, Phase 2a Study of the Efficacy and Safety of Oral AMT-101 in Subjects with Moderate to Severe Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: AMT -101 INN or Proposed INN: Not yet assigned Other descriptive name: AMT -101	Applied Molecular Transport Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	102	Phase 2	Serbia;United States;Belarus;Spain;Ukraine;Russian Federation;Italy;United Kingdom;Switzerland;India;France;Hungary;Canada;Poland;Romania;Kazakhstan;Bulgaria;Georgia;Germany;Moldova, Republic of
19	EUCTR2019-003596-19-DE (EUCTR)	29/07/2020	29/07/2020	A Three-Arm, Randomized, Placebo-Controlled, Double-Blind Phase 3 Study to Evaluate the Safety and Efficacy of Once-Daily and Twice-Daily Dosing of a Novel Hydrocortisone Acetate 90 mg Suppository Formulation Administered with the Sephure® Suppository Applicator in Subjects with Ulcerative Colitis of the Rectum.	A Three-Arm, Randomized, Placebo-Controlled, Double-Blind Phase 3 Study to Evaluate the Safety and Efficacy of Once-Daily and Twice-Daily Dosing of a Novel Hydrocortisone Acetate 90 mg Suppository Formulation Administered with the Sephure® Suppository Applicator in Subjects with Ulcerative Colitis of the Rectum. - cessa	Ulcerative Colitis of the Rectum MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;Level: HLT;Classification code 10027682;Term: Immune and associated conditions NEC;System Organ Class: 10021428 - Immune system disorders MedDRA version: 20.0;Level: SOC;Classification code 10021428;Term: Immune system disorders;Level: HLGT;Classification code 10027665;Term: Immune disorders NEC;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: 90 mg hydrocortisone acetate suppository with Sephure suppository applicator INN or Proposed INN: HYDROCORTISONE ACETATE	Cristcot HCA LLC	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	618	Phase 3	United States;Philippines;Hong Kong;Spain;Poland;Ukraine;Romania;Russian Federation;Germany;Italy;India
20	EUCTR2019-004469-41-AT (EUCTR)	27/07/2020	26/03/2020	A trial to investigate the safety and efficacy of PN-943 in patients with moderate or severe Ulcerative Colitis (a long-term condition where the colon and rectum become inflamed)	A Phase 2 Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center Study to Evaluate the Safety and Efficacy of Oral PN-943 in Subjects with Moderate to Severe Active Ulcerative Colitis	Ulcerative colitis (US) is a chronic relapsing inflammatory bowel disease of the large intestine characterized by bloody diarrhoea, abdominal cramps and fatigue. UC is characterized by inflammation and ulceration of mainly the mucosal and occasionally submucosal intestinal layers. MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: PN-943 Other descriptive name: PN-943 Product Code: PN-943 Other descriptive name: PN-943	Protagonist Therapeutics, Inc	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	150	Phase 2	Serbia;United States;Ukraine;Austria;Russian Federation;Italy;Hungary;Canada;Poland;Bulgaria;Georgia;Germany;Korea, Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
21	EUCTR2019-002485-12-GB (EUCTR)	14/07/2020	30/03/2020	Determination of the Optimal Treatment Target in Ulcerative Colitis	VERDICT: In actiVE ulcerative colitis, a RanDomIzed Controlled Trial for determination of the optimal treatment target - VERDICT	Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Entyvio INN or Proposed INN: vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio INN or Proposed INN: vedolizumab Other descriptive name: VEDOLIZUMAB	Alimentiv Inc. (formerly Robarts Clinical Trials)	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	660	Phase 4	France;Belarus;United States;Canada;Poland;Belgium;Ukraine;Russian Federation;Netherlands;Italy;United Kingdom
22	EUCTR2018-004694-27-FR (EUCTR)	06/07/2020	10/04/2020	Safety and Efficacy of BMS-986165 Compared with Placebo in Subjects with Ulcerative Colitis	A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: BMS-986165 Product Code: BMS-986165 INN or Proposed INN: BMS-986165 Other descriptive name: BMS986165	Bristol-Myers Squibb International Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	120	Phase 2	United States;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Australia;Germany;Japan;Korea, Republic of
23	EUCTR2018-004002-25-NL (EUCTR)	06/07/2020	17/09/2019	A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis	A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis - QUASAR	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab	Janssen-Cilag International NV	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	950	Phase 2;Phase 3	Poland;Romania;Bulgaria;Germany;Japan;Sweden;United States;Portugal;Taiwan;Spain;Ukraine;Israel;Russian Federation;Italy;France;Australia;Netherlands;China;Korea, Republic of;Czechia;Turkey;United Kingdom;Hungary;Canada;Argentina;Brazil;Belgium
24	EUCTR2018-003986-33-PT (EUCTR)	06/07/2020	28/10/2019	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis	A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	330	Phase 3	United States;Serbia;Belarus;Portugal;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany
25	EUCTR2017-004092-31-AT (EUCTR)	02/07/2020	20/09/2019	A study of the efficacy and safety of Mirikizumab in Ulcerative Colitis	I6T-MC-AMAPA Phase 3, Multicenter, Open-Label Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients with Moderately toSeverely Active Ulcerative Colitis (LUCENT 3) - LUCENT 3	moderately to severely active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: mirikizumab Other descriptive name: MIRIKIZUMAB	Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	840	Phase 3	United States;Serbia;Taiwan;Saudi Arabia;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Netherlands;Latvia;China;Moldova, Republic of;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Germany;Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
26	NCT04209556 (ClinicalTrials.gov)	June 30, 2020	1/12/2019	A Study To Evaluate The Safety And Efficacy Of PF-06826647 In Participants With Moderate To Severe Ulcerative Colitis	A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP, PLACEBO-CONTROLLED STUDY WITH AN OPEN LABEL EXTENSION TO EVALUATE THE SAFETY AND EFFICACY OF PF-06826647 IN PARTICIPANTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Ulcerative Colitis	Drug: PF-06826647 100 mg QD;Drug: PF-06826647 300 mg QD;Drug: PF-06826647 600 mg QD;Drug: Placebo;Drug: PF-6826647 400 mg QD	Pfizer	NULL	Recruiting	18 Years	75 Years	All	202	Phase 2	United States
27	EUCTR2019-003334-16-DE (EUCTR)	26/06/2020	05/05/2020	Novel budenosid suppository in addition to basic therapy with oral mesalazine compared to basic therapy alone for treatment of ulcerative colitis	Randomised, double-blind, placebo-controlled, multicentre study to compare the efficacy and safety of novel 4 mg budesonide suppository in combination with oral mesalazine versus oral mesalazine monotherapy in patients with acute ulcerative colitis	acute ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Budenofalk® suppositories INN or Proposed INN: BUDESONIDE Other descriptive name: Budenofalk® suppositories (BUS) Trade Name: Salofalk 3g gastro-resistant prolonged-release granules Product Name: Salofalk 3g gastro-resistant prolonged-release granules INN or Proposed INN: MESALAZINE	Dr. Falk Pharma GmbH	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	360	Phase 3	Belarus;Poland;Ukraine;Russian Federation;Bulgaria;Latvia;Germany
28	EUCTR2018-003987-29-FR (EUCTR)	11/06/2020	12/09/2019	An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis	An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	702	Phase 3	United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan
29	EUCTR2019-003849-15-HR (EUCTR)	05/06/2020	20/11/2020	Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) asmaintenance therapy in patients with Ulcerative Colitis	A Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients with Moderately to Severely Active Ulcerative Colitis	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Remsima Product Code: Remsima (CT-P13) INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB	Celltrion, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	615	Phase 3	United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Italy;France;Peru;South Africa;Latvia;Moldova, Republic of;Czechia;Turkey;Austria;Hungary;Mexico;Brazil;Poland;Croatia;Bulgaria;Germany
30	EUCTR2019-002698-74-BE (EUCTR)	03/06/2020	02/04/2020	A study to evaluate the efficacy and safety of PF 06480605 in adult participants with moderate to severe ulcerative colitis	A PHASE 2B, MULTICENTER, RANDOMIZED, DOUBLEBLIND,PLACEBO CONTROLLED DOSE-RANGINGSTUDY TO EVALUATE THE EFFICACY, SAFETY, ANDPHARMACOKINETICS OF PF-06480605 IN ADULTPARTICIPANTS WITH MODERATE TO SEVEREULCERATIVE COLITIS - Tuscany 2	A phase 2b randomised, double-blind, placebo controlled dose-ranging study in Adults with Moderate to Severe Ulcerative Colitis MedDRA version: 20.0;Level: HLT;Classification code 10009888;Term: Colitis (excl infective);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: PF-06480605 Product Code: PF-06480605 INN or Proposed INN: PF-06480605 Other descriptive name: Anti-TL1A	Pfizer Inc	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	240	Phase 2	United States;Serbia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Australia;South Africa;China;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
31	EUCTR2019-002698-74-FR (EUCTR)	20/05/2020	24/01/2020	A study to evaluate the efficacy and safety of PF 06480605 in adult participants with moderate to severe ulcerative colitis	A PHASE 2B, MULTICENTER, RANDOMIZED, DOUBLEBLIND,PLACEBO CONTROLLED DOSE-RANGINGSTUDY TO EVALUATE THE EFFICACY, SAFETY, ANDPHARMACOKINETICS OF PF-06480605 IN ADULTPARTICIPANTS WITH MODERATE TO SEVEREULCERATIVE COLITIS - Tuscany 2	A phase 2b randomised, double-blind, placebo controlled dose-ranging study in Adults with Moderate to Severe Ulcerative Colitis MedDRA version: 20.0;Level: HLT;Classification code 10009888;Term: Colitis (excl infective);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: PF-06480605 Product Code: PF-06480605 INN or Proposed INN: PF-06480605 Other descriptive name: Anti-TL1A	Pfizer Inc	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	240	Phase 2	United States;Serbia;Slovakia;Spain;Ukraine;Turkey;Austria;Russian Federation;Israel;Italy;India;France;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Germany;Japan;China
32	EUCTR2019-000733-39-FR (EUCTR)	14/05/2020	20/02/2020	Open-label maintenance therapy in moderate to severe Ulcerative Colitis patients	A phase 2b, open-label, efficacy and safety study of ABX464 as maintenance therapy in patients with moderate to severe Ulcerative Colitis.	Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464	ABIVAX	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	232	Phase 2	Belarus;Serbia;Slovenia;Slovakia;Spain;Ukraine;Ireland;Austria;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Netherlands
33	EUCTR2018-004002-25-BG (EUCTR)	13/05/2020	24/02/2020	A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis	A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis - QUASAR	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: GUSELKUMAB Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab	Janssen-Cilag International NV	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	950	Phase 2;Phase 3	United States;Portugal;Taiwan;Spain;Ukraine;Israel;Russian Federation;Italy;France;Malaysia;Australia;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden
34	EUCTR2019-003849-15-ES (EUCTR)	12/05/2020	28/02/2020	Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) asmaintenance therapy in patients with Ulcerative Colitis	A Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients with Moderately to Severely Active Ulcerative Colitis	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Remsima Product Code: Remsima (CT-P13) INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB	Celltrion, Inc.	NULL	Not Recruiting			Female: yes Male: yes	615	Phase 3	United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Italy;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Hungary;Czech Republic;Mexico;Brazil;Poland;Croatia;Bulgaria;Germany
35	EUCTR2019-003113-34-NO (EUCTR)	04/05/2020	21/01/2020	Ulcerative colitis	A randomized, multi-center, subject and investigator blinded, placebo controlled, parallel group study to assess the efficacy, safety and tolerability of LYS006 in patients with mild to moderate ulcerative colitis - NA	Mild to moderate ulcerative colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: LYS006 Product Code: LYS006 INN or Proposed INN: not yet defined Other descriptive name: LYS006	Novartis Pharma AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	45	Phase 2	United States;Hungary;Czech Republic;Poland;Russian Federation;Bulgaria;Germany;Norway
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
36	EUCTR2019-003780-21-NL (EUCTR)	04/05/2020	21/02/2020	An investigation of tofacitinib in patients with ulcerative colitis	Pharmacokinetics and Pharmacodynamic Biomarkers of Tofacitinib Therapy in Patients with Ulcerative Colitis (PROPHETIC Study)	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: XELJANZ Product Name: XELJANZ INN or Proposed INN: TOFACITINIB	Robarts Clinical Trials	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	100	Phase 4	United States;Canada;Spain;Belgium;Netherlands;Italy
37	EUCTR2018-003278-28-BG (EUCTR)	22/04/2020	23/05/2019	Safety, tolerability, efficacy and dose-response of GSK2831781 in ulcerative colitis.	A multicentre randomized, double-blind, placebo-controlled Phase 2 study to evaluate the safety, tolerability, efficacy, dose-response, pharmacokinetics and pharmacodynamics of repeat dosing of an anti-LAG3 cell depleting monoclonal antibody (GSK2831781) in patients with active ulcerative colitis	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: GSK2831781 INN or Proposed INN: Not Assigned Other descriptive name: GSK2831781	GlaxoSmithKline Research & Development Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	320	Phase 2	United States;Serbia;Czechia;Estonia;Slovakia;Ukraine;Russian Federation;United Kingdom;India;France;Czech Republic;Hungary;Mexico;Canada;Poland;South Africa;Bulgaria;Netherlands;Japan;Korea, Republic of
38	EUCTR2019-000733-39-GB (EUCTR)	16/04/2020	31/01/2020	Open-label maintenance therapy in moderate to severe Ulcerative Colitis patients	A phase 2b, open-label, efficacy and safety study of ABX464 as maintenance therapy in patients with moderate to severe Ulcerative Colitis.	Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464	ABIVAX	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	244	Phase 2	Belarus;Serbia;Slovakia;Slovenia;Spain;Ukraine;Austria;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany
39	EUCTR2019-002698-74-HU (EUCTR)	15/04/2020	20/04/2020	A study to evaluate the efficacy and safety of PF 06480605 in adult participants with moderate to severe ulcerative colitis	A PHASE 2B, MULTICENTER, RANDOMIZED, DOUBLEBLIND,PLACEBO CONTROLLED DOSE-RANGINGSTUDY TO EVALUATE THE EFFICACY, SAFETY, ANDPHARMACOKINETICS OF PF-06480605 IN ADULTPARTICIPANTS WITH MODERATE TO SEVEREULCERATIVE COLITIS - Tuscany 2	A phase 2b randomised, double-blind, placebo controlled dose-ranging study in Adults with Moderate to Severe Ulcerative Colitis MedDRA version: 20.0;Level: HLT;Classification code 10009888;Term: Colitis (excl infective);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: PF-06480605 Product Code: PF-06480605 INN or Proposed INN: PF-06480605 Other descriptive name: Anti-TL1A	Pfizer Inc	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	240	Phase 2	United States;Serbia;Slovakia;Spain;Ukraine;Turkey;Austria;Russian Federation;Israel;Italy;India;France;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Germany;Japan;China
40	EUCTR2018-003987-29-AT (EUCTR)	15/04/2020	09/10/2019	An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis	An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	702	Phase 3	United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
41	EUCTR2018-004002-25-DE (EUCTR)	07/04/2020	23/08/2019	A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis	A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis - QUASAR	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: GUSELKUMAB Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab	Janssen-Cilag International NV	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	950	Phase 2;Phase 3	United States;Portugal;Hong Kong;Taiwan;Spain;Ukraine;Israel;Russian Federation;Italy;France;Malaysia;Australia;Netherlands;China;Korea, Republic of;Czechia;Turkey;United Kingdom;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden
42	EUCTR2018-003986-33-AT (EUCTR)	07/04/2020	20/09/2019	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis	A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	330	Phase 3	United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan
43	EUCTR2017-003703-22-BG (EUCTR)	07/04/2020	06/02/2020	Phase 2 Dose-finding IMU-838 for Ulcerative Colitis (CALDOSE-1)	A phase 2, multicenter, randomized, double-blind, placebo controlled, dose-finding study to evaluate the efficacy and safety of IMU 838 for induction and maintenance therapy in moderate-to-severe ulcerative colitis CALDOSE-1	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838	Immunic AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	240	Phase 2	United States;Serbia;Belarus;Portugal;Spain;Ukraine;Russian Federation;United Kingdom;Czech Republic;Macedonia, the former Yugoslav Republic of;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Netherlands;Bosnia and Herzegovina
44	EUCTR2019-003849-15-FR (EUCTR)	03/04/2020	03/02/2020	Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) asmaintenance therapy in patients with Ulcerative Colitis	A Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients with Moderately to Severely Active Ulcerative Colitis	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Remsima Product Code: Remsima (CT-P13) INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB	Celltrion, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	615	Phase 3	United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Italy;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Hungary;Czech Republic;Mexico;Brazil;Poland;Croatia;Bulgaria;Germany
45	EUCTR2019-003849-15-BG (EUCTR)	03/04/2020	07/02/2020	Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) asmaintenance therapy in patients with Ulcerative Colitis	A Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients with Moderately to Severely Active Ulcerative Colitis	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Remsima Product Code: Remsima (CT-P13) INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB	Celltrion, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	615	Phase 3	Serbia;Belarus;Greece;Spain;Ukraine;Turkey;Austria;Russian Federation;Israel;Italy;France;Czech Republic;Mexico;Poland;Croatia;Peru;South Africa;Bulgaria;Germany;Latvia;Moldova, Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
46	EUCTR2019-003849-15-GR (EUCTR)	03/04/2020	02/04/2020	Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) asmaintenance therapy in patients with Ulcerative Colitis	A Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients with Moderately to Severely Active Ulcerative Colitis	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Remsima Product Code: Remsima (CT-P13) INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB	Celltrion, Inc.	NULL	Not Recruiting			Female: yes Male: yes	615	Phase 3	United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Italy;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Hungary;Czech Republic;Mexico;Brazil;Poland;Croatia;Bulgaria;Germany
47	EUCTR2019-002698-74-ES (EUCTR)	01/04/2020	23/01/2020	A study to evaluate the efficacy and safety of PF 06480605 in adult participants with moderate to severe ulcerative colitis	A PHASE 2B, MULTICENTER, RANDOMIZED, DOUBLEBLIND,PLACEBO CONTROLLED DOSE-RANGINGSTUDY TO EVALUATE THE EFFICACY, SAFETY, ANDPHARMACOKINETICS OF PF-06480605 IN ADULTPARTICIPANTS WITH MODERATE TO SEVEREULCERATIVE COLITIS - Tuscany 2	A phase 2b randomised, double-blind, placebo controlled dose-ranging study in Adults with Moderate to Severe Ulcerative Colitis MedDRA version: 20.0;Level: HLT;Classification code 10009888;Term: Colitis (excl infective);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: PF-06480605 Product Code: PF-06480605 INN or Proposed INN: PF-06480605 Other descriptive name: Anti-TL1A	Pfizer Inc	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	240	Phase 2	United States;Serbia;Slovakia;Spain;Ukraine;Turkey;Austria;Russian Federation;Israel;Italy;India;France;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Germany;Japan;China
48	NCT04225819 (ClinicalTrials.gov)	April 1, 2020	3/1/2020	Adjunctive Treatment With Vitamin D3 in Patients With Active IBD	Adjunctive Treatment With Vitamin D3 in Patients With Active IBD (ACTIVATED): A Randomized, Double-blind, Placebo-controlled Trial	IBD;Inflammatory Bowel Diseases;Crohn Disease;Ulcerative Colitis;Vitamin D3 Deficiency	Dietary Supplement: Vitamin D3;Other: Placebo	Massachusetts General Hospital	NULL	Not yet recruiting	18 Years	N/A	All	100	N/A	NULL
49	EUCTR2019-002698-74-BG (EUCTR)	27/03/2020	31/01/2020	A study to evaluate the efficacy and safety of PF 06480605 in adult participants with moderate to severe ulcerative colitis	A PHASE 2B, MULTICENTER, RANDOMIZED, DOUBLEBLIND,PLACEBO CONTROLLED DOSE-RANGINGSTUDY TO EVALUATE THE EFFICACY, SAFETY, ANDPHARMACOKINETICS OF PF-06480605 IN ADULTPARTICIPANTS WITH MODERATE TO SEVEREULCERATIVE COLITIS - Tuscany 2	A phase 2b randomised, double-blind, placebo controlled dose-ranging study in Adults with Moderate to Severe Ulcerative Colitis MedDRA version: 20.0;Level: HLT;Classification code 10009888;Term: Colitis (excl infective);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: PF-06480605 Product Code: PF-06480605 INN or Proposed INN: PF-06480605 Other descriptive name: Anti-TL1A	Pfizer Inc	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	240	Phase 2	Serbia;United States;Slovakia;Spain;Ukraine;Turkey;Austria;Russian Federation;Israel;Italy;India;France;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Germany;Japan;China
50	EUCTR2019-002698-74-SK (EUCTR)	26/03/2020	31/01/2020	A study to evaluate the efficacy and safety of PF 06480605 in adult participants with moderate to severe ulcerative colitis	A PHASE 2B, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED DOSE-RANGING STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF PF-06480605 IN ADULT PARTICIPANTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS - Tuscany 2	A phase 2b randomised, double-blind, placebo controlled dose-ranging study in Adults with Moderate to Severe Ulcerative Colitis MedDRA version: 20.0;Level: HLT;Classification code 10009888;Term: Colitis (excl infective);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: PF-06480605 100 mg/ml Product Code: PF-06480605 INN or Proposed INN: PF-06480605 Other descriptive name: Anti-TL1A	Pfizer Inc	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	240	Phase 2	Serbia;United States;Slovakia;Spain;Ukraine;Turkey;Russian Federation;Israel;Italy;India;France;Czech Republic;Mexico;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Japan;China
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
51	EUCTR2018-003524-36-IE (EUCTR)	25/03/2020	05/11/2019	Randomized, mulitcenter study to investigate how infliximab dosing calculated by a computer compares to the standard dosing during the induction of infliximab in patients with severe colitis ulcerosa.	Randomized, Multicenter Study to Investigate the Efficacy of Dashboard Driven Individualized Dosing of Infliximab Compared To Standard Dosing During the Induction in Patients with Acute Severe Ulcerative Colitis - TITRATE	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Remicade Product Name: NA Product Code: NA INN or Proposed INN: INFLIXIMAB Trade Name: Metoject INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE DISODIUM Trade Name: Puri-Nethol INN or Proposed INN: MERCAPTOPURINE Trade Name: Remsima INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra INN or Proposed INN: INFLIXIMAB Trade Name: Flixabi INN or Proposed INN: INFLIXIMAB	UMC Amsterdam location AMC	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	124	Phase 4	Ireland;Netherlands
52	EUCTR2019-002698-74-PL (EUCTR)	24/03/2020	11/02/2020	A study to evaluate the efficacy and safety of PF 06480605 in adult participants with moderate to severe ulcerative colitis	A PHASE 2B, MULTICENTER, RANDOMIZED, DOUBLEBLIND,PLACEBO CONTROLLED DOSE-RANGINGSTUDY TO EVALUATE THE EFFICACY, SAFETY, ANDPHARMACOKINETICS OF PF-06480605 IN ADULTPARTICIPANTS WITH MODERATE TO SEVEREULCERATIVE COLITIS - Tuscany 2	A phase 2b randomised, double-blind, placebo controlled dose-ranging study in Adults with Moderate to Severe Ulcerative Colitis MedDRA version: 20.0;Level: HLT;Classification code 10009888;Term: Colitis (excl infective);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: PF-06480605 Product Code: PF-06480605 INN or Proposed INN: PF-06480605 Other descriptive name: Anti-TL1A	Pfizer Inc	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	240	Phase 2	United States;Serbia;Slovakia;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;India;France;Hungary;Mexico;Canada;Poland;Belgium;Romania;Australia;South Africa;Bulgaria;Germany;China;Japan
53	EUCTR2019-003849-15-AT (EUCTR)	20/03/2020	06/02/2020	Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) asmaintenance therapy in patients with Ulcerative Colitis	A Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients with Moderately to Severely Active Ulcerative Colitis	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Remsima Product Code: Remsima (CT-P13) INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB	Celltrion, Inc.	NULL	Not Recruiting			Female: yes Male: yes	615	Phase 3	United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Italy;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Hungary;Czech Republic;Mexico;Brazil;Poland;Croatia;Bulgaria;Germany
54	EUCTR2019-000733-39-DE (EUCTR)	20/03/2020	13/03/2020	Open-label maintenance therapy in moderate to severe Ulcerative Colitis patients	A phase 2b, open-label, efficacy and safety study of ABX464 as maintenance therapy in patients with moderate to severe Ulcerative Colitis.	Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464	ABIVAX	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	244	Phase 2	Belarus;Serbia;Czechia;Slovakia;Slovenia;Spain;Ukraine;Austria;United Kingdom;France;Hungary;Canada;Belgium;Poland;Germany
55	EUCTR2016-000642-62-SE (EUCTR)	18/03/2020	25/10/2018	A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis	M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	462	Phase 3	Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
56	EUCTR2016-000642-62-FR (EUCTR)	10/03/2020	30/07/2019	A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis	M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	462	Phase 3	Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Singapore;Croatia;Germany;Norway;Japan
57	EUCTR2018-001605-93-AT (EUCTR)	09/03/2020	07/11/2019	An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis	A 54-Week Treatment, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo and Active-Controlled, Parallel-Group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis - Phase 2 Dose-finding UC Study	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139 Trade Name: Entyvio INN or Proposed INN: Entyvio Other descriptive name: VEDOLIZUMAB Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139	Allergan Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	375	Phase 2	United States;Taiwan;Spain;Israel;Russian Federation;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;China;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Bulgaria;Germany;Japan
58	EUCTR2017-003703-22-PT (EUCTR)	02/03/2020	18/12/2019	Phase 2 Dose-finding IMU-838 for Ulcerative Colitis (CALDOSE-1)	A phase 2, multicenter, randomized, double-blind, placebo controlled, dose-finding study to evaluate the efficacy and safety of IMU 838 for induction and maintenance therapy in moderate-to-severe ulcerative colitis CALDOSE-1	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838	Immunic AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	240	Phase 2	United States;Serbia;Portugal;Belarus;Spain;Ukraine;Russian Federation;United Kingdom;Czech Republic;Macedonia, the former Yugoslav Republic of;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Netherlands;Bosnia and Herzegovina
59	EUCTR2018-003987-29-PT (EUCTR)	02/03/2020	28/10/2019	An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis	An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	702	Phase 3	Germany;Japan;Georgia;United States;Serbia;Belarus;Portugal;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria
60	NCT04309058 (ClinicalTrials.gov)	March 2020	24/2/2020	Observation of the Effect of Vitamin D Supplementation on Chronic Course of Patients With Ulcerative Colitis Based on Vitamin D Receptor Fok I Gene Polymorphism	Observation of the Effect of Vitamin D Supplementation on Chronic Course of Patients With Ulcerative Colitis Based on Vitamin D Receptor Fok I Gene Polymorphism,a Prospective Cohort Study	Ulcerative Colitis;Vitamin D Deficiency;Vitamin D Supplement	Drug: Vitamin D drops	Second Affiliated Hospital of Wenzhou Medical University	NULL	Not yet recruiting	N/A	N/A	All	100	Early Phase 1	China
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
61	EUCTR2018-004002-25-ES (EUCTR)	28/02/2020	04/09/2019	A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis	A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis - QUASAR	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Janssen-Cilag International NV	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1000	Phase 2;Phase 3	Portugal;United States;Taiwan;Hong Kong;Thailand;Spain;Ukraine;Russian Federation;Israel;Italy;France;Malaysia;Australia;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Bulgaria;Germany;Japan;Sweden
62	EUCTR2018-003986-33-DK (EUCTR)	28/02/2020	02/10/2019	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis	A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	330	Phase 3	Moldova, Republic of;Serbia;Portugal;United States;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Israel;Chile;Italy;Switzerland;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Bulgaria;Germany
63	EUCTR2019-003220-21-GB (EUCTR)	26/02/2020	12/12/2019	Management of diarrhoea in ulcerative colitis: multi-arm multi stage trial of low FODMAP diet, amitriptyline, ondansetron, or loperamide: MODULATE.	Management of diarrhoea in ulcerative colitis: multi-arm multi-stage trial of low FODMAP diet, amitriptyline, ondansetron, or loperamide: MODULATE. - MODULATE	Diarrhoea in patients with stable ulcerative colitis. MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10066557;Term: Chronic diarrhoea;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Amitriptyline Product Name: Amitriptyline INN or Proposed INN: Amitriptyline hydrochloride Product Name: Ondansetron INN or Proposed INN: Ondansetron hydrochloride dihydrate Product Name: Loperamide INN or Proposed INN: loperamide hydrochloride	University of Leeds	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	491	Phase 2;Phase 3	United Kingdom
64	EUCTR2019-003113-34-HU (EUCTR)	25/02/2020	09/01/2020	Study of efficacy, safety and tolerability of LYS006 in patients with mild to moderate ulcerative colitis	A randomized, multi-center, subject and investigator blinded, placebo controlled, parallel group study to assess the efficacy, safety and tolerability of LYS006 in patients with mild to moderate ulcerative colitis - NA	Mild to moderate ulcerative colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Novartis Pharma AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	45	Phase 2	United States;Czech Republic;Hungary;Poland;Russian Federation;Bulgaria;Norway;Germany
65	EUCTR2018-003986-33-GB (EUCTR)	24/02/2020	17/09/2019	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis	A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	330	Phase 3	Serbia;Portugal;United States;Belarus;Estonia;Taiwan;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Bulgaria;Germany;Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
66	EUCTR2019-003113-34-DE (EUCTR)	19/02/2020	08/11/2019	Ulcerative colitis	A randomized, multi-center, subject and investigator blinded, placebo controlled, parallel group study to assess the efficacy, safety and tolerability of LYS006 in patients with mild to moderate ulcerative colitis - NA	Mild to moderate ulcerative colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: LYS006 Product Code: LYS006 INN or Proposed INN: not yet defined Other descriptive name: LYS006	Novartis Pharma AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	45	Phase 2	United States;Hungary;Czech Republic;Norway;Germany
67	EUCTR2018-003987-29-BG (EUCTR)	17/02/2020	23/10/2019	An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis	An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	702	Phase 3	United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan
68	EUCTR2018-003986-33-ES (EUCTR)	14/02/2020	24/02/2020	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis	A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Arena Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	330	Phase 3	Serbia;Portugal;United States;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Israel;Chile;Italy;Switzerland;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Bulgaria;Germany
69	EUCTR2019-000733-39-AT (EUCTR)	13/02/2020	14/10/2019	Open-label maintenance therapy in moderate to severe Ulcerative Colitis patients	A phase 2b, open-label, efficacy and safety study of ABX464 as maintenance therapy in patients with moderate to severe Ulcerative Colitis.	Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464	ABIVAX	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	244	Phase 2	Belarus;Serbia;Czechia;Slovakia;Slovenia;Spain;Ukraine;Austria;United Kingdom;France;Hungary;Canada;Belgium;Poland;Germany
70	EUCTR2018-003558-26-GB (EUCTR)	11/02/2020	05/11/2019	Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments.	A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-a] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment. - Investigate the safety and efficacy of study drug ABX464-103	Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464	ABIVAX	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	244	Phase 2	United States;Belarus;Serbia;Slovenia;Slovakia;Spain;Ukraine;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
71	EUCTR2018-003986-33-BG (EUCTR)	11/02/2020	23/10/2019	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis	A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	330	Phase 3	United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan
72	EUCTR2018-004002-25-PT (EUCTR)	03/02/2020	06/08/2019	A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis	A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis - QUASAR	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: GUSELKUMAB Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab	Janssen-Cilag International NV	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	950	Phase 2;Phase 3	Portugal;United States;Taiwan;Hong Kong;Spain;Thailand;Ukraine;Russian Federation;Israel;Italy;France;Malaysia;Australia;Netherlands;China;Korea, Republic of;Czechia;Turkey;United Kingdom;Hungary;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Japan;Sweden
73	EUCTR2018-003986-33-LV (EUCTR)	24/01/2020	01/11/2019	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis	A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	330	Phase 3	South Africa;Serbia;Portugal;United States;Belarus;Estonia;Taiwan;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Israel;Chile;Italy;Switzerland;India;France;Australia;Denmark;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Bulgaria;Germany
74	EUCTR2018-003987-29-DE (EUCTR)	23/01/2020	30/09/2019	An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis	An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	702	Phase 3	United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan
75	EUCTR2018-003985-15-AT (EUCTR)	21/01/2020	08/07/2019	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis	A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Arena Pharmaceuticals Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	372	Phase 3	Serbia;Portugal;United States;Belarus;Estonia;Taiwan;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Bulgaria;Germany;Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
76	EUCTR2018-003985-15-FR (EUCTR)	20/01/2020	12/07/2019	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis	A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Arena Pharmaceuticals Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	372	Phase 3	Serbia;Portugal;United States;Belarus;Estonia;Taiwan;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Bulgaria;Germany;Japan
77	EUCTR2018-003986-33-FR (EUCTR)	14/01/2020	20/09/2019	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis	A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	330	Phase 3	United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany
78	EUCTR2018-003986-33-LT (EUCTR)	31/12/2019	08/10/2019	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis	A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	330	Phase 3	United States;Serbia;Portugal;Belarus;Estonia;Taiwan;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan
79	EUCTR2018-003987-29-ES (EUCTR)	20/12/2019	20/12/2019	An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis	An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Arena Pharmaceuticals Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	702	Phase 3	Serbia;Portugal;United States;Belarus;Estonia;Taiwan;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Bulgaria;Germany;Japan
80	EUCTR2019-003662-40-DE (EUCTR)	18/12/2019	22/10/2019	Prospective, open-label, single-arm, single-center phase IV clinical trial to evaluate efficacy and safety of the adalimumab biosimilar Amgevita in subjects with moderate to severe active chronic inflammatory bowel diesease (Crohn's disease and ulcerative colitis)	Prospective, open-label, single-arm, single-center phase IV clinical trial to evaluate efficacy and safety of the adalimumab biosimilar Amgevita in subjects with moderate to severe active chronic inflammatory bowel diesease (Crohn's disease and ulcerative colitis) - Amgevita de novo in CED	MedDRA version: 20.1;Level: PT;Classification code 10021972;Term: Inflammatory bowel disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Amgevita 40 mg Injektionslösung in einer Fertigspritze INN or Proposed INN: ADALIMUMAB Trade Name: Amgevita 40 mg Injektionslösung im Fertigpen INN or Proposed INN: ADALIMUMAB	Universitätsklinikum Erlangen	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	82	Phase 4	Germany
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
81	EUCTR2018-005086-39-HR (EUCTR)	16/12/2019	17/01/2020	A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacyand Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis	A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis	Mild to Moderate Ulcerative Colitis Inflammatory bowel disease (IBD) is an autoimmune disease of the gastrointestinal (GI) tract with unknown etiology that encompasses 2 primary clinical manifestations: ulcerative colitis (UC) and Crohn’s disease (CD). UC manifests through complex interactions between the gut microbiome, dysregulated immune responses, genetic mutations, diet, and other environmental factors. MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: BT-11 500 mg Product Code: BT-11 INN or Proposed INN: to be requested Other descriptive name: BT-11 Product Name: BT-11 1000mg Product Code: BT-11 INN or Proposed INN: to be requested Other descriptive name: BT-11	Landos Biopharma Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	195	Phase 2	Belarus;Serbia;United States;Ukraine;Russian Federation;Hungary;Canada;Poland;Croatia;Bulgaria;Georgia;Moldova, Republic of;Bosnia and Herzegovina
82	EUCTR2018-003278-28-NL (EUCTR)	13/12/2019	22/07/2019	Safety, tolerability, efficacy and dose-response of GSK2831781 in ulcerative colitis.	A multicentre randomized, double-blind, placebo-controlled Phase 2 study to evaluate the safety, tolerability, efficacy, dose-response, pharmacokinetics and pharmacodynamics of repeat dosing of an anti-LAG3 cell depleting monoclonal antibody (GSK2831781) in patients with active ulcerative colitis	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: GSK2831781 INN or Proposed INN: Not Assigned Other descriptive name: GSK2831781	GlaxoSmithKline Research & Development Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	320	Phase 2	Serbia;United States;Czechia;Estonia;Slovenia;Slovakia;Ukraine;Russian Federation;United Kingdom;India;France;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;South Africa;Bulgaria;Netherlands;Korea, Republic of
83	EUCTR2019-000733-39-ES (EUCTR)	11/12/2019	11/11/2019	Open-label maintenance therapy in moderate to severe Ulcerative Colitis patients	A phase 2b, open-label, efficacy and safety study of ABX464 as maintenance therapy in patients with moderate to severe Ulcerative Colitis.	Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		ABIVAX	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	232	Phase 2	Serbia;Belarus;Slovakia;Slovenia;Spain;Ukraine;Ireland;Austria;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Netherlands;Germany
84	EUCTR2018-003558-26-FR (EUCTR)	10/12/2019	08/02/2019	Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments.	A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-a] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment.	Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		ABIVAX	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	232	Phase 2	Serbia;Belarus;Slovakia;Slovenia;Spain;Ukraine;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Netherlands;Germany
85	EUCTR2018-000334-35-NO (EUCTR)	27/11/2019	12/06/2019	BI 655130 long-term treatment in patients with moderate-to-severe ulcerative colitis	An open label, long term safety trial of BI 655130 treatment in patients with moderate to severely active ulcerative colitis who have completed previous BI 655130 trials	Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]	Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 INN or Proposed INN: spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 INN or Proposed INN: spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1	Boehringer Ingelheim Norway KS	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	160	Phase 2	United States;Spain;Austria;Russian Federation;United Kingdom;Italy;Hungary;Canada;Belgium;Poland;Norway;Germany;Netherlands;Japan;Korea, Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
86	EUCTR2019-000733-39-SK (EUCTR)	21/11/2019	06/09/2019	Open-label maintenance therapy in moderate to severe Ulcerative Colitis patients	A phase 2b, open-label, efficacy and safety study of ABX464 as maintenance therapy in patients with moderate to severe Ulcerative Colitis.	Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464	ABIVAX	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	244	Phase 2	Belarus;Serbia;Czechia;Slovakia;Slovenia;Spain;Ukraine;Austria;United Kingdom;France;Hungary;Canada;Belgium;Poland;Germany
87	EUCTR2017-003703-22-HR (EUCTR)	20/11/2019	13/01/2020	Phase 2 Dose-finding IMU-838 for Ulcerative Colitis (CALDOSE-1)	A phase 2, multicenter, randomized, double-blind, placebo controlled, dose-finding study to evaluate the efficacy and safety of IMU 838 for induction and maintenance therapy in moderate-to-severe ulcerative colitis CALDOSE-1	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838	Immunic AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	240	Phase 2	United States;Serbia;Belarus;Portugal;Czechia;Spain;Ukraine;North Macedonia;Russian Federation;United Kingdom;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Netherlands;Bosnia and Herzegovina
88	EUCTR2018-003987-29-DK (EUCTR)	20/11/2019	02/10/2019	An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis	An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	702	Phase 3	United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan
89	EUCTR2018-003987-29-LT (EUCTR)	14/11/2019	06/11/2019	An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis	An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	702	Phase 3	United States;Serbia;Portugal;Belarus;Estonia;Taiwan;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan
90	EUCTR2019-000733-39-SI (EUCTR)	11/11/2019	16/10/2019	Open-label maintenance therapy in moderate to severe Ulcerative Colitis patients	A phase 2b, open-label, efficacy and safety study of ABX464 as maintenance therapy in patients with moderate to severe Ulcerative Colitis.	Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464	ABIVAX	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	244	Phase 2	Belarus;Serbia;Czechia;Slovenia;Slovakia;Spain;Ukraine;Austria;United Kingdom;France;Hungary;Canada;Belgium;Poland;Germany
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
91	EUCTR2019-000733-39-PL (EUCTR)	09/11/2019	12/09/2019	Open-label maintenance therapy in moderate to severe Ulcerative Colitis patients	A phase 2b, open-label, efficacy and safety study of ABX464 as maintenance therapy in patients with moderate to severe Ulcerative Colitis.	Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464	ABIVAX	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	232	Phase 2	Serbia;Belarus;Slovakia;Slovenia;Spain;Ukraine;Ireland;Austria;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Netherlands;Germany
92	EUCTR2018-003986-33-HR (EUCTR)	08/11/2019	17/01/2020	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis	A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	330	Phase 3	United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany
93	EUCTR2018-003987-29-LV (EUCTR)	07/11/2019	16/09/2019	An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis	An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	702	Phase 3	Serbia;Portugal;United States;Belarus;Estonia;Taiwan;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Bulgaria;Germany;Japan;Lithuania;Turkey;Austria;United Kingdom
94	EUCTR2018-003986-33-HU (EUCTR)	07/11/2019	08/11/2019	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis	A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	330	Phase 3	Serbia;Portugal;United States;Belarus;Estonia;Taiwan;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Israel;Chile;Italy;Switzerland;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Bulgaria;Germany
95	EUCTR2018-003987-29-HU (EUCTR)	07/11/2019	17/09/2019	An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis	An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	702	Phase 3	Serbia;Portugal;United States;Belarus;Estonia;Taiwan;Slovakia;Thailand;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Bulgaria;Germany;Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
96	EUCTR2016-000642-62-DE (EUCTR)	04/11/2019	18/10/2018	A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis	M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	522	Phase 3	Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden
97	EUCTR2018-000334-35-HU (EUCTR)	31/10/2019	06/09/2019	BI 655130 long-term treatment in patients with moderate-to-severe ulcerative colitis	An open label, long term safety trial of BI 655130 treatment in patients with moderate to severely active ulcerative colitis who have completed previous BI 655130 trials	Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]	Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1	Boehringer Ingelheim RCV GmbH&Co. KG	NULL	Not Recruiting			Female: yes Male: yes	160	Phase 2	United States;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;Korea, Republic of
98	EUCTR2018-003558-26-DE (EUCTR)	30/10/2019	15/03/2019	Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments.	A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-a] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment.	Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464	ABIVAX	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	232	Phase 2	Belarus;Serbia;Czechia;Slovenia;Slovakia;Spain;Ukraine;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Germany;Netherlands
99	EUCTR2018-003349-41-DE (EUCTR)	30/10/2019	19/12/2018	Clinical trial to evaluate the benefit and safety of ST-0529 in subjects who are suffering from active ulcerative colitis	A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of ST-0529 in Subjects with Moderately to Severely Active Ulcerative Colitis	Active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ST-0529 Product Code: FP-CYA-050 INN or Proposed INN: CICLOSPORIN Other descriptive name: cyclosporine Product Name: ST-0529 Product Code: FP-CYA-053 INN or Proposed INN: CICLOSPORIN Other descriptive name: cyclosporine	Sublimity Therapeutics (Hold Co) Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	280	Phase 2	Belarus;Serbia;United States;Ukraine;Israel;Russian Federation;United Kingdom;France;Hungary;Canada;Poland;Bulgaria;Germany
100	EUCTR2018-002135-19-BG (EUCTR)	30/10/2019	11/07/2019	A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Ulcerative Colitis (UC)	A 3-Year, Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects with Ulcerative Colitis (UC) - TD-1473 LTS UC Study	Moderately-to-severely active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060	Theravance Biopharma Ireland Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	500	Phase 3	Portugal;Serbia;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Australia;South Africa;Korea, Republic of;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
101	EUCTR2018-005086-39-HU (EUCTR)	28/10/2019	08/04/2019	A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacyand Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis	A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacyand Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis	Mild to Moderate Ulcerative Colitis Inflammatory bowel disease (IBD) is an autoimmune disease of the gastrointestinal (GI) tract with unknown etiology that encompasses 2 primary clinical manifestations: ulcerative colitis (UC) and Crohn’s disease (CD). UC manifests through complex interactions between the gut microbiome, dysregulated immune responses, genetic mutations, diet, and other environmental factors. MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: BT-11 INN or Proposed INN: to be requested Product Code: BT-11 INN or Proposed INN: to be requested	Landos Biopharma Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	195	Phase 2	United States;Serbia;Belarus;Hungary;Poland;Ukraine;Croatia;Russian Federation;Georgia;Moldova, Republic of;Bosnia and Herzegovina
102	EUCTR2018-003278-28-HU (EUCTR)	24/10/2019	25/03/2019	Safety, tolerability, efficacy and dose-response of GSK2831781 in ulcerative colitis.	A multicentre randomized, double-blind (sponsor open), placebo-controlled Phase 2 study to evaluate the safety, tolerability, efficacy, dose-response, pharmacokinetics and pharmacodynamics of repeat dosing of an anti-LAG3 cell depleting monoclonal antibody (GSK2831781) in patients with active ulcerative colitis	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		GlaxoSmithKline Research & Development Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	320	Phase 2	Serbia;United States;Estonia;Slovakia;Slovenia;Ukraine;Lithuania;Russian Federation;United Kingdom;India;France;Hungary;Czech Republic;Canada;Poland;South Africa;Bulgaria;Netherlands;Korea, Republic of
103	EUCTR2018-004002-25-BE (EUCTR)	21/10/2019	10/09/2019	A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis	A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis - QUASAR	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Janssen-Cilag International NV	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	950	Phase 2;Phase 3	United States;Portugal;Taiwan;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden
104	EUCTR2018-003985-15-ES (EUCTR)	21/10/2019	21/10/2019	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis	A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	372	Phase 3	Serbia;Portugal;United States;Belarus;Estonia;Taiwan;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Bulgaria;Germany;Japan
105	EUCTR2018-004002-25-FR (EUCTR)	15/10/2019	14/08/2019	A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis	A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis - QUASAR	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Janssen-Cilag International NV	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1000	Phase 2;Phase 3	United States;Portugal;Taiwan;Hong Kong;Spain;Ukraine;Israel;Russian Federation;Italy;France;Malaysia;Australia;China;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Japan;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
106	EUCTR2018-004002-25-SE (EUCTR)	15/10/2019	03/07/2019	A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis	A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis - QUASAR	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: GUSELKUMAB Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab	Janssen-Cilag International NV	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	950	Phase 2;Phase 3	United States;Portugal;Hong Kong;Taiwan;Spain;Ukraine;Israel;Russian Federation;Italy;France;Malaysia;Australia;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden
107	EUCTR2018-003986-33-BE (EUCTR)	14/10/2019	15/07/2019	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis	A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	330	Phase 3	United States;Serbia;Portugal;Belarus;Estonia;Taiwan;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany
108	EUCTR2018-003985-15-PT (EUCTR)	14/10/2019	10/07/2019	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis	A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Arena Pharmaceuticals Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	372	Phase 3	Serbia;United States;Portugal;Belarus;Estonia;Taiwan;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Bulgaria;Germany;Japan
109	EUCTR2018-004890-28-IT (EUCTR)	09/10/2019	07/10/2020	Study for the research of predictive factors of response to Tofacitinib therapy in patients with ulcerative rectal colitis.	(A)nalysis of immunological (VA)riables in ex vivo (T)ofacitinib-treated human biopsies from (A)ctive ulcerative colitis patients to predict clinical (R)esponse (the AVATAR study). - AVATAR	Ulcerative colitis MedDRA version: 20.0;Level: LLT;Classification code 10045282;Term: UC;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Xeljanz Product Name: Xeljanz Product Code: [N/A]	DIP. MEDICINA DEI SISTEMI UNIVERSITà DEGLI STUDI DI ROMA TOR VERGATA	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	60	Phase 4	Italy
110	EUCTR2018-004002-25-GB (EUCTR)	09/10/2019	20/08/2019	A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis	A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis - QUASAR	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab	Janssen-Cilag International NV	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	950	Phase 2;Phase 3	United States;Portugal;Taiwan;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
111	EUCTR2018-001605-93-BG (EUCTR)	09/10/2019	20/09/2019	An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis	A 54-Week Treatment, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo and Active-Controlled, Parallel-Group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis - Phase 2 Dose-finding UC Study	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Allergan Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	375	Phase 2	United States;Taiwan;Spain;Russian Federation;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;China;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Bulgaria;Germany;Japan
112	EUCTR2018-003987-29-NL (EUCTR)	07/10/2019	22/08/2019	An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis	An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	702	Phase 3	Portugal;United States;Belarus;Serbia;Estonia;Taiwan;Slovakia;Spain;Thailand;Ukraine;Lebanon;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;China;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;Japan
113	EUCTR2018-005086-39-PL (EUCTR)	07/10/2019	06/05/2019	A Study to Evaluate Efficacy and Safety of BT-11 product oral tablets in Mild to Moderate Ulcerative Colitis	A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis	Mild to Moderate Ulcerative Colitis Inflammatory bowel disease (IBD) is an autoimmune disease of the gastrointestinal (GI) tract with unknown etiology that encompasses 2 primary clinical manifestations: ulcerative colitis (UC) and Crohn’s disease (CD). UC manifests through complex interactions between the gut microbiome, dysregulated immune responses, genetic mutations, diet, and other environmental factors. MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: BT-11 500 mg Product Code: BT-11 INN or Proposed INN: to be requested Other descriptive name: BT-11 Product Name: BT-11 1000mg Product Code: BT-11 INN or Proposed INN: to be requested Other descriptive name: BT-11	Landos Biopharma Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	195	Phase 2	United States;Serbia;Belarus;Hungary;Poland;Ukraine;Croatia;Russian Federation;Georgia;Moldova, Republic of;Bosnia and Herzegovina
114	EUCTR2017-004230-28-CZ (EUCTR)	04/10/2019	11/07/2019	BI 655130 induction treatment in patients with moderate-to severe ulcerative colitis	A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI 655130 Induction Therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy	Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]	Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1	Boehringer Ingelheim International GmbH	NULL	Not Recruiting			Female: yes Male: yes	550	Phase 2;Phase 3	United States;Taiwan;Greece;Spain;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;China;Korea, Republic of
115	EUCTR2018-003986-33-NL (EUCTR)	03/10/2019	22/08/2019	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis	A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	330	Phase 3	Portugal;United States;Belarus;Serbia;Estonia;Taiwan;Slovakia;Spain;Thailand;Ukraine;Lebanon;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;China;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
116	EUCTR2018-003987-29-HR (EUCTR)	02/10/2019	20/01/2020	An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis	An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	702	Phase 3	United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Israel;Switzerland;Italy;France;Denmark;Australia;South Africa;Latvia;Netherlands;China;Moldova, Republic of;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Croatia;Georgia;Bulgaria;Germany;Japan
117	EUCTR2018-004002-25-HU (EUCTR)	01/10/2019	13/08/2019	A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis	A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis - QUASAR	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Janssen-Cilag International NV	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1000	Phase 2;Phase 3	Portugal;United States;Taiwan;Hong Kong;Thailand;Spain;Ukraine;Russian Federation;Israel;Italy;France;Malaysia;Australia;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Bulgaria;Germany;Japan;Sweden
118	EUCTR2018-003490-10-FR (EUCTR)	30/09/2019	26/09/2019	An open-label randomized trial COmparing staNdard of care versus Treat to target with telemonitoRing and patient education in patients with ulcerative cOlitis initiating adalimumab : The CONTROL trial	An open-label randomized trial COmparing staNdard of care versus Treat to target with telemonitoRing and patient education in patients with ulcerative cOlitis initiating adalimumab : The CONTROL trial - CONTROL	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		GETAID	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	238	Phase 4	France
119	EUCTR2018-003985-15-BG (EUCTR)	27/09/2019	12/08/2019	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis	A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	372	Phase 3	United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan
120	EUCTR2018-003985-15-DK (EUCTR)	27/09/2019	24/07/2019	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis	A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	372	Phase 3	United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Latvia;Netherlands;China;Moldova, Republic of;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
121	EUCTR2018-003278-28-CZ (EUCTR)	25/09/2019	15/04/2019	Safety, tolerability, efficacy and dose-response of GSK2831781 in ulcerative colitis.	A multicentre randomized, double-blind, placebo-controlled Phase 2 study to evaluate the safety, tolerability, efficacy, dose-response, pharmacokinetics and pharmacodynamics of repeat dosing of an anti-LAG3 cell depleting monoclonal antibody (GSK2831781) in patients with active ulcerative colitis	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		GlaxoSmithKline Research & Development Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	320	Phase 2	Serbia;United States;Estonia;Slovenia;Ukraine;Lithuania;Russian Federation;United Kingdom;India;France;Czech Republic;Hungary;Mexico;Canada;Poland;South Africa;Bulgaria;Netherlands;Korea, Republic of
122	EUCTR2018-004694-27-DE (EUCTR)	24/09/2019	24/05/2019	Safety and Efficacy of BMS-986165 Compared with Placebo in Subjects with Ulcerative Colitis	A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: BMS-986165 Product Code: BMS-986165 INN or Proposed INN: BMS-986165 Other descriptive name: BMS986165	Bristol-Myers Squibb International Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	120	Phase 2	United States;Czechia;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Australia;Germany;Japan;Korea, Republic of
123	EUCTR2018-001605-93-BE (EUCTR)	23/09/2019	07/06/2019	An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis	A 54-Week Treatment, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo and Active-Controlled, Parallel-Group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis - Phase 2b Dose-finding UC Study	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139 Trade Name: Entyvio INN or Proposed INN: Entyvio Other descriptive name: VEDOLIZUMAB Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139	AstraZeneca AB	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	375	Phase 2	Czechia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Bulgaria;Germany;Japan;United States;Taiwan;Spain;Israel;Russian Federation;Colombia;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;China;Korea, Republic of
124	EUCTR2017-004496-31-NL (EUCTR)	20/09/2019	27/09/2018	A Study of the Efficacy and Safety of Golimumab in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis	A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety,and Pharmacokinetics of Golimumab Treatment, a Human anti-TNFa Monoclonal Antibody, Administered Subcutaneously in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis - PURSUIT 2	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Janssen Biologics BV	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	125	Phase 3	France;United States;Taiwan;Poland;Brazil;Belgium;Spain;Israel;Netherlands;Italy;Korea, Republic of
125	EUCTR2018-003985-15-NL (EUCTR)	18/09/2019	09/07/2019	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis	A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	372	Phase 3	Serbia;Portugal;United States;Belarus;Estonia;Taiwan;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;India;France;Australia;Denmark;South Africa;Latvia;Netherlands;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Bulgaria;Germany;Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
126	EUCTR2018-003987-29-BE (EUCTR)	16/09/2019	01/07/2019	An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis	An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	702	Phase 3	United States;Serbia;Portugal;Belarus;Estonia;Taiwan;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan
127	EUCTR2018-001605-93-FR (EUCTR)	13/09/2019	25/06/2019	An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis	A 54-Week Treatment, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo and Active-Controlled, Parallel-Group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis - Phase 2 Dose-finding UC Study	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Allergan Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	900	Phase 2	United States;Taiwan;Spain;Russian Federation;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;China;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Bulgaria;Germany;Japan
128	EUCTR2018-002135-19-GR (EUCTR)	13/09/2019	04/06/2019	A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Ulcerative Colitis (UC)	A 3-Year, Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects with Ulcerative Colitis (UC) - TD-1473 LTS UC Study	Moderately-to-severely active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Theravance Biopharma Ireland Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	500	Phase 3	Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;United Kingdom;France;Hungary;Canada;Poland;Croatia;Australia;Georgia;South Africa;Bulgaria;Germany
129	EUCTR2018-002136-24-FR (EUCTR)	10/09/2019	19/12/2018	A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Ulcerative Colitis	A Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with TD-1473 in Subjects with Moderately-to-Severely Active Ulcerative Colitis - Rhea: Efficacy and Safety of TD-1473 in Ulcerative Colitis	Moderately-to-Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Theravance Biopharma Ireland Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	880	Phase 2;Phase 3	Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;United Kingdom;India;France;Hungary;Canada;Poland;Croatia;Australia;South Africa;Bulgaria;Georgia;Germany
130	EUCTR2017-004230-28-HU (EUCTR)	06/09/2019	08/07/2019	BI 655130 induction treatment in patients with moderate-to severe ulcerative colitis	A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI 655130 Induction Therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy	Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]	Product Name: spesolimab Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Name: spesolimab Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1	Boehringer Ingelheim International GmbH	NULL	Not Recruiting			Female: yes Male: yes	550	Phase 2;Phase 3	Spain;Austria;Russian Federation;Israel;United Kingdom;Italy;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;China;Korea, Republic of;United States;Taiwan;Greece
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
131	EUCTR2017-004092-31-DE (EUCTR)	05/09/2019	15/05/2019	A study of the efficacy and safety of Mirikizumab in Ulcerative Colitis	I6T-MC-AMAPA Phase 3, Multicenter, Open-Label Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients with Moderately toSeverely Active Ulcerative Colitis (LUCENT 3) - LUCENT 3	moderately to severely active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: mirikizumab Other descriptive name: MIRIKIZUMAB	Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	840	Phase 3	Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Germany;Japan
132	EUCTR2016-000642-62-HR (EUCTR)	30/08/2019	20/01/2020	A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis	M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	462	Phase 3	Portugal;Belarus;United States;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden
133	EUCTR2018-003558-26-BE (EUCTR)	29/08/2019	27/05/2019	Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments.	A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-a] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment.	Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464	ABIVAX	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	244	Phase 2	United States;Belarus;Serbia;Slovakia;Slovenia;Spain;Ukraine;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany
134	EUCTR2018-003985-15-LT (EUCTR)	27/08/2019	10/07/2019	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis	A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	372	Phase 3	United States;Serbia;Portugal;Belarus;Estonia;Taiwan;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan
135	EUCTR2018-003985-15-EE (EUCTR)	26/08/2019	15/07/2019	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis	A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Arena Pharmaceuticals Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	372	Phase 3	Serbia;Portugal;United States;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Bulgaria;Germany;Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
136	EUCTR2018-002135-19-DE (EUCTR)	26/08/2019	25/02/2019	A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Ulcerative Colitis (UC)	A 3-Year, Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects with Ulcerative Colitis (UC) - TD-1473 LTS UC Study	Moderately-to-severely active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060	Theravance Biopharma Ireland Limited	NULL	Not Recruiting			Female: yes Male: yes	500	Phase 3	Portugal;Serbia;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Australia;South Africa;Korea, Republic of;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Japan
137	EUCTR2017-004092-31-HR (EUCTR)	19/08/2019	20/01/2020	A study of the efficacy and safety of Mirikizumab in Ulcerative Colitis	I6T-MC-AMAP A Phase 3, Multicenter, Open-Label Extension Study to Evaluate the Long- Term Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 3) - LUCENT 3	moderately to severely active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	840	Phase 3	Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Germany;Japan
138	EUCTR2018-004491-35-PL (EUCTR)	19/08/2019	03/07/2019	A study evaluating safety and efficacy of Itacitinib as treatment of moderate to severe ulcerative Colitis	A Phase 2, Double-Blind, Dose-Ranging, Placebo-Controlled Study With Open-Label Extension to Evaluate the Safety and Efficacy of Itacitinib in Moderate to Severe Ulcerative Colitis	Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Incyte Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	206	Phase 2	United States;Czech Republic;Poland;Romania;Germany
139	NCT03861143 (ClinicalTrials.gov)	August 14, 2019	27/2/2019	Efficacy and Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis	A Randomized , Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis	Ulcerative Colitis	Drug: BT-11 (500 mg);Drug: BT-11 (1000 mg);Drug: Placebo	Landos Biopharma Inc.	NULL	Active, not recruiting	18 Years	65 Years	All	198	Phase 2	United States;Bosnia and Herzegovina;Croatia;Poland;Ukraine;Belarus;Georgia;Hungary;Moldova, Republic of;Russian Federation;Serbia
140	EUCTR2018-003985-15-HR (EUCTR)	14/08/2019	24/12/2019	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis	A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	372	Phase 3	Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan;United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
141	EUCTR2017-004092-31-ES (EUCTR)	13/08/2019	11/06/2019	A study of the efficacy and safety of Mirikizumab in Ulcerative Colitis	I6T-MC-AMAPA Phase 3, Multicenter, Open-Label Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients with Moderately toSeverely Active Ulcerative Colitis (LUCENT 3) - LUCENT 3	moderately to severely active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: mirikizumab Other descriptive name: MIRIKIZUMAB	Lilly S.A.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	840	Phase 3	Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Germany;Japan
142	EUCTR2018-004694-27-CZ (EUCTR)	13/08/2019	19/07/2019	Safety and Efficacy of BMS-986165 Compared with Placebo in Subjects with Ulcerative Colitis	A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: BMS-986165 Product Code: BMS-986165 INN or Proposed INN: BMS-986165 Other descriptive name: BMS986165	Bristol-Myers Squibb International Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	120	Phase 2	United States;Hungary;Czech Republic;Poland;Belgium;Australia;Russian Federation;Germany;Japan;Italy;United Kingdom;Korea, Republic of
143	EUCTR2018-001605-93-ES (EUCTR)	07/08/2019	09/08/2019	An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis	A 54-Week Treatment, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo and Active-Controlled, Parallel-Group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis - Phase 2 Dose-finding UC Study	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139 Trade Name: Entyvio INN or Proposed INN: Entyvio Other descriptive name: VEDOLIZUMAB Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139	Allergan Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	900	Phase 2	United States;Taiwan;Spain;Russian Federation;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;China;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Bulgaria;Germany;Japan
144	EUCTR2018-003278-28-PL (EUCTR)	03/08/2019	11/06/2019	Safety, tolerability, efficacy and dose-response of GSK2831781 in ulcerative colitis.	A multicentre randomized, double-blind, placebo-controlled Phase 2 study to evaluate the safety, tolerability, efficacy, dose-response, pharmacokinetics and pharmacodynamics of repeat dosing of an anti-LAG3 cell depleting monoclonal antibody (GSK2831781) in patients with active ulcerative colitis	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: GSK2831781 INN or Proposed INN: Not Assigned Other descriptive name: GSK2831781	GlaxoSmithKline Research & Development Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	320	Phase 2	United States;Serbia;Estonia;Slovakia;Ukraine;Lithuania;Russian Federation;United Kingdom;India;France;Czech Republic;Hungary;Mexico;Canada;Poland;South Africa;Bulgaria;Netherlands;Japan;Korea, Republic of
145	NCT03591770 (ClinicalTrials.gov)	July 31, 2019	9/7/2018	Shingrix Vaccine in Patients With Moderate to Severe Ulcerative Colitis on Tofacitinib	The Immunogenicity and Safety of Shingrix Vaccine in Patients With Moderate to Severe Ulcerative Colitis on Tofacitinib	Inflammatory Bowel Diseases	Biological: SHINGRIX	Boston Medical Center	NULL	Suspended	50 Years	N/A	All	100	Phase 4	United States
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
146	EUCTR2016-000642-62-PT (EUCTR)	29/07/2019	16/10/2018	A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis	M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	462	Phase 3	Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Singapore;United States;Belarus;Portugal;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Croatia;Germany;Norway;Japan;Sweden
147	EUCTR2018-003985-15-HU (EUCTR)	29/07/2019	16/07/2019	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis	A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Arena Pharmaceuticals Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	372	Phase 3	Serbia;Portugal;United States;Belarus;Estonia;Taiwan;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Bulgaria;Germany;Japan
148	EUCTR2016-000642-62-GB (EUCTR)	26/07/2019	25/10/2018	A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis	M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	522	Phase 3	Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden
149	EUCTR2018-004694-27-GB (EUCTR)	23/07/2019	30/04/2019	Safety and Efficacy of BMS-986165 Compared with Placebo in Subjects with Ulcerative Colitis	A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Bristol-Myers Squibb International Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	120	Phase 2	United States;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Australia;Germany;Japan;Korea, Republic of
150	EUCTR2019-001032-54-FR (EUCTR)	23/07/2019	19/06/2019	Impact of anti-cytomegalovirus (valganciclovir) treatment in the management of relapsing ulcerative colitis (UC) requiring vedolizumab therapy: a randomized clinical trial comparing a strategy with or without antiviral therapy	Impact of anti-cytomegalovirus (valganciclovir) treatment in the management of relapsing ulcerative colitis (UC) requiring vedolizumab therapy: a randomized clinical trial comparing a strategy with or without antiviral therapy - CYTOVEDO	Patient with active ulcerative colitis who failed to anti-TNF with endoscopic active disease with an endoscopic Mayo score> 1 and 2 biopsies of the inflammatory tissue and presence of a CMV infection in the inflammatory tissue objectified by a viral load greater than 5 IU / 100000 cells by qPCR. MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10058881;Term: Cytomegalovirus viremia;System Organ Class: 100000004862 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		CHU de Saint Etienne	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	120	Phase 4	France
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
151	EUCTR2018-003349-41-FR (EUCTR)	11/07/2019	27/05/2019	Clinical trial to evaluate the benefit and safety of ST-0529 in subjects who are suffering from active ulcerative colitis	A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of ST-0529 in Subjects with Moderately to Severely Active Ulcerative Colitis	Active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Sublimity Therapeutics (Hold Co) Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	280	Phase 2	Serbia;United States;Belarus;Spain;Ukraine;Ireland;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Romania;Bulgaria;Germany
152	EUCTR2018-003985-15-LV (EUCTR)	05/07/2019	02/07/2019	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis	A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Arena Pharmaceuticals Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	372	Phase 3	Serbia;Portugal;United States;Belarus;Estonia;Taiwan;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Bulgaria;Germany;Japan
153	EUCTR2018-001605-93-GB (EUCTR)	01/07/2019	04/04/2019	An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis	A 54-Week Treatment, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo and Active-Controlled, Parallel-Group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis - Phase 2 Dose-finding UC Study	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139 Trade Name: Entyvio INN or Proposed INN: Entyvio Other descriptive name: VEDOLIZUMAB Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139	AstraZeneca AB	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	375	Phase 2	United States;Taiwan;Spain;Israel;Russian Federation;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Bulgaria;Germany;Japan
154	EUCTR2018-003986-33-SK (EUCTR)	01/07/2019	02/05/2019	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis	A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	330	Phase 3	United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan
155	EUCTR2017-004230-28-GR (EUCTR)	01/07/2019	03/05/2019	BI 655130 induction treatment in patients with moderate-to severe ulcerative colitis	A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI 655130 Induction Therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy	Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]		Boehringer Ingelheim International GmbH	NULL	Not Recruiting			Female: yes Male: yes	550	Phase 2;Phase 3	United States;Taiwan;Greece;Spain;Austria;Russian Federation;Israel;Italy;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;China;Korea, Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
156	EUCTR2018-004694-27-PL (EUCTR)	30/06/2019	15/05/2019	Safety and Efficacy of BMS-986165 Compared with Placebo in Subjects with Ulcerative Colitis	A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Bristol-Myers Squibb International Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	120	Phase 2	United States;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Australia;Germany;Japan;Korea, Republic of
157	EUCTR2018-003987-29-SK (EUCTR)	25/06/2019	15/04/2019	An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis	An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	702	Phase 3	United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan
158	EUCTR2017-004997-32-DE (EUCTR)	25/06/2019	14/12/2018	A Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's Disease	A PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE	Ulcerative Colitis (UC) or Crohn's Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: UTTR1147A/RO7021610 (Active) INN or Proposed INN: n.a. Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc	Genentech, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	320	Phase 2	United States;Serbia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Poland;Bulgaria;Netherlands;Germany
159	EUCTR2018-004694-27-HU (EUCTR)	25/06/2019	06/05/2019	Safety and Efficacy of BMS-986165 Compared with Placebo in Subjects with Ulcerative Colitis	A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: BMS-986165 Product Code: BMS-986165 INN or Proposed INN: BMS-986165 Other descriptive name: BMS986165	Bristol-Myers Squibb International Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	120	Phase 2	United States;Spain;Russian Federation;Switzerland;United Kingdom;Italy;Hungary;Czech Republic;Canada;Belgium;Poland;Germany;Japan;Korea, Republic of
160	EUCTR2018-002136-24-DE (EUCTR)	25/06/2019	27/12/2018	A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Ulcerative Colitis	A Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with TD-1473 in Subjects with Moderately-to-Severely Active Ulcerative Colitis - Rhea: Efficacy and Safety of TD-1473 in Ulcerative Colitis	Moderately-to-Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060	Theravance Biopharma Ireland Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	880	Phase 2;Phase 3	Portugal;Serbia;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Australia;South Africa;Korea, Republic of;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
161	EUCTR2018-003985-15-SK (EUCTR)	21/06/2019	16/04/2019	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis	A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	372	Phase 3	Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan;United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand
162	EUCTR2016-000642-62-GR (EUCTR)	21/06/2019	25/10/2018	A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis	M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	522	Phase 3	Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden
163	EUCTR2018-002135-19-PL (EUCTR)	19/06/2019	05/04/2019	A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Ulcerative Colitis (UC)	A 3-Year, Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects with Ulcerative Colitis (UC) - TD-1473 LTS UC Study	Moderately-to-severely active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060	Theravance Biopharma Ireland Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	500	Phase 3	Portugal;Serbia;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Australia;South Africa;Korea, Republic of;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Japan
164	EUCTR2016-000642-62-IE (EUCTR)	18/06/2019	26/11/2018	A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis	M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	522	Phase 3	Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden
165	EUCTR2017-004230-28-DK (EUCTR)	14/06/2019	24/03/2019	BI655130 (SPESOLIMAB) induction treatment in patients with moderate-to-severe ulcerative colitis	A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI655130 (SPESOLIMAB) Induction Therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy	Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]	Product Name: spesolimab Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Name: spesolimab Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1	Boehringer Ingelheim Denmark A/S	NULL	Not Recruiting			Female: yes Male: yes	550	Phase 2;Phase 3	United States;Taiwan;Greece;Spain;Austria;Russian Federation;Israel;Italy;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Denmark;Australia;Norway;Netherlands;Germany;Japan;China;Korea, Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
166	EUCTR2016-000642-62-NL (EUCTR)	13/06/2019	11/10/2018	A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis	M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	462	Phase 3	Portugal;Belarus;Serbia;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden
167	EUCTR2018-003558-26-SI (EUCTR)	12/06/2019	07/03/2019	Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments.	A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-a] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment.	Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464	ABIVAX	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	244	Phase 2	United States;Belarus;Serbia;Slovenia;Slovakia;Spain;Ukraine;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany
168	EUCTR2018-002136-24-BG (EUCTR)	12/06/2019	18/01/2019	A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Ulcerative Colitis	A Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with TD-1473 in Subjects with Moderately-to-Severely Active Ulcerative Colitis - Rhea: Efficacy and Safety of TD-1473 in Ulcerative Colitis	Moderately-to-Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060	Theravance Biopharma Ireland Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	880	Phase 2;Phase 3	Serbia;United States;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Australia;South Africa;Korea, Republic of;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Japan
169	NCT03760003 (ClinicalTrials.gov)	June 11, 2019	29/11/2018	Dose-Ranging Phase 2b Study of ABX464 in Moderate to Severe Ulcerative Colitis	A Randomized, Double Blind, Placebo Controlled, Parallel Group, Multiple Dose, Induction Study to Evaluate the Safety, Tolerability and Optimal Dose of ABX464 Compared With Placebo in Patients With Moderate to Severe Ulcerative Colitis Who Have Inadequate Response, Loss of Response, or Intolerance With at Least One of the Following Agents: Immunosuppressant Treatment (i.e. Azathioprine, 6-mercaptopurine, Methotrexate), Tumor Necrosis Factor Alpha [TNF-a] Inhibitors, Vedolizumab, JAK Inhibitors and/or Corticosteroid Treatment	Ulcerative Colitis	Drug: ABX464 25mg;Drug: ABX464 50mg;Drug: ABX464 100mg;Drug: Placebo	Abivax S.A.	NULL	Recruiting	18 Years	75 Years	All	232	Phase 2	United States;Austria;Belarus;Belgium;Canada;Czechia;France;Germany;Hungary;Italy;Poland;Serbia;Slovakia;Slovenia;Spain;Ukraine;United Kingdom
170	EUCTR2018-002135-19-ES (EUCTR)	10/06/2019	12/04/2019	A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Ulcerative Colitis (UC)	A 3-Year, Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects with Ulcerative Colitis (UC) - TD-1473 LTS UC Study	Moderately-to-severely active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Theravance Biopharma Ireland Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	500	Phase 3	Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;United Kingdom;France;Hungary;Canada;Poland;Croatia;Australia;South Africa;Bulgaria;Georgia;Germany
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
171	EUCTR2018-002135-19-PT (EUCTR)	05/06/2019	15/03/2019	A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Ulcerative Colitis (UC)	A 3-Year, Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects with Ulcerative Colitis (UC) - TD-1473 LTS UC Study	Moderately-to-severely active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Theravance Biopharma Ireland Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	500	Phase 3	Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;United Kingdom;France;Hungary;Canada;Poland;Croatia;Australia;Georgia;South Africa;Bulgaria;Germany
172	EUCTR2013-004279-11-FR (EUCTR)	03/06/2019	09/04/2019	A study of the effectiveness (efficacy) and safety of etrolizumab treatment, compared with Adalimumab and Placebo, in inducing disease remission in ulcerative colitis patients who have not previously received TNF inhibitors	PHASE III, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (INDUCTION OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH ADALIMUMAB AND PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - HIBISCUS I	Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	350	Phase 3	United States;Serbia;Estonia;Hong Kong;Slovakia;Ukraine;Russian Federation;France;Mexico;Argentina;Brazil;Poland;Australia;Bulgaria
173	EUCTR2018-003349-41-BG (EUCTR)	29/05/2019	27/02/2019	Clinical trial to evaluate the benefit and safety of ST-0529 in subjects who are suffering from active ulcerative colitis	A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of ST-0529 in Subjects with Moderately to Severely Active Ulcerative Colitis	Active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ST-0529 Product Code: FP-CYA-050 INN or Proposed INN: CICLOSPORIN Other descriptive name: cyclosporine Product Name: ST-0529 Product Code: FP-CYA-053 INN or Proposed INN: CICLOSPORIN Other descriptive name: cyclosporine	Sublimity Therapeutics (Hold Co) Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	280	Phase 2	Belarus;Serbia;United States;Ukraine;Israel;Russian Federation;United Kingdom;France;Hungary;Canada;Poland;Bulgaria;Germany
174	EUCTR2018-002135-19-SK (EUCTR)	28/05/2019	15/03/2019	A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Ulcerative Colitis (UC)	A 3-Year, Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects with Ulcerative Colitis (UC) - TD-1473 LTS UC Study	Moderately-to-severely active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060	Theravance Biopharma Ireland Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	500	Phase 3	Portugal;Serbia;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Australia;South Africa;Korea, Republic of;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Japan
175	EUCTR2018-000930-37-ES (EUCTR)	27/05/2019	22/01/2019	A Study to Investigate safety and how well ABBV-323 works and how safe it is in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy	A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of ABBV-323 in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	60	Phase 2	France;United States;Canada;Spain;Netherlands;Germany;Italy;United Kingdom
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
176	EUCTR2018-002136-24-ES (EUCTR)	23/05/2019	11/04/2019	A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Ulcerative Colitis	A Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with TD-1473 in Subjects with Moderately-to-Severely Active Ulcerative Colitis - Rhea: Efficacy and Safety of TD-1473 in Ulcerative Colitis	Moderately-to-Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060	Theravance Biopharma Ireland Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	880	Phase 2;Phase 3	United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;United Kingdom;India;France;Hungary;Canada;Poland;Croatia;Australia;South Africa;Bulgaria;Georgia;Germany
177	EUCTR2018-003558-26-SK (EUCTR)	23/05/2019	20/03/2019	Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments.	A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-a] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment.	Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464	ABIVAX	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	244	Phase 2	Slovenia;Spain;Ukraine;Austria;United Kingdom;Italy;France;Czech Republic;United States;Belarus;Serbia;Slovakia;Hungary;Canada;Belgium;Poland;Germany
178	EUCTR2018-003558-26-HU (EUCTR)	21/05/2019	25/03/2019	Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments.	A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-a] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment.	Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464	ABIVAX	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	232	Phase 2	United States;Belarus;Serbia;Czechia;Slovakia;Slovenia;Spain;Ukraine;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Germany
179	EUCTR2017-004092-31-FR (EUCTR)	21/05/2019	18/04/2019	A study of the efficacy and safety of Mirikizumab in Ulcerative Colitis	I6T-MC-AMAP A Phase 3, Multicenter, Open-Label Extension Study to Evaluate the Long- Term Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 3) - LUCENT 3	moderately to severely active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	840	Phase 3	Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Germany;Japan
180	EUCTR2018-003558-26-PL (EUCTR)	20/05/2019	12/04/2019	Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments.	A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-a] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment.	Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464	ABIVAX	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	244	Phase 2	Serbia;United States;Belarus;Slovakia;Slovenia;Spain;Ukraine;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Germany
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
181	EUCTR2016-004676-22-SI (EUCTR)	20/05/2019	06/02/2019	A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis Who Responded to Induction treatment in M16-067 or M16-065”	A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Risankizumab Product Code: ABBV-006 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	760	Phase 3	Bulgaria;Germany;New Zealand;Japan;Sweden;Romania;Croatia;United States;Serbia;Portugal;Belarus;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium
182	EUCTR2017-004576-57-PL (EUCTR)	18/05/2019	01/08/2019	Novel budesonide capsules vs. budesonide tabltes in patients with ulcerative colitis refractory to standard treatment with mesalazine	Randomised, double-blind, double-dummy, active-controlled, phase III clinical trial on the efficacy and safety of an 8-week add-on treatment with budesonide 9 mg capsules vs. budesonide 6 mg capsules vs. budesonide-MMX® 9 mg tablets in patients with ulcerative colitis refractory to standard treatment with mesalazine - TOPICAL-2	Patients with active ulcerative colitis refractory to standard treatment with mesalazine MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Budesonide 9 mg prolonged-release capsules, hard (BUX-PVII prototype) INN or Proposed INN: BUDESONIDE Product Name: Budesonide 6 mg prolonged-release capsules, hard (BUX-PVII prototype) INN or Proposed INN: BUDESONIDE Trade Name: CortimentMMX 9 mg INN or Proposed INN: BUDESONIDE	Dr. Falk Pharma GmbH	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	777	Phase 3	Hungary;Czech Republic;Slovakia;Poland;Ukraine;Lithuania;Russian Federation;Latvia;Germany
183	EUCTR2013-001682-16-DK (EUCTR)	09/05/2019	13/05/2014	A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis	A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	840	Phase 3	United States;Slovakia;Spain;Austria;Israel;Switzerland;Italy;Czech Republic;Hungary;Canada;Poland;Denmark;Germany;Netherlands;Japan
184	EUCTR2018-000930-37-FR (EUCTR)	07/05/2019	07/12/2018	A Study to Investigate safety and how well ABBV-323 works and how safe it is in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy	A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of ABBV-323 in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	60	Phase 2	United States;France;Canada;Spain;Netherlands;Germany;Italy;United Kingdom
185	EUCTR2018-003278-28-FR (EUCTR)	07/05/2019	09/05/2019	Safety, tolerability, efficacy and dose-response of GSK2831781 in ulcerative colitis.	A multicentre randomized, double-blind (sponsor open), placebo-controlled Phase 2 study to evaluate the safety, tolerability, efficacy, dose-response, pharmacokinetics and pharmacodynamics of repeat dosing of an anti-LAG3 cell depleting monoclonal antibody (GSK2831781) in patients with active ulcerative colitis	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: GSK2831781 INN or Proposed INN: Not Assigned Other descriptive name: GSK2831781	GlaxoSmithKline Research & Development Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	320	Phase 2	Serbia;United States;Estonia;Slovakia;Slovenia;Ukraine;Lithuania;Russian Federation;United Kingdom;India;France;Czech Republic;Hungary;Canada;Poland;South Africa;Bulgaria;Netherlands;Korea, Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
186	EUCTR2018-001510-15-DE (EUCTR)	02/05/2019	19/11/2018	A Proof-of-concept Study of the Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis	A Phase 2a Randomized, Double-blind, Active-controlled, Parallel-group, Multicenter, Proof-of-concept Clinical Study to Evaluate the Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis - VEGA	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Trade Name: TREMFYA ® Product Name: Guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Trade Name: Simponi ® Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB	Janssen-Cilag International NV	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	210	Phase 2	United States;Mexico;Argentina;Poland;Brazil;Ukraine;Australia;Russian Federation;Germany
187	EUCTR2018-003594-95-NL (EUCTR)	30/04/2019	30/04/2019	Addition of methotrexate to regain clinical response in IBD patients on anti-TNF therapy	Methotrexate to suppress immunogenicity to anti-tumor necrosis factor therapy in IBD patients with loss of response	Inflammatory bowel disease: Crohn's disease and Ulcerative colitis MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Amsterdam UMC location AMC	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	60	Phase 4	Netherlands
188	EUCTR2018-003278-28-GB (EUCTR)	29/04/2019	14/12/2018	Safety, tolerability, efficacy and dose-response of GSK2831781 in ulcerative colitis.	A multicentre randomized, double-blind, placebo-controlled Phase 2 study to evaluate the safety, tolerability, efficacy, dose-response, pharmacokinetics and pharmacodynamics of repeat dosing of an anti-LAG3 cell depleting monoclonal antibody (GSK2831781) in patients with active ulcerative colitis	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: GSK2831781 INN or Proposed INN: Not Assigned Other descriptive name: GSK2831781	GlaxoSmithKline Research & Development Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	320	Phase 2	United States;Serbia;Estonia;Slovenia;Slovakia;Ukraine;Lithuania;Russian Federation;Israel;United Kingdom;India;France;Czech Republic;Hungary;Mexico;Canada;Poland;South Africa;Bulgaria;Netherlands;Korea, Republic of
189	EUCTR2017-004576-57-DE (EUCTR)	26/04/2019	08/01/2019	Novel budesonide capsules vs. budesonide tablets in patients with ulcerative colitis refractory to standard treatment with mesalazine	Randomised, double-blind, double-dummy, active-controlled, phase III clinical trial on the efficacy and safety of an 8-week add-on treatment with budesonide 9 mg capsules vs. budesonide 6 mg capsules vs. budesonide-MMX® 9 mg tablets in patients with ulcerative colitis refractory to standard treatment with mesalazine - TOPICAL-2	Patients with active ulcerative colitis refractory to standard treatment with mesalazine MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Budesonide 9 mg prolonged-release capsule, hard (BUX-PVII prototype) INN or Proposed INN: BUDESONIDE Product Name: Budesonide 6 mg prolonged-release capsule, hard (BUX-PVII prototype) INN or Proposed INN: BUDESONIDE Trade Name: CortimentMMX 9 mg INN or Proposed INN: BUDESONIDE	Dr. Falk Pharma GmbH	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	777	Phase 3	Serbia;Czechia;Czech Republic;Hungary;Slovakia;Poland;Ukraine;Lithuania;Russian Federation;Latvia;Germany
190	EUCTR2018-003524-36-NL (EUCTR)	25/04/2019	19/11/2018	Randomized, mulitcenter study to investigate how infliximab dosing calculated by a computer compares to the standard dosing during the induction of infliximab in patients with severe colitis ulcerosa.	Randomized, Multicenter Study to Investigate the Efficacy of Dashboard Driven Individualized Dosing of Infliximab Compared To Standard Dosing During the Induction in Patients with Acute Severe Ulcerative Colitis - TITRATE	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		UMC Amsterdam location AMC	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	98	Phase 4	Netherlands
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
191	EUCTR2017-003703-22-PL (EUCTR)	25/04/2019	26/04/2018	Phase 2 Dose-finding IMU-838 for Ulcerative Colitis (CALDOSE-1)	A phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-finding study to evaluate the efficacy and safety of IMU-838 for induction and maintenance therapy in moderate-to-severe ulcerative colitis CALDOSE-1	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838	Immunic AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	240	Phase 2	Serbia;Portugal;United States;Belarus;Spain;Ukraine;Russian Federation;United Kingdom;Czech Republic;Macedonia, the former Yugoslav Republic of;Poland;Belgium;Romania;Croatia;Bulgaria;Germany;Netherlands;Bosnia and Herzegovina
192	EUCTR2018-000930-37-DE (EUCTR)	24/04/2019	18/10/2018	A Study to Investigate safety and how well Ravagalimab (ABBV-323) works and how safe it is in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy	A Multicenter, Single-Arm, Open-Label Study to Investigate the Efficacy and Safety of Ravagalimab (ABBV-323) in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Ravagalimab Product Code: ABBV-323 Other descriptive name: ABBV-323	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	40	Phase 2	United States;France;Hungary;Canada;Spain;Netherlands;Germany;United Kingdom;Italy;Korea, Republic of
193	EUCTR2017-004576-57-LV (EUCTR)	15/04/2019	14/01/2019	Novel budesonide capsules vs. budesonide tables in patients with ulcerative colitis refractory to standard treatment with mesalazine	Randomised, double-blind, double-dummy, active-controlled, phase III clinical trial on the efficacy and safety of an 8-week add-on treatment with budesonide 9 mg capsules vs. budesonide 6 mg capsules vs. budesonide-MMX® 9 mg tablets in patients with ulcerative colitis refractory to standard treatment with mesalazine - TOPICAL-2	Patients with active ulcerative colitis refractory to standard treatment with mesalazine MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Dr. Falk Pharma GmbH	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	777	Phase 3	Hungary;Czech Republic;Slovakia;Poland;Ukraine;Lithuania;Russian Federation;Germany;Latvia
194	EUCTR2018-002135-19-HU (EUCTR)	11/04/2019	19/02/2019	A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Ulcerative Colitis (UC)	A 3-Year, Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects with Ulcerative Colitis (UC) - TD-1473 LTS UC Study	Moderately-to-severely active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Theravance Biopharma Ireland Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	500	Phase 3	Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;United Kingdom;France;Hungary;Canada;Poland;Croatia;Australia;Georgia;South Africa;Bulgaria;Germany
195	EUCTR2013-004277-27-HU (EUCTR)	11/04/2019	25/02/2019	A study of the effectiveness (efficacy) and safety of etrolizumab treatment, compared with Adalimumab and Placebo, in inducing disease remission in ulcerative colitis patients who have not previously received TNF inhibitors	PHASE III, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBOCONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (INDUCTION OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH ADALIMUMAB AND PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - HIBISCUS II	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	350	Phase 3	United States;Greece;Ukraine;Turkey;Lithuania;Russian Federation;Colombia;Hungary;Czech Republic;Argentina;Poland;Brazil;Malaysia;Croatia;Australia;Bulgaria;Latvia;New Zealand
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
196	EUCTR2018-002136-24-PL (EUCTR)	04/04/2019	18/01/2019	A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Ulcerative Colitis	A Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with TD-1473 in Subjects with Moderately-to-Severely Active Ulcerative Colitis - Rhea: Efficacy and Safety of TD-1473 in Ulcerative Colitis	Moderately-to-Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060	Theravance Biopharma Ireland Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	880	Phase 2;Phase 3	United States;Portugal;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Australia;South Africa;Korea, Republic of;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Japan
197	EUCTR2018-002136-24-GR (EUCTR)	03/04/2019	18/02/2019	A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Ulcerative Colitis	A Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with TD-1473 in Subjects with Moderately-to-Severely Active Ulcerative Colitis - Rhea: Efficacy and Safety of TD-1473 in Ulcerative Colitis	Moderately-to-Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060	Theravance Biopharma Ireland Limited	NULL	Not Recruiting			Female: yes Male: yes	880	Phase 2;Phase 3	Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;United Kingdom;India;France;Hungary;Canada;Poland;Croatia;Australia;Georgia;South Africa;Bulgaria;Germany
198	EUCTR2018-002135-19-FR (EUCTR)	02/04/2019	02/04/2019	A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Ulcerative Colitis (UC)	A 3-Year, Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects with Ulcerative Colitis (UC) - TD-1473 LTS UC Study	Moderately-to-severely active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Theravance Biopharma Ireland Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	500	Phase 3	Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;United Kingdom;France;Hungary;Canada;Poland;Croatia;Australia;South Africa;Bulgaria;Georgia;Germany
199	EUCTR2018-003349-41-GB (EUCTR)	28/03/2019	21/12/2018	Clinical trial to evaluate the benefit and safety of ST-0529 in subjects who are suffering from active ulcerative colitis	A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of ST-0529 in Subjects with Moderately to Severely Active Ulcerative Colitis	Active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ST-0529 Product Code: FP-CYA-050 INN or Proposed INN: CICLOSPORIN Other descriptive name: cyclosporine	Sublimity Therapeutics (Hold Co) Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	380	Phase 2	Belarus;Serbia;United States;Spain;Ukraine;Ireland;Israel;Russian Federation;Italy;United Kingdom;France;Hungary;Canada;Poland;Romania;Bulgaria;Germany
200	EUCTR2017-004576-57-CZ (EUCTR)	27/03/2019	15/03/2019	Novel budesonide capsules vs. budesonide tablets in patients with ulcerative colitis refractory to standard treatment with mesalazine	Randomised, double-blind, double-dummy, active-controlled, phase III clinical trial on the efficacy and safety of an 8-week add-on treatment with budesonide 9 mg capsules vs. budesonide 6 mg capsules vs. budesonide-MMX® 9 mg tablets in patients with ulcerative colitis refractory to standard treatment with mesalazine - TOPICAL-2	Patients with active ulcerative colitis refractory to standard treatment with mesalazine MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Budesonide 9 mg prolonged-release capsules, hard (BUX-PVII prototype) INN or Proposed INN: BUDESONIDE Product Name: Budesonide 6 mg prolonged-release capsules, hard (BUX-PVII prototype) INN or Proposed INN: BUDESONIDE Trade Name: CortimentMMX 9 mg INN or Proposed INN: BUDESONIDE	Dr. Falk Pharma GmbH	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	777	Phase 3	Hungary;Czech Republic;Slovakia;Poland;Ukraine;Lithuania;Russian Federation;Latvia;Germany
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
201	EUCTR2018-000334-35-NL (EUCTR)	21/03/2019	29/08/2018	BI 655130 long-term treatment in patients with moderate-to-severe ulcerative colitis	An open label, long term safety trial of BI 655130 treatment in patients with moderate to severely active ulcerative colitis who have completed previous BI 655130 trials	Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]	Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1	Boehringer Ingelheim bv Netherlands	NULL	Not Recruiting			Female: yes Male: yes	160	Phase 2	United States;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;Korea, Republic of
202	EUCTR2016-000642-62-LT (EUCTR)	19/03/2019	15/11/2018	A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis	M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	462	Phase 3	Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden
203	EUCTR2013-004277-27-CZ (EUCTR)	18/03/2019	29/03/2019	A study of the effectiveness (efficacy) and safety of etrolizumab treatment, compared with Adalimumab and Placebo, in inducing disease remission in ulcerative colitis patients who have not previously received TNF inhibitors	PHASE III, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBOCONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (INDUCTION OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH ADALIMUMAB AND PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - HIBISCUS II	Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	350	Phase 3	United States;Greece;Ukraine;Lithuania;Turkey;Russian Federation;Colombia;Czech Republic;Hungary;Argentina;Poland;Malaysia;Brazil;Croatia;Australia;Bulgaria;Latvia;New Zealand
204	EUCTR2018-002136-24-PT (EUCTR)	18/03/2019	02/01/2019	A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Ulcerative Colitis	A Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with TD-1473 in Subjects with Moderately-to-Severely Active Ulcerative Colitis - Rhea: Efficacy and Safety of TD-1473 in Ulcerative Colitis	Moderately-to-Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060	Theravance Biopharma Ireland Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	880	Phase 2;Phase 3	United States;Portugal;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Australia;South Africa;Korea, Republic of;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Japan
205	NCT03884439 (ClinicalTrials.gov)	March 18, 2019	4/3/2019	Infliximab Biosimilar Pfizer Drug Use Investigation (Crohn's Disease or Ulcerative Colitis)	Infliximab BS for Intravenous Drip Infusion 100 mg Pfizer General Investigation (Crohn's Disease or Ulcerative Colitis)	Crohn's Disease;Ulcerative Colitis	Drug: Infliximab [infliximab biosimilar 3]	Pfizer	NULL	Recruiting	N/A	N/A	All	300		Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
206	EUCTR2017-004576-57-LT (EUCTR)	15/03/2019	29/01/2019	Novel budesonide capsules vs. budesonide tablets in patients with ulcerative colitis refractory to standard treatment with mesalazine	Randomised, double-blind, double-dummy, active-controlled, phase III clinical trial on the efficacy and safety of an 8-week add-on treatment with budesonide 9 mg capsules vs. budesonide 6 mg capsules vs. budesonide-MMX® 9 mg tablets in patients with ulcerative colitis refractory to standard treatment with mesalazine - TOPICAL-2	Patients with active ulcerative colitis refractory to standard treatment with mesalazine MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Budesonide 9 mg prolonged-release capsule, hard (BUX-PVII prototype) INN or Proposed INN: BUDESONIDE Product Name: Budesonide 6 mg prolonged-release capsule, hard (BUX-PVII prototype) INN or Proposed INN: BUDESONIDE Trade Name: CortimentMMX 9 mg INN or Proposed INN: BUDESONIDE	Dr. Falk Pharma GmbH	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	777	Phase 3	Hungary;Czech Republic;Slovakia;Poland;Ukraine;Lithuania;Russian Federation;Latvia;Germany
207	EUCTR2018-003364-31-PL (EUCTR)	15/03/2019	23/01/2019	A Phase II Study in Patients With Moderate to Severe Active Ulcerative Colitis.	A Phase II randomized, placebo controlled, double-blind, 4 arms dose-ranging study to evaluate the efficacy and safety of SHR0302 compared to placebo in patients with moderate to severe active Ulcerative Colitis.	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHR0302 INN or Proposed INN: Pending	Reistone Biopharma Company Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	152	Phase 2	United States;Poland;Ukraine;China
208	EUCTR2016-000642-62-PL (EUCTR)	14/03/2019	12/06/2019	A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis	M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	462	Phase 3	Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Singapore;Croatia;Germany;Norway;Japan;Sweden
209	EUCTR2017-004576-57-SK (EUCTR)	12/03/2019	18/01/2019	Novel budesonide capsules vs. budesonide tablets in patients with ulcerative colitis refractory to standard treatment with mesalazine	Randomised, double-blind, double-dummy, active-controlled, phase III clinical trial on the efficacy and safety of an 8-week add-on treatment with budesonide 9 mg capsules vs. budesonide 6 mg capsules vs. budesonide-MMX® 9 mg tablets in patients with ulcerative colitis refractory to standard treatment with mesalazine - TOPICAL-2	Patients with active ulcerative colitis refractory to standard treatment with mesalazine MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Budesonide 9 mg prolonged-release capsules, hard (BUX-PVII prototype) INN or Proposed INN: BUDESONIDE Product Name: Budesonide 6 mg prolonged-release capsules, hard (BUX-PVII prototype) INN or Proposed INN: BUDESONIDE Trade Name: CortimentMMX 9 mg INN or Proposed INN: BUDESONIDE	Dr. Falk Pharma GmbH	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	777	Phase 3	Hungary;Czech Republic;Slovakia;Poland;Ukraine;Lithuania;Russian Federation;Latvia;Germany
210	EUCTR2017-004576-57-HU (EUCTR)	11/03/2019	16/01/2019	Novel budesonide capsules vs. budesonide tablets in patients with ulcerative colitis refractory to standard treatment with mesalazine	Randomised, double-blind, double-dummy, active-controlled, phase III clinical trial on the efficacy and safety of an 8-week add-on treatment with budesonide 9 mg capsules vs. budesonide 6 mg capsules vs. budesonide-MMX® 9 mg tablets in patients with ulcerative colitis refractory to standard treatment with mesalazine - TOPICAL-2	Patients with active ulcerative colitis refractory to standard treatment with mesalazine MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Budesonide 9 mg prolonged-release capsules, hard (BUX-PVII prototype) INN or Proposed INN: BUDESONIDE Product Name: Budesonide 6 mg prolonged-release capsules, hard (BUX-PVII prototype) INN or Proposed INN: BUDESONIDE Trade Name: CortimentMMX 9 mg INN or Proposed INN: BUDESONIDE	Dr. Falk Pharma GmbH	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	777	Phase 3	Czech Republic;Hungary;Slovakia;Poland;Ukraine;Lithuania;Russian Federation;Latvia;Germany
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
211	EUCTR2018-001510-15-PL (EUCTR)	01/03/2019	04/02/2019	A Proof-of-concept Study of the Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis	A Phase 2a Randomized, Double-blind, Active-controlled, Parallel-group, Multicenter, Proof-of-concept Clinical Study to Evaluate the Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis - VEGA	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Janssen-Cilag International NV	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	210	Phase 2	United States;Mexico;Argentina;Brazil;Poland;Ukraine;Australia;Russian Federation;Germany
212	NCT03773445 (ClinicalTrials.gov)	March 1, 2019	25/11/2018	Golimumab Trough Levels in Patients With Ulcerative Colitis	Association of Golimumab Trough Levels With Endoscopic and Histologic Healing in Patients With Ulcerative Colitis	Ulcerative Colitis	Diagnostic Test: Golimumab trough levels;Diagnostic Test: Antibodies to golimumab;Diagnostic Test: Histology;Diagnostic Test: Colonoscopy	Hospital San Carlos, Madrid	Hospital Universitario La Fe;Hospital Universitario 12 de Octubre;Hospital Universitario Ramon y Cajal;Gregorio Marañón Hospital;Complejo Hospitalario de Navarra;Hospital Universitario Fundación Alcorcón;Hospital Infanta Sofia;Hospital Clínico Universitario de Valencia;Puerta de Hierro University Hospital;Hospital Universitario La Paz;Hospital Universitario de Fuenlabrada;Merck Sharp & Dohme Corp.	Recruiting	18 Years	N/A	All	100		Spain
213	EUCTR2018-003349-41-PL (EUCTR)	27/02/2019	15/01/2019	Clinical trial to evaluate the benefit and safety of ST-0529 in subjects who are suffering from active ulcerative colitis	A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of ST-0529 in Subjects with Moderately to Severely Active Ulcerative Colitis	Active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ST-0529 Product Code: FP-CYA-050 INN or Proposed INN: CICLOSPORIN Other descriptive name: cyclosporine Product Name: ST-0529 Product Code: FP-CYA-053 INN or Proposed INN: CICLOSPORIN Other descriptive name: cyclosporine	Sublimity Therapeutics (Hold Co) Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	280	Phase 2	Belarus;Serbia;United States;Ukraine;Israel;Russian Federation;United Kingdom;France;Hungary;Canada;Poland;Bulgaria;Germany
214	EUCTR2017-000574-11-GR (EUCTR)	26/02/2019	27/11/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn’s Disease (AIDA)	A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn’s Disease (AIDA) - AIDA	Ulcerative colitis or Crohn’s Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody	Shire Human Genetic Therapies, Inc.	NULL	Not Recruiting			Female: yes Male: yes	2453	Phase 3	United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;New Zealand
215	EUCTR2018-000334-35-PL (EUCTR)	21/02/2019	07/12/2018	BI 655130 long-term treatment in patients with moderate-to-severe ulcerative colitis	An open label, long term safety trial of BI 655130 (Spesolimab) treatment in patients with moderate to severely active ulcerative colitis who have completed previous BI 655130 trials	Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]	Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1	Boehringer Ingelheim RCV GmbH&Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	160	Phase 2	United States;Czechia;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;Hungary;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;Korea, Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
216	EUCTR2018-003349-41-HU (EUCTR)	19/02/2019	08/01/2019	Clinical trial to evaluate the benefit and safety of ST-0529 in subjects who are suffering from active ulcerative colitis	A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of ST-0529 in Subjects with Moderately to Severely Active Ulcerative Colitis	Active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Sublimity Therapeutics (Hold Co) Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	280	Phase 2	Serbia;United States;Belarus;Spain;Ukraine;Ireland;Turkey;Russian Federation;Israel;United Kingdom;France;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Germany
217	EUCTR2018-002136-24-SK (EUCTR)	19/02/2019	28/12/2018	A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Ulcerative Colitis	A Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with TD-1473 in Subjects with Moderately-to-Severely Active Ulcerative Colitis - Rhea: Efficacy and Safety of TD-1473 in Ulcerative Colitis	Moderately-to-Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060	Theravance Biopharma Ireland Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	880	Phase 2;Phase 3	Portugal;Serbia;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Australia;South Africa;Korea, Republic of;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Japan
218	EUCTR2018-002136-24-HU (EUCTR)	18/02/2019	29/03/2019	A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Ulcerative Colitis	A Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with TD-1473 in Subjects with Moderately-to-Severely Active Ulcerative Colitis - Rhea: Efficacy and Safety of TD-1473 in Ulcerative Colitis	Moderately-to-Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060	Theravance Biopharma Ireland Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	880	Phase 2;Phase 3	Portugal;Serbia;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Australia;South Africa;Korea, Republic of;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Japan
219	EUCTR2017-003229-14-HR (EUCTR)	08/02/2019	16/05/2019	AN INDUCTION STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS	A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 1) - LUCENT 1	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1160	Phase 3	Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan
220	EUCTR2017-003238-96-HR (EUCTR)	08/02/2019	17/05/2019	A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS	A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-ARM, PLACEBO-CONTROLLED MAINTENANCE STUDY OF MIRIKIZUMAB IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS (LUCENT 2) - LUCENT 2	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1044	Phase 3	Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
221	EUCTR2017-004997-32-HU (EUCTR)	04/02/2019	04/04/2019	A Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's Disease	A PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE	Ulcerative Colitis (UC) or Crohn's Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Genentech, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	320	Phase 2	Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;United Kingdom;Italy;Hungary;Poland;Bulgaria;Germany;Netherlands
222	EUCTR2016-004676-22-HR (EUCTR)	01/02/2019	16/05/2019	A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis Who Responded to Induction treatment in M16-067 or M16-065”	A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Risankizumab Product Code: ABBV-006 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	760	Phase 3	Serbia;Portugal;United States;Belarus;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden
223	JPRN-JapicCTI-194603	01/2/2019	30/01/2019	Specified Drug-Use Survey on Vedolizumab for IV Infusion 300 mg [Ulcerative Colitis]	Specified Drug-Use Survey on Entyvio for IV Infusion 300 mg [Ulcerative Colitis]	Ulcerative colitis	Intervention name : Vedolizumab INN of the intervention : Vedolizumab Dosage And administration of the intervention : Vedolizumab intravenous (IV) infusion 300 mg, at Weeks 0, 2 and 6, and every 8 weeks thereafter, for up to 54 weeks. Participants will receive IV infusion as part of routine medical care. Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : -	Takeda Pharmaceutical Company Limited	NULL	recruiting			BOTH	1000	NA	Japan
224	NCT03824561 (ClinicalTrials.gov)	February 1, 2019	29/1/2019	Specified Drug-Use Survey on Vedolizumab for IV Infusion 300 mg [Ulcerative Colitis]	Specified Drug-Use Survey on Entyvio for IV Infusion 300 mg [Ulcerative Colitis]	Ulcerative Colitis	Drug: Vedolizumab	Takeda	NULL	Recruiting	N/A	N/A	All	1000		Japan
225	EUCTR2017-004496-31-PL (EUCTR)	30/01/2019	06/12/2018	A Study of the Efficacy and Safety of Golimumab in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis	A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety,and Pharmacokinetics of Golimumab Treatment, a Human anti-TNFa Monoclonal Antibody, Administered Subcutaneously in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis - PURSUIT 2	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Remicade Product Name: Infliximab Product Code: CNTO312 INN or Proposed INN: INFLIXIMAB	Janssen Biologics BV	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	125	Phase 3	United States;France;Taiwan;Spain;Brazil;Belgium;Poland;Israel;Netherlands;Italy;Korea, Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
226	EUCTR2017-004997-32-NL (EUCTR)	30/01/2019	06/12/2018	A Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's Disease	A PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE	Ulcerative Colitis (UC) or Crohn's Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: UTTR1147A/RO7021610 (Active) INN or Proposed INN: n.a. Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc	Genentech, Inc.	NULL	Not Recruiting			Female: yes Male: yes	320	Phase 2	Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;United Kingdom;Italy;Hungary;Poland;Bulgaria;Netherlands;Germany
227	EUCTR2016-000642-62-SK (EUCTR)	28/01/2019	28/01/2019	A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	522	Phase 3	Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden
228	EUCTR2017-004092-31-HU (EUCTR)	23/01/2019	15/06/2018	A study of the efficacy and safety of Mirikizumab in Ulcerative Colitis	I6T-MC-AMAP A Phase 3, Multicenter, Open-Label Extension Study to Evaluate the Long- Term Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 3) - LUCENT 3	moderately to severely active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	840	Phase 3	Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Germany;Japan
229	EUCTR2016-004676-22-DE (EUCTR)	22/01/2019	15/06/2018	A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis	A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Risankizumab Product Code: ABBV-006 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	942	Phase 3	United States;Serbia;Portugal;Belarus;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Czechia;Slovenia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden
230	EUCTR2016-000642-62-ES (EUCTR)	17/01/2019	24/01/2019	A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis	M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	462	Phase 3	Portugal;Serbia;Belarus;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Singapore;Croatia;Germany;Norway;Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
231	EUCTR2016-000642-62-CZ (EUCTR)	14/01/2019	14/11/2018	A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis	M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	522	Phase 3	Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden
232	EUCTR2016-004676-22-BE (EUCTR)	14/01/2019	04/04/2018	A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis Who Responded to Induction treatment in M16-067 or M16-065”	A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Risankizumab Product Code: ABBV-006 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	760	Phase 3	United States;Serbia;Portugal;Belarus;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden
233	EUCTR2017-004092-31-PL (EUCTR)	08/01/2019	17/10/2018	A study of the efficacy and safety of Mirikizumab in Ulcerative Colitis	I6T-MC-AMAPA Phase 3, Multicenter, Open-Label Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients with Moderately toSeverely Active Ulcerative Colitis (LUCENT 3) - LUCENT 3	moderately to severely active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: mirikizumab Other descriptive name: MIRIKIZUMAB	Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	840	Phase 3	United States;Serbia;Taiwan;Saudi Arabia;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Georgia;Germany;Japan
234	EUCTR2017-004997-32-GB (EUCTR)	04/01/2019	09/10/2018	A Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's Disease	A PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE	Ulcerative Colitis (UC) or Crohn's Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: UTTR1147A/RO7021610 (Active) INN or Proposed INN: n.a. Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc	Genentech, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	320	Phase 2	United States;Serbia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Poland;Bulgaria;Netherlands;Germany
235	EUCTR2018-000930-37-GB (EUCTR)	03/01/2019	01/11/2018	A Study to Investigate safety and how well Ravagalimab (ABBV-323) works and how safe it is in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy	A Multicenter, Single-Arm, Open-Label Study to Investigate the Efficacy and Safety of Ravagalimab (ABBV-323) in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Ravagalimab Other descriptive name: ABBV-323	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	40	Phase 2	United States;France;Hungary;Canada;Spain;Netherlands;Germany;Italy;United Kingdom;Korea, Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
236	EUCTR2016-000642-62-AT (EUCTR)	02/01/2019	30/10/2018	A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis	M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	522	Phase 3	Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden
237	EUCTR2018-002925-47-ES (EUCTR)	28/12/2018	16/11/2018	prediction of response to therapy in inflammatory bowel disease	Identification of predictive biomarkers for response to biologic therapies in inflammatory bowel disease by proteomic and mass cytometry approaches	Inflammatory bowel disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Fundación de Investigación Biomédica del Hospital Universitario de La Princesa	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	180	Phase 4	Spain
238	EUCTR2018-000930-37-NL (EUCTR)	21/12/2018	11/10/2018	A Study to Investigate safety and how well ABBV-323 works and how safe it is in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy	A Multicenter, Single-Arm, Open-Label Study to Investigate the Efficacy and Safety of ABBV-323 in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	40	Phase 2	France;United States;Canada;Spain;Germany;Netherlands;Italy;United Kingdom;Korea, Republic of
239	EUCTR2016-004676-22-GB (EUCTR)	20/12/2018	03/07/2018	A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis	A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safetyof Risankizumab in Subjects with Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Risankizumab Product Code: ABBV-006 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	942	Phase 3	United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Czechia;Slovenia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden
240	EUCTR2016-000642-62-HU (EUCTR)	19/12/2018	08/01/2019	A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis	M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	462	Phase 3	Portugal;Serbia;Belarus;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Singapore;Croatia;Germany;Norway;Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
241	EUCTR2017-004496-31-FR (EUCTR)	17/12/2018	14/09/2018	A Study of the Efficacy and Safety of Golimumab in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis	A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety,and Pharmacokinetics of Golimumab Treatment, a Human anti-TNFa Monoclonal Antibody, Administered Subcutaneously in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis - PURSUIT 2	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Janssen Biologics BV	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	125	Phase 3	United States;France;Taiwan;Poland;Brazil;Belgium;Spain;Israel;Netherlands;Italy;Korea, Republic of
242	EUCTR2017-004997-32-IE (EUCTR)	14/12/2018	13/12/2018	A Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's Disease	A PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE	Ulcerative Colitis (UC) or Crohn's Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: UTTR1147A/RO7021610 (Active) INN or Proposed INN: n.a. Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc	Genentech, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	320	Phase 2	Serbia;United States;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Poland;Bulgaria;Netherlands;Germany
243	EUCTR2016-000642-62-LV (EUCTR)	13/12/2018	15/10/2018	A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis	M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	462	Phase 3	Portugal;Serbia;Belarus;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Singapore;Croatia;Germany;Norway;Japan
244	EUCTR2018-000334-35-DE (EUCTR)	12/12/2018	20/08/2018	BI 655130 long-term treatment in patients with moderate-to-severe ulcerative colitis	An open label, long term safety trial of BI 655130 (Spesolimab) treatment in patients with moderate to severely active ulcerative colitis who have completed previous BI 655130 trials	Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]	Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1	Boehringer Ingelheim Pharma GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	160	Phase 2	United States;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Denmark;Norway;Germany;Netherlands;Japan;Korea, Republic of
245	EUCTR2017-002350-36-GB (EUCTR)	10/12/2018	13/04/2018	A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared with Placebo and Compared with Vedolizumab in Patients with Moderate to Severe Ulcerative Colitis.	A PHASE II, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF UTTR1147A COMPARED WITH PLACEBO AND COMPARED WITH VEDOLIZUMAB IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Ulcerative colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: n.a. Product Code: UTTR1147A/RO7021610 (Active) INN or Proposed INN: n.a. Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc Trade Name: Entyvio 300mg Product Code: RO7246311 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB	Genentech, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	270	Phase 2	United States;Serbia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Poland;Bulgaria;Netherlands;Germany
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
246	EUCTR2017-004997-32-ES (EUCTR)	10/12/2018	17/09/2018	A Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's Disease	A PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE	Ulcerative Colitis (UC) or Crohn's Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Roche Farma, S.A por delegación de Genentech, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	320	Phase 2	Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;United Kingdom;Italy;Hungary;Poland;Bulgaria;Germany;Netherlands
247	EUCTR2016-004677-40-DE (EUCTR)	04/12/2018	26/06/2018	A Study to Evaluate the Efficacy and Safety of Risankizumab in Subjectswith Moderately to Severely Active Ulcerative Colitis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled InductionStudy to Evaluate the Efficacy and Safety of Risankizumab in Subjects withModerately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1547	Phase 2;Phase 3	United States;Serbia;Portugal;Belarus;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Czechia;Slovenia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden
248	EUCTR2016-004677-40-BE (EUCTR)	29/11/2018	04/04/2018	A Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1547	Phase 2;Phase 3	Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden;United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Denmark;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Turkey
249	EUCTR2017-003229-14-DK (EUCTR)	20/11/2018	11/10/2018	AN INDUCTION STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS	A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 1) - LUCENT 1	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB	Eli Lilly Cork Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1160	Phase 3	Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan
250	EUCTR2017-003238-96-DK (EUCTR)	20/11/2018	09/10/2018	A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS	A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-ARM, PLACEBO-CONTROLLED MAINTENANCE STUDY OF MIRIKIZUMAB IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS (LUCENT 2) - LUCENT 2	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1044	Phase 3	Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
251	EUCTR2016-000642-62-FI (EUCTR)	13/11/2018	16/10/2018	A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis	M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	462	Phase 3	Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden
252	EUCTR2017-004496-31-BE (EUCTR)	07/11/2018	25/07/2018	A Study of the Efficacy and Safety of Golimumab in Pediatric Participantswith Moderately to Severely Active Ulcerative Colitis	A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety,and Pharmacokinetics of Golimumab Treatment, a Human anti-TNFaMonoclonal Antibody, Administered Subcutaneously in PediatricParticipants with Moderately to Severely Active Ulcerative Colitis - PURSUIT 2	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Remicade Product Name: Infliximab INN or Proposed INN: INFLIXIMAB	Janssen Biologics BV	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	125	Phase 3	France;United States;Taiwan;Poland;Brazil;Spain;Belgium;Israel;Netherlands;Italy;Korea, Republic of
253	EUCTR2017-004092-31-LV (EUCTR)	02/11/2018	27/08/2018	A study of the efficacy and safety of Mirikizumab in Ulcerative Colitis	I6T-MC-AMAP A Phase 3, Multicenter, Open-Label Extension Study to Evaluate the Long- Term Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 3) - LUCENT 3	moderately to severely active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	840	Phase 3	Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Germany;Japan
254	EUCTR2017-003229-14-GB (EUCTR)	24/10/2018	04/05/2018	AN INDUCTION STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS	A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 1) - LUCENT 1	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1160	Phase 3	Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan
255	EUCTR2017-003229-14-AT (EUCTR)	24/10/2018	22/06/2018	AN INDUCTION STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS	A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 1) - LUCENT 1	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1160	Phase 3	Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
256	EUCTR2017-003238-96-AT (EUCTR)	24/10/2018	22/06/2018	A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS	A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-ARM, PLACEBO-CONTROLLED MAINTENANCE STUDY OF MIRIKIZUMAB IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS (LUCENT 2) - LUCENT 2	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1044	Phase 3	Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan
257	EUCTR2017-004092-31-DK (EUCTR)	23/10/2018	26/06/2018	A study of the efficacy and safety of Mirikizumab in Ulcerative Colitis	I6T-MC-AMAP A Phase 3, Multicenter, Open-Label Extension Study to Evaluate the Long- Term Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 3) - LUCENT 3	moderately to severely active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	840	Phase 3	Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Germany;Japan
258	EUCTR2018-000334-35-BE (EUCTR)	22/10/2018	06/07/2018	BI 655130 long-term treatment in patients with moderate-to-severe ulcerative colitis	An open label, long term safety trial of BI 655130 treatment in patients with moderate to severely active ulcerative colitis who have completed previous BI 655130 trials	Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]		SCS Boehringer Ingelheim Comm. V	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	160	Phase 2	United States;Spain;Austria;Russian Federation;United Kingdom;Italy;Hungary;Canada;Belgium;Poland;Norway;Germany;Netherlands;Japan;Korea, Republic of
259	EUCTR2017-003238-96-GB (EUCTR)	22/10/2018	04/05/2018	A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS	A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-ARM, PLACEBO-CONTROLLED MAINTENANCE STUDY OF MIRIKIZUMAB IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS (LUCENT 2) - LUCENT 2	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1044	Phase 3	Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan
260	EUCTR2018-000334-35-GB (EUCTR)	22/10/2018	25/07/2018	BI 655130 long-term treatment in patients with moderate-to-severe ulcerative colitis	An open label, long term safety trial of BI 655130 (Spesolimab) treatment in patients with moderate to severely active ulcerative colitis who have completed previous BI 655130 trials	Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]	Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1	Boehringer Ingelheim LImited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	160	Phase 2	United States;Spain;Austria;Russian Federation;United Kingdom;Italy;Hungary;Canada;Belgium;Poland;Norway;Germany;Netherlands;Japan;Korea, Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
261	EUCTR2017-000402-38-SE (EUCTR)	19/10/2018	25/05/2018	A clinical trail to evaluate the testicular safety of Filgotinib in adult males with Ulcerative Colitis	A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Testicular Safety of Filgotinib in Adult Males with Moderately to Severely Active Ulcerative Colitis	To evaluate the testicular safety of filgotinib in adult males with ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: GS-6034 INN or Proposed INN: FILGOTINIB	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: no Male: yes	250	Phase 2	United States;Portugal;Spain;Ukraine;Austria;Russian Federation;Sri Lanka;United Kingdom;Italy;India;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Australia;Germany;Netherlands;New Zealand;Sweden
262	EUCTR2017-004496-31-ES (EUCTR)	15/10/2018	28/08/2018	A Study of the Efficacy and Safety of Golimumab in Pediatric Participantswith Moderately to Severely Active Ulcerative Colitis	A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety,and Pharmacokinetics of Golimumab Treatment, a Human anti-TNFaMonoclonal Antibody, Administered Subcutaneously in PediatricParticipants with Moderately to Severely Active Ulcerative Colitis - PURSUIT 2	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Remicade Product Name: Infliximab INN or Proposed INN: INFLIXIMAB	Janssen Biologics BV	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	125	Phase 3	France;United States;Taiwan;Poland;Brazil;Belgium;Spain;Israel;Netherlands;Italy;Korea, Republic of
263	EUCTR2017-003238-96-DE (EUCTR)	15/10/2018	03/05/2018	A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS	A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-ARM, PLACEBO-CONTROLLED MAINTENANCE STUDY OF MIRIKIZUMAB IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS (LUCENT 2) - LUCENT 2	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB	Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1044	Phase 3	United States;Serbia;Taiwan;Saudi Arabia;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Latvia;Netherlands;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Romania;Germany;Japan
264	EUCTR2017-003229-14-DE (EUCTR)	15/10/2018	30/04/2018	AN INDUCTION STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS	A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 1) - LUCENT 1	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB	Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1160	Phase 3	Germany;Japan;United States;Serbia;Taiwan;Saudi Arabia;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Latvia;Netherlands;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Romania
265	EUCTR2017-004092-31-NL (EUCTR)	10/10/2018	01/06/2018	A study of the efficacy and safety of Mirikizumab in Ulcerative Colitis	I6T-MC-AMAPA Phase 3, Multicenter, Open-Label Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients with Moderately toSeverely Active Ulcerative Colitis (LUCENT 3) - LUCENT 3	moderately to severely active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: mirikizumab Other descriptive name: MIRIKIZUMAB	Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	840	Phase 3	Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;Denmark;Latvia;Netherlands;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Germany;Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
266	EUCTR2017-002350-36-GR (EUCTR)	03/10/2018	10/09/2018	A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared with Placebo and Compared with Vedolizumab in Patients with Moderate to Severe Ulcerative Colitis.	A PHASE II, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF UTTR1147A COMPARED WITH PLACEBO AND COMPARED WITH VEDOLIZUMAB IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Ulcerative colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: n.a. Product Code: UTTR1147A/RO7021610 (Active) INN or Proposed INN: n.a. Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc Trade Name: Entyvio 300mg Product Code: RO7246311 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB	Genentech, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	270	Phase 2	Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;United Kingdom;Italy;Hungary;Poland;Bulgaria;Germany;Netherlands
267	EUCTR2017-000574-11-EE (EUCTR)	03/10/2018	11/06/2018	Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn’s Disease (AIDA)	A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn’s Disease (AIDA) - AIDA	Ulcerative colitis or Crohn’s Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Shire Human Genetic Therapies, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2453	Phase 3	Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Italy;Switzerland;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
268	EUCTR2016-004676-22-SE (EUCTR)	02/10/2018	16/04/2018	A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis	A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Risankizumab Product Code: ABBV-006 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	942	Phase 3	United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden
269	EUCTR2016-004677-40-SE (EUCTR)	02/10/2018	16/04/2018	A Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1547	Phase 2;Phase 3	United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden
270	NCT03669029 (ClinicalTrials.gov)	October 1, 2018	4/7/2018	Optimization of Golimumab Treatment in Ulcerative Colitis	Optimization of Golimumab Treatment in Ulcerative Colitis	Colitis, Ulcerative	Drug: Golimumab 50 mg in patients <80 kg and Golimumab 100 mg in patients >80 kg;Drug: Golimumab treatment optimization.	Hospital de Manises	Valencia University General Hospital;Hospital Clínico Universitario de Valencia;Hospital de Sagunto;Hospital Universitario La Fe;Hospital General Universitario de Alicante;Hospital Universitario Doctor Peset;Hospital Arnau de Vilanova;Hospital Provincial de Castellon;Merck Sharp & Dohme Corp.	Unknown status	18 Years	80 Years	All	50	Phase 4	Spain
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
271	EUCTR2017-002350-36-DE (EUCTR)	27/09/2018	13/04/2018	A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared with Placebo and Compared with Vedolizumab in Patients with Moderate to Severe Ulcerative Colitis.	A PHASE II, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF UTTR1147A COMPARED WITH PLACEBO AND COMPARED WITH VEDOLIZUMAB IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Ulcerative colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: n.a. Product Code: UTTR1147A/RO7021610 (Active) INN or Proposed INN: n.a. Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc Trade Name: Entyvio 300mg Product Code: RO7246311 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB	Genentech, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	270	Phase 2	Serbia;United States;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Poland;Bulgaria;Netherlands;Germany
272	EUCTR2017-003238-96-HU (EUCTR)	27/09/2018	13/06/2018	A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS	A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-ARM, PLACEBO-CONTROLLED MAINTENANCE STUDY OF MIRIKIZUMAB IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS (LUCENT 2) - LUCENT 2	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1044	Phase 3	Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan
273	EUCTR2017-003229-14-HU (EUCTR)	27/09/2018	15/06/2018	AN INDUCTION STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS	A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 1) - LUCENT 1	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB	Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1160	Phase 3	Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan
274	EUCTR2018-000334-35-ES (EUCTR)	17/09/2018	17/07/2018	BI 655130 long-term treatment in patients with moderate-to-severe ulcerative colitis	An open label, long term safety trial of BI 655130 treatment in patients with moderate to severely active ulcerative colitis who have completed previous BI 655130 trials	Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]	Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1	Boehringer Ingelheim España, S.A.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	160	Phase 2	United States;Spain;Austria;Russian Federation;United Kingdom;Italy;Canada;Belgium;Poland;Germany;Netherlands;Japan;Korea, Republic of
275	EUCTR2017-004092-31-BE (EUCTR)	13/09/2018	07/06/2018	A study of the efficacy and safety of Mirikizumab in Ulcerative Colitis	I6T-MC-AMAPA Phase 3, Multicenter, Open-Label Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients with Moderately toSeverely Active Ulcerative Colitis (LUCENT 3) - LUCENT 3	moderately to severely active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: mirikizumab Other descriptive name: MIRIKIZUMAB	Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	840	Phase 3	Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Germany;Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
276	EUCTR2018-002794-21-GB (EUCTR)	11/09/2018	04/09/2018	Investigation of the Faecal loss of Vedolizumab and its role in influencing serum drug levels, Outcomes and Response in ulcerative colitis	Investigation of the Faecal loss of Vedolizumab and its role in influencing serum drug levels, Outcomes and Response in ulcerative colitis - FAVOUR	Ulcerative colitis (UC) MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Guy's & St Thomas NHS Foundation Trust	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	30	Phase 4	United Kingdom
277	EUCTR2018-001051-12-FR (EUCTR)	07/09/2018	19/04/2018	VEDO - PREDIRESPUC project - Vedolizumab and anti-vedolizumab antibody in the prediction of therapeutic response in Ulcerative Colitis	VEDO - PREDIRESPUC project - Value of pharmacokinetic assays (Vedolizumab and anti-vedolizumab antibody) in the prediction of induction and maintenance therapeutic response in Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: ENTYVIO Product Name: ENTYVIO Product Code: 1	CHU Saint-Etienne	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	125	Phase 4	France
278	EUCTR2017-003229-14-SK (EUCTR)	06/09/2018	06/07/2018	AN INDUCTION STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS	A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 1) - LUCENT 1	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1160	Phase 3	Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan
279	EUCTR2018-002673-21-FR (EUCTR)	04/09/2018	06/07/2018	EFFICACI : EFFicacy of intravenous Infliximab versus vedolizumab after failure of subCutaneous Anti-TNF in patients with UlCerative colitis : A double blinded Randomized Clinical Trial.	EFFICACI : EFFicacy of intravenous Infliximab versus vedolizumab after failure of subCutaneous Anti-TNF in patients with UlCerative colitis : A double blinded Randomized Clinical Trial. - EFFICACI	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]	Trade Name: Remicade Product Name: infliximab INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra Product Name: infliximab INN or Proposed INN: INFLIXIMAB Trade Name: Flixabi Product Name: infliximab INN or Proposed INN: INFLIXIMAB Trade Name: Remsima Product Name: infliximab INN or Proposed INN: INFLIXIMAB Trade Name: Entyvio Product Name: Vedolizumab Other descriptive name: VEDOLIZUMAB	Centre Hospitalier Universitaire de Rennes	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	150	Phase 4	France
280	EUCTR2017-003238-96-SK (EUCTR)	04/09/2018	20/07/2018	A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS	A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-ARM, PLACEBO-CONTROLLED MAINTENANCE STUDY OF MIRIKIZUMAB IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS (LUCENT 2) - LUCENT 2	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1044	Phase 3	Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
281	EUCTR2017-004230-28-NL (EUCTR)	30/08/2018	15/03/2018	BI 655130 induction treatment in patients with moderate-tosevere ulcerative colitis	A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI 655130 Induction Therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy	Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]	Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1	Boehringer Ingelheim bv	NULL	Not Recruiting			Female: yes Male: yes	550	Phase 2;Phase 3	United States;Taiwan;Greece;Spain;Austria;Russian Federation;Italy;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Netherlands;Germany;Japan;Korea, Republic of
282	EUCTR2017-003238-96-LV (EUCTR)	30/08/2018	21/05/2018	A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS	A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-ARM, PLACEBO-CONTROLLED MAINTENANCE STUDY OF MIRIKIZUMAB IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS (LUCENT 2) - LUCENT 2	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1044	Phase 3	Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan
283	EUCTR2016-004676-22-LV (EUCTR)	30/08/2018	29/08/2018	A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis Who Responded to Induction treatment in M16-067 or M16-065”	A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Risankizumab Product Code: ABBV-006 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	760	Phase 3	Korea, Republic of;Serbia;Portugal;United States;Belarus;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;China;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden
284	EUCTR2017-002350-36-NL (EUCTR)	28/08/2018	24/04/2018	A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared with Placebo and Compared with Vedolizumab in Patients with Moderate to Severe Ulcerative Colitis.	A PHASE II, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF UTTR1147A COMPARED WITH PLACEBO AND COMPARED WITH VEDOLIZUMAB IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Ulcerative colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: UTTR1147A/RO7021610 (Active) INN or Proposed INN: n.a. Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc Trade Name: Entyvio 300mg Product Code: RO7246311 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB	Genentech, Inc.	NULL	Not Recruiting			Female: yes Male: yes	330	Phase 2	Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;United Kingdom;Italy;Hungary;Poland;Bulgaria;Netherlands;Germany
285	EUCTR2017-002350-36-IE (EUCTR)	28/08/2018	16/04/2018	A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared with Placebo and Compared with Vedolizumab in Patients with Moderate to Severe Ulcerative Colitis.	A PHASE II, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF UTTR1147A COMPARED WITH PLACEBO AND COMPARED WITH VEDOLIZUMAB IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Ulcerative colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: n.a. Product Code: UTTR1147A/RO7021610 (Active) INN or Proposed INN: n.a. Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc Trade Name: Entyvio 300mg Product Code: RO7246311 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB	Genentech, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	270	Phase 2	Serbia;United States;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Poland;Bulgaria;Netherlands;Germany
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
286	EUCTR2017-000573-37-EE (EUCTR)	27/08/2018	11/06/2018	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 303).	A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Shire Human Genetic Therapies, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	772	Phase 3	Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Italy;Switzerland;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
287	EUCTR2016-004676-22-LT (EUCTR)	23/08/2018	26/06/2018	A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis	A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Risankizumab Product Code: ABBV-006 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	942	Phase 3	United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Denmark;South Africa;Latvia;Netherlands;China;Korea, Republic of;Czechia;Slovenia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden
288	EUCTR2016-004677-40-LT (EUCTR)	23/08/2018	13/06/2018	A Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1547	Phase 2;Phase 3	United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Denmark;South Africa;Latvia;Netherlands;China;Korea, Republic of;Czechia;Slovenia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden
289	EUCTR2017-002350-36-BG (EUCTR)	22/08/2018	28/05/2018	A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared with Placebo and Compared with Vedolizumab in Patients with Moderate to Severe Ulcerative Colitis.	A PHASE II, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF UTTR1147A COMPARED WITH PLACEBO AND COMPARED WITH VEDOLIZUMAB IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Ulcerative colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: n.a. Product Code: UTTR1147A/RO7021610 (Active) INN or Proposed INN: n.a. Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc Trade Name: Entyvio 300mg Product Code: RO7246311 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB	Genentech, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	270	Phase 2	United States;Serbia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Poland;Bulgaria;Netherlands;Germany
290	EUCTR2018-000334-35-AT (EUCTR)	20/08/2018	09/07/2018	BI 655130 long-term treatment in patients with moderate-to-severe ulcerative colitis	An open label, long term safety trial of BI 655130 (Spesolimab) treatment in patients with moderate to severely active ulcerative colitis who have completed previous BI 655130 trials	Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]	Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 INN or Proposed INN: spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 INN or Proposed INN: spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1	Boehringer Ingelheim RCV GmbH&Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	160	Phase 2	United States;Spain;Austria;Russian Federation;Italy;United Kingdom;Hungary;Canada;Belgium;Poland;Norway;Germany;Netherlands;Japan;Korea, Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
291	EUCTR2017-003238-96-CZ (EUCTR)	16/08/2018	30/05/2018	A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS	A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-ARM, PLACEBO-CONTROLLED MAINTENANCE STUDY OF MIRIKIZUMAB IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS (LUCENT 2) - LUCENT 2	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1044	Phase 3	Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan
292	EUCTR2017-003229-14-CZ (EUCTR)	16/08/2018	30/05/2018	AN INDUCTION STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS	A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 1) - LUCENT 1	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB	Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1160	Phase 3	France;Malaysia;Denmark;Australia;Latvia;Netherlands;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Romania;Germany;Japan;United States;Serbia;Taiwan;Saudi Arabia;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India
293	EUCTR2017-003229-14-LV (EUCTR)	03/08/2018	21/05/2018	AN INDUCTION STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS	A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 1) - LUCENT 1	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1160	Phase 3	Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan
294	EUCTR2017-003238-96-ES (EUCTR)	01/08/2018	04/06/2018	A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS	A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-ARM, PLACEBO-CONTROLLED MAINTENANCE STUDY OF MIRIKIZUMAB IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS (LUCENT 2) - LUCENT 2	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB	Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1044	Phase 3	Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan
295	EUCTR2017-003238-96-BE (EUCTR)	27/07/2018	07/06/2018	A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS	A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-ARM, PLACEBO-CONTROLLED MAINTENANCE STUDY OF MIRIKIZUMAB IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS (LUCENT 2) - LUCENT 2	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1044	Phase 3	Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
296	EUCTR2017-003229-14-BE (EUCTR)	27/07/2018	08/06/2018	AN INDUCTION STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS	A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 1) - LUCENT 1	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1160	Phase 3	Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan
297	EUCTR2017-002108-28-DE (EUCTR)	25/07/2018	27/03/2018	A study to evaluate the efficacy, safety, tolerability and pharmacokinetics of PF-06687234/placebo as add-on therapy to infliximab in subjects with ulcerative colitis who are not in remission	A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06687234 AS ADD-ON THERAPY TO INFLIXIMAB IN ACTIVE ULCERATIVE COLITIS SUBJECTS WHO ARE NOT IN REMISSION (BUILD UC) - BUILD UC	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Dekavil Product Code: PF-06687234 INN or Proposed INN: PF-06687234 Other descriptive name: F8IL10	Pfizer Inc, 235 East 42nd Street, New York, New York 10017	NULL	Not Recruiting			Female: yes Male: yes	76	Phase 2	United States;Serbia;Saudi Arabia;Spain;Belgium;Australia;Israel;Germany;Italy;Korea, Republic of
298	EUCTR2015-001600-64-AT (EUCTR)	25/07/2018	17/04/2018	The purpose of this study is to determine whether long-term RPC1063 is safe and effective in the treatment of ulcerative colitis (UC).	A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of long-term RPC1063 in Ulcerative Colitis	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Celgene International II Sàrl	NULL	Not Recruiting			Female: yes Male: yes	1200	Phase 3	Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;New Zealand
299	EUCTR2017-000402-38-BE (EUCTR)	25/07/2018	30/05/2018	A clinical trial to evaluate the testicular safety of Filgotinib in adult males with Moderately to Severely Active Inflammatory Bowel Disease	A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Testicular Safety of Filgotinib in Adult Males with Moderately to Severely Active Inflammatory Bowel Disease	To evaluate the testicular safety of filgotinib in adult males with moderately to severely Active Inflammatory Bowel Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Gilead Sciences, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: no Male: yes	250	Phase 2	Portugal;United States;Spain;Ukraine;Austria;Russian Federation;Sri Lanka;Switzerland;United Kingdom;Italy;India;France;Canada;Poland;Belgium;Australia;Netherlands;Germany;New Zealand;Sweden
300	EUCTR2017-003229-14-ES (EUCTR)	24/07/2018	04/06/2018	AN INDUCTION STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS	A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 1) - LUCENT 1	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB	Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1160	Phase 3	Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
301	EUCTR2017-003703-22-NL (EUCTR)	24/07/2018	05/03/2018	Phase 2 Dose-finding IMU-838 for Ulcerative Colitis (CALDOSE-1)	A phase 2, multicenter, randomized, double-blind, placebo controlled, dose-finding study to evaluate the efficacy and safety of IMU 838 for induction and maintenance therapy in moderate-to-severe ulcerative colitis CALDOSE-1	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838	Immunic AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	210	Phase 2	Serbia;United States;Czech Republic;Poland;Belgium;Spain;Ukraine;Russian Federation;Germany;Netherlands;United Kingdom
302	EUCTR2017-003238-96-NL (EUCTR)	24/07/2018	14/05/2018	A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS	A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-ARM, PLACEBO-CONTROLLED MAINTENANCE STUDY OF MIRIKIZUMAB IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS (LUCENT 2) - LUCENT 2	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB	Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1044	Phase 3	Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;Denmark;Latvia;Netherlands;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan
303	EUCTR2015-001600-64-GR (EUCTR)	23/07/2018	19/04/2018	The purpose of this study is to determine whether long-term RPC1063 is safe and effective in the treatment of ulcerative colitis (UC).	A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of long-term RPC1063 in Ulcerative Colitis	ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: 0.25 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride	Celgene International II Sàrl	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1200	Phase 3	Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;New Zealand
304	EUCTR2015-000319-41-GR (EUCTR)	23/07/2018	18/04/2018	The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC).	A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Inductionand Maintenance Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of RPC1063 in Ulcerative Colitis	ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: 0.25 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride	Celgene International II Sàrl (CIS II)	NULL	Not Recruiting			Female: yes Male: yes	900	Phase 3	United States;Belarus;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;New Zealand
305	EUCTR2016-004676-22-PT (EUCTR)	16/07/2018	02/07/2018	A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis Who Responded to Induction treatment in M16-067 or M16-065”	A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Risankizumab Product Code: ABBV-006 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	760	Phase 3	United States;Serbia;Belarus;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
306	EUCTR2016-004677-40-PT (EUCTR)	16/07/2018	01/06/2018	A Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	720	Phase 2;Phase 3	United States;Serbia;Belarus;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden
307	EUCTR2017-000402-38-ES (EUCTR)	13/07/2018	25/07/2018	A clinical trial to evaluate the testicular safety of Filgotinib in adult males with Ulcerative Colitis	A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Testicular Safety of Filgotinib in Adult Males with Moderately to Severely Active Ulcerative Colitis	To evaluate the testicular safety of filgotinib in adult males with ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: GS-6034 INN or Proposed INN: FILGOTINIB	Gilead Sciences, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: no Male: yes	250	Phase 2	Portugal;United States;Spain;Ukraine;Austria;Russian Federation;Sri Lanka;Italy;United Kingdom;India;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Australia;Netherlands;Germany;New Zealand;Sweden
308	EUCTR2015-000319-41-ES (EUCTR)	12/07/2018	21/05/2018	The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC).	A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Induction and Maintenance Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of RPC1063 in Ulcerative Colitis	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride	Celgene International II Sàrl (CIS II)	NULL	Not Recruiting			Female: yes Male: yes	900	Phase 3	France;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;New Zealand
309	EUCTR2015-001600-64-ES (EUCTR)	12/07/2018	21/05/2018	The purpose of this study is to determine whether long-term RPC1063 is safe and effective in the treatment of ulcerative colitis (UC).	A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of long-term RPC1063 in Ulcerative Colitis	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: 0.25 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride	Celgene International II Sàrl	NULL	Not Recruiting			Female: yes Male: yes	1200	Phase 3	Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;New Zealand
310	EUCTR2018-001546-33-GB (EUCTR)	11/07/2018	14/05/2018	The effects of switching one drug, used to treat either Ulcerative Colitis (UC) or Crohn’s disease (CD) to another drug, also used to treat UC or Crohn’s disease	IBD Biosimilar to Biosimilar Infliximab Switching Study - iBiSS v1.0	Inflammatory Bowel Disease in particular Crohn's Disease and Ulcerative Colitis MedDRA version: 20.1;Level: PT;Classification code 10021972;Term: Inflammatory bowel disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Flixabi Product Name: Flixabi INN or Proposed INN: Infliximab	University Southampton Hospital NHS Foundation Trust	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 4	United Kingdom
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
311	EUCTR2017-003229-14-LT (EUCTR)	05/07/2018	31/05/2018	AN INDUCTION STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS	A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 1) - LUCENT 1	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB	Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1160	Phase 3	United States;Serbia;Taiwan;Saudi Arabia;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Latvia;Netherlands;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Romania;Germany;Japan
312	EUCTR2017-003238-96-LT (EUCTR)	05/07/2018	31/05/2018	A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS	A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-ARM, PLACEBO-CONTROLLED MAINTENANCE STUDY OF MIRIKIZUMAB IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS (LUCENT 2) - LUCENT 2	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB	Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1044	Phase 3	United States;Serbia;Taiwan;Saudi Arabia;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Latvia;Netherlands;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Romania;Germany;Japan
313	EUCTR2017-004092-31-LT (EUCTR)	05/07/2018	25/05/2018	A study of the efficacy and safety of Mirikizumab in Ulcerative Colitis	I6T-MC-AMAPA Phase 3, Multicenter, Open-Label Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients with Moderately toSeverely Active Ulcerative Colitis (LUCENT 3) - LUCENT 3	moderately to severely active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: mirikizumab Other descriptive name: MIRIKIZUMAB	Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	840	Phase 3	Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Germany;Japan
314	EUCTR2016-004677-40-DK (EUCTR)	28/06/2018	12/06/2018	A Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1547	Phase 2;Phase 3	United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Denmark;South Africa;Latvia;Netherlands;China;Korea, Republic of;Czechia;Slovenia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden
315	EUCTR2017-002274-39-NL (EUCTR)	27/06/2018	19/12/2017	A multi-center parallel group study of tofacitinib in subjects with ulcerative colitis in stable remission	A PHASE 3B/4, MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP STUDY OF TOFACITINIB (CP-690,550) IN SUBJECTS WITH ULCERATIVE COLITIS IN STABLE REMISSION	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: XELJANZ Product Name: Tofacitinib citrate Product Code: CP -690,550 -10 INN or Proposed INN: tofacitinib Other descriptive name: CP -690,550	Pfizer Inc, 235 East 42nd Street, New York, New York 10017	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	130	Phase 3;Phase 4	United States;Serbia;Slovakia;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;South Africa;Netherlands;Germany;Japan;New Zealand;Korea, Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
316	EUCTR2017-000574-11-BE (EUCTR)	27/06/2018	14/12/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn's Disease (AIDA)	A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA) - AIDA	Ulcerative colitis or Crohn's Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2453	Phase 3	United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
317	EUCTR2017-004967-11-FR (EUCTR)	26/06/2018	06/04/2018	Prospective multicenter randomized controlled double-blind label study of the prophylaxis of recurrent pouchitis after fecal microbiota transplant in UC with ileo-anal anastomosis.	Poca - Poca	Patients operated with an IPAA for Ulcerative Colitis with active recurrent pouchitis, who respond after 4 weeks of an antibiotherapy, will be randomized MedDRA version: 20.1;Level: LLT;Classification code 10000638;Term: Active ileal inflammation;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: suspension de microbiote fécal Product Code: PRD5973697	CHU Nantes	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	42	Phase 3	France
318	EUCTR2016-004676-22-AT (EUCTR)	25/06/2018	06/04/2018	A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis	A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Risankizumab Product Code: ABBV-006 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	942	Phase 3	United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Denmark;South Africa;Latvia;Netherlands;China;Korea, Republic of;Czechia;Slovenia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden
319	EUCTR2017-004092-31-GB (EUCTR)	25/06/2018	14/05/2018	A study of the efficacy and safety of Mirikizumab in Ulcerative Colitis	I6T-MC-AMAPA Phase 3, Multicenter, Open-Label Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients with Moderately toSeverely Active Ulcerative Colitis (LUCENT 3) - LUCENT 3	moderately to severely active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: mirikizumab Other descriptive name: MIRIKIZUMAB	Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	840	Phase 3	Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Germany;Japan
320	EUCTR2016-004677-40-AT (EUCTR)	25/06/2018	06/04/2018	A Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1547	Phase 2;Phase 3	United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Denmark;South Africa;Latvia;Netherlands;China;Korea, Republic of;Czechia;Slovenia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
321	EUCTR2015-001600-64-LV (EUCTR)	22/06/2018	13/04/2018	The purpose of this study is to determine whether long-term RPC1063 is safe and effective in the treatment of ulcerative colitis (UC).	A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of long-term RPC1063 in Ulcerative Colitis	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Celgene International II Sàrl	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1200	Phase 3	Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;New Zealand
322	EUCTR2015-000319-41-LV (EUCTR)	22/06/2018	13/04/2018	The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC).	A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Inductionand Maintenance Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of RPC1063 in Ulcerative Colitis	ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: 0.25mg RPC103 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC103 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride	Celgene International II Sàrl (CIS II)	NULL	Not Recruiting			Female: yes Male: yes	900	Phase 3	United States;Belarus;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;New Zealand
323	EUCTR2017-002350-36-HU (EUCTR)	14/06/2018	19/04/2018	A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared with Placebo and Compared with Vedolizumab in Patients with Moderate to Severe Ulcerative Colitis.	A PHASE II, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF UTTR1147A COMPARED WITH PLACEBO AND COMPARED WITH VEDOLIZUMAB IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Ulcerative colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: n.a. Product Code: UTTR1147A/RO7021610 (Active) INN or Proposed INN: n.a. Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc Trade Name: Entyvio 300mg Product Code: RO7246311 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB	Genentech, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	270	Phase 2	Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;United Kingdom;Italy;Hungary;Poland;Bulgaria;Germany;Netherlands
324	NCT04329481 (ClinicalTrials.gov)	June 12, 2018	29/3/2020	The Effect of Mycobiome Supplementation on Gastrointestinal Symptoms in IBD Patients	The Effect of Mycobiome Supplementation on Gastrointestinal Symptoms in IBD Patients	Ulcerative Colitis;Crohn Disease;Inflammatory Bowel Diseases	Dietary Supplement: Mycodigest supplement	Tel-Aviv Sourasky Medical Center	NULL	Recruiting	18 Years	70 Years	All	100	N/A	Israel
325	EUCTR2017-000572-28-BE (EUCTR)	08/06/2018	14/12/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 302).	A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 302)	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Shire Human Genetic Therapies, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	825	Phase 3	Portugal;United States;Slovakia;Greece;Spain;Ukraine;Ireland;Colombia;Switzerland;France;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Korea, Republic of;Bosnia and Herzegovina
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
326	EUCTR2017-003284-35-ES (EUCTR)	05/06/2018	09/04/2018	Investigate the efficacy and safety of study drug ABX464 50 mg once daily in patients with moderate to severe Active Ulcerative Colitis.	A follow-up Phase IIa study to evaluate the long-term safety and efficacy profile of ABX464 given at 50 mg once daily in subjects with Moderate to Severe Active Ulcerative Colitis - A follow-up study in patients with moderate to severe active ulcerative colitis.	Moderate to severe Ulcerative Colitis. MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464	ABIVAX	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	30	Phase 2	Hungary;Spain
327	EUCTR2017-004230-28-DE (EUCTR)	04/06/2018	31/01/2018	BI 655130 (SPESOLIMAB) induction treatment in patients with moderate-tosevere ulcerative colitis	A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI 655130 (SPESOLIMAB) Induction Therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy	Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]	Product Name: Spesolimab Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Name: Spesolimab Product Code: BI 655130 INN or Proposed INN: SPESOLIMAB Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1	Boehringer Ingelheim Pharma GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	550	Phase 2;Phase 3	United States;Taiwan;Greece;Spain;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;China;Korea, Republic of
328	EUCTR2015-000319-41-AT (EUCTR)	25/05/2018	17/04/2018	The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC).	A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Induction and Maintenance Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of RPC1063 in Ulcerative Colitis	ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: 0.25mg RPC103 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC103 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride	Celgene International II Sàrl (CIS II)	NULL	Not Recruiting			Female: yes Male: yes	900	Phase 3	United States;Belarus;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;New Zealand
329	EUCTR2017-000402-38-NL (EUCTR)	24/05/2018	13/11/2017	A clinical trail to evaluate the testicular safety of Filgotinib in adult males with Moderately to Severely Active Inflammatory Bowel Disease	A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Testicular Safety of Filgotinib in Adult Males with Moderately to Severely Active Inflammatory Bowel Disease	To evaluate the testicular safety of filgotinib in adult males with moderately to severely Active Inflammatory Bowel Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Gilead Sciences, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: no Male: yes	250	Phase 2	Portugal;United States;Spain;Ukraine;Austria;Russian Federation;Sri Lanka;Switzerland;United Kingdom;Italy;India;France;Canada;Belgium;Poland;Australia;Netherlands;Germany;New Zealand;Sweden
330	EUCTR2017-004230-28-IT (EUCTR)	22/05/2018	05/11/2020	BI 655130 induction treatment in patients with moderate-tosevereulcerative colitis	A Phase II/III Randomized, Double-blind, Placebo-controlled, MulticenterStudy to Evaluate the Safety and Efficacy of BI 655130 Induction Therapyin patients with moderate-to-severely active ulcerative colitis who havefailed previous biologics therapy - -	Moderate-to-severely active ulcerative colitis MedDRA version: 20.0;Level: LLT;Classification code 10045282;Term: UC;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]	Product Name: - Product Code: [BI 655130] Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1	BOEHRINGER-INGELHEIM ITALIA S.P.A.	NULL	Not Recruiting			Female: yes Male: yes	550	Phase 2;Phase 3	United States;Taiwan;Greece;Spain;Austria;Russian Federation;Italy;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany;Netherlands;Japan;Korea, Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
331	EUCTR2017-003649-10-GB (EUCTR)	15/05/2018	11/12/2017	A Pharmacokinetic, Pharmacodynamic, and Safety Study of Etrolizumab Followed by Open-Label Extension and Safety Monitoring in Pediatric Patients From 4 Years to Less Than 18 Years of Age with Moderate to Severe Ulcerative Colitis or Moderate to Severe Crohn’s Disease	A PHASE I, OPEN–LABEL, RANDOMIZED, PHARMACOKINETIC, PHARMACODYNAMIC, AND SAFETY STUDY OF ETROLIZUMAB FOLLOWED BY OPEN–LABEL EXTENSION AND SAFETY MONITORING IN PEDIATRIC PATIENTS FROM 4 YEARS TO LESS THAN 18 YEARS OF AGE WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR MODERATE TO SEVERE CROHN’S DISEASE	Moderate to severe ulcerative colitis (UC); moderate to severe Crohn’s disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrolizumab Product Code: 549-0261/F02-01 INN or Proposed INN: ETROLIZUMAB Other descriptive name: ETROLIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	24	Phase 1	Spain;Poland;Belgium;Germany;United Kingdom
332	EUCTR2017-002231-41-NL (EUCTR)	14/05/2018	26/09/2017	A study to investigate how the body responds to the study drug Vedolizumab in child patients with Ulcerative Colitis or Crohn’s Disease	A Phase 2, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease(A Phase 2, Randomized, Double-Blind, Dose-Ranging Study With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease) - Hubble	Ulcerative Colitis and Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	80	Phase 2	Canada;Poland;Belgium;Ukraine;Israel;Germany;Netherlands;United Kingdom;United States;France;Hungary
333	EUCTR2017-003703-22-GB (EUCTR)	03/05/2018	31/01/2018	Phase 2 Dose-finding IMU-838 for Ulcerative Colitis (CALDOSE-1)	A phase 2, multicenter, randomized, double-blind, placebo controlled, dose-finding study to evaluate the efficacy and safety of IMU 838 for induction and maintenance therapy in moderate-to-severe ulcerative colitis CALDOSE-1	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium dihydrate Other descriptive name: IM90838 Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium dihydrate Other descriptive name: IM90838	Immunic AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	240	Phase 2	Serbia;Portugal;United States;Belarus;Spain;Ukraine;Russian Federation;United Kingdom;Czech Republic;Macedonia, the former Yugoslav Republic of;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Netherlands;Bosnia and Herzegovina
334	EUCTR2017-003649-10-BE (EUCTR)	02/05/2018	27/02/2018	A Pharmacokinetic, Pharmacodynamic, and Safety Study of Etrolizumab Followed by Open-Label Extension and Safety Monitoring in Pediatric Patients From 4 Years to Less Than 18 Years of Age with Moderate to Severe Ulcerative Colitis or Moderate to Severe Crohn’s Disease	A PHASE I, OPEN–LABEL, RANDOMIZED, PHARMACOKINETIC, PHARMACODYNAMIC, AND SAFETY STUDY OF ETROLIZUMAB FOLLOWED BY OPEN–LABEL EXTENSION AND SAFETY MONITORING IN PEDIATRIC PATIENTS FROM 4 YEARS TO LESS THAN 18 YEARS OF AGE WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR MODERATE TO SEVERE CROHN’S DISEASE	Moderate to severe ulcerative colitis (UC); moderate to severe Crohn’s disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrolizumab Product Code: 549-0261/F02-01 INN or Proposed INN: ETROLIZUMAB Other descriptive name: ETROLIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	60	Phase 1	United States;Poland;Spain;Belgium;Germany;United Kingdom
335	EUCTR2017-003649-10-DE (EUCTR)	30/04/2018	07/02/2018	A Pharmacokinetic, Pharmacodynamic, and Safety Study of Etrolizumab Followed by Open-Label Extension and Safety Monitoring in Pediatric Patients From 4 Years to Less Than 18 Years of Age with Moderate to Severe Ulcerative Colitis or Moderate to Severe Crohn’s Disease	A PHASE I, OPEN–LABEL, RANDOMIZED, PHARMACOKINETIC, PHARMACODYNAMIC, AND SAFETY STUDY OF ETROLIZUMAB FOLLOWED BY OPEN–LABEL EXTENSION AND SAFETY MONITORING IN PEDIATRIC PATIENTS FROM 4 YEARS TO LESS THAN 18 YEARS OF AGE WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR MODERATE TO SEVERE CROHN’S DISEASE	Moderate to severe ulcerative colitis (UC); moderate to severe Crohn’s disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrolizumab Product Code: 549-0261/F02-01 INN or Proposed INN: ETROLIZUMAB Other descriptive name: ETROLIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 1	United States;Poland;Belgium;Spain;Germany;United Kingdom
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
336	EUCTR2017-003703-22-ES (EUCTR)	29/04/2018	20/02/2018	Phase 2 Dose-finding IMU-838 for Ulcerative Colitis (CALDOSE-1)	A phase 2, multicenter, randomized, double-blind, placebo controlled, dose-finding study to evaluate the efficacy and safety of IMU 838 for induction and maintenance therapy in moderate-to-severe ulcerative colitis CALDOSE-1	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Immunic AG	NULL	Not Recruiting			Female: yes Male: yes	210	Phase 2	Serbia;United States;Czech Republic;Slovakia;Poland;Belgium;Spain;Ukraine;Russian Federation;Netherlands;Germany;United Kingdom
337	EUCTR2017-000574-11-HR (EUCTR)	27/04/2018	27/08/2018	Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn’s Disease (AIDA)	A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn’s Disease (AIDA) - AIDA	Ulcerative colitis or Crohn’s Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2453	Phase 3	United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
338	EUCTR2017-000573-37-HR (EUCTR)	23/04/2018	07/12/2018	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 303).	A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	772	Phase 3	United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
339	EUCTR2017-000574-11-PT (EUCTR)	23/04/2018	22/12/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn's Disease (AIDA)	A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA) - AIDA	Ulcerative colitis or Crohn's Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2453	Phase 3	United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
340	EUCTR2016-003708-29-BG (EUCTR)	20/04/2018	17/01/2018	Study to evaluate the effectiveness of oral PF-06651600 and PF-06700841 in subjects with moderate to severe ulcerative colitis, a disease characterized by continuous inflammation that is localized to the colon	A Phase 2B, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Dose Ranging Study of Oral PF-06651600 and PF-06700841 as Induction and Chronic Therapy in Subjects with Moderate to Severe Ulcerative Colitis - Vibrato	Moderate to severe Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	360	Phase 2	Serbia;United States;Slovakia;Spain;Ukraine;Lithuania;Turkey;Austria;Russian Federation;Israel;Italy;Czech Republic;Hungary;Canada;Poland;Romania;Denmark;Bulgaria;Georgia;Netherlands;Germany;Korea, Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
341	EUCTR2017-000599-27-HR (EUCTR)	20/04/2018	07/12/2018	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 301).	A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 301)	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	825	Phase 3	United States;Serbia;Czechia;Slovakia;Greece;Lithuania;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Poland;Brazil;Romania;Croatia;Australia;South Africa;Germany;Netherlands;Japan;New Zealand
342	EUCTR2017-002350-36-ES (EUCTR)	15/04/2018	06/06/2018	A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared with Placebo and Compared with Vedolizumab in Patients with Moderate to Severe Ulcerative Colitis.	A PHASE II, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF UTTR1147A COMPARED WITH PLACEBO AND COMPARED WITH VEDOLIZUMAB IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Ulcerative colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: UTTR1147A/RO7021610 (Active) INN or Proposed INN: n.a. Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc Trade Name: Entyvio 300mg Product Code: RO7246311 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB	Roche Farma, S.A por delegación de Genentech, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	330	Phase 2	Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;United Kingdom;Italy;Hungary;Poland;Bulgaria;Germany;Netherlands
343	EUCTR2017-004230-28-GB (EUCTR)	13/04/2018	01/02/2018	BI 655130 (SPESOLIMAB) induction treatment in patients with moderate-tosevere ulcerative colitis	A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI 655130 (SPESOLIMAB) Induction Therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy	Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]	Product Name: Spesolimab Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Name: Spesolimab Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1	Boehringer Ingelheim Limited	NULL	Not Recruiting			Female: yes Male: yes	550	Phase 2;Phase 3	United States;Taiwan;Greece;Spain;Austria;Russian Federation;Israel;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;China;Korea, Republic of
344	EUCTR2017-002274-39-GB (EUCTR)	12/04/2018	20/12/2017	A multi-center parallel group study of tofacitinib in subjects with ulcerative colitis in stable remission	A PHASE 3B/4, MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP STUDY OF TOFACITINIB (CP-690,550) IN SUBJECTS WITH ULCERATIVE COLITIS IN STABLE REMISSION	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Pfizer Inc, 235 East 42nd Street, New York, New York 10017	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	130	Phase 3;Phase 4	Serbia;United States;Slovakia;Spain;Ukraine;Austria;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;South Africa;Netherlands;Germany;New Zealand;Japan;Korea, Republic of
345	EUCTR2017-002108-28-ES (EUCTR)	12/04/2018	20/04/2018	A study to evaluate the efficacy, safety, tolerability and pharmacokinetics of PF-06687234/placebo as add-on therapy to infliximab in subjects with ulcerative colitis who are not in remission	A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06687234 AS ADD-ON THERAPY TO INFLIXIMAB IN ACTIVE ULCERATIVE COLITIS SUBJECTS WHO ARE NOT IN REMISSION (BUILD UC) - BUILD UC	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Dekavil Product Code: PF-06687234 INN or Proposed INN: Dekavil Other descriptive name: F8IL10	Pfizer Inc, 235 East 42nd Street, New York, New York 10017	NULL	Not Recruiting			Female: yes Male: yes	98	Phase 2	United States;Serbia;Saudi Arabia;Belgium;Spain;Australia;Israel;Germany;Italy;Korea, Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
346	EUCTR2017-000599-27-DE (EUCTR)	10/04/2018	24/10/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 301).	A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 301)	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Not Recruiting			Female: yes Male: yes	825	Phase 3	United States;Serbia;Slovakia;Greece;Lithuania;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Poland;Brazil;Romania;Croatia;Australia;South Africa;Germany;Netherlands;Japan;New Zealand
347	EUCTR2017-000573-37-DE (EUCTR)	10/04/2018	24/10/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 303).	A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Not Recruiting			Female: yes Male: yes	772	Phase 3	United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;New Zealand
348	EUCTR2017-000574-11-DE (EUCTR)	10/04/2018	25/10/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn's Disease (AIDA)	A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA) - AIDA	Ulcerative colitis or Crohn's Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Not Recruiting			Female: yes Male: yes	2453	Phase 3	United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
349	EUCTR2017-003284-35-PL (EUCTR)	06/04/2018	05/03/2018	A follow-up study in patients with moderate to severe active ulcerative colitis.	A follow-up Phase IIa study to evaluate the long-term safety and efficacy profile of ABX464given at 50 mg once daily in subjects with Moderate to Severe Active Ulcerative Colitis. - Follow-up study in Moderate to Severe Active Ulcerative Colitis subjects.	Moderate to severe Ulcerative Colitis. MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464	ABIVAX	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	30	Phase 2	Hungary;Spain;Belgium;Poland
350	EUCTR2017-002108-28-BE (EUCTR)	30/03/2018	22/03/2018	A study to evaluate the efficacy, safety, tolerability and pharmacokinetics of PF-06687234/placebo as add-on therapy to infliximab in subjects with ulcerative colitis who are not in remission	A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06687234 AS ADD-ON THERAPY TO INFLIXIMAB IN ACTIVE ULCERATIVE COLITIS SUBJECTS WHO ARE NOT IN REMISSION (BUILD UC) - BUILD UC	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Pfizer Inc, 235 East 42nd Street, New York, New York 10017	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	76	Phase 2	Serbia;United States;Saudi Arabia;Spain;Belgium;Australia;Israel;Germany;Italy;Korea, Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
351	EUCTR2016-000641-31-BE (EUCTR)	29/03/2018	31/10/2016	Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1055	Phase 2;Phase 3	Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan
352	EUCTR2017-003524-75-NL (EUCTR)	27/03/2018	19/02/2018	Mesenchymal Stromal Cells for the treatment of Ulcerative Colitis	Allogeneic Bone Marrow Derived Mesenchymal Stromal Cells for the Treatment of Refractory Proctitis in Ulcerative Colitis - BMMSCproctitis	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Mesenchymal stromal cells Product Code: MSC INN or Proposed INN: n.a. Other descriptive name: MESENCHYMAL CELLS	Leiden University Medical Center	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	14	Phase 2	Netherlands
353	EUCTR2017-002182-21-NL (EUCTR)	20/03/2018	28/09/2017	An extension study to investigate how safe Vedolizumab is in child patients with Ulcerative Colitis or Crohn’s Disease	A Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease. (Long-term Safety With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease) - Hubble Zoom	Ulcerative Colitis or Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Takeda Development Centre Europe, Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	80	Phase 2	France;United States;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Germany;Netherlands;United Kingdom
354	EUCTR2017-000573-37-NL (EUCTR)	15/03/2018	02/11/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 303).	A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody	Shire Human Genetic Therapies, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	772	Phase 3	Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Italy;Switzerland;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
355	EUCTR2017-000574-11-NL (EUCTR)	15/03/2018	02/11/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn's Disease (AIDA)	A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA) - AIDA	Ulcerative colitis or Crohn's Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody	Shire Human Genetic Therapies, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2453	Phase 3	Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Italy;Switzerland;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
356	EUCTR2017-000573-37-IE (EUCTR)	13/03/2018	04/09/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 303).	A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	772	Phase 3	Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Lebanon;Ireland;Russian Federation;Israel;Colombia;Italy;Switzerland;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
357	EUCTR2017-000573-37-PT (EUCTR)	13/03/2018	21/12/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 303).	A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Shire Human Genetic Therapies, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	772	Phase 3	Serbia;United States;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Italy;Switzerland;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
358	EUCTR2017-000574-11-IE (EUCTR)	13/03/2018	04/09/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn's Disease (AIDA)	A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA) - AIDA	Ulcerative colitis or Crohn's Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2453	Phase 3	Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Lebanon;Ireland;Russian Federation;Israel;Colombia;Italy;Switzerland;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
359	EUCTR2017-000572-28-PT (EUCTR)	13/03/2018	22/12/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 302).	A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 302)	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	825	Phase 3	United States;Portugal;Slovakia;Greece;Spain;Ukraine;Lebanon;Ireland;Turkey;Colombia;Switzerland;France;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Bosnia and Herzegovina;Korea, Republic of
360	EUCTR2017-004230-28-BE (EUCTR)	09/03/2018	22/01/2018	BI 655130 induction treatment in patients with moderate-tosevere ulcerative colitis	A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI 655130 Induction Therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy	Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]	Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1	SCS Boehringer Ingelheim Comm. V	NULL	Not Recruiting			Female: yes Male: yes	550	Phase 2;Phase 3	United States;Taiwan;Greece;Spain;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Japan;China;Korea, Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
361	EUCTR2017-000573-37-GB (EUCTR)	07/03/2018	25/09/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 303).	A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Shire Human Genetic Therapies, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	772	Phase 3	Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Lebanon;Ireland;Russian Federation;Israel;Colombia;Italy;Switzerland;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
362	EUCTR2017-000599-27-GB (EUCTR)	07/03/2018	05/12/2018	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 301).	A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 301)	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Shire Human Genetic Therapies, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	825	Phase 3	Serbia;United States;Slovakia;Greece;Lithuania;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Poland;Brazil;Romania;Croatia;Australia;South Africa;Netherlands;Germany;New Zealand;Japan
363	EUCTR2017-000574-11-GB (EUCTR)	06/03/2018	21/09/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn's Disease (AIDA)	A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA) - AIDA	Ulcerative colitis or Crohn's Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2453	Phase 3	Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Lebanon;Ireland;Russian Federation;Israel;Colombia;Italy;Switzerland;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
364	EUCTR2017-004230-28-AT (EUCTR)	27/02/2018	18/01/2018	BI 655130 (SPESOLIMAB) induction treatment in patients with moderate-to severe ulcerative colitis	A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI 655130 (SPESOLIMAB) Induction Therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy	Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]	Product Name: spesolimab Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Name: spesolimab Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1	Boehringer Ingelheim RCV GmbH & Co KG	NULL	Not Recruiting			Female: yes Male: yes	550	Phase 2;Phase 3	United States;Taiwan;Greece;Spain;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;China;Korea, Republic of
365	EUCTR2017-000573-37-CZ (EUCTR)	27/02/2018	01/11/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 303).	A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Not Recruiting			Female: yes Male: yes	772	Phase 3	United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
366	EUCTR2017-000599-27-CZ (EUCTR)	26/02/2018	01/11/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 301).	A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 301)	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Not Recruiting			Female: yes Male: yes	825	Phase 3	United States;Serbia;Slovakia;Greece;Lithuania;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Poland;Brazil;Romania;Croatia;Australia;South Africa;Germany;Netherlands;Japan;New Zealand
367	EUCTR2016-004217-26-IT (EUCTR)	22/02/2018	22/02/2018	A Randomised Dose-Optimisation Study to Evaluate the Efficacy and Safety of Cobitolimod in Moderate to Severe Active Ulcerative Colitis Patients	A Randomised Dose-Optimisation Study to Evaluate the Efficacy and Safety of Cobitolimod in Moderate to Severe Active Ulcerative Colitis Patients - CONDUCT	Moderate to Severe left-sided Active Ulcerative Colitis MedDRA version: 20.0;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Cobitolimod Product Code: DIMs0150 INN or Proposed INN: Cobitolimod Other descriptive name: DIMS0150 Product Name: Cobitolimod Product Code: DIMS0150 INN or Proposed INN: Cobitolimod Other descriptive name: DIMS0150 Product Name: Cobitolimod Product Code: DIMS0150 INN or Proposed INN: Cobitolimod Other descriptive name: DIMS0150	INDEX PHARMACEUTICALS AB	NULL	Not Recruiting			Female: yes Male: yes	215	Phase 2	Serbia;Spain;Ukraine;Russian Federation;Montenegro;Italy;France;Czech Republic;Hungary;Poland;Romania;Germany;Sweden
368	EUCTR2017-002274-39-BE (EUCTR)	22/02/2018	18/12/2017	A multi-center parallel group study of tofacitinib in subjects with ulcerative colitis in stable remission	A PHASE 3B/4, MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP STUDY OF TOFACITINIB (CP-690,550) IN SUBJECTS WITH ULCERATIVE COLITIS IN STABLE REMISSION	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: XELJANZ Product Name: Tofacitinib citrate Product Code: CP -690,550 -10 INN or Proposed INN: tofacitinib Other descriptive name: CP -690,550	Pfizer Inc, 235 East 42nd Street, New York, New York 10017	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	130	Phase 3;Phase 4	United States;Poland;Serbia;South Africa;Czechia;Germany;Slovakia;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Netherlands;Japan;New Zealand;Korea, Republic of;Canada;Belgium
369	EUCTR2017-000937-30-AT (EUCTR)	22/02/2018	03/01/2018	Investigate the efficacy and safety of study drug ABX464 50 mg once daily versus placebo with patients with moderate to severe Active Ulcerative Colitis.	A Phase IIa study to evaluate the safety and efficacy of ABX464 50 mg once daily versus Placebo in subjects with Moderate to Severe Active Ulcerative Colitis who have failed or are intolerant to immunomodulators, Anti-TNFa, vedolizumab and/or corticosteroids. - Safety and efficacy study of ABX464 in patients with moderate to severe Active Ulcerative Colitis.	Moderate to severe Ulcerative Colitis. MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464	ABIVAX	NULL	Not Recruiting			Female: yes Male: yes	30	Phase 2	France;Hungary;Spain;Poland;Belgium;Austria;Germany
370	EUCTR2017-000574-11-ES (EUCTR)	16/02/2018	19/12/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis (AIDA)	A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis (AIDA) - AIDA	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody	Shire Human Genetic Therapies, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1114	Phase 3	Serbia;Portugal;United States;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
371	EUCTR2017-000573-37-ES (EUCTR)	16/02/2018	19/12/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 303).	A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody	Shire Human Genetic Therapies, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	772	Phase 3	Serbia;Portugal;United States;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
372	EUCTR2017-000572-28-ES (EUCTR)	16/02/2018	19/12/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 302).	A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 302) - FIGARO UC 302	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody	Shire Human Genetic Therapies, Inc.	NULL	Not Recruiting			Female: yes Male: yes	825	Phase 3	United States;Portugal;Slovakia;Greece;Spain;Ukraine;Ireland;Colombia;Switzerland;France;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Bosnia and Herzegovina;Korea, Republic of
373	EUCTR2017-000572-28-FR (EUCTR)	16/02/2018	16/02/2018	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 302).	A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 302)	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody	Shire Human Genetic Therapies, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	825	Phase 3	Portugal;United States;Slovakia;Greece;Spain;Ukraine;Ireland;Colombia;Switzerland;France;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Korea, Republic of;Bosnia and Herzegovina
374	EUCTR2017-004772-65-DK (EUCTR)	05/02/2018	04/12/2017	Probiotic Treatment of Ulcerative Colitis with Trichuris suis ova (TSO)	Probiotic Treatment of Ulcerative Colitis with Trichuris suis ova (TSO) - PROCTO	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		ParaTech A/S	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	120	Phase 2	Denmark
375	NCT03358706 (ClinicalTrials.gov)	February 2, 2018	27/11/2017	A Study to Evaluate the Effect of Ustekinumab on Cytochrome P450 Enzyme Activities Following Induction and Maintenance Dosing in Participants With Active Crohn's Disease or Ulcerative Colitis	A Phase 1, Open-label, Drug Interaction Study to Evaluate the Effect of Ustekinumab on Cytochrome P450 Enzyme Activities Following Induction and Maintenance Dosing in Participants With Active Crohn's Disease or Ulcerative Colitis.	Crohn Disease;Ulcerative Colitis	Drug: Ustekinumab IV Infusion;Drug: Ustekinumab SC Injection;Drug: Midazolam 2 mg;Drug: Warfarin 10 mg;Drug: Vitamin K 10 mg;Drug: Omeprazole 20 mg;Drug: Dextromethorphan 30 mg;Drug: Caffeine 100 mg	Janssen Research & Development, LLC	NULL	Recruiting	18 Years	75 Years	All	57	Phase 1	United States;Belgium;Germany;Sweden;United Kingdom;Austria;Denmark
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
376	EUCTR2017-000574-11-LT (EUCTR)	30/01/2018	31/10/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn’s Disease (AIDA)	A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn’s Disease (AIDA) - AIDA	Ulcerative colitis or Crohn’s Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2453	Phase 3	United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
377	EUCTR2017-000573-37-LT (EUCTR)	30/01/2018	31/10/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 303).	A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	772	Phase 3	United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
378	EUCTR2017-000599-27-LT (EUCTR)	30/01/2018	31/10/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 301).	A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 301)	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	825	Phase 3	United States;Serbia;Slovakia;Greece;Lithuania;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Poland;Brazil;Romania;Croatia;Australia;South Africa;Germany;Netherlands;Japan;New Zealand
379	EUCTR2017-000402-38-PT (EUCTR)	29/01/2018	13/11/2017	A clinical trail to evaluate the testicular safety of Filgotinib in adult males with Moderately to Severely Active Inflammatory Bowel Disease	A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Testicular Safety of Filgotinib in Adult Males with Moderately to Severely Active Inflammatory Bowel Disease	To evaluate the testicular safety of filgotinib in adult males with moderately to severely Active Inflammatory Bowel Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: GS-6034 INN or Proposed INN: FILGOTINIB	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: no Male: yes	250	Phase 2	Portugal;United States;Taiwan;Spain;Ukraine;Austria;Russian Federation;United Kingdom;India;Canada;Belgium;Poland;Romania;Australia;Germany;Netherlands;New Zealand;Sweden
380	EUCTR2017-000573-37-BG (EUCTR)	24/01/2018	22/11/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 303).	A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	772	Phase 3	Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Lebanon;Ireland;Russian Federation;Israel;Colombia;Italy;Switzerland;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
381	EUCTR2017-000574-11-HU (EUCTR)	23/01/2018	27/10/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn's Disease (AIDA)	A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA) - AIDA	Ulcerative colitis or Crohn's Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Shire Human Genetic Therapies, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2453	Phase 3	Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Italy;Switzerland;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
382	EUCTR2013-001744-65-BE (EUCTR)	23/01/2018	27/02/2017	A clinical trial to investigate the safety and effectiveness of MMX Mesalamine/mesalazine in Children and Adolescents aged 5-17 years who have mild to moderate Ulcerative Colitis	A Phase 3, Multicenter, Randomized, Double-blind Study to Determine the Safety and Efficacy of MMX Mesalamine/Mesalazine in Paediatric Subjects with Mild to Moderate Ulcerative Colitis, in both Acute and Maintenance Phases	Mild to Moderate Ulcerative Colitis MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Mezavant Gastro-resistant, prolonged release tablets Product Name: Mezavant Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: Mesalazine Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: Mesalazine Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: Mesalazine	Shire Development LLC	NULL	Not Recruiting			Female: yes Male: yes	132	Phase 3	United States;Hungary;Slovakia;Canada;Poland;Belgium;Israel;Netherlands;Germany;United Kingdom;Sweden
383	EUCTR2017-000402-38-DE (EUCTR)	23/01/2018	27/10/2017	A clinical trail to evaluate the testicular safety of Filgotinib in adult males with Moderately to Severely Active Inflammatory Bowel Disease	A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Testicular Safety of Filgotinib in Adult Males with Moderately to Severely Active Inflammatory Bowel Disease	To evaluate the testicular safety of filgotinib in adult males with moderately to severely Active Inflammatory Bowel Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: GS-6034 INN or Proposed INN: FILGOTINIB	Gilead Sciences, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: no Male: yes	250	Phase 2	United States;Portugal;Taiwan;Spain;Ukraine;Austria;Russian Federation;United Kingdom;India;Canada;Belgium;Poland;Romania;Australia;Germany;Netherlands;New Zealand;Sweden
384	EUCTR2017-000573-37-HU (EUCTR)	22/01/2018	23/01/2018	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 303).	A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Shire Human Genetic Therapies, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	772	Phase 3	Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
385	EUCTR2017-000572-28-HU (EUCTR)	22/01/2018	27/10/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 302).	A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 302)	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	825	Phase 3	United States;Portugal;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Turkey;Colombia;Switzerland;France;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Bosnia and Herzegovina;Korea, Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
386	EUCTR2017-000402-38-AT (EUCTR)	19/01/2018	30/10/2017	A clinical trial to evaluate the testicular safety of Filgotinib in adult males with Moderately to Severely Active Inflammatory Bowel Disease	A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Testicular Safety of Filgotinib in Adult Males with Moderately to Severely Active Inflammatory Bowel Disease	To evaluate the testicular safety of filgotinib in adult males with moderately to severely Active Inflammatory Bowel Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Gilead Sciences, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: no Male: yes	250	Phase 2	Portugal;United States;Spain;Ukraine;Austria;Russian Federation;Sri Lanka;Switzerland;United Kingdom;Italy;India;France;Canada;Belgium;Poland;Australia;Germany;Netherlands;New Zealand;Sweden
387	EUCTR2017-000402-38-GB (EUCTR)	19/01/2018	23/10/2017	A clinical trial to evaluate the testicular safety of Filgotinib in adult males with Moderately to Severely Active Inflammatory Bowel Disease	A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Testicular Safety of Filgotinib in Adult Males with Moderately to Severely Active Inflammatory Bowel Disease	To evaluate the testicular safety of filgotinib in adult males with moderately to severely Active Inflammatory Bowel Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: GS-6034 INN or Proposed INN: FILGOTINIB	Gilead Sciences, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: no Male: yes	250	Phase 2	United States;Portugal;Spain;Ukraine;Austria;Russian Federation;United Kingdom;India;Canada;Belgium;Poland;Romania;Australia;Germany;Netherlands;New Zealand;Sweden
388	EUCTR2017-000572-28-BG (EUCTR)	19/01/2018	24/11/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 302).	A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 302)	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Not Recruiting			Female: yes Male: yes	825	Phase 3	United States;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Lebanon;Ireland;Turkey;Colombia;Switzerland;France;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Bosnia and Herzegovina;Korea, Republic of
389	EUCTR2017-002231-41-PL (EUCTR)	17/01/2018	13/10/2017	A study to investigate how the body responds to the study drug Vedolizumab in child patients with Ulcerative Colitis or Crohn’s Disease	A Phase 2, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease (A Phase 2, Randomized, Double-Blind, Dose-Ranging Study With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease) - Hubble	Ulcerative Colitis and Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Takeda Development Centre Europe, Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	80	Phase 2	France;United States;Hungary;Canada;Belgium;Poland;Ukraine;Israel;Netherlands;Germany;United Kingdom
390	EUCTR2017-002182-21-PL (EUCTR)	17/01/2018	13/10/2017	An extension study to investigate how safe Vedolizumab is in child patients with Ulcerative Colitis or Crohn’s Disease	A Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease.(Long-term Safety With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis orCrohn’s Disease) - Hubble Zoom	Ulcerative Colitis or Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB	Takeda Development Centre Europe, Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	80	Phase 2	United States;France;Hungary;Canada;Belgium;Poland;Ukraine;Israel;Netherlands;Germany;United Kingdom
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
391	EUCTR2017-002274-39-CZ (EUCTR)	16/01/2018	14/12/2017	A multi-center parallel group study of tofacitinib in subjects with ulcerative colitis in stable remission	A PHASE 3B/4, MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP STUDY OF TOFACITINIB (CP-690,550) IN SUBJECTS WITH ULCERATIVE COLITIS IN STABLE REMISSION	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: XELJANZ Product Name: Tofacitinib citrate Product Code: CP -690,550 -10 INN or Proposed INN: tofacitinib Other descriptive name: CP -690,550	Pfizer Inc, 235 East 42nd Street, New York, New York 10017	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	130	Phase 3;Phase 4	Serbia;United States;Slovakia;Spain;Ukraine;Austria;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;South Africa;Netherlands;Germany;New Zealand;Japan;Korea, Republic of
392	EUCTR2017-002182-21-BE (EUCTR)	10/01/2018	14/09/2017	An extension study to investigate how safe Vedolizumab is in child patients with Ulcerative Colitis or Crohn’s Disease	A Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease.(Long-term Safety With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis orCrohn’s Disease) - Hubble Zoom	Ulcerative Colitis or Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB	Takeda Development Centre Europe, Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	80	Phase 2	France;United States;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom
393	EUCTR2013-001744-65-DE (EUCTR)	10/01/2018	20/02/2017	A clinical trial to investigate the safety and effectiveness of MMX Mesalamine/mesalazine in Children and Adolescents aged 5-17 years who have mild to moderate Ulcerative Colitis	A Phase 3, Multicenter, Randomized, Double-blind Study to Determine the Safety and Efficacy of MMX Mesalamine/Mesalazine in Paediatric Subjects with Mild to Moderate Ulcerative Colitis, in both Acute and Maintenance Phases	Mild to Moderate Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Mezavant Gastro-resistant, prolonged release tablets Product Name: Mezavant Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: Mesalazine Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: Mesalazine Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: Mesalazine	Shire Development LLC	NULL	Not Recruiting			Female: yes Male: yes	132	Phase 3	United States;Hungary;Slovakia;Canada;Poland;Belgium;Israel;Netherlands;Germany;United Kingdom;Sweden
394	EUCTR2017-002231-41-BE (EUCTR)	10/01/2018	14/09/2017	A study to investigate how the body responds to the study drug Vedolizumab in child patients with Ulcerative Colitis or Crohn’s Disease	A Phase 2, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease(A Phase 2, Randomized, Double-Blind, Dose-Ranging Study With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease) - Hubble	Ulcerative Colitis and Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	80	Phase 2	United States;France;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom
395	EUCTR2017-002274-39-AT (EUCTR)	04/01/2018	20/12/2017	A multi-center parallel group study of tofacitinib in subjects with ulcerative colitis in stable remission	A PHASE 3B/4, MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP STUDY OF TOFACITINIB (CP-690,550) IN SUBJECTS WITH ULCERATIVE COLITIS IN STABLE REMISSION	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: XELJANZ Product Name: Tofacitinib citrate Product Code: CP -690,550 -10 INN or Proposed INN: tofacitinib Other descriptive name: CP -690,550	Pfizer Inc, 235 East 42nd Street, New York, New York 10017	NULL	Not Recruiting			Female: yes Male: yes	130	Phase 3	Serbia;United States;Slovakia;Spain;Ukraine;Austria;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;South Africa;Netherlands;Germany;New Zealand;Japan;Korea, Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
396	EUCTR2017-000574-11-BG (EUCTR)	04/01/2018	24/11/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn's Disease (AIDA)	A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA) - AIDA	Ulcerative colitis or Crohn's Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2453	Phase 3	Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Portugal;Serbia;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil
397	EUCTR2017-003284-35-HU (EUCTR)	03/01/2018	22/11/2017	A follow-up study in patients with moderate to severe active ulcerative colitis.	A follow-up Phase IIa study to evaluate the long-term safety and efficacy profile of ABX464 given at 50 mg once daily in subjects with Moderate to Severe Active Ulcerative Colitis. - A Follow-up study in Moderate to Severe Active Ulcerative Colitis subjects	Moderate to severe Ulcerative Colitis. MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		ABIVAX	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	30	Phase 2	Hungary;Spain;Poland;Belgium
398	NCT03394586 (ClinicalTrials.gov)	January 1, 2018	28/12/2017	Real-world Data Regarding Treatment of Ulcerative Colitis Patients With Golimumab	Real-world Data Regarding Treatment of Ulcerative Colitis Patients With Golimumab	Ulcerative Colitis;Flare Up, Symptom	Drug: Exposure to golimumab	University of Zurich	NULL	Unknown status	N/A	N/A	All	100		Switzerland
399	EUCTR2017-000574-11-AT (EUCTR)	22/12/2017	30/10/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn's Disease (AIDA)	A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA) - AIDA	Ulcerative colitis or Crohn's Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2453	Phase 3	United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
400	EUCTR2017-000573-37-AT (EUCTR)	22/12/2017	30/10/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 303).	A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	772	Phase 3	United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;New Zealand
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
401	EUCTR2017-000599-27-AT (EUCTR)	22/12/2017	30/10/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 301).	A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 301)	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Not Recruiting			Female: yes Male: yes	825	Phase 3	United States;Serbia;Slovakia;Greece;Lithuania;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Poland;Brazil;Romania;Croatia;Australia;South Africa;Germany;Netherlands;Japan;New Zealand
402	EUCTR2017-002274-39-HU (EUCTR)	21/12/2017	19/12/2017	A multi-center parallel group study of tofacitinib in subjects with ulcerative colitis in stable remission	A PHASE 3B/4, MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP STUDY OF TOFACITINIB (CP-690,550) IN SUBJECTS WITH ULCERATIVE COLITIS IN STABLE REMISSION	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: XELJANZ Product Name: Tofacitinib citrate Product Code: CP -690,550 -10 INN or Proposed INN: tofacitinib Other descriptive name: CP -690,550	Pfizer Inc, 235 East 42nd Street, New York, New York 10017	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	130	Phase 3;Phase 4	United States;Serbia;Slovakia;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Poland;South Africa;Germany;Netherlands;Japan;New Zealand;Korea, Republic of
403	EUCTR2017-002274-39-ES (EUCTR)	21/12/2017	22/12/2017	A multi-center parallel group study of tofacitinib in subjects with ulcerative colitis in stable remission	A PHASE 3B/4, MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP STUDY OF TOFACITINIB (CP-690,550) IN SUBJECTS WITH ULCERATIVE COLITIS IN STABLE REMISSION	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: XELJANZ Product Name: Tofacitinib citrate Product Code: CP -690,550 -10 INN or Proposed INN: tofacitinib Other descriptive name: CP -690,550	Pfizer Inc, 235 East 42nd Street, New York, New York 10017	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	130	Phase 3	Serbia;United States;Slovakia;Spain;Ukraine;Austria;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;South Africa;Netherlands;Germany;New Zealand;Japan;Korea, Republic of
404	EUCTR2017-003284-35-BE (EUCTR)	19/12/2017	09/11/2017	A follow-up study in patients with moderate to severe active ulcerative colitis.	A follow-up Phase IIa study to evaluate the long-term safety and efficacy profile of ABX464 given at 50 mg once daily in subjects with Moderate to Severe Active Ulcerative Colitis. - Follow-up study in Moderate to Severe Active Ulcerative Colitis subjects	Moderate to severe Ulcerative Colitis. MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464	ABIVAX	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	30	Phase 2	Hungary;Spain;Poland;Belgium
405	EUCTR2014-001594-14-DE (EUCTR)	19/12/2017	22/09/2014	Can FITC-Adalimumab predict the efficacy of Adalimumab in patients with colitis ulcerosa, when it is applied to the intestinal mucosa during an endoscopic examination? Is FITC-Adalimumab safe and tolerable in this setting? Open-label, one-arm clinical trial in one study site	Prospective, single-centre, open-label, one-arm clinical trial, phase I/IIa, to assess the safety and tolerability and to investigate the predictive power of FITC-Adalimumab, when topically applied twice to the intestinal mucosa as an in-vitro diagnostic in the framework of a confocal laser-endomicroscopic examination of colitis ulcerosa patients with an indication for Adalimumab treatment - MAgIC	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: FITC-Adalimumab Product Code: FITC-Adalimumab INN or Proposed INN: FITC-Adalimumab Other descriptive name: FITC-ADALIMUMAB	Universitätsklinikum Erlangen	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	25	Phase 1;Phase 2	Germany
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
406	EUCTR2017-002182-21-DE (EUCTR)	18/12/2017	13/09/2017	An extension study to investigate how safe Vedolizumab is in child patients with Ulcerative Colitis or Crohn’s Disease	A Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease.(Long-term Safety With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis orCrohn’s Disease) - Hubble Zoom	Ulcerative Colitis or Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB	Takeda Development Centre Europe, Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	80	Phase 2	France;United States;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom
407	EUCTR2017-002182-21-FR (EUCTR)	18/12/2017	15/12/2017	An extension study to investigate how safe Vedolizumab is in child patients with Ulcerative Colitis or Crohn’s Disease	A Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease.(Long-term Safety With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis orCrohn’s Disease) - Hubble Zoom	Ulcerative Colitis or Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	80	Phase 2	United States;France;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom
408	EUCTR2017-002231-41-DE (EUCTR)	18/12/2017	14/09/2017	A study to investigate how the body responds to the study drug Vedolizumab in child patients with Ulcerative Colitis or Crohn’s Disease	A Phase 2, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease(A Phase 2, Randomized, Double-Blind, Dose-Ranging Study With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease) - Hubble	Ulcerative Colitis and Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB	Takeda Development Centre Europe, Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	80	Phase 2	France;United States;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom
409	EUCTR2017-000572-28-SK (EUCTR)	13/12/2017	21/11/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 302).	A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 302)	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Not Recruiting			Female: yes Male: yes	825	Phase 3	United States;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Lebanon;Ireland;Turkey;Colombia;Switzerland;France;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Korea, Republic of;Bosnia and Herzegovina
410	EUCTR2017-000573-37-SK (EUCTR)	13/12/2017	21/11/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 303).	A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	772	Phase 3	United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
411	EUCTR2017-000574-11-SK (EUCTR)	13/12/2017	21/11/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn’s Disease (AIDA)	A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn’s Disease (AIDA) - AIDA	Ulcerative colitis or Crohn’s Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2453	Phase 3	Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Poland;Belgium;Croatia;Bulgaria;Germany;Netherlands
412	EUCTR2017-000937-30-PL (EUCTR)	13/12/2017	25/09/2017	Investigate the efficacy and safety of study drug ABX464 50 mg once daily versus placebo with patients with moderate to severe Active Ulcerative Colitis.	A Phase IIa study to evaluate the safety and efficacy of ABX464 50 mg once daily versus Placebo in subjects with Moderate to Severe Active Ulcerative Colitis who have failed or are intolerant to immunomodulators, Anti-TNFa, vedolizumab and/or corticosteroids. - Safety and efficacy study of ABX464 in patients with moderate to severe Active Ulcerative Colitis.	Moderate to severe Ulcerative Colitis. MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464	ABIVAX	NULL	Not Recruiting			Female: yes Male: yes	30	Phase 2	France;Hungary;Spain;Belgium;Poland;Austria;Germany
413	EUCTR2017-000572-28-GR (EUCTR)	11/12/2017	28/11/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 302).	A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 302)	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody	Shire Human Genetic Therapies, Inc.	NULL	Not Recruiting			Female: yes Male: yes	825	Phase 3	United States;Portugal;Slovakia;Greece;Spain;Ukraine;Ireland;Colombia;Switzerland;France;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Bosnia and Herzegovina;Korea, Republic of
414	EUCTR2017-000573-37-GR (EUCTR)	11/12/2017	01/12/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 303).	A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody	Shire Human Genetic Therapies, Inc.	NULL	Not Recruiting			Female: yes Male: yes	772	Phase 3	United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Japan;New Zealand
415	EUCTR2017-002274-39-SK (EUCTR)	08/12/2017	27/10/2017	A multi-center parallel group study of tofacitinib in subjects with ulcerative colitis in stable remission	A PHASE 3B/4, MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP STUDY OF TOFACITINIB (CP-690,550) IN SUBJECTS WITH ULCERATIVE COLITIS IN STABLE REMISSION	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: XELJANZ Product Name: Tofacitinib citrate Product Code: CP -690,550 -10 INN or Proposed INN: tofacitinib Other descriptive name: CP -690,550	Pfizer Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	130	Phase 3;Phase 4	United States;Serbia;Slovakia;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;South Africa;Germany;Netherlands;Japan;New Zealand;Korea, Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
416	EUCTR2017-000937-30-ES (EUCTR)	27/11/2017	10/10/2017	Investigate the efficacy and safety of study drug ABX464 50 mg once daily versus placebo with patients with moderate to severe Active Ulcerative Colitis.	A Phase IIa study to evaluate the safety and efficacy of ABX464 50 mg once daily versus Placebo in subjects with Moderate to Severe Active Ulcerative Colitis who have failed or are intolerant to immunomodulators, Anti-TNFa, vedolizumab and/or corticosteroids. - Safety and efficacy study of ABX464 in patients with moderate to severe Active Ulcerative Colitis.	Moderate to severe Ulcerative Colitis. MedDRA version: 20.0;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		ABIVAX	NULL	Not Recruiting			Female: yes Male: yes	30	Phase 2	France;Hungary;Poland;Belgium;Spain;Austria;Germany
417	EUCTR2016-000420-26-BG (EUCTR)	17/11/2017	19/04/2017	A study to test the effectiveness of bimekizumab as a treatment for ulcerative colitis to look for unwanted side effects and to measure how the drug is distributed, modified and cleared from the body.	A MULTICENTER, SUBJECT-BLIND, INVESTIGATOR-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY, SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF AN IV LOADING DOSE FOLLOWED BY SC ADMINISTRATION OF BIMEKIZUMAB (UCB4940) IN SUBJECTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS	MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS MedDRA version: 20.0;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Bimekizumab Product Code: UCB4940 INN or Proposed INN: Bimekizumab Other descriptive name: UCB4940	UCB Biopharma SPRL	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 2	Czech Republic;Spain;Poland;Romania;South Africa;Georgia;Bulgaria;United Kingdom;Moldova, Republic of;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2019-004224-38-HU
(EUCTR)

30/12/2020

22/10/2020

A Clinical Study of the Efficacy, Safety and Pharmacokinetics of Ustekinumab as Intravenous Induction Treatment Followed by Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis

A Phase 3 Study of the Efficacy, Safety and Pharmacokinetics of Ustekinumab as Open-label Intravenous Induction Treatment Followed by Randomized Double-blind Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis - UNIFI-Jr

Moderately to Severely Active Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: STELARA ®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA ®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA ®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: USTEKINUMAB

Janssen-Cilag International NV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 3

United States;Hungary;Poland;Belgium;Russian Federation;Germany;United Kingdom;Japan

EUCTR2020-001398-59-HR
(EUCTR)

02/12/2020

07/12/2020

Clinical trial to evaluate the efficacy and the safety of OSE-127 versus placebo in subjects with ulcerative colitis who have failed or are intolerant to previous treatment(s)

Randomized, double-blind, Phase 2 study to evaluate the efficacy and the safety of OSE-127 versus placebo in subjects with moderate to severe active ulcerative colitis who have failed or are intolerant to previous treatment(s)

Moderate to severe Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: OSE-127
Product Code: OSE-127
INN or Proposed INN: AS INN
Other descriptive name: humanized recombinant IgG4 monoclonal antibody against CD-127

OSE Immunotherapeutics

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

150

Phase 2

Belarus;Serbia;Ukraine;Lithuania;Russian Federation;France;Hungary;Belgium;Poland;Croatia;Bulgaria;Georgia;Latvia

EUCTR2019-002698-74-GB
(EUCTR)

17/11/2020

30/03/2020

A study to evaluate the efficacy and safety of PF 06480605 in adult participants with moderate to severe ulcerative colitis

A PHASE 2B, MULTICENTER, RANDOMIZED, DOUBLEBLIND,PLACEBO CONTROLLED DOSE-RANGINGSTUDY TO EVALUATE THE EFFICACY, SAFETY, ANDPHARMACOKINETICS OF PF-06480605 IN ADULTPARTICIPANTS WITH MODERATE TO SEVEREULCERATIVE COLITIS - Tuscany 2

A phase 2b randomised, double-blind, placebo controlled dose-ranging study in Adults with Moderate to Severe Ulcerative Colitis
MedDRA version: 20.0;Level: HLT;Classification code 10009888;Term: Colitis (excl infective);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: PF-06480605
Product Code: PF-06480605
INN or Proposed INN: PF-06480605
Other descriptive name: Anti-TL1A

Pfizer Inc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

240

Phase 2

United States;Serbia;Slovakia;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;India;France;Hungary;Mexico;Canada;Poland;Belgium;Romania;Australia;South Africa;Bulgaria;Germany;China;Japan

EUCTR2020-004391-18-FR
(EUCTR)

28/10/2020

14/09/2020

IMPACT OF ANTI-TNF, VEDOLIZUMAB AND TOFACITINIB ON AORTIC STIFFNESS, CAROTID INTIMA-MEDIA THICKNESS AND CARDIOVASCULAR RISK OF PATIENTS WITH ULCERATIVE COLITIS

IMPACT OF ANTI-TNF, VEDOLIZUMAB AND TOFACITINIB ON AORTIC STIFFNESS, CAROTID INTIMA-MEDIA THICKNESS AND CARDIOVASCULAR RISK OF PATIENTS WITH ULCERATIVE COLITIS - VASC-UC

ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Inflectra 100 mg
Product Name: Inflectra 100 mg
Trade Name: AMGEVITA
Product Name: AMGEVITA
Trade Name: Simponi
Product Name: Simponi
Trade Name: Entyvio 300 mg
Product Name: Entyvio 300 mg
Trade Name: XELJANZ
Product Name: XELJANZ

CHU Amiens-Picardie

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

100

Phase 4

France

EUCTR2020-002695-12-NL
(EUCTR)

14/10/2020

02/09/2020

Treatment of refractory pouchitis with tofacitinib

Tofacitinib in the treatment of chronic, recurrent and/or antibiotic refractory pouchitis: a multi-omics approach - TOFA-Pouchitis

Chronic, recurrent and/or antibiotic refractory pouchitis in patients with ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Xeljanz 5mg film-coated tablets

Amsterdam UMC, location AMC

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Netherlands

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2020-001398-59-BG
(EUCTR)

13/10/2020

18/09/2020

Clinical trial to evaluate the efficacy and the safety of OSE-127 versus placebo in subjects with ulcerative colitis who have failed or are intolerant to previous treatment(s)

Product Name: OSE-127
Product Code: OSE-127
INN or Proposed INN: OSE-127
Other descriptive name: humanized recombinant IgG4 monoclonal antibody against CD-127

OSE Immunotherapeutics

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

150

Phase 2

Belarus;Serbia;Ukraine;Lithuania;Russian Federation;France;Hungary;Belgium;Poland;Croatia;Bulgaria;Georgia;Latvia

EUCTR2020-000047-31-FR
(EUCTR)

07/10/2020

13/05/2020

A study of AMT-101 in patients with Ulcerative Colitis.

A Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter, Phase 2a Study of the Efficacy and Safety of Oral AMT-101 in Subjects with Moderate to Severe Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: AMT -101
INN or Proposed INN: Not yet assigned
Other descriptive name: AMT -101

Applied Molecular Transport Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

102

Phase 2

United States;Serbia;Belarus;Spain;Ukraine;Russian Federation;United Kingdom;Switzerland;Italy;India;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Kazakhstan;Bulgaria;Georgia;Netherlands;Germany;Moldova, Republic of

NCT04535882
(ClinicalTrials.gov)

October 1, 2020

28/8/2020

Effectiveness of Serum Leucine-rich Alpha-2 Glycoprotein Levels on IBD

Association Between Serum Leucine-rich Alpha-2 Glycoprotein Levels and Endoscopic Activity of Ulcerative Colitis or Crohn's Disease Colitis

LRG Levels

Diagnostic Test: serum leucine-rich alpha-2 glycoprotein (LRG) levels

Showa Inan General Hospital

NULL

Recruiting

N/A

All

100

Japan

EUCTR2020-001398-59-LV
(EUCTR)

21/09/2020

28/07/2020

Clinical trial to evaluate the efficacy and the safety of OSE-127 versus placebo in subjects with ulcerative colitis who have failed or are intolerant to previous treatment(s)

Product Name: OSE-127
Product Code: OSE-127
Other descriptive name: humanized recombinant IgG4 monoclonal antibody against CD-127

OSE Immunotherapeutics

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

150

Phase 2

Belarus;Serbia;Ukraine;Lithuania;Russian Federation;France;Hungary;Belgium;Poland;Croatia;Bulgaria;Georgia;Latvia

EUCTR2020-000047-31-HU
(EUCTR)

09/09/2020

07/07/2020

A study of AMT-101 in patients with Ulcerative Colitis.

A Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter, Phase 2a Study of the Efficacy and Safety of Oral AMT-101 in Subjects with Moderate to Severe Ulcerative Colitis

Product Name: AMT -101
INN or Proposed INN: Not yet assigned
Other descriptive name: AMT -101

Applied Molecular Transport Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

102

Phase 2

United States;Serbia;Belarus;Spain;Ukraine;Russian Federation;United Kingdom;Switzerland;Italy;India;France;Hungary;Canada;Poland;Belgium;Romania;Kazakhstan;Bulgaria;Georgia;Germany;Netherlands;Moldova, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2019-002698-74-DE
(EUCTR)

08/09/2020

21/02/2020

A study to evaluate the efficacy and safety of PF 06480605 in adult participants with moderate to severe ulcerative colitis

Product Name: PF-06480605
Product Code: PF-06480605
INN or Proposed INN: PF-06480605
Other descriptive name: Anti-TL1A

Pfizer Inc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

240

Phase 2

EUCTR2019-004652-11-SI
(EUCTR)

28/08/2020

31/08/2020

A Study of Etrolizumab-Based Induction Therapy Combinations Followed by Etrolizumab Maintenance Therapy in Patients with Moderate-To-Severe Ulcerative Colitis

RANDOMIZED, OPEN-LABEL PHASE 3B STUDY OF ETROLIZUMAB BASED INDUCTION THERAPY COMBINATIONS FOLLOWED BY ETROLIZUMAB MAINTENANCE THERAPY IN PATIENTS WITH MODERATE-TO-SEVERE ULCERATIVE COLITIS - Lantana

Ulcerative Colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Etrolizumab
Product Code: RO5490261/F04-02
INN or Proposed INN: Etrolizumab
Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223
Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB
Other descriptive name: INFLIXIMAB
Trade Name: Xeljanz
INN or Proposed INN: TOFACITINIB
Other descriptive name: TOFACITINIB
Trade Name: Xeljanz
INN or Proposed INN: TOFACITINIB
Other descriptive name: TOFACITINIB
Trade Name: Stelara
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Trade Name: Stelara
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

372

Phase 3

Serbia;United States;Slovakia;Spain;Ukraine;Ireland;Israel;Russian Federation;Italy;Switzerland;France;Latvia;Netherlands;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Brazil;Belgium;Poland;Germany

NCT04576000
(ClinicalTrials.gov)

August 25, 2020

17/9/2020

Identification of Biomarkers of Tofacitinib Therapy in Patients With Ulcerative Colitis

PhaRmacOkinetics and PHarmacodynamic BiomarkErs of TofacItinib Therapy in Patients With Ulcerative Colitis (PROPHETIC)

Ulcerative Colitis

Drug: Tofacitinib

Robarts Clinical Trials Inc.

NULL

Recruiting

18 Years

N/A

All

100

United States;Belgium;Canada;Italy;Netherlands;Spain

EUCTR2018-000930-37-HU
(EUCTR)

17/08/2020

24/06/2020

A Study to Investigate safety and how well Ravagalimab (ABBV-323) works and how safe it is in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy

A Multicenter, Single-Arm, Open-Label Study to Investigate the Efficacy and Safety of Ravagalimab (ABBV-323) in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy

Product Name: Ravagalimab
Product Code: ABBV-323
Other descriptive name: ABBV-323

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

United States;France;Hungary;Canada;Spain;Netherlands;Germany;United Kingdom;Italy;Korea, Republic of

EUCTR2019-003999-39-NO
(EUCTR)

17/08/2020

29/04/2020

A placebo-controlled study followed by an open label treatment to evaluate the safety and efficacy of PF-06826647 in participants with moderate to severe ulcerative colitis

A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP, PLACEBO-CONTROLLED STUDY WITH AN OPEN LABEL EXTENSION TO EVALUATE THE SAFETY AND EFFICACY OF PF-06826647 IN PARTICIPANTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

moderate to severe ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: PF-06826647
Product Code: PF-06826647
INN or Proposed INN: PF-06826647

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

202

Phase 2

United States;United Arab Emirates;Qatar;Saudi Arabia;Hong Kong;Slovakia;Morocco;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Italy;India;France;Macedonia, the former Yugoslav Republic of;Puerto Rico;Jordan;Malaysia;Australia;Tunisia;China;Bosnia and Herzegovina;Oman;Turkey;United Kingdom;Czech Republic;Armenia;Mexico;Brazil;Belgium;Poland;Romania;Croatia;Georgia;Germany;Norway

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2019-004469-41-DE
(EUCTR)

11/08/2020

26/03/2020

A trial to investigate the safety and efficacy of PN-943 in patients with moderate or severe Ulcerative Colitis (a long-term condition where the colon and rectum become inflamed)

A Phase 2 Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center Study to Evaluate the Safety and Efficacy of Oral PN-943 in Subjects with Moderate to Severe Active Ulcerative Colitis

Ulcerative colitis (US) is a chronic relapsing inflammatory bowel disease of the large intestine characterized by bloody diarrhoea, abdominal cramps and fatigue. UC is characterized by inflammation and ulceration of mainly the mucosal and occasionally submucosal intestinal layers.
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: PN-943
Other descriptive name: PN-943
Product Code: PN-943
Other descriptive name: PN-943

Protagonist Therapeutics, Inc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

150

Phase 2

Serbia;United States;Ukraine;Austria;Russian Federation;Italy;Hungary;Canada;Poland;Bulgaria;Georgia;Germany;Korea, Republic of

EUCTR2019-004469-41-BG
(EUCTR)

11/08/2020

27/04/2020

A trial to investigate the safety and efficacy of PN-943 in patients with moderate or severe Ulcerative Colitis (a long-term condition where the colon and rectum become inflamed)

Product Code: PN-943
Other descriptive name: PN-943
Product Code: PN-943
Other descriptive name: PN-943

Protagonist Therapeutics, Inc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

150

Phase 2

Serbia;United States;Ukraine;Austria;Russian Federation;Italy;Hungary;Canada;Poland;Bulgaria;Georgia;Germany;Korea, Republic of

EUCTR2020-000047-31-GB
(EUCTR)

03/08/2020

20/04/2020

A study of AMT-101 in patients with Ulcerative Colitis.

A Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter, Phase 2a Study of the Efficacy and Safety of Oral AMT-101 in Subjects with Moderate to Severe Ulcerative Colitis

Product Name: AMT -101
INN or Proposed INN: Not yet assigned
Other descriptive name: AMT -101

Applied Molecular Transport Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

102

Phase 2

Serbia;United States;Belarus;Spain;Ukraine;Russian Federation;Italy;United Kingdom;Switzerland;India;France;Hungary;Canada;Poland;Romania;Kazakhstan;Bulgaria;Georgia;Germany;Moldova, Republic of

EUCTR2019-003596-19-DE
(EUCTR)

29/07/2020

A Three-Arm, Randomized, Placebo-Controlled, Double-Blind Phase 3 Study to Evaluate the Safety and Efficacy of Once-Daily and Twice-Daily Dosing of a Novel Hydrocortisone Acetate 90 mg Suppository Formulation Administered with the Sephure® Suppository Applicator in Subjects with Ulcerative Colitis of the Rectum.

Ulcerative Colitis of the Rectum
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;Level: HLT;Classification code 10027682;Term: Immune and associated conditions NEC;System Organ Class: 10021428 - Immune system disorders
MedDRA version: 20.0;Level: SOC;Classification code 10021428;Term: Immune system disorders;Level: HLGT;Classification code 10027665;Term: Immune disorders NEC;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: 90 mg hydrocortisone acetate suppository with Sephure suppository applicator
INN or Proposed INN: HYDROCORTISONE ACETATE

Cristcot HCA LLC

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

618

Phase 3

United States;Philippines;Hong Kong;Spain;Poland;Ukraine;Romania;Russian Federation;Germany;Italy;India

EUCTR2019-004469-41-AT
(EUCTR)

27/07/2020

26/03/2020

A trial to investigate the safety and efficacy of PN-943 in patients with moderate or severe Ulcerative Colitis (a long-term condition where the colon and rectum become inflamed)

Product Code: PN-943
Other descriptive name: PN-943
Product Code: PN-943
Other descriptive name: PN-943

Protagonist Therapeutics, Inc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

150

Phase 2

Serbia;United States;Ukraine;Austria;Russian Federation;Italy;Hungary;Canada;Poland;Bulgaria;Georgia;Germany;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2019-002485-12-GB
(EUCTR)

14/07/2020

30/03/2020

Determination of the Optimal Treatment Target in Ulcerative Colitis

VERDICT: In actiVE ulcerative colitis, a RanDomIzed Controlled Trial for determination of the optimal treatment target - VERDICT

Trade Name: Entyvio
INN or Proposed INN: vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Entyvio
INN or Proposed INN: vedolizumab
Other descriptive name: VEDOLIZUMAB

Alimentiv Inc. (formerly Robarts Clinical Trials)

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

660

Phase 4

France;Belarus;United States;Canada;Poland;Belgium;Ukraine;Russian Federation;Netherlands;Italy;United Kingdom

EUCTR2018-004694-27-FR
(EUCTR)

06/07/2020

10/04/2020

Safety and Efficacy of BMS-986165 Compared with Placebo in Subjects with Ulcerative Colitis

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: BMS-986165
Other descriptive name: BMS986165

Bristol-Myers Squibb International Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

120

Phase 2

United States;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Australia;Germany;Japan;Korea, Republic of

EUCTR2018-004002-25-NL
(EUCTR)

06/07/2020

17/09/2019

A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis

A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis - QUASAR

Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab

Janssen-Cilag International NV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

950

Phase 2;Phase 3

Poland;Romania;Bulgaria;Germany;Japan;Sweden;United States;Portugal;Taiwan;Spain;Ukraine;Israel;Russian Federation;Italy;France;Australia;Netherlands;China;Korea, Republic of;Czechia;Turkey;United Kingdom;Hungary;Canada;Argentina;Brazil;Belgium

EUCTR2018-003986-33-PT
(EUCTR)

06/07/2020

28/10/2019

A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis

A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine

Arena Pharmaceuticals, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

330

Phase 3

United States;Serbia;Belarus;Portugal;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany

EUCTR2017-004092-31-AT
(EUCTR)

02/07/2020

20/09/2019

A study of the efficacy and safety of Mirikizumab in Ulcerative Colitis

I6T-MC-AMAPA Phase 3, Multicenter, Open-Label Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients with Moderately toSeverely Active Ulcerative Colitis (LUCENT 3) - LUCENT 3

moderately to severely active Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: mirikizumab
Other descriptive name: MIRIKIZUMAB

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

840

Phase 3

United States;Serbia;Taiwan;Saudi Arabia;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Netherlands;Latvia;China;Moldova, Republic of;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Germany;Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT04209556
(ClinicalTrials.gov)

June 30, 2020

1/12/2019

A Study To Evaluate The Safety And Efficacy Of PF-06826647 In Participants With Moderate To Severe Ulcerative Colitis

Ulcerative Colitis

Drug: PF-06826647 100 mg QD;Drug: PF-06826647 300 mg QD;Drug: PF-06826647 600 mg QD;Drug: Placebo;Drug: PF-6826647 400 mg QD

Pfizer

NULL

Recruiting

18 Years

75 Years

All

202

Phase 2

United States

EUCTR2019-003334-16-DE
(EUCTR)

26/06/2020

05/05/2020

Novel budenosid suppository in addition to basic therapy with oral mesalazine compared to basic therapy alone for treatment of ulcerative colitis

Randomised, double-blind, placebo-controlled, multicentre study to compare the efficacy and safety of novel 4 mg budesonide suppository in combination with oral mesalazine versus oral mesalazine monotherapy in patients with acute ulcerative colitis

acute ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Budenofalk® suppositories
INN or Proposed INN: BUDESONIDE
Other descriptive name: Budenofalk® suppositories (BUS)
Trade Name: Salofalk 3g gastro-resistant prolonged-release granules
Product Name: Salofalk 3g gastro-resistant prolonged-release granules
INN or Proposed INN: MESALAZINE

Dr. Falk Pharma GmbH

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

360

Phase 3

Belarus;Poland;Ukraine;Russian Federation;Bulgaria;Latvia;Germany

EUCTR2018-003987-29-FR
(EUCTR)

11/06/2020

12/09/2019

An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis

An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE

Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine

Arena Pharmaceuticals Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

702

Phase 3

United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan

EUCTR2019-003849-15-HR
(EUCTR)

05/06/2020

20/11/2020

Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) asmaintenance therapy in patients with Ulcerative Colitis

A Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients with Moderately to Severely Active Ulcerative Colitis

Trade Name: Remsima
Product Code: Remsima (CT-P13)
INN or Proposed INN: INFLIXIMAB
Trade Name: Inflectra
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB

Celltrion, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

615

Phase 3

United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Italy;France;Peru;South Africa;Latvia;Moldova, Republic of;Czechia;Turkey;Austria;Hungary;Mexico;Brazil;Poland;Croatia;Bulgaria;Germany

EUCTR2019-002698-74-BE
(EUCTR)

03/06/2020

02/04/2020

A study to evaluate the efficacy and safety of PF 06480605 in adult participants with moderate to severe ulcerative colitis

Product Name: PF-06480605
Product Code: PF-06480605
INN or Proposed INN: PF-06480605
Other descriptive name: Anti-TL1A

Pfizer Inc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

240

Phase 2

United States;Serbia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Australia;South Africa;China;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2019-002698-74-FR
(EUCTR)

20/05/2020

24/01/2020

A study to evaluate the efficacy and safety of PF 06480605 in adult participants with moderate to severe ulcerative colitis

Product Name: PF-06480605
Product Code: PF-06480605
INN or Proposed INN: PF-06480605
Other descriptive name: Anti-TL1A

Pfizer Inc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

240

Phase 2

United States;Serbia;Slovakia;Spain;Ukraine;Turkey;Austria;Russian Federation;Israel;Italy;India;France;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Germany;Japan;China

EUCTR2019-000733-39-FR
(EUCTR)

14/05/2020

20/02/2020

Open-label maintenance therapy in moderate to severe Ulcerative Colitis patients

A phase 2b, open-label, efficacy and safety study of ABX464 as maintenance therapy in patients with moderate to severe Ulcerative Colitis.

Moderate to Severe Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464

ABIVAX

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

232

Phase 2

Belarus;Serbia;Slovenia;Slovakia;Spain;Ukraine;Ireland;Austria;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Netherlands

EUCTR2018-004002-25-BG
(EUCTR)

13/05/2020

24/02/2020

A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis

Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: GUSELKUMAB
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab

Janssen-Cilag International NV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

950

Phase 2;Phase 3

United States;Portugal;Taiwan;Spain;Ukraine;Israel;Russian Federation;Italy;France;Malaysia;Australia;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden

EUCTR2019-003849-15-ES
(EUCTR)

12/05/2020

28/02/2020

Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) asmaintenance therapy in patients with Ulcerative Colitis

Trade Name: Remsima
Product Code: Remsima (CT-P13)
INN or Proposed INN: INFLIXIMAB
Trade Name: Inflectra
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB

Celltrion, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

615

Phase 3

United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Italy;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Hungary;Czech Republic;Mexico;Brazil;Poland;Croatia;Bulgaria;Germany

EUCTR2019-003113-34-NO
(EUCTR)

04/05/2020

21/01/2020

Ulcerative colitis

A randomized, multi-center, subject and investigator blinded, placebo controlled, parallel group study to assess the efficacy, safety and tolerability of LYS006 in patients with mild to moderate ulcerative colitis - NA

Mild to moderate ulcerative colitis
MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: LYS006
Product Code: LYS006
INN or Proposed INN: not yet defined
Other descriptive name: LYS006

Novartis Pharma AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

United States;Hungary;Czech Republic;Poland;Russian Federation;Bulgaria;Germany;Norway

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2019-003780-21-NL
(EUCTR)

04/05/2020

21/02/2020

An investigation of tofacitinib in patients with ulcerative colitis

Pharmacokinetics and Pharmacodynamic Biomarkers of Tofacitinib Therapy in Patients with Ulcerative Colitis (PROPHETIC Study)

Trade Name: XELJANZ
Product Name: XELJANZ
INN or Proposed INN: TOFACITINIB

Robarts Clinical Trials

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

100

Phase 4

United States;Canada;Spain;Belgium;Netherlands;Italy

EUCTR2018-003278-28-BG
(EUCTR)

22/04/2020

23/05/2019

Safety, tolerability, efficacy and dose-response of GSK2831781 in ulcerative colitis.

A multicentre randomized, double-blind, placebo-controlled Phase 2 study to evaluate the safety, tolerability, efficacy, dose-response, pharmacokinetics and pharmacodynamics of repeat dosing of an anti-LAG3 cell depleting monoclonal antibody (GSK2831781) in patients with active ulcerative colitis

Product Code: GSK2831781
INN or Proposed INN: Not Assigned
Other descriptive name: GSK2831781

GlaxoSmithKline Research & Development Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

320

Phase 2

United States;Serbia;Czechia;Estonia;Slovakia;Ukraine;Russian Federation;United Kingdom;India;France;Czech Republic;Hungary;Mexico;Canada;Poland;South Africa;Bulgaria;Netherlands;Japan;Korea, Republic of

EUCTR2019-000733-39-GB
(EUCTR)

16/04/2020

31/01/2020

Open-label maintenance therapy in moderate to severe Ulcerative Colitis patients

A phase 2b, open-label, efficacy and safety study of ABX464 as maintenance therapy in patients with moderate to severe Ulcerative Colitis.

Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464

ABIVAX

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

244

Phase 2

Belarus;Serbia;Slovakia;Slovenia;Spain;Ukraine;Austria;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany

EUCTR2019-002698-74-HU
(EUCTR)

15/04/2020

20/04/2020

A study to evaluate the efficacy and safety of PF 06480605 in adult participants with moderate to severe ulcerative colitis

Product Name: PF-06480605
Product Code: PF-06480605
INN or Proposed INN: PF-06480605
Other descriptive name: Anti-TL1A

Pfizer Inc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

240

Phase 2

United States;Serbia;Slovakia;Spain;Ukraine;Turkey;Austria;Russian Federation;Israel;Italy;India;France;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Germany;Japan;China

EUCTR2018-003987-29-AT
(EUCTR)

15/04/2020

09/10/2019

An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis

An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE

Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine

Arena Pharmaceuticals Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

702

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2018-004002-25-DE
(EUCTR)

07/04/2020

23/08/2019

A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis

Janssen-Cilag International NV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

950

Phase 2;Phase 3

United States;Portugal;Hong Kong;Taiwan;Spain;Ukraine;Israel;Russian Federation;Italy;France;Malaysia;Australia;Netherlands;China;Korea, Republic of;Czechia;Turkey;United Kingdom;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden

EUCTR2018-003986-33-AT
(EUCTR)

07/04/2020

20/09/2019

A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis

A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12

Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine

Arena Pharmaceuticals, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

330

Phase 3

EUCTR2017-003703-22-BG
(EUCTR)

07/04/2020

06/02/2020

Phase 2 Dose-finding IMU-838 for Ulcerative Colitis (CALDOSE-1)

A phase 2, multicenter, randomized, double-blind, placebo controlled, dose-finding study to evaluate the efficacy and safety of IMU 838 for induction and maintenance therapy in moderate-to-severe ulcerative colitis CALDOSE-1

Product Name: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Product Name: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Product Name: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838

Immunic AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

240

Phase 2

United States;Serbia;Belarus;Portugal;Spain;Ukraine;Russian Federation;United Kingdom;Czech Republic;Macedonia, the former Yugoslav Republic of;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Netherlands;Bosnia and Herzegovina

EUCTR2019-003849-15-FR
(EUCTR)

03/04/2020

03/02/2020

Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) asmaintenance therapy in patients with Ulcerative Colitis

Trade Name: Remsima
Product Code: Remsima (CT-P13)
INN or Proposed INN: INFLIXIMAB
Trade Name: Inflectra
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB

Celltrion, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

615

Phase 3

United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Italy;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Hungary;Czech Republic;Mexico;Brazil;Poland;Croatia;Bulgaria;Germany

EUCTR2019-003849-15-BG
(EUCTR)

03/04/2020

07/02/2020

Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) asmaintenance therapy in patients with Ulcerative Colitis

Trade Name: Remsima
Product Code: Remsima (CT-P13)
INN or Proposed INN: INFLIXIMAB
Trade Name: Inflectra
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB

Celltrion, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

615

Phase 3

Serbia;Belarus;Greece;Spain;Ukraine;Turkey;Austria;Russian Federation;Israel;Italy;France;Czech Republic;Mexico;Poland;Croatia;Peru;South Africa;Bulgaria;Germany;Latvia;Moldova, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2019-003849-15-GR
(EUCTR)

03/04/2020

02/04/2020

Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) asmaintenance therapy in patients with Ulcerative Colitis

Trade Name: Remsima
Product Code: Remsima (CT-P13)
INN or Proposed INN: INFLIXIMAB
Trade Name: Inflectra
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB

Celltrion, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

615

Phase 3

United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Italy;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Hungary;Czech Republic;Mexico;Brazil;Poland;Croatia;Bulgaria;Germany

EUCTR2019-002698-74-ES
(EUCTR)

01/04/2020

23/01/2020

A study to evaluate the efficacy and safety of PF 06480605 in adult participants with moderate to severe ulcerative colitis

Product Name: PF-06480605
Product Code: PF-06480605
INN or Proposed INN: PF-06480605
Other descriptive name: Anti-TL1A

Pfizer Inc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

240

Phase 2

NCT04225819
(ClinicalTrials.gov)

April 1, 2020

3/1/2020

Adjunctive Treatment With Vitamin D3 in Patients With Active IBD

Adjunctive Treatment With Vitamin D3 in Patients With Active IBD (ACTIVATED): A Randomized, Double-blind, Placebo-controlled Trial

IBD;Inflammatory Bowel Diseases;Crohn Disease;Ulcerative Colitis;Vitamin D3 Deficiency

Dietary Supplement: Vitamin D3;Other: Placebo

Massachusetts General Hospital

NULL

Not yet recruiting

18 Years

N/A

All

100

N/A

NULL

EUCTR2019-002698-74-BG
(EUCTR)

27/03/2020

31/01/2020

A study to evaluate the efficacy and safety of PF 06480605 in adult participants with moderate to severe ulcerative colitis

Product Name: PF-06480605
Product Code: PF-06480605
INN or Proposed INN: PF-06480605
Other descriptive name: Anti-TL1A

Pfizer Inc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

240

Phase 2

Serbia;United States;Slovakia;Spain;Ukraine;Turkey;Austria;Russian Federation;Israel;Italy;India;France;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Germany;Japan;China

EUCTR2019-002698-74-SK
(EUCTR)

26/03/2020

31/01/2020

A study to evaluate the efficacy and safety of PF 06480605 in adult participants with moderate to severe ulcerative colitis

A PHASE 2B, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED DOSE-RANGING STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF PF-06480605 IN ADULT PARTICIPANTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS - Tuscany 2

Product Name: PF-06480605 100 mg/ml
Product Code: PF-06480605
INN or Proposed INN: PF-06480605
Other descriptive name: Anti-TL1A

Pfizer Inc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

240

Phase 2

Serbia;United States;Slovakia;Spain;Ukraine;Turkey;Russian Federation;Israel;Italy;India;France;Czech Republic;Mexico;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Japan;China

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2018-003524-36-IE
(EUCTR)

25/03/2020

05/11/2019

Randomized, mulitcenter study to investigate how infliximab dosing calculated by a computer compares to the standard dosing during the induction of infliximab in patients with severe colitis ulcerosa.

Randomized, Multicenter Study to Investigate the Efficacy of Dashboard Driven Individualized Dosing of Infliximab Compared To Standard Dosing During the Induction in Patients with Acute Severe Ulcerative Colitis - TITRATE

Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Remicade
Product Name: NA
Product Code: NA
INN or Proposed INN: INFLIXIMAB
Trade Name: Metoject
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE DISODIUM
Trade Name: Puri-Nethol
INN or Proposed INN: MERCAPTOPURINE
Trade Name: Remsima
INN or Proposed INN: INFLIXIMAB
Trade Name: Inflectra
INN or Proposed INN: INFLIXIMAB
Trade Name: Flixabi
INN or Proposed INN: INFLIXIMAB

UMC Amsterdam location AMC

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

124

Phase 4

Ireland;Netherlands

EUCTR2019-002698-74-PL
(EUCTR)

24/03/2020

11/02/2020

A study to evaluate the efficacy and safety of PF 06480605 in adult participants with moderate to severe ulcerative colitis

Product Name: PF-06480605
Product Code: PF-06480605
INN or Proposed INN: PF-06480605
Other descriptive name: Anti-TL1A

Pfizer Inc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

240

Phase 2

EUCTR2019-003849-15-AT
(EUCTR)

20/03/2020

06/02/2020

Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) asmaintenance therapy in patients with Ulcerative Colitis

Trade Name: Remsima
Product Code: Remsima (CT-P13)
INN or Proposed INN: INFLIXIMAB
Trade Name: Inflectra
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB

Celltrion, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

615

Phase 3

United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Italy;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Hungary;Czech Republic;Mexico;Brazil;Poland;Croatia;Bulgaria;Germany

EUCTR2019-000733-39-DE
(EUCTR)

20/03/2020

13/03/2020

Open-label maintenance therapy in moderate to severe Ulcerative Colitis patients

A phase 2b, open-label, efficacy and safety study of ABX464 as maintenance therapy in patients with moderate to severe Ulcerative Colitis.

Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464

ABIVAX

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

244

Phase 2

Belarus;Serbia;Czechia;Slovakia;Slovenia;Spain;Ukraine;Austria;United Kingdom;France;Hungary;Canada;Belgium;Poland;Germany

EUCTR2016-000642-62-SE
(EUCTR)

18/03/2020

25/10/2018

A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis

M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

462

Phase 3

Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2016-000642-62-FR
(EUCTR)

10/03/2020

30/07/2019

A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

462

Phase 3

EUCTR2018-001605-93-AT
(EUCTR)

09/03/2020

07/11/2019

An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis

A 54-Week Treatment, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo and Active-Controlled, Parallel-Group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis - Phase 2 Dose-finding UC Study

Product Name: Brazikumab
Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139
Trade Name: Entyvio
INN or Proposed INN: Entyvio
Other descriptive name: VEDOLIZUMAB
Product Name: Brazikumab
Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139

Allergan Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

375

Phase 2

United States;Taiwan;Spain;Israel;Russian Federation;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;China;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Bulgaria;Germany;Japan

EUCTR2017-003703-22-PT
(EUCTR)

02/03/2020

18/12/2019

Phase 2 Dose-finding IMU-838 for Ulcerative Colitis (CALDOSE-1)

Immunic AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

240

Phase 2

United States;Serbia;Portugal;Belarus;Spain;Ukraine;Russian Federation;United Kingdom;Czech Republic;Macedonia, the former Yugoslav Republic of;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Netherlands;Bosnia and Herzegovina

EUCTR2018-003987-29-PT
(EUCTR)

02/03/2020

28/10/2019

An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis

An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE

Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine

Arena Pharmaceuticals Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

702

Phase 3

Germany;Japan;Georgia;United States;Serbia;Belarus;Portugal;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria

NCT04309058
(ClinicalTrials.gov)

March 2020

24/2/2020

Observation of the Effect of Vitamin D Supplementation on Chronic Course of Patients With Ulcerative Colitis Based on Vitamin D Receptor Fok I Gene Polymorphism

Observation of the Effect of Vitamin D Supplementation on Chronic Course of Patients With Ulcerative Colitis Based on Vitamin D Receptor Fok I Gene Polymorphism,a Prospective Cohort Study

Ulcerative Colitis;Vitamin D Deficiency;Vitamin D Supplement

Drug: Vitamin D drops

Second Affiliated Hospital of Wenzhou Medical University

NULL

Not yet recruiting

N/A

All

100

Early Phase 1

China

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2018-004002-25-ES
(EUCTR)

28/02/2020

04/09/2019

A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis

Moderately to Severely Active Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Janssen-Cilag International NV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1000

Phase 2;Phase 3

Portugal;United States;Taiwan;Hong Kong;Thailand;Spain;Ukraine;Russian Federation;Israel;Italy;France;Malaysia;Australia;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Bulgaria;Germany;Japan;Sweden

EUCTR2018-003986-33-DK
(EUCTR)

28/02/2020

02/10/2019

A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis

A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12

Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine

Arena Pharmaceuticals, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

330

Phase 3

Moldova, Republic of;Serbia;Portugal;United States;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Israel;Chile;Italy;Switzerland;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Bulgaria;Germany

EUCTR2019-003220-21-GB
(EUCTR)

26/02/2020

12/12/2019

Management of diarrhoea in ulcerative colitis: multi-arm multi stage trial of low FODMAP diet, amitriptyline, ondansetron, or loperamide: MODULATE.

Management of diarrhoea in ulcerative colitis: multi-arm multi-stage trial of low FODMAP diet, amitriptyline, ondansetron, or loperamide: MODULATE. - MODULATE

Diarrhoea in patients with stable ulcerative colitis.
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10066557;Term: Chronic diarrhoea;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Amitriptyline
Product Name: Amitriptyline
INN or Proposed INN: Amitriptyline hydrochloride
Product Name: Ondansetron
INN or Proposed INN: Ondansetron hydrochloride dihydrate
Product Name: Loperamide
INN or Proposed INN: loperamide hydrochloride

University of Leeds

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

491

Phase 2;Phase 3

United Kingdom

EUCTR2019-003113-34-HU
(EUCTR)

25/02/2020

09/01/2020

Study of efficacy, safety and tolerability of LYS006 in patients with mild to moderate ulcerative colitis

Mild to moderate ulcerative colitis
MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Novartis Pharma AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

United States;Czech Republic;Hungary;Poland;Russian Federation;Bulgaria;Norway;Germany

EUCTR2018-003986-33-GB
(EUCTR)

24/02/2020

17/09/2019

A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis

A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12

Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine

Arena Pharmaceuticals, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

330

Phase 3

Serbia;Portugal;United States;Belarus;Estonia;Taiwan;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Bulgaria;Germany;Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2019-003113-34-DE
(EUCTR)

19/02/2020

08/11/2019

Ulcerative colitis

Product Name: LYS006
Product Code: LYS006
INN or Proposed INN: not yet defined
Other descriptive name: LYS006

Novartis Pharma AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

United States;Hungary;Czech Republic;Norway;Germany

EUCTR2018-003987-29-BG
(EUCTR)

17/02/2020

23/10/2019

An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis

An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE

Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine

Arena Pharmaceuticals Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

702

Phase 3

EUCTR2018-003986-33-ES
(EUCTR)

14/02/2020

24/02/2020

A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis

A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Arena Pharmaceuticals, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

330

Phase 3

Serbia;Portugal;United States;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Israel;Chile;Italy;Switzerland;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Bulgaria;Germany

EUCTR2019-000733-39-AT
(EUCTR)

13/02/2020

14/10/2019

Open-label maintenance therapy in moderate to severe Ulcerative Colitis patients

A phase 2b, open-label, efficacy and safety study of ABX464 as maintenance therapy in patients with moderate to severe Ulcerative Colitis.

Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464

ABIVAX

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

244

Phase 2

Belarus;Serbia;Czechia;Slovakia;Slovenia;Spain;Ukraine;Austria;United Kingdom;France;Hungary;Canada;Belgium;Poland;Germany

EUCTR2018-003558-26-GB
(EUCTR)

11/02/2020

05/11/2019

Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments.

A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-a] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment. - Investigate the safety and efficacy of study drug ABX464-103

Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464
Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464

ABIVAX

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

244

Phase 2

United States;Belarus;Serbia;Slovenia;Slovakia;Spain;Ukraine;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2018-003986-33-BG
(EUCTR)

11/02/2020

23/10/2019

A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis

A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12

Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine

Arena Pharmaceuticals, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

330

Phase 3

EUCTR2018-004002-25-PT
(EUCTR)

03/02/2020

06/08/2019

A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis

Janssen-Cilag International NV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

950

Phase 2;Phase 3

Portugal;United States;Taiwan;Hong Kong;Spain;Thailand;Ukraine;Russian Federation;Israel;Italy;France;Malaysia;Australia;Netherlands;China;Korea, Republic of;Czechia;Turkey;United Kingdom;Hungary;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Japan;Sweden

EUCTR2018-003986-33-LV
(EUCTR)

24/01/2020

01/11/2019

A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis

A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12

Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine

Arena Pharmaceuticals, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

330

Phase 3

South Africa;Serbia;Portugal;United States;Belarus;Estonia;Taiwan;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Israel;Chile;Italy;Switzerland;India;France;Australia;Denmark;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Bulgaria;Germany

EUCTR2018-003987-29-DE
(EUCTR)

23/01/2020

30/09/2019

An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis

An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE

Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine

Arena Pharmaceuticals Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

702

Phase 3

EUCTR2018-003985-15-AT
(EUCTR)

21/01/2020

08/07/2019

A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Arena Pharmaceuticals Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

372

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2018-003985-15-FR
(EUCTR)

20/01/2020

12/07/2019

A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Arena Pharmaceuticals Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

372

Phase 3

EUCTR2018-003986-33-FR
(EUCTR)

14/01/2020

20/09/2019

A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis

A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12

Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine

Arena Pharmaceuticals, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

330

Phase 3

United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany

EUCTR2018-003986-33-LT
(EUCTR)

31/12/2019

08/10/2019

A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis

A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12

Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine

Arena Pharmaceuticals, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

330

Phase 3

United States;Serbia;Portugal;Belarus;Estonia;Taiwan;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan

EUCTR2018-003987-29-ES
(EUCTR)

20/12/2019

An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis

An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Arena Pharmaceuticals Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

702

Phase 3

EUCTR2019-003662-40-DE
(EUCTR)

18/12/2019

22/10/2019

Prospective, open-label, single-arm, single-center phase IV clinical trial to evaluate efficacy and safety of the adalimumab biosimilar Amgevita in subjects with moderate to severe active chronic inflammatory bowel diesease (Crohn's disease and ulcerative colitis)

MedDRA version: 20.1;Level: PT;Classification code 10021972;Term: Inflammatory bowel disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Amgevita 40 mg Injektionslösung in einer Fertigspritze
INN or Proposed INN: ADALIMUMAB
Trade Name: Amgevita 40 mg Injektionslösung im Fertigpen
INN or Proposed INN: ADALIMUMAB

Universitätsklinikum Erlangen

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2018-005086-39-HR
(EUCTR)

16/12/2019

17/01/2020

A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacyand Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis

A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis

Mild to Moderate Ulcerative Colitis Inflammatory bowel disease (IBD) is an autoimmune disease of the gastrointestinal (GI) tract with unknown etiology that encompasses 2 primary clinical manifestations: ulcerative colitis (UC) and Crohn’s disease (CD). UC manifests through complex interactions between the gut microbiome, dysregulated immune responses, genetic mutations, diet, and other environmental factors.
MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: BT-11 500 mg
Product Code: BT-11
INN or Proposed INN: to be requested
Other descriptive name: BT-11
Product Name: BT-11 1000mg
Product Code: BT-11
INN or Proposed INN: to be requested
Other descriptive name: BT-11

Landos Biopharma Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

195

Phase 2

Belarus;Serbia;United States;Ukraine;Russian Federation;Hungary;Canada;Poland;Croatia;Bulgaria;Georgia;Moldova, Republic of;Bosnia and Herzegovina

EUCTR2018-003278-28-NL
(EUCTR)

13/12/2019

22/07/2019

Safety, tolerability, efficacy and dose-response of GSK2831781 in ulcerative colitis.

Product Code: GSK2831781
INN or Proposed INN: Not Assigned
Other descriptive name: GSK2831781

GlaxoSmithKline Research & Development Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

320

Phase 2

Serbia;United States;Czechia;Estonia;Slovenia;Slovakia;Ukraine;Russian Federation;United Kingdom;India;France;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;South Africa;Bulgaria;Netherlands;Korea, Republic of

EUCTR2019-000733-39-ES
(EUCTR)

11/12/2019

11/11/2019

Open-label maintenance therapy in moderate to severe Ulcerative Colitis patients

A phase 2b, open-label, efficacy and safety study of ABX464 as maintenance therapy in patients with moderate to severe Ulcerative Colitis.

Moderate to Severe Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

ABIVAX

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

232

Phase 2

Serbia;Belarus;Slovakia;Slovenia;Spain;Ukraine;Ireland;Austria;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Netherlands;Germany

EUCTR2018-003558-26-FR
(EUCTR)

10/12/2019

08/02/2019

Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments.

Moderate to Severe Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

ABIVAX

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

232

Phase 2

Serbia;Belarus;Slovakia;Slovenia;Spain;Ukraine;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Netherlands;Germany

EUCTR2018-000334-35-NO
(EUCTR)

27/11/2019

12/06/2019

BI 655130 long-term treatment in patients with moderate-to-severe ulcerative colitis

An open label, long term safety trial of BI 655130 treatment in patients with moderate to severely active ulcerative colitis who have completed previous BI 655130 trials

Moderate-to-severely active ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

Product Code: BI 655130
INN or Proposed INN: Spesolimab
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Product Code: BI 655130
INN or Proposed INN: spesolimab
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Product Code: BI 655130
INN or Proposed INN: Spesolimab
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Product Code: BI 655130
INN or Proposed INN: spesolimab
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1

Boehringer Ingelheim Norway KS

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

160

Phase 2

United States;Spain;Austria;Russian Federation;United Kingdom;Italy;Hungary;Canada;Belgium;Poland;Norway;Germany;Netherlands;Japan;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2019-000733-39-SK
(EUCTR)

21/11/2019

06/09/2019

Open-label maintenance therapy in moderate to severe Ulcerative Colitis patients

A phase 2b, open-label, efficacy and safety study of ABX464 as maintenance therapy in patients with moderate to severe Ulcerative Colitis.

Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464

ABIVAX

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

244

Phase 2

Belarus;Serbia;Czechia;Slovakia;Slovenia;Spain;Ukraine;Austria;United Kingdom;France;Hungary;Canada;Belgium;Poland;Germany

EUCTR2017-003703-22-HR
(EUCTR)

20/11/2019

13/01/2020

Phase 2 Dose-finding IMU-838 for Ulcerative Colitis (CALDOSE-1)

Immunic AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

240

Phase 2

United States;Serbia;Belarus;Portugal;Czechia;Spain;Ukraine;North Macedonia;Russian Federation;United Kingdom;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Netherlands;Bosnia and Herzegovina

EUCTR2018-003987-29-DK
(EUCTR)

20/11/2019

02/10/2019

An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis

An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE

Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine

Arena Pharmaceuticals Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

702

Phase 3

EUCTR2018-003987-29-LT
(EUCTR)

14/11/2019

06/11/2019

An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis

An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE

Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine

Arena Pharmaceuticals Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

702

Phase 3

EUCTR2019-000733-39-SI
(EUCTR)

11/11/2019

16/10/2019

Open-label maintenance therapy in moderate to severe Ulcerative Colitis patients

A phase 2b, open-label, efficacy and safety study of ABX464 as maintenance therapy in patients with moderate to severe Ulcerative Colitis.

Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464

ABIVAX

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

244

Phase 2

Belarus;Serbia;Czechia;Slovenia;Slovakia;Spain;Ukraine;Austria;United Kingdom;France;Hungary;Canada;Belgium;Poland;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2019-000733-39-PL
(EUCTR)

09/11/2019

12/09/2019

Open-label maintenance therapy in moderate to severe Ulcerative Colitis patients

A phase 2b, open-label, efficacy and safety study of ABX464 as maintenance therapy in patients with moderate to severe Ulcerative Colitis.

Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464

ABIVAX

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

232

Phase 2

Serbia;Belarus;Slovakia;Slovenia;Spain;Ukraine;Ireland;Austria;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Netherlands;Germany

EUCTR2018-003986-33-HR
(EUCTR)

08/11/2019

17/01/2020

A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis

A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12

Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine

Arena Pharmaceuticals, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

330

Phase 3

United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany

EUCTR2018-003987-29-LV
(EUCTR)

07/11/2019

16/09/2019

An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis

An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE

Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine

Arena Pharmaceuticals Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

702

Phase 3

Serbia;Portugal;United States;Belarus;Estonia;Taiwan;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Bulgaria;Germany;Japan;Lithuania;Turkey;Austria;United Kingdom

EUCTR2018-003986-33-HU
(EUCTR)

07/11/2019

08/11/2019

A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis

A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12

Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine

Arena Pharmaceuticals, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

330

Phase 3

Serbia;Portugal;United States;Belarus;Estonia;Taiwan;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Israel;Chile;Italy;Switzerland;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Bulgaria;Germany

EUCTR2018-003987-29-HU
(EUCTR)

07/11/2019

17/09/2019

An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis

An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE

Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine

Arena Pharmaceuticals Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

702

Phase 3

Serbia;Portugal;United States;Belarus;Estonia;Taiwan;Slovakia;Thailand;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Bulgaria;Germany;Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2016-000642-62-DE
(EUCTR)

04/11/2019

18/10/2018

A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

522

Phase 3

Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden

EUCTR2018-000334-35-HU
(EUCTR)

31/10/2019

06/09/2019

BI 655130 long-term treatment in patients with moderate-to-severe ulcerative colitis

An open label, long term safety trial of BI 655130 treatment in patients with moderate to severely active ulcerative colitis who have completed previous BI 655130 trials

Boehringer Ingelheim RCV GmbH&Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

160

Phase 2

United States;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;Korea, Republic of

EUCTR2018-003558-26-DE
(EUCTR)

30/10/2019

15/03/2019

Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments.

Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464
Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464

ABIVAX

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

232

Phase 2

Belarus;Serbia;Czechia;Slovenia;Slovakia;Spain;Ukraine;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Germany;Netherlands

EUCTR2018-003349-41-DE
(EUCTR)

30/10/2019

19/12/2018

Clinical trial to evaluate the benefit and safety of ST-0529 in subjects who are suffering from active ulcerative colitis

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of ST-0529 in Subjects with Moderately to Severely Active Ulcerative Colitis

Active ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: ST-0529
Product Code: FP-CYA-050
INN or Proposed INN: CICLOSPORIN
Other descriptive name: cyclosporine
Product Name: ST-0529
Product Code: FP-CYA-053
INN or Proposed INN: CICLOSPORIN
Other descriptive name: cyclosporine

Sublimity Therapeutics (Hold Co) Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

280

Phase 2

Belarus;Serbia;United States;Ukraine;Israel;Russian Federation;United Kingdom;France;Hungary;Canada;Poland;Bulgaria;Germany

100

EUCTR2018-002135-19-BG
(EUCTR)

30/10/2019

11/07/2019

A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Ulcerative Colitis (UC)

A 3-Year, Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects with Ulcerative Colitis (UC) - TD-1473 LTS UC Study

Moderately-to-severely active Ulcerative Colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: TD-1473
Product Code: TD-1473
INN or Proposed INN: Not assigned
Other descriptive name: THRX-139060
Product Name: TD-1473
Product Code: TD-1473
INN or Proposed INN: Not assigned
Other descriptive name: THRX-139060
Product Name: TD-1473
Product Code: TD-1473
INN or Proposed INN: Not assigned
Other descriptive name: THRX-139060

Theravance Biopharma Ireland Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

500

Phase 3

Portugal;Serbia;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Australia;South Africa;Korea, Republic of;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

101

EUCTR2018-005086-39-HU
(EUCTR)

28/10/2019

08/04/2019

A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacyand Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis

Product Code: BT-11
INN or Proposed INN: to be requested
Product Code: BT-11
INN or Proposed INN: to be requested

Landos Biopharma Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

195

Phase 2

United States;Serbia;Belarus;Hungary;Poland;Ukraine;Croatia;Russian Federation;Georgia;Moldova, Republic of;Bosnia and Herzegovina

102

EUCTR2018-003278-28-HU
(EUCTR)

24/10/2019

25/03/2019

Safety, tolerability, efficacy and dose-response of GSK2831781 in ulcerative colitis.

A multicentre randomized, double-blind (sponsor open), placebo-controlled Phase 2 study to evaluate the safety, tolerability, efficacy, dose-response, pharmacokinetics and pharmacodynamics of repeat dosing of an anti-LAG3 cell depleting monoclonal antibody (GSK2831781) in patients with active ulcerative colitis

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

GlaxoSmithKline Research & Development Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

320

Phase 2

Serbia;United States;Estonia;Slovakia;Slovenia;Ukraine;Lithuania;Russian Federation;United Kingdom;India;France;Hungary;Czech Republic;Canada;Poland;South Africa;Bulgaria;Netherlands;Korea, Republic of

103

EUCTR2018-004002-25-BE
(EUCTR)

21/10/2019

10/09/2019

A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis

Moderately to Severely Active Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Janssen-Cilag International NV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

950

Phase 2;Phase 3

United States;Portugal;Taiwan;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden

104

EUCTR2018-003985-15-ES
(EUCTR)

21/10/2019

A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52

Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine

Arena Pharmaceuticals Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

372

Phase 3

105

EUCTR2018-004002-25-FR
(EUCTR)

15/10/2019

14/08/2019

A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis

Moderately to Severely Active Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Janssen-Cilag International NV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1000

Phase 2;Phase 3

United States;Portugal;Taiwan;Hong Kong;Spain;Ukraine;Israel;Russian Federation;Italy;France;Malaysia;Australia;China;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Japan;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

106

EUCTR2018-004002-25-SE
(EUCTR)

15/10/2019

03/07/2019

A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis

Janssen-Cilag International NV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

950

Phase 2;Phase 3

United States;Portugal;Hong Kong;Taiwan;Spain;Ukraine;Israel;Russian Federation;Italy;France;Malaysia;Australia;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden

107

EUCTR2018-003986-33-BE
(EUCTR)

14/10/2019

15/07/2019

A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis

A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12

Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine

Arena Pharmaceuticals, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

330

Phase 3

United States;Serbia;Portugal;Belarus;Estonia;Taiwan;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany

108

EUCTR2018-003985-15-PT
(EUCTR)

14/10/2019

10/07/2019

A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Arena Pharmaceuticals Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

372

Phase 3

Serbia;United States;Portugal;Belarus;Estonia;Taiwan;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Bulgaria;Germany;Japan

109

EUCTR2018-004890-28-IT
(EUCTR)

09/10/2019

07/10/2020

Study for the research of predictive factors of response to Tofacitinib therapy in patients with ulcerative rectal colitis.

(A)nalysis of immunological (VA)riables in ex vivo (T)ofacitinib-treated human biopsies from (A)ctive ulcerative colitis patients to predict clinical (R)esponse (the AVATAR study). - AVATAR

Ulcerative colitis
MedDRA version: 20.0;Level: LLT;Classification code 10045282;Term: UC;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Xeljanz
Product Name: Xeljanz
Product Code: [N/A]

DIP. MEDICINA DEI SISTEMI UNIVERSITà DEGLI STUDI DI ROMA TOR VERGATA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

Italy

110

EUCTR2018-004002-25-GB
(EUCTR)

09/10/2019

20/08/2019

A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis

Janssen-Cilag International NV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

950

Phase 2;Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

111

EUCTR2018-001605-93-BG
(EUCTR)

09/10/2019

20/09/2019

An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Allergan Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

375

Phase 2

United States;Taiwan;Spain;Russian Federation;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;China;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Bulgaria;Germany;Japan

112

EUCTR2018-003987-29-NL
(EUCTR)

07/10/2019

22/08/2019

An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis

An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE

Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine

Arena Pharmaceuticals Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

702

Phase 3

Portugal;United States;Belarus;Serbia;Estonia;Taiwan;Slovakia;Spain;Thailand;Ukraine;Lebanon;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;China;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;Japan

113

EUCTR2018-005086-39-PL
(EUCTR)

07/10/2019

06/05/2019

A Study to Evaluate Efficacy and Safety of BT-11 product oral tablets in Mild to Moderate Ulcerative Colitis

A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis

Landos Biopharma Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

195

Phase 2

United States;Serbia;Belarus;Hungary;Poland;Ukraine;Croatia;Russian Federation;Georgia;Moldova, Republic of;Bosnia and Herzegovina

114

EUCTR2017-004230-28-CZ
(EUCTR)

04/10/2019

11/07/2019

BI 655130 induction treatment in patients with moderate-to severe ulcerative colitis

A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI 655130 Induction Therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy

Product Code: BI 655130
INN or Proposed INN: BI 655130
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1

Boehringer Ingelheim International GmbH

NULL

Not Recruiting

Female: yes
Male: yes

550

Phase 2;Phase 3

United States;Taiwan;Greece;Spain;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;China;Korea, Republic of

115

EUCTR2018-003986-33-NL
(EUCTR)

03/10/2019

22/08/2019

A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis

A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12

Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine

Arena Pharmaceuticals, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

330

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

116

EUCTR2018-003987-29-HR
(EUCTR)

02/10/2019

20/01/2020

An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis

An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE

Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine

Arena Pharmaceuticals Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

702

Phase 3

United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Israel;Switzerland;Italy;France;Denmark;Australia;South Africa;Latvia;Netherlands;China;Moldova, Republic of;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Croatia;Georgia;Bulgaria;Germany;Japan

117

EUCTR2018-004002-25-HU
(EUCTR)

01/10/2019

13/08/2019

A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis

Moderately to Severely Active Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Janssen-Cilag International NV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1000

Phase 2;Phase 3

Portugal;United States;Taiwan;Hong Kong;Thailand;Spain;Ukraine;Russian Federation;Israel;Italy;France;Malaysia;Australia;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Bulgaria;Germany;Japan;Sweden

118

EUCTR2018-003490-10-FR
(EUCTR)

30/09/2019

26/09/2019

An open-label randomized trial COmparing staNdard of care versus Treat to target with telemonitoRing and patient education in patients with ulcerative cOlitis initiating adalimumab : The CONTROL trial

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

GETAID

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

238

Phase 4

France

119

EUCTR2018-003985-15-BG
(EUCTR)

27/09/2019

12/08/2019

A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52

Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine

Arena Pharmaceuticals Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

372

Phase 3

120

EUCTR2018-003985-15-DK
(EUCTR)

27/09/2019

24/07/2019

A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52

Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine

Arena Pharmaceuticals Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

372

Phase 3

United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Latvia;Netherlands;China;Moldova, Republic of;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

121

EUCTR2018-003278-28-CZ
(EUCTR)

25/09/2019

15/04/2019

Safety, tolerability, efficacy and dose-response of GSK2831781 in ulcerative colitis.

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

GlaxoSmithKline Research & Development Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

320

Phase 2

Serbia;United States;Estonia;Slovenia;Ukraine;Lithuania;Russian Federation;United Kingdom;India;France;Czech Republic;Hungary;Mexico;Canada;Poland;South Africa;Bulgaria;Netherlands;Korea, Republic of

122

EUCTR2018-004694-27-DE
(EUCTR)

24/09/2019

24/05/2019

Safety and Efficacy of BMS-986165 Compared with Placebo in Subjects with Ulcerative Colitis

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: BMS-986165
Other descriptive name: BMS986165

Bristol-Myers Squibb International Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

120

Phase 2

United States;Czechia;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Australia;Germany;Japan;Korea, Republic of

123

EUCTR2018-001605-93-BE
(EUCTR)

23/09/2019

07/06/2019

An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis

AstraZeneca AB

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

375

Phase 2

Czechia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Bulgaria;Germany;Japan;United States;Taiwan;Spain;Israel;Russian Federation;Colombia;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;China;Korea, Republic of

124

EUCTR2017-004496-31-NL
(EUCTR)

20/09/2019

27/09/2018

A Study of the Efficacy and Safety of Golimumab in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis

A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety,and Pharmacokinetics of Golimumab Treatment, a Human anti-TNFa Monoclonal Antibody, Administered Subcutaneously in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis - PURSUIT 2

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Janssen Biologics BV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

125

Phase 3

France;United States;Taiwan;Poland;Brazil;Belgium;Spain;Israel;Netherlands;Italy;Korea, Republic of

125

EUCTR2018-003985-15-NL
(EUCTR)

18/09/2019

09/07/2019

A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52

Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine

Arena Pharmaceuticals Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

372

Phase 3

Serbia;Portugal;United States;Belarus;Estonia;Taiwan;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;India;France;Australia;Denmark;South Africa;Latvia;Netherlands;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Bulgaria;Germany;Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

126

EUCTR2018-003987-29-BE
(EUCTR)

16/09/2019

01/07/2019

An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis

An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE

Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine

Arena Pharmaceuticals Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

702

Phase 3

United States;Serbia;Portugal;Belarus;Estonia;Taiwan;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan

127

EUCTR2018-001605-93-FR
(EUCTR)

13/09/2019

25/06/2019

An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Allergan Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

900

Phase 2

128

EUCTR2018-002135-19-GR
(EUCTR)

13/09/2019

04/06/2019

A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Ulcerative Colitis (UC)

A 3-Year, Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects with Ulcerative Colitis (UC) - TD-1473 LTS UC Study

Moderately-to-severely active Ulcerative Colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Theravance Biopharma Ireland Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

500

Phase 3

Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;United Kingdom;France;Hungary;Canada;Poland;Croatia;Australia;Georgia;South Africa;Bulgaria;Germany

129

EUCTR2018-002136-24-FR
(EUCTR)

10/09/2019

19/12/2018

A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Ulcerative Colitis

A Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with TD-1473 in Subjects with Moderately-to-Severely Active Ulcerative Colitis - Rhea: Efficacy and Safety of TD-1473 in Ulcerative Colitis

Moderately-to-Severely Active Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Theravance Biopharma Ireland Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

880

Phase 2;Phase 3

Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;United Kingdom;India;France;Hungary;Canada;Poland;Croatia;Australia;South Africa;Bulgaria;Georgia;Germany

130

EUCTR2017-004230-28-HU
(EUCTR)

06/09/2019

08/07/2019

BI 655130 induction treatment in patients with moderate-to severe ulcerative colitis

Product Name: spesolimab
Product Code: BI 655130
INN or Proposed INN: Spesolimab
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Product Name: spesolimab
Product Code: BI 655130
INN or Proposed INN: Spesolimab
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1

Boehringer Ingelheim International GmbH

NULL

Not Recruiting

Female: yes
Male: yes

550

Phase 2;Phase 3

Spain;Austria;Russian Federation;Israel;United Kingdom;Italy;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;China;Korea, Republic of;United States;Taiwan;Greece

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

131

EUCTR2017-004092-31-DE
(EUCTR)

05/09/2019

15/05/2019

A study of the efficacy and safety of Mirikizumab in Ulcerative Colitis

Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: mirikizumab
Other descriptive name: MIRIKIZUMAB

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

840

Phase 3

Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Germany;Japan

132

EUCTR2016-000642-62-HR
(EUCTR)

30/08/2019

20/01/2020

A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

462

Phase 3

Portugal;Belarus;United States;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden

133

EUCTR2018-003558-26-BE
(EUCTR)

29/08/2019

27/05/2019

Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments.

Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464
Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464

ABIVAX

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

244

Phase 2

United States;Belarus;Serbia;Slovakia;Slovenia;Spain;Ukraine;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany

134

EUCTR2018-003985-15-LT
(EUCTR)

27/08/2019

10/07/2019

A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52

Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine

Arena Pharmaceuticals Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

372

Phase 3

135

EUCTR2018-003985-15-EE
(EUCTR)

26/08/2019

15/07/2019

A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Arena Pharmaceuticals Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

372

Phase 3

Serbia;Portugal;United States;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Bulgaria;Germany;Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

136

EUCTR2018-002135-19-DE
(EUCTR)

26/08/2019

25/02/2019

A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Ulcerative Colitis (UC)

A 3-Year, Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects with Ulcerative Colitis (UC) - TD-1473 LTS UC Study

Theravance Biopharma Ireland Limited

NULL

Not Recruiting

Female: yes
Male: yes

500

Phase 3

137

EUCTR2017-004092-31-HR
(EUCTR)

19/08/2019

20/01/2020

A study of the efficacy and safety of Mirikizumab in Ulcerative Colitis

I6T-MC-AMAP A Phase 3, Multicenter, Open-Label Extension Study to Evaluate the Long- Term Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 3) - LUCENT 3

moderately to severely active Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

840

Phase 3

138

EUCTR2018-004491-35-PL
(EUCTR)

19/08/2019

03/07/2019

A study evaluating safety and efficacy of Itacitinib as treatment of moderate to severe ulcerative Colitis

A Phase 2, Double-Blind, Dose-Ranging, Placebo-Controlled Study With Open-Label Extension to Evaluate the Safety and Efficacy of Itacitinib in Moderate to Severe Ulcerative Colitis

Moderate to Severe Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Incyte Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

206

Phase 2

United States;Czech Republic;Poland;Romania;Germany

139

NCT03861143
(ClinicalTrials.gov)

August 14, 2019

27/2/2019

Efficacy and Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis

A Randomized , Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis

Ulcerative Colitis

Drug: BT-11 (500 mg);Drug: BT-11 (1000 mg);Drug: Placebo

Landos Biopharma Inc.

NULL

Active, not recruiting

18 Years

65 Years

All

198

Phase 2

United States;Bosnia and Herzegovina;Croatia;Poland;Ukraine;Belarus;Georgia;Hungary;Moldova, Republic of;Russian Federation;Serbia

140

EUCTR2018-003985-15-HR
(EUCTR)

14/08/2019

24/12/2019

A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52

Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine

Arena Pharmaceuticals Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

372

Phase 3

Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan;United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

141

EUCTR2017-004092-31-ES
(EUCTR)

13/08/2019

11/06/2019

A study of the efficacy and safety of Mirikizumab in Ulcerative Colitis

Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: mirikizumab
Other descriptive name: MIRIKIZUMAB

Lilly S.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

840

Phase 3

Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Germany;Japan

142

EUCTR2018-004694-27-CZ
(EUCTR)

13/08/2019

19/07/2019

Safety and Efficacy of BMS-986165 Compared with Placebo in Subjects with Ulcerative Colitis

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: BMS-986165
Other descriptive name: BMS986165

Bristol-Myers Squibb International Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

120

Phase 2

United States;Hungary;Czech Republic;Poland;Belgium;Australia;Russian Federation;Germany;Japan;Italy;United Kingdom;Korea, Republic of

143

EUCTR2018-001605-93-ES
(EUCTR)

07/08/2019

09/08/2019

An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis

Allergan Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

900

Phase 2

144

EUCTR2018-003278-28-PL
(EUCTR)

03/08/2019

11/06/2019

Safety, tolerability, efficacy and dose-response of GSK2831781 in ulcerative colitis.

Product Code: GSK2831781
INN or Proposed INN: Not Assigned
Other descriptive name: GSK2831781

GlaxoSmithKline Research & Development Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

320

Phase 2

United States;Serbia;Estonia;Slovakia;Ukraine;Lithuania;Russian Federation;United Kingdom;India;France;Czech Republic;Hungary;Mexico;Canada;Poland;South Africa;Bulgaria;Netherlands;Japan;Korea, Republic of

145

NCT03591770
(ClinicalTrials.gov)

July 31, 2019

9/7/2018

Shingrix Vaccine in Patients With Moderate to Severe Ulcerative Colitis on Tofacitinib

The Immunogenicity and Safety of Shingrix Vaccine in Patients With Moderate to Severe Ulcerative Colitis on Tofacitinib

Inflammatory Bowel Diseases

Biological: SHINGRIX

Boston Medical Center

NULL

Suspended

50 Years

N/A

All

100

Phase 4

United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

146

EUCTR2016-000642-62-PT
(EUCTR)

29/07/2019

16/10/2018

A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

462

Phase 3

Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Singapore;United States;Belarus;Portugal;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Croatia;Germany;Norway;Japan;Sweden

147

EUCTR2018-003985-15-HU
(EUCTR)

29/07/2019

16/07/2019

A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Arena Pharmaceuticals Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

372

Phase 3

148

EUCTR2016-000642-62-GB
(EUCTR)

26/07/2019

25/10/2018

A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

522

Phase 3

Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden

149

EUCTR2018-004694-27-GB
(EUCTR)

23/07/2019

30/04/2019

Safety and Efficacy of BMS-986165 Compared with Placebo in Subjects with Ulcerative Colitis

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Bristol-Myers Squibb International Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

120

Phase 2

United States;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Australia;Germany;Japan;Korea, Republic of

150

EUCTR2019-001032-54-FR
(EUCTR)

23/07/2019

19/06/2019

Impact of anti-cytomegalovirus (valganciclovir) treatment in the management of relapsing ulcerative colitis (UC) requiring vedolizumab therapy: a randomized clinical trial comparing a strategy with or without antiviral therapy

Patient with active ulcerative colitis who failed to anti-TNF with endoscopic active disease with an endoscopic Mayo score> 1 and 2 biopsies of the inflammatory tissue and presence of a CMV infection in the inflammatory tissue objectified by a viral load greater than 5 IU / 100000 cells by qPCR.
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10058881;Term: Cytomegalovirus viremia;System Organ Class: 100000004862 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

CHU de Saint Etienne

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

120

Phase 4

France

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

151

EUCTR2018-003349-41-FR
(EUCTR)

11/07/2019

27/05/2019

Clinical trial to evaluate the benefit and safety of ST-0529 in subjects who are suffering from active ulcerative colitis

Active ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Sublimity Therapeutics (Hold Co) Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

280

Phase 2

Serbia;United States;Belarus;Spain;Ukraine;Ireland;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Romania;Bulgaria;Germany

152

EUCTR2018-003985-15-LV
(EUCTR)

05/07/2019

02/07/2019

A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Arena Pharmaceuticals Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

372

Phase 3

153

EUCTR2018-001605-93-GB
(EUCTR)

01/07/2019

04/04/2019

An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis

AstraZeneca AB

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

375

Phase 2

United States;Taiwan;Spain;Israel;Russian Federation;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Bulgaria;Germany;Japan

154

EUCTR2018-003986-33-SK
(EUCTR)

01/07/2019

02/05/2019

A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis

A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12

Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine

Arena Pharmaceuticals Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

330

Phase 3

United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan

155

EUCTR2017-004230-28-GR
(EUCTR)

01/07/2019

03/05/2019

BI 655130 induction treatment in patients with moderate-to severe ulcerative colitis

Moderate-to-severely active ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

Boehringer Ingelheim International GmbH

NULL

Not Recruiting

Female: yes
Male: yes

550

Phase 2;Phase 3

United States;Taiwan;Greece;Spain;Austria;Russian Federation;Israel;Italy;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;China;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

156

EUCTR2018-004694-27-PL
(EUCTR)

30/06/2019

15/05/2019

Safety and Efficacy of BMS-986165 Compared with Placebo in Subjects with Ulcerative Colitis

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Bristol-Myers Squibb International Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

120

Phase 2

United States;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Australia;Germany;Japan;Korea, Republic of

157

EUCTR2018-003987-29-SK
(EUCTR)

25/06/2019

15/04/2019

An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis

An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE

Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine

Arena Pharmaceuticals Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

702

Phase 3

United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan

158

EUCTR2017-004997-32-DE
(EUCTR)

25/06/2019

14/12/2018

A Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's Disease

A PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE

Ulcerative Colitis (UC) or Crohn's Disease (CD)
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: UTTR1147A/RO7021610 (Active)
INN or Proposed INN: n.a.
Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc

Genentech, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

320

Phase 2

United States;Serbia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Poland;Bulgaria;Netherlands;Germany

159

EUCTR2018-004694-27-HU
(EUCTR)

25/06/2019

06/05/2019

Safety and Efficacy of BMS-986165 Compared with Placebo in Subjects with Ulcerative Colitis

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: BMS-986165
Other descriptive name: BMS986165

Bristol-Myers Squibb International Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

120

Phase 2

United States;Spain;Russian Federation;Switzerland;United Kingdom;Italy;Hungary;Czech Republic;Canada;Belgium;Poland;Germany;Japan;Korea, Republic of

160

EUCTR2018-002136-24-DE
(EUCTR)

25/06/2019

27/12/2018

A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Ulcerative Colitis

Moderately-to-Severely Active Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Theravance Biopharma Ireland Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

880

Phase 2;Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

161

EUCTR2018-003985-15-SK
(EUCTR)

21/06/2019

16/04/2019

A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52

Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine

Arena Pharmaceuticals Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

372

Phase 3

Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan;United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand

162

EUCTR2016-000642-62-GR
(EUCTR)

21/06/2019

25/10/2018

A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

522

Phase 3

Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden

163

EUCTR2018-002135-19-PL
(EUCTR)

19/06/2019

05/04/2019

A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Ulcerative Colitis (UC)

A 3-Year, Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects with Ulcerative Colitis (UC) - TD-1473 LTS UC Study

Theravance Biopharma Ireland Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

500

Phase 3

164

EUCTR2016-000642-62-IE
(EUCTR)

18/06/2019

26/11/2018

A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

522

Phase 3

Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden

165

EUCTR2017-004230-28-DK
(EUCTR)

14/06/2019

24/03/2019

BI655130 (SPESOLIMAB) induction treatment in patients with moderate-to-severe ulcerative colitis

A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI655130 (SPESOLIMAB) Induction Therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy

Boehringer Ingelheim Denmark A/S

NULL

Not Recruiting

Female: yes
Male: yes

550

Phase 2;Phase 3

United States;Taiwan;Greece;Spain;Austria;Russian Federation;Israel;Italy;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Denmark;Australia;Norway;Netherlands;Germany;Japan;China;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

166

EUCTR2016-000642-62-NL
(EUCTR)

13/06/2019

11/10/2018

A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

462

Phase 3

Portugal;Belarus;Serbia;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden

167

EUCTR2018-003558-26-SI
(EUCTR)

12/06/2019

07/03/2019

Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments.

Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464
Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464

ABIVAX

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

244

Phase 2

United States;Belarus;Serbia;Slovenia;Slovakia;Spain;Ukraine;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany

168

EUCTR2018-002136-24-BG
(EUCTR)

12/06/2019

18/01/2019

A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Ulcerative Colitis

Theravance Biopharma Ireland Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

880

Phase 2;Phase 3

Serbia;United States;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Australia;South Africa;Korea, Republic of;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Japan

169

NCT03760003
(ClinicalTrials.gov)

June 11, 2019

29/11/2018

Dose-Ranging Phase 2b Study of ABX464 in Moderate to Severe Ulcerative Colitis

A Randomized, Double Blind, Placebo Controlled, Parallel Group, Multiple Dose, Induction Study to Evaluate the Safety, Tolerability and Optimal Dose of ABX464 Compared With Placebo in Patients With Moderate to Severe Ulcerative Colitis Who Have Inadequate Response, Loss of Response, or Intolerance With at Least One of the Following Agents: Immunosuppressant Treatment (i.e. Azathioprine, 6-mercaptopurine, Methotrexate), Tumor Necrosis Factor Alpha [TNF-a] Inhibitors, Vedolizumab, JAK Inhibitors and/or Corticosteroid Treatment

Ulcerative Colitis

Drug: ABX464 25mg;Drug: ABX464 50mg;Drug: ABX464 100mg;Drug: Placebo

Abivax S.A.

NULL

Recruiting

18 Years

75 Years

All

232

Phase 2

United States;Austria;Belarus;Belgium;Canada;Czechia;France;Germany;Hungary;Italy;Poland;Serbia;Slovakia;Slovenia;Spain;Ukraine;United Kingdom

170

EUCTR2018-002135-19-ES
(EUCTR)

10/06/2019

12/04/2019

A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Ulcerative Colitis (UC)

A 3-Year, Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects with Ulcerative Colitis (UC) - TD-1473 LTS UC Study

Moderately-to-severely active Ulcerative Colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Theravance Biopharma Ireland Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

500

Phase 3

Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;United Kingdom;France;Hungary;Canada;Poland;Croatia;Australia;South Africa;Bulgaria;Georgia;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

171

EUCTR2018-002135-19-PT
(EUCTR)

05/06/2019

15/03/2019

A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Ulcerative Colitis (UC)

A 3-Year, Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects with Ulcerative Colitis (UC) - TD-1473 LTS UC Study

Moderately-to-severely active Ulcerative Colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Theravance Biopharma Ireland Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

500

Phase 3

Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;United Kingdom;France;Hungary;Canada;Poland;Croatia;Australia;Georgia;South Africa;Bulgaria;Germany

172

EUCTR2013-004279-11-FR
(EUCTR)

03/06/2019

09/04/2019

A study of the effectiveness (efficacy) and safety of etrolizumab treatment, compared with Adalimumab and Placebo, in inducing disease remission in ulcerative colitis patients who have not previously received TNF inhibitors

PHASE III, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (INDUCTION OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH ADALIMUMAB AND PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - HIBISCUS I

Product Name: Etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

350

Phase 3

United States;Serbia;Estonia;Hong Kong;Slovakia;Ukraine;Russian Federation;France;Mexico;Argentina;Brazil;Poland;Australia;Bulgaria

173

EUCTR2018-003349-41-BG
(EUCTR)

29/05/2019

27/02/2019

Clinical trial to evaluate the benefit and safety of ST-0529 in subjects who are suffering from active ulcerative colitis

Sublimity Therapeutics (Hold Co) Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

280

Phase 2

Belarus;Serbia;United States;Ukraine;Israel;Russian Federation;United Kingdom;France;Hungary;Canada;Poland;Bulgaria;Germany

174

EUCTR2018-002135-19-SK
(EUCTR)

28/05/2019

15/03/2019

A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Ulcerative Colitis (UC)

A 3-Year, Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects with Ulcerative Colitis (UC) - TD-1473 LTS UC Study

Theravance Biopharma Ireland Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

500

Phase 3

175

EUCTR2018-000930-37-ES
(EUCTR)

27/05/2019

22/01/2019

A Study to Investigate safety and how well ABBV-323 works and how safe it is in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy

A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of ABBV-323 in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

France;United States;Canada;Spain;Netherlands;Germany;Italy;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

176

EUCTR2018-002136-24-ES
(EUCTR)

23/05/2019

11/04/2019

A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Ulcerative Colitis

Moderately-to-Severely Active Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Theravance Biopharma Ireland Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

880

Phase 2;Phase 3

United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;United Kingdom;India;France;Hungary;Canada;Poland;Croatia;Australia;South Africa;Bulgaria;Georgia;Germany

177

EUCTR2018-003558-26-SK
(EUCTR)

23/05/2019

20/03/2019

Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments.

Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464
Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464

ABIVAX

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

244

Phase 2

Slovenia;Spain;Ukraine;Austria;United Kingdom;Italy;France;Czech Republic;United States;Belarus;Serbia;Slovakia;Hungary;Canada;Belgium;Poland;Germany

178

EUCTR2018-003558-26-HU
(EUCTR)

21/05/2019

25/03/2019

Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments.

Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464
Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464

ABIVAX

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

232

Phase 2

United States;Belarus;Serbia;Czechia;Slovakia;Slovenia;Spain;Ukraine;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Germany

179

EUCTR2017-004092-31-FR
(EUCTR)

21/05/2019

18/04/2019

A study of the efficacy and safety of Mirikizumab in Ulcerative Colitis

I6T-MC-AMAP A Phase 3, Multicenter, Open-Label Extension Study to Evaluate the Long- Term Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 3) - LUCENT 3

moderately to severely active Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

840

Phase 3

180

EUCTR2018-003558-26-PL
(EUCTR)

20/05/2019

12/04/2019

Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments.

Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464
Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464

ABIVAX

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

244

Phase 2

Serbia;United States;Belarus;Slovakia;Slovenia;Spain;Ukraine;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

181

EUCTR2016-004676-22-SI
(EUCTR)

20/05/2019

06/02/2019

A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis Who Responded to Induction treatment in M16-067 or M16-065”

A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065

Product Name: Risankizumab
Product Code: ABBV-006
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

760

Phase 3

Bulgaria;Germany;New Zealand;Japan;Sweden;Romania;Croatia;United States;Serbia;Portugal;Belarus;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium

182

EUCTR2017-004576-57-PL
(EUCTR)

18/05/2019

01/08/2019

Novel budesonide capsules vs. budesonide tabltes in patients with ulcerative colitis refractory to standard treatment with mesalazine

Randomised, double-blind, double-dummy, active-controlled, phase III clinical trial on the efficacy and safety of an 8-week add-on treatment with budesonide 9 mg capsules vs. budesonide 6 mg capsules vs. budesonide-MMX® 9 mg tablets in patients with ulcerative colitis refractory to standard treatment with mesalazine - TOPICAL-2

Patients with active ulcerative colitis refractory to standard treatment with mesalazine
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Budesonide 9 mg prolonged-release capsules, hard (BUX-PVII prototype)
INN or Proposed INN: BUDESONIDE
Product Name: Budesonide 6 mg prolonged-release capsules, hard (BUX-PVII prototype)
INN or Proposed INN: BUDESONIDE
Trade Name: CortimentMMX 9 mg
INN or Proposed INN: BUDESONIDE

Dr. Falk Pharma GmbH

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

777

Phase 3

Hungary;Czech Republic;Slovakia;Poland;Ukraine;Lithuania;Russian Federation;Latvia;Germany

183

EUCTR2013-001682-16-DK
(EUCTR)

09/05/2019

13/05/2014

A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis

Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

840

Phase 3

United States;Slovakia;Spain;Austria;Israel;Switzerland;Italy;Czech Republic;Hungary;Canada;Poland;Denmark;Germany;Netherlands;Japan

184

EUCTR2018-000930-37-FR
(EUCTR)

07/05/2019

07/12/2018

A Study to Investigate safety and how well ABBV-323 works and how safe it is in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy

A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of ABBV-323 in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

United States;France;Canada;Spain;Netherlands;Germany;Italy;United Kingdom

185

EUCTR2018-003278-28-FR
(EUCTR)

07/05/2019

09/05/2019

Safety, tolerability, efficacy and dose-response of GSK2831781 in ulcerative colitis.

Product Code: GSK2831781
INN or Proposed INN: Not Assigned
Other descriptive name: GSK2831781

GlaxoSmithKline Research & Development Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

320

Phase 2

Serbia;United States;Estonia;Slovakia;Slovenia;Ukraine;Lithuania;Russian Federation;United Kingdom;India;France;Czech Republic;Hungary;Canada;Poland;South Africa;Bulgaria;Netherlands;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

186

EUCTR2018-001510-15-DE
(EUCTR)

02/05/2019

19/11/2018

A Proof-of-concept Study of the Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis

A Phase 2a Randomized, Double-blind, Active-controlled, Parallel-group, Multicenter, Proof-of-concept Clinical Study to Evaluate the Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis - VEGA

Product Name: Guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Trade Name: TREMFYA ®
Product Name: Guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Trade Name: Simponi ®
Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: GOLIMUMAB

Janssen-Cilag International NV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

210

Phase 2

United States;Mexico;Argentina;Poland;Brazil;Ukraine;Australia;Russian Federation;Germany

187

EUCTR2018-003594-95-NL
(EUCTR)

30/04/2019

Addition of methotrexate to regain clinical response in IBD patients on anti-TNF therapy

Methotrexate to suppress immunogenicity to anti-tumor necrosis factor therapy in IBD patients with loss of response

Inflammatory bowel disease: Crohn's disease and Ulcerative colitis
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Amsterdam UMC location AMC

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

Netherlands

188

EUCTR2018-003278-28-GB
(EUCTR)

29/04/2019

14/12/2018

Safety, tolerability, efficacy and dose-response of GSK2831781 in ulcerative colitis.

Product Code: GSK2831781
INN or Proposed INN: Not Assigned
Other descriptive name: GSK2831781

GlaxoSmithKline Research & Development Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

320

Phase 2

United States;Serbia;Estonia;Slovenia;Slovakia;Ukraine;Lithuania;Russian Federation;Israel;United Kingdom;India;France;Czech Republic;Hungary;Mexico;Canada;Poland;South Africa;Bulgaria;Netherlands;Korea, Republic of

189

EUCTR2017-004576-57-DE
(EUCTR)

26/04/2019

08/01/2019

Novel budesonide capsules vs. budesonide tablets in patients with ulcerative colitis refractory to standard treatment with mesalazine

Product Name: Budesonide 9 mg prolonged-release capsule, hard (BUX-PVII prototype)
INN or Proposed INN: BUDESONIDE
Product Name: Budesonide 6 mg prolonged-release capsule, hard (BUX-PVII prototype)
INN or Proposed INN: BUDESONIDE
Trade Name: CortimentMMX 9 mg
INN or Proposed INN: BUDESONIDE

Dr. Falk Pharma GmbH

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

777

Phase 3

Serbia;Czechia;Czech Republic;Hungary;Slovakia;Poland;Ukraine;Lithuania;Russian Federation;Latvia;Germany

190

EUCTR2018-003524-36-NL
(EUCTR)

25/04/2019

19/11/2018

Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

UMC Amsterdam location AMC

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

Netherlands

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

191

EUCTR2017-003703-22-PL
(EUCTR)

25/04/2019

26/04/2018

Phase 2 Dose-finding IMU-838 for Ulcerative Colitis (CALDOSE-1)

A phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-finding study to evaluate the efficacy and safety of IMU-838 for induction and maintenance therapy in moderate-to-severe ulcerative colitis CALDOSE-1

Immunic AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

240

Phase 2

Serbia;Portugal;United States;Belarus;Spain;Ukraine;Russian Federation;United Kingdom;Czech Republic;Macedonia, the former Yugoslav Republic of;Poland;Belgium;Romania;Croatia;Bulgaria;Germany;Netherlands;Bosnia and Herzegovina

192

EUCTR2018-000930-37-DE
(EUCTR)

24/04/2019

18/10/2018

A Study to Investigate safety and how well Ravagalimab (ABBV-323) works and how safe it is in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy

A Multicenter, Single-Arm, Open-Label Study to Investigate the Efficacy and Safety of Ravagalimab (ABBV-323) in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy

Product Name: Ravagalimab
Product Code: ABBV-323
Other descriptive name: ABBV-323

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

United States;France;Hungary;Canada;Spain;Netherlands;Germany;United Kingdom;Italy;Korea, Republic of

193

EUCTR2017-004576-57-LV
(EUCTR)

15/04/2019

14/01/2019

Novel budesonide capsules vs. budesonide tables in patients with ulcerative colitis refractory to standard treatment with mesalazine

Patients with active ulcerative colitis refractory to standard treatment with mesalazine
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Dr. Falk Pharma GmbH

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

777

Phase 3

Hungary;Czech Republic;Slovakia;Poland;Ukraine;Lithuania;Russian Federation;Germany;Latvia

194

EUCTR2018-002135-19-HU
(EUCTR)

11/04/2019

19/02/2019

A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Ulcerative Colitis (UC)

A 3-Year, Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects with Ulcerative Colitis (UC) - TD-1473 LTS UC Study

Moderately-to-severely active Ulcerative Colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Theravance Biopharma Ireland Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

500

Phase 3

Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;United Kingdom;France;Hungary;Canada;Poland;Croatia;Australia;Georgia;South Africa;Bulgaria;Germany

195

EUCTR2013-004277-27-HU
(EUCTR)

11/04/2019

25/02/2019

PHASE III, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBOCONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (INDUCTION OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH ADALIMUMAB AND PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - HIBISCUS II

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

350

Phase 3

United States;Greece;Ukraine;Turkey;Lithuania;Russian Federation;Colombia;Hungary;Czech Republic;Argentina;Poland;Brazil;Malaysia;Croatia;Australia;Bulgaria;Latvia;New Zealand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

196

EUCTR2018-002136-24-PL
(EUCTR)

04/04/2019

18/01/2019

A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Ulcerative Colitis

Theravance Biopharma Ireland Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

880

Phase 2;Phase 3

United States;Portugal;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Australia;South Africa;Korea, Republic of;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Japan

197

EUCTR2018-002136-24-GR
(EUCTR)

03/04/2019

18/02/2019

A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Ulcerative Colitis

Moderately-to-Severely Active Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Theravance Biopharma Ireland Limited

NULL

Not Recruiting

Female: yes
Male: yes

880

Phase 2;Phase 3

Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;United Kingdom;India;France;Hungary;Canada;Poland;Croatia;Australia;Georgia;South Africa;Bulgaria;Germany

198

EUCTR2018-002135-19-FR
(EUCTR)

02/04/2019

A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Ulcerative Colitis (UC)

A 3-Year, Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects with Ulcerative Colitis (UC) - TD-1473 LTS UC Study

Moderately-to-severely active Ulcerative Colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Theravance Biopharma Ireland Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

500

Phase 3

Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;United Kingdom;France;Hungary;Canada;Poland;Croatia;Australia;South Africa;Bulgaria;Georgia;Germany

199

EUCTR2018-003349-41-GB
(EUCTR)

28/03/2019

21/12/2018

Clinical trial to evaluate the benefit and safety of ST-0529 in subjects who are suffering from active ulcerative colitis

Product Name: ST-0529
Product Code: FP-CYA-050
INN or Proposed INN: CICLOSPORIN
Other descriptive name: cyclosporine

Sublimity Therapeutics (Hold Co) Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

380

Phase 2

Belarus;Serbia;United States;Spain;Ukraine;Ireland;Israel;Russian Federation;Italy;United Kingdom;France;Hungary;Canada;Poland;Romania;Bulgaria;Germany

200

EUCTR2017-004576-57-CZ
(EUCTR)

27/03/2019

15/03/2019

Novel budesonide capsules vs. budesonide tablets in patients with ulcerative colitis refractory to standard treatment with mesalazine

Dr. Falk Pharma GmbH

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

777

Phase 3

Hungary;Czech Republic;Slovakia;Poland;Ukraine;Lithuania;Russian Federation;Latvia;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

201

EUCTR2018-000334-35-NL
(EUCTR)

21/03/2019

29/08/2018

BI 655130 long-term treatment in patients with moderate-to-severe ulcerative colitis

An open label, long term safety trial of BI 655130 treatment in patients with moderate to severely active ulcerative colitis who have completed previous BI 655130 trials

Boehringer Ingelheim bv Netherlands

NULL

Not Recruiting

Female: yes
Male: yes

160

Phase 2

United States;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;Korea, Republic of

202

EUCTR2016-000642-62-LT
(EUCTR)

19/03/2019

15/11/2018

A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

462

Phase 3

Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden

203

EUCTR2013-004277-27-CZ
(EUCTR)

18/03/2019

29/03/2019

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

350

Phase 3

United States;Greece;Ukraine;Lithuania;Turkey;Russian Federation;Colombia;Czech Republic;Hungary;Argentina;Poland;Malaysia;Brazil;Croatia;Australia;Bulgaria;Latvia;New Zealand

204

EUCTR2018-002136-24-PT
(EUCTR)

18/03/2019

02/01/2019

A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Ulcerative Colitis

Theravance Biopharma Ireland Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

880

Phase 2;Phase 3

205

NCT03884439
(ClinicalTrials.gov)

March 18, 2019

4/3/2019

Infliximab Biosimilar Pfizer Drug Use Investigation (Crohn's Disease or Ulcerative Colitis)

Infliximab BS for Intravenous Drip Infusion 100 mg Pfizer General Investigation (Crohn's Disease or Ulcerative Colitis)

Crohn's Disease;Ulcerative Colitis

Drug: Infliximab [infliximab biosimilar 3]

Pfizer

NULL

Recruiting

N/A

All

300

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

206

EUCTR2017-004576-57-LT
(EUCTR)

15/03/2019

29/01/2019

Novel budesonide capsules vs. budesonide tablets in patients with ulcerative colitis refractory to standard treatment with mesalazine

Dr. Falk Pharma GmbH

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

777

Phase 3

Hungary;Czech Republic;Slovakia;Poland;Ukraine;Lithuania;Russian Federation;Latvia;Germany

207

EUCTR2018-003364-31-PL
(EUCTR)

15/03/2019

23/01/2019

A Phase II Study in Patients With Moderate to Severe Active Ulcerative Colitis.

A Phase II randomized, placebo controlled, double-blind, 4 arms dose-ranging study to evaluate the efficacy and safety of SHR0302 compared to placebo in patients with moderate to severe active Ulcerative Colitis.

Product Code: SHR0302
INN or Proposed INN: Pending

Reistone Biopharma Company Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

152

Phase 2

United States;Poland;Ukraine;China

208

EUCTR2016-000642-62-PL
(EUCTR)

14/03/2019

12/06/2019

A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

462

Phase 3

209

EUCTR2017-004576-57-SK
(EUCTR)

12/03/2019

18/01/2019

Novel budesonide capsules vs. budesonide tablets in patients with ulcerative colitis refractory to standard treatment with mesalazine

Dr. Falk Pharma GmbH

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

777

Phase 3

Hungary;Czech Republic;Slovakia;Poland;Ukraine;Lithuania;Russian Federation;Latvia;Germany

210

EUCTR2017-004576-57-HU
(EUCTR)

11/03/2019

16/01/2019

Novel budesonide capsules vs. budesonide tablets in patients with ulcerative colitis refractory to standard treatment with mesalazine

Dr. Falk Pharma GmbH

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

777

Phase 3

Czech Republic;Hungary;Slovakia;Poland;Ukraine;Lithuania;Russian Federation;Latvia;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

211

EUCTR2018-001510-15-PL
(EUCTR)

01/03/2019

04/02/2019

A Proof-of-concept Study of the Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Janssen-Cilag International NV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

210

Phase 2

United States;Mexico;Argentina;Brazil;Poland;Ukraine;Australia;Russian Federation;Germany

212

NCT03773445
(ClinicalTrials.gov)

March 1, 2019

25/11/2018

Golimumab Trough Levels in Patients With Ulcerative Colitis

Association of Golimumab Trough Levels With Endoscopic and Histologic Healing in Patients With Ulcerative Colitis

Ulcerative Colitis

Diagnostic Test: Golimumab trough levels;Diagnostic Test: Antibodies to golimumab;Diagnostic Test: Histology;Diagnostic Test: Colonoscopy

Hospital San Carlos, Madrid

Hospital Universitario La Fe;Hospital Universitario 12 de Octubre;Hospital Universitario Ramon y Cajal;Gregorio Marañón Hospital;Complejo Hospitalario de Navarra;Hospital Universitario Fundación Alcorcón;Hospital Infanta Sofia;Hospital Clínico Universitario de Valencia;Puerta de Hierro University Hospital;Hospital Universitario La Paz;Hospital Universitario de Fuenlabrada;Merck Sharp & Dohme Corp.

Recruiting

18 Years

N/A

All

100

Spain

213

EUCTR2018-003349-41-PL
(EUCTR)

27/02/2019

15/01/2019

Clinical trial to evaluate the benefit and safety of ST-0529 in subjects who are suffering from active ulcerative colitis

Sublimity Therapeutics (Hold Co) Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

280

Phase 2

Belarus;Serbia;United States;Ukraine;Israel;Russian Federation;United Kingdom;France;Hungary;Canada;Poland;Bulgaria;Germany

214

EUCTR2017-000574-11-GR
(EUCTR)

26/02/2019

27/11/2017

Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn’s Disease (AIDA)

A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn’s Disease (AIDA) - AIDA

Ulcerative colitis or Crohn’s Disease
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody
Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody

Shire Human Genetic Therapies, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

2453

Phase 3

United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;New Zealand

215

EUCTR2018-000334-35-PL
(EUCTR)

21/02/2019

07/12/2018

BI 655130 long-term treatment in patients with moderate-to-severe ulcerative colitis

An open label, long term safety trial of BI 655130 (Spesolimab) treatment in patients with moderate to severely active ulcerative colitis who have completed previous BI 655130 trials

Product Code: BI 655130
INN or Proposed INN: BI 655130
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Product Code: BI 655130
INN or Proposed INN: BI 655130
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Product Code: BI 655130
INN or Proposed INN: Spesolimab
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Product Code: BI 655130
INN or Proposed INN: Spesolimab
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1

Boehringer Ingelheim RCV GmbH&Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

160

Phase 2

United States;Czechia;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;Hungary;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

216

EUCTR2018-003349-41-HU
(EUCTR)

19/02/2019

08/01/2019

Clinical trial to evaluate the benefit and safety of ST-0529 in subjects who are suffering from active ulcerative colitis

Active ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Sublimity Therapeutics (Hold Co) Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

280

Phase 2

Serbia;United States;Belarus;Spain;Ukraine;Ireland;Turkey;Russian Federation;Israel;United Kingdom;France;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Germany

217

EUCTR2018-002136-24-SK
(EUCTR)

19/02/2019

28/12/2018

A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Ulcerative Colitis

Theravance Biopharma Ireland Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

880

Phase 2;Phase 3

218

EUCTR2018-002136-24-HU
(EUCTR)

18/02/2019

29/03/2019

A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Ulcerative Colitis

Theravance Biopharma Ireland Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

880

Phase 2;Phase 3

219

EUCTR2017-003229-14-HR
(EUCTR)

08/02/2019

16/05/2019

AN INDUCTION STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS

A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 1) - LUCENT 1

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1160

Phase 3

Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan

220

EUCTR2017-003238-96-HR
(EUCTR)

08/02/2019

17/05/2019

A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS

A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-ARM, PLACEBO-CONTROLLED MAINTENANCE STUDY OF MIRIKIZUMAB IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS (LUCENT 2) - LUCENT 2

Moderately to Severely Active Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1044

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

221

EUCTR2017-004997-32-HU
(EUCTR)

04/02/2019

04/04/2019

A Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's Disease

A PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE

Ulcerative Colitis (UC) or Crohn's Disease (CD)
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Genentech, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

320

Phase 2

Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;United Kingdom;Italy;Hungary;Poland;Bulgaria;Germany;Netherlands

222

EUCTR2016-004676-22-HR
(EUCTR)

01/02/2019

16/05/2019

A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis Who Responded to Induction treatment in M16-067 or M16-065”

Product Name: Risankizumab
Product Code: ABBV-006
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

760

Phase 3

Serbia;Portugal;United States;Belarus;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden

223

JPRN-JapicCTI-194603

01/2/2019

30/01/2019

Specified Drug-Use Survey on Vedolizumab for IV Infusion 300 mg [Ulcerative Colitis]

Specified Drug-Use Survey on Entyvio for IV Infusion 300 mg [Ulcerative Colitis]

Ulcerative colitis

Intervention name : Vedolizumab
INN of the intervention : Vedolizumab
Dosage And administration of the intervention : Vedolizumab intravenous (IV) infusion 300 mg, at Weeks 0, 2 and 6, and every 8 weeks thereafter, for up to 54 weeks. Participants will receive IV infusion as part of routine medical care.
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -

Takeda Pharmaceutical Company Limited

NULL

recruiting

BOTH

1000

Japan

224

NCT03824561
(ClinicalTrials.gov)

February 1, 2019

29/1/2019

Specified Drug-Use Survey on Vedolizumab for IV Infusion 300 mg [Ulcerative Colitis]

Specified Drug-Use Survey on Entyvio for IV Infusion 300 mg [Ulcerative Colitis]

Ulcerative Colitis

Drug: Vedolizumab

Takeda

NULL

Recruiting

N/A

All

1000

Japan

225

EUCTR2017-004496-31-PL
(EUCTR)

30/01/2019

06/12/2018

A Study of the Efficacy and Safety of Golimumab in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis

Trade Name: Simponi
Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: GOLIMUMAB
Trade Name: Simponi
Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: GOLIMUMAB
Trade Name: Simponi
Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: GOLIMUMAB
Trade Name: Remicade
Product Name: Infliximab
Product Code: CNTO312
INN or Proposed INN: INFLIXIMAB

Janssen Biologics BV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

125

Phase 3

United States;France;Taiwan;Spain;Brazil;Belgium;Poland;Israel;Netherlands;Italy;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

226

EUCTR2017-004997-32-NL
(EUCTR)

30/01/2019

06/12/2018

A Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's Disease

A PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE

Product Name: UTTR1147A/RO7021610 (Active)
INN or Proposed INN: n.a.
Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc

Genentech, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

320

Phase 2

Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;United Kingdom;Italy;Hungary;Poland;Bulgaria;Netherlands;Germany

227

EUCTR2016-000642-62-SK
(EUCTR)

28/01/2019

A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

522

Phase 3

Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden

228

EUCTR2017-004092-31-HU
(EUCTR)

23/01/2019

15/06/2018

A study of the efficacy and safety of Mirikizumab in Ulcerative Colitis

I6T-MC-AMAP A Phase 3, Multicenter, Open-Label Extension Study to Evaluate the Long- Term Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 3) - LUCENT 3

moderately to severely active Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

840

Phase 3

Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Germany;Japan

229

EUCTR2016-004676-22-DE
(EUCTR)

22/01/2019

15/06/2018

A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis

A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis

Product Name: Risankizumab
Product Code: ABBV-006
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

942

Phase 3

United States;Serbia;Portugal;Belarus;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Czechia;Slovenia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden

230

EUCTR2016-000642-62-ES
(EUCTR)

17/01/2019

24/01/2019

A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

462

Phase 3

Portugal;Serbia;Belarus;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Singapore;Croatia;Germany;Norway;Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

231

EUCTR2016-000642-62-CZ
(EUCTR)

14/01/2019

14/11/2018

A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

522

Phase 3

Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden

232

EUCTR2016-004676-22-BE
(EUCTR)

14/01/2019

04/04/2018

A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis Who Responded to Induction treatment in M16-067 or M16-065”

Product Name: Risankizumab
Product Code: ABBV-006
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

760

Phase 3

United States;Serbia;Portugal;Belarus;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden

233

EUCTR2017-004092-31-PL
(EUCTR)

08/01/2019

17/10/2018

A study of the efficacy and safety of Mirikizumab in Ulcerative Colitis

Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: mirikizumab
Other descriptive name: MIRIKIZUMAB

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

840

Phase 3

United States;Serbia;Taiwan;Saudi Arabia;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Georgia;Germany;Japan

234

EUCTR2017-004997-32-GB
(EUCTR)

04/01/2019

09/10/2018

A Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's Disease

A PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE

Product Name: UTTR1147A/RO7021610 (Active)
INN or Proposed INN: n.a.
Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc

Genentech, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

320

Phase 2

United States;Serbia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Poland;Bulgaria;Netherlands;Germany

235

EUCTR2018-000930-37-GB
(EUCTR)

03/01/2019

01/11/2018

A Study to Investigate safety and how well Ravagalimab (ABBV-323) works and how safe it is in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy

A Multicenter, Single-Arm, Open-Label Study to Investigate the Efficacy and Safety of Ravagalimab (ABBV-323) in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy

Product Name: Ravagalimab
Other descriptive name: ABBV-323

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

United States;France;Hungary;Canada;Spain;Netherlands;Germany;Italy;United Kingdom;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

236

EUCTR2016-000642-62-AT
(EUCTR)

02/01/2019

30/10/2018

A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

522

Phase 3

Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden

237

EUCTR2018-002925-47-ES
(EUCTR)

28/12/2018

16/11/2018

prediction of response to therapy in inflammatory bowel disease

Identification of predictive biomarkers for response to biologic therapies in inflammatory bowel disease by proteomic and mass cytometry approaches

Inflammatory bowel disease
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Fundación de Investigación Biomédica del Hospital Universitario de La Princesa

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

180

Phase 4

Spain

238

EUCTR2018-000930-37-NL
(EUCTR)

21/12/2018

11/10/2018

A Study to Investigate safety and how well ABBV-323 works and how safe it is in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy

A Multicenter, Single-Arm, Open-Label Study to Investigate the Efficacy and Safety of ABBV-323 in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

France;United States;Canada;Spain;Germany;Netherlands;Italy;United Kingdom;Korea, Republic of

239

EUCTR2016-004676-22-GB
(EUCTR)

20/12/2018

03/07/2018

A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis

A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safetyof Risankizumab in Subjects with Ulcerative Colitis

Product Name: Risankizumab
Product Code: ABBV-006
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

942

Phase 3

United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Czechia;Slovenia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden

240

EUCTR2016-000642-62-HU
(EUCTR)

19/12/2018

08/01/2019

A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

462

Phase 3

Portugal;Serbia;Belarus;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Singapore;Croatia;Germany;Norway;Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

241

EUCTR2017-004496-31-FR
(EUCTR)

17/12/2018

14/09/2018

A Study of the Efficacy and Safety of Golimumab in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Janssen Biologics BV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

125

Phase 3

United States;France;Taiwan;Poland;Brazil;Belgium;Spain;Israel;Netherlands;Italy;Korea, Republic of

242

EUCTR2017-004997-32-IE
(EUCTR)

14/12/2018

13/12/2018

A Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's Disease

A PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE

Product Name: UTTR1147A/RO7021610 (Active)
INN or Proposed INN: n.a.
Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc

Genentech, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

320

Phase 2

Serbia;United States;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Poland;Bulgaria;Netherlands;Germany

243

EUCTR2016-000642-62-LV
(EUCTR)

13/12/2018

15/10/2018

A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

462

Phase 3

Portugal;Serbia;Belarus;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Singapore;Croatia;Germany;Norway;Japan

244

EUCTR2018-000334-35-DE
(EUCTR)

12/12/2018

20/08/2018

BI 655130 long-term treatment in patients with moderate-to-severe ulcerative colitis

An open label, long term safety trial of BI 655130 (Spesolimab) treatment in patients with moderate to severely active ulcerative colitis who have completed previous BI 655130 trials

Boehringer Ingelheim Pharma GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

160

Phase 2

United States;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Denmark;Norway;Germany;Netherlands;Japan;Korea, Republic of

245

EUCTR2017-002350-36-GB
(EUCTR)

10/12/2018

13/04/2018

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared with Placebo and Compared with Vedolizumab in Patients with Moderate to Severe Ulcerative Colitis.

A PHASE II, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF UTTR1147A COMPARED WITH PLACEBO AND COMPARED WITH VEDOLIZUMAB IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Ulcerative colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: n.a.
Product Code: UTTR1147A/RO7021610 (Active)
INN or Proposed INN: n.a.
Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc
Trade Name: Entyvio 300mg
Product Code: RO7246311
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB

Genentech, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

270

Phase 2

United States;Serbia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Poland;Bulgaria;Netherlands;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

246

EUCTR2017-004997-32-ES
(EUCTR)

10/12/2018

17/09/2018

A Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's Disease

A PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE

Ulcerative Colitis (UC) or Crohn's Disease (CD)
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Roche Farma, S.A por delegación de Genentech, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

320

Phase 2

Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;United Kingdom;Italy;Hungary;Poland;Bulgaria;Germany;Netherlands

247

EUCTR2016-004677-40-DE
(EUCTR)

04/12/2018

26/06/2018

A Study to Evaluate the Efficacy and Safety of Risankizumab in Subjectswith Moderately to Severely Active Ulcerative Colitis

A Multicenter, Randomized, Double-Blind, Placebo-Controlled InductionStudy to Evaluate the Efficacy and Safety of Risankizumab in Subjects withModerately to Severely Active Ulcerative Colitis

Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1547

Phase 2;Phase 3

248

EUCTR2016-004677-40-BE
(EUCTR)

29/11/2018

04/04/2018

A Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis

Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1547

Phase 2;Phase 3

Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden;United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Denmark;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Turkey

249

EUCTR2017-003229-14-DK
(EUCTR)

20/11/2018

11/10/2018

AN INDUCTION STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS

Product Name: mirikizumab
Product Code: LY3074828
INN or Proposed INN: MIRIKIZUMAB
Other descriptive name: MIRIKIZUMAB

Eli Lilly Cork Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1160

Phase 3

250

EUCTR2017-003238-96-DK
(EUCTR)

20/11/2018

09/10/2018

A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS

Moderately to Severely Active Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1044

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

251

EUCTR2016-000642-62-FI
(EUCTR)

13/11/2018

16/10/2018

A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

462

Phase 3

Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden

252

EUCTR2017-004496-31-BE
(EUCTR)

07/11/2018

25/07/2018

A Study of the Efficacy and Safety of Golimumab in Pediatric Participantswith Moderately to Severely Active Ulcerative Colitis

A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety,and Pharmacokinetics of Golimumab Treatment, a Human anti-TNFaMonoclonal Antibody, Administered Subcutaneously in PediatricParticipants with Moderately to Severely Active Ulcerative Colitis - PURSUIT 2

Trade Name: Simponi
Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: GOLIMUMAB
Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: GOLIMUMAB
Trade Name: Simponi
Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: GOLIMUMAB
Trade Name: Remicade
Product Name: Infliximab
INN or Proposed INN: INFLIXIMAB

Janssen Biologics BV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

125

Phase 3

France;United States;Taiwan;Poland;Brazil;Spain;Belgium;Israel;Netherlands;Italy;Korea, Republic of

253

EUCTR2017-004092-31-LV
(EUCTR)

02/11/2018

27/08/2018

A study of the efficacy and safety of Mirikizumab in Ulcerative Colitis

I6T-MC-AMAP A Phase 3, Multicenter, Open-Label Extension Study to Evaluate the Long- Term Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 3) - LUCENT 3

moderately to severely active Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

840

Phase 3

254

EUCTR2017-003229-14-GB
(EUCTR)

24/10/2018

04/05/2018

AN INDUCTION STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1160

Phase 3

255

EUCTR2017-003229-14-AT
(EUCTR)

24/10/2018

22/06/2018

AN INDUCTION STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1160

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

256

EUCTR2017-003238-96-AT
(EUCTR)

24/10/2018

22/06/2018

A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS

Moderately to Severely Active Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1044

Phase 3

257

EUCTR2017-004092-31-DK
(EUCTR)

23/10/2018

26/06/2018

A study of the efficacy and safety of Mirikizumab in Ulcerative Colitis

I6T-MC-AMAP A Phase 3, Multicenter, Open-Label Extension Study to Evaluate the Long- Term Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 3) - LUCENT 3

moderately to severely active Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

840

Phase 3

258

EUCTR2018-000334-35-BE
(EUCTR)

22/10/2018

06/07/2018

BI 655130 long-term treatment in patients with moderate-to-severe ulcerative colitis

An open label, long term safety trial of BI 655130 treatment in patients with moderate to severely active ulcerative colitis who have completed previous BI 655130 trials

Moderate-to-severely active ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

SCS Boehringer Ingelheim Comm. V

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

160

Phase 2

United States;Spain;Austria;Russian Federation;United Kingdom;Italy;Hungary;Canada;Belgium;Poland;Norway;Germany;Netherlands;Japan;Korea, Republic of

259

EUCTR2017-003238-96-GB
(EUCTR)

22/10/2018

04/05/2018

A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS

Moderately to Severely Active Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1044

Phase 3

260

EUCTR2018-000334-35-GB
(EUCTR)

22/10/2018

25/07/2018

BI 655130 long-term treatment in patients with moderate-to-severe ulcerative colitis

An open label, long term safety trial of BI 655130 (Spesolimab) treatment in patients with moderate to severely active ulcerative colitis who have completed previous BI 655130 trials

Product Code: BI 655130
INN or Proposed INN: Spesolimab
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Product Code: BI 655130
INN or Proposed INN: Spesolimab
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Product Code: BI 655130
INN or Proposed INN: Spesolimab
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Product Code: BI 655130
INN or Proposed INN: Spesolimab
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1

Boehringer Ingelheim LImited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

160

Phase 2

United States;Spain;Austria;Russian Federation;United Kingdom;Italy;Hungary;Canada;Belgium;Poland;Norway;Germany;Netherlands;Japan;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

261

EUCTR2017-000402-38-SE
(EUCTR)

19/10/2018

25/05/2018

A clinical trail to evaluate the testicular safety of Filgotinib in adult males with Ulcerative Colitis

A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Testicular Safety of Filgotinib in Adult Males with Moderately to Severely Active Ulcerative Colitis

To evaluate the testicular safety of filgotinib in adult males with ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: GS-6034
INN or Proposed INN: FILGOTINIB

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: no
Male: yes

250

Phase 2

United States;Portugal;Spain;Ukraine;Austria;Russian Federation;Sri Lanka;United Kingdom;Italy;India;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Australia;Germany;Netherlands;New Zealand;Sweden

262

EUCTR2017-004496-31-ES
(EUCTR)

15/10/2018

28/08/2018

A Study of the Efficacy and Safety of Golimumab in Pediatric Participantswith Moderately to Severely Active Ulcerative Colitis

A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety,and Pharmacokinetics of Golimumab Treatment, a Human anti-TNFaMonoclonal Antibody, Administered Subcutaneously in PediatricParticipants with Moderately to Severely Active Ulcerative Colitis - PURSUIT 2

Janssen Biologics BV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

125

Phase 3

France;United States;Taiwan;Poland;Brazil;Belgium;Spain;Israel;Netherlands;Italy;Korea, Republic of

263

EUCTR2017-003238-96-DE
(EUCTR)

15/10/2018

03/05/2018

A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS

Product Name: mirikizumab
Product Code: LY3074828
INN or Proposed INN: MIRIKIZUMAB
Other descriptive name: MIRIKIZUMAB
Product Name: mirikizumab
Product Code: LY3074828
INN or Proposed INN: MIRIKIZUMAB
Other descriptive name: MIRIKIZUMAB

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1044

Phase 3

United States;Serbia;Taiwan;Saudi Arabia;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Latvia;Netherlands;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Romania;Germany;Japan

264

EUCTR2017-003229-14-DE
(EUCTR)

15/10/2018

30/04/2018

AN INDUCTION STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS

Product Name: mirikizumab
Product Code: LY3074828
INN or Proposed INN: MIRIKIZUMAB
Other descriptive name: MIRIKIZUMAB

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1160

Phase 3

Germany;Japan;United States;Serbia;Taiwan;Saudi Arabia;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Latvia;Netherlands;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Romania

265

EUCTR2017-004092-31-NL
(EUCTR)

10/10/2018

01/06/2018

A study of the efficacy and safety of Mirikizumab in Ulcerative Colitis

Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: mirikizumab
Other descriptive name: MIRIKIZUMAB

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

840

Phase 3

Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;Denmark;Latvia;Netherlands;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Germany;Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

266

EUCTR2017-002350-36-GR
(EUCTR)

03/10/2018

10/09/2018

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared with Placebo and Compared with Vedolizumab in Patients with Moderate to Severe Ulcerative Colitis.

Genentech, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

270

Phase 2

Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;United Kingdom;Italy;Hungary;Poland;Bulgaria;Germany;Netherlands

267

EUCTR2017-000574-11-EE
(EUCTR)

03/10/2018

11/06/2018

Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn’s Disease (AIDA)

A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn’s Disease (AIDA) - AIDA

Ulcerative colitis or Crohn’s Disease
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Shire Human Genetic Therapies, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2453

Phase 3

Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Italy;Switzerland;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan

268

EUCTR2016-004676-22-SE
(EUCTR)

02/10/2018

16/04/2018

A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis

A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis

Product Name: Risankizumab
Product Code: ABBV-006
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

942

Phase 3

United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden

269

EUCTR2016-004677-40-SE
(EUCTR)

02/10/2018

16/04/2018

A Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis

Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1547

Phase 2;Phase 3

United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden

270

NCT03669029
(ClinicalTrials.gov)

October 1, 2018

4/7/2018

Optimization of Golimumab Treatment in Ulcerative Colitis

Colitis, Ulcerative

Drug: Golimumab 50 mg in patients <80 kg and Golimumab 100 mg in patients >80 kg;Drug: Golimumab treatment optimization.

Hospital de Manises

Valencia University General Hospital;Hospital Clínico Universitario de Valencia;Hospital de Sagunto;Hospital Universitario La Fe;Hospital General Universitario de Alicante;Hospital Universitario Doctor Peset;Hospital Arnau de Vilanova;Hospital Provincial de Castellon;Merck Sharp & Dohme Corp.

Unknown status

18 Years

80 Years

All

Phase 4

Spain

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

271

EUCTR2017-002350-36-DE
(EUCTR)

27/09/2018

13/04/2018

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared with Placebo and Compared with Vedolizumab in Patients with Moderate to Severe Ulcerative Colitis.

Genentech, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

270

Phase 2

Serbia;United States;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Poland;Bulgaria;Netherlands;Germany

272

EUCTR2017-003238-96-HU
(EUCTR)

27/09/2018

13/06/2018

A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS

Moderately to Severely Active Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1044

Phase 3

Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan

273

EUCTR2017-003229-14-HU
(EUCTR)

27/09/2018

15/06/2018

AN INDUCTION STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS

Product Name: mirikizumab
Product Code: LY3074828
INN or Proposed INN: MIRIKIZUMAB
Other descriptive name: MIRIKIZUMAB

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1160

Phase 3

Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan

274

EUCTR2018-000334-35-ES
(EUCTR)

17/09/2018

17/07/2018

BI 655130 long-term treatment in patients with moderate-to-severe ulcerative colitis

An open label, long term safety trial of BI 655130 treatment in patients with moderate to severely active ulcerative colitis who have completed previous BI 655130 trials

Boehringer Ingelheim España, S.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

160

Phase 2

United States;Spain;Austria;Russian Federation;United Kingdom;Italy;Canada;Belgium;Poland;Germany;Netherlands;Japan;Korea, Republic of

275

EUCTR2017-004092-31-BE
(EUCTR)

13/09/2018

07/06/2018

A study of the efficacy and safety of Mirikizumab in Ulcerative Colitis

Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: mirikizumab
Other descriptive name: MIRIKIZUMAB

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

840

Phase 3

Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Germany;Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

276

EUCTR2018-002794-21-GB
(EUCTR)

11/09/2018

04/09/2018

Investigation of the Faecal loss of Vedolizumab and its role in influencing serum drug levels, Outcomes and Response in ulcerative colitis

Investigation of the Faecal loss of Vedolizumab and its role in influencing serum drug levels, Outcomes and Response in ulcerative colitis - FAVOUR

Ulcerative colitis (UC)
MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Guy's & St Thomas NHS Foundation Trust

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

United Kingdom

277

EUCTR2018-001051-12-FR
(EUCTR)

07/09/2018

19/04/2018

VEDO - PREDIRESPUC project - Vedolizumab and anti-vedolizumab antibody in the prediction of therapeutic response in Ulcerative Colitis

VEDO - PREDIRESPUC project - Value of pharmacokinetic assays (Vedolizumab and anti-vedolizumab antibody) in the prediction of induction and maintenance therapeutic response in Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: ENTYVIO
Product Name: ENTYVIO
Product Code: 1

CHU Saint-Etienne

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

125

Phase 4

France

278

EUCTR2017-003229-14-SK
(EUCTR)

06/09/2018

06/07/2018

AN INDUCTION STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1160

Phase 3

279

EUCTR2018-002673-21-FR
(EUCTR)

04/09/2018

06/07/2018

EFFICACI : EFFicacy of intravenous Infliximab versus vedolizumab after failure of subCutaneous Anti-TNF in patients with UlCerative colitis : A double blinded Randomized Clinical Trial.

EFFICACI : EFFicacy of intravenous Infliximab versus vedolizumab after failure of subCutaneous Anti-TNF in patients with UlCerative colitis : A double blinded Randomized Clinical Trial. - EFFICACI

Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

Trade Name: Remicade
Product Name: infliximab
INN or Proposed INN: INFLIXIMAB
Trade Name: Inflectra
Product Name: infliximab
INN or Proposed INN: INFLIXIMAB
Trade Name: Flixabi
Product Name: infliximab
INN or Proposed INN: INFLIXIMAB
Trade Name: Remsima
Product Name: infliximab
INN or Proposed INN: INFLIXIMAB
Trade Name: Entyvio
Product Name: Vedolizumab
Other descriptive name: VEDOLIZUMAB

Centre Hospitalier Universitaire de Rennes

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

150

Phase 4

France

280

EUCTR2017-003238-96-SK
(EUCTR)

04/09/2018

20/07/2018

A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS

Moderately to Severely Active Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1044

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

281

EUCTR2017-004230-28-NL
(EUCTR)

30/08/2018

15/03/2018

BI 655130 induction treatment in patients with moderate-tosevere ulcerative colitis

Product Code: BI 655130
INN or Proposed INN: BI 655130
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1

Boehringer Ingelheim bv

NULL

Not Recruiting

Female: yes
Male: yes

550

Phase 2;Phase 3

United States;Taiwan;Greece;Spain;Austria;Russian Federation;Italy;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Netherlands;Germany;Japan;Korea, Republic of

282

EUCTR2017-003238-96-LV
(EUCTR)

30/08/2018

21/05/2018

A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS

Moderately to Severely Active Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1044

Phase 3

Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan

283

EUCTR2016-004676-22-LV
(EUCTR)

30/08/2018

29/08/2018

A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis Who Responded to Induction treatment in M16-067 or M16-065”

Product Name: Risankizumab
Product Code: ABBV-006
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

760

Phase 3

Korea, Republic of;Serbia;Portugal;United States;Belarus;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;China;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden

284

EUCTR2017-002350-36-NL
(EUCTR)

28/08/2018

24/04/2018

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared with Placebo and Compared with Vedolizumab in Patients with Moderate to Severe Ulcerative Colitis.

Product Code: UTTR1147A/RO7021610 (Active)
INN or Proposed INN: n.a.
Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc
Trade Name: Entyvio 300mg
Product Code: RO7246311
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB

Genentech, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

330

Phase 2

Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;United Kingdom;Italy;Hungary;Poland;Bulgaria;Netherlands;Germany

285

EUCTR2017-002350-36-IE
(EUCTR)

28/08/2018

16/04/2018

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared with Placebo and Compared with Vedolizumab in Patients with Moderate to Severe Ulcerative Colitis.

Genentech, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

270

Phase 2

Serbia;United States;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Poland;Bulgaria;Netherlands;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

286

EUCTR2017-000573-37-EE
(EUCTR)

27/08/2018

11/06/2018

Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 303).

A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303

Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Shire Human Genetic Therapies, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

772

Phase 3

287

EUCTR2016-004676-22-LT
(EUCTR)

23/08/2018

26/06/2018

A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis

A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis

Product Name: Risankizumab
Product Code: ABBV-006
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

942

Phase 3

United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Denmark;South Africa;Latvia;Netherlands;China;Korea, Republic of;Czechia;Slovenia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden

288

EUCTR2016-004677-40-LT
(EUCTR)

23/08/2018

13/06/2018

A Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis

Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1547

Phase 2;Phase 3

United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Denmark;South Africa;Latvia;Netherlands;China;Korea, Republic of;Czechia;Slovenia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden

289

EUCTR2017-002350-36-BG
(EUCTR)

22/08/2018

28/05/2018

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared with Placebo and Compared with Vedolizumab in Patients with Moderate to Severe Ulcerative Colitis.

Genentech, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

270

Phase 2

United States;Serbia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Poland;Bulgaria;Netherlands;Germany

290

EUCTR2018-000334-35-AT
(EUCTR)

20/08/2018

09/07/2018

BI 655130 long-term treatment in patients with moderate-to-severe ulcerative colitis

An open label, long term safety trial of BI 655130 (Spesolimab) treatment in patients with moderate to severely active ulcerative colitis who have completed previous BI 655130 trials

Boehringer Ingelheim RCV GmbH&Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

160

Phase 2

United States;Spain;Austria;Russian Federation;Italy;United Kingdom;Hungary;Canada;Belgium;Poland;Norway;Germany;Netherlands;Japan;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

291

EUCTR2017-003238-96-CZ
(EUCTR)

16/08/2018

30/05/2018

A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS

Moderately to Severely Active Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1044

Phase 3

292

EUCTR2017-003229-14-CZ
(EUCTR)

16/08/2018

30/05/2018

AN INDUCTION STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS

Product Name: mirikizumab
Product Code: LY3074828
INN or Proposed INN: MIRIKIZUMAB
Other descriptive name: MIRIKIZUMAB

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1160

Phase 3

France;Malaysia;Denmark;Australia;Latvia;Netherlands;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Romania;Germany;Japan;United States;Serbia;Taiwan;Saudi Arabia;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India

293

EUCTR2017-003229-14-LV
(EUCTR)

03/08/2018

21/05/2018

AN INDUCTION STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1160

Phase 3

Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan

294

EUCTR2017-003238-96-ES
(EUCTR)

01/08/2018

04/06/2018

A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1044

Phase 3

295

EUCTR2017-003238-96-BE
(EUCTR)

27/07/2018

07/06/2018

A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS

Moderately to Severely Active Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1044

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

296

EUCTR2017-003229-14-BE
(EUCTR)

27/07/2018

08/06/2018

AN INDUCTION STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1160

Phase 3

297

EUCTR2017-002108-28-DE
(EUCTR)

25/07/2018

27/03/2018

A study to evaluate the efficacy, safety, tolerability and pharmacokinetics of PF-06687234/placebo as add-on therapy to infliximab in subjects with ulcerative colitis who are not in remission

A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06687234 AS ADD-ON THERAPY TO INFLIXIMAB IN ACTIVE ULCERATIVE COLITIS SUBJECTS WHO ARE NOT IN REMISSION (BUILD UC) - BUILD UC

Product Name: Dekavil
Product Code: PF-06687234
INN or Proposed INN: PF-06687234
Other descriptive name: F8IL10

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Serbia;Saudi Arabia;Spain;Belgium;Australia;Israel;Germany;Italy;Korea, Republic of

298

EUCTR2015-001600-64-AT
(EUCTR)

25/07/2018

17/04/2018

The purpose of this study is to determine whether long-term RPC1063 is safe and effective in the treatment of ulcerative colitis (UC).

A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of long-term RPC1063 in Ulcerative Colitis

Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Celgene International II Sàrl

NULL

Not Recruiting

Female: yes
Male: yes

1200

Phase 3

Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;New Zealand

299

EUCTR2017-000402-38-BE
(EUCTR)

25/07/2018

30/05/2018

A clinical trial to evaluate the testicular safety of Filgotinib in adult males with Moderately to Severely Active Inflammatory Bowel Disease

A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Testicular Safety of Filgotinib in Adult Males with Moderately to Severely Active Inflammatory Bowel Disease

To evaluate the testicular safety of filgotinib in adult males with moderately to severely Active Inflammatory Bowel Disease
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: no
Male: yes

250

Phase 2

Portugal;United States;Spain;Ukraine;Austria;Russian Federation;Sri Lanka;Switzerland;United Kingdom;Italy;India;France;Canada;Poland;Belgium;Australia;Netherlands;Germany;New Zealand;Sweden

300

EUCTR2017-003229-14-ES
(EUCTR)

24/07/2018

04/06/2018

AN INDUCTION STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS

Product Name: mirikizumab
Product Code: LY3074828
INN or Proposed INN: MIRIKIZUMAB
Other descriptive name: MIRIKIZUMAB

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1160

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

301

EUCTR2017-003703-22-NL
(EUCTR)

24/07/2018

05/03/2018

Phase 2 Dose-finding IMU-838 for Ulcerative Colitis (CALDOSE-1)

Immunic AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

210

Phase 2

Serbia;United States;Czech Republic;Poland;Belgium;Spain;Ukraine;Russian Federation;Germany;Netherlands;United Kingdom

302

EUCTR2017-003238-96-NL
(EUCTR)

24/07/2018

14/05/2018

A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1044

Phase 3

Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;Denmark;Latvia;Netherlands;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan

303

EUCTR2015-001600-64-GR
(EUCTR)

23/07/2018

19/04/2018

The purpose of this study is to determine whether long-term RPC1063 is safe and effective in the treatment of ulcerative colitis (UC).

A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of long-term RPC1063 in Ulcerative Colitis

ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: 0.25 mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod
Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride
Product Name: 1.0 mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod
Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride

Celgene International II Sàrl

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1200

Phase 3

304

EUCTR2015-000319-41-GR
(EUCTR)

23/07/2018

18/04/2018

The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC).

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Inductionand Maintenance Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of RPC1063 in Ulcerative Colitis

Celgene International II Sàrl (CIS II)

NULL

Not Recruiting

Female: yes
Male: yes

900

Phase 3

United States;Belarus;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;New Zealand

305

EUCTR2016-004676-22-PT
(EUCTR)

16/07/2018

02/07/2018

A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis Who Responded to Induction treatment in M16-067 or M16-065”

Product Name: Risankizumab
Product Code: ABBV-006
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

760

Phase 3

United States;Serbia;Belarus;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

306

EUCTR2016-004677-40-PT
(EUCTR)

16/07/2018

01/06/2018

A Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy

Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

720

Phase 2;Phase 3

307

EUCTR2017-000402-38-ES
(EUCTR)

13/07/2018

25/07/2018

A clinical trial to evaluate the testicular safety of Filgotinib in adult males with Ulcerative Colitis

A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Testicular Safety of Filgotinib in Adult Males with Moderately to Severely Active Ulcerative Colitis

Product Code: GS-6034
INN or Proposed INN: FILGOTINIB

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: no
Male: yes

250

Phase 2

Portugal;United States;Spain;Ukraine;Austria;Russian Federation;Sri Lanka;Italy;United Kingdom;India;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Australia;Netherlands;Germany;New Zealand;Sweden

308

EUCTR2015-000319-41-ES
(EUCTR)

12/07/2018

21/05/2018

The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC).

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Induction and Maintenance Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of RPC1063 in Ulcerative Colitis

Product Name: 0.25mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod
Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride
Product Name: 1.0 mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod
Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride

Celgene International II Sàrl (CIS II)

NULL

Not Recruiting

Female: yes
Male: yes

900

Phase 3

France;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;New Zealand

309

EUCTR2015-001600-64-ES
(EUCTR)

12/07/2018

21/05/2018

The purpose of this study is to determine whether long-term RPC1063 is safe and effective in the treatment of ulcerative colitis (UC).

A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of long-term RPC1063 in Ulcerative Colitis

Celgene International II Sàrl

NULL

Not Recruiting

Female: yes
Male: yes

1200

Phase 3

310

EUCTR2018-001546-33-GB
(EUCTR)

11/07/2018

14/05/2018

The effects of switching one drug, used to treat either Ulcerative Colitis (UC) or Crohn’s disease (CD) to another drug, also used to treat UC or Crohn’s disease

IBD Biosimilar to Biosimilar Infliximab Switching Study - iBiSS v1.0

Inflammatory Bowel Disease in particular Crohn's Disease and Ulcerative Colitis
MedDRA version: 20.1;Level: PT;Classification code 10021972;Term: Inflammatory bowel disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Flixabi
Product Name: Flixabi
INN or Proposed INN: Infliximab

University Southampton Hospital NHS Foundation Trust

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 4

United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

311

EUCTR2017-003229-14-LT
(EUCTR)

05/07/2018

31/05/2018

AN INDUCTION STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS

Product Name: mirikizumab
Product Code: LY3074828
INN or Proposed INN: MIRIKIZUMAB
Other descriptive name: MIRIKIZUMAB

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1160

Phase 3

United States;Serbia;Taiwan;Saudi Arabia;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Latvia;Netherlands;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Romania;Germany;Japan

312

EUCTR2017-003238-96-LT
(EUCTR)

05/07/2018

31/05/2018

A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1044

Phase 3

United States;Serbia;Taiwan;Saudi Arabia;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Latvia;Netherlands;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Romania;Germany;Japan

313

EUCTR2017-004092-31-LT
(EUCTR)

05/07/2018

25/05/2018

A study of the efficacy and safety of Mirikizumab in Ulcerative Colitis

Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: mirikizumab
Other descriptive name: MIRIKIZUMAB

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

840

Phase 3

Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Germany;Japan

314

EUCTR2016-004677-40-DK
(EUCTR)

28/06/2018

12/06/2018

A Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis

Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1547

Phase 2;Phase 3

United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Denmark;South Africa;Latvia;Netherlands;China;Korea, Republic of;Czechia;Slovenia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden

315

EUCTR2017-002274-39-NL
(EUCTR)

27/06/2018

19/12/2017

A multi-center parallel group study of tofacitinib in subjects with ulcerative colitis in stable remission

A PHASE 3B/4, MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP STUDY OF TOFACITINIB (CP-690,550) IN SUBJECTS WITH ULCERATIVE COLITIS IN STABLE REMISSION

Trade Name: XELJANZ
Product Name: Tofacitinib citrate
Product Code: CP -690,550 -10
INN or Proposed INN: tofacitinib
Other descriptive name: CP -690,550

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

130

Phase 3;Phase 4

United States;Serbia;Slovakia;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;South Africa;Netherlands;Germany;Japan;New Zealand;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

316

EUCTR2017-000574-11-BE
(EUCTR)

27/06/2018

14/12/2017

Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn's Disease (AIDA)

A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA) - AIDA

Ulcerative colitis or Crohn's Disease
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab

Shire Human Genetic Therapies, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2453

Phase 3

United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan

317

EUCTR2017-004967-11-FR
(EUCTR)

26/06/2018

06/04/2018

Prospective multicenter randomized controlled double-blind label study of the prophylaxis of recurrent pouchitis after fecal microbiota transplant in UC with ileo-anal anastomosis.

Poca - Poca

Patients operated with an IPAA for Ulcerative Colitis with active recurrent pouchitis, who respond after 4 weeks of an antibiotherapy, will be randomized
MedDRA version: 20.1;Level: LLT;Classification code 10000638;Term: Active ileal inflammation;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: suspension de microbiote fécal
Product Code: PRD5973697

CHU Nantes

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 3

France

318

EUCTR2016-004676-22-AT
(EUCTR)

25/06/2018

06/04/2018

A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis

A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis

Product Name: Risankizumab
Product Code: ABBV-006
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

942

Phase 3

United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Denmark;South Africa;Latvia;Netherlands;China;Korea, Republic of;Czechia;Slovenia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden

319

EUCTR2017-004092-31-GB
(EUCTR)

25/06/2018

14/05/2018

A study of the efficacy and safety of Mirikizumab in Ulcerative Colitis

Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: mirikizumab
Other descriptive name: MIRIKIZUMAB

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

840

Phase 3

Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Germany;Japan

320

EUCTR2016-004677-40-AT
(EUCTR)

25/06/2018

06/04/2018

A Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis

Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1547

Phase 2;Phase 3

United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Denmark;South Africa;Latvia;Netherlands;China;Korea, Republic of;Czechia;Slovenia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

321

EUCTR2015-001600-64-LV
(EUCTR)

22/06/2018

13/04/2018

The purpose of this study is to determine whether long-term RPC1063 is safe and effective in the treatment of ulcerative colitis (UC).

A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of long-term RPC1063 in Ulcerative Colitis

Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Celgene International II Sàrl

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1200

Phase 3

322

EUCTR2015-000319-41-LV
(EUCTR)

22/06/2018

13/04/2018

The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC).

Product Name: 0.25mg RPC103
Product Code: RPC1063
INN or Proposed INN: Ozanimod
Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride
Product Name: 1.0 mg RPC103
Product Code: RPC1063
INN or Proposed INN: Ozanimod
Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride

Celgene International II Sàrl (CIS II)

NULL

Not Recruiting

Female: yes
Male: yes

900

Phase 3

323

EUCTR2017-002350-36-HU
(EUCTR)

14/06/2018

19/04/2018

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared with Placebo and Compared with Vedolizumab in Patients with Moderate to Severe Ulcerative Colitis.

Genentech, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

270

Phase 2

Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;United Kingdom;Italy;Hungary;Poland;Bulgaria;Germany;Netherlands

324

NCT04329481
(ClinicalTrials.gov)

June 12, 2018

29/3/2020

The Effect of Mycobiome Supplementation on Gastrointestinal Symptoms in IBD Patients

Ulcerative Colitis;Crohn Disease;Inflammatory Bowel Diseases

Dietary Supplement: Mycodigest supplement

Tel-Aviv Sourasky Medical Center

NULL

Recruiting

18 Years

70 Years

All

100

N/A

Israel

325

EUCTR2017-000572-28-BE
(EUCTR)

08/06/2018

14/12/2017

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 302)

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Shire Human Genetic Therapies, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

825

Phase 3

Portugal;United States;Slovakia;Greece;Spain;Ukraine;Ireland;Colombia;Switzerland;France;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Korea, Republic of;Bosnia and Herzegovina

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

326

EUCTR2017-003284-35-ES
(EUCTR)

05/06/2018

09/04/2018

Investigate the efficacy and safety of study drug ABX464 50 mg once daily in patients with moderate to severe Active Ulcerative Colitis.

A follow-up Phase IIa study to evaluate the long-term safety and efficacy profile of ABX464 given at 50 mg once daily in subjects with Moderate to Severe Active Ulcerative Colitis - A follow-up study in patients with moderate to severe active ulcerative colitis.

Moderate to severe Ulcerative Colitis.
MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464

ABIVAX

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Hungary;Spain

327

EUCTR2017-004230-28-DE
(EUCTR)

04/06/2018

31/01/2018

BI 655130 (SPESOLIMAB) induction treatment in patients with moderate-tosevere ulcerative colitis

A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI 655130 (SPESOLIMAB) Induction Therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy

Product Name: Spesolimab
Product Code: BI 655130
INN or Proposed INN: Spesolimab
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Product Name: Spesolimab
Product Code: BI 655130
INN or Proposed INN: SPESOLIMAB
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1

Boehringer Ingelheim Pharma GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

550

Phase 2;Phase 3

328

EUCTR2015-000319-41-AT
(EUCTR)

25/05/2018

17/04/2018

The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC).

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Induction and Maintenance Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of RPC1063 in Ulcerative Colitis

Celgene International II Sàrl (CIS II)

NULL

Not Recruiting

Female: yes
Male: yes

900

Phase 3

329

EUCTR2017-000402-38-NL
(EUCTR)

24/05/2018

13/11/2017

A clinical trail to evaluate the testicular safety of Filgotinib in adult males with Moderately to Severely Active Inflammatory Bowel Disease

A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Testicular Safety of Filgotinib in Adult Males with Moderately to Severely Active Inflammatory Bowel Disease

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: no
Male: yes

250

Phase 2

Portugal;United States;Spain;Ukraine;Austria;Russian Federation;Sri Lanka;Switzerland;United Kingdom;Italy;India;France;Canada;Belgium;Poland;Australia;Netherlands;Germany;New Zealand;Sweden

330

EUCTR2017-004230-28-IT
(EUCTR)

22/05/2018

05/11/2020

BI 655130 induction treatment in patients with moderate-tosevereulcerative colitis

A Phase II/III Randomized, Double-blind, Placebo-controlled, MulticenterStudy to Evaluate the Safety and Efficacy of BI 655130 Induction Therapyin patients with moderate-to-severely active ulcerative colitis who havefailed previous biologics therapy - -

Moderate-to-severely active ulcerative colitis
MedDRA version: 20.0;Level: LLT;Classification code 10045282;Term: UC;System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

Product Name: -
Product Code: [BI 655130]
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1

BOEHRINGER-INGELHEIM ITALIA S.P.A.

NULL

Not Recruiting

Female: yes
Male: yes

550

Phase 2;Phase 3

United States;Taiwan;Greece;Spain;Austria;Russian Federation;Italy;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany;Netherlands;Japan;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

331

EUCTR2017-003649-10-GB
(EUCTR)

15/05/2018

11/12/2017

A Pharmacokinetic, Pharmacodynamic, and Safety Study of Etrolizumab Followed by Open-Label Extension and Safety Monitoring in Pediatric Patients From 4 Years to Less Than 18 Years of Age with Moderate to Severe Ulcerative Colitis or Moderate to Severe Crohn’s Disease

A PHASE I, OPEN–LABEL, RANDOMIZED, PHARMACOKINETIC, PHARMACODYNAMIC, AND SAFETY STUDY OF ETROLIZUMAB FOLLOWED BY OPEN–LABEL EXTENSION AND SAFETY MONITORING IN PEDIATRIC PATIENTS FROM 4 YEARS TO LESS THAN 18 YEARS OF AGE WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR MODERATE TO SEVERE CROHN’S DISEASE

Moderate to severe ulcerative colitis (UC); moderate to severe Crohn’s disease (CD)
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Etrolizumab
Product Code: 549-0261/F02-01
INN or Proposed INN: ETROLIZUMAB
Other descriptive name: ETROLIZUMAB

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 1

Spain;Poland;Belgium;Germany;United Kingdom

332

EUCTR2017-002231-41-NL
(EUCTR)

14/05/2018

26/09/2017

A study to investigate how the body responds to the study drug Vedolizumab in child patients with Ulcerative Colitis or Crohn’s Disease

A Phase 2, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease(A Phase 2, Randomized, Double-Blind, Dose-Ranging Study With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease) - Hubble

Ulcerative Colitis and Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB

Takeda Development Centre Europe, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Canada;Poland;Belgium;Ukraine;Israel;Germany;Netherlands;United Kingdom;United States;France;Hungary

333

EUCTR2017-003703-22-GB
(EUCTR)

03/05/2018

31/01/2018

Phase 2 Dose-finding IMU-838 for Ulcerative Colitis (CALDOSE-1)

Product Name: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Product Name: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium dihydrate
Other descriptive name: IM90838
Product Name: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium dihydrate
Other descriptive name: IM90838

Immunic AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

240

Phase 2

Serbia;Portugal;United States;Belarus;Spain;Ukraine;Russian Federation;United Kingdom;Czech Republic;Macedonia, the former Yugoslav Republic of;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Netherlands;Bosnia and Herzegovina

334

EUCTR2017-003649-10-BE
(EUCTR)

02/05/2018

27/02/2018

Product Name: Etrolizumab
Product Code: 549-0261/F02-01
INN or Proposed INN: ETROLIZUMAB
Other descriptive name: ETROLIZUMAB

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 1

United States;Poland;Spain;Belgium;Germany;United Kingdom

335

EUCTR2017-003649-10-DE
(EUCTR)

30/04/2018

07/02/2018

Product Name: Etrolizumab
Product Code: 549-0261/F02-01
INN or Proposed INN: ETROLIZUMAB
Other descriptive name: ETROLIZUMAB

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

Phase 1

United States;Poland;Belgium;Spain;Germany;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

336

EUCTR2017-003703-22-ES
(EUCTR)

29/04/2018

20/02/2018

Phase 2 Dose-finding IMU-838 for Ulcerative Colitis (CALDOSE-1)

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Immunic AG

NULL

Not Recruiting

Female: yes
Male: yes

210

Phase 2

Serbia;United States;Czech Republic;Slovakia;Poland;Belgium;Spain;Ukraine;Russian Federation;Netherlands;Germany;United Kingdom

337

EUCTR2017-000574-11-HR
(EUCTR)

27/04/2018

27/08/2018

Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn’s Disease (AIDA)

A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn’s Disease (AIDA) - AIDA

Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab

Shire Human Genetic Therapies, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2453

Phase 3

338

EUCTR2017-000573-37-HR
(EUCTR)

23/04/2018

07/12/2018

Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab

Shire Human Genetic Therapies, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

772

Phase 3

United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan

339

EUCTR2017-000574-11-PT
(EUCTR)

23/04/2018

22/12/2017

Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn's Disease (AIDA)

A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA) - AIDA

Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab

Shire Human Genetic Therapies, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2453

Phase 3

340

EUCTR2016-003708-29-BG
(EUCTR)

20/04/2018

17/01/2018

Study to evaluate the effectiveness of oral PF-06651600 and PF-06700841 in subjects with moderate to severe ulcerative colitis, a disease characterized by continuous inflammation that is localized to the colon

A Phase 2B, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Dose Ranging Study of Oral PF-06651600 and PF-06700841 as Induction and Chronic Therapy in Subjects with Moderate to Severe Ulcerative Colitis - Vibrato

Moderate to severe Ulcerative Colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

360

Phase 2

Serbia;United States;Slovakia;Spain;Ukraine;Lithuania;Turkey;Austria;Russian Federation;Israel;Italy;Czech Republic;Hungary;Canada;Poland;Romania;Denmark;Bulgaria;Georgia;Netherlands;Germany;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

341

EUCTR2017-000599-27-HR
(EUCTR)

20/04/2018

07/12/2018

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 301)

Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab

Shire Human Genetic Therapies, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

825

Phase 3

United States;Serbia;Czechia;Slovakia;Greece;Lithuania;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Poland;Brazil;Romania;Croatia;Australia;South Africa;Germany;Netherlands;Japan;New Zealand

342

EUCTR2017-002350-36-ES
(EUCTR)

15/04/2018

06/06/2018

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared with Placebo and Compared with Vedolizumab in Patients with Moderate to Severe Ulcerative Colitis.

Roche Farma, S.A por delegación de Genentech, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

330

Phase 2

Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;United Kingdom;Italy;Hungary;Poland;Bulgaria;Germany;Netherlands

343

EUCTR2017-004230-28-GB
(EUCTR)

13/04/2018

01/02/2018

BI 655130 (SPESOLIMAB) induction treatment in patients with moderate-tosevere ulcerative colitis

A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI 655130 (SPESOLIMAB) Induction Therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy

Product Name: Spesolimab
Product Code: BI 655130
INN or Proposed INN: Spesolimab
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Product Name: Spesolimab
Product Code: BI 655130
INN or Proposed INN: Spesolimab
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1

Boehringer Ingelheim Limited

NULL

Not Recruiting

Female: yes
Male: yes

550

Phase 2;Phase 3

United States;Taiwan;Greece;Spain;Austria;Russian Federation;Israel;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;China;Korea, Republic of

344

EUCTR2017-002274-39-GB
(EUCTR)

12/04/2018

20/12/2017

A multi-center parallel group study of tofacitinib in subjects with ulcerative colitis in stable remission

A PHASE 3B/4, MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP STUDY OF TOFACITINIB (CP-690,550) IN SUBJECTS WITH ULCERATIVE COLITIS IN STABLE REMISSION

Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

130

Phase 3;Phase 4

Serbia;United States;Slovakia;Spain;Ukraine;Austria;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;South Africa;Netherlands;Germany;New Zealand;Japan;Korea, Republic of

345

EUCTR2017-002108-28-ES
(EUCTR)

12/04/2018

20/04/2018

A study to evaluate the efficacy, safety, tolerability and pharmacokinetics of PF-06687234/placebo as add-on therapy to infliximab in subjects with ulcerative colitis who are not in remission

Product Name: Dekavil
Product Code: PF-06687234
INN or Proposed INN: Dekavil
Other descriptive name: F8IL10

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Serbia;Saudi Arabia;Belgium;Spain;Australia;Israel;Germany;Italy;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

346

EUCTR2017-000599-27-DE
(EUCTR)

10/04/2018

24/10/2017

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 301)

Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab

Shire Human Genetic Therapies, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

825

Phase 3

United States;Serbia;Slovakia;Greece;Lithuania;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Poland;Brazil;Romania;Croatia;Australia;South Africa;Germany;Netherlands;Japan;New Zealand

347

EUCTR2017-000573-37-DE
(EUCTR)

10/04/2018

24/10/2017

Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab

Shire Human Genetic Therapies, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

772

Phase 3

348

EUCTR2017-000574-11-DE
(EUCTR)

10/04/2018

25/10/2017

Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn's Disease (AIDA)

A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA) - AIDA

Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab

Shire Human Genetic Therapies, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

2453

Phase 3

349

EUCTR2017-003284-35-PL
(EUCTR)

06/04/2018

05/03/2018

A follow-up study in patients with moderate to severe active ulcerative colitis.

A follow-up Phase IIa study to evaluate the long-term safety and efficacy profile of ABX464given at 50 mg once daily in subjects with Moderate to Severe Active Ulcerative Colitis. - Follow-up study in Moderate to Severe Active Ulcerative Colitis subjects.

Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464

ABIVAX

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Hungary;Spain;Belgium;Poland

350

EUCTR2017-002108-28-BE
(EUCTR)

30/03/2018

22/03/2018

A study to evaluate the efficacy, safety, tolerability and pharmacokinetics of PF-06687234/placebo as add-on therapy to infliximab in subjects with ulcerative colitis who are not in remission

Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Serbia;United States;Saudi Arabia;Spain;Belgium;Australia;Israel;Germany;Italy;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

351

EUCTR2016-000641-31-BE
(EUCTR)

29/03/2018

31/10/2016

Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1055

Phase 2;Phase 3

Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan

352

EUCTR2017-003524-75-NL
(EUCTR)

27/03/2018

19/02/2018

Mesenchymal Stromal Cells for the treatment of Ulcerative Colitis

Allogeneic Bone Marrow Derived Mesenchymal Stromal Cells for the Treatment of Refractory Proctitis in Ulcerative Colitis - BMMSCproctitis

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Mesenchymal stromal cells
Product Code: MSC
INN or Proposed INN: n.a.
Other descriptive name: MESENCHYMAL CELLS

Leiden University Medical Center

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Netherlands

353

EUCTR2017-002182-21-NL
(EUCTR)

20/03/2018

28/09/2017

An extension study to investigate how safe Vedolizumab is in child patients with Ulcerative Colitis or Crohn’s Disease

A Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease. (Long-term Safety With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease) - Hubble Zoom

Ulcerative Colitis or Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Takeda Development Centre Europe, Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

France;United States;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Germany;Netherlands;United Kingdom

354

EUCTR2017-000573-37-NL
(EUCTR)

15/03/2018

02/11/2017

Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody
Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody

Shire Human Genetic Therapies, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

772

Phase 3

355

EUCTR2017-000574-11-NL
(EUCTR)

15/03/2018

02/11/2017

Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn's Disease (AIDA)

A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA) - AIDA

Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody
Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody

Shire Human Genetic Therapies, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2453

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

356

EUCTR2017-000573-37-IE
(EUCTR)

13/03/2018

04/09/2017

Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab

Shire Human Genetic Therapies, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

772

Phase 3

Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Lebanon;Ireland;Russian Federation;Israel;Colombia;Italy;Switzerland;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan

357

EUCTR2017-000573-37-PT
(EUCTR)

13/03/2018

21/12/2017

Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Shire Human Genetic Therapies, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

772

Phase 3

Serbia;United States;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Italy;Switzerland;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan

358

EUCTR2017-000574-11-IE
(EUCTR)

13/03/2018

04/09/2017

Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn's Disease (AIDA)

A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA) - AIDA

Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab

Shire Human Genetic Therapies, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2453

Phase 3

359

EUCTR2017-000572-28-PT
(EUCTR)

13/03/2018

22/12/2017

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 302)

Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab

Shire Human Genetic Therapies, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

825

Phase 3

United States;Portugal;Slovakia;Greece;Spain;Ukraine;Lebanon;Ireland;Turkey;Colombia;Switzerland;France;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Bosnia and Herzegovina;Korea, Republic of

360

EUCTR2017-004230-28-BE
(EUCTR)

09/03/2018

22/01/2018

BI 655130 induction treatment in patients with moderate-tosevere ulcerative colitis

Product Code: BI 655130
INN or Proposed INN: BI 655130
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1

SCS Boehringer Ingelheim Comm. V

NULL

Not Recruiting

Female: yes
Male: yes

550

Phase 2;Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

361

EUCTR2017-000573-37-GB
(EUCTR)

07/03/2018

25/09/2017

Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Shire Human Genetic Therapies, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

772

Phase 3

362

EUCTR2017-000599-27-GB
(EUCTR)

07/03/2018

05/12/2018

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 301)

Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Shire Human Genetic Therapies, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

825

Phase 3

Serbia;United States;Slovakia;Greece;Lithuania;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Poland;Brazil;Romania;Croatia;Australia;South Africa;Netherlands;Germany;New Zealand;Japan

363

EUCTR2017-000574-11-GB
(EUCTR)

06/03/2018

21/09/2017

Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn's Disease (AIDA)

A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA) - AIDA

Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab

Shire Human Genetic Therapies, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2453

Phase 3

364

EUCTR2017-004230-28-AT
(EUCTR)

27/02/2018

18/01/2018

BI 655130 (SPESOLIMAB) induction treatment in patients with moderate-to severe ulcerative colitis

A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI 655130 (SPESOLIMAB) Induction Therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy

Boehringer Ingelheim RCV GmbH & Co KG

NULL

Not Recruiting

Female: yes
Male: yes

550

Phase 2;Phase 3

365

EUCTR2017-000573-37-CZ
(EUCTR)

27/02/2018

01/11/2017

Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab

Shire Human Genetic Therapies, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

772

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

366

EUCTR2017-000599-27-CZ
(EUCTR)

26/02/2018

01/11/2017

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 301)

Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab

Shire Human Genetic Therapies, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

825

Phase 3

367

EUCTR2016-004217-26-IT
(EUCTR)

22/02/2018

A Randomised Dose-Optimisation Study to Evaluate the Efficacy and Safety of Cobitolimod in Moderate to Severe Active Ulcerative Colitis Patients

A Randomised Dose-Optimisation Study to Evaluate the Efficacy and Safety of Cobitolimod in Moderate to Severe Active Ulcerative Colitis Patients - CONDUCT

Moderate to Severe left-sided Active Ulcerative Colitis
MedDRA version: 20.0;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Cobitolimod
Product Code: DIMs0150
INN or Proposed INN: Cobitolimod
Other descriptive name: DIMS0150
Product Name: Cobitolimod
Product Code: DIMS0150
INN or Proposed INN: Cobitolimod
Other descriptive name: DIMS0150
Product Name: Cobitolimod
Product Code: DIMS0150
INN or Proposed INN: Cobitolimod
Other descriptive name: DIMS0150

INDEX PHARMACEUTICALS AB

NULL

Not Recruiting

Female: yes
Male: yes

215

Phase 2

Serbia;Spain;Ukraine;Russian Federation;Montenegro;Italy;France;Czech Republic;Hungary;Poland;Romania;Germany;Sweden

368

EUCTR2017-002274-39-BE
(EUCTR)

22/02/2018

18/12/2017

A multi-center parallel group study of tofacitinib in subjects with ulcerative colitis in stable remission

A PHASE 3B/4, MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP STUDY OF TOFACITINIB (CP-690,550) IN SUBJECTS WITH ULCERATIVE COLITIS IN STABLE REMISSION

Trade Name: XELJANZ
Product Name: Tofacitinib citrate
Product Code: CP -690,550 -10
INN or Proposed INN: tofacitinib
Other descriptive name: CP -690,550

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

130

Phase 3;Phase 4

United States;Poland;Serbia;South Africa;Czechia;Germany;Slovakia;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Netherlands;Japan;New Zealand;Korea, Republic of;Canada;Belgium

369

EUCTR2017-000937-30-AT
(EUCTR)

22/02/2018

03/01/2018

Investigate the efficacy and safety of study drug ABX464 50 mg once daily versus placebo with patients with moderate to severe Active Ulcerative Colitis.

A Phase IIa study to evaluate the safety and efficacy of ABX464 50 mg once daily versus Placebo in subjects with Moderate to Severe Active Ulcerative Colitis who have failed or are intolerant to immunomodulators, Anti-TNFa, vedolizumab and/or corticosteroids. - Safety and efficacy study of ABX464 in patients with moderate to severe Active Ulcerative Colitis.

Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464

ABIVAX

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

France;Hungary;Spain;Poland;Belgium;Austria;Germany

370

EUCTR2017-000574-11-ES
(EUCTR)

16/02/2018

19/12/2017

Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis (AIDA)

A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis (AIDA) - AIDA

Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody
Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody

Shire Human Genetic Therapies, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1114

Phase 3

Serbia;Portugal;United States;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

371

EUCTR2017-000573-37-ES
(EUCTR)

16/02/2018

19/12/2017

Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody
Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody

Shire Human Genetic Therapies, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

772

Phase 3

372

EUCTR2017-000572-28-ES
(EUCTR)

16/02/2018

19/12/2017

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 302) - FIGARO UC 302

Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody
Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody

Shire Human Genetic Therapies, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

825

Phase 3

United States;Portugal;Slovakia;Greece;Spain;Ukraine;Ireland;Colombia;Switzerland;France;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Bosnia and Herzegovina;Korea, Republic of

373

EUCTR2017-000572-28-FR
(EUCTR)

16/02/2018

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 302)

Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody
Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody

Shire Human Genetic Therapies, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

825

Phase 3

Portugal;United States;Slovakia;Greece;Spain;Ukraine;Ireland;Colombia;Switzerland;France;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Korea, Republic of;Bosnia and Herzegovina

374

EUCTR2017-004772-65-DK
(EUCTR)

05/02/2018

04/12/2017

Probiotic Treatment of Ulcerative Colitis with Trichuris suis ova (TSO)

Probiotic Treatment of Ulcerative Colitis with Trichuris suis ova (TSO) - PROCTO

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

ParaTech A/S

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

120

Phase 2

Denmark

375

NCT03358706
(ClinicalTrials.gov)

February 2, 2018

27/11/2017

A Study to Evaluate the Effect of Ustekinumab on Cytochrome P450 Enzyme Activities Following Induction and Maintenance Dosing in Participants With Active Crohn's Disease or Ulcerative Colitis

A Phase 1, Open-label, Drug Interaction Study to Evaluate the Effect of Ustekinumab on Cytochrome P450 Enzyme Activities Following Induction and Maintenance Dosing in Participants With Active Crohn's Disease or Ulcerative Colitis.

Crohn Disease;Ulcerative Colitis

Drug: Ustekinumab IV Infusion;Drug: Ustekinumab SC Injection;Drug: Midazolam 2 mg;Drug: Warfarin 10 mg;Drug: Vitamin K 10 mg;Drug: Omeprazole 20 mg;Drug: Dextromethorphan 30 mg;Drug: Caffeine 100 mg

Janssen Research & Development, LLC

NULL

Recruiting

18 Years

75 Years

All

Phase 1

United States;Belgium;Germany;Sweden;United Kingdom;Austria;Denmark

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

376

EUCTR2017-000574-11-LT
(EUCTR)

30/01/2018

31/10/2017

Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn’s Disease (AIDA)

A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn’s Disease (AIDA) - AIDA

Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab

Shire Human Genetic Therapies, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2453

Phase 3

377

EUCTR2017-000573-37-LT
(EUCTR)

30/01/2018

31/10/2017

Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab

Shire Human Genetic Therapies, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

772

Phase 3

378

EUCTR2017-000599-27-LT
(EUCTR)

30/01/2018

31/10/2017

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 301)

Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab

Shire Human Genetic Therapies, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

825

Phase 3

379

EUCTR2017-000402-38-PT
(EUCTR)

29/01/2018

13/11/2017

A clinical trail to evaluate the testicular safety of Filgotinib in adult males with Moderately to Severely Active Inflammatory Bowel Disease

A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Testicular Safety of Filgotinib in Adult Males with Moderately to Severely Active Inflammatory Bowel Disease

To evaluate the testicular safety of filgotinib in adult males with moderately to severely Active Inflammatory Bowel Disease
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: GS-6034
INN or Proposed INN: FILGOTINIB

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: no
Male: yes

250

Phase 2

Portugal;United States;Taiwan;Spain;Ukraine;Austria;Russian Federation;United Kingdom;India;Canada;Belgium;Poland;Romania;Australia;Germany;Netherlands;New Zealand;Sweden

380

EUCTR2017-000573-37-BG
(EUCTR)

24/01/2018

22/11/2017

Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab

Shire Human Genetic Therapies, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

772

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

381

EUCTR2017-000574-11-HU
(EUCTR)

23/01/2018

27/10/2017

Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn's Disease (AIDA)

A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA) - AIDA

Ulcerative colitis or Crohn's Disease
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Shire Human Genetic Therapies, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2453

Phase 3

Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Italy;Switzerland;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan

382

EUCTR2013-001744-65-BE
(EUCTR)

23/01/2018

27/02/2017

A clinical trial to investigate the safety and effectiveness of MMX Mesalamine/mesalazine in Children and Adolescents aged 5-17 years who have mild to moderate Ulcerative Colitis

A Phase 3, Multicenter, Randomized, Double-blind Study to Determine the Safety and Efficacy of MMX Mesalamine/Mesalazine in Paediatric Subjects with Mild to Moderate Ulcerative Colitis, in both Acute and Maintenance Phases

Mild to Moderate Ulcerative Colitis
MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Mezavant Gastro-resistant, prolonged release tablets
Product Name: Mezavant
Product Code: SPD476
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalazine
Product Code: SPD476
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalazine
Product Code: SPD476
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalazine

Shire Development LLC

NULL

Not Recruiting

Female: yes
Male: yes

132

Phase 3

United States;Hungary;Slovakia;Canada;Poland;Belgium;Israel;Netherlands;Germany;United Kingdom;Sweden

383

EUCTR2017-000402-38-DE
(EUCTR)

23/01/2018

27/10/2017

A clinical trail to evaluate the testicular safety of Filgotinib in adult males with Moderately to Severely Active Inflammatory Bowel Disease

A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Testicular Safety of Filgotinib in Adult Males with Moderately to Severely Active Inflammatory Bowel Disease

To evaluate the testicular safety of filgotinib in adult males with moderately to severely Active Inflammatory Bowel Disease
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: GS-6034
INN or Proposed INN: FILGOTINIB

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: no
Male: yes

250

Phase 2

United States;Portugal;Taiwan;Spain;Ukraine;Austria;Russian Federation;United Kingdom;India;Canada;Belgium;Poland;Romania;Australia;Germany;Netherlands;New Zealand;Sweden

384

EUCTR2017-000573-37-HU
(EUCTR)

22/01/2018

23/01/2018

Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Shire Human Genetic Therapies, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

772

Phase 3

Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan

385

EUCTR2017-000572-28-HU
(EUCTR)

22/01/2018

27/10/2017

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 302)

Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab

Shire Human Genetic Therapies, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

825

Phase 3

United States;Portugal;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Turkey;Colombia;Switzerland;France;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Bosnia and Herzegovina;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

386

EUCTR2017-000402-38-AT
(EUCTR)

19/01/2018

30/10/2017

A clinical trial to evaluate the testicular safety of Filgotinib in adult males with Moderately to Severely Active Inflammatory Bowel Disease

A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Testicular Safety of Filgotinib in Adult Males with Moderately to Severely Active Inflammatory Bowel Disease

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: no
Male: yes

250

Phase 2

Portugal;United States;Spain;Ukraine;Austria;Russian Federation;Sri Lanka;Switzerland;United Kingdom;Italy;India;France;Canada;Belgium;Poland;Australia;Germany;Netherlands;New Zealand;Sweden

387

EUCTR2017-000402-38-GB
(EUCTR)

19/01/2018

23/10/2017

A clinical trial to evaluate the testicular safety of Filgotinib in adult males with Moderately to Severely Active Inflammatory Bowel Disease

A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Testicular Safety of Filgotinib in Adult Males with Moderately to Severely Active Inflammatory Bowel Disease

To evaluate the testicular safety of filgotinib in adult males with moderately to severely Active Inflammatory Bowel Disease
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: GS-6034
INN or Proposed INN: FILGOTINIB

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: no
Male: yes

250

Phase 2

United States;Portugal;Spain;Ukraine;Austria;Russian Federation;United Kingdom;India;Canada;Belgium;Poland;Romania;Australia;Germany;Netherlands;New Zealand;Sweden

388

EUCTR2017-000572-28-BG
(EUCTR)

19/01/2018

24/11/2017

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 302)

Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab

Shire Human Genetic Therapies, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

825

Phase 3

United States;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Lebanon;Ireland;Turkey;Colombia;Switzerland;France;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Bosnia and Herzegovina;Korea, Republic of

389

EUCTR2017-002231-41-PL
(EUCTR)

17/01/2018

13/10/2017

A study to investigate how the body responds to the study drug Vedolizumab in child patients with Ulcerative Colitis or Crohn’s Disease

A Phase 2, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease (A Phase 2, Randomized, Double-Blind, Dose-Ranging Study With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease) - Hubble

Ulcerative Colitis and Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Takeda Development Centre Europe, Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

France;United States;Hungary;Canada;Belgium;Poland;Ukraine;Israel;Netherlands;Germany;United Kingdom

390

EUCTR2017-002182-21-PL
(EUCTR)

17/01/2018

13/10/2017

An extension study to investigate how safe Vedolizumab is in child patients with Ulcerative Colitis or Crohn’s Disease

A Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease.(Long-term Safety With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis orCrohn’s Disease) - Hubble Zoom

Ulcerative Colitis or Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Entyvio
Product Name: Vedolizumab
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Entyvio
Product Name: Vedolizumab
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Entyvio
Product Name: Vedolizumab
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Entyvio
Product Name: Vedolizumab
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB

Takeda Development Centre Europe, Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

United States;France;Hungary;Canada;Belgium;Poland;Ukraine;Israel;Netherlands;Germany;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

391

EUCTR2017-002274-39-CZ
(EUCTR)

16/01/2018

14/12/2017

A multi-center parallel group study of tofacitinib in subjects with ulcerative colitis in stable remission

A PHASE 3B/4, MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP STUDY OF TOFACITINIB (CP-690,550) IN SUBJECTS WITH ULCERATIVE COLITIS IN STABLE REMISSION

Trade Name: XELJANZ
Product Name: Tofacitinib citrate
Product Code: CP -690,550 -10
INN or Proposed INN: tofacitinib
Other descriptive name: CP -690,550

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

130

Phase 3;Phase 4

392

EUCTR2017-002182-21-BE
(EUCTR)

10/01/2018

14/09/2017

An extension study to investigate how safe Vedolizumab is in child patients with Ulcerative Colitis or Crohn’s Disease

A Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease.(Long-term Safety With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis orCrohn’s Disease) - Hubble Zoom

Ulcerative Colitis or Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Takeda Development Centre Europe, Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

France;United States;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom

393

EUCTR2013-001744-65-DE
(EUCTR)

10/01/2018

20/02/2017

A clinical trial to investigate the safety and effectiveness of MMX Mesalamine/mesalazine in Children and Adolescents aged 5-17 years who have mild to moderate Ulcerative Colitis

Mild to Moderate Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Shire Development LLC

NULL

Not Recruiting

Female: yes
Male: yes

132

Phase 3

United States;Hungary;Slovakia;Canada;Poland;Belgium;Israel;Netherlands;Germany;United Kingdom;Sweden

394

EUCTR2017-002231-41-BE
(EUCTR)

10/01/2018

14/09/2017

A study to investigate how the body responds to the study drug Vedolizumab in child patients with Ulcerative Colitis or Crohn’s Disease

Takeda Development Centre Europe, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;France;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom

395

EUCTR2017-002274-39-AT
(EUCTR)

04/01/2018

20/12/2017

A multi-center parallel group study of tofacitinib in subjects with ulcerative colitis in stable remission

A PHASE 3B/4, MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP STUDY OF TOFACITINIB (CP-690,550) IN SUBJECTS WITH ULCERATIVE COLITIS IN STABLE REMISSION

Trade Name: XELJANZ
Product Name: Tofacitinib citrate
Product Code: CP -690,550 -10
INN or Proposed INN: tofacitinib
Other descriptive name: CP -690,550

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

130

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

396

EUCTR2017-000574-11-BG
(EUCTR)

04/01/2018

24/11/2017

Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn's Disease (AIDA)

A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA) - AIDA

Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab

Shire Human Genetic Therapies, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2453

Phase 3

Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Portugal;Serbia;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil

397

EUCTR2017-003284-35-HU
(EUCTR)

03/01/2018

22/11/2017

A follow-up study in patients with moderate to severe active ulcerative colitis.

A follow-up Phase IIa study to evaluate the long-term safety and efficacy profile of ABX464 given at 50 mg once daily in subjects with Moderate to Severe Active Ulcerative Colitis. - A Follow-up study in Moderate to Severe Active Ulcerative Colitis subjects

Moderate to severe Ulcerative Colitis.
MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

ABIVAX

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Hungary;Spain;Poland;Belgium

398

NCT03394586
(ClinicalTrials.gov)

January 1, 2018

28/12/2017

Real-world Data Regarding Treatment of Ulcerative Colitis Patients With Golimumab

Ulcerative Colitis;Flare Up, Symptom

Drug: Exposure to golimumab

University of Zurich

NULL

Unknown status

N/A

All

100

Switzerland

399

EUCTR2017-000574-11-AT
(EUCTR)

22/12/2017

30/10/2017

Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn's Disease (AIDA)

A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA) - AIDA

Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab

Shire Human Genetic Therapies, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2453

Phase 3

400

EUCTR2017-000573-37-AT
(EUCTR)

22/12/2017

30/10/2017

Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab

Shire Human Genetic Therapies, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

772

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

401

EUCTR2017-000599-27-AT
(EUCTR)

22/12/2017

30/10/2017

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 301)

Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab

Shire Human Genetic Therapies, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

825

Phase 3

402

EUCTR2017-002274-39-HU
(EUCTR)

21/12/2017

19/12/2017

A multi-center parallel group study of tofacitinib in subjects with ulcerative colitis in stable remission

A PHASE 3B/4, MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP STUDY OF TOFACITINIB (CP-690,550) IN SUBJECTS WITH ULCERATIVE COLITIS IN STABLE REMISSION

Trade Name: XELJANZ
Product Name: Tofacitinib citrate
Product Code: CP -690,550 -10
INN or Proposed INN: tofacitinib
Other descriptive name: CP -690,550

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

130

Phase 3;Phase 4

United States;Serbia;Slovakia;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Poland;South Africa;Germany;Netherlands;Japan;New Zealand;Korea, Republic of

403

EUCTR2017-002274-39-ES
(EUCTR)

21/12/2017

22/12/2017

A multi-center parallel group study of tofacitinib in subjects with ulcerative colitis in stable remission

A PHASE 3B/4, MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP STUDY OF TOFACITINIB (CP-690,550) IN SUBJECTS WITH ULCERATIVE COLITIS IN STABLE REMISSION

Trade Name: XELJANZ
Product Name: Tofacitinib citrate
Product Code: CP -690,550 -10
INN or Proposed INN: tofacitinib
Other descriptive name: CP -690,550

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

130

Phase 3

404

EUCTR2017-003284-35-BE
(EUCTR)

19/12/2017

09/11/2017

A follow-up study in patients with moderate to severe active ulcerative colitis.

A follow-up Phase IIa study to evaluate the long-term safety and efficacy profile of ABX464 given at 50 mg once daily in subjects with Moderate to Severe Active Ulcerative Colitis. - Follow-up study in Moderate to Severe Active Ulcerative Colitis subjects

Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464

ABIVAX

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Hungary;Spain;Poland;Belgium

405

EUCTR2014-001594-14-DE
(EUCTR)

19/12/2017

22/09/2014

Can FITC-Adalimumab predict the efficacy of Adalimumab in patients with colitis ulcerosa, when it is applied to the intestinal mucosa during an endoscopic examination? Is FITC-Adalimumab safe and tolerable in this setting? Open-label, one-arm clinical trial in one study site

Prospective, single-centre, open-label, one-arm clinical trial, phase I/IIa, to assess the safety and tolerability and to investigate the predictive power of FITC-Adalimumab, when topically applied twice to the intestinal mucosa as an in-vitro diagnostic in the framework of a confocal laser-endomicroscopic examination of colitis ulcerosa patients with an indication for Adalimumab treatment - MAgIC

Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: FITC-Adalimumab
Product Code: FITC-Adalimumab
INN or Proposed INN: FITC-Adalimumab
Other descriptive name: FITC-ADALIMUMAB

Universitätsklinikum Erlangen

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 1;Phase 2

Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

406

EUCTR2017-002182-21-DE
(EUCTR)

18/12/2017

13/09/2017

An extension study to investigate how safe Vedolizumab is in child patients with Ulcerative Colitis or Crohn’s Disease

A Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease.(Long-term Safety With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis orCrohn’s Disease) - Hubble Zoom

Ulcerative Colitis or Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Takeda Development Centre Europe, Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

France;United States;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom

407

EUCTR2017-002182-21-FR
(EUCTR)

18/12/2017

15/12/2017

An extension study to investigate how safe Vedolizumab is in child patients with Ulcerative Colitis or Crohn’s Disease

A Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease.(Long-term Safety With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis orCrohn’s Disease) - Hubble Zoom

Ulcerative Colitis or Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Takeda Development Centre Europe, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;France;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom

408

EUCTR2017-002231-41-DE
(EUCTR)

18/12/2017

14/09/2017

A study to investigate how the body responds to the study drug Vedolizumab in child patients with Ulcerative Colitis or Crohn’s Disease

Takeda Development Centre Europe, Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

France;United States;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom

409

EUCTR2017-000572-28-SK
(EUCTR)

13/12/2017

21/11/2017

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 302)

Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab

Shire Human Genetic Therapies, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

825

Phase 3

410

EUCTR2017-000573-37-SK
(EUCTR)

13/12/2017

21/11/2017

Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab

Shire Human Genetic Therapies, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

772

Phase 3

United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

411

EUCTR2017-000574-11-SK
(EUCTR)

13/12/2017

21/11/2017

Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn’s Disease (AIDA)

A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn’s Disease (AIDA) - AIDA

Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab

Shire Human Genetic Therapies, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2453

Phase 3

Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Poland;Belgium;Croatia;Bulgaria;Germany;Netherlands

412

EUCTR2017-000937-30-PL
(EUCTR)

13/12/2017

25/09/2017

Investigate the efficacy and safety of study drug ABX464 50 mg once daily versus placebo with patients with moderate to severe Active Ulcerative Colitis.

Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464

ABIVAX

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

France;Hungary;Spain;Belgium;Poland;Austria;Germany

413

EUCTR2017-000572-28-GR
(EUCTR)

11/12/2017

28/11/2017

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 302)

Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody
Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody

Shire Human Genetic Therapies, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

825

Phase 3

United States;Portugal;Slovakia;Greece;Spain;Ukraine;Ireland;Colombia;Switzerland;France;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Bosnia and Herzegovina;Korea, Republic of

414

EUCTR2017-000573-37-GR
(EUCTR)

11/12/2017

01/12/2017

Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody
Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody

Shire Human Genetic Therapies, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

772

Phase 3

United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Japan;New Zealand

415

EUCTR2017-002274-39-SK
(EUCTR)

08/12/2017

27/10/2017

A multi-center parallel group study of tofacitinib in subjects with ulcerative colitis in stable remission

A PHASE 3B/4, MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP STUDY OF TOFACITINIB (CP-690,550) IN SUBJECTS WITH ULCERATIVE COLITIS IN STABLE REMISSION

Trade Name: XELJANZ
Product Name: Tofacitinib citrate
Product Code: CP -690,550 -10
INN or Proposed INN: tofacitinib
Other descriptive name: CP -690,550

Pfizer Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

130

Phase 3;Phase 4

United States;Serbia;Slovakia;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;South Africa;Germany;Netherlands;Japan;New Zealand;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

416

EUCTR2017-000937-30-ES
(EUCTR)

27/11/2017

10/10/2017

Investigate the efficacy and safety of study drug ABX464 50 mg once daily versus placebo with patients with moderate to severe Active Ulcerative Colitis.

Moderate to severe Ulcerative Colitis.
MedDRA version: 20.0;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

ABIVAX

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

France;Hungary;Poland;Belgium;Spain;Austria;Germany

417

EUCTR2016-000420-26-BG
(EUCTR)

17/11/2017

19/04/2017

A study to test the effectiveness of bimekizumab as a treatment for ulcerative colitis to look for unwanted side effects and to measure how the drug is distributed, modified and cleared from the body.

A MULTICENTER, SUBJECT-BLIND, INVESTIGATOR-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY, SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF AN IV LOADING DOSE FOLLOWED BY SC ADMINISTRATION OF BIMEKIZUMAB (UCB4940) IN SUBJECTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS

MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS
MedDRA version: 20.0;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Bimekizumab
Product Code: UCB4940
INN or Proposed INN: Bimekizumab
Other descriptive name: UCB4940

UCB Biopharma SPRL

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Czech Republic;Spain;Poland;Romania;South Africa;Georgia;Bulgaria;United Kingdom;Moldova, Republic of;Italy

418

EUCTR2017-002182-21-GB
(EUCTR)

16/11/2017

11/09/2017

An extension study to investigate how safe Vedolizumab is in child patients with Ulcerative Colitis or Crohn’s Disease

A Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease.(Long-term Safety With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis orCrohn’s Disease) - Hubble Zoom

Ulcerative Colitis or Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Takeda Development Centre Europe, Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

France;United States;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom

419

EUCTR2017-002231-41-GB
(EUCTR)

15/11/2017

11/09/2017

A study to investigate how the body responds to the study drug Vedolizumab in child patients with Ulcerative Colitis or Crohn’s Disease

Takeda Development Centre Europe, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

France;United States;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom

420

NCT03266484
(ClinicalTrials.gov)

November 13, 2017

25/8/2017

Effect of a Probiotic Mixture on the Gut Microbiome and Fatigue in Patients With Quiescent Inflammatory Bowel Disease

Effect of Dietary Therapy With a Probiotic Mixture on the Gut Microbiome and Fatigue Symptoms in Patients With Quiescent Inflammatory Bowel Disease - A Clinical Trial

Inflammatory Bowel Diseases;Crohn Disease;Ulcerative Colitis

Dietary Supplement: Probiotic Mixture;Dietary Supplement: Placebo

Massachusetts General Hospital

Winclove Bio Industries BV

Recruiting

18 Years

75 Years

All

100

N/A

United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

421

EUCTR2015-001346-29-CZ
(EUCTR)

13/11/2017

03/06/2016

A Multi-Center, Open-Label Study of Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Ulcerative Colitis Who Completed the Study M11-290

A Multi-Center, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Ulcerative Colitis Who Completed the Study M11-290

Ulcerative Colitis
MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use
Product Name: Adalimumab
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 3

United States;Slovakia;Spain;Austria;Israel;United Kingdom;Czech Republic;Hungary;European Union;Canada;Poland;Belgium;Japan;New Zealand;Sweden

422

EUCTR2016-003708-29-NL
(EUCTR)

09/11/2017

19/07/2017

Moderate to severe Ulcerative Colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Code: PF-06651600 10 mg
INN or Proposed INN: PF-06651600
Other descriptive name: PF-06651600 -15
Product Code: PF-06651600 50 mg
INN or Proposed INN: PF-06651600
Other descriptive name: PF-06651600 -15
Product Code: PF-06700841 5 mg
INN or Proposed INN: PF-06700841
Other descriptive name: PF-06700841 -15
Product Code: PF-06700841 25 mg
INN or Proposed INN: PF-06700841
Other descriptive name: PF-06700841 -15

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

360

Phase 2

Serbia;United States;Slovakia;Spain;Ukraine;Ireland;Lithuania;Turkey;Austria;Russian Federation;Israel;Italy;Hungary;Czech Republic;Canada;Poland;Romania;Denmark;Bulgaria;Georgia;Netherlands;Germany;Korea, Republic of

423

EUCTR2017-000937-30-FR
(EUCTR)

07/11/2017

19/09/2017

Investigate the efficacy and safety of study drug ABX464 50 mg once daily versus placebo with patients with moderate to severe Active Ulcerative Colitis.

Moderate to severe Ulcerative Colitis.
MedDRA version: 20.0;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000016670;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464

ABIVAX

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

France;Hungary;Spain;Poland;Belgium;Austria;Germany

424

EUCTR2016-002765-58-NL
(EUCTR)

06/11/2017

16/08/2017

A Long Term Study to Follow the Safety of a New Treatment in Patients with Ulcerative Colitis

A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Ulcerative Colitis

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1000

Phase 3

United States;Serbia;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;Japan;New Zealand;Sweden

425

EUCTR2016-001392-78-NL
(EUCTR)

06/11/2017

16/08/2017

A study to assess a new treatment in patients with moderately to Severely active Ulcerative Colitis

Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Ulcerative Colitis

Moderately to Severely Active Ulcerative Colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1300

Phase 2;Phase 3

Mexico;United States;Serbia;Portugal;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;New Zealand;Japan;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

426

EUCTR2017-002231-41-HU
(EUCTR)

25/10/2017

19/09/2017

A study to investigate how the body responds to the study drug Vedolizumab in child patients with Ulcerative Colitis or Crohn’s Disease

Takeda Development Centre Europe, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;France;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom

427

EUCTR2017-002182-21-HU
(EUCTR)

25/10/2017

12/09/2017

An extension study to investigate how safe Vedolizumab is in child patients with Ulcerative Colitis or Crohn’s Disease

A Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease.(Long-term Safety With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis orCrohn’s Disease) - Hubble Zoom

Ulcerative Colitis or Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Takeda Development Centre Europe, Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

France;United States;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom

428

EUCTR2013-004278-88-PL
(EUCTR)

24/10/2017

09/09/2017

A study to investigate the effectiveness (efficacy) and safety of etrolizumab in ulcerative colitis patients who have been previouslyexposed to TNF inhibitors.

PHASE III, DOUBLE BLIND, PLACEBO-CONTROLLED,MULTICENTER STUDY OF THE EFFICACY AND SAFETY OFETROLIZUMAB DURING INDUCTION AND MAINTENANCE INPATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVECOLITIS WHO HAVE BEEN PREVIOUSLY EXPOSED TO TNFINHIBITORS - HICKORY

Ulcerative colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: ETROLIZUMAB
Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

605

Phase 3

United States;Greece;Spain;Lithuania;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Denmark;Netherlands;Germany;Korea, Republic of

429

EUCTR2016-002691-27-NL
(EUCTR)

19/10/2017

01/06/2017

An open label study to study changes in the structure of the mucosa of the bowel in subjects during treatment with tofacitinib for moderate to severe ulcerative colitis

An open label exploratory analysis of the histological, immunological and microbiome changes of the colonic mucosa during treatment with tofacitinib for moderate-severe ulcerative colitis - TOFA-histo

Ulcerative colitis
MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Xeljanz 5 mg film-coated tablets

Academic Medical Center

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

Netherlands

430

NCT03172195
(ClinicalTrials.gov)

October 11, 2017

23/5/2017

Detection of Herpesvirus DNA (CMV, EBV, HHV-6 and HSV) in Colonic Tissue: Impact on Ulcerative Colitis Flare-up

Colitis, Ulcerative

Procedure: rectosigmoidoscopy;Biological: biopsies;Biological: blood sample

Centre Hospitalier Universitaire de Saint Etienne

NULL

Recruiting

18 Years

N/A

All

100

N/A

France

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

431

EUCTR2017-000937-30-DE
(EUCTR)

10/10/2017

25/09/2017

Investigate the efficacy and safety of study drug ABX464 50 mg once daily versus placebo with patients with moderate to severe Active Ulcerative Colitis.

Moderate to severe Ulcerative Colitis.
MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

ABIVAX

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

France;Hungary;Spain;Poland;Belgium;Austria;Germany

432

EUCTR2017-000937-30-BE
(EUCTR)

29/09/2017

03/08/2017

Investigate the efficacy and safety of study drug ABX464 50 mg once daily versus placebo with patients with moderate to severe Active Ulcerative Colitis.

Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464

ABIVAX

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Hungary;Spain;Poland;Belgium;Austria;Germany

433

EUCTR2017-001389-10-GB
(EUCTR)

28/09/2017

17/08/2017

Randomised Double Blind Clinical Trial in Acute Severe Colitis: The IASO trial

A phase II randomised placebo controlled double blinded trial of Interleukin 1 blockade in Acute Severe Colitis - IASO

Acute Severe Ulcerative Colitis
MedDRA version: 20.0;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000016670 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Cambridge University Hospitals NHS Foundation Trust & University of Cambridge

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

214

Phase 2

United Kingdom

434

EUCTR2016-000674-38-HR
(EUCTR)

21/08/2017

06/11/2017

Long Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis.

A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects with Ulcerative Colitis (UC)

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

950

Phase 3

Portugal;Serbia;Belarus;United States;Estonia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden

435

EUCTR2016-000641-31-HR
(EUCTR)

21/08/2017

06/11/2017

Efficacy and Safety of ABT-494 in Subjects With Moderately to Severely Active Ulcerative Colitis

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABT-494 for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1055

Phase 2;Phase 3

Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;United States;Serbia;Saudi Arabia;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

436

EUCTR2016-003708-29-DE
(EUCTR)

07/08/2017

24/04/2017

Moderate to severe Ulcerative Colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

360

Phase 2

United States;Serbia;Slovakia;Spain;Ukraine;Turkey;Lithuania;Austria;Russian Federation;Israel;Italy;Czech Republic;Hungary;Canada;Poland;Romania;Denmark;Bulgaria;Georgia;Germany;Netherlands;Korea, Republic of

437

EUCTR2016-003708-29-AT
(EUCTR)

07/08/2017

24/04/2017

Moderate to severe Ulcerative Colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

360

Phase 2

United States;Serbia;Slovakia;Spain;Ukraine;Lithuania;Turkey;Austria;Russian Federation;Israel;Italy;Czech Republic;Hungary;Canada;Poland;Romania;Denmark;Bulgaria;Georgia;Germany;Netherlands;Korea, Republic of

438

EUCTR2016-004572-21-DE
(EUCTR)

26/07/2017

24/03/2017

A study in patients with mild or moderate ulcerative colitis who take a TNF inhibitor. The study investigates whether bowel inflammation improves when patients take BI 655130 in addition to their current therapy.

Proof-of-concept study of BI 655130 add-on treatment in patients with mild-to-moderately active ulcerative colitis during TNF inhibitor therapy

Mild-to-moderately active ulcerative colitis on TNF inhibitor therapy
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Boehringer Ingelheim Pharma GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Spain;Denmark;Netherlands;Norway;Germany;United Kingdom

439

EUCTR2017-000100-20-GB
(EUCTR)

17/07/2017

14/03/2017

This study tests how BI 655130 works in patients with active ulcerative colitis. The study also tests how well BI 655130 is tolerated and whether it helps the patients.

Exploratory Trial to Assess Mechanism of Action, Clinical Effect, Safety and Tolerability of 12 Weeks of Treatment with BI 655130 in Patients with Active Ulcerative Colitis (UC)

Active ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Boehringer Ingelheim Limited

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Belgium;Germany;United Kingdom

440

EUCTR2016-003708-29-HU
(EUCTR)

30/06/2017

11/05/2017

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

360

Phase 2

Serbia;United States;Slovakia;Spain;Ukraine;Lithuania;Turkey;Austria;Russian Federation;Israel;Italy;Hungary;Czech Republic;Canada;Poland;Romania;Denmark;Bulgaria;Georgia;Netherlands;Germany;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

441

EUCTR2016-003708-29-DK
(EUCTR)

27/06/2017

21/04/2017

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

360

Phase 2

442

EUCTR2016-001392-78-HR
(EUCTR)

26/06/2017

12/09/2017

A study to assess a new treatment in patients with moderately to Severely active Ulcerative Colitis

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1300

Phase 2;Phase 3

Bulgaria;Norway;Germany;Iceland;New Zealand;Japan;Sweden;Georgia;United States;Serbia;Portugal;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia

443

EUCTR2016-002765-58-HR
(EUCTR)

26/06/2017

12/09/2017

A Long Term Study to Follow the Safety of a New Treatment in Patients with Ulcerative Colitis

A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Ulcerative Colitis

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1000

Phase 3

Serbia;Portugal;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Germany;Iceland;New Zealand;Japan;Sweden

444

EUCTR2016-003452-75-NL
(EUCTR)

23/06/2017

04/01/2017

A study to examine the safety and effect of the study drug PTG-100 in patients with inflammation of the colon

A PHASE 2B RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL ADAPTIVE 2-STAGE, MULTI-CENTRE STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ORAL PTG-100 INDUCTION IN SUBJECTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS

Moderate to Severe Active Ulcerative Colitis
MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Protagonist Therapeutics, Inc

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2

Serbia;United States;Slovenia;Greece;Ukraine;Russian Federation;United Kingdom;Czech Republic;Hungary;Poland;Belgium;Croatia;Netherlands;Germany;Latvia;Bosnia and Herzegovina

445

EUCTR2016-004572-21-NL
(EUCTR)

21/06/2017

28/03/2017

Proof-of-concept study of BI 655130 add-on treatment in patients with mild-to-moderately active ulcerative colitis during TNF inhibitor therapy

Mild-to-moderately active ulcerative colitis on TNF inhibitor therapy
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: BI 655130
Product Code: BI 655130
INN or Proposed INN: BI 655130
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1

Boehringer Ingelheim BV Netherlands

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Spain;Denmark;Germany;Norway;Netherlands;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

446

EUCTR2016-000674-38-IE
(EUCTR)

19/06/2017

04/10/2016

Long Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis.

A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects with Ulcerative Colitis (UC)

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

950

Phase 3

Portugal;United States;Belarus;Serbia;Estonia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden

447

EUCTR2016-004572-21-GB
(EUCTR)

09/06/2017

26/04/2017

Proof-of-concept study of BI 655130 add-on treatment in patients with mild-to-moderately active ulcerative colitis during TNF inhibitor therapy

Mild-to-moderately active ulcerative colitis on TNF inhibitor therapy
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: BI 655130
Product Code: BI 655130
INN or Proposed INN: BI 655130
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1

Boehringer Ingelheim Limited

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Spain;Denmark;Netherlands;Germany;Norway;United Kingdom

448

EUCTR2016-004572-21-DK
(EUCTR)

07/06/2017

09/03/2017

Proof-of-concept study of BI 655130 add-on treatment in patients with mild-to-moderately active ulcerative colitis during TNF inhibitor therapy

Mild-to-moderately active ulcerative colitis on TNF inhibitor therapy
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: BI 655130
Product Code: BI 655130
INN or Proposed INN: BI 655130
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1

Boehringer Ingelheim Pharma GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Spain;Denmark;Netherlands;Germany;Norway;United Kingdom

449

EUCTR2016-003708-29-PL
(EUCTR)

07/06/2017

26/04/2017

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

360

Phase 2

450

EUCTR2017-000100-20-DE
(EUCTR)

06/06/2017

09/03/2017

This study tests how BI 655130 works in patients with active ulcerative colitis. The study also tests how well BI 655130 is tolerated and whether it helps the patients.

Exploratory Trial to Assess Mechanism of Action, Clinical Effect, Safety and Tolerability of 12 Weeks of Treatment with BI 655130 in Patients with Active Ulcerative Colitis (UC)

Active ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Boehringer Ingelheim Pharma GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Belgium;Germany;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

451

EUCTR2016-003708-29-LT
(EUCTR)

06/06/2017

18/04/2017

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

360

Phase 2

452

EUCTR2016-001392-78-SE
(EUCTR)

24/05/2017

12/12/2016

A study to assess a new treatment in patients with moderately to Severely active Ulcerative Colitis

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1300

Phase 2;Phase 3

453

EUCTR2016-004572-21-NO
(EUCTR)

24/05/2017

14/03/2017

Proof-of-concept study of BI 655130 add-on treatment in patients with mild-to-moderately active ulcerative colitis during TNF inhibitor therapy

Mild-to-moderately active ulcerative colitis on TNF inhibitor therapy
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: BI 655130
Product Code: BI 655130
INN or Proposed INN: BI 655130
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1

Boehringer Ingelheim Norway KS

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Spain;Denmark;Netherlands;Germany;Norway;United Kingdom

454

EUCTR2016-002765-58-SE
(EUCTR)

24/05/2017

12/12/2016

A Long Term Study to Follow the Safety of a New Treatment in Patients with Ulcerative Colitis

A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Ulcerative Colitis

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1000

Phase 3

United States;Serbia;Portugal;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;New Zealand;Japan;Sweden

455

EUCTR2016-000641-31-FR
(EUCTR)

22/05/2017

02/06/2017

Efficacy and Safety of ABT-494 in Subjects With Moderately to Severely Active Ulcerative Colitis

Product Name: ABT-494
INN or Proposed INN: ABT-494
Other descriptive name: ABT-494
Product Name: ABT-494
INN or Proposed INN: ABT-494
Other descriptive name: ABT-494
Product Name: ABT-494
INN or Proposed INN: ABT-494
Other descriptive name: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1055

Phase 2;Phase 3

Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Singapore;Croatia;Kazakhstan;Norway;Japan;New Zealand;Sweden;Portugal;Serbia;Belarus;United States;Estonia;Saudi Arabia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

456

EUCTR2016-003708-29-ES
(EUCTR)

22/05/2017

31/05/2017

Moderate to severe Ulcerative Colitis (UC)
MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

360

Phase 2

Serbia;United States;Philippines;Slovakia;Spain;Ukraine;Lithuania;Turkey;Austria;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Norway;Netherlands;Germany;Korea, Republic of

457

EUCTR2016-001158-16-NL
(EUCTR)

17/05/2017

01/06/2017

Study to test whether PF-06480605 is safe and improves symptoms in patients with ulcerative colitis

A PHASE 2A, MULTICENTER, SINGLE ARM, OPEN-LABEL, TWO-STAGE, STUDY TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06480605 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Ulcerative colitis (UC)
MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: PF-06480605
INN or Proposed INN: PF-06480605
Other descriptive name: PF-06480605

Pfizer Inc. 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;France;Poland;Belgium;Netherlands;Italy;Korea, Republic of

458

EUCTR2015-001942-28-FR
(EUCTR)

16/05/2017

02/12/2015

A study to investigate the safety and effectiveness of treatment with the drug APD334 in patients with ulcerative colitis (a form of inflammatory bowel disease)

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study to Investigate the Safety and Efficacy of APD334 in Patients with Moderately to Severely Active Ulcerative Colitis

Ulcerative colitis
MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: APD334
INN or Proposed INN: Not yet available
Product Code: APD334
INN or Proposed INN: Not yet available

Arena Pharmaceuticals, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

240

Phase 2

United States;Spain;Ukraine;Lithuania;Austria;Russian Federation;Israel;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Latvia;Germany;New Zealand

459

EUCTR2017-000330-61-ES
(EUCTR)

16/05/2017

07/04/2017

Effect of Beclometasone dipropionate (BDP) on faecal Calprotectin levels in patients with clinically inactive Ulcerative Colitis at risk of relapse. BeCalCU study

Effect of Beclometasone dipropionate (BDP) on faecal Calprotectin levels in patients with clinically inactive Ulcerative Colitis at risk of relapse. BeCalCU study - BeCalCU

Clinically inactive Ulcerative Colitis at risk of relapse
MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Clipper
Product Name: Beclometasone dipropionate
INN or Proposed INN: BECLOMETASONE DIPROPIONATE

CHIESI ESPAÑA S.A.U.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 3

Spain

460

EUCTR2016-004572-21-ES
(EUCTR)

11/05/2017

31/03/2017

Proof-of-concept study of BI 655130 add-on treatment in patients with mild-to-moderately active ulcerative colitis during TNF inhibitor therapy

Mild-to-moderately active ulcerative colitis on TNF inhibitor therapy
MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: BI 655130
Product Code: BI 655130
INN or Proposed INN: BI 655130
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1

Boehringer Ingelheim España, S.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Spain;Denmark;Netherlands;Germany;Norway

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

461

EUCTR2016-003452-75-HR
(EUCTR)

11/05/2017

07/06/2017

A study to examine the safety and effect of the study drug PTG-100 in patients with inflammation of the colon

Moderate to Severe Active Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: PTG-100
Product Code: PTG-100
INN or Proposed INN: -
Other descriptive name: PN-10884A
Product Name: PTG-100
Product Code: PTG-100
INN or Proposed INN: -
Other descriptive name: PN-10884A

Protagonist Therapeutics, Inc

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2

Serbia;United States;Slovenia;Greece;Ukraine;Russian Federation;United Kingdom;Czech Republic;Hungary;Poland;Belgium;Croatia;Germany;Latvia;Netherlands;Bosnia and Herzegovina

462

NCT03151525
(ClinicalTrials.gov)

May 8, 2017

8/5/2017

Two Therapeutic Strategies for the Maintenance of Remission in Patients With Ulcerative Colitis

Comparison Between Two Therapeutic Strategies for the Maintenance of Clinical and Endoscopic Remission in Patients With Ulcerative Colitis Treated by Infliximab

Colitis, Ulcerative

Drug: Azathioprine;Drug: Infliximab

Istituto Clinico Humanitas

Agenzia Italiana del Farmaco

Recruiting

18 Years

65 Years

All

100

Phase 4

Italy

463

EUCTR2017-000100-20-BE
(EUCTR)

08/05/2017

17/03/2017

This study tests how BI 655130 works in patients with active ulcerative colitis. The study also tests how well BI 655130 is tolerated and whether it helps the patients.

Exploratory Trial to Assess Mechanism of Action, Clinical Effect, Safety and Tolerability of 12 Weeks of Treatment with BI 655130 in Patients with Active Ulcerative Colitis (UC)

Product Name: BI 655130
Product Code: BI 655130
INN or Proposed INN: BI 655130
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1

SCS Boehringer Ingelheim Comm. V

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Belgium;Germany;United Kingdom

464

EUCTR2016-002765-58-GR
(EUCTR)

05/05/2017

14/12/2016

A Long Term Study to Follow the Safety of a New Treatment in Patients with Ulcerative Colitis

A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Ulcerative Colitis

Ulcerative Colitis (UC)
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1000

Phase 3

Serbia;Portugal;United States;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Iceland;Germany;New Zealand;Japan;Sweden

465

NCT03110198
(ClinicalTrials.gov)

May 2017

19/2/2017

Mesalazine With Hydrocortisone Sodium Succinate Enema for 4-Week Treatment in Patients With Ulcerative Colitis

A Randomized, Double-blind Study Investigating the Efficacy and Safety of Mesalazine With Hydrocortisone Sodium Succinate (100mg QD) Enema for 4-Week Treatment in Patients With Ulcerative Colitis (UC)

Ulcerative Colitis, Unspecified

Drug: Mesalazine;Drug: hydrocortisone sodium succinate;Drug: Mesalazine with hydrocortisone sodium succinate

Xijing Hospital of Digestive Diseases

Shanghai Tongji Hospital, Tongji University School of Medicine;First Affiliated Hospital of Zhongshan Medical University

Recruiting

18 Years

70 Years

All

528

Phase 4

China

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

466

EUCTR2016-001833-29-NL
(EUCTR)

24/04/2017

23/01/2017

A multicentre, randomised, double-blind (sponsor-unblinded), placebo-controlled study with open label extension to investigate the safety and tolerability, pharmacokinetics, pharmacodynamics, and efficacy of GSK2982772 in subjects with active ulcerative colitis

A multicentre, randomised, double-blind (sponsor-unblinded),placebo-controlled study with open label extension to investigatethe safety and tolerability, pharmacokinetics, pharmacodynamics, and efficacy of GSK2982772 in subjects with active ulcerative colitis.

Active ulcerative colitis
MedDRA version: 20.0;Level: HLGT;Classification code 10017969;Term: Gastrointestinal inflammatory conditions;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: GSK2982772
Product Code: GSK2982772
INN or Proposed INN: Not Available
Other descriptive name: GSK2982772A, where A denotes the free base

GlaxoSmithKline Research & Development Ltd

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Poland;Germany;Netherlands;United Kingdom;Sweden

467

EUCTR2016-002765-58-IS
(EUCTR)

24/04/2017

21/12/2016

A Long Term Study to Follow the Safety of a New Treatment in Patients with Ulcerative Colitis

A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Ulcerative Colitis

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1000

Phase 3

Serbia;Portugal;United States;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Iceland;Germany;New Zealand;Japan;Sweden

468

EUCTR2016-001392-78-IS
(EUCTR)

24/04/2017

21/12/2016

A study to assess a new treatment in patients with moderately to Severely active Ulcerative Colitis

Moderately to Severely Active Ulcerative Colitis (UC)
MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1300

Phase 2;Phase 3

Serbia;Portugal;United States;Belarus;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Iceland;Germany;New Zealand;Japan;Sweden

469

EUCTR2016-001684-36-ES
(EUCTR)

19/04/2017

10/03/2017

EFFICACY AND SAFETY STUDY OF GED-0507-34-LEVO (GED0507) FOR TREATMENT OF PATIENTS WITH ACTIVE ULCERATIVE COLITIS

A PHASE 2, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF GED-0507-34-LEVO (GED0507) FOR TREATMENT OF SUBJECTS WITH ACTIVE ULCERATIVE COLITIS

Ulcerative Colitis
MedDRA version: 19.1;Level: LLT;Classification code 10021184;Term: IBD;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 19.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: GED-0507-34-Levo
Product Code: GED0507
INN or Proposed INN: (S)-(-)-3-(4-Aminophenyl)-2-methoxypropionic Acid
Other descriptive name: GED-0507-34-LEVO

PPM SERVICES SA

NULL

Not Recruiting

Female: yes
Male: yes

207

Phase 2

France;United States;Hungary;Slovakia;Canada;Poland;Spain;Ukraine;Bulgaria;Latvia;Italy

470

EUCTR2016-003708-29-SK
(EUCTR)

18/04/2017

24/02/2017

Moderate to severe Ulcerative Colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Pfizer Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

360

Phase 2

Italy;Czech Republic;Hungary;Canada;Poland;Romania;Denmark;Bulgaria;Georgia;Germany;Netherlands;Korea, Republic of;United States;Serbia;Slovakia;Spain;Ukraine;Lithuania;Turkey;Austria;Russian Federation;Israel

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

471

EUCTR2016-000674-38-CZ
(EUCTR)

06/04/2017

22/09/2016

Long Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis.

A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects with Ulcerative Colitis (UC)

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

950

Phase 3

472

EUCTR2016-002765-58-BG
(EUCTR)

04/04/2017

31/03/2017

A Long Term Study to Follow the Safety of a New Treatment in Patients with Ulcerative Colitis

A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Ulcerative Colitis

Ulcerative Colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1000

Phase 3

Serbia;Portugal;United States;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Iceland;Germany;New Zealand;Japan;Sweden

473

EUCTR2016-001392-78-BG
(EUCTR)

04/04/2017

07/02/2017

A study to assess a new treatment in patients with moderately to Severely active Ulcerative Colitis

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1300

Phase 2;Phase 3

474

EUCTR2016-003452-75-CZ
(EUCTR)

03/04/2017

19/12/2016

A study to examine the safety and effect of the study drug PTG-100 in patients with inflammation of the colon

Protagonist Therapeutics, Inc

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2

United States;Serbia;Slovenia;Greece;Ukraine;Russian Federation;United Kingdom;Czech Republic;Hungary;Belgium;Poland;Croatia;Germany;Latvia;Netherlands;Bosnia and Herzegovina

475

EUCTR2016-002765-58-BE
(EUCTR)

31/03/2017

09/12/2016

A Long Term Study to Follow the Safety of a New Treatment in Patients with Ulcerative Colitis

A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Ulcerative Colitis

Ulcerative Colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1000

Phase 3

Serbia;Portugal;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Germany;Iceland;New Zealand;Japan;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

476

EUCTR2016-000641-31-LT
(EUCTR)

31/03/2017

11/10/2016

Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1055

Phase 2;Phase 3

Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan

477

EUCTR2016-000674-38-LT
(EUCTR)

31/03/2017

25/10/2016

Long Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis.

A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects with Ulcerative Colitis (UC)

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

950

Phase 3

Portugal;United States;Belarus;Serbia;Estonia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Turkey;Lithuania;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden

478

EUCTR2016-001392-78-BE
(EUCTR)

31/03/2017

09/12/2016

A study to assess a new treatment in patients with moderately to Severely active Ulcerative Colitis

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1300

Phase 2;Phase 3

479

EUCTR2016-001392-78-GR
(EUCTR)

31/03/2017

14/12/2016

A study to assess a new treatment in patients with moderately to Severely active Ulcerative Colitis

Moderately to Severely Active Ulcerative Colitis (UC)
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1300

Phase 2;Phase 3

United States;Serbia;Portugal;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;New Zealand;Japan;Sweden

480

EUCTR2016-002765-58-DE
(EUCTR)

27/03/2017

05/04/2017

A Long Term Study to Follow the Safety of a New Treatment in Patients with Ulcerative Colitis

A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Ulcerative Colitis

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1000

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

481

EUCTR2015-001942-28-DE
(EUCTR)

27/03/2017

13/10/2015

A study to investigate the safety and effectiveness of treatment with the drug APD334 in patients with ulcerative colitis (a form of inflammatory bowel disease)

Product Code: APD334
INN or Proposed INN: Not yet available
Product Code: APD334
INN or Proposed INN: Not yet available

Arena Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2

United States;Spain;Ukraine;Lithuania;Austria;Israel;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Latvia;Germany;New Zealand

482

EUCTR2016-001392-78-DE
(EUCTR)

27/03/2017

05/04/2017

A study to assess a new treatment in patients with moderately to Severely active Ulcerative Colitis

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1300

Phase 2;Phase 3

483

EUCTR2016-003633-26-PL
(EUCTR)

23/03/2017

27/12/2016

A STUDY TO INVESTIGATE THE SAFETY AND TOLERABILITY OF TREATMENT WITH LYC-30937-EC IN PATIENTS WITH ULCERATIVE COLITIS

A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS THE SAFETY AND TOLERABILITY OF LYC-30937-EC IN SUBJECTS WITH ACTIVE ULCERATIVE COLITIS

Product Code: LYC-30937 -EC
INN or Proposed INN: LYC-30937
Other descriptive name: LYC-30937

Lycera Corp.

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 2

Serbia;United States;Hungary;Czech Republic;Canada;Poland;Netherlands

484

EUCTR2015-002558-11-BG
(EUCTR)

14/03/2017

06/01/2017

A study to investigate the efficacy and safety of Mesalamine 2 g extended release granules (Sachet) for maintenance of clinical and endoscopic remission in Ulcerative Colitis

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 2 g Extended Release Granules (Sachet) for Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis

Ulcerative colitis
MedDRA version: 20.0;Level: LLT;Classification code 10058816;Term: Colitis ulcerative acute episode;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Ferring International PharmaScience Center U.S., Inc.

NULL

Not Recruiting

Female: yes
Male: yes

260

Phase 3

Serbia;United States;Hungary;Mexico;Canada;Belgium;Ukraine;Russian Federation;Bulgaria;Latvia;Switzerland

485

EUCTR2015-002557-35-BG
(EUCTR)

14/03/2017

06/01/2017

A study to investigate the efficacy and safety of Mesalamine 4 g extended release granules (Sachet) for the induction of clinical and endoscopic remission in mild to moderate Ulcerative Colitis

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 4 g Extended Release Granules (Sachet) for the Induction of Clinical and Endoscopic Remission in Active, Mild to Moderate Ulcerative Colitis

Active, mild to moderate ulcerative colitis
MedDRA version: 20.0;Level: LLT;Classification code 10058816;Term: Colitis ulcerative acute episode;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Ferring International PharmaScience Center U.S., Inc.

NULL

Not Recruiting

Female: yes
Male: yes

220

Phase 3

Serbia;United States;Hungary;Mexico;Canada;Belgium;Ukraine;Russian Federation;Bulgaria;Latvia;Switzerland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

486

EUCTR2016-001392-78-PT
(EUCTR)

13/03/2017

13/12/2016

A study to assess a new treatment in patients with moderately to Severely active Ulcerative Colitis

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1300

Phase 2;Phase 3

United States;Serbia;Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;New Zealand;Japan;Sweden

487

EUCTR2016-002765-58-PT
(EUCTR)

13/03/2017

13/12/2016

A Long Term Study to Follow the Safety of a New Treatment in Patients with Ulcerative Colitis

A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Ulcerative Colitis

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1000

Phase 3

Serbia;United States;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Germany;Iceland;New Zealand;Japan;Sweden

488

EUCTR2016-003633-26-CZ
(EUCTR)

10/03/2017

12/12/2016

A STUDY TO INVESTIGATE THE SAFETY AND TOLERABILITY OF TREATMENT WITH LYC-30937-EC IN PATIENTS WITH ULCERATIVE COLITIS

A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS THE SAFETY AND TOLERABILITY OF LYC-30937-EC IN SUBJECTS WITH ACTIVE ULCERATIVE COLITIS

Ulcerative Colitis
MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Lycera Corp.

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 2

Serbia;United States;Hungary;Czech Republic;Canada;Poland;Netherlands

489

EUCTR2016-000641-31-CZ
(EUCTR)

02/03/2017

29/09/2016

Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1055

Phase 2;Phase 3

Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan;Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil

490

EUCTR2016-000674-38-FI
(EUCTR)

21/02/2017

26/09/2016

Long Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis.

A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects with Ulcerative Colitis (UC)

Ulcerative Colitis
MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

950

Phase 3

Portugal;Serbia;Belarus;United States;Estonia;Saudi Arabia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Singapore;Croatia;Kazakhstan;Germany;Norway;Japan;New Zealand;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

491

EUCTR2016-003452-75-LV
(EUCTR)

20/02/2017

23/11/2016

A study to examine the safety and effect of the study drug PTG-100 in patients with inflammation of the colon

Protagonist Therapeutics, Inc

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2

Serbia;United States;Slovenia;Greece;Ukraine;Russian Federation;United Kingdom;Czech Republic;Hungary;Poland;Belgium;Croatia;Latvia;Germany;Netherlands;Bosnia and Herzegovina

492

EUCTR2016-001684-36-LV
(EUCTR)

20/02/2017

22/12/2016

EFFICACY AND SAFETY STUDY OF GED-0507-34-LEVO (GED0507) FOR TREATMENT OF PATIENTS WITH ACTIVE ULCERATIVE COLITIS

A PHASE 2, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF GED-0507-34-LEVO (GED0507) FOR TREATMENT OF SUBJECTS WITH ACTIVE ULCERATIVE COLITIS

Product Name: GED-0507-34-Levo
Product Code: GED0507
INN or Proposed INN: (S)-(-)-3-(4-Aminophenyl)-2-methoxypropionic Acid
Other descriptive name: GED-0507-34-LEVO

PPM SERVICES SA

NULL

Not Recruiting

Female: yes
Male: yes

207

Phase 2

France;United States;Hungary;Slovakia;Canada;Poland;Spain;Ukraine;Bulgaria;Latvia;Italy

493

EUCTR2016-002765-58-SK
(EUCTR)

16/02/2017

14/12/2016

A Long Term Study to Follow the Safety of a New Treatment in Patients with Ulcerative Colitis

A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Ulcerative Colitis

Ulcerative Colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Gilead Sciences, Inc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1000

Phase 3

494

EUCTR2016-001392-78-SK
(EUCTR)

16/02/2017

14/12/2016

A study to assess a new treatment in patients with moderately to Severely active Ulcerative Colitis

Moderately to Severely Active Ulcerative Colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1300

Phase 2;Phase 3

495

EUCTR2016-003452-75-BE
(EUCTR)

13/02/2017

07/12/2016

A study to examine the safety and effect of the study drug PTG-100 in patients with inflammation of the colon

Protagonist Therapeutics, Inc

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2

Serbia;United States;Slovenia;Greece;Ukraine;Russian Federation;United Kingdom;Czech Republic;Hungary;Poland;Belgium;Croatia;Germany;Latvia;Netherlands;Bosnia and Herzegovina

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

496

EUCTR2016-003452-75-HU
(EUCTR)

13/02/2017

01/12/2016

A study to examine the safety and effect of the study drug PTG-100 in patients with inflammation of the colon

Protagonist Therapeutics, Inc

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2

Serbia;United States;Slovenia;Greece;Ukraine;Russian Federation;United Kingdom;Hungary;Czech Republic;Poland;Belgium;Croatia;Germany;Latvia;Netherlands;Bosnia and Herzegovina

497

EUCTR2016-002765-58-CZ
(EUCTR)

09/02/2017

12/12/2016

A Long Term Study to Follow the Safety of a New Treatment in Patients with Ulcerative Colitis

A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Ulcerative Colitis

Ulcerative Colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1000

Phase 3

498

EUCTR2016-003452-75-PL
(EUCTR)

09/02/2017

04/01/2017

A study to examine the safety and effect of the study drug PTG-100 in patients with inflammation of the colon

Protagonist Therapeutics, Inc

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2

Serbia;United States;Slovenia;Greece;Ukraine;Russian Federation;United Kingdom;Czech Republic;Hungary;Poland;Belgium;Croatia;Netherlands;Germany;Latvia;Bosnia and Herzegovina

499

EUCTR2016-000641-31-FI
(EUCTR)

07/02/2017

26/09/2016

Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

1055

Phase 2;Phase 3

Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan

500

EUCTR2016-000420-26-PL
(EUCTR)

31/01/2017

01/02/2017

SEVERE ACTIVE ULCERATIVE COLITIS
MedDRA version: 20.0;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Bimekizumab
Product Code: UCB4940
INN or Proposed INN: Bimekizumab
Other descriptive name: UCB4940

UCB Biopharma SPRL

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

France;Czech Republic;Spain;Poland;Romania;Bulgaria;Georgia;South Africa;Moldova, Republic of;Italy;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

501

EUCTR2016-001392-78-AT
(EUCTR)

31/01/2017

13/12/2016

A study to assess a new treatment in patients with moderately to Severely active Ulcerative Colitis

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1300

Phase 2;Phase 3

502

EUCTR2016-001392-78-ES
(EUCTR)

31/01/2017

01/02/2017

A study to assess a new treatment in patients with moderately to Severely active Ulcerative Colitis

Moderately to Severely Active Ulcerative Colitis (UC)
MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1300

Phase 2;Phase 3

Serbia;Portugal;Belarus;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Iceland;Germany;New Zealand;Japan;Sweden

503

EUCTR2016-002765-58-ES
(EUCTR)

31/01/2017

01/02/2017

A Long Term Study to Follow the Safety of a New Treatment in Patients with Ulcerative Colitis

A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Ulcerative Colitis

Ulcerative Colitis (UC)
MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1000

Phase 3

504

EUCTR2016-002765-58-AT
(EUCTR)

31/01/2017

13/12/2016

A Long Term Study to Follow the Safety of a New Treatment in Patients with Ulcerative Colitis

A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Ulcerative Colitis

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1000

Phase 3

505

EUCTR2016-001392-78-HU
(EUCTR)

30/01/2017

01/12/2016

A study to assess a new treatment in patients with moderately to Severely active Ulcerative Colitis

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1300

Phase 2;Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

506

EUCTR2016-000674-38-SE
(EUCTR)

30/01/2017

28/09/2016

Long Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis.

A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects with Ulcerative Colitis (UC)

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

950

Phase 3

507

EUCTR2016-000641-31-SE
(EUCTR)

30/01/2017

29/09/2016

Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

1055

Phase 2;Phase 3

Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan

508

EUCTR2016-002765-58-HU
(EUCTR)

30/01/2017

01/12/2016

A Long Term Study to Follow the Safety of a New Treatment in Patients with Ulcerative Colitis

A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Ulcerative Colitis

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1000

Phase 3

Serbia;Portugal;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Germany;Iceland;New Zealand;Japan;Sweden

509

EUCTR2016-002765-58-FR
(EUCTR)

25/01/2017

19/12/2016

A Long Term Study to Follow the Safety of a New Treatment in Patients with Ulcerative Colitis

A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Ulcerative Colitis

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1000

Phase 3

Brazil;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Iceland;Germany;New Zealand;Japan;Sweden;Argentina;Poland;Belgium;Serbia;Portugal;United States;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada

510

EUCTR2015-001600-64-HR
(EUCTR)

19/01/2017

05/06/2017

The purpose of this study is to determine whether long-term RPC1063 is safe and effective in the treatment of ulcerative colitis (UC).

A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of long-term RPC1063 in Ulcerative Colitis

Celgene International II Sàrl

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1350

Phase 3

United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

511

NCT03000101
(ClinicalTrials.gov)

January 19, 2017

19/12/2016

Study of the Role of Pomegranate Juice Ellagitannins in the Modulation of Inflammation in Inflammatory Bowel Disease

New Insight and Knowledge on Anti-inflammatory Effectiveness of Dietary Phenolics (NIKE)

Crohn's Disease;Ulcerative Colitis

Other: 100% pomegranate juice;Other: placebo beverage

Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

University of Bologna;Conserve Italia;GAT Foods

Active, not recruiting

18 Years

80 Years

All

N/A

Italy

512

EUCTR2015-000319-41-HR
(EUCTR)

17/01/2017

05/06/2017

The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC).

Celgene International II Sàrl (CIS II)

NULL

Not Recruiting

Female: yes
Male: yes

900

Phase 3

United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand

513

EUCTR2016-003633-26-NL
(EUCTR)

17/01/2017

24/10/2016

A STUDY TO INVESTIGATE THE SAFETY AND TOLERABILITY OF TREATMENT WITH LYC-30937-EC IN PATIENTS WITH ULCERATIVE COLITIS

A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS THE SAFETY AND TOLERABILITY OF LYC-30937-EC IN SUBJECTS WITH ACTIVE ULCERATIVE COLITIS

Ulcerative Colitis
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: LYC-30937 -EC
INN or Proposed INN: LYC-30937
Other descriptive name: LYC-30937

Lycera Corp.

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 2

Serbia;United States;Hungary;Czech Republic;Canada;Poland;Netherlands

514

EUCTR2016-001833-29-PL
(EUCTR)

09/01/2017

26/10/2016

Active ulcerative colitis
MedDRA version: 20.0;Level: HLGT;Classification code 10017969;Term: Gastrointestinal inflammatory conditions;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

GlaxoSmithKline Research & Development Ltd

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Poland;Netherlands;Germany;United Kingdom;Sweden

515

EUCTR2016-000641-31-PT
(EUCTR)

09/01/2017

06/10/2016

Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1055

Phase 2;Phase 3

Portugal;Belarus;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

516

EUCTR2016-000674-38-PT
(EUCTR)

09/01/2017

11/10/2016

Long Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis.

A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects with Ulcerative Colitis (UC)

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

950

Phase 3

Portugal;Belarus;Taiwan;Slovakia;Greece;Ukraine;Chile;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Turkey;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan

517

EUCTR2016-000674-38-BE
(EUCTR)

06/01/2017

31/10/2016

Long Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis.

A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects with Ulcerative Colitis (UC)

Ulcerative Colitis
MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

950

Phase 3

Portugal;Serbia;Belarus;United States;Estonia;Saudi Arabia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Croatia;Kazakhstan;Germany;Norway;Japan;New Zealand;Sweden

518

EUCTR2016-000678-40-BG
(EUCTR)

05/01/2017

01/11/2016

Program to allow continuation of treatment with Entyvio (Vedolizumab IV) for patients with ulcerative colitis and Chron´s disease who previously participated in a clinical trial with this same treatment

Entyvio (Vedolizumab IV) Extended Access Program in Ulcerative Colitis and Crohn’s Disease

Ulcerative Colitis and Crohn’s Disease
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Entyvio
INN or Proposed INN: vedolizumab
Other descriptive name: VEDOLIZUMAB

Takeda Development Centre Europe Limited

NULL

Not Recruiting

Female: yes
Male: yes

385

Phase 4

Turkey;Russian Federation;Italy;India;Czech Republic;Hungary;Poland;Malaysia;Serbia;Taiwan;Estonia;Slovakia;Ukraine;Romania;Australia;Bulgaria;South Africa;Latvia;New Zealand;Korea, Republic of

519

EUCTR2016-003633-26-HU
(EUCTR)

23/12/2016

08/11/2016

A STUDY TO INVESTIGATE THE SAFETY AND TOLERABILITY OF TREATMENT WITH LYC-30937-EC IN PATIENTS WITH ULCERATIVE COLITIS

A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS THE SAFETY AND TOLERABILITY OF LYC-30937-EC IN SUBJECTS WITH ACTIVE ULCERATIVE COLITIS

Product Code: LYC-30937 -EC
INN or Proposed INN: LYC-30937
Other descriptive name: LYC-30937

Lycera Corp.

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 2

Serbia;United States;Czech Republic;Hungary;Canada;Poland;Netherlands

520

EUCTR2016-000641-31-IE
(EUCTR)

22/12/2016

04/10/2016

Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1055

Phase 2;Phase 3

Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

521

EUCTR2016-000674-38-GR
(EUCTR)

21/12/2016

03/10/2016

Long Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis.

A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects with Ulcerative Colitis (UC)

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

950

Phase 3

522

EUCTR2016-000641-31-GR
(EUCTR)

19/12/2016

12/10/2016

Efficacy and Safety of ABT-494 in Subjects With Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 19.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: ABT-494
INN or Proposed INN: -
Other descriptive name: ABT-494
Product Name: ABT-494
INN or Proposed INN: -
Other descriptive name: ABT-494
Product Name: ABT-494
INN or Proposed INN: -
Other descriptive name: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1055

Phase 2;Phase 3

Serbia;Belarus;United States;Estonia;Saudi Arabia;Taiwan;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Austria;Egypt;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Singapore;Kazakhstan;Norway;Japan;New Zealand

523

EUCTR2016-000674-38-ES
(EUCTR)

16/12/2016

14/12/2016

Long Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis.

A Phase 3 Multicenter, Open-Label Extension (OLE) Study to Evaluate the Long-Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis (UC)

Product Name: ABT-494
INN or Proposed INN: ABT-494
Other descriptive name: ABT-494
Product Name: ABT-494
INN or Proposed INN: ABT-494
Other descriptive name: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

950

Phase 3

Serbia;Belarus;United States;Estonia;Saudi Arabia;Taiwan;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Egypt;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Singapore;Kazakhstan;Norway;Japan;New Zealand

524

EUCTR2016-000641-31-ES
(EUCTR)

16/12/2016

14/12/2016

Efficacy and Safety of ABT-494 in Subjects With Moderately to Severely Active Ulcerative Colitis

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1055

Phase 2;Phase 3

525

EUCTR2016-001684-36-SK
(EUCTR)

12/12/2016

26/07/2016

EFFICACY AND SAFETY STUDY OF GED-0507-34-LEVO (GED0507) FOR TREATMENT OF PATIENTS WITH ACTIVE ULCERATIVE COLITIS

A PHASE 2, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF GED-0507-34-LEVO (GED0507) FOR TREATMENT OF SUBJECTS WITH ACTIVE ULCERATIVE COLITIS

Ulcerative Colitis
MedDRA version: 20.0;Level: LLT;Classification code 10021184;Term: IBD;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0;Classification code 10045365;Term: Ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: GED-0507-34-Levo
Product Code: GED0507
INN or Proposed INN: (S)-(-)-3-(4-Aminophenyl)-2-methoxypropionic Acid
Other descriptive name: GED-0507-34-LEVO

PPM SERVICES SA

NULL

Not Recruiting

Female: yes
Male: yes

207

Phase 2

France;United States;Hungary;Slovakia;Canada;Poland;Spain;Ukraine;Bulgaria;Latvia;Italy;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

526

EUCTR2016-000641-31-EE
(EUCTR)

08/12/2016

03/11/2016

Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1055

Phase 2;Phase 3

Singapore;Croatia;Kazakhstan;Norway;Japan;New Zealand;Sweden;Argentina;Belgium;Poland;Brazil;Portugal;Serbia;Belarus;United States;Saudi Arabia;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;European Union;Mexico;Canada

527

EUCTR2016-000674-38-EE
(EUCTR)

08/12/2016

04/10/2016

Long Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis.

A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects with Ulcerative Colitis (UC)

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

950

Phase 3

Portugal;Serbia;Belarus;United States;Saudi Arabia;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Singapore;Croatia;Kazakhstan;Norway;Japan;New Zealand;Sweden

528

EUCTR2016-001392-78-GB
(EUCTR)

08/12/2016

06/12/2016

A study to assess a new treatment in patients with moderately to Severely active Ulcerative Colitis

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1300

Phase 2;Phase 3

529

EUCTR2016-002765-58-GB
(EUCTR)

08/12/2016

06/12/2016

A Long Term Study to Follow the Safety of a New Treatment in Patients with Ulcerative Colitis

A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Ulcerative Colitis

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1000

Phase 3

Portugal;Serbia;United States;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Iceland;Germany;New Zealand;Japan;Sweden

530

EUCTR2016-000641-31-GB
(EUCTR)

07/12/2016

11/01/2017

Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1055

Phase 2;Phase 3

Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

531

EUCTR2016-001409-18-NO
(EUCTR)

06/12/2016

09/05/2016

A study to evaluate the safety of stopping versus continuing anti TNF therapy in ulcerative colitis patients in remission, and to evaluate the safety and efficacy of restarting anti TNF therapy in patients with disease recurrence

A prospective, open randomized, parallel-group study to evaluate the outcome of discontinuing or continuing anti-tumor necrosis factor treatment in patients with ulcerative colitis in sustained clinical remission. - The Biostop study

Ulcerative colitis
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: 1.Remicade
INN or Proposed INN: INFLIXIMAB
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Simponi
INN or Proposed INN: GOLIMUMAB

Helse More og Romsdal Hospital Trust

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

Norway

532

EUCTR2016-001158-16-BE
(EUCTR)

05/12/2016

15/09/2016

Study to test whether PF-06480605 is safe and improves symptoms in patients with ulcerative colitis

Ulcerative colitis (UC)
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: PF-06480605
INN or Proposed INN: PF-06480605
Other descriptive name: PF-06480605

Pfizer Inc. 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

France;United States;Poland;Belgium;Netherlands;Italy;Korea, Republic of

533

NCT02895100
(ClinicalTrials.gov)

December 2016

4/9/2016

Safety and Efficacy Study of PTG-100 in the Treatment of Moderate to Severe Ulcerative Colitis

A Phase 2b Randomised, Double-blind, Placebo-controlled, Parallel, Adaptive 2-Stage, Multi-Centre Study to Evaluate the Safety and Efficacy of Oral PTG-100 Induction in Subjects With Moderate to Severe Active Ulcerative Colitis

Ulcerative Colitis

Drug: PTG-100;Drug: Placebo

Protagonist Therapeutics, Inc.

NULL

Terminated

18 Years

80 Years

All

100

Phase 2

United States;Australia;Belgium;Bosnia and Herzegovina;Canada;Croatia;Czechia;Germany;Hungary;Korea, Republic of;Latvia;Netherlands;New Zealand;Poland;Russian Federation;Serbia;Ukraine

534

EUCTR2016-000641-31-HU
(EUCTR)

29/11/2016

28/09/2016

Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1055

Phase 2;Phase 3

Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan

535

EUCTR2016-000674-38-GB
(EUCTR)

25/11/2016

28/09/2016

Long Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis.

A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects with Ulcerative Colitis (UC)

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

950

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

536

EUCTR2016-000674-38-HU
(EUCTR)

24/11/2016

10/10/2016

Long Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis.

A Phase 3 Multicenter, Open-Label Extension (OLE) Study to Evaluate the Long-Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis (UC)

Ulcerative Colitis
MedDRA version: 19.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: ABT-494
INN or Proposed INN: ABT-494
Other descriptive name: ABT-494
Product Name: ABT-494
INN or Proposed INN: ABT-494
Other descriptive name: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

950

Phase 3

Serbia;Belarus;United States;Estonia;Saudi Arabia;Taiwan;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Egypt;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Singapore;Kazakhstan;Norway;Japan;New Zealand

537

EUCTR2016-000674-38-NL
(EUCTR)

23/11/2016

22/08/2016

Long Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis.

A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects with Ulcerative Colitis (UC)

Ulcerative Colitis
MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

950

Phase 3

538

EUCTR2016-000641-31-NL
(EUCTR)

23/11/2016

08/08/2016

Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1055

Phase 2;Phase 3

Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;United States;Serbia;Saudi Arabia;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan

539

EUCTR2016-000674-38-AT
(EUCTR)

23/11/2016

23/09/2016

Long Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis.

A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects with Ulcerative Colitis

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

950

Phase 3

Greece;Ukraine;Chile;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Turkey;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan;Belarus;Portugal;Taiwan;Slovakia

540

EUCTR2016-000641-31-LV
(EUCTR)

22/11/2016

10/10/2016

Efficacy and Safety of ABT-494 in Subjects With Moderately to Severely Active Ulcerative Colitis

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1055

Phase 2;Phase 3

Serbia;Belarus;United States;Estonia;Saudi Arabia;Taiwan;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Austria;Egypt;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Singapore;Kazakhstan;Norway;Japan;New Zealand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

541

EUCTR2016-000674-38-LV
(EUCTR)

22/11/2016

29/09/2016

Long Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis.

A Phase 3 Multicenter, Open-Label Extension (OLE) Study to Evaluate the Long-Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis (UC)

Product Name: ABT-494
INN or Proposed INN: ABT-494
Other descriptive name: ABT-494
Product Name: ABT-494
INN or Proposed INN: ABT-494
Other descriptive name: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

950

Phase 3

Serbia;Belarus;United States;Estonia;Saudi Arabia;Taiwan;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Egypt;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Singapore;Kazakhstan;Norway;Japan;New Zealand

542

EUCTR2016-001684-36-BG
(EUCTR)

17/11/2016

18/10/2016

EFFICACY AND SAFETY STUDY OF GED-0507-34-LEVO (GED0507) FOR TREATMENT OF PATIENTS WITH ACTIVE ULCERATIVE COLITIS

A PHASE 2, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF GED-0507-34-LEVO (GED0507) FOR TREATMENT OF SUBJECTS WITH ACTIVE ULCERATIVE COLITIS

Ulcerative Colitis
MedDRA version: 20.0;Level: LLT;Classification code 10021184;Term: IBD;System Organ Class: 100000016704
MedDRA version: 20.0;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670
MedDRA version: 20.0;Classification code 10045366;Term: Ulcerative colitis, unspecified;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: GED-0507-34-Levo
Product Code: GED0507
INN or Proposed INN: (S)-(-)-3-(4-Aminophenyl)-2-methoxypropionic Acid
Other descriptive name: GED-0507-34-LEVO

PPM SERVICES SA

NULL

Not Recruiting

Female: yes
Male: yes

207

Phase 2

France;United States;Hungary;Slovakia;Canada;Poland;Spain;Ukraine;Bulgaria;Latvia;Italy;United Kingdom

543

EUCTR2016-000518-31-CZ
(EUCTR)

07/11/2016

30/08/2016

A STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF TREATMENT WITH LYC-30937-EC IN PATIENTS WITH ULCERATIVE COLITIS

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PARALLEL GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF INDUCTION THERAPY WITH LYC-30937-EC IN SUBJECTS WITH ACTIVE ULCERATIVE COLITIS

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Lycera Corp.

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 2

Serbia;United States;Hungary;Czech Republic;Canada;Poland;Netherlands

544

NCT03136419
(ClinicalTrials.gov)

October 31, 2016

5/4/2017

Microbiota and Immune microEnvironment in Pouchitis

Microbiota and Immune microEnvironment in Pouchitis: Randomized Controlled Trial Oral Administration of Lactobacillus Casei DG After Ileostomy Closure in Ileal Pouch Mucosa

Pouchitis;Ulcerative Colitis;Ileal Pouch

Dietary Supplement: Lactobacillus casei DG;Dietary Supplement: Placebo

University of Padova

NULL

Recruiting

18 Years

100 Years

All

N/A

Italy

545

EUCTR2016-000641-31-PL
(EUCTR)

25/10/2016

30/09/2016

Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1055

Phase 2;Phase 3

Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;United States;Serbia;Saudi Arabia;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

546

EUCTR2016-000674-38-PL
(EUCTR)

25/10/2016

27/09/2016

Long Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis.

A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects with Ulcerative Colitis (UC)

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

950

Phase 3

Portugal;United States;Belarus;Serbia;Estonia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Singapore;Croatia;Germany;Norway;Japan;Sweden

547

EUCTR2016-000518-31-PL
(EUCTR)

21/10/2016

19/08/2016

A STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF TREATMENT WITH LYC-30937-EC IN PATIENTS WITH ULCERATIVE COLITIS

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PARALLEL GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF INDUCTION THERAPY WITH LYC-30937-EC IN SUBJECTS WITH ACTIVE ULCERATIVE COLITIS

Product Code: LYC-30937 -EC
INN or Proposed INN: LYC-30937
Other descriptive name: LYC-30937

Lycera Corp.

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 2

Serbia;United States;Hungary;Czech Republic;Canada;Poland;Netherlands

548

EUCTR2013-004280-31-SK
(EUCTR)

21/10/2016

26/07/2016

A study to investigate the effectiveness (efficacy) and safety of etrolizumab treatment in maintaining disease remission in ulcerative colitis patients who have not previously been treated with TNF inhibitors

PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (MAINTENANCE OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - LAUREL

Product Name: etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

350

Phase 3

Germany;United States;Slovakia;Ukraine;Israel;Italy;Czech Republic;Hungary;Mexico;Canada;Brazil;Poland;Denmark;South Africa

549

EUCTR2016-001684-36-HU
(EUCTR)

19/10/2016

10/08/2016

EFFICACY AND SAFETY STUDY OF GED-0507-34-LEVO (GED0507) FOR TREATMENT OF PATIENTS WITH ACTIVE ULCERATIVE COLITIS

A PHASE 2, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF GED-0507-34-LEVO (GED0507) FOR TREATMENT OF SUBJECTS WITH ACTIVE ULCERATIVE COLITIS

Product Name: GED-0507-34-Levo
Product Code: GED0507
INN or Proposed INN: (S)-(-)-3-(4-Aminophenyl)-2-methoxypropionic Acid
Other descriptive name: GED-0507-34-LEVO

PPM SERVICES SA

NULL

Not Recruiting

Female: yes
Male: yes

207

Phase 2

United States;Slovakia;Spain;Ukraine;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Poland;Bulgaria;Latvia

550

EUCTR2016-000641-31-AT
(EUCTR)

17/10/2016

11/10/2016

Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1055

Phase 2;Phase 3

Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

551

EUCTR2016-002061-54-IT
(EUCTR)

13/10/2016

15/11/2018

Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®) in the treatment of rheumatoid arthritis, spondyloarthritis and chronic inflammatory bowel diseases.

Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®) in the treatment of rheumatoid arthritis, spondyloarthritis and chronic inflammatory bowel diseases.Evaluation of immunogenicity and clinical response - Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®)

Rheumatoid arthritis, seronegative spondylo arthritis,Crohn's Disease, Ulcerative Colitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0;Classification code 10039073;Term: Rheumatoid arthritis;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0;Classification code 10075634;Term: Acute haemorrhagic ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: REMSIMA - 100 MG POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLANCONCINO (VETRO) - 1 FLACONCINO
Product Name: Remsima
Product Code: 42942019

UNIVERSITÀ CATTOLICA DEL SACRO CUORE- POLICLINICO A. GEMELLI

NULL

Not Recruiting

Female: yes
Male: yes

250

Phase 4

Italy

552

EUCTR2015-001600-64-BG
(EUCTR)

13/10/2016

01/10/2015

The purpose of this study is to determine whether long-term RPC1063 is safe and effective in the treatment of ulcerative colitis (UC).

A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of long-term RPC1063 in Ulcerative Colitis

Celgene International II Sàrl

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1350

Phase 3

553

EUCTR2015-005260-41-NL
(EUCTR)

13/10/2016

15/02/2016

Efficacy of optimized thiopurine therapy in ulcerative colitis.

Efficacy of optimized thiopurine therapy in ulcerative colitis. - OPTIC

Ulcerative Colitis
MedDRA version: 19.0;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Mercaptopurine (Puri-Nethol)

Academic Medical Centre

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 3

Netherlands

554

EUCTR2016-000420-26-CZ
(EUCTR)

06/10/2016

27/07/2016

Product Name: Bimekizumab
Product Code: UCB4940
INN or Proposed INN: Bimekizumab
Other descriptive name: UCB4940

UCB Biopharma SPRL

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

France;Czech Republic;Poland;Spain;Romania;Bulgaria;Georgia;South Africa;Moldova, Republic of;Italy;United Kingdom

555

EUCTR2016-000420-26-ES
(EUCTR)

05/10/2016

05/08/2016

SEVERE ACTIVE ULCERATIVE COLITIS
MedDRA version: 19.0;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Bimekizumab
Product Code: UCB4940
INN or Proposed INN: Bimekizumab
Other descriptive name: UCB4940

UCB Biopharma SPRL

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Poland;Spain;Romania;France;Czech Republic;Bulgaria;South Africa;Georgia;United Kingdom;Moldova, Republic of;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

556

EUCTR2016-000518-31-HU
(EUCTR)

05/10/2016

27/07/2016

A STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF TREATMENT WITH LYC-30937-EC IN PATIENTS WITH ULCERATIVE COLITIS

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PARALLEL GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF INDUCTION THERAPY WITH LYC-30937-EC IN SUBJECTS WITH ACTIVE ULCERATIVE COLITIS

Product Code: LYC-30937 -EC
INN or Proposed INN: LYC-30937
Other descriptive name: LYC-30937

Lycera Corp.

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 2

Serbia;United States;Czech Republic;Hungary;Canada;Poland;Netherlands

557

EUCTR2013-004280-31-PL
(EUCTR)

29/09/2016

12/09/2016

Ulcerative colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

350

Phase 3

United States;Slovakia;Ukraine;Israel;Italy;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Denmark;South Africa;Germany

558

EUCTR2016-003073-18-GB
(EUCTR)

29/09/2016

16/09/2016

A study designed to investigate how radiolabelled RPC1063 is taken up, broken down and removed from the body

A Phase I, Single-Centre, Single Dose Oral Excretion Balance Study of [14C]-RPC1063 in Healthy Male Adults - ADME study of [14C]-RPC1063 in healthy male subjects (QCL117686)

The drug is a potential treatment for adult patients with relapsing multiple sclerosis (RMS) and for adult patients with moderately to severely active inflammatory bowel disease (IBD), including ulcerative colitis (UC) and Crohn’s disease (CD).
MedDRA version: 19.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 19.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Celgene International II Sàrl

NULL

Not Recruiting

Female: no
Male: yes

Phase 1

United Kingdom

559

EUCTR2016-001158-16-PL
(EUCTR)

23/09/2016

21/09/2016

Study to test whether PF-06480605 is safe and improves symptoms in patients with ulcerative colitis

Product Code: PF-06480605
INN or Proposed INN: PF-06480605
Other descriptive name: PF-06480605

Pfizer Inc. 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

France;United States;Belgium;Poland;Netherlands;Italy;Korea, Republic of

560

EUCTR2016-000674-38-SK
(EUCTR)

20/09/2016

26/07/2016

Long Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis.

A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects with Ulcerative Colitis (UC)

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

950

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

561

EUCTR2016-000641-31-SK
(EUCTR)

20/09/2016

26/07/2016

Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1055

Phase 2;Phase 3

Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan

562

EUCTR2016-001833-29-GB
(EUCTR)

16/09/2016

08/08/2016

Active ulcerative colitis
MedDRA version: 20.0;Level: HLGT;Classification code 10017969;Term: Gastrointestinal inflammatory conditions;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

GlaxoSmithKline Research & Development Ltd

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Poland;Netherlands;Germany;United Kingdom;Sweden

563

EUCTR2015-002109-12-LT
(EUCTR)

09/09/2016

21/03/2016

A study that continues from APD334-003 which investigates the safety and effectiveness of treatment with the drug APD334 in patients with ulcerative colitis (a form of inflammatory bowel disease)

An Extension Study of APD334-003 in Patients with Moderately to Severely Active Ulcerative Colitis

Product Name: APD334
INN or Proposed INN: Not yet available
Other descriptive name: APD334

Arena Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2

United States;Spain;Ukraine;Lithuania;Austria;Russian Federation;Israel;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Latvia;Germany;New Zealand

564

EUCTR2016-001833-29-SE
(EUCTR)

07/09/2016

19/07/2016

A multicentre, randomised, double-blind (sponsor-unblinded),placebo-controlled study with open label extension to investigatethe safety and tolerability, pharmacokinetics, pharmacodynamics, and efficacy of GSK2982772 in subjects with active ulcerative colitis.

Active ulcerative colitis
MedDRA version: 20.0;Level: HLGT;Classification code 10017969;Term: Gastrointestinal inflammatory conditions;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: GSK2982772
Product Code: GSK2982772
INN or Proposed INN: Not Available
Other descriptive name: GSK2982772A, where A denotes the free base

GlaxoSmithKline Research & Development Ltd

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Poland;Russian Federation;Netherlands;Germany;United Kingdom;Sweden

565

EUCTR2015-002558-11-LV
(EUCTR)

01/09/2016

01/07/2016

A study to investigate the efficacy and safety of Mesalamine 2 g extended release granules (Sachet) for maintenance of clinical and endoscopic remission in Ulcerative Colitis

Ulcerative colitis
MedDRA version: 19.0;Level: LLT;Classification code 10058816;Term: Colitis ulcerative acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Pentasa Compact 2g, granulate with prolonged release
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalamine , 5-aminosalicylic acid [5-ASA]

Ferring International PharmaScience Center U.S., Inc.

NULL

Not Recruiting

Female: yes
Male: yes

260

Phase 3

Serbia;United States;Belarus;Ukraine;Ireland;Lithuania;Russian Federation;Switzerland;Hungary;Mexico;Canada;Belgium;Bulgaria;Latvia

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

566

EUCTR2015-002557-35-LV
(EUCTR)

01/09/2016

01/07/2016

A study to investigate the efficacy and safety of Mesalamine 4 g extended release granules (Sachet) for the induction of clinical and endoscopic remission in mild to moderate Ulcerative Colitis

Active, mild to moderate ulcerative colitis
MedDRA version: 19.0;Level: LLT;Classification code 10058816;Term: Colitis ulcerative acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Pentasa Compact 4g, granulate with prolonged release
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalamine , 5-aminosalicylic acid [5-ASA]

Ferring International PharmaScience Center U.S., Inc.

NULL

Not Recruiting

Female: yes
Male: yes

220

Phase 3

Serbia;United States;Belarus;Ukraine;Ireland;Lithuania;Russian Federation;Switzerland;Hungary;Mexico;Canada;Belgium;Bulgaria;Latvia

567

EUCTR2016-000390-20-BG
(EUCTR)

29/08/2016

18/07/2016

A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study toEvaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg RectalSolution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patientswith Moderate to Severe Disease Activity

A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity

Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: TOP1288 Rectal solution
INN or Proposed INN: Not Applied for
Other descriptive name: TOP1288 rectal solution

TOPIVERT Pharma Limited

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Hungary;Czech Republic;Poland;Ukraine;Lithuania;Bulgaria;Latvia;United Kingdom

568

EUCTR2015-001942-28-AT
(EUCTR)

26/08/2016

28/06/2016

A study to investigate the safety and effectiveness of treatment with the drug APD334 in patients with ulcerative colitis (a form of inflammatory bowel disease)

Product Code: APD334
INN or Proposed INN: Not yet available
Product Code: APD334
INN or Proposed INN: Not yet available

Arena Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

156

Phase 2

United States;Spain;Ukraine;Lithuania;Austria;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Germany;Latvia

569

EUCTR2015-003123-57-PL
(EUCTR)

26/08/2016

16/05/2016

An investigational study to assess the safety and effectiveness of an investigational drug in people with moderate to severe ulcerative colitis

A Phase 2, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study of LY3074828 in Subjects with Moderate to Severe Ulcerative Colitis - AMAC

Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2

United States;Ukraine;Lithuania;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Denmark;Georgia;Netherlands;Moldova, Republic of;Japan

570

EUCTR2015-002109-12-AT
(EUCTR)

26/08/2016

22/06/2016

A study that continues from APD334-003 which investigates the safety and effectiveness of treatment with the drug APD334 in patients with ulcerative colitis (a form of inflammatory bowel disease)

An Extension Study of APD334-003 in Patients with Moderately to Severely Active Ulcerative Colitis

Product Name: APD334
INN or Proposed INN: Not yet available
Other descriptive name: APD334

Arena Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

156

Phase 2

United States;Spain;Ukraine;Lithuania;Austria;Russian Federation;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Latvia

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

571

EUCTR2016-002433-30-DK
(EUCTR)

25/08/2016

21/06/2016

Effect of azathioprine and allopurinol compared to azaothioprine monotherapy in ulcerative colitis

Low-dose azathioprine and allopurinol versus azathioprine monotherapy for patients with ulcerative colitis: protocol for an investigator initiated, open, multicentre, parallel arm, randomised controlled trial - AAUC

Trade Name: Imurel
INN or Proposed INN: Azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Allopurinol
INN or Proposed INN: ALLOPURINOL

Hvidovre Hospital

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 3

Denmark

572

EUCTR2016-000678-40-EE
(EUCTR)

22/08/2016

20/06/2016

Entyvio (Vedolizumab IV) Extended Access Program in Ulcerative Colitis and Crohn’s Disease

Trade Name: Entyvio
INN or Proposed INN: vedolizumab
Other descriptive name: VEDOLIZUMAB

Takeda Development Centre Europe Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

385

Phase 4

Serbia;Estonia;Taiwan;Slovakia;Ukraine;Turkey;Russian Federation;Italy;India;Czech Republic;Hungary;Poland;Malaysia;Romania;Australia;South Africa;Bulgaria;Latvia;New Zealand;Korea, Republic of

573

EUCTR2015-001346-29-BE
(EUCTR)

22/08/2016

22/09/2015

Ulcerative Colitis
MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

United States;Slovakia;Spain;Israel;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Japan;New Zealand;Sweden

574

EUCTR2016-000678-40-LV
(EUCTR)

19/08/2016

10/05/2016

Entyvio (Vedolizumab IV) Extended Access Program in Ulcerative Colitis and Crohn’s Disease

Trade Name: Entyvio
INN or Proposed INN: vedolizumab
Other descriptive name: VEDOLIZUMAB

Takeda Development Centre Europe Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

385

Phase 4

Serbia;Taiwan;Estonia;Slovakia;Ukraine;Turkey;Russian Federation;Italy;India;Czech Republic;Hungary;Malaysia;Poland;Romania;Australia;South Africa;Bulgaria;Latvia;New Zealand;Korea, Republic of

575

EUCTR2016-000518-31-NL
(EUCTR)

16/08/2016

27/06/2016

A STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF TREATMENT WITH LYC-30937-EC IN PATIENTS WITH ULCERATIVE COLITIS

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PARALLEL GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF INDUCTION THERAPY WITH LYC-30937-EC IN SUBJECTS WITH ACTIVE ULCERATIVE COLITIS

Ulcerative Colitis
MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: LYC-30937 -EC
INN or Proposed INN: LYC-30937
Other descriptive name: LYC-30937

Lycera Corp.

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 2

Serbia;United States;Hungary;Czech Republic;Canada;Poland;Netherlands

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

576

JPRN-UMIN000026485

2016/08/01

10/03/2017

Research on the Efficacy of Fecal Microbiota Transplantation and Microbiota in Japanese Children with Ulcerative Colitis.

ulcerative colitis

Fecal Microbiota Transplantation(on Day1, 2 and 3, week 2, 3 and 5) after antibiotic pretreatment using amoxicillin 40mg/kg/day, fosfomycin 100mg/kg/day and metronidazole 16mg/kg/day.

National Center for Child Health and Development

10Probiotics Research Laboratory, Juntendo University Graduate School of Medicine, Tokyo, Japan. Yakult Central Institute, Tokyo, Japan

Recruiting

2years-old

18years-old

Male and Female

Not selected

Japan

577

NCT02865707
(ClinicalTrials.gov)

August 2016

12/7/2016

Ulcerative Colitis Relapse Prevention by Prebiotics

Prevention of Ulcerative Colitis by Prebiotics: Efficacy and Protective Mechanisms

Ulcerative Colitis

Dietary Supplement: Synergy-1;Dietary Supplement: Maltodextrin

University of Alberta

University of British Columbia

Recruiting

18 Years

75 Years

All

100

N/A

Canada

578

EUCTR2015-002109-12-BG
(EUCTR)

27/07/2016

27/04/2016

A study that continues from APD334-003 which investigates the safety and effectiveness of treatment with the drug APD334 in patients with ulcerative colitis (a form of inflammatory bowel disease)

An Extension Study of APD334-003 in Patients with Moderately to Severely Active Ulcerative Colitis

Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Arena Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

156

Phase 2

United States;Spain;Ukraine;Lithuania;Austria;Russian Federation;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Germany;Latvia;Korea, Republic of

579

EUCTR2016-000390-20-CZ
(EUCTR)

18/07/2016

A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patients with Moderate Disease Activity

A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity

Symptomatic Ulcerative Colitis Patients with Moderate to Severe DiseaseActivity
MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: TOP1288 Rectal solution
INN or Proposed INN: Not Applied for
Other descriptive name: TOP1288 rectal solution

TOPIVERT Pharma Limited

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Hungary;Czech Republic;Poland;Ukraine;Lithuania;Bulgaria;Latvia;United Kingdom

580

EUCTR2016-000390-20-LT
(EUCTR)

15/07/2016

05/07/2016

A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity

Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity
MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: TOP1288 Rectal solution
INN or Proposed INN: Not Applied for
Other descriptive name: TOP1288 rectal solution

TOPIVERT Pharma Limited

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Hungary;Czech Republic;Poland;Ukraine;Lithuania;Bulgaria;Latvia;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

581

EUCTR2016-000205-36-DE
(EUCTR)

11/07/2016

14/03/2016

A Clinical Trial to Evaluate Activity, Safety and Tolerability of FE 999301 by Intravenous Infusions in Patients with Active Inflammatory Bowel Disease (IBD).

A Single-Centre, Exploratory Trial to Assess the Mechanisms of Molecular Activity, Safety and Tolerability of One Dose Level of FE 999301 by Intravenous Infusions in Patients with Active Inflammatory Bowel Disease (IBD) - FUTURE

Inflammatory Bowel Disease (Crohn`s Disease and Ulcerative Colitis)
MedDRA version: 19.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 19.0;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: FE 999301

University Hospital Schleswig-Holstein (UKSH)

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Germany

582

EUCTR2016-000678-40-HU
(EUCTR)

07/07/2016

19/05/2016

Entyvio (Vedolizumab IV) Extended Access Program in Ulcerative Colitis and Crohn’s Disease

Ulcerative Colitis and Crohn’s Disease
MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 19.1;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Entyvio
INN or Proposed INN: vedolizumab
Other descriptive name: VEDOLIZUMAB

Takeda Development Centre Europe Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

385

Phase 4

Serbia;Taiwan;Estonia;Slovakia;Ukraine;Turkey;Russian Federation;Italy;India;Hungary;Czech Republic;Poland;Malaysia;Romania;Australia;South Africa;Bulgaria;Latvia;New Zealand;Korea, Republic of

583

EUCTR2016-000390-20-HU
(EUCTR)

05/07/2016

14/06/2016

A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity

Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity
MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: TOP1288 Rectal solution
INN or Proposed INN: Not Applied for
Other descriptive name: TOP1288 rectal solution

TOPIVERT Pharma Limited

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Czech Republic;Hungary;Poland;Ukraine;Lithuania;Bulgaria;Latvia;United Kingdom

584

JPRN-UMIN000019958

2016/07/02

27/11/2015

Research for biomarkers of inflammatory bowel disease. - Investigation of the usefulness of LRG for evaluation of disease condition after adalimumab treatments

Crohn's disease, ulcerative colitis

Patients with Crohn's disease or ulcerative colitis

Adalimumab administration subcutaneously for 52 weeks using the recommended dosing regimens.

Iwate Medical UniversityKochi Medical School HospitalKeio University School of Medicine

NULL

Complete: follow-up continuing

15years-old

Not applicable

Male and Female

100

Not applicable

Japan

585

EUCTR2015-000482-31-BE
(EUCTR)

30/06/2016

14/03/2016

Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's Disease

A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn’s Disease - Vedolizumab SC Long-Term Open-Label Extension Study

Ulcerative Colitis Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Takeda Development Centre Europe, Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

692

Phase 3

Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

586

EUCTR2015-000480-14-BE
(EUCTR)

30/06/2016

14/03/2016

Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Product Name: Vedolizumab SC
Product Code: MLN0002 SC
INN or Proposed INN: Vedolizumab SC

Takeda Development Centre Europe, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 3

Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Australia;Denmark;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden

587

EUCTR2014-005217-24-ES
(EUCTR)

29/06/2016

10/11/2015

An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative Colitis

A Combined Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Induction and Maintenance StudyEvaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Ulcerative Colitis - NA

Product Code: GS-5745
INN or Proposed INN: GS-5745
Other descriptive name: GS-5745

Gilead Sciences, Inc

NULL

Not Recruiting

Female: yes
Male: yes

1600

Phase 2;Phase 3

Belarus;United States;Philippines;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Israel;Colombia;Switzerland;Vietnam;India;Malaysia;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Belgium;Brazil;Iran, Islamic Republic of;Romania;Croatia;Bulgaria;Iceland;Germany;New Zealand;Sweden

588

EUCTR2016-000390-20-PL
(EUCTR)

28/06/2016

16/06/2016

English A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study toEvaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg RectalSolution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patientswith Moderate to Severe Disease Activity

A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity

Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: TOP1288 Rectal solution
INN or Proposed INN: Not Applied for
Other descriptive name: TOP1288 rectal solution

TOPIVERT Pharma Limited

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Hungary;Czech Republic;Poland;Ukraine;Lithuania;Bulgaria;Latvia;United Kingdom

589

EUCTR2016-000678-40-CZ
(EUCTR)

27/06/2016

18/05/2016

Entyvio (Vedolizumab IV) Extended Access Program in Ulcerative Colitis and Crohn’s Disease

Ulcerative Colitis and Crohn’s Disease
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Takeda Development Centre Europe Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

385

Phase 4

Serbia;Taiwan;Estonia;Slovakia;Ukraine;Turkey;Russian Federation;Italy;India;Czech Republic;Hungary;Poland;Malaysia;Romania;Australia;South Africa;Bulgaria;Latvia;New Zealand;Korea, Republic of

590

EUCTR2015-002109-12-BE
(EUCTR)

20/06/2016

14/04/2016

A study that continues from APD334-003 which investigates the safety and effectiveness of treatment with the drug APD334 in patients with ulcerative colitis (a form of inflammatory bowel disease)

An Extension Study of APD334-003 in Patients with Moderately to Severely Active Ulcerative Colitis

Product Name: APD334
INN or Proposed INN: Not yet available
Other descriptive name: APD334

Arena Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

156

Phase 2

United States;Spain;Ukraine;Lithuania;Austria;Russian Federation;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Latvia

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

591

EUCTR2016-000390-20-LV
(EUCTR)

17/06/2016

14/06/2016

A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity

Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity
MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: TOP1288 Rectal solution
INN or Proposed INN: Not Applied for
Other descriptive name: TOP1288 rectal solution

TOPIVERT Pharma Limited

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Hungary;Czech Republic;Poland;Ukraine;Lithuania;Bulgaria;Latvia;United Kingdom

592

EUCTR2015-000480-14-DE
(EUCTR)

14/06/2016

09/03/2016

Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Takeda Development Centre Europe, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 3

Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden

593

EUCTR2015-000482-31-HR
(EUCTR)

13/06/2016

06/07/2016

Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's Disease

Ulcerative ColitisCrohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Vedolizumab SC
Product Code: MLN0002 SC
INN or Proposed INN: Vedolizumab SC
Trade Name: Entyvio
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB

Takeda Development Centre Europe, Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

692

Phase 3

United States;Serbia;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;Denmark;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Czechia;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan;Sweden

594

EUCTR2016-000390-20-GB
(EUCTR)

10/06/2016

06/06/2016

A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity

Symptomatic Ulcerative Colitis Patients with Moderate Disease Activity
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

TOPIVERT Pharma Limited

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Hungary;Czech Republic;Poland;Ukraine;Lithuania;Bulgaria;Latvia;United Kingdom

595

EUCTR2015-000480-14-HR
(EUCTR)

10/06/2016

06/07/2016

Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Takeda Development Centre Europe, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 3

Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;Australia;Denmark;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

596

EUCTR2016-001278-13-FI
(EUCTR)

08/06/2016

15/04/2016

Immunologic, genetic and bowel microbes as predictors of the treatment response for TNFalpha-blocking drugs in patients with Crohn’s disease or ulcerative colitis

Immunologic, genetic and microbiomic predictors of the treatment response for TNFalpha-blocking drugs – prospective follow-up cohort of patients with Crohn’s disease or ulcerative colitis - PROSIBD

Ulcerative colitis and Crohn's disease
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 19.0;Classification code 10013099;Term: Disease Crohns;Classification code 10058815;Term: Crohn's disease acute episode;Classification code 10057035;Term: Crohn's ileocolitis;Classification code 10011405;Term: Crohn's enteritis;Classification code 10011406;Term: Crohn's ileitis;Classification code 10076318;Term: Crohn's disease relapse;Level: PT;Classification code 10011401;Term: Crohn's disease;Classification code 10011402;Term: Crohn's disease (colon);Classification code 10075466;Term: Fistulising Crohn's disease;Classification code 10066678;Term: Acute ulcerative colitis;Classification code 10075465;Term: Fistulizing Crohn's disease;Classification code 10011400;Term: Crohn's colitis;System Organ Class: 10017947 - Gastrointe;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Remsima
Product Name: Remsima
INN or Proposed INN: INFLIXIMAB

Taina Sipponen

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 4

Finland

597

EUCTR2015-003123-57-DK
(EUCTR)

03/06/2016

22/03/2016

An investigational study to assess the safety and effectiveness of an investigational drug in people with moderate to severe ulcerative colitis

A Phase 2, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study of LY3074828 in Subjects with Moderate to Severe Ulcerative Colitis - AMAC

Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2

United States;Ukraine;Lithuania;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;Australia;Georgia;Netherlands;Moldova, Republic of;Japan

598

EUCTR2015-003123-57-NL
(EUCTR)

02/06/2016

12/11/2015

An investigational study to assess the safety and effectiveness of an investigational drug in people with moderate to severe ulcerative colitis

A Phase 2, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study of LY3074828 in Subjects with Moderate to Severe Ulcerative Colitis - AMAC

Ulcerative colitis
MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: LY3074828
INN or Proposed INN: Not assigned
Other descriptive name: LY3074828

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

240

Phase 2

United States;Ukraine;Lithuania;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Denmark;Georgia;Netherlands;Moldova, Republic of;Japan

599

EUCTR2015-000480-14-DK
(EUCTR)

31/05/2016

17/03/2016

Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Takeda Development Centre Europe, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 3

600

EUCTR2015-000482-31-DK
(EUCTR)

31/05/2016

17/03/2016

Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's Disease

Ulcerative ColitisCrohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Vedolizumab SC
Product Code: MLN0002 SC
INN or Proposed INN: Vedolizumab SC

Takeda Development Centre Europe, Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

692

Phase 3

United States;Serbia;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;Australia;Denmark;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

601

EUCTR2015-000480-14-ES
(EUCTR)

29/05/2016

18/03/2016

Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Takeda Development Centre Europe, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 3

602

EUCTR2015-000482-31-ES
(EUCTR)

29/05/2016

18/03/2016

Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's Disease

A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn?s Disease - Vedolizumab SC Long-Term Open-Label Extension Study

Ulcerative ColitisCrohn?s Disease
MedDRA version: 18.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Vedolizumab SC
Product Code: MLN0002 SC
INN or Proposed INN: Vedolizumab SC

Takeda Development Centre Europe, Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

692

Phase 3

Romania;Croatia;Bulgaria;Germany;Japan;Sweden;Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Australia;Denmark;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Belgium

603

EUCTR2015-000482-31-NL
(EUCTR)

25/05/2016

27/01/2016

Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's Disease

Takeda Development Centre Europe, Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

692

Phase 3

Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;Japan;Sweden

604

EUCTR2014-005217-24-DE
(EUCTR)

24/05/2016

23/10/2015

An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative Colitis

Product Code: GS-5745
INN or Proposed INN: GS-5745
Other descriptive name: GS-5745

Gilead Sciences, Inc

NULL

Not Recruiting

Female: yes
Male: yes

1600

Phase 2;Phase 3

605

EUCTR2014-005217-24-IS
(EUCTR)

10/05/2016

28/04/2016

An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative Colitis

Product Code: GS-5745
INN or Proposed INN: GS-5745
Other descriptive name: GS-5745

Gilead Sciences, Inc

NULL

Not Recruiting

Female: yes
Male: yes

1600

Phase 2;Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

606

EUCTR2015-002109-12-CZ
(EUCTR)

09/05/2016

22/02/2016

A study that continues from APD334-003 which investigates the safety and effectiveness of treatment with the drug APD334 in patients with ulcerative colitis (a form of inflammatory bowel disease)

An Extension Study of APD334-003 in Patients with Moderately to Severely Active Ulcerative Colitis

Product Name: APD334
INN or Proposed INN: Not yet available
Other descriptive name: APD334

Arena Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2

United States;Spain;Ukraine;Lithuania;Austria;Russian Federation;Israel;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Latvia;Germany;New Zealand

607

EUCTR2015-000482-31-DE
(EUCTR)

09/05/2016

09/03/2016

Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's Disease

Takeda Development Centre Europe, Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

692

Phase 3

Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;Japan;Sweden

608

EUCTR2015-000480-14-HU
(EUCTR)

09/05/2016

22/03/2016

Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Takeda Development Centre Europe, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 3

Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden

609

EUCTR2015-000482-31-HU
(EUCTR)

09/05/2016

22/03/2016

Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's Disease

Ulcerative ColitisCrohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Vedolizumab SC
Product Code: MLN0002 SC
INN or Proposed INN: Vedolizumab SC

Takeda Development Centre Europe, Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

692

Phase 3

United States;Serbia;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;Denmark;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan;Sweden

610

EUCTR2015-000480-14-LT
(EUCTR)

04/05/2016

18/03/2016

Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Takeda Development Centre Europe, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 3

Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

611

EUCTR2015-000482-31-LT
(EUCTR)

04/05/2016

18/03/2016

Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's Disease

Ulcerative ColitisCrohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Vedolizumab SC
Product Code: MLN0002 SC
INN or Proposed INN: Vedolizumab SC

Takeda Development Centre Europe, Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

692

Phase 3

United States;Serbia;Estonia;Slovakia;Spain;Ukraine;Israel;Colombia;Denmark;South Africa;Netherlands;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan;Sweden;Australia;Bosnia and Herzegovina;Russian Federation;Italy

612

EUCTR2015-001942-28-BE
(EUCTR)

03/05/2016

17/03/2016

A study to investigate the safety and effectiveness of treatment with the drug APD334 in patients with ulcerative colitis (a form of inflammatory bowel disease)

Product Code: APD334
INN or Proposed INN: Not yet available
Product Code: APD334
INN or Proposed INN: Not yet available

Arena Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

156

Phase 2

United States;Spain;Ukraine;Lithuania;Austria;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Latvia

613

EUCTR2015-001942-28-PL
(EUCTR)

29/04/2016

19/01/2016

A study to investigate the safety and effectiveness of treatment with the drug APD334 in patients with ulcerative colitis (a form of inflammatory bowel disease)

Product Code: APD334
INN or Proposed INN: Not yet available
Product Code: APD334
INN or Proposed INN: Not yet available

Arena Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

156

Phase 2

United States;Spain;Ukraine;Lithuania;Austria;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Latvia;Germany;Korea, Republic of

614

EUCTR2015-001600-64-NL
(EUCTR)

28/04/2016

13/10/2015

The purpose of this study is to determine whether long-term RPC1063 is safe and effective in the treatment of ulcerative colitis (UC).

A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of long-term RPC1063 in Ulcerative Colitis

Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Celgene International II Sàrl

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1200

Phase 3

Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;New Zealand

615

EUCTR2015-001555-69-PL
(EUCTR)

28/04/2016

22/12/2015

A clinical study to test the safety and possible benefits of an investigational study drug, KHK4083, in patients with ulcerative colitis.

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Multiple Ascending Dose Study (Induction Therapy) and Long-term Extension Therapy of an Anti-OX40 Monoclonal Antibody (KHK4083) in Subjects with Moderately Active Ulcerative Colitis

Moderately Active Ulcerative Colitis, defined as:•Total Mayo Clinic score of 4 to 9 (range: 0 to 12, with higher scores indicating more disease activity);•Endoscopy subscore (mMES determined by a central reader) of at least 2; and•Disease that extends = 15 cm from the anal verge.
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: KHK4083
Product Code: KHK4083
INN or Proposed INN: Not available

Kyowa Kirin Pharmaceutical Development, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Serbia;United States;Hungary;Czech Republic;Poland;Romania;Russian Federation

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

616

EUCTR2015-000482-31-CZ
(EUCTR)

13/04/2016

21/01/2016

Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's Disease

Ulcerative ColitisCrohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Vedolizumab SC
Product Code: MLN0002 SC
INN or Proposed INN: Vedolizumab SC
Trade Name: Entyvio
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB

Takeda Development Centre Europe, Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

692

Phase 3

United States;Serbia;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;Denmark;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan;Sweden

617

EUCTR2015-000480-14-CZ
(EUCTR)

13/04/2016

21/01/2016

Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Takeda Development Centre Europe, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 3

618

EUCTR2015-000482-31-SE
(EUCTR)

05/04/2016

16/03/2016

Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's Disease

Ulcerative ColitisCrohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Vedolizumab SC
Product Code: MLN0002 SC
INN or Proposed INN: Vedolizumab SC

Takeda Development Centre Europe, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

692

Phase 3

United States;Serbia;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;Denmark;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan;Sweden

619

EUCTR2015-000480-14-SE
(EUCTR)

04/04/2016

16/03/2016

Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Takeda Development Centre Europe, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 3

620

EUCTR2015-001346-29-ES
(EUCTR)

31/03/2016

30/10/2015

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

United States;Slovakia;Spain;Israel;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Japan;New Zealand;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

621

EUCTR2014-005217-24-HR
(EUCTR)

29/03/2016

28/04/2016

An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative Colitis

Product Code: GS-5745
INN or Proposed INN: GS-5745
Other descriptive name: GS-5745

Gilead Sciences, Inc

NULL

Not Recruiting

Female: yes
Male: yes

1600

Phase 2;Phase 3

622

EUCTR2015-003123-57-GB
(EUCTR)

29/03/2016

04/11/2015

An investigational study to assess the safety and effectiveness of an investigational drug in people with moderate to severe ulcerative colitis

A Phase 2, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study of LY3074828 in Subjects with Moderate to Severe Ulcerative Colitis - AMAC

Ulcerative colitis
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2

United States;Ukraine;Lithuania;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Denmark;Georgia;Netherlands;Moldova, Republic of;Japan

623

EUCTR2015-000482-31-BG
(EUCTR)

23/03/2016

16/02/2016

Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's Disease

Ulcerative ColitisCrohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Vedolizumab SC
Product Code: MLN0002 SC
INN or Proposed INN: Vedolizumab SC
Trade Name: Entyvio
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB

Takeda Development Centre Europe, Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

692

Phase 3

United States;Serbia;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;Denmark;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan;Sweden

624

EUCTR2015-000482-31-GB
(EUCTR)

21/03/2016

08/03/2016

Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's Disease

Ulcerative ColitisCrohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Vedolizumab SC
Product Code: MLN0002 SC
INN or Proposed INN: Vedolizumab SC

Takeda Development Centre Europe, Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

692

Phase 3

United States;Serbia;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;Denmark;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan;Sweden

625

EUCTR2015-000480-14-NL
(EUCTR)

21/03/2016

29/12/2015

Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Takeda Development Centre Europe, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 3

Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

626

EUCTR2015-000480-14-BG
(EUCTR)

17/03/2016

16/02/2016

Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis

Takeda Development Centre Europe, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 3

627

EUCTR2015-000480-14-GB
(EUCTR)

14/03/2016

07/03/2016

Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Takeda Development Centre Europe, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 3

628

EUCTR2015-002109-12-GB
(EUCTR)

14/03/2016

29/12/2015

A study that continues from APD334-003 which investigates the safety and effectiveness of treatment with the drug APD334 in patients with ulcerative colitis (a form of inflammatory bowel disease)

An Extension Study of APD334-003 in Patients with Moderately to Severely Active Ulcerative Colitis

Ulcerative colitis
MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Arena Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2

United States;Spain;Ukraine;Lithuania;Austria;Russian Federation;Israel;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Germany;Latvia;New Zealand

629

EUCTR2013-001205-84-BE
(EUCTR)

11/03/2016

17/02/2015

LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo vs. mesalamine for maintenance of remission in patients with ulcerative colitis

Randomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 48-weeks treatment with gastro-resistant phosphatidylcholine (LT-02) versus placebo versus mesalamine for maintenance of remission in patients with ulcerative colitis - Phosphatidylcholine (LT-02) vs. placebo vs. mesalamine for maintenance of remission in UC

Maintenance of remission in ulcerative colitis (UC)
MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: gastro-resistant phosphatidylcholine granules
Product Code: LT-02
INN or Proposed INN: Phosphatidylcholine
Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE
Trade Name: Salofalk Granu-Stix 500 mg
INN or Proposed INN: MESALAZINE

Dr. Falk Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 3

Slovakia;Ukraine;Lithuania;Austria;Russian Federation;Israel;Switzerland;Czech Republic;Hungary;Belgium;Poland;Germany;Latvia;Netherlands

630

EUCTR2013-001205-84-HU
(EUCTR)

07/03/2016

04/01/2016

LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo vs. mesalamine for maintenance of remission in patients with ulcerative colitis

Maintenance of remission in ulcerative colitis (UC)
MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Dr. Falk Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 3

Slovakia;Ukraine;Lithuania;Austria;Israel;Russian Federation;Switzerland;Hungary;Belgium;Poland;Germany;Latvia;Netherlands

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

631

EUCTR2015-001555-69-CZ
(EUCTR)

07/03/2016

14/12/2015

A clinical study to test the safety and possible benefits of an investigational study drug, KHK4083, in patients with ulcerative colitis.

Product Name: KHK4083
Product Code: KHK4083
INN or Proposed INN: Not available

Kyowa Kirin Pharmaceutical Development, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Serbia;United States;Hungary;Czech Republic;Poland;Russian Federation

632

EUCTR2014-005217-24-SE
(EUCTR)

02/03/2016

03/11/2015

An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative Colitis

Product Code: GS-5745
INN or Proposed INN: GS-5745
Other descriptive name: GS-5745

Gilead Sciences, Inc

NULL

Not Recruiting

Female: yes
Male: yes

1600

Phase 2;Phase 3

633

EUCTR2015-002109-12-ES
(EUCTR)

25/02/2016

10/12/2015

A study that continues from APD334-003 which investigates the safety and effectiveness of treatment with the drug APD334 in patients with ulcerative colitis (a form of inflammatory bowel disease)

An Extension Study of APD334-003 in Patients with Moderately to Severely Active Ulcerative Colitis

Product Name: APD334
INN or Proposed INN: Not yet available
Other descriptive name: APD334

Arena Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2

United States;Spain;Ukraine;Lithuania;Austria;Russian Federation;Israel;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Latvia;Germany;New Zealand

634

EUCTR2015-000939-33-HR
(EUCTR)

16/02/2016

28/04/2016

Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitis compared to Adalimumab SC

A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis - Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis

Takeda Development Centre Europe, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

758

Phase 3

Serbia;Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Denmark;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany

635

EUCTR2015-002557-35-HU
(EUCTR)

09/02/2016

16/11/2015

A study to investigate the efficacy and safety of Mesalamine 4 g extended release granules (Sachet) for the induction of clinical and endoscopic remission in mild to moderate Ulcerative Colitis

Active, mild to moderate ulcerative colitis
MedDRA version: 19.1;Level: LLT;Classification code 10058816;Term: Colitis ulcerative acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Pentasa Compact 4g, granulate with prolonged release
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalamine , 5-aminosalicylic acid [5-ASA]

Ferring International PharmaScience Center U.S., Inc.

NULL

Not Recruiting

Female: yes
Male: yes

220

Phase 3

Serbia;United States;Hungary;Mexico;Canada;Belgium;Ukraine;Russian Federation;Bulgaria;Latvia;Switzerland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

636

EUCTR2015-003364-36-HU
(EUCTR)

09/02/2016

02/12/2015

A study using a new drug (GED-0301) to investigate if the new drug works and is safe in subjects suffering ulcerative colitis.

A Phase 2, Open-label, Multicenter Study to Explore the Efficacy and Safety of Mongersen (GED-0301) in Subjects with Active Ulcerative Colitis.

Ulcerative Colitis.
MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: Mongersen
Other descriptive name: GED-0301

Celgene Corporation

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Hungary;Slovakia;Canada;Poland;Bulgaria

637

EUCTR2015-002558-11-HU
(EUCTR)

09/02/2016

16/11/2015

A study to investigate the efficacy and safety of Mesalamine 2 g extended release granules (Sachet) for maintenance of clinical and endoscopic remission in Ulcerative Colitis

Ulcerative colitis
MedDRA version: 19.1;Level: LLT;Classification code 10058816;Term: Colitis ulcerative acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Pentasa Compact 2g, granulate with prolonged release
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalamine , 5-aminosalicylic acid [5-ASA]

Ferring International PharmaScience Center U.S., Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

260

Phase 3

Serbia;United States;Hungary;Mexico;Canada;Belgium;Ukraine;Russian Federation;Bulgaria;Latvia;Switzerland

638

EUCTR2015-003123-57-BE
(EUCTR)

09/02/2016

01/10/2015

An investigational study to assess the safety and effectiveness of an investigational drug in people with moderate to severe ulcerative colitis

A Phase 2, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study of LY3074828 in Subjects with Moderate to Severe Ulcerative Colitis - AMAC

Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2

United States;Ukraine;Lithuania;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Denmark;Georgia;Netherlands;Moldova, Republic of;Japan

639

EUCTR2015-003364-36-BG
(EUCTR)

09/02/2016

28/01/2016

A study using a new drug (GED-0301) to investigate if the new drug works and is safe in subjects suffering ulcerative colitis.

A Phase 2, Open-label, Multicenter Study to Explore the Efficacy and Safety of Mongersen (GED-0301) in Subjects with Active Ulcerative Colitis.

Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: Mongersen
Other descriptive name: GED-0301

Celgene Corporation

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Hungary;Slovakia;Canada;Poland;Bulgaria

640

EUCTR2015-001346-29-GB
(EUCTR)

08/02/2016

28/09/2015

Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use
Product Name: Adalimumab
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

United States;Czech Republic;Hungary;European Union;Canada;Spain;Belgium;Israel;New Zealand;Japan;United Kingdom;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

641

EUCTR2014-005606-38-PL
(EUCTR)

05/02/2016

17/11/2015

A Study to Evaluate the Safety and Efficacy of the Ustekinumab Induction and Maintenance Therapy in Participants with Moderately to Severely Active Ulcerative Colitis

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis - UNIFI

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Trade Name: STELARA ®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab

Janssen-Cilag International NV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

951

Phase 3

United States;Serbia;Slovakia;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Denmark;South Africa;Bulgaria;Netherlands;Germany;New Zealand;Korea, Republic of

642

EUCTR2015-001346-29-HU
(EUCTR)

02/02/2016

28/09/2015

Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use
Product Name: Adalimumab
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 3

United States;Hungary;Canada;Spain;Australia;Israel;United Kingdom;New Zealand

643

EUCTR2015-000319-41-NL
(EUCTR)

26/01/2016

01/07/2015

The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC).

Celgene International II Sàrl (CIS II)

NULL

Not Recruiting

Female: yes
Male: yes

900

Phase 3

United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand

644

EUCTR2015-000482-31-SK
(EUCTR)

22/01/2016

05/01/2016

Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's Disease

Ulcerative ColitisCrohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Vedolizumab SC
Product Code: MLN0002 SC
INN or Proposed INN: Vedolizumab SC
Trade Name: ENTYVIO
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB

Takeda Development Centre Europe, Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

692

Phase 3

United States;Serbia;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;Denmark;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan;Sweden

645

EUCTR2015-000480-14-SK
(EUCTR)

22/01/2016

05/01/2016

Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Takeda Development Centre Europe, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

646

EUCTR2015-003364-36-SK
(EUCTR)

22/01/2016

07/12/2015

A study using a new drug (GED-0301) to investigate if the new drug works and is safe in subjects suffering ulcerative colitis.

A Phase 2, Open-label, Multicenter Study to Explore the Efficacy and Safety of Mongersen (GED-0301) in Subjects with Active Ulcerative Colitis.

Ulcerative Colitis.
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: Mongersen
Other descriptive name: GED-0301

Celgene Corporation

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Hungary;Slovakia;Canada;Poland;Bulgaria

647

EUCTR2015-000939-33-NL
(EUCTR)

21/01/2016

30/09/2015

Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitis compared to Adalimumab SC

Ulcerative Colitis
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Takeda Development Centre Europe, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

658

Phase 3

Serbia;Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Denmark;Latvia;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany

648

EUCTR2014-002981-64-BG
(EUCTR)

20/01/2016

25/09/2015

Clinical trial that will compare the efficacy and safety of apremilast versus placebo, in patients with active ulcerative colitis, a chronic inflammatory of the colon of unknown origin

A PHASE 2, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF APREMILAST (CC-10004) FOR TREATMENT OF SUBJECTS WITH ACTIVE ULCERATIVE COLITIS

Subjects with active ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Apremilast
Product Code: CC -10004
INN or Proposed INN: APREMILAST
Other descriptive name: APREMILAST
Product Name: Apremilast
Product Code: CC -10004
INN or Proposed INN: APREMILAST
Other descriptive name: APREMILAST
Product Name: Apremilast
Product Code: CC -10004
INN or Proposed INN: APREMILAST
Other descriptive name: APREMILAST

Celgene Corporation

NULL

Not Recruiting

Female: yes
Male: yes

165

Phase 2

United States;Slovakia;Ukraine;Russian Federation;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany;Netherlands;New Zealand

649

EUCTR2015-002109-12-HU
(EUCTR)

18/01/2016

21/01/2016

A study that continues from APD334-003 which investigates the safety and effectiveness of treatment with the drug APD334 in patients with ulcerative colitis (a form of inflammatory bowel disease)

An Extension Study of APD334-003 in Patients with Moderately to Severely Active Ulcerative Colitis

Product Name: APD334
INN or Proposed INN: Not yet available
Other descriptive name: APD334

Arena Pharmaceuticals, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

240

Phase 2

United States;Spain;Ukraine;Lithuania;Austria;Israel;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Germany;Latvia;New Zealand

650

EUCTR2015-001555-69-HU
(EUCTR)

15/01/2016

17/11/2015

A clinical study to test the safety and possible benefits of an investigational study drug, KHK4083, in patients with ulcerative colitis.

Product Name: KHK4083
Product Code: KHK4083
INN or Proposed INN: Not available

Kyowa Kirin Pharmaceutical Development, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Serbia;United States;Czech Republic;Hungary;Poland;Russian Federation

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

651

JPRN-UMIN000022954

2016/01/15

05/07/2016

A study related to usability of Mesalazine Controlled-Release Tablets and Granules.

ulcerative colitis

Patients take Mesalazine Controlled-release tablets at first, 3-12 weeks, then take granules, 3-12 weeks
Patients take Mesalazine Controlled-release granules at first, 3-12 weeks, then take tablets, 3-12 weeks

Kitasato University Kitasato Institute Hospital

NULL

Recruiting

Not applicable

100years-old

Male and Female

Not applicable

Japan

652

EUCTR2014-005217-24-BE
(EUCTR)

14/01/2016

26/10/2015

An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: GS-5745
INN or Proposed INN: GS-5745
Other descriptive name: GS-5745

Gilead Sciences, Inc

NULL

Not Recruiting

Female: yes
Male: yes

1600

Phase 2;Phase 3

Belarus;United States;Philippines;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Israel;Colombia;Switzerland;Vietnam;India;Malaysia;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Brazil;Belgium;Iran, Islamic Republic of;Romania;Croatia;Bulgaria;Iceland;Germany;New Zealand;Sweden

653

EUCTR2015-003123-57-CZ
(EUCTR)

14/01/2016

05/11/2015

An investigational study to assess the safety and effectiveness of an investigational drug in people with moderate to severe ulcerative colitis

A Phase 2, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study of LY3074828 in Subjects with Moderate to Severe Ulcerative Colitis - AMAC

Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2

United States;Ukraine;Lithuania;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Denmark;Georgia;Netherlands;Moldova, Republic of;Japan

654

EUCTR2015-001942-28-GB
(EUCTR)

12/01/2016

21/09/2015

A study to investigate the safety and effectiveness of treatment with the drug APD334 in patients with ulcerative colitis (a form of inflammatory bowel disease)

Product Code: APD334
INN or Proposed INN: Not yet available
Product Code: APD334
INN or Proposed INN: Not yet available

Arena Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2

United States;Spain;Ukraine;Lithuania;Austria;Russian Federation;Israel;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Latvia;Germany;New Zealand

655

EUCTR2015-000939-33-PL
(EUCTR)

08/01/2016

24/11/2015

Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitis compared to Adalimumab SC

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Takeda Development Centre Europe, Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

758

Phase 3

Serbia;Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Belgium;Poland;Romania;Croatia;Bulgaria;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

656

EUCTR2015-000939-33-PT
(EUCTR)

08/01/2016

25/11/2015

Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitis compared to Adalimumab SC

Takeda Development Centre Europe, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

658

Phase 3

Serbia;United States;Portugal;Taiwan;Estonia;Hong Kong;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany

657

EUCTR2015-002109-12-LV
(EUCTR)

08/01/2016

20/11/2015

A study that continues from APD334-003 which investigates the safety and effectiveness of treatment with the drug APD334 in patients with ulcerative colitis (a form of inflammatory bowel disease)

An Extension Study of APD334-003 in Patients with Moderately to Severely Active Ulcerative Colitis

Product Name: APD334
INN or Proposed INN: Not yet available
Other descriptive name: APD334

Arena Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2

United States;Spain;Ukraine;Lithuania;Austria;Russian Federation;Israel;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Latvia;Germany;New Zealand

658

EUCTR2015-000939-33-HU
(EUCTR)

05/01/2016

03/11/2015

Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitis compared to Adalimumab SC

Ulcerative Colitis
MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Takeda Development Centre Europe, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

758

Phase 3

Serbia;Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Denmark;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany

659

EUCTR2015-000939-33-ES
(EUCTR)

05/01/2016

05/11/2015

Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitis compared to Adalimumab SC

Takeda Development Centre Europe, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

658

Phase 3

660

EUCTR2015-003123-57-HU
(EUCTR)

05/01/2016

06/11/2015

An investigational study to assess the safety and effectiveness of an investigational drug in people with moderate to severe ulcerative colitis

A Phase 2, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study of LY3074828 in Subjects with Moderate to Severe Ulcerative Colitis - AMAC

Ulcerative colitis
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2

United States;Ukraine;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Australia;Denmark;Georgia;Netherlands;Moldova, Republic of;Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

661

EUCTR2014-005217-24-BG
(EUCTR)

05/01/2016

19/10/2015

An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative Colitis

Product Code: GS-5745
INN or Proposed INN: GS-5745
Other descriptive name: GS-5745

Gilead Sciences, Inc

NULL

Not Recruiting

Female: yes
Male: yes

1600

Phase 2;Phase 3

662

EUCTR2015-001942-28-LT
(EUCTR)

31/12/2015

20/11/2015

A study to investigate the safety and effectiveness of treatment with the drug APD334 in patients with ulcerative colitis (a form of inflammatory bowel disease)

Product Code: APD334
INN or Proposed INN: Not yet available
Product Code: APD334
INN or Proposed INN: Not yet available

Arena Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2

Czech Republic;Canada;Poland;Belgium;Romania;United States;Spain;Ukraine;Lithuania;Austria;Russian Federation;Israel;United Kingdom;France;Hungary;Australia;Bulgaria;Latvia;Germany;New Zealand;Korea, Republic of

663

EUCTR2015-003123-57-LT
(EUCTR)

31/12/2015

17/11/2015

An investigational study to assess the safety and effectiveness of an investigational drug in people with moderate to severe ulcerative colitis

A Phase 2, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study of LY3074828 in Subjects with Moderate to Severe Ulcerative Colitis - AMAC

Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2

United States;Ukraine;Lithuania;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Denmark;Georgia;Netherlands;Moldova, Republic of;Japan

664

EUCTR2015-004724-62-IE
(EUCTR)

22/12/2015

05/11/2015

Golimumab dose variation to achieve response in Colitis

Golimumab (GLM) dose Optimisation to Adequate Levels to Achieve Response in Colitis. (GOAL-ARC)

Trade Name: Simponi
Product Name: Simponi
INN or Proposed INN: GOLIMUMAB
INN or Proposed INN: GOLIMUMAB

UCD

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

136

Phase 4

Ireland

665

EUCTR2014-005217-24-CZ
(EUCTR)

22/12/2015

06/10/2015

An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative Colitis

Product Code: GS-5745
INN or Proposed INN: GS-5745
Other descriptive name: GS-5745

Gilead Sciences, Inc

NULL

Not Recruiting

Female: yes
Male: yes

1600

Phase 2;Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

666

EUCTR2014-005217-24-NL
(EUCTR)

17/12/2015

26/10/2015

An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative Colitis

Product Code: GS-5745
INN or Proposed INN: GS-5745
Other descriptive name: GS-5745

Gilead Sciences, Inc

NULL

Not Recruiting

Female: yes
Male: yes

1600

Phase 2;Phase 3

667

EUCTR2015-000939-33-SK
(EUCTR)

11/12/2015

27/08/2015

Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitis compared to Adalimumab SC

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Takeda Development Centre Europe, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

758

Phase 3

668

EUCTR2015-001942-28-CZ
(EUCTR)

10/12/2015

15/09/2015

A study to investigate the safety and effectiveness of treatment with the drug APD334 in patients with ulcerative colitis (a form of inflammatory bowel disease)

Product Code: APD334
INN or Proposed INN: Not yet available
Product Code: APD334
INN or Proposed INN: Not yet available

Arena Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2

United States;Spain;Ukraine;Lithuania;Austria;Israel;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Latvia;Germany;New Zealand

669

EUCTR2015-000939-33-LT
(EUCTR)

08/12/2015

12/11/2015

Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitis compared to Adalimumab SC

Takeda Development Centre Europe, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

758

Phase 3

Serbia;Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany

670

EUCTR2015-002558-11-BE
(EUCTR)

07/12/2015

04/11/2015

A study to investigate the efficacy and safety of Mesalamine 2 g extended release granules (Sachet) for maintenance of clinical and endoscopic remission in Ulcerative Colitis

Ulcerative colitis
MedDRA version: 18.1;Level: LLT;Classification code 10058816;Term: Colitis ulcerative acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Pentasa Compact 2g, granulate with prolonged release
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalamine , 5-aminosalicylic acid [5-ASA]

Ferring International PharmaScience Center U.S., Inc.

NULL

Not Recruiting

Female: yes
Male: yes

260

Phase 3

United States;Slovakia;Ukraine;Israel;Russian Federation;Switzerland;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Latvia;New Zealand;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

671

EUCTR2015-002557-35-BE
(EUCTR)

07/12/2015

04/11/2015

A study to investigate the efficacy and safety of Mesalamine 4 g extended release granules (Sachet) for the induction of clinical and endoscopic remission in mild to moderate Ulcerative Colitis

Active, mild to moderate ulcerative colitis
MedDRA version: 18.1;Level: LLT;Classification code 10058816;Term: Colitis ulcerative acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Pentasa Compact 4g, granulate with prolonged release
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalamine , 5-aminosalicylic acid [5-ASA]

Ferring International PharmaScience Center U.S., Inc.

NULL

Not Recruiting

Female: yes
Male: yes

220

Phase 3

United States;Slovakia;Ukraine;Israel;Russian Federation;Switzerland;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Latvia

672

EUCTR2015-000939-33-BE
(EUCTR)

07/12/2015

04/11/2015

Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitis compared to Adalimumab SC

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Takeda Development Centre Europe, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

758

Phase 3

673

EUCTR2015-000939-33-DK
(EUCTR)

04/12/2015

25/11/2015

Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitis compared to Adalimumab SC

Ulcerative Colitis
MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Takeda Development Centre Europe, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

758

Phase 3

674

EUCTR2015-001942-28-ES
(EUCTR)

04/12/2015

05/10/2015

A study to investigate the safety and effectiveness of treatment with the drug APD334 in patients with ulcerative colitis (a form of inflammatory bowel disease)

Ulcerative colitis
MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: APD334
INN or Proposed INN: Not yet available
Product Code: APD334
INN or Proposed INN: Not yet available

Arena Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2

United States;Spain;Ukraine;Lithuania;Austria;Russian Federation;Israel;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Latvia;Germany;New Zealand

675

EUCTR2015-001022-42-IT
(EUCTR)

01/12/2015

29/03/2019

A Phase 2a, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Trial of IBD98-M Delayed-release Capsules to Induce Remission in Patients with Active, Mild to Moderate Ulcerative Colitis

Active, Mild to Moderate Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Holy Stone Healthcare Co., Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

676

EUCTR2015-001600-64-BE
(EUCTR)

30/11/2015

01/03/2016

The purpose of this study is to determine whether long-term RPC1063 is safe and effective in the treatment of ulcerative colitis (UC).

A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of long-term RPC1063 in Ulcerative Colitis

Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Celgene International II Sàrl

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1350

Phase 3

Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;New Zealand

677

EUCTR2014-005217-24-GB
(EUCTR)

27/11/2015

22/10/2015

An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative Colitis

Product Code: GS-5745
INN or Proposed INN: GS-5745
Other descriptive name: GS-5745

Gilead Sciences, Inc

NULL

Not Recruiting

Female: yes
Male: yes

1600

Phase 2;Phase 3

United States;Belarus;Philippines;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Colombia;Switzerland;Vietnam;India;Malaysia;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Belgium;Brazil;Iran, Islamic Republic of;Croatia;Romania;Bulgaria;Iceland;Germany;New Zealand;Sweden

678

EUCTR2015-000939-33-LV
(EUCTR)

27/11/2015

05/11/2015

Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitis compared to Adalimumab SC

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Takeda Development Centre Europe, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

758

Phase 3

Serbia;Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany

679

EUCTR2015-000939-33-BG
(EUCTR)

26/11/2015

05/10/2015

Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitis compared to Adalimumab SC

Takeda Development Centre Europe, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

758

Phase 3

680

EUCTR2014-005217-24-HU
(EUCTR)

19/11/2015

22/09/2015

An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative Colitis

Product Code: GS-5745
INN or Proposed INN: GS-5745
Other descriptive name: GS-5745

Gilead Sciences, Inc

NULL

Not Recruiting

Female: yes
Male: yes

1600

Phase 2;Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

681

EUCTR2015-000939-33-EE
(EUCTR)

16/11/2015

10/11/2015

Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitis compared to Adalimumab SC

Ulcerative Colitis
MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Takeda Development Centre Europe, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

758

Phase 3

682

EUCTR2015-001600-64-DE
(EUCTR)

13/11/2015

04/08/2015

The purpose of this study is to determine whether long-term RPC1063 is safe and effective in the treatment of ulcerative colitis (UC).

A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of long-term RPC1063 in Ulcerative Colitis

Celgene International II Sàrl (CIS II)

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1350

Phase 3

Belarus;United States;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;New Zealand

683

EUCTR2014-005217-24-IE
(EUCTR)

12/11/2015

11/12/2015

An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative Colitis

Product Code: GS-5745
INN or Proposed INN: GS-5745
Other descriptive name: GS-5745

Gilead Sciences, Inc

NULL

Not Recruiting

Female: yes
Male: yes

1600

Phase 2;Phase 3

684

EUCTR2015-000939-33-CZ
(EUCTR)

11/11/2015

18/08/2015

Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitis compared to Adalimumab SC

Ulcerative Colitis
MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Takeda Development Centre Europe, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

758

Phase 3

685

EUCTR2015-000939-33-DE
(EUCTR)

10/11/2015

30/10/2015

Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitis compared to Adalimumab SC

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Takeda Development Centre Europe, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

758

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

686

EUCTR2015-000939-33-GB
(EUCTR)

06/11/2015

29/10/2015

Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitis compared to Adalimumab SC

Ulcerative Colitis
MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB

Takeda Development Centre Europe, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

758

Phase 3

687

EUCTR2014-005217-24-AT
(EUCTR)

06/11/2015

22/10/2015

An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative Colitis

Product Code: GS-5745
INN or Proposed INN: GS-5745
Other descriptive name: GS-5745

Gilead Sciences, Inc

NULL

Not Recruiting

Female: yes
Male: yes

1600

Phase 2;Phase 3

Ukraine;Ireland;Israel;Colombia;Switzerland;Vietnam;India;Malaysia;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Belgium;Brazil;Iran, Islamic Republic of;Romania;Croatia;Bulgaria;Iceland;Germany;New Zealand;Sweden;Belarus;United States;Philippines;Taiwan;Hong Kong;Slovakia;Spain

688

EUCTR2014-005217-24-LV
(EUCTR)

06/11/2015

03/11/2015

An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative Colitis

Product Code: GS-5745
INN or Proposed INN: GS-5745
Other descriptive name: GS-5745

Gilead Sciences, Inc

NULL

Not Recruiting

Female: yes
Male: yes

1600

Phase 2;Phase 3

Belarus;United States;Philippines;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Israel;Colombia;Switzerland;Vietnam;India;Malaysia;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;Korea, Republic of;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Belgium;Brazil;Iran, Islamic Republic of;Romania;Croatia;Bulgaria;Iceland;Germany;New Zealand;Sweden

689

EUCTR2013-003032-77-PL
(EUCTR)

05/11/2015

28/08/2014

A Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in PediatricSubjects with Moderate to Severe Ulcerative Colitis.

Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB

Abbvie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

United States;Slovakia;Spain;Austria;Israel;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Poland;Belgium;New Zealand

690

EUCTR2014-005606-38-DK
(EUCTR)

02/11/2015

30/06/2015

A Study to Evaluate the Safety and Efficacy of the Ustekinumab Induction and Maintenance Therapy in Participants with Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Janssen-Cilag International NV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

951

Phase 3

Serbia;United States;Slovakia;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Australia;South Africa;Bulgaria;Netherlands;Germany;New Zealand;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

691

EUCTR2015-000319-41-SK
(EUCTR)

22/10/2015

04/06/2015

The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC).

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Induction and Maintenance Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of RPC1063 in Ulcerative Colitis

ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Celgene International II Sàrl (CIS II)

NULL

Not Recruiting

Female: yes
Male: yes

1050

Phase 3

692

EUCTR2014-005606-38-SK
(EUCTR)

22/10/2015

07/07/2015

A Study to Evaluate the Safety and Efficacy of the Ustekinumab Induction and Maintenance Therapy in Participants with Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Trade Name: STELARA ®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab

Janssen-Cilag International NV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

951

Phase 3

693

EUCTR2014-005606-38-BG
(EUCTR)

21/10/2015

03/09/2015

A Study to Evaluate the Safety and Efficacy of the Ustekinumab Induction and Maintenance Therapy in Participants with Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Janssen-Cilag International NV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

951

Phase 3

Serbia;United States;Slovakia;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Australia;Denmark;Bulgaria;South Africa;Netherlands;Germany;New Zealand;Korea, Republic of

694

EUCTR2014-005635-14-LT
(EUCTR)

21/10/2015

03/07/2015

Open-label, multi-centre, proof of concept phase IIa clinical trial on the efficacy and tolerability of an 8 week oral treatment with once daily 9 mg budesonide in patients with active ulcerative colitis

Patients with active ulcerative colitis
MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Budesonide 9 mg capsules, hard (BUX-PV)
INN or Proposed INN: BUDESONIDE

Dr. Falk Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Hungary;Lithuania;Latvia

695

EUCTR2015-001600-64-CZ
(EUCTR)

14/10/2015

31/07/2015

The purpose of this study is to determine whether long-term RPC1063 is safe and effective in the treatment of ulcerative colitis (UC).

A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of long-term RPC1063 in Ulcerative Colitis

Celgene International II Sàrl

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1350

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

696

EUCTR2015-001600-64-SK
(EUCTR)

13/10/2015

27/08/2015

The purpose of this study is to determine whether long-term RPC1063 is safe and effective in the treatment of ulcerative colitis (UC).

A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of long-term RPC1063 in Ulcerative Colitis

Celgene International II Sàrl

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1350

Phase 3

United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;Australia;South Africa;Djibouti;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand

697

EUCTR2013-001205-84-AT
(EUCTR)

13/10/2015

02/09/2015

LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo vs. mesalamine for maintenance of remission in patients with ulcerative colitis

Maintenance of remission in ulcerative colitis (UC)
MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Dr. Falk Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 3

Slovakia;Ukraine;Lithuania;Austria;Russian Federation;Israel;Switzerland;Czech Republic;Hungary;Belgium;Poland;Germany;Latvia;Netherlands

698

EUCTR2014-002981-64-NL
(EUCTR)

12/10/2015

19/05/2015

Clinical trial that will compare the efficacy and safety of apremilast versus placebo, in patients with active ulcerative colitis, a chronic inflammatory of the colon of unknown origin

A PHASE 2, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF APREMILAST (CC-10004) FOR TREATMENT OF SUBJECTS WITH ACTIVE ULCERATIVE COLITIS

Subjects with active ulcerative colitis
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Celgene Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

165

Phase 2

United States;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Netherlands;Germany;New Zealand

699

EUCTR2015-001600-64-HU
(EUCTR)

12/10/2015

01/09/2015

The purpose of this study is to determine whether long-term RPC1063 is safe and effective in the treatment of ulcerative colitis (UC).

A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of long-term RPC1063 in Ulcerative Colitis

Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Celgene International II Sárl (CIS II)

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1350

Phase 3

Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;New Zealand

700

EUCTR2014-005606-38-DE
(EUCTR)

07/10/2015

04/05/2015

A Study to Evaluate the Safety and Efficacy of the Ustekinumab Induction and Maintenance Therapy in Participants with Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Trade Name: STELARA ®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab

Janssen-Cilag International NV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

951

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

701

EUCTR2015-000319-41-BE
(EUCTR)

06/10/2015

24/07/2015

The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC).

Celgene International II Sàrl (CIS II)

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

900

Phase 3

702

EUCTR2014-002981-64-DE
(EUCTR)

29/09/2015

08/06/2015

Clinical trial that will compare the efficacy and safety of apremilast versus placebo, in patients with active ulcerative colitis, a chronic inflammatory of the colon of unknown origin

A PHASE 2, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF APREMILAST (CC-10004) FOR TREATMENT OF SUBJECTS WITH ACTIVE ULCERATIVE COLITIS

Subjects with active ulcerative colitis
MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Celgene Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

165

Phase 2

United States;Slovakia;Ukraine;Russian Federation;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany;Netherlands;New Zealand

703

EUCTR2015-001600-64-GB
(EUCTR)

28/09/2015

06/08/2015

The purpose of this study is to determine whether long-term RPC1063 is safe and effective in the treatment of ulcerative colitis (UC).

A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis (Clinical Study”) - Efficacy and Safety Study of long-term RPC1063 in Ulcerative Colitis

Product Name: 0.25 mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod
Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxyben
Product Name: 1.0 mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod
Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxyben

Celgene International II Sàrl

NULL

Not Recruiting

Female: yes
Male: yes

1350

Phase 3

United States;Belarus;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand

704

EUCTR2014-005606-38-BE
(EUCTR)

24/09/2015

08/07/2015

A Study to Evaluate the Safety and Efficacy of the Ustekinumab Induction and Maintenance Therapy in Participants with Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Trade Name: STELARA ®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab

Janssen-Cilag International NV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

951

Phase 3

705

EUCTR2015-000319-41-DE
(EUCTR)

18/09/2015

02/06/2015

The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC).

Celgene International II Sàrl (CIS II)

NULL

Not Recruiting

Female: yes
Male: yes

1050

Phase 3

Belarus;United States;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;New Zealand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

706

EUCTR2014-005606-38-NL
(EUCTR)

16/09/2015

03/07/2015

A Study to Evaluate the Safety and Efficacy of the Ustekinumab Induction and Maintenance Therapy in Participants with Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Trade Name: STELARA ®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab

Janssen-Cilag International NV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

951

Phase 3

707

EUCTR2015-001954-14-NL
(EUCTR)

14/09/2015

25/08/2015

Efficacy and safety of Infliximab-biosimilar (Inflectra) compared to Infliximab-innovator (Remicade) in patients with inflammatory bowel disease in remission: the SIMILAR Trial”

SIMILAR Trial: Santeon InflixMab biosimILAr ResearchA randomized, controlled, double blind, phase 4 noninferiority trial to assess efficacy of Infliximab-biosimilar (Inflectra) compared to Infliximab-innovator (Remicade) in patients with inflammatory bowel disease in remission. - SIMILAR Trial: Santeon InflixMab biosimILAr Research

ulcerative colitis and Crohn’s disease
MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Inflectra 100 mg powder for concentrate for solution for infusion
Product Name: Inflectra 100 mg powder for concentrate for solution for infusion
Trade Name: Remicade 100 mg powder for concentrate for solution for infusion.
Product Name: Remicade 100 mg powder for concentrate for solution for infusion.
Product Code: EMEA/H/C/000240

Santeon

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

Netherlands

708

EUCTR2014-002981-64-HU
(EUCTR)

14/09/2015

27/05/2015

Clinical trial that will compare the efficacy and safety of apremilast versus placebo, in patients with active ulcerative colitis, a chronic inflammatory of the colon of unknown origin

A PHASE 2, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF APREMILAST (CC-10004) FOR TREATMENT OF SUBJECTS WITH ACTIVE ULCERATIVE COLITIS

Subjects with active ulcerative colitis
MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Celgene Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

165

Phase 2

United States;Slovakia;Ukraine;Turkey;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Poland;Australia;Bulgaria;Netherlands;Germany;New Zealand

709

EUCTR2015-000319-41-CZ
(EUCTR)

14/09/2015

16/06/2015

The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC).

Celgene International II Sàrl (CIS II)

NULL

Not Recruiting

Female: yes
Male: yes

900

Phase 3

710

EUCTR2014-005606-38-CZ
(EUCTR)

27/08/2015

26/06/2015

A Study to Evaluate the Safety and Efficacy of the Ustekinumab Induction and Maintenance Therapy in Participants with Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Janssen-Cilag International NV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

951

Phase 3

Serbia;United States;Slovakia;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Australia;Denmark;South Africa;Bulgaria;Netherlands;Germany;New Zealand;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

711

EUCTR2014-002981-64-IT
(EUCTR)

20/08/2015

05/11/2020

Clinical trial that will compare the efficacy and safety of apremilast versus placebo, in patients with active ulcerative colitis, a chronic inflammatory of the colon of unknown origin

A Phase 2, randomized, placebo-controlled, multicenter study to investigate the efficacy and safety of apremilast (CC-10004) for treatment of subjects with active ulcerative colitis - na

Product Name: Apremilast
Product Code: CC -10004
INN or Proposed INN: APREMILAST
Other descriptive name: APREMILAST
Product Name: Apremilast
Product Code: [CC-10004]
INN or Proposed INN: Apremilast
Other descriptive name: APREMILAST
Product Name: Apremilast
Product Code: CC -10004
INN or Proposed INN: APREMILAST
Other descriptive name: APREMILAST

CELGENE CORPORATION

NULL

Not Recruiting

Female: yes
Male: yes

165

Phase 2

United States;Czechia;Slovakia;Spain;Ukraine;Turkey;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany;Netherlands;New Zealand

712

EUCTR2014-002981-64-CZ
(EUCTR)

13/08/2015

05/05/2015

Clinical trial that will compare the efficacy and safety of apremilast versus placebo, in patients with active ulcerative colitis, a chronic inflammatory of the colon of unknown origin

A PHASE 2, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF APREMILAST (CC-10004) FOR TREATMENT OF SUBJECTS WITH ACTIVE ULCERATIVE COLITIS

Subjects with active ulcerative colitis
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Celgene Corporation

NULL

Not Recruiting

Female: yes
Male: yes

165

Phase 2

United States;Slovakia;Ukraine;Russian Federation;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany;Netherlands;New Zealand

713

EUCTR2014-005606-38-HU
(EUCTR)

12/08/2015

16/06/2015

A Study to Evaluate the Safety and Efficacy of the Ustekinumab Induction and Maintenance Therapy in Participants with Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Trade Name: STELARA ®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab

Janssen-Cilag International NV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

951

Phase 3

Serbia;United States;Slovakia;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Australia;Denmark;South Africa;Bulgaria;Netherlands;Germany;New Zealand;Korea, Republic of

714

EUCTR2015-000319-41-GB
(EUCTR)

10/08/2015

13/07/2015

The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC).

Celgene International II Sàrl

NULL

Not Recruiting

Female: yes
Male: yes

900

Phase 3

715

EUCTR2015-000319-41-HU
(EUCTR)

10/08/2015

05/06/2015

The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC).

ulcerative colitis
MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Celgene International II Sárl (CIS II)

NULL

Not Recruiting

Female: yes
Male: yes

900

Phase 3

Belarus;United States;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;New Zealand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

716

EUCTR2014-004887-39-PL
(EUCTR)

08/08/2015

07/07/2015

A study comparing the use of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects with Rheumatoid Arthritis

An Open-labelled, Single-arm, Multicentre Clinical Study to Evaluate the Usability and Safety of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects with Rheumatoid Arthritis

Subjects with Rheumatoid Arthritis. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), Axial spondyloarthritis without radiographic evidence of AS, psoriasis (Ps), psoriatic arthritis (PsA), and ulcerative colitis (UC).
MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Code: SB5
INN or Proposed INN: ADALIMUMAB
Product Code: SB5
INN or Proposed INN: ADALIMUMAB

Samsung Bioepis Co., Ltd

NULL

Not Recruiting

Female: yes
Male: yes

Poland

717

EUCTR2014-005635-14-HU
(EUCTR)

29/07/2015

03/06/2015

Patients with active ulcerative colitis
MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Budesonide 9 mg capsules, hard (BUX-PV)
INN or Proposed INN: BUDESONIDE

Dr. Falk Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Hungary;Lithuania;Latvia

718

EUCTR2014-005606-38-AT
(EUCTR)

20/07/2015

16/06/2015

A Study to Evaluate the Safety and Efficacy of the Ustekinumab Induction and Maintenance Therapy in Participants with Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Trade Name: STELARA ®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab

Janssen-Cilag International NV

NULL

Not Recruiting

Female: yes
Male: yes

951

Phase 3

719

EUCTR2014-005635-14-LV
(EUCTR)

10/07/2015

23/02/2015

Product Name: Budesonide 9 mg capsules, hard (BUX-PV)
INN or Proposed INN: BUDESONIDE

Dr. Falk Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Hungary;Lithuania;Latvia

720

JPRN-UMIN000018075

2015/06/26

25/06/2015

Significance of optimal therapy for ulcerative colitis patients with clinical remission who have colonic active lesions

Ulcerative colitis

normal dosage of 5-ASA (dosage for maintenance therapy) to maximaum dosage of 5-ASA
no optimized therapy

Center for Diagnostic and Therapeutic Endoscopy,Keio University

NULL

Complete: follow-up complete

20years-old

Not applicable

Male and Female

100

Not selected

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

721

EUCTR2014-005635-14-DE
(EUCTR)

08/06/2015

18/02/2015

Product Name: Budesonide 9 mg capsules, hard (BUX-PV)
INN or Proposed INN: BUDESONIDE

Dr. Falk Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Hungary;Lithuania;Latvia;Germany

722

EUCTR2014-000784-41-DK
(EUCTR)

15/04/2015

28/01/2015

Amino acids in j-pouch surgery for ulcerative colitis

Amino acids in ileal pouch-anal anastomosis for ulcerative colitis: a randomized, double-blind placebo-controlled trial - Amino acids in ileal pouch-anal anastomosis

Ileal pouch-anal anastomosis for ulcerative colitis
MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Vaminolac, komb.
Product Name: Vaminolac, komb.
INN or Proposed INN: Vaminolac, komb.
Other descriptive name: Vaminolac, komb.

Department of Medicine and Endocrinology

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

Denmark

723

EUCTR2013-000366-11-RO
(EUCTR)

25/03/2015

11/03/2015

Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05.

A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC)

Product Code: TP05
INN or Proposed INN: MESALAZINE
Trade Name: Asacol
INN or Proposed INN: MESALAZINE

Tillotts Pharma AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

800

Serbia;Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden

724

EUCTR2013-001205-84-SK
(EUCTR)

23/03/2015

05/02/2015

LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo vs. mesalamine for maintenance of remission in patients with ulcerative colitis

Maintenance of remission in ulcerative colitis (UC)
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Dr. Falk Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 3

Slovakia;Ukraine;Lithuania;Austria;Russian Federation;Israel;Switzerland;Czech Republic;Hungary;Belgium;Poland;Germany;Latvia;Netherlands

725

EUCTR2013-004435-72-BG
(EUCTR)

16/03/2015

06/11/2014

An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase II/III studies

AN OPEN LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE II/III STUDIES - Cottonwood

Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2100

Phase 3

Serbia;Portugal;United States;Philippines;Hong Kong;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Switzerland;Vietnam;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

726

EUCTR2014-002579-27-IT
(EUCTR)

03/03/2015

19/01/2015

Pilot study on the efficacy of golimumab in normalizing the symptoms and lesions of the colon-rectum in patients with ulcerative colitis who only respond to therapy with cortisone

Pilot study on the efficacy of golimumab in the induction and maintenance of clinical and endoscopic remission in patients with steroid-dependent ulcerative colitis. - UC-GOL

active steroid-dependent ulcerative colitis
MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: SIMPONI
Product Name: SIMPONI
Product Code: NA
INN or Proposed INN: GOLIMUMAB

Istituto Clinico Humanitas

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 4

Italy

727

EUCTR2013-001744-65-NL
(EUCTR)

02/03/2015

07/08/2014

A clinical trial to investigate the safety and effectiveness of MMX Mesalamine/mesalazine in Children and Adolescents aged 5-17 years who have mild to moderate Ulcerative Colitis

Mild to Moderate Ulcerative Colitis
MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Shire Devlopment LLC

NULL

Not Recruiting

Female: yes
Male: yes

128

Phase 3

United States;Hungary;Slovakia;Canada;Belgium;Poland;Israel;Germany;Netherlands;United Kingdom

728

NCT02412085
(ClinicalTrials.gov)

March 2015

26/3/2015

Golimumab in Steroid-dependent Ulcerative Colitis: Induction and Maintenance of Clinical and Endoscopic Remission

Pilot Study to Evaluate the Efficacy of Golimumab for Induction and Maintenance of Clinical and Endoscopic Remission in Patients With Steroid-dependent Ulcerative Colitis

Colitis, Ulcerative

Drug: Golimumab

Istituto Clinico Humanitas

NULL

Recruiting

18 Years

65 Years

Both

100

Phase 4

Italy

729

EUCTR2013-004435-72-IT
(EUCTR)

27/02/2015

29/09/2014

An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase III studies

AN OPEN LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE III STUDIES - Cottonwood

Ulcerative colitis
MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: ND
Other descriptive name: ETROLIZUMAB

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2568

Phase 3

Serbia;Portugal;United States;Philippines;Hong Kong;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Colombia;Switzerland;Italy;Vietnam;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden

730

EUCTR2013-001205-84-LV
(EUCTR)

26/02/2015

23/12/2014

LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo vs. mesalamine for maintenance of remission in patients with ulcerative colitis

Dr. Falk Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 3

Slovakia;Ukraine;Lithuania;Austria;Russian Federation;Israel;Switzerland;Czech Republic;Hungary;Belgium;Poland;Latvia;Germany;Netherlands

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

731

EUCTR2013-004435-72-DE
(EUCTR)

06/02/2015

18/07/2014

An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase II/III studies

AN OPEN LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE II/III STUDIES - Cottonwood

Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2100

Phase 3

732

EUCTR2013-002042-36-FR
(EUCTR)

04/02/2015

22/06/2015

A Study to Evaluate the Accuracy of the Length-109 Probe Set Panel (a Genetic Test) in Predicting Response to Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis

A Phase 2a Open-label Study to Evaluate Prediction of Response to Golimumab Using a Transcriptomic Profile in Subjects with Moderately to Severely Active Ulcerative Colitis - PROgECT

Moderately to Severely Active Ulcerative Colitis
MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Simponi
Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: GOLIMUMAB
Trade Name: Simponi
Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: GOLIMUMAB

Janssen Biologics B.V.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

100

Phase 2a

United States;Ukraine;Israel;Russian Federation;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Germany;Netherlands

733

EUCTR2013-004435-72-NL
(EUCTR)

28/01/2015

04/08/2014

An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase II/III studies

AN OPEN LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE II/III STUDIES - Cottonwood

Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2100

Phase 3

Serbia;Portugal;United States;Philippines;Hong Kong;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Switzerland;Vietnam;France;Malaysia;Australia;Denmark;South Africa;Latvia;Netherlands;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden

734

EUCTR2014-001893-32-PL
(EUCTR)

20/01/2015

22/10/2014

Placebo-controlled study to assess efficicay, safety and tolerability and to investigate the pharmacokinetics of GLPG1205 in subjects with moderate to severe Ulcerative Colitis

Phase II, Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of GLPG1205 in Patients with Moderate to Severe Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: GLPG1205
Product Code: G321605
Other descriptive name: GLPG1205

Galapagos NV

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Hungary;Czech Republic;Belgium;Poland;Russian Federation;Germany

735

EUCTR2013-001205-84-PL
(EUCTR)

20/01/2015

22/09/2014

LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo vs. mesalamine for maintenance of remission in patients with ulcerative colitis

Dr. Falk Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 3

Slovakia;Ukraine;Lithuania;Austria;Russian Federation;Israel;Switzerland;Czech Republic;Hungary;Poland;Belgium;Germany;Latvia;Netherlands

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

736

EUCTR2014-001893-32-CZ
(EUCTR)

19/01/2015

18/09/2014

Placebo-controlled study to assess efficicay, safety and tolerability and to investigate the pharmacokinetics of GLPG1205 in subjects with moderate to severe Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: GLPG1205
Product Code: G321605
Other descriptive name: GLPG1205

Galapagos NV

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Hungary;Czech Republic;Poland;Belgium;Russian Federation;Germany

737

EUCTR2013-001682-16-BE
(EUCTR)

15/01/2015

22/04/2014

Ulcerative colitis
MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

840

Phase 3

United States;Hungary;Canada;Poland;Spain;Belgium;Israel;Netherlands;Germany;Italy;Japan;Switzerland

738

EUCTR2013-001205-84-DE
(EUCTR)

13/01/2015

08/08/2014

LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo vs. mesalamine for maintenance of remission in patients with ulcerative colitis

Maintenance of remission in ulcerative colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Dr. Falk Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 3

Slovakia;Ukraine;Lithuania;Austria;Russian Federation;Israel;Switzerland;Czech Republic;Hungary;Belgium;Poland;Germany;Latvia;Netherlands

739

EUCTR2013-004282-14-NL
(EUCTR)

13/01/2015

04/08/2014

A study of the effectiveness (efficacy) and safety of etrolizumab compared with infliximab in ulcerative colitis patients who have not previously received TNF inhibitors

PHASE III, RANDOMIZED, MULTICENTER DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OFETROLIZUMAB COMPARED WITH INFLIXIMAB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - GARDENIA

Product Name: Etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB
Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

720

Phase 3

Portugal;Philippines;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;Vietnam;France;Czech Republic;Hungary;Canada;Belgium;Singapore;Romania;South Africa;Netherlands;Germany;Norway;Sweden;Korea, Republic of

740

EUCTR2013-004277-27-BG
(EUCTR)

12/01/2015

06/10/2014

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

350

Phase 3

United States;Greece;Ukraine;Turkey;Lithuania;Russian Federation;Colombia;Czech Republic;Hungary;Argentina;Poland;Brazil;Malaysia;Croatia;Australia;Bulgaria;Latvia;New Zealand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

741

EUCTR2013-004279-11-BG
(EUCTR)

12/01/2015

06/10/2014

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

350

Phase 3

United States;Serbia;Estonia;Hong Kong;Slovakia;Ukraine;Russian Federation;France;Mexico;Argentina;Brazil;Poland;Australia;Bulgaria

742

EUCTR2013-004435-72-PT
(EUCTR)

09/01/2015

23/07/2014

An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase II/III studies

AN OPEN LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE II/III STUDIES - Cottonwood

Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2100

Phase 3

Serbia;United States;Portugal;Philippines;Hong Kong;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Switzerland;Vietnam;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden

743

EUCTR2013-004282-14-PT
(EUCTR)

09/01/2015

23/07/2014

A study to evaluate the effectiveness (efficacy) and safety of etrolizumab compared with infliximab in patients with moderate to severe ulcerative colitis who have not previously received TNF inhibitors

PHASE III, RANDOMIZED, MULTICENTER DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ETROLIZUMAB COMPARED WITH INFLIXIMAB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - GARDENIA

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

390

Phase 3

Portugal;Philippines;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;Vietnam;France;Czech Republic;Hungary;Canada;Belgium;Singapore;Romania;South Africa;Norway;Netherlands;Germany;Korea, Republic of;Sweden

744

NCT02289417
(ClinicalTrials.gov)

January 8, 2015

10/11/2014

Efficacy and Safety Study of Apremilast to Treat Active Ulcerative Colitis

A Phase 2, Randomized, Placebo-controlled, Multicenter Study to Investigate the Efficacy and Safety of Apremilast (CC-10004) for Treatment of Subjects With Active Ulcerative Colitis

Ulcerative Colitis

Drug: Apremilast;Drug: Placebo

Amgen

NULL

Completed

18 Years

N/A

All

170

Phase 2

United States;Australia;Bulgaria;Canada;Czechia;France;Germany;Hungary;Italy;Netherlands;New Zealand;Poland;Russian Federation;Ukraine;Czech Republic

745

EUCTR2013-004435-72-BE
(EUCTR)

22/12/2014

27/08/2014

An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase II/III studies

AN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE II/III STUDIES - Cottonwood

Product Name: etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: ETROLIZUMAB
Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2100

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

746

EUCTR2013-004435-72-ES
(EUCTR)

22/12/2014

11/08/2014

An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase III studies

AN OPEN LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE III STUDIES

Product Name: etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: -
Other descriptive name: ETROLIZUMAB

Roche Farma S.A. en nombre de F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2568

Phase 3

747

EUCTR2014-004740-35-DK
(EUCTR)

19/12/2014

25/11/2014

Loperamide vs. Placebo's effect on Ileostomy output

Loperamide vs. Placebo's effect on ileostomy output: A clincal randomized patientblinded crossover study

Patients with ileostomy because of ulcerative colitis, rectal cancer or short bowel syndrom
MedDRA version: 17.1;Level: LLT;Classification code 10012727;Term: Diarrhea;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Imolope
Product Name: Imolope
Product Code: A07DA03
INN or Proposed INN: LOPERAMIDE

Department of surgery, Odense University Hospital

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

Denmark

748

EUCTR2013-004280-31-DK
(EUCTR)

17/12/2014

29/07/2014

PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (MAINTENANCE OF REMISSION) AND SAFETY OF ETROLIZUMABCOMPARED WITH PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - Laurel

Product Name: etrolizumab
Product Code: Ro 549-0261/F04
Other descriptive name: ETROLIZUMAB

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

350

Phase 3

United States;Hungary;Czech Republic;Slovakia;Canada;Poland;Denmark;South Africa;Israel;Germany

749

EUCTR2014-001893-32-DE
(EUCTR)

15/12/2014

24/09/2014

Placebo-controlled study to assess efficacy, safety and tolerability and to investigate the pharmacokinetics of GLPG1205 in subjects with moderate to severe Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: GLPG1205
Product Code: G321605
Other descriptive name: GLPG1205

Galapagos NV

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Hungary;Czech Republic;Poland;Belgium;Russian Federation;Germany

750

EUCTR2014-003262-25-PT
(EUCTR)

12/12/2014

20/11/2014

Study to correlate a new biomarker (ST2) with clinical activity in Ulcerative Colitis patients under golimumab

An open label, single group assignment design study to correlate soluble ST2 with clinical, endoscopic and histological activity in moderate to severe Ulcerative Colitis patients under golimumab - EVOLUTION

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

Portugal

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

751

EUCTR2013-004282-14-BE
(EUCTR)

11/12/2014

27/08/2014

PHASE III, RANDOMIZED, MULTICENTER DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ETROLIZUMAB COMPARED WITH INFLIXIMAB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - GARDENIA

Product Name: Etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB
Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

390

Phase 3

Portugal;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Singapore;Romania;South Africa;Norway;Netherlands;Germany;Korea, Republic of;Sweden

752

EUCTR2013-004277-27-GR
(EUCTR)

08/12/2014

Ulcerative Colitis
MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

350

Phase 3

United States;Greece;Ukraine;Turkey;Lithuania;Russian Federation;Colombia;Czech Republic;Hungary;Argentina;Brazil;Malaysia;Poland;Croatia;Australia;Bulgaria;Latvia;New Zealand

753

EUCTR2014-001893-32-HU
(EUCTR)

08/12/2014

18/09/2014

Placebo-controlled study to assess efficicay, safety and tolerability and to investigate the pharmacokinetics of GLPG1205 in subjects with moderate to severe Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: GLPG1205
Product Code: G321605
Other descriptive name: GLPG1205

Galapagos NV

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Czech Republic;Hungary;Poland;Belgium;Russian Federation;Germany

754

EUCTR2013-001682-16-PL
(EUCTR)

08/12/2014

22/09/2014

Trade Name: Humira 40 mg/0.8 ml solution for injection
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

840

Phase 3

United States;Slovakia;Spain;Austria;Israel;Switzerland;Italy;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Germany;Netherlands;Japan

755

EUCTR2013-003032-77-HU
(EUCTR)

04/12/2014

30/12/2013

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Ulcerative Colitis.

Ulcerative colitis
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

225

Phase 3

United States;Slovakia;Spain;Austria;Israel;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;New Zealand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

756

EUCTR2013-004435-72-FR
(EUCTR)

02/12/2014

22/06/2015

An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase III studies

AN OPEN LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE III STUDIES

Product Name: etrolizumab
Product Code: Ro 549-0261/F04
Other descriptive name: ETROLIZUMAB

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2568

Phase 3

757

EUCTR2013-001682-16-NL
(EUCTR)

28/11/2014

01/05/2014

Trade Name: Humira 40 mg/0.8 ml solution for injection
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

840

Phase 3

United States;Slovakia;Spain;Austria;Israel;Switzerland;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Japan

758

EUCTR2013-004282-14-ES
(EUCTR)

25/11/2014

06/08/2014

A study of the effectiveness (efficacy) and safety of etrolizumab compared with infliximab in ulcerative colitis patients who have not previously received TNF inhibitors

Ulcerative Colitis
MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB
Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB

Roche Farma S.A. en nombre de F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

720

Phase 3

Portugal;Philippines;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;Vietnam;Czech Republic;Hungary;Canada;Belgium;Singapore;Romania;South Africa;Norway;Netherlands;Germany;Korea, Republic of;Sweden

759

EUCTR2013-004280-31-DE
(EUCTR)

24/11/2014

30/07/2014

Ulcerative colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

350

Phase 3

United States;Slovakia;Ukraine;Israel;Italy;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Denmark;South Africa;Germany

760

EUCTR2014-001893-32-BE
(EUCTR)

24/11/2014

18/09/2014

Placebo-controlled study to assess efficicay, safety and tolerability and to investigate the pharmacokinetics of GLPG1205 in subjects with moderate to severe Ulcerative Colitis

Product Name: GLPG1205
Product Code: G321605
Other descriptive name: GLPG1205

Galapagos NV

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Hungary;Czech Republic;Poland;Belgium;Russian Federation;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

761

EUCTR2013-004278-88-BE
(EUCTR)

21/11/2014

10/06/2014

A study to investigate the effectiveness (efficacy) and safety of etrolizumab in ulcerative colitis patients who have been previously exposed to TNF inhibitors.

PHASE III, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF THE EFFICACY AND SAFETY OF ETROLIZUMAB DURING INDUCTION AND MAINTENANCE IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO HAVE BEEN PREVIOUSLY EXPOSED TO TNF INHIBITORS - HICKORY

Product Name: etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: ETROLIZUMAB
Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

605

Phase 3

762

EUCTR2013-004278-88-NL
(EUCTR)

19/11/2014

23/06/2014

A study to investigate the effectiveness (efficacy) and safety of etrolizumab in ulcerative colitis patients who have been previously exposed to TNF inhibitors.

Product Name: etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: ETROLIZUMAB
Other descriptive name: rhuMAb Beta7, Anti Beta 7, PRO145223

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

605

Phase 3

United States;Greece;Spain;Lithuania;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Australia;Denmark;Netherlands;Germany;Korea, Republic of

763

EUCTR2013-004435-72-SK
(EUCTR)

13/11/2014

20/10/2014

An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase II/III studies

AN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE II/III STUDIES - Cottonwood

Product Name: etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: ETROLIZUMAB
Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2100

Phase 3

United States;Serbia;Portugal;Philippines;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Colombia;Switzerland;Italy;Vietnam;France;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden

764

EUCTR2013-004279-11-SK
(EUCTR)

13/11/2014

08/10/2014

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

350

Phase 3

Serbia;United States;Estonia;Hong Kong;Slovakia;Ukraine;Russian Federation;France;Mexico;Argentina;Brazil;Poland;Australia;Bulgaria

765

EUCTR2013-004282-14-DE
(EUCTR)

10/11/2014

18/07/2014

Product Name: Etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB
Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

390

Phase 3

Portugal;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Singapore;Romania;South Africa;Germany;Netherlands;Norway;Sweden;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

766

EUCTR2013-004282-14-IT
(EUCTR)

10/11/2014

16/09/2014

A study of the effectiveness (efficacy) and safety of etrolizumab compared with infliximab in ulcerative colitis patients who have not previously received TNF inhibitors

Product Name: Etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB
Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

720

Phase 3

767

EUCTR2013-004435-72-DK
(EUCTR)

07/11/2014

21/07/2014

An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase II/III studies

AN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE II/III STUDIES - Cottonwood

Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2100

Phase 3

768

EUCTR2013-003032-77-CZ
(EUCTR)

06/11/2014

31/07/2014

A Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in PediatricSubjects with Moderate to Severe Ulcerative Colitis.

Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB

Abbvie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

United States;Slovakia;Spain;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;New Zealand

769

EUCTR2013-004435-72-SE
(EUCTR)

05/11/2014

16/07/2014

An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase II/III studies

AN OPEN LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE II/III STUDIES - Cottonwood

Product Name: etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: ETROLIZUMAB
Other descriptive name: ETROLIZUMAB

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2625

Phase 3

Bulgaria;Norway;Germany;New Zealand;Sweden;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Serbia;Portugal;United States;Philippines;Hong Kong;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Switzerland;Vietnam;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico

770

EUCTR2013-003032-77-GB
(EUCTR)

30/10/2014

19/12/2013

A Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Ulcerative Colitis.

Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

United States;Slovakia;Spain;Austria;Israel;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Poland;New Zealand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

771

EUCTR2013-004435-72-HU
(EUCTR)

29/10/2014

30/10/2014

An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase II/III studies

AN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE II/III STUDIES - Cottonwood

Product Name: etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: ETROLIZUMAB
Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2625

Phase 3

772

EUCTR2013-004282-14-HU
(EUCTR)

29/10/2014

30/10/2014

PHASE III, RANDOMIZED, MULTICENTER DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ETROLIZUMAB COMPARED WITH INFLIXIMAB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - GARDENIA

Product Name: Etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB
Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

390

Phase 3

Portugal;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Czech Republic;Canada;Belgium;Singapore;Romania;South Africa;Germany;Netherlands;Norway;Sweden;Korea, Republic of

773

EUCTR2013-004435-72-GB
(EUCTR)

24/10/2014

15/07/2014

An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase II/III studies

AN OPEN LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE II/III STUDIES - Cottonwood

Product Name: etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: ETROLIZUMAB
Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2625

Phase 3

774

EUCTR2013-001744-65-GB
(EUCTR)

22/10/2014

31/03/2014

A clinical trial to investigate the safety and effectiveness of MMX Mesalamine/mesalazine in Children and Adolescents aged 5-17 years who have mild to moderate Ulcerative Colitis

Mild to Moderate Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Shire Development LLC

NULL

Not Recruiting

Female: yes
Male: yes

132

Phase 3

United States;Hungary;Slovakia;Canada;Poland;Belgium;Israel;Netherlands;Germany;United Kingdom;Sweden

775

EUCTR2012-003702-27-BE
(EUCTR)

21/10/2014

04/02/2014

LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis

Randomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 12-weeks add-on treatment with LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis refractory to standard treatment with mesalamine - Phosphatidylcholine (LT-02) vs. placebo for induction of remission in mesalamine-refractory UC

Acute Ulcerative Colitis (UC)
MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: gastro-resistant phosphatidylcholine granules
Product Code: LT-02
INN or Proposed INN: Phosphatidylcholine
Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE

Dr. Falk Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

762

Phase 3

Slovakia;Ukraine;Lithuania;Austria;Israel;Russian Federation;Switzerland;Czech Republic;Hungary;Belgium;Poland;Netherlands;Germany;Latvia

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

776

EUCTR2013-004278-88-DE
(EUCTR)

20/10/2014

06/06/2014

A study to investigate the effectiveness (efficacy) and safety of etrolizumab in ulcerative colitis patients who have been previously exposed to TNF inhibitors.

Product Name: etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: ETROLIZUMAB
Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

605

Phase 3

United States;Greece;Spain;Lithuania;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Denmark;Netherlands;Germany;Korea, Republic of

777

EUCTR2013-001744-65-PL
(EUCTR)

20/10/2014

19/08/2014

A clinical trial to investigate the safety and effectiveness of MMX Mesalamine/mesalazine in Children and Adolescents aged 5-17 years who have mild to moderate Ulcerative Colitis

Shire Devlopment LLC

NULL

Not Recruiting

Female: yes
Male: yes

132

Phase 3

United States;Hungary;Slovakia;Canada;Belgium;Poland;Israel;Netherlands;Germany;United Kingdom;Sweden

778

EUCTR2013-004435-72-NO
(EUCTR)

17/10/2014

06/08/2014

An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase II/III studies

AN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE II/III STUDIES - Cottonwood

Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2100

Phase 3

779

EUCTR2013-004282-14-NO
(EUCTR)

17/10/2014

04/08/2014

A study of the effectiveness (efficacy) and safety of etrolizumab compared with infliximab in ulcerative colitis patients who have not previously received TNF inhibitors

Product Name: Etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB
Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

720

Phase 3

Portugal;Philippines;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;Vietnam;France;Czech Republic;Hungary;Canada;Belgium;Singapore;Romania;South Africa;Norway;Germany;Netherlands;Sweden;Korea, Republic of

780

EUCTR2013-004280-31-CZ
(EUCTR)

07/10/2014

21/07/2014

Product Name: etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

350

Phase 3

United States;Slovakia;Ukraine;Israel;Italy;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Denmark;South Africa;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

781

EUCTR2013-004279-11-EE
(EUCTR)

03/10/2014

09/09/2014

Ulcerative Colitis
MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

350

Phase 3

United States;Serbia;Estonia;Hong Kong;Slovakia;Ukraine;Russian Federation;France;Mexico;Argentina;Brazil;Poland;Australia;Bulgaria

782

EUCTR2013-004435-72-CZ
(EUCTR)

02/10/2014

21/07/2014

An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase II/III studies

AN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE II/III STUDIES - Cottonwood

Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2100

Phase 3

783

EUCTR2013-004435-72-GR
(EUCTR)

30/09/2014

20/08/2014

An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase III studies

AN OPEN LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE III STUDIES

Product Name: etrolizumab
Product Code: Ro 549-0261/F04
Other descriptive name: ETROLIZUMAB

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2568

Phase 3

784

EUCTR2012-003702-27-NL
(EUCTR)

30/09/2014

14/04/2014

LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis

Product Name: gastro-resistant phosphatidylcholine granules
Product Code: LT-02
INN or Proposed INN: Phosphatidylcholine
Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE

Dr. Falk Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

762

Phase 3

Slovakia;Ukraine;Lithuania;Austria;Israel;Russian Federation;Switzerland;Czech Republic;Hungary;Poland;Belgium;Netherlands;Germany;Latvia

785

EUCTR2013-004277-27-LT
(EUCTR)

30/09/2014

22/07/2014

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

350

Phase 3

United States;Greece;Ukraine;Turkey;Lithuania;Russian Federation;Colombia;Czech Republic;Hungary;Argentina;Poland;Brazil;Malaysia;Croatia;Australia;Bulgaria;Latvia;New Zealand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

786

EUCTR2013-004435-72-LT
(EUCTR)

30/09/2014

22/07/2014

An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase II/III studies

AN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE II/III STUDIES - Cottonwood

Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2100

Phase 3

Serbia;Portugal;United States;Philippines;Hong Kong;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Switzerland;Vietnam;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden

787

EUCTR2013-004282-14-GB
(EUCTR)

29/09/2014

15/07/2014

PHASE III, RANDOMIZED, MULTICENTER DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ETROLIZUMAB COMPARED WITH INFLIXIMAB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - GARDENIA

Product Name: Etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB
Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

390

Phase 3

Portugal;Spain;Austria;Israel;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Singapore;Romania;South Africa;Germany;Netherlands;Norway;Sweden;Korea, Republic of

788

EUCTR2013-002042-36-NL
(EUCTR)

24/09/2014

13/06/2014

A Study to Evaluate the Accuracy of the Length-109 Probe Set Panel (a Genetic Test) in Predicting Response to Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis

A Phase 2a Open-label Study to Evaluate Prediction of Response to Golimumab Using a Transcriptomic Profile in Subjects with Moderately to Severely Active Ulcerative Colitis - PROgECT

Moderately to Severely Active Ulcerative Colitis
MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Simponi
Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: GOLIMUMAB
Trade Name: Simponi
Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: GOLIMUMAB

Janssen Biologics B.V.

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 2a

United States;Ukraine;Israel;Russian Federation;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Netherlands;Germany

789

EUCTR2013-001744-65-HU
(EUCTR)

24/09/2014

15/07/2014

A clinical trial to investigate the safety and effectiveness of MMX Mesalamine/mesalazine in Children and Adolescents aged 5-17 years who have mild to moderate Ulcerative Colitis

Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets
Product Name: Mezavant XL
Product Code: SPD476
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalazine
Product Code: SPD476
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalazine
Product Code: SPD476
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalazine

Shire Devlopment LLC

NULL

Not Recruiting

Female: yes
Male: yes

132

Phase 3

United States;Hungary;Slovakia;Canada;Poland;Belgium;Israel;Netherlands;Germany;United Kingdom

790

EUCTR2013-001682-16-DE
(EUCTR)

22/09/2014

10/04/2014

Trade Name: Humira 40 mg/0.8 ml solution for injection
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

840

Phase 3

United States;Slovakia;Spain;Austria;Israel;Switzerland;Italy;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Germany;Netherlands;Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

791

EUCTR2013-004278-88-GR
(EUCTR)

22/09/2014

03/06/2014

A study to investigate the effectiveness (efficacy) and safety of etrolizumab in ulcerative colitis patients who are not responding to treatment with or are intolerant to TNF inhibitors.

Product Name: etrolizumab
Product Code: Ro 549-0261/F04
Other descriptive name: ETROLIZUMAB

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

800

Phase 3

792

EUCTR2013-004435-72-EE
(EUCTR)

19/09/2014

29/07/2014

An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase III studies

AN OPEN LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE II/III STUDIES - Cottonwood

Product Name: etrolizumab
Product Code: Ro 549-0261/F04
Other descriptive name: ETROLIZUMAB

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2625

Phase 3

793

EUCTR2013-004280-31-HU
(EUCTR)

19/09/2014

31/07/2014

Product Name: etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

350

Phase 3

United States;Slovakia;Ukraine;Israel;Italy;Hungary;Czech Republic;Mexico;Canada;Poland;Brazil;Denmark;South Africa;Germany

794

EUCTR2013-004282-14-CZ
(EUCTR)

16/09/2014

18/07/2014

PHASE III, RANDOMIZED, MULTICENTER DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ETROLIZUMAB COMPARED WITH INFLIXIMAB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - GARDENIA

Product Name: Etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB
Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

390

Phase 3

Portugal;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Singapore;Romania;South Africa;Norway;Netherlands;Germany;Korea, Republic of;Sweden

795

EUCTR2013-001744-65-SK
(EUCTR)

11/09/2014

17/07/2014

A clinical trial to investigate the safety and effectiveness of MMX Mesalamine/mesalazine in Children and Adolescents aged 5-17 years who have mild to moderate Ulcerative Colitis

Mild to Moderate Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Shire Devlopment LLC

NULL

Not Recruiting

Female: yes
Male: yes

132

Phase 3

United States;Hungary;Slovakia;Canada;Poland;Belgium;Israel;Netherlands;Germany;United Kingdom;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

796

EUCTR2013-002042-36-BG
(EUCTR)

11/09/2014

30/04/2014

A Study to Evaluate the Accuracy of the Length-109 Probe Set Panel (a Genetic Test) in Predicting Response to Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis

A Phase 2a Open-label Study to Evaluate Prediction of Response to Golimumab Using a Transcriptomic Profile in Subjects with Moderately to Severely Active Ulcerative Colitis - PROgECT

Moderately to Severely Active Ulcerative Colitis
MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Simponi
Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: GOLIMUMAB
Trade Name: Simponi
Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: GOLIMUMAB

Janssen Biologics B.V.

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 2a

United States;Ukraine;Israel;Russian Federation;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Germany;Netherlands

797

EUCTR2013-003032-77-IT
(EUCTR)

10/09/2014

19/12/2013

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Ulcerative Colitis.

Ulcerative colitis
MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

225

Phase 3

United States;Slovakia;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;New Zealand

798

EUCTR2013-004435-72-LV
(EUCTR)

05/09/2014

22/07/2014

An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase II/III studies

AN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE II/III STUDIES - Cottonwood

Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2625

Phase 3

799

EUCTR2013-004278-88-FR
(EUCTR)

04/09/2014

22/06/2015

A study to investigate the effectiveness (efficacy) and safety of etrolizumab in ulcerative colitis patients who are not responding to treatment with or are intolerant to TNF inhibitors.

Product Name: etrolizumab
Product Code: Ro 549-0261/F04
Other descriptive name: ETROLIZUMAB

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

800

Phase 3

800

EUCTR2013-000263-88-RO
(EUCTR)

03/09/2014

30/05/2014

A study to evaluate the dose response of JNJ-54781532 in participants with moderately to severely active ulcerative colitis (UC).

A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-response Study Evaluating the Efficacy and Safety of JNJ-54781532 in Subjects with Moderately to Severely Active Ulcerative Colitis

Product Name: JNJ-54781532-AAD-5 mg
INN or Proposed INN: Not available
Other descriptive name: ASP015K
Product Name: JNJ-54781532-AAD-10 mg
INN or Proposed INN: Not available
Other descriptive name: ASP015K
Product Name: JNJ-54781532-AAD-30 mg
INN or Proposed INN: Not available
Other descriptive name: ASP015K

Janssen-Cilag International NV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

220

Phase 2b

France;United States;Hungary;Canada;Poland;Belgium;Ukraine;Romania;Russian Federation;Bulgaria;Netherlands;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

801

EUCTR2013-004282-14-AT
(EUCTR)

03/09/2014

22/07/2014

A study to evaluate the effectiveness (efficacy) and safety of Etrolizumabcompared with Infliximab in patients with moderate to severe ulcerativecolitis who have not previously received TNF inhibitors

Product Name: Etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB
Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

390

Phase 3

Portugal;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Singapore;Romania;South Africa;Germany;Netherlands;Norway;Sweden;Korea, Republic of

802

EUCTR2013-004435-72-AT
(EUCTR)

03/09/2014

22/07/2014

An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase II/III studies

AN OPEN LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE II/III STUDIES - Cottonwood

Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2100

Phase 3

803

EUCTR2013-001682-16-IT
(EUCTR)

02/09/2014

23/04/2014

Trade Name: Humira 40 mg/0.8 ml solution for injection
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

525

Phase 3

United States;Slovakia;Spain;Austria;Israel;Italy;Switzerland;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Germany;Netherlands;Japan

804

EUCTR2013-004278-88-IT
(EUCTR)

01/09/2014

01/07/2014

A study to investigate the effectiveness (efficacy) and safety of etrolizumab in ulcerative colitis patients who are not responding to treatment with or are intolerant to TNF inhibitors.

Product Name: etrolizumab
Product Code: Ro 549-0261/F04
Other descriptive name: ETROLIZUMAB

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

800

Phase 3

805

EUCTR2013-003032-77-BE
(EUCTR)

25/08/2014

02/01/2014

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Ulcerative Colitis.

Abbvie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

225

Phase 3

United States;Slovakia;Spain;Austria;Israel;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;New Zealand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

806

EUCTR2013-001682-16-CZ
(EUCTR)

21/08/2014

18/06/2014

Trade Name: Humira 40 mg/0.8 ml solution for injection
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

840

Phase 3

United States;Slovakia;Spain;Austria;Israel;Switzerland;Italy;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Germany;Netherlands;Japan

807

EUCTR2013-004278-88-DK
(EUCTR)

21/08/2014

10/06/2014

A study to investigate the effectiveness (efficacy) and safety of etrolizumab in ulcerative colitis patients who have been previouslyexposed to TNF inhibitors.

Product Name: etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: ETROLIZUMAB
Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

800

Phase 3

Hungary;United States;Greece;Spain;Lithuania;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Denmark;Australia;Netherlands;Germany;Korea, Republic of

808

EUCTR2014-002056-40-NO
(EUCTR)

12/08/2014

13/06/2014

A study to evaluate the safety and efficacy of switching from regular infliximab to biosimilar infliximab in patients with rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, ulcerative colitis, Crohn's disease and psoriasis

A RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SWITCHING FROM INNOVATOR INFLIXIMAB TO BIOSIMILAR INFLIXIMAB COMPARED WITH CONTINUED TREATMENT WITH INNOVATOR INFLIXIMAB IN PATIENTS WITH RHEUMATOID ARTHRITIS, SPONDYLOARTHRITIS, PSORIATIC ARTHRITIS, ULCERATIVE COLITIS, CROHN’S DISEASEAND CHRONIC PLAQUE PSORIASISTHE NOR-SWITCH STUDY - NOR_SWITCH

Rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, ulcerative colitis, Crohn’s disease and chronic plaque psoriasis
MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 18.0;Level: LLT;Classification code 10071117;Term: Plaque psoriasis;System Organ Class: 100000004858
MedDRA version: 18.0;Classification code 10037160;Term: Psoriatic arthritis;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 18.0;Classification code 10045365;Term: Ulcerative colitis;Classification code 10002556;Term: Ankylosing spondylitis;Classification code 10071400;Term: Axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Remicade 100 mg pulver til konsentrat til infusjonsvæske, oppløsning
Trade Name: Remsima 100 mg pulver til konsentrat til infusjonsvæske, oppløsning

Diakonhjemmet Hospital AS

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Norway

809

EUCTR2013-004277-27-HR
(EUCTR)

12/08/2014

05/09/2014

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

350

Phase 3

United States;Greece;Ukraine;Turkey;Lithuania;Russian Federation;Colombia;Czech Republic;Hungary;Argentina;Poland;Brazil;Malaysia;Croatia;Australia;Bulgaria;Latvia;New Zealand

810

EUCTR2013-004435-72-HR
(EUCTR)

12/08/2014

05/09/2014

An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase III studies

AN OPEN LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE III STUDIES

Product Name: etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: ETROLIZUMAB
Other descriptive name: ETROLIZUMAB

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2100

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

811

EUCTR2013-004278-88-HU
(EUCTR)

04/08/2014

10/06/2014

A study to investigate the effectiveness (efficacy) and safety of etrolizumab in ulcerative colitis patients who have been previously exposed to TNF inhibitors.

Product Name: etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: ETROLIZUMAB
Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

605

Phase 3

812

EUCTR2013-002042-36-DE
(EUCTR)

31/07/2014

27/05/2014

A Study to Evaluate the Accuracy of the Length-109 Probe Set Panel (a Genetic Test) in Predicting Response to Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis

A Phase 2a Open-label Study to Evaluate Prediction of Response to Golimumab Using a Transcriptomic Profile in Subjects with Moderately to Severely Active Ulcerative Colitis - PROgECT

Trade Name: Simponi
Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: GOLIMUMAB
Trade Name: Simponi
Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: GOLIMUMAB

Janssen Biologics B.V.

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 2a

United States;Ukraine;Israel;Russian Federation;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Germany;Netherlands

813

EUCTR2012-003702-27-PL
(EUCTR)

29/07/2014

20/05/2014

LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis

Acute Ulcerative Colitis (UC)
MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: gastro-resistant phosphatidylcholine granules
Product Code: LT-02
INN or Proposed INN: Phosphatidylcholine
Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE

Dr. Falk Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

762

Phase 3

Slovakia;Ukraine;Lithuania;Austria;Russian Federation;Israel;Switzerland;Czech Republic;Hungary;Poland;Belgium;Germany;Latvia;Netherlands

814

EUCTR2013-004277-27-LV
(EUCTR)

28/07/2014

21/07/2014

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

350

Phase 3

United States;Greece;Ukraine;Turkey;Lithuania;Russian Federation;Colombia;Czech Republic;Hungary;Argentina;Poland;Brazil;Malaysia;Croatia;Australia;Bulgaria;Latvia;New Zealand

815

EUCTR2013-004282-14-FR
(EUCTR)

28/07/2014

22/06/2015

A study of the effectiveness (efficacy) and safety of etrolizumab compared with infliximab in ulcerative colitis patients who have not previously received TNF inhibitors

Ulcerative Colitis
MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB
Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

720

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

816

EUCTR2013-004278-88-ES
(EUCTR)

25/07/2014

13/06/2014

A study to investigate the effectiveness (efficacy) and safety of etrolizumab in ulcerative colitis patients who are not responding to treatment with or are intolerant to TNF inhibitors.

Product Name: etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: -
Other descriptive name: ETROLIZUMAB

Roche Farma S.A en nombre de F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

800

Phase 3

United States;Greece;Spain;Lithuania;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Australia;Denmark;Netherlands;Germany;Korea, Republic of

817

EUCTR2013-001682-16-ES
(EUCTR)

25/07/2014

08/05/2014

Ulcerative colitis
MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

525

Phase 3

United States;Slovakia;Spain;Austria;Israel;Switzerland;Italy;Czech Republic;Hungary;Canada;Poland;Denmark;Germany;Netherlands;Japan

818

JPRN-JapicCTI-142648

22/7/2014

03/09/2014

Study to Evaluate the Safety and Efficacy of Two Drug Regimens in Subjects with Moderate to Severe Ulcerative Colitis

Ulcerative Colitis

Intervention name : adalimumab
INN of the intervention : adalimumab
Dosage And administration of the intervention : subcutaneous injection
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : subcutaneous injection

AbbVie GK

NULL

complete

BOTH

100

Phase 3

Japan, North America, Europe

819

EUCTR2013-002042-36-BE
(EUCTR)

10/07/2014

20/02/2014

A Study to Evaluate the Accuracy of the Length-109 Probe Set Panel (a Genetic Test) in Predicting Response to Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis

A Phase 2a Open-label Study to Evaluate Prediction of Response to Golimumab Using a Transcriptomic Profile in Subjects with Moderately to Severely Active Ulcerative Colitis - PROgECT

Trade Name: Simponi
Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: GOLIMUMAB
Trade Name: Simponi
Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: GOLIMUMAB

Janssen Biologics B.V.

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 2a

United States;Ukraine;Israel;Russian Federation;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Germany;Netherlands

820

EUCTR2013-004278-88-CZ
(EUCTR)

09/07/2014

09/06/2014

A study to investigate the effectiveness (efficacy) and safety of etrolizumab in ulcerative colitis patients who have been previously exposed to TNF inhibitors.

Ulcerative colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

605

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

821

EUCTR2013-001682-16-AT
(EUCTR)

03/07/2014

16/06/2014

Ulcerative colitis
MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Humira 40 mg/0.8 ml solution for injection
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

840

Phase 3

United States;Slovakia;Spain;Austria;Israel;Switzerland;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Germany;Netherlands;Japan

822

EUCTR2013-004278-88-AT
(EUCTR)

02/07/2014

11/06/2014

A study to investigate the effectiveness (efficacy) and safety of etrolizumab in ulcerative colitis patients who have been previously exposed to TNF inhibitors.

PHASE III, DOUBLE BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF THE EFFICACY AND SAFETY OF ETROLIZUMAB DURING INDUCTION AND MAINTENANCE IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO HAVE BEEN PREVIOUSLY EXPOSED TO TNF INHIBITORS - HICKORY

Product Name: etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: Etrolizumab
Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

605

Phase 3

Spain;United States;Greece;Lithuania;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Australia;Denmark;Netherlands;Germany;Korea, Republic of

823

NCT02155335
(ClinicalTrials.gov)

July 1, 2014

2/6/2014

Preference for a Prefilled Syringe or Smartject™ Device for Delivering Golimumab in Participants Suffering From Moderate-to-severe Ulcerative Colitis (MK-8259-027)

Preference for a Prefilled Syringe or Smartject™ Device for Delivering SIMPONI (Golimumab) in Patients Suffering From Moderate to Severe Ulcerative Colitis

Ulcerative Colitis

Drug: Prefilled Syringe delivery of Golimumab;Drug: Smartject Device delivery of Golimumab

Merck Sharp & Dohme Corp.

NULL

Completed

18 Years

N/A

All

100

Phase 4

Belgium

824

EUCTR2013-005013-13-PL
(EUCTR)

25/06/2014

31/03/2014

A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy

A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy

Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis.
MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: SB5
INN or Proposed INN: ADALIMUMAB
Other descriptive name: SB5
Trade Name: Humira ®
Product Name: Humira ®
INN or Proposed INN: ADALIMUMAB

Samsung Bioepis Co., Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

490

Bosnia and Herzegovina;Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;Latvia;United Kingdom;Korea, Republic of

825

EUCTR2013-004278-88-LT
(EUCTR)

19/06/2014

24/04/2014

A study to investigate the effectiveness (efficacy) and safety of etrolizumab in ulcerative colitis patients who have been previously exposed to TNF inhibitors.

PHASE III, DOUBLE BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF THE EFFICACY AND SAFETY OF ETROLIZUMAB DURING INDUCTION AND MAINTENANCE IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO HAVE BEEN PREVIOUSLY EXPOSED TO TNF INHIBITORS - HICKORY

Product Name: etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: ETROLIZUMAB
Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

605

Phase 3

United States;Greece;Spain;Lithuania;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Denmark;Netherlands;Germany;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

826

EUCTR2013-000366-11-SK
(EUCTR)

19/06/2014

21/05/2014

Product Code: TP05
INN or Proposed INN: MESALAZINE
Trade Name: Asacol
INN or Proposed INN: MESALAZINE

Tillotts Pharma AG

NULL

Not Recruiting

Female: yes
Male: yes

800

Phase 3

Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;Hungary;Czech Republic;Canada;Belgium;Poland;Romania;Denmark;Bulgaria;Latvia;Sweden

827

EUCTR2013-001682-16-HU
(EUCTR)

18/06/2014

22/04/2014

Trade Name: Humira 40 mg/0.8 ml solution for injection
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

525

United States;Hungary;Slovakia;Canada;Israel;Japan;Switzerland

828

EUCTR2013-003060-31-BG
(EUCTR)

18/06/2014

10/04/2014

A Placebo Controlled Trial of HMPL-004 in Subjects with Mild to Moderate Active Ulcerative Colitis

A Phase III Double Blind, Multi-Center Placebo Controlled Maintenance Trial of HMPL-004 in Subjects with Mild to Moderate Ulcerative Colitis with Clinical Remission or Response from Induction Therapy. (NATRUL-4)

Ulcerative Colitis (UC)
MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Nutrition Science Partners Limited

NULL

Not Recruiting

Female: yes
Male: yes

460

Phase 3

United States;Hungary;Czech Republic;Poland;Ukraine;Lithuania;Bulgaria;Latvia

829

EUCTR2014-000656-29-BE
(EUCTR)

13/06/2014

05/03/2014

Study to evaluate delivery preference of Simponi (golimumab) by Ulcerative Colitis patients: delivery using a prefilled syringe or the Smartject™ device

Preference for a prefilled syringe or Smartject™ device for delivering SIMPONI (golimumab) in patients suffering from moderate to severe ulcerative colitis - SMART

Ulcerative Colitis
MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

Trade Name: Simponi ® (Golimumab)
Product Name: Simponi (Golimumab)
Product Code: MK-8259
INN or Proposed INN: GOLIMUMAB
Other descriptive name: Simponi
Trade Name: Simponi ® (Golimumab)
Product Name: Simponi (Golimumab)
Product Code: MK-8259
INN or Proposed INN: GOLIMUMAB
Other descriptive name: Simponi

MSD Belgium BVBA/SPRL

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Belgium

830

EUCTR2013-003060-31-PL
(EUCTR)

11/06/2014

19/03/2014

A Placebo Controlled Trial of HMPL-004 in Subjects with Mild to Moderate Active Ulcerative Colitis

Ulcerative Colitis (UC)
MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Nutrition Science Partners Limited

NULL

Not Recruiting

Female: yes
Male: yes

460

Phase 3

United States;Hungary;Czech Republic;Poland;Ukraine;Lithuania;Bulgaria;Latvia

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

831

EUCTR2012-003702-27-SK
(EUCTR)

10/06/2014

06/03/2014

LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis

Acute Ulcerative Colitis (UC)
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: gastro-resistant phosphatidylcholine granules
Product Code: LT-02
INN or Proposed INN: Phosphatidylcholine
Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE

Dr. Falk Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

762

Phase 3

Slovakia;Ukraine;Lithuania;Austria;Russian Federation;Israel;Switzerland;Czech Republic;Hungary;Belgium;Poland;Germany;Latvia;Netherlands

832

EUCTR2013-001682-16-SK
(EUCTR)

10/06/2014

29/04/2014

Trade Name: Humira 40 mg/0.8 ml solution for injection
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

840

Phase 3

United States;Slovakia;Spain;Austria;Israel;Switzerland;Italy;Czech Republic;Hungary;Canada;Poland;Denmark;Germany;Netherlands;Japan

833

EUCTR2013-002042-36-PL
(EUCTR)

09/06/2014

06/05/2014

A Study to Evaluate the Accuracy of the Length-109 Probe Set Panel (a Genetic Test) in Predicting Response to Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis

A Phase 2a Open-label Study to Evaluate Prediction of Response to Golimumab Using a Transcriptomic Profile in Subjects with Moderately to Severely Active Ulcerative Colitis - PROgECT

Moderately to Severely Active Ulcerative Colitis
MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Simponi
Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: GOLIMUMAB
Trade Name: Simponi
Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: GOLIMUMAB

Janssen Biologics B.V.

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 2

United States;Ukraine;Israel;Russian Federation;France;Czech Republic;Hungary;Canada;Poland;Belgium;Bulgaria;Germany;Netherlands

834

EUCTR2013-002042-36-CZ
(EUCTR)

04/06/2014

21/03/2014

A Study to Evaluate the Accuracy of the Length-109 Probe Set Panel (a Genetic Test) in Predicting Response to Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis

A Phase 2a Open-label Study to Evaluate Prediction of Response to Golimumab Using a Transcriptomic Profile in Subjects with Moderately to Severely Active Ulcerative Colitis - PROgECT

Trade Name: Simponi
Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: GOLIMUMAB
Trade Name: Simponi
Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: GOLIMUMAB

Janssen Biologics B.V.

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 2a

United States;Ukraine;Israel;Russian Federation;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Germany;Netherlands

835

EUCTR2012-003702-27-LV
(EUCTR)

20/05/2014

25/03/2014

LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis

Product Name: gastro-resistant phosphatidylcholine granules
Product Code: LT-02
INN or Proposed INN: Phosphatidylcholine
Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE

Dr. Falk Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

762

Phase 3

Slovakia;Ukraine;Lithuania;Austria;Israel;Russian Federation;Switzerland;Czech Republic;Hungary;Belgium;Poland;Latvia;Netherlands;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

836

EUCTR2012-003702-27-HU
(EUCTR)

19/05/2014

07/03/2014

LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis

Acute Ulcerative Colitis (UC)
MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: gastro-resistant phosphatidylcholine granules
Product Code: LT-02
INN or Proposed INN: Phosphatidylcholine
Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE

Dr. Falk Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

762

Phase 3

Slovakia;Ukraine;Lithuania;Austria;Russian Federation;Israel;Switzerland;Hungary;Czech Republic;Belgium;Poland;Germany;Latvia;Netherlands

837

EUCTR2012-003702-27-CZ
(EUCTR)

15/05/2014

24/02/2014

LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis

Product Name: Gastro-resistant phosphatidylcholine granules
Product Code: LT-02
INN or Proposed INN: Phosphatidylcholine
Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE

Dr. Falk Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

762

Phase 3

Slovakia;Ukraine;Lithuania;Austria;Russian Federation;Israel;Switzerland;Czech Republic;Hungary;Belgium;Poland;Germany;Latvia;Netherlands

838

EUCTR2013-002042-36-HU
(EUCTR)

12/05/2014

21/02/2014

A Study to Evaluate the Accuracy of the Length-109 Probe Set Panel (a Genetic Test) in Predicting Response to Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis

A Phase 2a Open-label Study to Evaluate Prediction of Response to Golimumab Using a Transcriptomic Profile in Subjects with Moderately to Severely Active Ulcerative Colitis - PROgECT

Moderately to Severely Active Ulcerative Colitis
MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Simponi
Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: GOLIMUMAB
Trade Name: Simponi
Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: GOLIMUMAB

Janssen Biologics B.V.

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 2a

United States;Ukraine;Israel;Russian Federation;France;Hungary;Czech Republic;Canada;Poland;Belgium;Bulgaria;Netherlands;Germany

839

EUCTR2012-003702-27-LT
(EUCTR)

12/05/2014

19/03/2014

LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis

Product Name: gastro-resistant phosphatidylcholine granules
Product Code: LT-02
INN or Proposed INN: Phosphatidylcholine
Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE

Dr. Falk Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

762

Phase 3

Slovakia;Ukraine;Lithuania;Austria;Israel;Russian Federation;Switzerland;Czech Republic;Hungary;Poland;Belgium;Netherlands;Germany;Latvia

840

EUCTR2012-003702-27-DE
(EUCTR)

08/05/2014

30/12/2013

LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis

Acute Ulcerative Colitis (UC)
MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: gastro-resistant phosphatidylcholine granules
Product Code: LT-02
INN or Proposed INN: Phosphatidylcholine
Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE

Dr. Falk Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

762

Phase 3

Slovakia;Ukraine;Lithuania;Austria;Russian Federation;Israel;Switzerland;Czech Republic;Hungary;Belgium;Poland;Germany;Latvia;Netherlands

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

841

EUCTR2013-005013-13-BG
(EUCTR)

28/04/2014

23/04/2014

A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy

Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis.
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: SB5
INN or Proposed INN: ADALIMUMAB
Other descriptive name: SB5
Trade Name: Humira ®
Product Name: Humira ®
INN or Proposed INN: ADALIMUMAB

Samsung Bioepis Co., Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

490

Phase 3

Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina

842

EUCTR2013-000366-11-BG
(EUCTR)

23/04/2014

06/03/2014

Product Code: TP05
INN or Proposed INN: MESALAZINE
Trade Name: Asacol
INN or Proposed INN: MESALAZINE

Tillotts Pharma AG

NULL

Not Recruiting

Female: yes
Male: yes

800

Phase 3

Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden

843

EUCTR2013-000263-88-BG
(EUCTR)

14/04/2014

17/02/2014

A study to evaluate the dose response of JNJ-54781532 in participants with moderately to severely active ulcerative colitis (UC).

Product Name: JNJ-54781532-AAD-5 mg
Other descriptive name: ASP015K
Product Name: JNJ-54781532-AAD-10 mg
Other descriptive name: ASP015K
Product Name: JNJ-54781532-AAD-30 mg
Other descriptive name: ASP015K

Janssen-Cilag International NV

NULL

Not Recruiting

Female: yes
Male: yes

220

Phase 2

France;United States;Hungary;Canada;Poland;Belgium;Ukraine;Romania;Russian Federation;Bulgaria;Netherlands;Germany

844

EUCTR2013-003060-31-CZ
(EUCTR)

10/04/2014

04/02/2014

A Placebo Controlled Trial of HMPL-004 in Subjects with Mild to Moderate Active Ulcerative Colitis

Nutrition Science Partners Limited

NULL

Not Recruiting

Female: yes
Male: yes

460

Phase 3

United States;Hungary;Czech Republic;Poland;Ukraine;Lithuania;Bulgaria;Latvia

845

EUCTR2012-002030-37-HR
(EUCTR)

09/04/2014

14/10/2014

Study to test whether PF-00547659 is safe and improves symptoms in patients with UC

A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS (TURANDOT) - TURANDOT

Product Code: PF-00547659
INN or Proposed INN: PF-00547659
Other descriptive name: Anti-MAdCAM antibody

Pfizer Inc, 235 East 42nd Street, New York, NY10017, United States

NULL

Not Recruiting

Female: yes
Male: yes

300

Serbia;United States;Slovakia;Spain;Russian Federation;Israel;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Belgium;Poland;Croatia;Bulgaria;Germany;Norway;New Zealand;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

846

EUCTR2013-005013-13-LT
(EUCTR)

08/04/2014

13/02/2014

A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy

Product Name: SB5
INN or Proposed INN: ADALIMUMAB
Other descriptive name: SB5
Trade Name: Humira ®
Product Name: Humira ®
INN or Proposed INN: ADALIMUMAB

Samsung Bioepis Co., Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

490

Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina

847

EUCTR2013-005013-13-CZ
(EUCTR)

03/04/2014

13/02/2014

A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy

Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis.
MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: SB5
INN or Proposed INN: ADALIMUMAB
Other descriptive name: SB5
Trade Name: Humira ®
Product Name: Humira ®
INN or Proposed INN: ADALIMUMAB

Samsung Bioepis Co., Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

490

Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina

848

EUCTR2013-003060-31-HU
(EUCTR)

02/04/2014

31/01/2014

A Placebo Controlled Trial of HMPL-004 in Subjects with Mild to Moderate Active Ulcerative Colitis

Nutrition Science Partners Limited

NULL

Not Recruiting

Female: yes
Male: yes

460

Phase 3

United States;Czech Republic;Hungary;Poland;Ukraine;Lithuania;Bulgaria;Latvia

849

EUCTR2012-003702-27-AT
(EUCTR)

02/04/2014

10/02/2014

LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis

Product Name: gastro-resistant phosphatidylcholine granules
Product Code: LT-02
INN or Proposed INN: Phosphatidylcholine
Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE

Dr. Falk Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

762

Phase 3

Slovakia;Ukraine;Lithuania;Austria;Israel;Russian Federation;Switzerland;Czech Republic;Hungary;Belgium;Poland;Netherlands;Germany;Latvia

850

EUCTR2011-005251-13-EE
(EUCTR)

31/03/2014

15/01/2014

A study to find out more about the effect of AMG 181 in people with moderate to severe ulcerative colitis

A Randomized, Double blind, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Ulcerative Colitis

Moderate to severe Ulcerative Colitis
MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: AMG 181
Product Code: AMG 181
INN or Proposed INN: AMG 181

Amgen Inc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

360

United States;Estonia;Greece;Austria;Russian Federation;United Kingdom;Italy;Switzerland;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Australia;Latvia;Netherlands;Norway;Germany;New Zealand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

851

EUCTR2013-003032-77-ES
(EUCTR)

25/03/2014

27/02/2014

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Ulcerative Colitis.

Ulcerative colitis
MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Abbvie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

225

Phase 3

United States;Slovakia;Spain;Austria;Israel;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;New Zealand

852

EUCTR2013-000366-11-LV
(EUCTR)

14/03/2014

07/02/2014

Ulcerative colitis
MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: TP05
INN or Proposed INN: MESALAZINE
Trade Name: Asacol
INN or Proposed INN: MESALAZINE

Tillotts Pharma AG

NULL

Not Recruiting

Female: yes
Male: yes

800

Phase 3

Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden

853

EUCTR2013-003032-77-SK
(EUCTR)

13/03/2014

23/01/2014

A Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Ulcerative Colitis.

Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Abbvie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

United States;Slovakia;Spain;Austria;Israel;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Poland;New Zealand

854

EUCTR2013-000366-11-LT
(EUCTR)

10/03/2014

22/01/2014

Product Code: TP05
INN or Proposed INN: MESALAZINE
Trade Name: Asacol
INN or Proposed INN: MESALAZINE

Tillotts Pharma AG

NULL

Not Recruiting

Female: yes
Male: yes

800

Phase 3

Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden

855

EUCTR2013-002651-15-NL
(EUCTR)

03/03/2014

18/09/2013

Adjusting the amount of medication (infliximab) in patients suffering from inflammatory bowel disease, using medication levels in blood.

Adjusting infliximab dose in IBD patients in remission, based on infliximab trough levels: the study on Infliximab Levels in IBD patients Steering Treatment, the ILIST pilot - ILIST-study

Crohns diseaseUlcerative colitis
MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Remicade (infliximab)
Product Name: infliximab

Zon MW

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

Netherlands

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

856

EUCTR2011-005251-13-LV
(EUCTR)

03/03/2014

16/01/2014

A study to find out more about the effect of AMG 181 in people with moderate to severe ulcerative colitis

A Randomized, Double blind, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Ulcerative Colitis

Product Name: AMG 181
Product Code: AMG 181
INN or Proposed INN: AMG 181

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

360

Phase 2

857

EUCTR2013-000366-11-HU
(EUCTR)

24/02/2014

28/11/2013

Product Code: TP05
INN or Proposed INN: MESALAZINE
Trade Name: Asacol
INN or Proposed INN: MESALAZINE

Tillotts Pharma AG

NULL

Not Recruiting

Female: yes
Male: yes

800

Phase 3

Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden

858

EUCTR2013-003060-31-LV
(EUCTR)

17/02/2014

16/12/2013

A Placebo Controlled Trial of HMPL-004 in Subjects with Mild to Moderate Active Ulcerative Colitis

Nutrition Science Partners Limited

NULL

Not Recruiting

Female: yes
Male: yes

460

Phase 3

United States;Hungary;Czech Republic;Poland;Ukraine;Lithuania;Bulgaria;Latvia

859

EUCTR2013-003060-31-LT
(EUCTR)

11/02/2014

30/12/2013

A Placebo Controlled Trial of HMPL-004 in Subjects with Mild to Moderate Active Ulcerative Colitis

Nutrition Science Partners Limited

NULL

Not Recruiting

Female: yes
Male: yes

460

Phase 3

United States;Hungary;Czech Republic;Poland;Ukraine;Lithuania;Bulgaria;Latvia

860

EUCTR2013-003032-77-AT
(EUCTR)

29/01/2014

08/01/2014

A Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Ulcerative Colitis.

Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Abbvie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

United States;Slovakia;Spain;Austria;Israel;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Poland;New Zealand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

861

EUCTR2013-000263-88-PL
(EUCTR)

29/01/2014

26/11/2013

A study to evaluate the dose response of JNJ-54781532 in participants with moderately to severely active ulcerative colitis (UC).

Ulcerative Colitis
MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: JNJ-54781532-AAD-5 mg
INN or Proposed INN: Not Assigned
Other descriptive name: ASP015K
Product Name: JNJ-54781532-AAD-10 mg
INN or Proposed INN: Not Assigned
Other descriptive name: ASP015K
Product Name: JNJ-54781532-AAD-30 mg
INN or Proposed INN: Not Assigned
Other descriptive name: ASP015K

Janssen-Cilag International NV

NULL

Not Recruiting

Female: yes
Male: yes

220

Phase 2b

United States;France;Hungary;Canada;Belgium;Poland;Ukraine;Romania;Bulgaria;Russian Federation;Germany;Netherlands

862

EUCTR2013-004583-56-GB
(EUCTR)

28/01/2014

23/12/2013

Go-colitis: Golimumab: A Phase 4 UK Study on its Utilisation and Impact in Ulcerative Colitis

Golimumab: A Phase 4, UK Open Label, Single arm Study on its Utilization and Impact in Ulcerative Colitis - Go-colitis

Ulcerative colitis
MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Simponi
Product Name: Simponi
INN or Proposed INN: golimumab

MSD

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 4

United Kingdom

863

EUCTR2013-000263-88-NL
(EUCTR)

23/01/2014

21/11/2013

A study to evaluate the dose response of JNJ-54781532 in participants with moderately to severely active ulcerative colitis (UC).

Janssen-Cilag International NV

NULL

Not Recruiting

Female: yes
Male: yes

220

Phase 2b

United States;France;Hungary;Canada;Belgium;Poland;Ukraine;Romania;Bulgaria;Russian Federation;Germany;Netherlands

864

EUCTR2013-001012-30-DE
(EUCTR)

20/01/2014

07/10/2013

Long Term Safety And Tolerability Of SAR339658 In Patients With Ulcerative Colitis (UC)

A Multicenter Single-Arm Open Label Extension Study Evaluating The Long Term Safety And Tolerability Of SAR339658 In Patients With Ulcerative Colitis (UC)

Ulcerative Colitis
MedDRA version: 16.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: SAR339658
INN or Proposed INN: Vatelizumab
Other descriptive name: SAR339658

Sanofi-aventis recherche & développement

NULL

Not Recruiting

Female: yes
Male: yes

United States;Canada;Poland;Belgium;Austria;Germany;Italy

865

EUCTR2013-000263-88-HU
(EUCTR)

16/01/2014

21/11/2013

A study to evaluate the dose response of JNJ-54781532 in participants with moderately to severely active ulcerative colitis (UC).

Ulcerative Colitis
MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Janssen-Cilag International NV

NULL

Not Recruiting

Female: yes
Male: yes

220

Phase 2b

France;United States;Hungary;Canada;Poland;Belgium;Ukraine;Romania;Russian Federation;Bulgaria;Netherlands;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

866

EUCTR2013-000263-88-BE
(EUCTR)

08/01/2014

29/10/2013

A study to evaluate the dose response of JNJ-54781532 in participants with moderately to severely active ulcerative colitis (UC).

Janssen-Cilag International NV

NULL

Not Recruiting

Female: yes
Male: yes

220

Phase 2b

United States;Ukraine;Russian Federation;Israel;France;Hungary;Canada;Belgium;Poland;Romania;Australia;Bulgaria;Germany;Netherlands

867

EUCTR2012-004366-18-BE
(EUCTR)

08/01/2014

27/06/2013

A Study to Assess the Safety and Pharmacokinetics (Serum Levels) of Golimumab in Children With Moderately to Severely Active Ulcerative Colitis

A Phase 1b Open-Label Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human anti-TNFa Antibody, in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT PEDS PK

Ulcerative Colitis in pediatric subjects
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti-TNF-alpha monoclonal antibody

Janssen Biologics B.V.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 1b

United States;France;Canada;Poland;Belgium;Denmark;Austria;Israel;Netherlands;Germany

868

EUCTR2013-000263-88-DE
(EUCTR)

07/01/2014

14/10/2013

A study to evaluate the dose response of JNJ-54781532 in participants with moderately to severely active ulcerative colitis (UC).

Janssen-Cilag International NV

NULL

Not Recruiting

Female: yes
Male: yes

220

Phase 2

France;United States;Hungary;Canada;Poland;Belgium;Ukraine;Romania;Russian Federation;Bulgaria;Netherlands;Germany

869

EUCTR2011-002411-29-PL
(EUCTR)

19/12/2013

17/10/2013

A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis.

An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A

Ulcerative Colitis
MedDRA version: 17.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: ADALIMUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

455

Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Norway;Germany;Sweden

870

EUCTR2013-002116-27-BG
(EUCTR)

19/12/2013

16/10/2013

A Placebo Controlled Trial of HMPL-004 in Subjects with Mild to Moderate Active Ulcerative Colitis

A Phase III, Randomized, Multi-Centre, Double-Blind,Placebo-Controlled Trial of HMPL-004 in Subjects with Mild to Moderate Active Ulcerative Colitis (NATRUL-3)

Nutrition Science Partners Limited

NULL

Not Recruiting

Female: yes
Male: yes

420

Phase 3

United States;Hungary;Czech Republic;Poland;Ukraine;Lithuania;Bulgaria;Latvia

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

871

EUCTR2012-004366-18-DE
(EUCTR)

17/12/2013

29/07/2013

A Study to Assess the Safety and Pharmacokinetics (Serum Levels) of Golimumab in Children With Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis in pediatric subjects
MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Janssen Biologics B.V.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 1

United States;France;Canada;Belgium;Poland;Denmark;Austria;Israel;Netherlands;Germany

872

EUCTR2013-000366-11-PL
(EUCTR)

12/12/2013

05/09/2013

Product Code: TP05
INN or Proposed INN: MESALAZINE
Trade Name: Asacol
INN or Proposed INN: MESALAZINE

Tillotts Pharma AG

NULL

Not Recruiting

Female: yes
Male: yes

800

Phase 3

Belarus;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Latvia;Sweden

873

EUCTR2012-004366-18-DK
(EUCTR)

11/12/2013

03/12/2013

A Study to Assess the Safety and Pharmacokinetics (Serum Levels) of Golimumab in Children With Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis in pediatric subjects
MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti-TNF-alpha monoclonal antibody

Janssen Biologics B.V.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 1

United States;France;Canada;Belgium;Poland;Austria;Denmark;Israel;Germany;Netherlands

874

EUCTR2011-001332-29-AT
(EUCTR)

02/12/2013

07/11/2013

The degradation and elimination of Infliximab

Pharmacokinetics of Infliximab

Inflammatory bowel disease (Ulcerative Colitis, Crohn's disease)
MedDRA version: 17.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: INFLIXIMAB
Other descriptive name: Remicade

Universitätsklinik für Innere Medizin III, Klinische Abteilung für Gastroenterologie und Hepatologie

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Austria

875

EUCTR2012-004366-18-NL
(EUCTR)

28/11/2013

16/08/2013

A Study to Assess the Safety and Pharmacokinetics (Serum Levels) of Golimumab in Children With Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis in pediatric subjects
MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti-TNF-alpha monoclonal antibody

Janssen Biologics B.V.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 1b

France;United States;Canada;Poland;Belgium;Denmark;Austria;Israel;Germany;Netherlands

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

876

EUCTR2011-002411-29-CZ
(EUCTR)

15/11/2013

16/09/2013

A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis.

An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A

Ulcerative Colitis
MedDRA version: 16.0;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: ADALIMUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

455

Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Germany;Norway;Sweden

877

EUCTR2013-002116-27-LT
(EUCTR)

14/11/2013

06/08/2013

A Placebo Controlled Trial of HMPL-004 in Subjects with Mild to Moderate Active Ulcerative Colitis

A Phase III, Randomized, Multi-Centre, Double-Blind,Placebo-Controlled Trial of HMPL-004 in Subjects with Mild to Moderate Active Ulcerative Colitis (NATRUL-3)

Ulcerative Colitis (UC)
MedDRA version: 16.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Nutrition Science Partners Limited

NULL

Not Recruiting

Female: yes
Male: yes

420

Phase 3

United States;Hungary;Czech Republic;Poland;Ukraine;Lithuania;Bulgaria;Latvia;Korea, Republic of

878

EUCTR2011-002411-29-SK
(EUCTR)

11/11/2013

14/10/2013

A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis.

An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A

Ulcerative Colitis
MedDRA version: 14.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: ADALIMUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

455

Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Poland;Belgium;Denmark;Germany;Norway;Sweden

879

EUCTR2012-002031-28-DE
(EUCTR)

05/11/2013

22/05/2013

Study to test the long term safety of PF-00547659 in subjects with Ulcerative Colitis

A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH ULCERATIVE COLITIS (TURANDOT II) - TURANDOT II

Product Code: PF-00547659
INN or Proposed INN: Anti-MAdCAM antibody
Other descriptive name: Anti-MAdCAM antibody

Shire Human Genetic Therapies, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

331

Phase 2

880

EUCTR2012-003123-38-NL
(EUCTR)

29/10/2013

27/05/2013

A CLINICAL EFFICACY AND SAFETY STUDY TO EVALUATE IN A BLINDED WAY THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS

A PHASE 2, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PARALLEL-GROUP STUDY TO EVALUATE THE CLINICAL EFFICACY AND SAFETY OF INDUCTION THERAPY WITH RPC1063 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS

Moderately to severely active Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: 0.25 mg RPC1063
INN or Proposed INN: RPC1063
Product Name: 0.5 mg RPC1063
INN or Proposed INN: RPC1063
Product Name: 1 mg RPC1063
INN or Proposed INN: RPC1063

Celgene International II Sàrl (CIS II).

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Hungary;Slovakia;Greece;Poland;Belgium;Ukraine;Russian Federation;Israel;Bulgaria;Netherlands;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

881

EUCTR2013-002116-27-LV
(EUCTR)

28/10/2013

26/06/2013

A Placebo Controlled Trial of HMPL-004 in Patients with Mild to Moderate Active Ulcerative Colitis

A Phase III, Randomized, Multi-Centre, Double-Blind,Placebo-Controlled Trial of HMPL-004 in Patients with Mild to Moderate Active Ulcerative Colitis (NATRUL-3)

Nutrition Science Partners Limited

NULL

Not Recruiting

Female: yes
Male: yes

420

Phase 3

United States;Hungary;Czech Republic;Poland;Ukraine;Lithuania;Bulgaria;Latvia;Korea, Republic of

882

EUCTR2013-002116-27-HU
(EUCTR)

24/10/2013

24/07/2013

A Placebo Controlled Trial of HMPL-004 in Patients with Mild to Moderate Active Ulcerative Colitis

A Phase III, Randomized, Multi-Centre, Double-Blind,Placebo-Controlled Trial of HMPL-004 in Patients with Mild to Moderate Active Ulcerative Colitis (NATRUL-3)

Nutrition Science Partners Limited

NULL

Not Recruiting

Female: yes
Male: yes

420

Phase 3

United States;Czech Republic;Hungary;Poland;Ukraine;Lithuania;Bulgaria;Latvia;Korea, Republic of

883

EUCTR2013-001012-30-PL
(EUCTR)

17/10/2013

05/09/2013

Long Term Safety And Tolerability Of SAR339658 In Patients With Ulcerative Colitis (UC)

A Multicenter Single-Arm Open Label Extension Study Evaluating The Long Term Safety And Tolerability Of SAR339658 In Patients With Ulcerative Colitis (UC)

Ulcerative Colitis
MedDRA version: 16.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: SAR339658
INN or Proposed INN: Vatelizumab
Other descriptive name: SAR339658

Sanofi-aventis recherche & développement

NULL

Not Recruiting

Female: yes
Male: yes

United States;Canada;Poland;Austria;Germany;Italy

884

EUCTR2013-001012-30-BE
(EUCTR)

09/10/2013

12/08/2013

Long Term Safety And Tolerability Of SAR339658 In Patients With Ulcerative Colitis (UC)

A Multicenter Single-Arm Open Label Extension Study Evaluating The Long Term Safety And Tolerability Of SAR339658 In Patients With Ulcerative Colitis (UC)

Product Code: SAR339658
INN or Proposed INN: Vatelizumab
Other descriptive name: SAR339658

Sanofi-aventis recherche & développement

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Canada;Poland;Belgium;Austria;Germany;Italy

885

EUCTR2012-002031-28-SE
(EUCTR)

09/10/2013

27/05/2013

Study to test the long term safety of PF-00547659 in subjects with Ulcerative Colitis

A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH ULCERATIVE COLITIS (TURANDOT II) - TURANDOT II

Product Code: PF-00547659
Other descriptive name: Anti-MAdCAM antibody

Pfizer Inc, 235 East 42nd Street, New York, NY10017, United States

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

270

United States;Serbia;Slovakia;Spain;Israel;Russian Federation;Italy;France;Denmark;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Brazil;Belgium;Poland;Croatia;Bulgaria;Germany;Norway;New Zealand;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

886

EUCTR2013-002116-27-CZ
(EUCTR)

09/10/2013

08/08/2013

A Placebo Controlled Trial of HMPL-004 in Subjects with Mild to Moderate Active Ulcerative Colitis

A Phase III, Randomized, Multi-Centre, Double-Blind,Placebo-Controlled Trial of HMPL-004 in Subjects with Mild to Moderate Active Ulcerative Colitis (NATRUL-3)

Nutrition Science Partners Limited

NULL

Not Recruiting

Female: yes
Male: yes

420

Phase 3

United States;Hungary;Czech Republic;Poland;Ukraine;Lithuania;Bulgaria;Latvia;Korea, Republic of

887

EUCTR2013-000366-11-ES
(EUCTR)

07/10/2013

12/07/2013

Ulcerative colitis
MedDRA version: 16.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: TP05
INN or Proposed INN: MESALAZINE
Trade Name: Asacol

Tillotts Pharma AG

NULL

Not Recruiting

Female: yes
Male: yes

800

Belarus;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Latvia;Sweden

888

EUCTR2012-002031-28-BG
(EUCTR)

03/10/2013

13/08/2013

Study to test the long term safety of PF-00547659 in subjects with Ulcerative Colitis

A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH ULCERATIVE COLITIS (TURANDOT II) - TURANDOT II

Product Code: PF-00547659
INN or Proposed INN: Anti-MAdCAM antibody
Other descriptive name: Anti-MAdCAM antibody

Shire Human Genetic Therapie, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

331

Phase 2

889

EUCTR2012-002030-37-BG
(EUCTR)

03/10/2013

24/09/2013

Study to test whether PF-00547659 is safe and improves symptoms in patients with UC

Product Code: PF-00547659
Other descriptive name: Anti-MAdCAM antibody

Pfizer Inc, 235 East 42nd Street, New York, NY10017, United States

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 2

890

EUCTR2013-001012-30-IT
(EUCTR)

30/09/2013

02/07/2013

Long Term Safety And Tolerability Of SAR339658 In Patients With Ulcerative Colitis (UC)

A Multicenter Single-Arm Open Label Extension Study Evaluating The Long Term Safety And Tolerability Of SAR339658 In Patients With Ulcerative Colitis (UC)

Product Code: SAR339658
INN or Proposed INN: Vatelizumab
Other descriptive name: SAR339658

Sanofi-aventis recherche & développement

NULL

Not Recruiting

Female: yes
Male: yes

United States;Canada;Poland;Austria;Germany;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

891

EUCTR2012-002030-37-DE
(EUCTR)

27/09/2013

22/05/2013

Study to test whether PF-00547659 is safe and improves symptoms in patients with UC

Ulcerative Colitis (UC)
MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: PF-00547659
INN or Proposed INN: not available
Other descriptive name: Anti-MAdCAM antibody

Pfizer Inc, 235 East 42nd Street, New York, NY10017, United States

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 2

892

EUCTR2012-002013-19-DE
(EUCTR)

25/09/2013

17/05/2013

Efficacy and Safety of SAR339658 in Patients with Moderate to Severe Ulcerative Colitis

A randomized, double-blind, placebo-controlled, multicenter study evaluating efficacy and safety of SAR339658 in patients with active moderate to severe Ulcerative Colitis (UC). - FUSCIA

Ulcerative Colitis
MedDRA version: 14.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: SAR339658
INN or Proposed INN: Vatelizumab

Sanofi aventis Recherche&Développement

NULL

Not Recruiting

Female: yes
Male: yes

France;United States;Canada;Belgium;Poland;Austria;Germany;Italy

893

EUCTR2012-002013-19-PL
(EUCTR)

12/09/2013

14/06/2013

Efficacy and Safety of SAR339658 in Patients with Moderate to Severe Ulcerative Colitis

A randomized, double-blind, placebo-controlled, multicenter study evaluating efficacy and safety of SAR339658 in patients with active moderate to severe Ulcerative Colitis (UC). - FUSCIA

Product Code: SAR339658
INN or Proposed INN: Vatelizumab

Sanofi aventis Recherche&Développement

NULL

Not Recruiting

Female: yes
Male: yes

France;United States;Canada;Belgium;Poland;Austria;Germany;Italy

894

EUCTR2013-000366-11-CZ
(EUCTR)

12/09/2013

05/06/2013

Product Code: TP05
INN or Proposed INN: MESALAZINE
Trade Name: Asacol
INN or Proposed INN: MESALAZINE

Tillotts Pharma AG

NULL

Not Recruiting

Female: yes
Male: yes

800

Phase 3

Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden

895

EUCTR2011-003208-19-CZ
(EUCTR)

05/09/2013

03/04/2013

GWP42003 symptomatic treatment of ulcerative colitis.

A randomised, double-blind, placebo-controlled parallel group, pilot study of GWP42003 in the symptomatic treatment of ulcerative colitis.

Symptoms of diarrhoea, rectal bleeding, stool frequency and inflammation in subjects with ulcerative colitis
MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: GWP42003
INN or Proposed INN: Not Applicable
Other descriptive name: CANNABIDIOL

GW Pharma Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Czech Republic;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

896

EUCTR2013-001012-30-AT
(EUCTR)

04/09/2013

12/07/2013

Long Term Safety And Tolerability Of SAR339658 In Patients With Ulcerative Colitis (UC)

A Multicenter Single-Arm Open Label Extension Study Evaluating The Long Term Safety And Tolerability Of SAR339658 In Patients With Ulcerative Colitis (UC)

Product Code: SAR339658
INN or Proposed INN: Vatelizumab
Other descriptive name: SAR339658

Sanofi-aventis recherche & développement

NULL

Not Recruiting

Female: yes
Male: yes

United States;Canada;Poland;Austria;Germany;Italy

897

EUCTR2013-000366-11-BE
(EUCTR)

02/09/2013

11/07/2013

Product Code: TP05
INN or Proposed INN: MESALAZINE
Trade Name: Asacol
INN or Proposed INN: MESALAZINE

Tillotts Pharma AG

NULL

Not Recruiting

Female: yes
Male: yes

800

Phase 3

Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden

898

EUCTR2013-000366-11-GB
(EUCTR)

30/08/2013

09/07/2013

Ulcerative colitis
MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Tillotts Pharma AG

NULL

Not Recruiting

Female: yes
Male: yes

800

Phase 3

Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden

899

EUCTR2011-004579-35-HR
(EUCTR)

27/08/2013

28/08/2014

A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis.

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Moderate to severe active Ulcerative Colitis
MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: CP -690,550-10
Product Code: CP -690,550-10
Other descriptive name: tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

545

Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand

900

EUCTR2011-004578-27-HR
(EUCTR)

26/08/2013

28/08/2014

A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis.

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Product Name: CP -690,550-10
Product Code: CP -690,550-10
Other descriptive name: tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

545

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

901

EUCTR2011-004580-79-HR
(EUCTR)

26/08/2013

28/08/2014

A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis.

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS

Product Code: CP -690,550-10
Other descriptive name: tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

654

Phase 3

902

EUCTR2011-004581-14-HR
(EUCTR)

26/08/2013

28/08/2014

A multi-center, open-label study of CP-690,550 in subjects with moderate to severe ulcerative colitis

A MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Product Name: CP -690,550-10
Product Code: CP -690,550-10
Other descriptive name: tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

725

Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan

903

EUCTR2013-000366-11-FI
(EUCTR)

20/08/2013

05/07/2013

Product Code: TP05
INN or Proposed INN: MESALAZINE
Trade Name: Asacol
INN or Proposed INN: MESALAZINE

Tillotts Pharma AG

NULL

Not Recruiting

Female: yes
Male: yes

800

Phase 3

Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden

904

EUCTR2012-004366-18-AT
(EUCTR)

30/07/2013

12/06/2013

A Study to Assess the Safety and Pharmacokinetics (Serum Levels) of Golimumab in Children With Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis in pediatric subjects
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti-TNF-alpha monoclonal antibody

Janssen Biologics B.V.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 1

United States;France;Canada;Poland;Belgium;Denmark;Austria;Israel;Netherlands;Germany

905

EUCTR2012-002013-19-BE
(EUCTR)

19/07/2013

19/02/2013

Efficacy and Safety of SAR339658 in Patients with Moderate to Severe Ulcerative Colitis

A randomized, double-blind, placebo-controlled, multicenter study evaluating efficacy and safety of SAR339658 in patients with active moderate to severe Ulcerative Colitis (UC). - FUSCIA

Product Code: SAR339658
INN or Proposed INN: Vatelizumab

Sanofi aventis Recherche&Développement

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

France;United States;Canada;Poland;Belgium;Austria;Germany;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

906

EUCTR2013-000366-11-IE
(EUCTR)

17/07/2013

16/05/2013

Product Code: TP05
INN or Proposed INN: MESALAZINE
Trade Name: Asacol
INN or Proposed INN: MESALAZINE

Tillotts Pharma AG

NULL

Not Recruiting

Female: yes
Male: yes

800

Phase 3

Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden

907

EUCTR2012-002031-28-HU
(EUCTR)

11/07/2013

15/05/2013

Study to test the long term safety of PF-00547659 in subjects with Ulcerative Colitis

A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH ULCERATIVE COLITIS (TURANDOT II) - TURANDOT II

Product Code: PF-00547659
Other descriptive name: Anti-MAdCAM antibody

Pfizer Inc, 235 East 42nd Street, New York, NY10017, United States

NULL

Not Recruiting

Female: yes
Male: yes

331

Phase 2

Serbia;United States;Slovakia;Spain;Russian Federation;Israel;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Brazil;Belgium;Poland;Croatia;Bulgaria;Germany;Norway;New Zealand;Sweden

908

EUCTR2013-000366-11-DK
(EUCTR)

10/07/2013

Product Code: TP05
INN or Proposed INN: MESALAZINE
Trade Name: Asacol
INN or Proposed INN: MESALAZINE

Tillotts Pharma AG

NULL

Not Recruiting

Female: yes
Male: yes

800

Phase 3

Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden

909

EUCTR2012-001653-13-IT
(EUCTR)

10/07/2013

27/03/2013

New Therapeutic Strategy in Ulcerative Colitis

New Therapeutic Options for the Maintenance of Remission of the Ulcerative Colitis in PediatricPatients

Ulcerative Colitis
MedDRA version: 15.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: AZAFOR 50mg
Product Name: AZATIOPRINA
Product Code: AZA
INN or Proposed INN: AZATHIOPRINE
Other descriptive name: AZATHIOPRINE

Dipartimento di Pediatria Università Federico II di Napoli

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

130

Italy

910

EUCTR2012-002030-37-ES
(EUCTR)

04/07/2013

10/06/2013

Study to test whether PF-00547659 is safe and improves symptoms in patients with UC

Product Code: PF-00547659
INN or Proposed INN: .
Other descriptive name: Anti-MAdCAM antibody

Pfizer Inc, 235 East 42nd Street, New York, NY10017, United States

NULL

Not Recruiting

Female: yes
Male: yes

300

United States;Serbia;Slovakia;Spain;Russian Federation;Israel;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

911

EUCTR2012-002031-28-ES
(EUCTR)

04/07/2013

10/06/2013

Study to test the long term safety of PF-00547659 in subjects with Ulcerative Colitis

A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH ULCERATIVE COLITIS (TURANDOT II) - TURANDOT II

Product Code: PF-00547659
INN or Proposed INN: .
Other descriptive name: Anti-MAdCAM antibody

Pfizer Inc, 235 East 42nd Street, New York, NY10017, United States

NULL

Not Recruiting

Female: yes
Male: yes

270

Phase 2

912

EUCTR2013-000366-11-SE
(EUCTR)

28/06/2013

13/05/2013

Product Code: TP05
INN or Proposed INN: MESALAZINE
Trade Name: Asacol
INN or Proposed INN: MESALAZINE

Tillotts Pharma AG

NULL

Not Recruiting

Female: yes
Male: yes

800

Phase 3

Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden

913

EUCTR2012-002030-37-HU
(EUCTR)

27/06/2013

15/05/2013

Study to test whether PF-00547659 is safe and improves symptoms in patients with UC

Product Code: PF-00547659
Other descriptive name: Anti-MAdCAM antibody

Pfizer Inc, 235 East 42nd Street, New York, NY10017, United States

NULL

Not Recruiting

Female: yes
Male: yes

300

Serbia;United States;Slovakia;Spain;Russian Federation;Israel;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Brazil;Belgium;Poland;Croatia;Bulgaria;Germany;Norway;New Zealand;Sweden

914

EUCTR2012-003123-38-GR
(EUCTR)

25/06/2013

10/05/2013

A CLINICAL EFFICACY AND SAFETY STUDY TO EVALUATE IN A BLINDED WAY THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS

Moderately to severely active Ulcerative Colitis
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Receptos, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

180

Phase 2

United States;Slovakia;Greece;Russian Federation;Israel;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Bulgaria;Netherlands;Germany;New Zealand;Korea, Republic of

915

EUCTR2012-002031-28-PL
(EUCTR)

18/06/2013

10/05/2013

Study to test the long term safety of PF-00547659 in subjects with Ulcerative Colitis

A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH ULCERATIVE COLITIS (TURANDOT II) - TURANDOT II

Product Code: PF-00547659
INN or Proposed INN: PF-00547659
Other descriptive name: Anti-MAdCAM antibody

Shire Human Genetic Therapies, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

270

Phase 2

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

916

EUCTR2012-004768-23-DE
(EUCTR)

12/06/2013

06/02/2013

A Phase 2a Trial of STNM01 by a Single Submucosal Injection to Investigate the Mucosal Healing Efficacy in Patients with Ulcerative Colitis

Ulcerative Colitis with active endoscopic lesion(s), ranging in severity from moderate to severe in endoscopic score not responding sufficiently to conventional treatment
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: STNM01 1.84 mg
Product Code: STNM01
INN or Proposed INN: STNM01

STELIC INSTITUTE & CO.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Germany

917

EUCTR2012-002031-28-AT
(EUCTR)

11/06/2013

29/05/2013

Study to test the long term safety of PF-00547659 in subjects with Ulcerative Colitis

A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH ULCERATIVE COLITIS (TURANDOT II) - TURANDOT II

Product Code: PF-00547659
INN or Proposed INN: Anti-MAdCAM antibody
Other descriptive name: Anti-MAdCAM antibody

Shire Human Genetic Therapies, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

331

Phase 2

918

EUCTR2012-002030-37-AT
(EUCTR)

11/06/2013

29/05/2013

Study to test whether PF-00547659 is safe and improves symptoms in patients with UC

Product Code: PF-00547659
INN or Proposed INN: not available
Other descriptive name: Anti-MAdCAM antibody

Pfizer Inc, 235 East 42nd Street, New York, NY10017, United States

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 2

919

EUCTR2012-002013-19-IT
(EUCTR)

02/06/2013

08/04/2013

Efficacy and Safety of SAR339658 in Patients with Moderate to Severe Ulcerative Colitis

A randomized, double-blind, placebo-controlled, multicenter study evaluating efficacy and safety of SAR339658 in patients with active moderate to severe Ulcerative Colitis (UC). - FUSCIA

Product Code: SAR339658
INN or Proposed INN: Vatelizumab

Sanofi aventis Recherche&Développement

NULL

Not Recruiting

Female: yes
Male: yes

United States;France;Canada;Poland;Belgium;Austria;Germany;Italy

920

EUCTR2012-002030-37-SE
(EUCTR)

31/05/2013

27/05/2013

Study to test whether PF-00547659 is safe and improves symptoms in patients with UC

Product Code: PF-00547659
Other descriptive name: Anti-MAdCAM antibody

Pfizer Inc, 235 East 42nd Street, New York, NY10017, United States

NULL

Not Recruiting

Female: yes
Male: yes

300

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

921

EUCTR2012-002030-37-CZ
(EUCTR)

30/05/2013

16/05/2013

Study to test whether PF-00547659 is safe and improves symptoms in patients with UC

Product Code: PF-00547659
Other descriptive name: Anti-MAdCAM antibody

Pfizer Inc, 235 East 42nd Street, New York, NY10017, United States

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 2

922

EUCTR2012-002031-28-CZ
(EUCTR)

30/05/2013

16/05/2013

Study to test the long term safety of PF-00547659 in subjects with Ulcerative Colitis

A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH ULCERATIVE COLITIS (TURANDOT II) - TURANDOT II

Product Code: PF-00547659
INN or Proposed INN: Anti-MAdCAM antibody
Other descriptive name: Anti-MAdCAM antibody

Shire Human Genetic Therapies, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

270

Phase 2

923

EUCTR2012-005521-73-CZ
(EUCTR)

16/05/2013

01/03/2013

Placebo-controlled, proof-of-concept oral dose study to explore the safety, pharmacokinetics and pharmacodynamics in subjects with mild to moderate ulcerative colitis

Exploratory, Phase II, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept study to evaluate the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of GLPG0974 in subjects with mild to moderate Ulcerative Colitis - Proof-of-concept oral dose, safety, tolerability, efficacy, PK and PD study

Mild to moderate Ulcerative Colitis
MedDRA version: 14.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: GLPG0974
INN or Proposed INN: GLPG0974

Galapagos NV

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Czech Republic;Belgium;Latvia

924

EUCTR2012-002031-28-NL
(EUCTR)

15/05/2013

22/02/2013

Study to test the long term safety of PF-00547659 in subjects with Ulcerative Colitis

A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH ULCERATIVE COLITIS (TURANDOT II) - TURANDOT II

Product Code: PF-00547659
INN or Proposed INN: Not applicable
Other descriptive name: Anti-MAdCAM antibody

Shire Human Genetic Therapies, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

270

Phase 2

925

EUCTR2012-002030-37-NL
(EUCTR)

15/05/2013

12/02/2013

Study to test whether PF-00547659 is safe and improves symptoms in patients with UC

Ulcerative Colitis (UC)
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: PF-00547659
INN or Proposed INN: Not applicable
Other descriptive name: Anti-MAdCAM antibody

Pfizer Inc, 235 East 42nd Street, New York, NY10017, United States

NULL

Not Recruiting

Female: yes
Male: yes

300

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

926

EUCTR2012-002031-28-IT
(EUCTR)

08/05/2013

01/07/2013

Study to test the long term safety of PF-00547659 in subjects with Ulcerative Colitis

A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH ULCERATIVE COLITIS (TURANDOT II) - TURANDOT II

Product Code: PF-00547659
Other descriptive name: Anti-MAdCAM antibody

Pfizer Inc, 235 East 42nd Street, New York, NY10017, United States

NULL

Not Recruiting

Female: yes
Male: yes

270

Phase 2

927

EUCTR2012-002030-37-PL
(EUCTR)

07/05/2013

12/04/2013

Study to test whether PF-00547659 is safe and improves symptoms in patients with UC

Product Code: PF-00547659
Other descriptive name: Anti-MAdCAM antibody

Pfizer Inc, 235 East 42nd Street, New York, NY10017, United States

NULL

Not Recruiting

Female: yes
Male: yes

300

928

EUCTR2012-002030-37-SK
(EUCTR)

02/05/2013

09/05/2013

Study to test whether PF-00547659 is safe and improves symptoms in patients with UC

Product Code: PF-00547659
Other descriptive name: Anti-MAdCAM antibody

Pfizer Inc, 235 East 42nd Street, New York, NY10017, United States

NULL

Not Recruiting

Female: yes
Male: yes

300

929

EUCTR2012-002031-28-SK
(EUCTR)

02/05/2013

05/02/2013

Study to test the long term safety of PF-00547659 in subjects with Ulcerative Colitis

A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH ULCERATIVE COLITIS (TURANDOT II) - TURANDOT II

Product Code: PF-00547659
INN or Proposed INN: Anti-MAdCAM antibody
Other descriptive name: PF-00547659

Shire Human Genetic Therapies, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

331

Phase 2

930

EUCTR2012-005521-73-LV
(EUCTR)

29/04/2013

13/03/2013

Placebo-controlled, proof-of-concept oral dose study to explore the safety, pharmacokinetics and pharmacodynamics in subjects with mild to moderate ulcerative colitis

Product Name: GLPG0974
INN or Proposed INN: GLPG0974

Galapagos NV

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Czech Republic;Latvia

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

931

EUCTR2012-003123-38-BG
(EUCTR)

24/04/2013

05/03/2013

A CLINICAL EFFICACY AND SAFETY STUDY TO EVALUATE IN A BLINDED WAY THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS

Product Name: 0.25 mg RPC1063
INN or Proposed INN: RPC1063
Product Name: 0.5 mg RPC1063
INN or Proposed INN: RPC1063
Product Name: 1 mg RPC1063
INN or Proposed INN: RPC1063

Celgene International II Sàrl (CIS II).

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Hungary;Slovakia;Greece;Poland;Belgium;Ukraine;Russian Federation;Israel;Bulgaria;Netherlands;Korea, Republic of

932

EUCTR2011-005251-13-PL
(EUCTR)

23/04/2013

10/01/2013

A study to find out more about the effect of AMG 181 in people with moderate to severe ulcerative colitis

A Randomized, Double blind, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Ulcerative Colitis

Product Name: AMG 181
Product Code: AMG 181
INN or Proposed INN: AMG 181

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

360

Phase 2

United States;Estonia;Greece;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Latvia;Norway;Netherlands;Germany

933

EUCTR2012-002030-37-IT
(EUCTR)

20/04/2013

02/04/2013

Study to test whether PF-00547659 is safe and improves symptoms in patients with UC

Ulcerative Colitis (UC)
MedDRA version: 15.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: PF-00547659
INN or Proposed INN: NA
Other descriptive name: Anti-MAdCAM antibody

Pfizer Inc, 235 East 42nd Street, New York, NY10017, United States

NULL

Not Recruiting

Female: yes
Male: yes

300

934

EUCTR2012-002013-19-AT
(EUCTR)

16/04/2013

21/03/2013

Efficacy and Safety of SAR339658 in Patients with Moderate to Severe Ulcerative Colitis

A randomized, double-blind, placebo-controlled, multicenter study evaluating efficacy and safety of SAR339658 in patients with active moderate to severe Ulcerative Colitis (UC). - FUSCIA

Product Code: SAR339658
INN or Proposed INN: Vatelizumab

Sanofi aventis Recherche&Développement

NULL

Not Recruiting

Female: yes
Male: yes

France;United States;Canada;Belgium;Poland;Austria;Germany;Italy

935

EUCTR2012-002031-28-BE
(EUCTR)

02/04/2013

01/02/2013

Study to test the long term safety of PF-00547659 in subjects with Ulcerative Colitis

A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH ULCERATIVE COLITIS (TURANDOT II) - TURANDOT II

Product Code: PF-00547659
INN or Proposed INN: PF-00547659
Other descriptive name: Anti-MAdCAM antibody

Shire Human Genetic Therapies, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

331

Phase 2

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

936

EUCTR2012-005521-73-BE
(EUCTR)

20/03/2013

08/02/2013

Placebo-controlled, proof-of-concept oral dose study to explore the safety, pharmacokinetics and pharmacodynamics in subjects with mild to moderate ulcerative colitis

Mild to moderate Ulcerative Colitis
MedDRA version: 16.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: GLPG0974
INN or Proposed INN: GLPG0974

Galapagos NV

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Czech Republic;Belgium;Latvia

937

EUCTR2011-004578-27-NL
(EUCTR)

04/03/2013

12/03/2012

A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis.

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Ulcerative colitis
MedDRA version: 15.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: CP -690,550-10
Product Code: CP -690,550-10
Other descriptive name: tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

545

Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan;United States;Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;India;France;Australia;Denmark;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada

938

EUCTR2012-003123-38-HU
(EUCTR)

12/02/2013

04/12/2012

A CLINICAL EFFICACY AND SAFETY STUDY TO EVALUATE IN A BLINDED WAY THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS

Moderately to severely active Ulcerative Colitis
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Celgene International II Sàrl (CIS II).

NULL

Not Recruiting

Female: yes
Male: yes

113

Phase 2

United States;Hungary;Slovakia;Greece;Poland;Belgium;Ukraine;Russian Federation;Israel;Bulgaria;Netherlands;Korea, Republic of

939

EUCTR2012-003123-38-PL
(EUCTR)

10/02/2013

15/01/2013

A CLINICAL EFFICACY AND SAFETY STUDY TO EVALUATE IN A BLINDED WAY THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS

Product Name: 0.25 mg RPC1063
INN or Proposed INN: RPC1063
Product Name: 0.5 mg RPC1063
INN or Proposed INN: RPC1063
Product Name: 1 mg RPC1063
INN or Proposed INN: RPC1063

Celgene International II Sàrl (CIS II)

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Slovakia;Greece;Ukraine;Israel;Russian Federation;Czech Republic;Hungary;Poland;Belgium;Bulgaria;Netherlands;Korea, Republic of

940

EUCTR2012-001830-32-LT
(EUCTR)

04/02/2013

04/10/2012

A comparative study on the efficacy and tolerability of an 8 week oral treatment with three times daily 1000 mg mesalazine versus three times daily 2x500 mg mesalazine in patients with active ulcerative colitis

Double-blind, double-dummy, randomised, multi-centre, comparative phase III clinical study on the efficacy and tolerability of an 8 week oral treatment with three times daily 1000 mg mesalazine versus three times daily 2x500 mg mesalazine in patients with active ulcerative colitis - TID 1000 mg mesalazine versus TID 2x500 mg mesalazine in active UC

Active ulcerative colitis
MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Mesalazine 1000 mg gastro-resistant tablets
Product Code: Mesalazine 1000 mg gastro-resistant tablets
INN or Proposed INN: Mesalazine
Trade Name: Salofalk® 500 mg gastro-resistant tablet
Product Name: Mesalazine 500 mg gastro-resistant tablets (Salofalk® 500 mg)
Product Code: Mesalazine 500 mg gastro-resistant tablets (Salofa
INN or Proposed INN: Mesalazine

Dr. Falk Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 3

Hungary;Poland;Ukraine;Lithuania;Russian Federation;Latvia

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

941

EUCTR2012-001830-32-PL
(EUCTR)

01/02/2013

18/10/2012

Active ulcerative colitis
MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Dr. Falk Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 3

Hungary;Poland;Ukraine;Lithuania;Russian Federation;Latvia

942

EUCTR2012-003123-38-SK
(EUCTR)

28/01/2013

04/03/2013

A CLINICAL EFFICACY AND SAFETY STUDY TO EVALUATE IN A BLINDED WAY THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS

Moderately to severely active Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Celgene International II Sàrl (CIS II).

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Hungary;Slovakia;Greece;Poland;Belgium;Ukraine;Russian Federation;Israel;Bulgaria;Netherlands;Korea, Republic of

943

JPRN-UMIN000009811

2013/01/23

21/01/2013

Comparison of randomized trials of antibiotic combination therapies for patients with ulcerative colitis

Comparison of randomized trials of antibiotic combination therapies for patients with ulcerative colitis - Antibiotics trials for ulcerative colitis

Ulcerative colitis

One group is to receive two-week combination therapy consisting of amoxicillin (Sawacillin) 500 mg t.i.d, tetracycline (Acromycin) 500 mg t.i.d, and metronidazole (Flagyl) 250 mg t.i.d. with an inhibitor of gastric acid secretion. Patients are to be followed for 3 months (first endpoint).
Another group will receive two week combination therapy consisting of amoxicillin (Sawacillin) 500 mg t.i.d, fosfomycin (Fosmicin) 1000mg t.i.d, and metrozole (Flagyl) 250 mg t.i.d, with an inhibitor of gastric acid secretion. Patients are to be followed for 3 months.

Division of General Medicine, Department of Internal Medicine, Nihon University School of Medicine

NULL

Complete: follow-up complete

16years-old

75years-old

Male and Female

Phase 3

Japan

944

EUCTR2012-003974-18-BG
(EUCTR)

18/01/2013

07/11/2012

A Randomized, Double-Blind, 12-Week, Placebo-Controlled Study Followed by a 12-Week Extension Phase Without Placebo to Evaluate the Efficacy and Safety of Oral VB-201 in Subjects with Mild to Moderate Ulcerative Colitis

Mild to Moderate Ulcerative Colitis
MedDRA version: 16.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: VB-201
INN or Proposed INN: Not applicable

Vascular Biogenics Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

110

Hungary;Bulgaria

945

EUCTR2011-004581-14-IT
(EUCTR)

18/01/2013

07/08/2012

A multi-center, open-label study of CP-690,550 in subjects with moderate to severe ulcerative colitis

A MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Ulcerative colitis (UC)
MedDRA version: 14.1;Level: LLT;Classification code 10045282;Term: UC;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: NA
Product Code: CP -690,550-10
Other descriptive name: tofacitinib
Product Name: NA
Product Code: CP -690,550-10
Other descriptive name: tofacitinib

PFIZER LIMITED

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

725

United States;Estonia;Taiwan;Spain;Ukraine;Austria;Russian Federation;Israel;Colombia;United Kingdom;Italy;India;Hungary;Czech Republic;Canada;Brazil;Denmark;Australia;South Africa;Germany;Netherlands;Latvia;Japan;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

946

EUCTR2011-004580-79-IT
(EUCTR)

18/01/2013

07/08/2012

maintenance therapy with CP-690,550 in subjects with ulcerative colitis

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS

ulcerative colitis (UC)
MedDRA version: 14.1;Level: LLT;Classification code 10045282;Term: UC;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: NA
Product Code: CP -690,550-10
Other descriptive name: tofacitinib
Product Name: NA
Product Code: CP -690,550-10
Other descriptive name: tofacitinib

PFIZER LIMITED

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

654

United States;Taiwan;Estonia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;Australia;Denmark;South Africa;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Croatia;Germany;New Zealand;Japan

947

EUCTR2011-004578-27-IT
(EUCTR)

18/01/2013

07/08/2012

A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis.

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Ulverative colitis
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: NA
Product Code: CP -690,550-10
Other descriptive name: tofacitinib
Product Name: NA
Product Code: CP -690,550-10
Other descriptive name: tofacitinib

PFIZER INC.

NULL

Not Recruiting

Female: yes
Male: yes

545

United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;India;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Korea, Democratic People's Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Croatia;Germany;Japan

948

EUCTR2012-001830-32-DE
(EUCTR)

15/01/2013

14/08/2012

Dr. Falk Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 3

Hungary;Poland;Ukraine;Lithuania;Russian Federation;Latvia;Germany

949

EUCTR2011-001568-22-HU
(EUCTR)

15/01/2013

18/07/2012

A placebo-controlled trial with rFXIII administered to subjects with mild to moderate active ulcerative colitis

A multicenter, randomised, double-blind, placebo-controlled, multiple-dose trial with rFXIII administered to subjects with mild to moderate active ulcerative colitis

Mild to moderate Ulcerative Colitis
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Recombinant Factor XIII (rFXIII)
INN or Proposed INN: Catridecacog

Novo Nordisk A/S

NULL

Not Recruiting

Female: yes
Male: yes

Hungary;European Union;Ukraine;Croatia;Denmark;Bulgaria;Russian Federation

950

EUCTR2012-002030-37-BE
(EUCTR)

08/01/2013

05/09/2012

A DOUBLE-BLIND, DOUBLE-DUMMY, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS (TURANDOT) - TURANDOT

Crohn’s Disease (CD) and Ulcerative Colitis (UC)
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: PF-00547659
Other descriptive name: Anti-MAdCAM antibody

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

300

Serbia;Slovakia;Spain;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Brazil;Croatia;Denmark;Australia;Bulgaria;South Africa;Netherlands;Germany;Norway;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

951

EUCTR2011-005251-13-NL
(EUCTR)

08/01/2013

23/07/2012

A study to find out more about the effect of AMG 181 in people with moderate to severe ulcerative colitis

A Randomized, Double blind, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Ulcerative Colitis

Product Name: AMG 181
Product Code: AMG 181
INN or Proposed INN: AMG 181

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

315

Phase 2

United States;Estonia;Greece;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Denmark;Latvia;Norway;Netherlands;Germany

952

EUCTR2011-000164-10-GB
(EUCTR)

04/01/2013

19/09/2012

Safety and Pharmacokinetics of MMX Mesalamine in Children and Adolescents With Ulcerative Colitis

A Phase 1, Multicenter, Open-label Study to Determine the Safety and Pharmacokinetics of MMX Mesalamine Following Administration in Children and Adolescents With Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: SPD476
INN or Proposed INN: mesalazine
Product Code: SPD476
INN or Proposed INN: mesalazine
Trade Name: Mezavant XL 1200mg gastro-resistant, prolonged release tablets
Product Code: SPD476
INN or Proposed INN: mesalazine

Shire Development LLC

NULL

Not Recruiting

Female: yes
Male: yes

Phase 1

United States;Slovakia;Poland;Australia;United Kingdom

953

NCT01745770
(ClinicalTrials.gov)

January 2013

5/12/2012

TID 1000 mg Mesalazine Versus TID 2x500 mg Mesalazine in Active Ulcerative Colitis (UC)

Double-blind, Double-dummy, Randomised, Multi-centre, Comparative Phase III Clinical Study on the Efficacy and Tolerability of an 8 Week Oral Treatment With Three Times Daily 1000 mg Mesalazine Versus Three Times Daily 2x500 mg Mesalazine in Patients With Active Ulcerative Colitis

Active Ulcerative Colitis

Drug: Mesalazine - TID 1000 mg;Drug: Mesalazine - TID 2x 500 mg

Dr. Falk Pharma GmbH

NULL

Completed

18 Years

75 Years

Both

306

Phase 3

Germany

954

EUCTR2011-005251-13-DE
(EUCTR)

21/12/2012

09/07/2012

A study to find out more about the effect of AMG 181 in people with moderate to severe ulcerative colitis

A Randomized, Double blind, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Ulcerative Colitis

Moderate to severe Ulcerative Colitis
MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: AMG 181
Product Code: AMG 181
INN or Proposed INN: AMG 181

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

360

Phase 2

United States;Estonia;Greece;Austria;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Latvia;Germany

955

EUCTR2012-004851-35-FI
(EUCTR)

19/12/2012

07/12/2012

Mesalalazine in pediatric ulcerative colitis

Once versus twice daily mesalazine to introduce remission in pediatric ulcerative colitis: a randomized controlled trial

Ulcerative colitis
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Children´s Hospital, University of Helsinki

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 4

Finland;Israel

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

956

EUCTR2012-003123-38-BE
(EUCTR)

11/12/2012

10/10/2012

A CLINICAL EFFICACY AND SAFETY STUDY TO EVALUATE IN A BLINDED WAY THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS

Moderately to severely active Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Celgene International II Sàrl (CIS II)

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Hungary;Slovakia;Greece;Poland;Belgium;Ukraine;Russian Federation;Israel;Bulgaria;Netherlands;Korea, Republic of

957

EUCTR2012-003974-18-HU
(EUCTR)

10/12/2012

28/09/2012

Study to Evaluate the Efficacy and Safety of Oral VB-201 in Subjects with Mild to Moderate Ulcerative Colitis

Product Code: VB-201
INN or Proposed INN: Not applicable

Vascular Biogenics Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

110

Hungary;Bulgaria

958

NCT01078935
(ClinicalTrials.gov)

December 2012

1/3/2010

The Effect of Probiotics on the Rate of Recovery of Inflammatory Bowel Disease Exacerbation, Endothelial Function, and Markers of Inflammation

The Effect of Probiotics on Bowel Disease

Crohn's Disease;Ulcerative Colitis

Dietary Supplement: probiotics;Dietary Supplement: placebo

The Baruch Padeh Medical Center, Poriya

Ministry of Health, Israel

Not yet recruiting

18 Years

80 Years

Both

100

Phase 4

NULL

959

EUCTR2010-023798-20-ES
(EUCTR)

29/11/2012

10/05/2012

A CLINICAL TRIAL WITH FAT-DERIVED ADULT STEM CELLS TO TREAT ULCERATIVE COLITIS

A PHASE I/IIA CLINICAL TRIAL TO EVALUATE SAFETY AND EFFICACY OF ADIPOSE TISSUE-DERIVED MESENCHYMAL STEM CELLS (ASC) ON INDUCTION TO REMISSION IN ULCERATIVE COLITIS - ALOASCU

MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: ASC
INN or Proposed INN: adipose tissue-derived mesenchymal stem cells
Other descriptive name: aloASC

Fundacion para la Investigacion Biomedica Hospital Universitario La Paz

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 1;Phase 2A

Spain

960

EUCTR2011-002462-20-SK
(EUCTR)

19/11/2012

27/09/2011

Clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitis

Randomised, double-blind, placebo-controlled prospective clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitis - K(D)PT in ulcerative colitis: proof of concept study

Acute mild to moderate ulcerative colitis.
MedDRA version: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: KdPT
Product Code: 20 mg
Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate
Product Name: KdPT
Product Code: 50 mg
Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate
Product Name: KdPT
Product Code: 100 mg
Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate
Product Name: KdPT
Product Code: 20 mg
Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate
Product Name: KdPT
Product Code: 50 mg
Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate
Product Name: KdPT
Product Code: 100 mg
Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate

Dr August Wolff GmbH & Co KG Arzneimittel

NULL

Not Recruiting

Female: yes
Male: yes

Hungary;Czech Republic;Slovakia;Poland;Germany;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

961

EUCTR2011-004581-14-NL
(EUCTR)

10/10/2012

12/03/2012

A multi-center, open-label study of CP-690,550 in subjects with moderate to severe ulcerative colitis

A MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Product Name: Tofacitinib citrate (clinical trial image)
Product Code: CP -690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: tofacitinib
Product Name: Tofacitinib citrate (Proposed commercial formulation - debossed)
Product Code: CP -690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

900

Phase 3

Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Italy;France;Denmark;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Belgium;Poland;Croatia;Romania;Germany;New Zealand

962

EUCTR2011-004579-35-NL
(EUCTR)

10/10/2012

12/03/2012

A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis.

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Moderate to severe active Ulcerative Colitis
MedDRA version: 15.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: CP -690,550-10
Product Code: CP -690,550-10
Other descriptive name: tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

545

United States;Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;India;France;Australia;Denmark;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Brazil;Romania;Croatia;Germany;New Zealand

963

EUCTR2011-001568-22-BG
(EUCTR)

05/10/2012

16/08/2012

A placebo-controlled trial with rFXIII administered to subjects with mild to moderate active ulcerative colitis

A multicenter, randomised, double-blind, placebo-controlled, multiple-dose trial with rFXIII administered to subjects with mild to moderate active ulcerative colitis

Mild to moderate Ulcerative Colitis
MedDRA version: 16.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Recombinant Factor XIII (rFXIII)
INN or Proposed INN: Catridecacog

Novo Nordisk A/S

NULL

Not Recruiting

Female: yes
Male: yes

Hungary;European Union;Ukraine;Croatia;Denmark;Russian Federation;Bulgaria

964

EUCTR2011-006084-22-GB
(EUCTR)

04/10/2012

15/08/2012

Usefulness of the measurement of blood levels of infliximab and adalimumab in inflammatory bowel disease patients in predicting response to treatment

Utilising drug levels and anti-drug antibodies to predict response to treatment in patients with Inflammatory Bowel Disease - Trough levels of anti-TNF agents in inflammatory bowel disease

Inflammatory bowel disease
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Remicade
Product Name: Infliximab
INN or Proposed INN: Infliximab
Trade Name: Humira
Product Name: adalimumab
INN or Proposed INN: Adalimumab

Royal Liverpool University Hospital

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

United Kingdom

965

EUCTR2012-001830-32-HU
(EUCTR)

04/10/2012

16/08/2012

Product Name: Mesalazine 1000 mg gastro-resistant tablets
Product Code: Mesalazine 1000 mg gastro-resistant tablets
INN or Proposed INN: Mesalazine
Trade Name: Salofalk® 500 mg gastro-resistant tablet
Product Name: Mesalazine 500 mg gastro-resistant tablets (Salofalk® 500 mg)
Product Code: Salofalk® 500 mg tablets
INN or Proposed INN: Mesalazine

Dr. Falk Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 3

Hungary;Poland;Ukraine;Lithuania;Russian Federation;Latvia

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

966

EUCTR2012-001830-32-LV
(EUCTR)

02/10/2012

05/09/2012

Active ulcerative colitis
MedDRA version: 15.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Dr. Falk Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 3

Hungary;Poland;Ukraine;Lithuania;Russian Federation;Germany;Latvia

967

EUCTR2012-002023-15-AT
(EUCTR)

21/09/2012

04/09/2012

Mesacol: The effect of mesalazine on molecular pathways ofcell adhesion in ulcerative colitis

Mesacol: The effect of mesalazine on molecular pathways ofcell adhesion in ulcerative colitis - Mesacol

Ulcerative colitis
MedDRA version: 14.1;Level: LLT;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Mezavant 1200 mg magensaftresistente Retardtabletten
INN or Proposed INN: MESALAZINE
Other descriptive name: 5-aminosalicylic acid

Medizinische Universität Wien, Universitätsklinik für Innere Medizin 3, Abteilung für Gastroenterologie und Hepatologie

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Austria

968

EUCTR2011-004578-27-PL
(EUCTR)

18/09/2012

20/06/2012

A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis.

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Product Name: CP -690,550-10
Product Code: CP -690,550-10
Other descriptive name: tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

545

Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Belgium;Poland;Romania;Croatia;Germany;New Zealand;Japan

969

EUCTR2011-004579-35-PL
(EUCTR)

17/09/2012

28/06/2012

A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis.

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Moderate to severe active Ulcerative Colitis
MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: CP -690,550-10
Product Code: CP -690,550-10
Other descriptive name: tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

545

Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Belgium;Poland;Romania;Croatia;Germany;New Zealand

970

EUCTR2011-004581-14-PL
(EUCTR)

17/09/2012

22/06/2012

A multi-center, open-label study of CP-690,550 in subjects with moderate to severe ulcerative colitis

A MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Product Name: Tofacitinib citrate (clinical trial image)
Product Code: CP -690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: tofacitinib
Product Name: Tofacitinib citrate (Proposed commercial formulation – debossed)
Product Code: CP -690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: tofacitinib

Pfizer Inc., 235 East 42nd Street, New York, New York 10017, United States

NULL

Not Recruiting

Female: yes
Male: yes

900

Phase 3

United States;Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

971

EUCTR2011-005251-13-IT
(EUCTR)

16/09/2012

27/08/2012

A study to find out more about the effect of AMG 181 in people with moderate to severe ulcerative colitis

A Randomized, Double blind, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Ulcerative Colitis

Moderate to severe Ulcerative Colitis
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: AMG181
Product Code: AMG181

AMGEN INC.

NULL

Not Recruiting

Female: yes
Male: yes

315

Phase 2

United States;Estonia;Greece;Austria;Italy;Switzerland;United Kingdom;Czech Republic;Hungary;Canada;Denmark;Latvia;Germany;Netherlands;Poland;Belgium;Australia

972

EUCTR2011-005251-13-BE
(EUCTR)

14/09/2012

18/07/2012

A study to find out more about the effect of AMG 181 in people with moderate to severe ulcerative colitis

A Randomized, Double blind, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Ulcerative Colitis

Moderate to severe Ulcerative Colitis
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: AMG 181
Product Code: AMG 181
INN or Proposed INN: AMG 181

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

360

Phase 2

United States;Estonia;Greece;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Australia;Denmark;Latvia;Germany;Netherlands;Norway

973

EUCTR2011-005115-82-LT
(EUCTR)

12/09/2012

24/05/2012

An 8 week study to compare budesonide MMX 9 mg versus placebo in patients with mild to moderate ulcerative colitis who experience a flare of their disease while taking an existing 5 aminosalicylic acid.

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Budesonide MMX® 9 mg Extended-release Tablets as Add-on Therapy in Patients with Active, Mild or Moderate Ulcerative Colitis not Adequately Controlled on a Background Oral 5-ASA Regimen

Product Name: Budesonide -MMX®
INN or Proposed INN: BUDESONIDE

Santarus, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

500

United States;Hungary;Estonia;Czech Republic;Canada;Poland;Ukraine;Lithuania;Bulgaria;Latvia

974

EUCTR2011-005251-13-HU
(EUCTR)

11/09/2012

18/07/2012

A study to find out more about the effect of AMG 181 in people with moderate to severe ulcerative colitis

A Randomized, Double blind, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Ulcerative Colitis

Product Name: AMG 181
Product Code: AMG 181
INN or Proposed INN: AMG 181

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

360

Phase 2

United States;Estonia;Greece;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Latvia;Netherlands;Germany;Norway

975

EUCTR2011-005251-13-AT
(EUCTR)

10/09/2012

23/07/2012

A study to find out more about the effect of AMG 181 in people with moderate to severe ulcerative colitis

A Randomized, Double blind, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Ulcerative Colitis

Moderate to severe Ulcerative Colitis
MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: AMG 181
Product Code: AMG 181
INN or Proposed INN: AMG 181

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

360

Phase 2

United States;Estonia;Greece;Austria;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Denmark;Latvia;Norway;Netherlands;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

976

EUCTR2011-005251-13-GB
(EUCTR)

06/09/2012

13/07/2012

A study to find out more about the effect of AMG 181 in people with moderate to severe ulcerative colitis

A Randomized, Double blind, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Ulcerative Colitis

Moderate to severe Ulcerative Colitis
MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

360

Phase 2

United States;Estonia;Greece;Austria;Italy;United Kingdom;Switzerland;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Denmark;Latvia;Norway;Netherlands;Germany

977

EUCTR2011-004765-32-NL
(EUCTR)

27/08/2012

25/04/2012

Investigation of the potential side effects and effects on the large bowel of Propionyl-L-carnitine Hydrochloride (ST 261) (given as tablets that release the active ingredient only in the large bowel) in Patients with Mild Ulcerative Colitis that are concomitantly treated with a Stable dose of aminosalicylates

Phase III, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter International Study to Investigate the Safety and Efficacy of Propionyl-L-carnitine Hydrochloride (ST 261) Modified Release Tablets in Patients Affected by Mild Ulcerative Colitis under Oral Stable Treatment - Propionyl-L-carnitine in Ulcerative Colitis

Mild ulcerative colitis
MedDRA version: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: PROPIONYL L-CARNITINE HYDROCHLORIDE
Product Code: ST 261
INN or Proposed INN: Levocarnitine propyl hydrochloride
Other descriptive name: (R)-3-(1-oxo-propoxy)-4-(N,N,N-trimethyl amonium chloride)-butanoic acid

Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

444

Phase 3

Czech Republic;Belgium;Israel;Russian Federation;Netherlands;Italy

978

EUCTR2011-001568-22-DK
(EUCTR)

23/08/2012

02/08/2012

A placebo-controlled trial with rFXIII administered to subjects with mild to moderate active ulcerative colitis

A multicenter, randomised, double-blind, placebo-controlled, multiple-dose trial with rFXIII administered to subjects with mild to moderate active ulcerative colitis

Mild to moderate Ulcerative Colitis
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Recombinant Factor XIII (rFXIII)
INN or Proposed INN: Catridecacog

Novo Nordisk A/S

NULL

Not Recruiting

Female: yes
Male: yes

Hungary;European Union;Ukraine;Croatia;Denmark;Bulgaria;Russian Federation

979

EUCTR2011-005251-13-DK
(EUCTR)

16/08/2012

11/07/2012

A study to find out more about the effect of AMG 181 in people with moderate to severe ulcerative colitis

A Randomized, Double blind, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Ulcerative Colitis

Moderate to severe Ulcerative Colitis
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: AMG 181
Product Code: AMG 181
INN or Proposed INN: AMG 181

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

360

Phase 2

United States;Estonia;Greece;Austria;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Australia;Latvia;Norway;Netherlands;Germany

980

EUCTR2011-002411-29-ES
(EUCTR)

10/08/2012

18/10/2011

A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis.

An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A

Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: ADALIMUMAB

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

680

Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Norway;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

981

EUCTR2011-004580-79-PL
(EUCTR)

05/08/2012

12/06/2012

A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis.

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS

Product Name: CP -690,550-10
Product Code: CP -690,550-10
Other descriptive name: tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

654

Phase 3

Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Belgium;Poland;Romania;Croatia;Germany;New Zealand;Japan

982

EUCTR2011-005251-13-CZ
(EUCTR)

26/07/2012

17/07/2012

A study to find out more about the effect of AMG 181 in people with moderate to severe ulcerative colitis

A Randomized, Double blind, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Ulcerative Colitis

Product Name: AMG 181
Product Code: AMG 181
INN or Proposed INN: AMG 181

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

360

Phase 2

United States;Estonia;Greece;Austria;United Kingdom;Italy;Switzerland;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Latvia;Netherlands;Norway;Germany

983

EUCTR2011-004579-35-ES
(EUCTR)

11/07/2012

09/03/2012

A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis.

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Moderate to severe active Ulcerative Colitis
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: CP -690,550-10
Product Code: CP -690,550-10
Other descriptive name: tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

545

United States;Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Romania;Croatia;Germany;New Zealand

984

EUCTR2011-004578-27-ES
(EUCTR)

11/07/2012

09/03/2012

A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis.

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Ulcerative colitis
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: CP -690,550-10
Product Code: CP -690,550-10
Other descriptive name: tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

545

985

EUCTR2011-004581-14-CZ
(EUCTR)

29/06/2012

08/02/2012

A multi-center, open-label study of CP-690,550 in subjects with moderate to severe ulcerative colitis

A MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

900

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

986

EUCTR2011-004578-27-CZ
(EUCTR)

29/06/2012

08/02/2012

A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis.

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Product Name: CP -690,550-10
Product Code: CP -690,550-10
Other descriptive name: tofacitinib

Pfizer Inc

,NULL

Not Recruiting

Female: yes
Male: yes

545

Phase 3

987

EUCTR2011-004579-35-CZ
(EUCTR)

29/06/2012

08/02/2012

A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis.

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Moderate to severe active Ulcerative Colitis
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: CP -690,550-10
Product Code: CP -690,550-10
Other descriptive name: tofacitinib

Pfizer Inc

,NULL

Not Recruiting

Female: yes
Male: yes

545

Phase 3

988

EUCTR2011-002411-29-FI
(EUCTR)

29/06/2012

11/06/2012

A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis.

An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A

Ulcerative Colitis
MedDRA version: 15.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: ADALIMUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

680

Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Norway;Sweden

989

EUCTR2011-002411-29-AT
(EUCTR)

26/06/2012

01/02/2012

A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis.

An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A

Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: ADALIMUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

455

Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Germany;Norway;Sweden

990

EUCTR2011-004580-79-CZ
(EUCTR)

26/06/2012

08/02/2012

A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis.

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS

Product Code: CP -690,550-10
Other descriptive name: tofacitinib

Pfizer Inc

NULL

Not Recruiting

Female: yes
Male: yes

654

Phase 3

India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand;Japan;Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

991

EUCTR2011-004770-28-AT
(EUCTR)

26/06/2012

15/02/2012

Phase III, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter International Study to Investigate the Safety and Efficacy of Propionyl-L-Carnitine (ST261) Modified Release Tablets in Patients Affected by Mild Ulcerative Colitis under Oral Stable Treatment. - Propionyl-L-Carnitine in Ulcerative Colitis

Mild ulcerative colitis
MedDRA version: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: PROPIONYL L-CARNITINE
Product Code: ST 261
INN or Proposed INN: Levocarnitine propyl hydrochloride
Other descriptive name: (R)-3-(1-oxo-propoxy)-4-(N,N,N-trimethyl amonium chloride)-butanoic acid

Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.

NULL

Not Recruiting

Female: yes
Male: yes

444

Phase 3

Hungary;Poland;Spain;Lithuania;Austria;Germany;Latvia

992

EUCTR2011-000164-10-SK
(EUCTR)

21/06/2012

13/04/2016

Safety and Pharmacokinetics of MMX Mesalamine in Children and Adolescents With Ulcerative Colitis

A Phase 1, Multicenter, Open-label Study to Determine the Safety and Pharmacokinetics of MMX Mesalamine Following Administration in Children and Adolescents With Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: SPD476
Product Code: SPD476
INN or Proposed INN: mesalazine
Product Name: SPD476
Product Code: SPD476
INN or Proposed INN: mesalazine
Product Name: SPD476
Product Code: SPD476
INN or Proposed INN: mesalazine

Shire Development Inc

NULL

Not Recruiting

Female: yes
Male: yes

Phase 1

United States;Slovakia;United Kingdom

993

EUCTR2011-005115-82-LV
(EUCTR)

15/06/2012

21/05/2012

Ulcerative Colitis
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Budesonide -MMX®
INN or Proposed INN: BUDESONIDE

Santarus, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

500

United States;Hungary;Estonia;Czech Republic;Canada;Poland;Ukraine;Lithuania;Bulgaria;Latvia

994

EUCTR2010-022766-27-SK
(EUCTR)

11/06/2012

27/01/2012

Study of safety and effectiveness of human-derived stem cells (multistem, also known as PF-05285401) in the treatment of ulcerative colitis

A PHASE 2 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF MULTISTEM (PF-05285401) IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Product Name: MultiStem
Product Code: PF-05285401
Other descriptive name: Multistem
Product Name: MultiStem
Product Code: PF-05285401
Other descriptive name: Multistem
Trade Name: Promiten
Other descriptive name: DEXTRAN 1 FOR INJECTION

Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK

NULL

Not Recruiting

Female: yes
Male: yes

128

Phase 2

United States;Hungary;Slovakia;Canada;Belgium;Poland;Italy;Sweden

995

EUCTR2011-004580-79-BE
(EUCTR)

08/06/2012

07/03/2012

A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis.

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS

Product Code: CP -690,550-10
Other descriptive name: tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

654

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

996

EUCTR2011-004579-35-BE
(EUCTR)

08/06/2012

08/03/2012

A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis.

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Moderate to severe active Ulcerative Colitis
MedDRA version: 16.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: CP -690,550-10
Product Code: CP -690,550-10
Other descriptive name: tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

545

997

EUCTR2011-004581-14-BE
(EUCTR)

07/06/2012

07/03/2012

A multi-center, open-label study of CP-690,550 in subjects with moderate to severe ulcerative colitis

A MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Product Name: Tofacitinib citrate (clinical trial image)
Product Code: CP -690,550-10
Other descriptive name: tofacitinib
Product Name: Tofacitinib citrate (Proposed commercial formulation – debossed)
Product Code: CP -690,550-10
Other descriptive name: tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

900

Phase 3

Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan

998

EUCTR2011-004578-27-BE
(EUCTR)

06/06/2012

07/03/2012

A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis.

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Product Name: CP -690,550-10
Product Code: CP -690,550-10
Other descriptive name: tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

545

999

EUCTR2011-004580-79-DE
(EUCTR)

06/06/2012

28/03/2012

A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis.

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS

Product Code: CP -690,550-10
INN or Proposed INN: not available
Other descriptive name: tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017, USA

NULL

Not Recruiting

Female: yes
Male: yes

654

Phase 3

Germany;New Zealand;Japan;Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia

1000

EUCTR2011-005251-13-GR
(EUCTR)

05/06/2012

14/05/2012

A study to find out more about the effect of AMG 181 in people with moderate to severe ulcerative colitis

A Randomized, Double blind, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Ulcerative Colitis

Product Name: AMG 181
Product Code: AMG 181
INN or Proposed INN: AMG 181

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

315

Phase 2

United States;Estonia;Greece;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Latvia;Germany;Norway

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1001

EUCTR2011-004581-14-DE
(EUCTR)

05/06/2012

29/03/2012

A multi-center, open-label study of CP-690,550 in subjects with moderate to severe ulcerative colitis

A MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Pfizer Inc, 235 East 42nd Street, New York, New York 10017, USA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

900

Phase 3

Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan

1002

EUCTR2011-005115-82-EE
(EUCTR)

05/06/2012

09/05/2012

Product Name: Budesonide -MMX®
INN or Proposed INN: BUDESONIDE

Santarus, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

500

United States;Hungary;Czech Republic;Estonia;Canada;Poland;Ukraine;Lithuania;Bulgaria;Latvia

1003

EUCTR2011-002411-29-PT
(EUCTR)

01/06/2012

03/01/2012

A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis.

An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A

Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: ADALIMUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

680

Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Norway;Sweden

1004

EUCTR2011-004578-27-HU
(EUCTR)

30/05/2012

10/02/2012

A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis.

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Product Name: CP -690,550-10
Product Code: CP -690,550-10
Other descriptive name: tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

545

Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan

1005

EUCTR2011-004579-35-DE
(EUCTR)

29/05/2012

21/03/2012

A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis.

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Product Name: CP -690,550-10
Product Code: CP -690,550-10
INN or Proposed INN: not available
Other descriptive name: tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017, USA

NULL

Not Recruiting

Female: yes
Male: yes

545

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1006

EUCTR2011-004578-27-DE
(EUCTR)

23/05/2012

05/03/2012

A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis.

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Product Name: CP -690,550-10
Product Code: CP -690,550-10
INN or Proposed INN: not availble
Other descriptive name: tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017, USA

NULL

Not Recruiting

Female: yes
Male: yes

545

Phase 3

1007

EUCTR2011-004578-27-LV
(EUCTR)

23/05/2012

01/03/2012

A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis.

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Product Name: CP -690,550-10
Product Code: CP -690,550-10
Other descriptive name: tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

545

1008

EUCTR2011-004581-14-LV
(EUCTR)

23/05/2012

01/03/2012

A multi-center, open-label study of CP-690,550 in subjects with moderate to severe ulcerative colitis

A MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Product Name: CP -690,550-10
Product Code: CP -690,550-10
Other descriptive name: tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

725

Phase 3

1009

EUCTR2011-004580-79-LV
(EUCTR)

23/05/2012

01/03/2012

A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis.

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS

Product Code: CP -690,550-10
Other descriptive name: tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

654

Phase 3

1010

EUCTR2011-004579-35-LV
(EUCTR)

23/05/2012

01/03/2012

A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis.

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Product Name: CP -690,550-10
Product Code: CP -690,550-10
Other descriptive name: tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

545

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1011

EUCTR2011-004579-35-AT
(EUCTR)

18/05/2012

21/03/2012

A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis.

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Product Name: CP -690,550-10
Product Code: CP -690,550-10
INN or Proposed INN: not available
Other descriptive name: tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

545

1012

EUCTR2011-004580-79-AT
(EUCTR)

18/05/2012

27/03/2012

A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis.

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS

Product Code: CP -690,550-10
INN or Proposed INN: not available
Other descriptive name: tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

654

Phase 3

1013

EUCTR2011-004581-14-AT
(EUCTR)

18/05/2012

27/03/2012

A multi-center, open-label study of CP-690,550 in subjects with moderate to severe ulcerative colitis

A MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Product Name: CP -690,550-10
Product Code: CP -690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: tofacitinib
Product Name: Tofacitinib citrate (Proposed commercial formulation – debossed)
Product Code: CP -690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

900

Phase 3

United States;Serbia;Estonia;Taiwan;Slovakia;Spain;Ukraine;Israel;Russian Federation;Italy;France;Denmark;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Brazil;Belgium;Poland;Croatia;Romania;Germany;New Zealand

1014

EUCTR2011-004580-79-ES
(EUCTR)

18/05/2012

09/03/2012

A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis.

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS

Product Code: CP -690,550-10
Other descriptive name: tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

654

Phase 3

Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan;New Zealand;United States

1015

EUCTR2011-004581-14-ES
(EUCTR)

18/05/2012

14/03/2012

A multi-center, open-label study of CP-690,550 in subjects with moderate to severe ulcerative colitis

A MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Product Name: CP -690,550-10
Product Code: CP -690,550-10
Other descriptive name: tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

725

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1016

EUCTR2011-004578-27-AT
(EUCTR)

18/05/2012

27/03/2012

A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis.

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Product Name: CP -690,550-10
Product Code: CP -690,550-10
INN or Proposed INN: not available
Other descriptive name: tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

545

1017

EUCTR2011-005115-82-BG
(EUCTR)

11/05/2012

11/04/2012

Product Name: Budesonide -MMX®
INN or Proposed INN: BUDESONIDE

Santarus, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

500

United States;Estonia;Hungary;Czech Republic;Canada;Poland;Ukraine;Lithuania;Bulgaria;Latvia

1018

EUCTR2011-002411-29-DE
(EUCTR)

11/05/2012

11/11/2011

A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis.

An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A

Ulcerative Colitis
MedDRA version: 16.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: ADALIMUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

455

Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;United Kingdom;Italy;Switzerland;France;Czech Republic;Canada;Poland;Belgium;Denmark;Germany;Norway;Sweden

1019

EUCTR2011-004579-35-HU
(EUCTR)

10/05/2012

10/02/2012

A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis.

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Product Name: CP -690,550-10
Product Code: CP -690,550-10
Other descriptive name: tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

545

Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand

1020

EUCTR2011-004581-14-HU
(EUCTR)

10/05/2012

10/02/2012

A multi-center, open-label study of CP-690,550 in subjects with moderate to severe ulcerative colitis

A MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Product Name: Tofacitinib citrate (clinical trial image)
Product Code: CP -690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: tofacitinib
Product Name: Tofacitinib citrate (Proposed commercial formulation – debossed)
Product Code: CP -690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

900

Phase 3

United States;Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1021

EUCTR2011-004580-79-HU
(EUCTR)

10/05/2012

10/02/2012

A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis.

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS

Product Code: CP -690,550-10
Other descriptive name: tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

654

Phase 3

Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand;Japan

1022

EUCTR2011-002411-29-GB
(EUCTR)

03/05/2012

07/11/2011

A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis.

An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A

Ulcerative Colitis
MedDRA version: 17.0;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: ADALIMUMAB

Abbvie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

455

Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;United Kingdom;Switzerland;France;Czech Republic;Canada;Poland;Belgium;Denmark;Norway;Netherlands;Germany;Sweden

1023

EUCTR2011-004580-79-SK
(EUCTR)

03/05/2012

10/04/2013

A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis.

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS

Product Code: CP -690,550-10
Other descriptive name: tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

654

Phase 3

1024

EUCTR2011-004770-28-DE
(EUCTR)

03/05/2012

09/02/2012

Phase III, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter International Study to Investigate the Safety and Efficacy of Propionyl-L-Carnitine Hydrochloride (ST261) Modified Release Tablets in Patients Affected by Mild Ulcerative Colitis under Oral Stable Treatment. - Propionyl-L-Carnitine in Ulcerative Colitis

Product Name: PROPIONYL L-CARNITINE
Product Code: ST 261
INN or Proposed INN: Propionylcarnitinhydrochlorid
Other descriptive name: (R)-3-(1-oxo-propoxy)-4-(N,N,N-trimethyl amonium chloride)-butanoic acid

Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.

NULL

Not Recruiting

Female: yes
Male: yes

444

Phase 3

Hungary;Poland;Spain;Lithuania;Austria;Latvia;Germany

1025

EUCTR2011-004578-27-SK
(EUCTR)

02/05/2012

12/04/2012

A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis.

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Product Name: CP -690,550-10
Product Code: CP -690,550-10
Other descriptive name: tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

545

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1026

EUCTR2011-004581-14-SK
(EUCTR)

02/05/2012

13/04/2012

A multi-center, open-label study of CP-690,550 in subjects with moderate to severe ulcerative colitis

A MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Product Name: Tofacitinib citrate (clinical trial image)
Product Code: CP -690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: tofacitinib
Product Name: Tofacitinib citrate (Proposed commercial formulation – debossed)
Product Code: CP -690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: tofacitinib

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

900

Phase 3

1027

EUCTR2011-004579-35-SK
(EUCTR)

02/05/2012

13/04/2012

A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis.

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Product Name: CP -690,550-10
Product Code: CP -690,550-10
Other descriptive name: tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

545

1028

EUCTR2011-004579-35-GB
(EUCTR)

01/05/2012

12/01/2012

A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis.

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Product Name: CP -690,550-10
Product Code: CP -690,550-10
Other descriptive name: tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

545

1029

EUCTR2011-004581-14-GB
(EUCTR)

01/05/2012

01/03/2012

A multi-center, open-label study of CP-690,550 in subjects with moderate to severe ulcerative colitis

A MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Product Name: Tofacitinib citrate (clinical trial image)
Product Code: CP -690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: tofacitinib
Product Name: Tofacitinib citrate (Proposed commercial formulation – debossed)
Product Code: CP -690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

900

Phase 3

1030

EUCTR2011-004580-79-GB
(EUCTR)

30/04/2012

14/02/2012

A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis.

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS

Ulcerative colitis
MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

654

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1031

EUCTR2011-004581-14-EE
(EUCTR)

26/04/2012

13/02/2012

A multi-center, open-label study of CP-690,550 in subjects with moderate to severe ulcerative colitis

A MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Product Name: Tofacitinib citrate (clinical trial image)
Product Code: CP -690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: tofacitinib
Product Name: Tofacitinib citrate (Proposed commercial formulation – debossed)
Product Code: CP -690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

900

Phase 3

1032

EUCTR2011-004580-79-EE
(EUCTR)

26/04/2012

13/02/2012

A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis.

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS

Product Code: CP -690,550-10
Other descriptive name: tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

654

Phase 3

1033

EUCTR2011-002411-29-SE
(EUCTR)

26/04/2012

13/10/2011

A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis.

An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A

Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: ADALIMUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

455

Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Germany;Norway;Sweden

1034

EUCTR2011-004578-27-EE
(EUCTR)

26/04/2012

14/02/2012

A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis.

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Product Name: CP -690,550-10
Product Code: CP -690,550-10
Other descriptive name: tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

545

1035

EUCTR2011-004579-35-EE
(EUCTR)

26/04/2012

14/02/2012

A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis.

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Product Name: CP -690,550-10
Product Code: CP -690,550-10
Other descriptive name: tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

545

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1036

EUCTR2011-004578-27-GB
(EUCTR)

26/04/2012

12/01/2012

A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis.

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Product Name: CP -690,550-10
Product Code: CP -690,550-10
Other descriptive name: tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

545

1037

EUCTR2011-004765-32-IT
(EUCTR)

26/04/2012

23/07/2012

Phase III, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter, International Study to investigate the safety and efficacy of ST261 (Propionyl-L-Carnitine Hydrochloride) modified release tablets in Patients Affected by mild Ulcerative Colitis under Oral Stable Treatment. - Propionyl-L-Carnitine in Ulcerative Colitis

SIGMA-TAU

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 3

Czech Republic;Belgium;Netherlands;Italy

1038

EUCTR2010-023762-49-BE
(EUCTR)

23/04/2012

21/11/2011

A study to evaluate the safety and how anrukinzumab (IMA-638) works in the body for patients with Ulcerative Colitis

A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, SPONSOR UNBLINDED, PLACEBO-CONTROLLED, MULTIPLE DOSE STUDY TO EVALUATE THE PHARMACODYNAMICS, PHARMACOKINETICS AND SAFETY OF ANRUKINZUMAB IN PATIENTS WITH ACTIVE ULCERATIVE COLITIS - IMA-638 Ulcerative Colitis Study

Ulcerative Colitis
MedDRA version: 14.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Not Applicable
Product Code: PF-05230917
INN or Proposed INN: Not Applicable
Other descriptive name: Not applicable

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2A

France;Belgium;United States;Hungary;Canada;Romania;Austria;Netherlands;Bulgaria;Spain;Germany;Poland

1039

EUCTR2011-005115-82-CZ
(EUCTR)

18/04/2012

08/02/2012

Product Name: Budesonide -MMX®
INN or Proposed INN: BUDESONIDE

Santarus, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

500

United States;Estonia;Hungary;Czech Republic;Canada;Poland;Ukraine;Lithuania;Bulgaria;Latvia

1040

EUCTR2011-004812-40-GB
(EUCTR)

12/04/2012

21/03/2012

Evaluation of efficacy and safety of tralokinumab in patients with active, moderate-to-severe ulcerative colitis.

A phase IIa, randomised, double-blind, placebo-controlled, parallel-arm, multicenter study to evaluate the efficacy and safety of tralokinumab (CAT-354), a recombinant human monoclonal antibody directed against interleukin-13 (IL-13), as add-on therapy, on clinical response in patients with active, moderate-to-severe, ulcerative colitis

Product Name: tralokinumab
Product Code: CAT-354
INN or Proposed INN: tralokinumab

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

110

Phase 2

Czech Republic;Netherlands;Germany;Italy;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1041

EUCTR2011-004770-28-LT
(EUCTR)

12/04/2012

15/02/2012

Mild ulcerative colitis
MedDRA version: 16.0;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.

NULL

Not Recruiting

Female: yes
Male: yes

444

Phase 3

France;Hungary;Spain;Poland;Lithuania;Austria;Latvia;Germany

1042

EUCTR2010-023588-16-DE
(EUCTR)

10/04/2012

05/05/2011

A study of a new iron medication for people with ulcerative colitis that is in remission and anaemia (low number of healthy red blood cells), who cannot use other oral iron medications either because they do not work, or because they cause side effects. (AEGIS 1)

A prospective, multicentre, randomised, double-blind, placebo controlled study with oral ST10-021 for the treatment of iron deficiency anaemia in subjects with quiescent ulcerative colitis where oral ferrous preparations have failed or cannot be used (AEGIS 1) - ST10-021 for IDA in quiescent UC

Iron deficiency anaemia in quiescent ulcerative colitis
MedDRA version: 17.0;Level: LLT;Classification code 10002062;Term: Anaemia iron deficiency;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 17.0;Level: PT;Classification code 10022972;Term: Iron deficiency anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

Product Name: ST10-021
Product Code: ST10-021
Other descriptive name: 3-hydroxy-2-methyl-4H-pyrane-4-one iron (III) complex (3:1), Ferric (3-hydroxy-2-methyl-4-pyrone), Tris-maltol-iron (III), Tri=maltol-iron (III)

Iron Therapeutics (Switzerland) AG

NULL

Not Recruiting

Female: yes
Male: yes

Hungary;Austria;Germany;United Kingdom

1043

EUCTR2011-005115-82-PL
(EUCTR)

10/04/2012

16/03/2012

Product Name: Budesonide -MMX®
INN or Proposed INN: BUDESONIDE

Santarus, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

500

United States;Estonia;Hungary;Czech Republic;Canada;Poland;Ukraine;Lithuania;Bulgaria;Latvia

1044

EUCTR2011-002411-29-DK
(EUCTR)

30/03/2012

28/11/2011

A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis.

An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A

Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: ADALIMUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

455

Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Poland;Belgium;Denmark;Germany;Norway;Sweden

1045

EUCTR2011-002411-29-IE
(EUCTR)

30/03/2012

09/02/2012

A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis.

An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A

Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: ADALIMUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

455

Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Norway;Germany;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1046

EUCTR2010-022766-27-IT
(EUCTR)

28/03/2012

27/04/2012

Study of safety and effectiveness of human-derived stem cells (multistem, also know as PF-05285401) in the treatment of ulcerative colitis.

Ulcerative Colitis
MedDRA version: 14.1;Level: LLT;Classification code 10045282;Term: UC;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Multistem
Product Code: PF-05285401
Other descriptive name: Multistem
Product Name: Multistem
Product Code: PF-05285401
Other descriptive name: Multistem
Trade Name: Promiten
INN or Proposed INN: DEXTRAN 1 FOR INJECTION

PFIZER LIMITED

NULL

Not Recruiting

Female: yes
Male: yes

128

Phase 2

United States;Hungary;Canada;Belgium;Italy;Sweden

1047

EUCTR2011-005115-82-HU
(EUCTR)

26/03/2012

07/02/2012

Product Name: Budesonide -MMX®
INN or Proposed INN: BUDESONIDE

Santarus, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

500

United States;Estonia;Czech Republic;Hungary;Canada;Poland;Ukraine;Lithuania;Bulgaria;Latvia

1048

EUCTR2011-004770-28-HU
(EUCTR)

21/03/2012

23/01/2012

Phase III, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter International Study to Investigate the Safety and Efficacy of Propionyl-L-Carnitine hydrochloride (ST261) Modified Release Tablets in Patients Affected by Mild Ulcerative Colitis under Oral Stable Treatment. - Propionyl-L-Carnitine in Ulcerative Colitis

Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.

NULL

Not Recruiting

Female: yes
Male: yes

444

Phase 3

Hungary;Poland;Spain;Lithuania;Austria;Germany;Latvia

1049

EUCTR2011-004581-14-DK
(EUCTR)

20/03/2012

09/02/2012

A multi-center, open-label study of CP-690,550 in subjects with moderate to severe ulcerative colitis

A MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Product Name: Tofacitinib citrate (clinical trial image)
Product Code: CP -690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: tofacitinib
Product Name: Tofacitinib citrate (Proposed commercial formulation – debossed)
Product Code: CP -690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

900

Phase 3

Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Italy;France;Australia;Denmark;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Belgium;Poland;Croatia;Romania;Germany;New Zealand

1050

EUCTR2011-004770-28-PL
(EUCTR)

17/03/2012

16/02/2012

Mild ulcerative colitis
MedDRA version: 15.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.

NULL

Not Recruiting

Female: yes
Male: yes

444

Phase 3

France;Hungary;Spain;Poland;Lithuania;Austria;Latvia;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1051

EUCTR2011-003130-14-IT
(EUCTR)

12/03/2012

05/03/2012

Clinical Trial to assess the efficacy and safety of Kappaproct

A placebo-controlled, double-blind, randomised study to assess the efficacy and safety of Kappaproct as an add-on to current practice in chronic active treatment refractory ulcerative colitis patients” - CSUC-01/10

Chronic active treatment refractory ulcerative colitis
MedDRA version: 14.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Kappaproct
Product Code: DIMS0150
INN or Proposed INN: NA
Other descriptive name: NA

INDEX PHARMACEUTICALS

NULL

Not Recruiting

Female: yes
Male: yes

132

Czech Republic;Hungary;Poland;Germany;United Kingdom;Italy

1052

EUCTR2011-002411-29-BE
(EUCTR)

07/03/2012

23/11/2011

A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis.

An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A

Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: ADALIMUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

455

Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Germany;Norway;Sweden

1053

EUCTR2011-004770-28-LV
(EUCTR)

29/02/2012

24/01/2012

Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.

NULL

Not Recruiting

Female: yes
Male: yes

444

Phase 3

France;Hungary;Spain;Poland;Lithuania;Austria;Germany;Latvia

1054

EUCTR2011-004770-28-ES
(EUCTR)

28/02/2012

11/01/2012

Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

444

Phase 3

Hungary;Germany;France;Spain;Latvia;Poland;Austria;Lithuania

1055

EUCTR2011-004579-35-DK
(EUCTR)

24/02/2012

A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis.

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Moderate to severe active Ulcerative Colitis
MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: CP -690,550-10
Product Code: CP -690,550-10
Other descriptive name: tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

545

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1056

EUCTR2011-004578-27-DK
(EUCTR)

24/02/2012

09/02/2012

A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis.

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Product Name: CP -690,550-10
Product Code: CP -690,550-10
Other descriptive name: tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

545

Phase 3

1057

EUCTR2011-004580-79-DK
(EUCTR)

24/02/2012

23/01/2012

A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis.

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS

Product Code: CP -690,550-10
Other descriptive name: tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

654

Phase 3

1058

EUCTR2011-004765-32-CZ
(EUCTR)

21/02/2012

15/12/2011

Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.

NULL

Not Recruiting

Female: yes
Male: yes

444

Phase 3

Czech Republic;Belgium;Netherlands;Italy

1059

EUCTR2011-002411-29-IT
(EUCTR)

20/02/2012

07/03/2012

A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis.

An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting.

Trade Name: Humira 40 mg solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB

ABBOTT GMBH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

680

Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;Czech Republic;Canada;Poland;Belgium;Denmark;Germany;Sweden

1060

EUCTR2011-002818-37-BE
(EUCTR)

15/02/2012

03/10/2011

A Phase II study to investigate GSK1605786 fo the treatment of patients with Ulcerative Colitis.

A phase II, 20-week, multi-centre, randomised, double-blind, placebo-controlled, parallel group proof of concept study to investigate the efficacy and safety of GSK1605786 for treatment of patients with active Ulcerative Colitis.

Subjects with Active Ulcerative Colitis.
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: GSK1605786A
Product Code: GSK1605786A

GlaxoSmithKline Research & Development Ltd

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Belgium;Netherlands;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1061

EUCTR2011-003532-32-LT
(EUCTR)

14/02/2012

28/11/2011

A Pilot Study to Evaluate Safety and Efficacy of LX1606 in Subjects With Acute, Mild to Moderate Ulcerative Colitis

Phase 2 Assessment of the Relationship between Serotonin and Efficacy in Ulcerative Colitis: A Multi-Center Randomized, Double Blind, Placebo-Controlled, Pilot Study to Evaluate Safety and Preliminary Efficacy of Orally Administered LX1606 in Subjects with Acute, Mild to Moderate Ulcerative Colitis

Acute mild to moderate ulcerative colitis
MedDRA version: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: LX1606
Product Code: LX1606
INN or Proposed INN: Telotristat etiprate
Other descriptive name: telotristat etiprate

Lexicon Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Slovakia;Poland;Belgium;Lithuania

1062

EUCTR2010-022766-27-BE
(EUCTR)

09/02/2012

08/11/2011

Study of safety and effectiveness of human-derived stem cells (multistem, also known as PF-05285401) in the treatment of ulcerative colitis

Product Name: MultiStem
Product Code: PF-05285401
INN or Proposed INN: N/A
Other descriptive name: Multistem
Product Name: MultiStem
Product Code: PF-05285401
INN or Proposed INN: N/A
Other descriptive name: Multistem
Trade Name: Promiten
INN or Proposed INN: Dextran
Other descriptive name: DEXTRAN 1 FOR INJECTION

Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK

NULL

Not Recruiting

Female: yes
Male: yes

128

Phase 2

United States;Hungary;Slovakia;Canada;Poland;Belgium;Germany;Italy;Sweden

1063

EUCTR2011-003409-36-DE
(EUCTR)

09/02/2012

17/11/2011

A study to evaluate the long term safety of rhuMab Beta7 in patients with moderate to severe ulcerative colitis (a form of inflammatory bowel disease)

A Phase II Open-Label Extension Study to Evaluate the Long-Term Safety of rhuMAb Beta7 in Patients with Moderate to Severe Ulcerative Colitis

Product Name: rhuMAb Beta7
Product Code: PRO145223 (RO5490261)
INN or Proposed INN: n.a.
Other descriptive name: rhuMAb Beta7

Genentech, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 2

United States;Hungary;Czech Republic;Canada;Spain;Belgium;Australia;Israel;Germany;United Kingdom;New Zealand

1064

EUCTR2011-002818-37-GB
(EUCTR)

08/02/2012

07/11/2011

A Phase II study to investigate GSK1605786 fo the treatment of patients with Ulcerative Colitis.

Product Name: GSK1605786A
Product Code: GSK1605786A

GlaxoSmithKline Research & Development Ltd

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Netherlands;United Kingdom

1065

EUCTR2010-022766-27-HU
(EUCTR)

07/02/2012

05/12/2011

Study of safety and effectiveness of human-derived stem cells (multistem, also known as PF-05285401) in the treatment of ulcerative colitis

Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK

NULL

Not Recruiting

Female: yes
Male: yes

128

Phase 2

United States;Hungary;Slovakia;Canada;Belgium;Poland;Germany;Italy;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1066

EUCTR2011-004812-40-DE
(EUCTR)

26/01/2012

25/11/2011

Evaluation of efficacy and safety of tralokinumab in patients with active, moderate-to-severe ulcerative colitis.

Product Name: tralokinumab
Product Code: CAT-354
INN or Proposed INN: tralokinumab

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

110

Phase 2a

Czech Republic;Netherlands;Germany;United Kingdom;Italy

1067

EUCTR2011-004812-40-NL
(EUCTR)

25/01/2012

22/12/2011

Evaluation of efficacy and safety of tralokinumab in patients with active, moderate-to-severe ulcerative colitis.

Ulcerative Colitis
MedDRA version: 15.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: tralokinumab
Product Code: CAT-354
INN or Proposed INN: tralokinumab

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

110

Phase 2a

Czech Republic;Netherlands;United Kingdom;Italy

1068

EUCTR2011-004812-40-CZ
(EUCTR)

24/01/2012

29/12/2011

Evaluation of efficacy and safety of tralokinumab in patients with active, moderate-to-severe ulcerative colitis.

Product Name: tralokinumab
Product Code: CAT-354
INN or Proposed INN: tralokinumab

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

110

Phase 2a

Czech Republic;Netherlands;United Kingdom;Italy

1069

EUCTR2011-004765-32-SK
(EUCTR)

19/01/2012

09/12/2011

Mild ulcerative colitis
MedDRA version: 14.0;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

444

Phase 3

Czech Republic;Slovakia;Belgium;Netherlands;Italy

1070

EUCTR2010-022766-27-SE
(EUCTR)

19/01/2012

03/11/2011

Study of safety and effectiveness of human-derived stem cells (multistem, also known as PF-05285401) in the treatment of ulcerative colitis

Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK

NULL

Not Recruiting

Female: yes
Male: yes

128

Phase 2

United States;Hungary;Slovakia;Canada;Belgium;Poland;Germany;Italy;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1071

EUCTR2011-003130-14-CZ
(EUCTR)

13/01/2012

14/10/2011

A study to see how effective and safe the drug Kappaproct is in patients with refractory ulcerative colitis when added to their standard care of treatment

Chronic active treatment refractory ulcerative colitis
MedDRA version: 16.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Kappaproct
INN or Proposed INN: DIMS0150
Other descriptive name: DIMS0150

InDex Pharmaceuticals AB

NULL

Not Recruiting

Female: yes
Male: yes

120

Hungary;Czech Republic;Poland;Germany;Italy;United Kingdom

1072

EUCTR2011-003409-36-CZ
(EUCTR)

11/01/2012

18/11/2011

A study to evaluate the long term safety of etrolizumab in patients with moderate to severe ulcerative colitis (a form of inflammatory bowel disease)

A Phase II Open-Label Extension Study to Evaluate the Long-Term Safety of Etrolizumab in Patients with Moderate to Severe Ulcerative Colitis

Ulcerative colitis
MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Etrolizumab
Product Code: RO5490261/F02
INN or Proposed INN: ETROLIZUMAB
Other descriptive name: rhuMAb Beta7; Anti Beta7; PRO145223

Genentech, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 2

United States;Hungary;Czech Republic;Canada;Belgium;Spain;Australia;Israel;Germany;New Zealand;United Kingdom

1073

EUCTR2011-004765-32-BE
(EUCTR)

10/01/2012

06/12/2011

Phase III, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter International Study to Investigate the Safety and Efficacy of Propionyl-L-carnitine Hydrochloride (ST261) Modified Release Tablets in Patients Affected by Mild Ulcerative Colitis under Oral Stable Treatment - Propionyl-L-carnitine in Ulcerative Colitis

Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.

NULL

Not Recruiting

Female: yes
Male: yes

444

Phase 3

Czech Republic;Slovakia;Belgium;Netherlands;Italy

1074

EUCTR2011-002411-29-GR
(EUCTR)

09/01/2012

07/12/2011

A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis.

An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A

Ulcerative Colitis
MedDRA version: 14.0;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: ADALIMUMAB

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

680

Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Norway;Sweden

1075

EUCTR2011-003283-78-IT
(EUCTR)

09/01/2012

01/03/2012

A PROOF-OF-CONCEPT CLINICAL STUDY, TO ASSESS THE EFFECT OF GED-0507-34-Levo 80 mg Tablets IN INDUCTION OF REMISSION OF ACTIVE ULCERATIVE COLITIS

Active Ulcerative Colitis Patients
MedDRA version: 14.1;Level: LLT;Classification code 10021184;Term: IBD;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: NA
Product Code: GED-0507-34-Levo
INN or Proposed INN: (-)-3-(4-Aminophenyl)-2-methoxypropionic acid
Other descriptive name: NA

GIULIANI

NULL

Not Recruiting

Female: yes
Male: yes

Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1076

EUCTR2011-005693-36-IT
(EUCTR)

09/01/2012

02/03/2012

Evaluation of the number of colon intraephitelial tumours in patients with ulcerative colitis after oral administration of the vital dye methylene blue

Intraepithelial neoplasia detection rate after single oral dose of methylene blue MMX modified release tablets administered to patients with long standing ulcerative colitis undergoing colonoscopy - NA

Patients affecetd by Long standing ulcerative colitis
MedDRA version: 14.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Methylene blue 25mg tablets
Product Code: NA
INN or Proposed INN: METHYLENE BLUE
Other descriptive name: NA

COSMO TECHNOLOGIES LTD

NULL

Not Recruiting

Female: yes
Male: yes

Italy

1077

EUCTR2010-023762-49-PL
(EUCTR)

06/01/2012

05/07/2011

A study to evaluate the safety and how anrukinzumab (IMA-638) works in the body for patients with Ulcerative Colitis

Product Name: Not Applicable
Product Code: PF-05230917
INN or Proposed INN: Not Applicable
Other descriptive name: Not applicable

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2A

United States;France;Hungary;Canada;Spain;Belgium;Poland;Romania;Austria;Bulgaria;Germany;Netherlands

1078

EUCTR2011-002818-37-NL
(EUCTR)

03/01/2012

16/02/2012

A Phase II study to investigate GSK1605786 fo the treatment of patients with Ulcerative Colitis.

Product Name: GSK1605786A
Product Code: GSK1605786A

GlaxoSmithKline Research & Development Ltd

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Netherlands;United Kingdom

1079

EUCTR2011-002462-20-IT
(EUCTR)

02/01/2012

08/03/2012

Prospective clinical study, where patients are receiving or the study drug or an inactive drug called placebo wihtout knowing which of the two drugs is taken, even the Investigator is aware of the therapy taken by the patients. Patients are assigned to a specific treatment according to a randomization list. The study is performed to assess the effects and tolerability of K(D)PT in ulcerative colitis.

mild to moderate ulcerative colitis
MedDRA version: 14.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Lysine -D-proline-threonine
Product Code: K(D)PT
INN or Proposed INN: NA
Other descriptive name: L-Lysyl-D-Prolyl-LThreonine acetate, lyophilisate

DR. AUGUST WOLFF GMBH & CO. KG

NULL

Not Recruiting

Female: yes
Male: yes

160

Hungary;Czech Republic;Slovakia;Poland;Germany;Italy

1080

EUCTR2011-003130-14-DE
(EUCTR)

30/12/2011

19/09/2011

A study to see how effective and safe the drug Kappaproct is in patients with refractory ulcerative colitis when added to their standard care of treatment

Product Name: Kappaproct
INN or Proposed INN: DIMS0150
Other descriptive name: DIMS0150

InDex Pharmaceuticals AB

NULL

Not Recruiting

Female: yes
Male: yes

120

Czech Republic;Hungary;Poland;Germany;Italy;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1081

EUCTR2011-002462-20-PL
(EUCTR)

27/12/2011

20/10/2011

Clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitis

Acute mild to moderate ulcerative colitis.
MedDRA version: 15.0;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Dr August Wolff GmbH & Co KG Arzneimittel

NULL

Not Recruiting

Female: yes
Male: yes

160

Hungary;Czech Republic;Poland;Germany;Italy

1082

EUCTR2011-003409-36-ES
(EUCTR)

23/12/2011

18/11/2011

A study to evaluate the long term safety of rhuMab Beta7 in patients with moderate to severe ulcerative colitis (a form of inflammatory bowel disease)

A Phase II Open-Label Extension Study to Evaluate the Long-Term Safety of rhuMAb Beta7 in Patients with Moderate to Severe Ulcerative Colitis

Ulcerative colitis
MedDRA version: 14.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: rhuMAb Beta7
Product Code: PRO145223 (RO5490261)
INN or Proposed INN: n.a.
Other descriptive name: rhuMAb Beta7

Genentech, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 2

United States;Hungary;Czech Republic;Canada;Belgium;Spain;Australia;Israel;Germany;United Kingdom;New Zealand

1083

EUCTR2011-003130-14-PL
(EUCTR)

22/12/2011

10/10/2011

A study to see how effective and safe the drug Kappaproct is in patients with refractory ulcerative colitis when added to their standard care of treatment

Product Name: Kappaproct
Other descriptive name: DIMS0150

InDex Pharmaceuticals AB

NULL

Not Recruiting

Female: yes
Male: yes

120

Czech Republic;Hungary;Poland;Germany;Italy;United Kingdom

1084

EUCTR2010-020448-37-NL
(EUCTR)

21/12/2011

16/09/2010

Randomized placebo-controlled multicenter exploratory Phase IIA study to assess the safety and efficacy of PEG-liposomal prednisolone sodium phosphate (Nanocort) in subjects with active ulcerative colitis.

Active Ulcerative Colitis
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: PEG -liposomal prednisolone sodium phosphate
Product Code: Nanocort
INN or Proposed INN: Prednisolone Sodium Phosphate
Other descriptive name: PREDNISOLONE SODIUM PHOSPHATE

Enceladus Pharmaceuticals

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2A

Belgium;Netherlands

1085

EUCTR2011-003532-32-SK
(EUCTR)

19/12/2011

10/11/2011

A Pilot Study to Evaluate Safety and Efficacy of LX1606 in Subjects With Acute, Mild to Moderate Ulcerative Colitis

Acute mild to moderate ulcerative colitis
MedDRA version: 14.0;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: LX1606
Product Code: LX1606
INN or Proposed INN: Non as of yet
Other descriptive name: telotristat etiprate

Lexicon Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Slovakia;Belgium;Poland;Lithuania

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1086

EUCTR2011-004268-31-DK
(EUCTR)

13/12/2011

21/11/2011

Adalimumab (Humira) in the treatment of chronic pouchitis

Chronic pouchitis after proctocolectomy and reconstruction with a J-pouch and with ulcerative colitis as primary diagnosis
MedDRA version: 14.0;Level: PT;Classification code 10036463;Term: Pouchitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Humira 40 mg solution for injection in pre-filled syringes
Product Name: Humira
Product Code: EMEA/H/C/000481

Odense University Hospital

NULL

Not Recruiting

Female: yes
Male: yes

Denmark

1087

EUCTR2011-004812-40-IT
(EUCTR)

12/12/2011

02/03/2012

Product Name: tralokinumab
Product Code: CAT-354
INN or Proposed INN: tralokinumab
Other descriptive name: NA

ASTRAZENECA

NULL

Not Recruiting

Female: yes
Male: yes

110

Phase 2a

Czech Republic;Netherlands;Germany;United Kingdom;Italy

1088

EUCTR2011-002462-20-HU
(EUCTR)

07/12/2011

22/09/2011

Clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitis

Dr August Wolff GmbH & Co KG Arzneimittel

NULL

Not Recruiting

Female: yes
Male: yes

Czech Republic;Hungary;Poland;Germany;Italy

1089

EUCTR2011-003409-36-GB
(EUCTR)

02/12/2011

06/12/2011

A study to evaluate the long term safety of etrolizumab in patients with moderate to severe ulcerative colitis (a form of inflammatory bowel disease)

A Phase II Open-Label Extension Study to Evaluate the Long-Term Safety of Etrolizumab in Patients with Moderate to Severe Ulcerative Colitis

Product Name: Etrolizumab
Product Code: RO5490261 / F02
INN or Proposed INN: Etrolizumab
Other descriptive name: rhuMAb Beta7; Anti Beta7; PRO145223

Genentech, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 2

United States;Hungary;Czech Republic;Canada;Spain;Belgium;Australia;Israel;Germany;New Zealand;United Kingdom

1090

NCT01496053
(ClinicalTrials.gov)

December 2011

15/12/2011

Anti-inflammatory Effect of Agaricus Blazei Murill in Inflammatory Bowel Disease (IBD)

Anti-inflammatory Effect of a Mushroom Extract (AndoSan)in Patients With Inflammatory Bowel Disease. A Prospective Study

Ulcerative Colitis;Crohn's Disease;Inflammatory Bowel Disease

Dietary Supplement: AndoSan;Dietary Supplement: Sugar Extract

Oslo University Hospital

ImmunoPharma AS

Completed

18 Years

60 Years

All

100

Phase 2;Phase 3

Norway

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1091

EUCTR2010-023762-49-DE
(EUCTR)

29/11/2011

17/08/2011

A study to evaluate the safety and how anrukinzumab (IMA-638) works in the body for patients with Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Not Applicable
Product Code: PF-05230917
INN or Proposed INN: Not Applicable
Other descriptive name: Not applicable

Pfizer Inc., 235 East 42nd Street, New York, NY 10017, USA

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2A

France;United States;Hungary;Canada;Poland;Belgium;Spain;Romania;Austria;Bulgaria;Netherlands;Germany

1092

EUCTR2011-002462-20-CZ
(EUCTR)

24/11/2011

20/09/2011

Clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitis

Acute mild to moderate ulcerative colitis.
MedDRA version: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Dr August Wolff GmbH & Co KG Arzneimittel

NULL

Not Recruiting

Female: yes
Male: yes

Hungary;Czech Republic;Poland;Germany;Italy

1093

EUCTR2011-003208-19-GB
(EUCTR)

16/11/2011

28/09/2011

GWP42003 symptomatic treatment of ulcerative colitis.

A randomised, double-blind, placebo-controlled parallel group, pilot study of GWP42003 in the symptomatic treatment of ulcerative colitis.

Symptoms of diarrhoea, rectal bleeding, stool frequency and inflammation in subjects with ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

GW Pharma Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Czech Republic;United Kingdom

1094

EUCTR2011-003409-36-BE
(EUCTR)

14/11/2011

A study to evaluate the long term safety of rhuMab Beta7 in patients with moderate to severe ulcerative colitis (a form of inflammatory bowel disease)

A Phase II Open-Label Extension Study to Evaluate the Long-Term Safety of rhuMAb Beta7 in Patients with Moderate to Severe Ulcerative Colitis

Ulcerative colitis
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: rhuMAb Beta7
Product Code: PRO145223 (RO5490261)
INN or Proposed INN: n.a.
Other descriptive name: rhuMAb Beta7

Genentech, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

120

Phase 2

United States;Hungary;Czech Republic;Canada;Spain;Belgium;Australia;Israel;Germany;United Kingdom;New Zealand

1095

EUCTR2010-023762-49-HU
(EUCTR)

09/11/2011

13/05/2011

A study to evaluate the safety and how anrukinzumab (IMA-638) works in the body for patients with Ulcerative Colitis

Product Name: Not Applicable
Product Code: PF-05230917
INN or Proposed INN: Not Applicable
Other descriptive name: Not applicable

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2A

Hungary;Germany;Canada;Netherlands;Belgium;Romania;France;Bulgaria;Spain;United States;Poland;Austria

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1096

EUCTR2011-002462-20-DE
(EUCTR)

25/10/2011

13/09/2011

Clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitis

Dr August Wolff GmbH & Co KG Arzneimittel

NULL

Not Recruiting

Female: yes
Male: yes

160

Hungary;Czech Republic;Poland;Germany;Italy

1097

EUCTR2010-022506-41-PL
(EUCTR)

24/10/2011

05/09/2011

Induction and Maintenance Study of BMS-936557 Patients with Moderate to Severe Ulcerative Colitis

A Phase IIb Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-936557 in Subjects with Active Ulcerative Colitis (UC)Pharmacogenetics Blood Sample Amendment 01 - Site Specific (version 1.0, date 04-oct-2010)Revised Protocol 04 incorporating Protocol amendment 06

Colitis, Ulcerative
MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Human anti-IP10 monoclonal antibody
Product Code: BMS-936557
INN or Proposed INN: Human anti-IP10 monoclonal antibody
Other descriptive name: MDX-1100
Product Name: Human anti-IP10 monoclonal antibody
Product Code: BMS-936557
INN or Proposed INN: Human anti-IP10 monoclonal antibody
Other descriptive name: MDX-1100

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

386

Phase 2b

United States;Austria;Italy;France;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Australia;South Africa;Netherlands;Germany

1098

EUCTR2011-000897-80-DE
(EUCTR)

19/10/2011

15/07/2011

A clinical study to investigate the safety and efficacy of the product rhuMAb BETA7 in treating patients with ulcerative colitis, a form of inflammatory bowel disease

PHASE II RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF rhuMAb BETA7 IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Product Name: rhuMAb Beta7
Product Code: PRO145223 (RO5490261)
INN or Proposed INN: n.a.
Other descriptive name: rhuMAb Beta7

Genentech, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 2

Israel;Germany;United States;Hungary;Czech Republic;Canada;Spain;Australia;United Kingdom;New Zealand

1099

EUCTR2011-003130-14-HU
(EUCTR)

14/10/2011

01/09/2011

A study to see how effective and safe the drug Kappaproct is in patients with refractory ulcerative colitis when added to their standard care of treatment

Product Name: Kappaproct
Other descriptive name: DIMS0150

InDex Pharmaceuticals AB

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

120

Czech Republic;Hungary;Poland;Germany;Italy;United Kingdom

1100

EUCTR2011-003130-14-GB
(EUCTR)

06/10/2011

11/08/2011

A study to see how effective and safe the drug Kappaproct is in patients with refractory ulcerative colitis when added to their standard care of treatment

Chronic active treatment refractory ulcerative colitis
MedDRA version: 14.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

InDex Pharmaceuticals AB

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 3

Czech Republic;Hungary;Poland;Germany;Italy;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1101

EUCTR2011-000897-80-ES
(EUCTR)

23/09/2011

04/07/2011

A clinical study to investigate the safety and efficacy of the productrhuMAb BETA7 in treating patients with ulcerative colitis, a form ofinflammatory bowel disease

PHASE II RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED STUDYTO EVALUATE THE EFFICACY AND SAFETY OF rhuMAb BETA7 INPATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Product Name: rhuMAb Beta7
Product Code: PRO145223 (RO5490261)
INN or Proposed INN: n.a.
Other descriptive name: rhuMAb Beta7

Genentech, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 2

United States;Hungary;Czech Republic;Canada;Spain;Australia;Israel;Germany;United Kingdom;New Zealand

1102

EUCTR2011-000897-80-CZ
(EUCTR)

14/09/2011

29/06/2011

A clinical study to investigate the safety and efficacy of the product rhuMAb BETA7 in treating patients with ulcerative colitis, a form of inflammatory bowel disease

PHASE II RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF rhuMAb BETA7 IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Product Name: rhuMAb Beta7
Product Code: PRO145223 (RO5490261)
INN or Proposed INN: n.a.
Other descriptive name: rhuMAb Beta7

Genentech, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 2

United States;Hungary;Czech Republic;Canada;Spain;Australia;Israel;Germany;United Kingdom;New Zealand

1103

EUCTR2011-000897-80-GB
(EUCTR)

06/09/2011

29/06/2011

A clinical study to investigate the safety and efficacy of the product rhuMAb BETA7 in treating patients with ulcerative colitis, a form of inflammatory bowel disease

PHASE II RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF rhuMAb BETA7 IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Product Name: rhuMAb Beta7
Product Code: PRO145223 (RO5490261)
INN or Proposed INN: n.a.
Other descriptive name: rhuMAb Beta7

Genentech, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 2

United States;Hungary;Czech Republic;Canada;Spain;Australia;Israel;Germany;New Zealand;United Kingdom

1104

EUCTR2011-000897-80-HU
(EUCTR)

05/09/2011

07/09/2011

A clinical study to investigate the safety and efficacy of the product rhuMAb BETA7 in treating patients with ulcerative colitis, a form of inflammatory bowel disease

PHASE II RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF rhuMAb BETA7 IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Product Name: rhuMAb Beta7
Product Code: PRO145223 (RO5490261)
INN or Proposed INN: n.a.
Other descriptive name: rhuMAb Beta7

Genentech, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 2

United States;Czech Republic;Hungary;Canada;Spain;Australia;Israel;Germany;United Kingdom;New Zealand

1105

EUCTR2010-022506-41-BE
(EUCTR)

23/08/2011

17/06/2011

Induction and Maintenance Study of BMS-936557 Patients with Moderate to Severe Ulcerative Colitis

Colitis, Ulcerative
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

386

Phase 2

United States;Austria;Italy;France;Hungary;Mexico;Canada;Belgium;Poland;Brazil;Australia;South Africa;Netherlands;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1106

EUCTR2011-000897-80-BE
(EUCTR)

16/08/2011

27/06/2011

A clinical study to investigate the safety and efficacy of the product rhuMAb BETA7 in treating patients with ulcerative colitis, a form of inflammatory bowel disease

PHASE II RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF rhuMAb BETA7 IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Product Name: rhuMAb Beta7
Product Code: PRO145223 (RO5490261)
INN or Proposed INN: n.a.
Other descriptive name: rhuMAb Beta7

Genentech, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 2

United States;Hungary;Czech Republic;Canada;Spain;Belgium;Australia;Israel;Germany;United Kingdom;New Zealand

1107

EUCTR2010-023797-39-GB
(EUCTR)

12/08/2011

16/07/2011

TREATMENT OF IRON DEFICIENCY ANAEMIA IN ADOLESCENTS WITH INFLAMMATORY BOWEL DISEASE

TREATMENT OF IRON DEFICIENCY ANAEMIA IN ADOLESCENTS WITH INFLAMMATORY BOWEL DISEASE USING FERROUS SULPHATE OR COSMOFER: TOLERANCE AND EFFECTS ON HAEMOGLOBIN, DISEASE ACTIVITY, MOOD, QUALITY OF LIFE AND AUTONOMIC NERVOUS SYSTEM ACTIVITY. AN OPEN LABEL PHASE IV NON-INFERIORITY STUDY. - TREATMENT OF IRON DEFICIENCY ANAEMIA IN ADOLESCENTS WITH IBD.

Barts Health NHS Trust

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

United Kingdom

1108

EUCTR2010-023588-16-HU
(EUCTR)

11/08/2011

27/05/2011

Iron deficiency anaemia in quiescent ulcerative colitis
MedDRA version: 14.1;Level: PT;Classification code 10022972;Term: Iron deficiency anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 14.1;Level: LLT;Classification code 10002062;Term: Anaemia iron deficiency;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

Iron Therapeutics (Switzerland) AG

NULL

Not Recruiting

Female: yes
Male: yes

Hungary;Austria;Germany;United Kingdom

1109

EUCTR2010-023588-16-GB
(EUCTR)

02/08/2011

11/05/2011

Iron deficiency anaemia in quiescent ulcerative colitis
MedDRA version: 16.0;Level: PT;Classification code 10022972;Term: Iron deficiency anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 16.0;Level: LLT;Classification code 10002062;Term: Anaemia iron deficiency;System Organ Class: 10005329 - Blood and lymphatic system disorders ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

Iron Therapeutics (Switzerland) AG

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

Hungary;Austria;Germany;United Kingdom

1110

EUCTR2010-023762-49-AT
(EUCTR)

22/07/2011

26/04/2011

A study to evaluate the safety and how anrukinzumab (IMA-638) works in the body for patients with Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Not Applicable
Product Code: PF-05230917
INN or Proposed INN: Not Applicable
Other descriptive name: Not applicable

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2A

France;United States;Hungary;Canada;Belgium;Spain;Poland;Romania;Austria;Bulgaria;Germany;Netherlands

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1111

EUCTR2010-022506-41-DE
(EUCTR)

18/07/2011

28/02/2011

Induction and Maintenance Study of BMS-936557 Patients with Moderateto Severe Ulcerative Colitis

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

386

Phase 2b

United States;Austria;Italy;France;Hungary;Mexico;Canada;Brazil;Poland;Belgium;Australia;South Africa;Germany;Netherlands

1112

EUCTR2011-002061-38-BE
(EUCTR)

29/06/2011

08/06/2011

Treating patients with infliximab based on their trough levels

A randomised prospective trough level monitoring study with real-time therapeutic adaptations: Trough level Adapted infliXImab Treatment scheme (TAXIT). - TAXIT

2) Crohn's disease and ulcerative colitis
MedDRA version: 13.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 13.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Remicade
Product Name: Remicade
Product Code: Remicade
INN or Proposed INN: INFLIXIMAB

Katholieke Universiteit Leuven

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

Belgium

1113

EUCTR2010-023588-16-AT
(EUCTR)

22/06/2011

16/05/2011

Iron Therapeutics (Switzerland) AG

NULL

Not Recruiting

Female: yes
Male: yes

Hungary;Austria;Germany;United Kingdom

1114

EUCTR2010-023762-49-BG
(EUCTR)

06/06/2011

31/05/2011

A study to evaluate the safety and how anrukinzumab (IMA-638) works in the body for patients with Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 15.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Not Applicable
Product Code: PF-05230917
INN or Proposed INN: Not Applicable
Other descriptive name: Not applicable

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2A

France;United States;Hungary;Canada;Belgium;Spain;Poland;Romania;Austria;Bulgaria;Germany;Netherlands

1115

EUCTR2010-022506-41-HU
(EUCTR)

31/05/2011

13/04/2011

Induction and Maintenance Study of BMS-936557 Patients with Moderate to Severe Ulcerative Colitis

Colitis, Ulcerative
MedDRA version: 16.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

386

Phase 2b

United States;Austria;Italy;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Australia;South Africa;Netherlands;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1116

EUCTR2010-022506-41-IT
(EUCTR)

16/05/2011

28/12/2011

A Phase IIb Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-936557 in Subjects with Active Ulcerative Colitis (UC)

Colitis, Ulcerative
MedDRA version: 14.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Human anti-IP10 monoclonal antibody
Product Code: BMS-936557
INN or Proposed INN: Human anti-IP10 monoclonal antibody
Product Name: Human anti-IP10 monoclonal antibody
Product Code: BMS-936557
INN or Proposed INN: Human anti-IP10 monoclonal antibody

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

386

Phase 2b

United States;Hungary;Mexico;Canada;Poland;Brazil;Austria;Australia;South Africa;Germany;Italy

1117

EUCTR2010-023762-49-ES
(EUCTR)

16/05/2011

11/02/2011

ESTUDIO EN FASE 2A, ALEATORIZADO, DOBLE CIEGO, SIN ENMASCARAMIENTO PARA EL PROMOTOR, CONTROLADO CON PLACEBO, DE DOSIS MÚLTIPLES PARA EVALUAR LA FARMACODINÁMICA, LA FARMACOCINÉTICA Y LA SEGURIDAD DE ANRUKINZUMAB EN PACIENTES CON COLITIS ULCEROSA ACTIVAA PHASE 2A, RANDOMIZED, DOUBLE-BLIND, SPONSOR UNBLINDED, PLACEBO-CONTROLLED, MULTIPLE DOSE STUDY TO EVALUATE THE PHARMACODYNAMICS, PHARMACOKINETICS AND SAFETY OF ANRUKINZUMAB IN PATIENTS WITH ACTIVE ULCERATIVE COLITIS

Colitis ulcerosa
MedDRA version: 12.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: Not Applicable
Product Code: PF-05230917
INN or Proposed INN: Not Applicable
Other descriptive name: Not applicable

Pfizer, S.L.U.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2A

Hungary;Belgium;Poland;Spain;Bulgaria;Germany

1118

EUCTR2010-022506-41-AT
(EUCTR)

05/05/2011

01/03/2011

Induction and Maintenance Study of BMS-936557 Patients with Moderateto Severe Ulcerative Colitis

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

386

Phase 2b

United States;Austria;Italy;France;Hungary;Mexico;Canada;Brazil;Poland;Belgium;Australia;South Africa;Netherlands;Germany

1119

NCT01772615
(ClinicalTrials.gov)

May 2011

17/1/2013

Treatment of Ulcerative Colitis With Ciprofloxacin and E. Coli Nissle

Active Ulcerative Colitis; Placebo Controlled Treatment Trial With Ciprofloxacin and E. Coli Nissle

Ulcerative Colitis

Drug: Ciprofloxacin;Dietary Supplement: E. coli Nissle

Hvidovre University Hospital

NULL

Completed

18 Years

N/A

Both

100

Phase 4

Denmark

1120

NCT01479660
(ClinicalTrials.gov)

March 2011

22/11/2011

Role of Healthy Bacteria in Ulcerative Colitis

Probiotic for the Restoration of Intestinal Permeability and Reduction of Intestinal Inflammation in Active Ulcerative Colitis: A Double Blind Randomized Placebo Controlled Trial

Ulcerative Colitis

Other: Control;Drug: Probiotic

Postgraduate Institute of Medical Education and Research

Ministry of Science and Technology, India

Recruiting

18 Years

65 Years

Both

100

Phase 4

India

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1121

EUCTR2010-019558-42-SK
(EUCTR)

23/02/2011

27/10/2010

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Pilot Study to Assess the Efficacy, Safety, and Tolerability of Baminercept in Subjects With Moderate to Severe Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 12.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: Baminercept
Product Code: BG9924
INN or Proposed INN: N/A
Other descriptive name: Baminercept

Biogen Idec Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 2

Hungary;Czech Republic;Slovakia;Belgium

1122

EUCTR2010-023494-19-SE
(EUCTR)

10/02/2011

27/12/2010

A Phase IIa, Multi-Centre, Double-blind, Randomised, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of K(D)PT after Multiple Ascending Doses in Patients with Active Mild to Moderate Ulcerative Colitis

Ulcerative colitis
MedDRA version: 12.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: Lysine -D-Proline-Threonine
Product Code: K(D)PT

Dr. August Wolff GmbH & Co. KG Arzneimittel

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Sweden

1123

EUCTR2010-019970-33-GB
(EUCTR)

01/02/2011

13/10/2010

A multi-centre, double-blind, placebo controlled, parallelgroup, proof of concept study to evaluate the efficacy,safety and tolerability of KRP203 in subjects withmoderately active refractory ulcerative colitis -

Ulcerative colitis
MedDRA version: 12.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Code: KRP203A
Product Code: KRP203A
Product Code: KRP203A

Novartis Services AG

NULL

Not Recruiting

Female: yes
Male: yes

Hungary;Germany;United Kingdom;Belgium;Sweden

1124

EUCTR2010-019558-42-HU
(EUCTR)

20/01/2011

10/11/2010

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Pilot Study to Assess the Efficacy, Safety, and Tolerability of Baminercept in Subjects With Moderate to Severe Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 12.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: Baminercept
Product Code: BG9924
INN or Proposed INN: N/A
Other descriptive name: Baminercept

Biogen Idec Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

100

Hungary;Czech Republic;Belgium

1125

EUCTR2010-019558-42-CZ
(EUCTR)

10/01/2011

25/10/2010

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Pilot Study to Assess the Efficacy, Safety, and Tolerability of Baminercept in Subjects With Moderate to Severe Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 12.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: Baminercept
Product Code: BG9924
INN or Proposed INN: N/A
Other descriptive name: Baminercept

Biogen Idec Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

100

Hungary;Czech Republic;Belgium

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1126

EUCTR2010-019558-42-BE
(EUCTR)

23/12/2010

13/10/2010

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Pilot Study to Assess the Efficacy, Safety, and Tolerability of Baminercept in Subjects With Moderate to Severe Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 12.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: Baminercept
Product Code: BG9924
INN or Proposed INN: N/A
Other descriptive name: Baminercept

Biogen Idec Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

100

Hungary;Czech Republic;Belgium

1127

EUCTR2010-019970-33-DE
(EUCTR)

22/12/2010

15/10/2010

Ulcerative colitis
MedDRA version: 12.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: KRP203
Product Code: KRP203
Product Name: KRP203
Product Code: KRP203
Product Name: KRP203
Product Code: KRP203

Novartis Services AG

NULL

Not Recruiting

Female: yes
Male: yes

Hungary;United Kingdom;Germany;Belgium;Sweden

1128

EUCTR2010-020448-37-BE
(EUCTR)

10/12/2010

22/12/2010

Product Name: PEG -liposomal prednisolone sodium phosphate
Product Code: Nanocort
INN or Proposed INN: Prednisolone Sodium Phosphate
Other descriptive name: PREDNISOLONE SODIUM PHOSPHATE

Enceladus Pharmaceuticals

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Belgium;Netherlands

1129

EUCTR2010-019970-33-BE
(EUCTR)

07/12/2010

20/09/2010

Ulcerative colitis
MedDRA version: 14.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders

Product Code: KRP203A
Product Code: KRP203A
Product Code: KRP203A

Novartis Services AG

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Hungary;Belgium;Germany;United Kingdom;Sweden

1130

EUCTR2010-019970-33-HU
(EUCTR)

11/11/2010

07/09/2010

Ulcerative colitis
MedDRA version: 12.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: n.a.
Product Code: KRP203A
Product Name: n.a
Product Code: KRP203A
Product Name: n.a
Product Code: KRP203A

Novartis Services AG

NULL

Not Recruiting

Female: yes
Male: yes

Hungary;Germany;United Kingdom;Belgium;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1131

EUCTR2009-017044-13-DE
(EUCTR)

03/11/2010

16/06/2010

A study to Evaluate the Ability to Maintain Clinical and Endoscopic Remission During a 12-Month period with 2.4g/day of drug given once a day in adults with ulcerative colitis

A Phase 3b/4, Open-label, Multicenter, Prospective Study to Evaluatethe Effect of Remission Status on the Ability to Maintain or AchieveClinical and Endoscopic Remission During a 12-Month, Long-termMaintenance Phase With 2.4g/day MMX® Mesalamine/mesalazineOnce Daily in Adult Subjects With Ulcerative Colitis - MOMENTUM

Ulcerative Colitis
MedDRA version: 13.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets
Product Name: Mezavant XL
Product Code: SPD476
INN or Proposed INN: MESALAZINE
Other descriptive name: MMX Mesalamine/Mesalazine
Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets
Product Name: Mezavant XL
Product Code: SPD476
INN or Proposed INN: MESALAZINE
Other descriptive name: MMX Mesalamine/Mesalazine

Shire Development Inc

NULL

Not Recruiting

Female: yes
Male: yes

1000

Phase 3b;Phase 4

United States;Spain;Ireland;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Canada;Poland;South Africa;Germany

1132

EUCTR2010-019970-33-SE
(EUCTR)

29/10/2010

10/09/2010

Ulcerative colitis
MedDRA version: 12.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: KRP203
Product Code: KRP203A
Product Name: KRP203
Product Code: KRP203A
Product Name: KRP203
Product Code: KRP203A

Novartis Services AG

NULL

Not Recruiting

Female: yes
Male: yes

Hungary;Belgium;Germany;United Kingdom;Sweden

1133

EUCTR2009-017044-13-BE
(EUCTR)

14/09/2010

06/05/2010

A study to Evaluate the Ability to Maintain Clinical and Endoscopic Remission During a 12-Month period with 2.4g/day of drug given once a day in adults with ulcerative colitis

Ulcerative Colitis
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856

Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets
Product Name: Mezavant XL
Product Code: SPD476
INN or Proposed INN: MESALAZINE
Other descriptive name: MMX Mesalamine/Mesalazine

Shire Development LLC

NULL

Not Recruiting

Female: yes
Male: yes

1000

Phase 4

United States;Spain;Ireland;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Canada;Belgium;Poland;South Africa;Germany

1134

EUCTR2009-017044-13-IE
(EUCTR)

10/08/2010

20/04/2010

A study to Evaluate the Ability to Maintain Clinical andEndoscopic Remission During a 12-Month period with 2.4g/day of druggiven once a day in adults with ulcerative colitis

Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets
Product Name: Mezavant XL
Product Code: SPD476
INN or Proposed INN: MESALAZINE
Other descriptive name: MMX Mesalamine/Mesalazine

Shire Development LLC

NULL

Not Recruiting

Female: yes
Male: yes

1000

Phase 3b;Phase 4

United States;Spain;Ireland;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Canada;Poland;South Africa;Germany

1135

EUCTR2009-017044-13-CZ
(EUCTR)

05/08/2010

28/05/2010

A study to Evaluate the Ability to Maintain Clinical and Endoscopic Remission During a 12-Month period with 2.4g/day of drug given once a day in adults with ulcerative colitis

Shire Development LLC

NULL

Not Recruiting

Female: yes
Male: yes

1000

Phase 3b;Phase 4

Hungary;Canada;Poland;South Africa;Germany;United States;Spain;Ireland;Russian Federation;Colombia;United Kingdom;India;France;Czech Republic

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1136

EUCTR2009-017044-13-FR
(EUCTR)

27/07/2010

22/06/2010

Ulcerative Colitis
MedDRA version: 12.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets
Product Name: Mezavant XL
Product Code: SPD476
INN or Proposed INN: MESALAZINE
Other descriptive name: MMX Mesalamine/Mesalazine

Shire Development Inc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1000

Phase 3b;Phase 4

Hungary;Germany;Czech Republic;United Kingdom;France;Ireland;Spain

1137

EUCTR2009-017044-13-HU
(EUCTR)

21/07/2010

26/04/2010

A Study to Evaluate the Ability to Maintain Clinical and Endoscopic Remission During a 12-Month period with 2.4g/day of drug given once a day in adults with ulcerative colitis

Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets
Product Name: Mezavant XL
Product Code: SPD476
INN or Proposed INN: MESALAZINE
Other descriptive name: MMX Mesalamine/Mesalazine

Shire Development LLC

NULL

Not Recruiting

Female: yes
Male: yes

1000

Phase 3b;Phase 4

United States;Spain;Ireland;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Canada;Poland;South Africa;Germany

1138

EUCTR2009-017044-13-GB
(EUCTR)

30/06/2010

17/03/2010

A study to Evaluate the Ability to Maintain Clinical and Endoscopic Remission During a 12-Month period with 2.4g/day of drug given once a day in adults with ulcerative colitis

A Phase 3b/4, Open-label, Multicenter, Prospective Study to Evaluate the Effect of Remission Status on the Ability to Maintain or Achieve Clinical and Endoscopic Remission During a 12-Month, Long-term Maintenance Phase With 2.4g/day MMX® Mesalamine/mesalazine Once Daily in Adult Subjects With Ulcerative Colitis - MOMENTUM

Ulcerative Colitis
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Shire Development LLC

NULL

Not Recruiting

Female: yes
Male: yes

1000

Phase 4

United States;Spain;Ireland;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Canada;Poland;Belgium;South Africa;Germany

1139

EUCTR2009-017044-13-ES
(EUCTR)

25/06/2010

19/04/2010

Estudio en fase 3b/4, abierto, multicéntrico y prospectivo para evaluar el efecto del estado de la remisión sobre la capacidad para mantener o alcanzar la remisión clínica y endoscópica durante una fase de mantenimiento a largo plazo de 12 meses con 2,4 g/día de MMX mesalamina/mesalazina una vez al día en pacientes adultos con colitis ulcerosaA Phase 3b/4, Open-label, Multicenter, Prospective Study to Evaluatethe Effect of Remission Status on the Ability to Maintain or AchieveClinical and Endoscopic Remission During a 12-Month, Long-termMaintenance Phase With 2.4g/day MMX® Mesalamine/mesalazineOnce Daily in Adult Subjects With Ulcerative Colitis

Colitis UlcerosaUlcerative Colitis
MedDRA version: 12.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets
Product Name: Mezavant XL
Product Code: SPD476
INN or Proposed INN: MESALAZINE
Other descriptive name: MMX Mesalamine/Mesalazine

Shire Development Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1000

Phase 3b;Phase 4

Hungary;Germany;Czech Republic;United Kingdom;France;Ireland;Spain

1140

NCT01149707
(ClinicalTrials.gov)

June 1, 2010

22/6/2010

Safety, Tolerability, Efficacy Study of PUR 0110 Rectal Enema in Mild-to-Moderate Distal Ulcerative Colitis

A 2-Week Exploratory Randomized, Double-Blind, Parallel-Group, Dose-Ranging, Placebo-Controlled Safety, Tolerability, Biomarker and Efficacy Clinical Study of PUR 0110 Rectal Enema in Mild-to-Moderate Distal Ulcerative Colitis

Left-Sided Ulcerative Colitis;Proctosigmoiditis

Drug: PUR 0110 Rectal Enema 250 mg;Drug: PUR 0110 Rectal Enema 500 mg;Drug: PUR 0110 Rectal Enema 1000 mg;Drug: Placebo Enema

PurGenesis Technologies Inc.

NULL

Completed

18 Years

75 Years

All

Phase 2

Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1141

EUCTR2009-013890-16-PT
(EUCTR)

28/05/2010

21/12/2009

Herica - Histological and Endoscopic evaluation of Remission induced by Infliximab in moderately to severely active ulcerative Colitis Patients - Herica

This national, multi-centre, open-label pilot study will assess the histologic remission in patients with moderate to severe active ulcerative colitis under infliximab treatment who have had an inadequate response to conventional therapy.Biopsies will be analyzed throughout the study in order to assess histological disease modifying effects in those patients.
MedDRA version: 16.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856

Trade Name: Remicade
Product Name: Remicade

GEDII - Grupo de Estudo da Doença inflamatória Intestinal

NULL

Not Recruiting

Female: yes
Male: yes

Portugal

1142

EUCTR2006-003399-37-CZ
(EUCTR)

24/05/2010

10/02/2010

A Study of the Safety and Effectiveness of CNTO 148 (golimumab) inPatients with Moderately to Severely Active Ulcerative Colitis

A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance

Ulcerative Colitis (UC)
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Golimumab Liquid in prefilled syringe
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa

Janssen Biologics B.V.

NULL

Not Recruiting

Female: yes
Male: yes

1228

Phase 3

United States;Serbia;Slovakia;Ukraine;Russian Federation;Israel;India;France;Australia;Denmark;South Africa;Latvia;Netherlands;Lithuania;Austria;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Germany;New Zealand;Japan;Sweden

1143

EUCTR2006-003398-28-CZ
(EUCTR)

24/05/2010

10/02/2010

A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous

Ulcerative Colitis (UC)
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

1002

Phase 2;Phase 3

France;Hungary;Czech Republic;Belgium;Lithuania;Denmark;Austria;Bulgaria;Netherlands;Latvia;Germany;Sweden

1144

EUCTR2009-017839-18-DE
(EUCTR)

14/05/2010

16/02/2010

A 2-WEEK EXPLORATORY RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP, DOSE-RANGING, PLACEBO-CONTROLLED SAFETY, TOLERABILITY, BIOMARKER AND EFFICACY CLINICAL STUDY OF PUR 0110 RECTAL ENEMA IN MILD-TO-MODERATE DISTAL ULCERATIVE COLITIS

Active mild-to-moderate distal ulcerative colitis
MedDRA version: 13.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders

Product Name: PUR 0110
Product Code: PUR 0110
Other descriptive name: PCT (PureCell Technologies Complex)
Product Name: PUR 0110
Product Code: PUR 0110
Other descriptive name: PCT (PureCell Technologies Complex)
Product Name: PUR 0110
Product Code: PUR 0110
Other descriptive name: PCT (PureCell Technologies Complex)

PurGenesis Techonologies Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Germany

1145

EUCTR2008-005903-25-BG
(EUCTR)

23/04/2010

14/04/2010

Exploratory, open-label study to demonstrate efficacy, safety and tolerability of SC12267 (35 mg) in patients with inflammatory bowel disease (Crohn’s disease and ulcerative colitis)

inflammatory bowel disease (Crohn’s disease and ulcerative colitis)
MedDRA version: 12.0;Level: LLT;Classification code 10021973;Term: Inflammatory bowel disease NOS

Product Name: SC12267
Product Code: SC12267
Trade Name: Prednisolon Jenapharm
INN or Proposed INN: Prednisolon
Trade Name: Prednisolon Jenapharm
INN or Proposed INN: Prednisolon
Trade Name: Prednisolon Jenapharm
INN or Proposed INN: Prednisolon

4SC AG

NULL

Not Recruiting

Female: yes
Male: yes

Germany;Bulgaria

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1146

EUCTR2008-002784-14-GB
(EUCTR)

26/03/2010

28/06/2010

An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease

A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease

Ulcerative Colitis and Crohn’s Disease
MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 18.1;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Takeda Development Centre Europe Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

2200

Phase 3

Portugal;Serbia;Estonia;Hong Kong;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;Malta;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Iceland;New Zealand;Sweden

1147

EUCTR2008-003169-19-GB
(EUCTR)

04/03/2010

17/09/2009

A Randomized, Double-blind, Placebo-controlled Study of a Controlled Release Minicapusle Formulation of Ciclosporin (CyCol™) in the Treatment of Ulcerative Colitis

Ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Sigmoid Pharma Ltd

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 2

Ireland;United Kingdom

1148

EUCTR2008-002784-14-SE
(EUCTR)

12/02/2010

23/01/2009

An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease

A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease

Ulcerative Colitis and Crohn’s Disease
MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 18.1;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Takeda Development Centre Europe Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

2200

Phase 3

Portugal;Serbia;United States;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Austria;Malta;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Iceland;New Zealand;Sweden

1149

EUCTR2008-002782-32-DK
(EUCTR)

18/12/2009

06/11/2008

A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Ulcerative Colitis

Moderate to Severe Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Millennium Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

826

Phase 3

Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland

1150

EUCTR2008-005237-30-NL
(EUCTR)

01/12/2009

18/08/2009

A Multicenter, Prospective, Long-term Registry of children with Crohn's Disease or Ulcerative Colitis

A Multicenter, Prospective, Long-term Registry of Pediatric Patients with Crohn's Disease or Ulcerative Colitis - DEVELOP

Pediatric patients with a confirmed diagnosis of CD or UC .
MedDRA version: 18.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB
Other descriptive name: Remsima and Inflectra

Janssen Biologics B.V.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

6000

United States;Canada;Netherlands;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1151

EUCTR2008-007952-90-LT
(EUCTR)

23/11/2009

15/09/2009

A randomized, multi-center, doubleblind, parallel group, placebocontrolled, phase IIb, dose ranging study to investigate the efficacy and safety of LT-02 in patients with mesalazine-refractory ulcerative colitis.

Patients with ulcerative colitis (UC) according to European Crohn's and Colitis Organisation (ECCO) consensus; Simple Clinical Colitis Activity Index (SCCAI) =5 and SCCAI subscore for blood in stool” =2 at Baseline Visit.
MedDRA version: 12.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: LT-02 (modified-release PC pellets)
Product Code: LT-02
INN or Proposed INN: Modified-release phosphatidylcholine
Product Name: LT-02 (modified-release PC pellets)
Product Code: LT-02
INN or Proposed INN: Modified-release phosphatidylcholine
Product Name: LT-02 (modified-release PC pellets)
Product Code: LT-02
INN or Proposed INN: Modified-release phosphatidylcholine

Lipid Therapeutics GmbH

NULL

Not Recruiting

Female: yes
Male: yes

144

Phase 2b

Germany;Lithuania

1152

EUCTR2009-015136-14-BE
(EUCTR)

20/11/2009

12/10/2009

Modified release metronidazole for the treatment of pouchitis after colectomy with ileo-anal pouch anastomosis for ulcerative colitis: a pharmacokinetic study

Pouchitis
MedDRA version: 12.0;Level: LLT;Classification code 10036463;Term: Pouchitis

Product Name: Metronidazole capsule 50 mg
Product Code: FP-110
INN or Proposed INN: Metronidazole
Trade Name: Flagyl
INN or Proposed INN: Metronidazole

FORMAC Pharmaceuticals NV

NULL

Not Recruiting

Female: yes
Male: yes

Belgium

1153

EUCTR2008-007952-90-DE
(EUCTR)

17/11/2009

04/08/2009

Lipid Therapeutics GmbH

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2b

Germany;Lithuania

1154

EUCTR2008-003169-19-IE
(EUCTR)

09/11/2009

05/06/2008

A Randomized, Double-blind, Placebo-controlled Study of a Controlled Release Minicapusle Formulation of Ciclosporin (CyCol™) in the Treatment of Ulcerative Colitis

Ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: CyCol
INN or Proposed INN: ciclosporin
Other descriptive name: cyclosporine (USAN)
Product Name: CyCol
INN or Proposed INN: ciclosporin
Other descriptive name: cyclosporine (USAN)

Sigmoid Pharma Ltd

NULL

Not Recruiting

Female: yes
Male: yes

United Kingdom;Ireland

1155

EUCTR2007-004157-28-SE
(EUCTR)

22/10/2009

06/05/2009

Long-term open-label safety and efficacy study of Adalimumab in subjectswith Ulcerative Colitis.

A Multicenter, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Ulcerative Colitis

Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: Adalimumab
Other descriptive name: ABT-Humira

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

592

Phase 3

Portugal;Slovakia;Spain;Austria;Israel;Italy;Switzerland;France;Hungary;Czech Republic;Puerto Rico;Canada;Belgium;Poland;Denmark;Australia;Netherlands;Norway;Germany;New Zealand;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1156

EUCTR2009-011608-51-DE
(EUCTR)

09/10/2009

21/07/2009

A Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-Inflammatory Effects of GSK1399686 in Patients with Mild to Moderately Active Ulcerative Colitis

Ulcerative colitis
MedDRA version: 15.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders

Product Name: GSK1399686
Product Code: GSK1399686
Trade Name: ASACOL
Product Name: ASACOL
Product Code: ASACOL
INN or Proposed INN: mesalazine
Other descriptive name: Overencapsulated mesalazine tablets
Product Name: GSK1399686
Product Code: GSK1399686
Product Name: GSK1399686
Product Code: GSK1399686
Product Name: GSK1399686
Product Code: GSK1399686

GlaxoSmithKline Research and Development Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

Germany;Sweden

1157

EUCTR2004-004184-29-DK
(EUCTR)

10/09/2009

10/10/2007

A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA

Ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Trade Name: Mezavant XL 1200 mg gastro-resistant prolonged release tablets
Product Name: Mezavant XL 1200 mg gastro-resistant prolonged release tablets
Product Code: SPD476
INN or Proposed INN: Mesalazine
Other descriptive name: 5-amino salicylic acid
Trade Name: Asacol Delayed Release Tablets
Product Name: Asacol
INN or Proposed INN: Mesalazine
Other descriptive name: 5-aminosalicylic acid

Shire Pharmaceutical Development Ltd

NULL

Not Recruiting

Female: yes
Male: yes

830

Phase 3

Portugal;Hungary;Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Spain;Sweden

1158

EUCTR2009-010921-38-NL
(EUCTR)

08/09/2009

02/03/2009

Chemopreventive effects of 5-ASA and UDCA in Ulcerative Colitis:A Double-blind, Randomized Placebo-controlled Pilot Study - CRC chemoprevention in UC

Ulcerative Colitis and the risk of developing colorectal cancer.
MedDRA version: 13.1;Level: PT;Classification code 10021972;Term: Inflammatory bowel disease;System Organ Class: 10017947 - Gastrointestinal disorders

Trade Name: Salofalk
INN or Proposed INN: mesalazine
Trade Name: Ursofalk
INN or Proposed INN: ursodeoxycholic acid

UMC Utrecht

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Netherlands

1159

EUCTR2008-002784-14-DE
(EUCTR)

02/09/2009

02/06/2009

An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease

A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease

Ulcerative Colitis and Crohn’s Disease
MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 17.1;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Takeda Development Centre Europe Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

2200

Phase 3

Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Austria;Malta;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Iceland;New Zealand;Sweden;Greece;Spain;Ukraine;Portugal;Serbia;United States;Taiwan;Estonia;Hong Kong;Slovakia

1160

EUCTR2008-002782-32-DE
(EUCTR)

24/08/2009

23/04/2009

Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Ulcerative Colitis

Moderate to Severe Ulcerative Colitis
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Millennium Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

995

Phase 3

Portugal;Serbia;Taiwan;Estonia;Hong Kong;Greece;Spain;Ireland;Israel;Russian Federation;Italy;Switzerland;India;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Democratic People's Republic of;Turkey;Austria;Malta;United Kingdom;Czech Republic;Hungary;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Iceland;New Zealand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1161

EUCTR2009-010065-23-DE
(EUCTR)

17/08/2009

14/04/2009

Conventional Step-Up versus Infliximab Monotherapy in Patients with Active Moderate to Severe Ulcerative Colitis. A Randomized, Open Label, Prospective, Multicenter Study (Phase 3, Protocol No. P05553) - MUNIX

Active Moderate to Severe Ulcerative Colitis
MedDRA version: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders

Trade Name: Remicade
INN or Proposed INN: infliximab
Other descriptive name: 100
Trade Name: Pentasa 500 mg Retardtabletten
Product Name: 5-Aminosalicylic acid (5-ASA)
INN or Proposed INN: 5-Aminosalicylic acid
Trade Name: Imurek 25mg Filmtabletten
INN or Proposed INN: azathioprine
Trade Name: Imurek 50mg Filmtabletten
INN or Proposed INN: azathioprine
Trade Name: Decortin H 1 mg
INN or Proposed INN: prednisolone
Trade Name: Decortin H 5mg
INN or Proposed INN: prednisolone
Trade Name: Decortin H 10mg
INN or Proposed INN: prednisolone
Trade Name: Decortin H 20mg
INN or Proposed INN: prednisolone
Trade Name: Decortin H 50 mg
INN or Proposed INN: prednisolone

Essex Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

Germany

1162

EUCTR2009-011608-51-SE
(EUCTR)

17/08/2009

22/06/2009

Ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

GlaxoSmithKline Research and Development Ltd

NULL

Not Recruiting

Female: yes
Male: yes

Germany;Sweden

1163

EUCTR2008-002784-14-AT
(EUCTR)

13/08/2009

28/10/2008

An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease

A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease

Ulcerative Colitis and Crohn’s Disease
MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670
MedDRA version: 20.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000016693;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Takeda Development Centre Europe Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

2200

Phase 3

1164

EUCTR2008-002782-32-AT
(EUCTR)

13/08/2009

28/10/2008

Moderate to Severe Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB
Other descriptive name: LDP-02

Millennium Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

826

Phase 3

Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland

1165

EUCTR2009-011608-51-BE
(EUCTR)

03/08/2009

23/06/2009

Ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

GlaxoSmithKline Research and Development Ltd

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Belgium;Germany;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1166

EUCTR2007-003815-30-PT
(EUCTR)

31/07/2009

05/03/2009

An Open Randomized Multicenter Clinical Investigation to Compare the Efficacy and Safety of Prednisone plus Adacolumn® GMA Apheresis versus Prednisone Alone in the Treatment of Patients with Mild or Moderately Active Steroid Dependent Ulcerative Colitis

Mild or Moderately Active Steroid Dependent Ulcerative Colitis
MedDRA version: 14.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders

Trade Name: Dacortin
Product Name: prednisone
INN or Proposed INN: Prednisone
INN or Proposed INN: Prednisone
Trade Name: Dacortin
Product Name: prednisone
Product Code: H02AB
INN or Proposed INN: PREDNISONE
INN or Proposed INN: PREDNISONE

GETECCU (Grupo Español de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa)

NULL

Not Recruiting

Female: yes
Male: yes

Portugal;Spain

1167

EUCTR2008-002784-14-IT
(EUCTR)

22/07/2009

17/03/2009

A Phase 3, Open-label Study to Determine the Long-term Safety and Efficacy of MLN0002 in Patients with Ulcerative Colitis and Crohn?s Disease - ND

Patients with Ulcerative Colitis (UC) and Crohn?s Disease (CD)
MedDRA version: 9.1;Level: LLT;Classification code 10045282
MedDRA version: 9.1;Level: PT;Classification code 10011401

Product Name: Vedolizumab
Product Code: MLN0002

MILLENNIUM PHARMACEUTICALS, INC.

NULL

Not Recruiting

Female: yes
Male: yes

1508

Phase 3

Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Austria;Malta;United Kingdom;Italy;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Latvia;Netherlands;Iceland;Sweden

1168

EUCTR2008-002782-32-IT
(EUCTR)

22/07/2009

22/01/2009

Patients with Moderate to Severe Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative

Product Name: Vedolizumab
Product Code: MLN0002
INN or Proposed INN: Vedolizumab

MILLENNIUM PHARMACEUTICALS, INC.

NULL

Not Recruiting

Female: yes
Male: yes

826

Phase 3

Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;United Kingdom;Italy;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland

1169

EUCTR2008-002782-32-GB
(EUCTR)

20/07/2009

27/11/2008

Moderate to Severe Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Millennium Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

826

Phase 3

Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland

1170

EUCTR2008-002782-32-CZ
(EUCTR)

13/07/2009

31/10/2008

Moderate to Severe Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Millennium Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

826

Phase 3

Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Czech Republic;Hungary;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1171

EUCTR2008-003913-28-IT
(EUCTR)

25/05/2009

16/04/2009

Randomised, double-blind,multicentre,12 months extension study to evaluate the safety and the efficacy of daily Budesonide MMX 6mg vs placebo in the maintenance of remission in subjects with ulcerative colitis. - ND

Mild to moderate ulcerative colitis.
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: Budesonide -MMX
Product Code: CB-01-02
INN or Proposed INN: Budesonide

COSMO TECHNOLOGIES LTD

NULL

Not Recruiting

Female: yes
Male: yes

150

Italy

1172

EUCTR2007-004867-22-SK
(EUCTR)

25/05/2009

28/05/2009

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AVONEX® in Subjects with Moderate to Severe Ulcerative Colitis.

Moderate to Severe Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Trade Name: Avonex
Product Name: Avonex

Biogen Idec Ltd

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 2

Czech Republic;Hungary;Slovakia

1173

EUCTR2008-004564-40-GB
(EUCTR)

20/05/2009

14/10/2008

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

CP-690,550 is being developed for the treatment of patients with moderate-to-severe ulcerative colitis.
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Code: CP -690,550
Product Code: CP -690,550
Product Code: CP -690,550

Pfizer limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK

NULL

Not Recruiting

Female: yes
Male: yes

200

Hungary;Czech Republic;Slovakia;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Sweden

1174

EUCTR2008-002784-14-EE
(EUCTR)

28/04/2009

27/10/2008

An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease

A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease

Ulcerative Colitis and Crohn’s Disease
MedDRA version: 14.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Millennium Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

2200

Phase 3

Portugal;Serbia;United States;Hong Kong;Estonia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Austria;Malta;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Iceland;Germany;Norway;New Zealand;Sweden;Israel;Russian Federation;Italy;Switzerland;India;France;Malaysia;Australia

1175

EUCTR2006-003607-40-FI
(EUCTR)

23/04/2009

26/02/2009

METEOR: A CONTROLLED, RANDOMIZED, DOUBLE-BLIND, MULTICENTER STUDY, COMPARING METH-OTREXATE VS PLACEBO IN THE REMISSION OF STEROID-DEPENDENT ULCERATIVE COLITIS - METEOR

Ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Trade Name: Trexan inj 25 mg/ml
INN or Proposed INN: Methotrexate

GETAID, Jean Minjoz Hospital

NULL

Not Recruiting

Female: yes
Male: yes

110

Finland;Belgium;Austria;Netherlands

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1176

EUCTR2008-002784-14-BE
(EUCTR)

21/04/2009

14/11/2008

An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease

A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease

Ulcerative Colitis and Crohn’s Disease
MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 18.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Takeda Development Centre Europe Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

2200

Phase 3

1177

EUCTR2008-002784-14-HU
(EUCTR)

20/04/2009

27/10/2008

An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease

A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Takeda Development Centre Europe ltd.

NULL

Not Recruiting

Female: yes
Male: yes

2200

Phase 3

Portugal;Serbia;United States;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Austria;Malta;United Kingdom;Hungary;Czech Republic;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Iceland;New Zealand;Sweden

1178

EUCTR2008-002782-32-HU
(EUCTR)

14/04/2009

27/10/2008

Moderate to Severe Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Millennium Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

826

Phase 3

Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland

1179

EUCTR2008-002782-32-GR
(EUCTR)

07/04/2009

05/11/2009

Moderate to Severe Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Millennium Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

826

Phase 3

Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland

1180

EUCTR2008-002784-14-GR
(EUCTR)

07/04/2009

05/11/2009

A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of MLN0002 in Patients with Ulcerative Colitis and Crohn’s Disease

Ulcerative Colitis and Crohn’s Disease
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
MedDRA version: 9.1;Classification code 10013099;Term: Disease Crohns

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Millennium Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1508

Phase 3

Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Austria;Malta;United Kingdom;Italy;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Latvia;Netherlands;Iceland;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1181

EUCTR2008-004610-27-SK
(EUCTR)

06/04/2009

09/02/2009

A double-blind, randomised, placebo and mesalazine controlled phase II study to explore the safety and activity of dersalazine in patients with mild to moderate active colitis

Mild to moderate active ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: Dersalazine sodium
Product Code: UR-12746-S
INN or Proposed INN: dersalazine sodium
Trade Name: Lixacol
Product Name: Lixacol
INN or Proposed INN: Mesalazine
Trade Name: Lixacol
Product Name: Lixacol
INN or Proposed INN: mesalazine

Palau Pharma S.A.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Hungary;Slovakia;Spain;Belgium

1182

EUCTR2008-002784-14-ES
(EUCTR)

02/04/2009

18/11/2008

A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of MLN0002 in Patients with Ulcerative Colitis and Crohn?s DiseaseEstudio abierto, de fase 3 para determinar la eficacia y la seguridad a largo plazo de MLN0002 en los pacientes con colitis ulcerosa (CU) y enfermedad de Crohn (EC)

Ulcerative Colitis and Crohn?s DiseaseColitis ulcerosa (CU) y enfermedad de Crohn (EC)
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
MedDRA version: 9.1;Classification code 10013099;Term: Disease Crohns

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Millennium Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1508

Phase 3

Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Austria;Malta;United Kingdom;Italy;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Latvia;Netherlands;Iceland;Sweden

1183

EUCTR2008-004564-40-NL
(EUCTR)

24/03/2009

11/11/2008

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

CP-690,550 is being developed for the treatment of patients with moderate-to-severe ulcerative colitis.
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Code: CP -690,550
Product Code: CP -690,550
Product Code: CP -690,550

Pfizer limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

200

Hungary;Czech Republic;Slovakia;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Sweden

1184

EUCTR2008-007292-25-IT
(EUCTR)

24/03/2009

16/03/2009

AN OPEN, PILOT PHASE III, RANDOMIZED CLINICAL TRIAL TO ASSESS THE TISSUTAL PHARMAKINETICS OF MESALAZINE TABLETS IN PATIENTS WITH MILD TO MODERATE LEFT-SIDED ULCERATIVE COLITIS IN ACTIVE PHASE - GIU-5-ASA1.2 MMx-02-08

Patients with established diagnosis of left-sided UC (rectum-sigmoid colon or colon up to the splenic flexure)
MedDRA version: 9.1;Level: LLT;Classification code 10024123;Term: Left-sided ulcerative (chronic) colitis

Trade Name: MEZAVANT
INN or Proposed INN: Mesalazine
Trade Name: ASACOL
INN or Proposed INN: Mesalazine

GIULIANI

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

Italy

1185

EUCTR2008-002784-14-FR
(EUCTR)

23/03/2009

14/11/2008

A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of MLN0002 in Patients with Ulcerative Colitis and Crohn’s Disease

Ulcerative Colitis and Crohn’s Disease
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
MedDRA version: 9.1;Classification code 10013099;Term: Disease Crohns

Millennium Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1508

Phase 3

Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Austria;Malta;United Kingdom;Italy;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Latvia;Netherlands;Iceland;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1186

EUCTR2008-000045-59-GB
(EUCTR)

17/03/2009

15/07/2008

Multicentre, controlled, randomized, investigator-blinded, comparative study of oral mesalazine 4g per day once daily versus 4g per day in two divided doses in patients with active ulcerative colitis. - MOTUS

Patients with mild to moderate active ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10058816;Term: Colitis ulcerative acute episode

Product Name: Pentasa 2g sachet prolonged release granules (95%)
INN or Proposed INN: MESALAZINE

Ferring Pharmaceuticals Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

398

United Kingdom;Netherlands;Belgium;France

1187

EUCTR2007-004157-28-PT
(EUCTR)

17/03/2009

12/12/2008

Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative

Trade Name: Humira 40 mg solution for injection in pre-filled syringe
INN or Proposed INN: Adalimumab
Other descriptive name: ABT-Humira

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

800

Phase 3

France;Portugal;Czech Republic;Hungary;Slovakia;Spain;Belgium;Austria;Netherlands;Germany;Italy;Sweden

1188

EUCTR2008-002782-32-FR
(EUCTR)

13/03/2009

14/11/2008

Moderate to Severe Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Millennium Pharmaceuticals, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

826

Phase 3

Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Ireland;Italy;Latvia;Austria;United Kingdom;Czech Republic;Iceland;Malta;Denmark;Belgium;Estonia;Spain;Greece

1189

EUCTR2008-002782-32-PT
(EUCTR)

09/03/2009

06/11/2008

Moderate to Severe Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Millennium Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

826

Phase 3

Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland

1190

EUCTR2008-002784-14-PT
(EUCTR)

06/03/2009

06/11/2008

A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of MLN0002 in Patients with Ulcerative Colitis and Crohn’s Disease

Ulcerative Colitis and Crohn’s Disease
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
MedDRA version: 9.1;Classification code 10013099;Term: Disease Crohns

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Millennium Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1508

Phase 3

Portugal;Hungary;Germany;Netherlands;Bulgaria;France;Ireland;Italy;Latvia;Austria;Sweden;United Kingdom;Slovakia;Czech Republic;Iceland;Malta;Belgium;Estonia;Spain;Greece

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1191

EUCTR2008-002782-32-ES
(EUCTR)

02/03/2009

23/10/2008

A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Ulcerative ColitisEstudio multicéntrico, ciego, controlado con placebo, aleatorizado, de fase 3, sobre la inducción y el mantenimiento de la respuesta clínica y la remisión con MLN0002, en pacientes con colitis ulcerosa moderada o grave

Moderate to Severe Ulcerative ColitisColitis ulcerosa moderada o grave
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Millennium Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

826

Phase 3

Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland

1192

EUCTR2008-004610-27-HU
(EUCTR)

26/02/2009

15/12/2008

A double-blind, randomised, placebo and mesalazine controlled phase II study to explore the safety and activity of dersalazine in patients with mild to moderate active colitis

Mild to moderate active ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Palau Pharma S.A.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Hungary;Belgium;Spain

1193

EUCTR2008-002784-14-CZ
(EUCTR)

20/02/2009

31/10/2008

An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease

A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease

Ulcerative Colitis and Crohn’s Disease
MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 18.1;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Takeda Development Centre Europe Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

2200

Phase 3

Portugal;Serbia;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Austria;Malta;United Kingdom;Czech Republic;Hungary;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Iceland;New Zealand;Sweden

1194

EUCTR2008-002782-32-NL
(EUCTR)

18/02/2009

05/11/2008

Moderate to Severe Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Millennium Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

826

Phase 3

Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Netherlands;Latvia;Iceland

1195

EUCTR2008-002784-14-NL
(EUCTR)

18/02/2009

05/11/2008

An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease

A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease

Ulcerative Colitis and Crohn’s Disease
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 19.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Takeda Development Centre Europe Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

2200

Phase 3

Portugal;Serbia;United States;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Turkey;Austria;Malta;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Iceland;New Zealand;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1196

EUCTR2008-002782-32-BE
(EUCTR)

08/02/2009

14/11/2008

Moderate to Severe Ulcerative Colitis
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Millennium Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

826

Phase 3

Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland

1197

EUCTR2008-004564-40-CZ
(EUCTR)

05/02/2009

23/01/2009

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

CP-690,550 is being developed for the treatment of patients with moderate-to-severe ulcerative colitis.
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Code: CP -690,550
Product Code: CP -690,550
Product Code: CP -690,550

Pfizer limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK

NULL

Not Recruiting

Female: yes
Male: yes

200

Hungary;Slovakia;United Kingdom;Czech Republic;Netherlands;Belgium;France;Spain;Italy;Sweden

1198

EUCTR2008-002783-33-AT
(EUCTR)

29/01/2009

28/10/2008

Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Crohn's Disease

Moderate to Severe Crohn's Disease
MedDRA version: 14.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Millennium Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1060

Phase 3

Portugal;Serbia;Hong Kong;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Italy;Switzerland;India;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Austria;Malta;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Iceland;Germany;Norway;New Zealand;Sweden

1199

EUCTR2008-002782-32-MT
(EUCTR)

28/01/2009

02/02/2009

Moderate to Severe Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Millennium Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

826

Phase 3

Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Ireland;Italy;Latvia;Austria;United Kingdom;Czech Republic;Iceland;Malta;Denmark;Belgium;Estonia;Spain;Greece

1200

EUCTR2008-002784-14-MT
(EUCTR)

28/01/2009

25/11/2008

A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease

Ulcerative Colitis and Crohn’s Disease
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
MedDRA version: 9.1;Classification code 10013099;Term: Disease Crohns

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Millennium Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1508

Phase 3

Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Ireland;Italy;Latvia;Austria;Sweden;United Kingdom;Slovakia;Czech Republic;Iceland;Malta;Belgium;Estonia;Spain;Greece

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1201

EUCTR2008-002783-33-MT
(EUCTR)

28/01/2009

25/11/2008

Moderate to Severe Crohn's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10013099;Term: Disease Crohns

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB
Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Millennium Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1060

Phase 3

Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Ireland;Italy;Latvia;Austria;Sweden;United Kingdom;Slovakia;Czech Republic;Iceland;Belgium;Malta;Denmark;Estonia;Spain;Greece

1202

EUCTR2008-002784-14-IS
(EUCTR)

27/01/2009

06/11/2008

An Open-label Study of Vedolizumab (MLN0002) in Patients WithUlcerative Colitis and Crohn's Disease

A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of MLN0002 in Patients with Ulcerative Colitis and Crohn’s Disease

Ulcerative Colitis and Crohn’s Disease
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
MedDRA version: 9.1;Classification code 10013099;Term: Disease Crohns;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Takeda Development Centre Europe Ltd

NULL

Not Recruiting

Female: yes
Male: yes

1508

Phase 3

Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Austria;Malta;United Kingdom;Italy;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Iceland;Latvia;Netherlands;Sweden

1203

EUCTR2008-004564-40-FR
(EUCTR)

26/01/2009

16/03/2009

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

CP-690,550 is being developed for the treatment of patients with moderate-to-severe ulcerative colitis.
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Code: CP -690,550
Product Code: CP -690,550
Product Code: CP -690,550

Pfizer limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

200

Hungary;Czech Republic;Slovakia;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Sweden

1204

EUCTR2008-004564-40-IT
(EUCTR)

23/01/2009

29/09/2008

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS - ND

CP-690,550 is being developed for the treatment of patients with moderate-to-severe ulcerative colitis.
MedDRA version: 9.1;Level: LLT;Classification code 10045282;Term: UC

Product Name: CP -690,550
Product Name: CP -690,550
Product Name: CP -690,550

PFIZER

NULL

Not Recruiting

Female: yes
Male: yes

200

Hungary;Czech Republic;Slovakia;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Sweden

1205

EUCTR2008-004564-40-SE
(EUCTR)

16/01/2009

01/10/2008

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

CP-690,550 is being developed for the treatment of patients with moderate-to-severe ulcerative colitis.
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Code: CP -690,550
Product Code: CP -690,550
Product Code: CP -690,550

Pfizer limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK

NULL

Not Recruiting

Female: yes
Male: yes

200

Hungary;Czech Republic;Slovakia;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1206

EUCTR2008-002784-14-BG
(EUCTR)

16/01/2009

12/01/2009

An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease

A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Takeda Development Centre Europe Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

2200

Phase 3

1207

EUCTR2008-002784-14-SK
(EUCTR)

15/01/2009

28/10/2008

An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease

A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease

Ulcerative Colitis and Crohn’s Disease
MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 18.1;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Takeda Development Centre Europe Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

2200

Phase 3

1208

EUCTR2008-004564-40-BE
(EUCTR)

13/01/2009

14/11/2008

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

CP-690,550 is being developed for the treatment of patients with moderate-to-severe ulcerative colitis.
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Code: CP -690,550
Product Code: CP -690,550
Product Code: CP -690,550

Pfizer limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK

NULL

Not Recruiting

Female: yes
Male: yes

200

Hungary;Czech Republic;Slovakia;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Sweden

1209

EUCTR2008-002782-32-EE
(EUCTR)

09/01/2009

24/10/2008

Moderate to Severe Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Millennium Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

826

Phase 3

Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland

1210

EUCTR2008-002784-14-IE
(EUCTR)

09/01/2009

28/10/2008

An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease

A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Millennium Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

2200

Phase 3

Portugal;Serbia;United States;Hong Kong;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Austria;Malta;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Iceland;Germany;Norway;New Zealand;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1211

EUCTR2008-002782-32-IS
(EUCTR)

09/01/2009

06/11/2008

Moderate to Severe Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Millennium Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

826

Phase 3

Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Iceland;Latvia;Netherlands

1212

EUCTR2008-002782-32-IE
(EUCTR)

09/01/2009

28/10/2008

Moderate to Severe Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Millennium Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

826

Phase 3

Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland

1213

EUCTR2008-005903-25-DE
(EUCTR)

08/01/2009

03/11/2008

Exploratory, open-label study to demonstrate efficacy, safety and tolerability of SC12267 (35 mg) in patients with inflammatory bowel disease (Crohn’s disease and ulcerative colitis)

inflammatory bowel disease (Crohn’s disease and ulcerative colitis)
MedDRA version: 12.0;Level: LLT;Classification code 10021973;Term: Inflammatory bowel disease NOS

4SC AG

NULL

Not Recruiting

Female: yes
Male: yes

Bulgaria;Germany

1214

EUCTR2008-002782-32-BG
(EUCTR)

08/01/2009

12/01/2009

Moderate to Severe Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Millennium Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

826

Phase 3

Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland

1215

JPRN-UMIN000008967

2009/01/01

24/09/2012

Efficacy of zinc-carnosine chelate compound, Polaprezinc, enemas in patients with ulcerative colitis

Ulcerative Colitis

Polaprezinc group: Polaprezinc enema contained 150 mg of Polaprezinc suspension in tap water (total volume 100 mL) daily for one week

Placebo group: 100 mL tap water enema daily for one week

The Jikei University School of MedicineDivision of Gastroenterology and Hepatology

NULL

Complete: follow-up complete

18years-old

Not applicable

Male and Female

Not applicable

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1216

EUCTR2008-002782-32-LV
(EUCTR)

19/12/2008

31/10/2008

Moderate to Severe Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Millennium Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

826

Phase 3

Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland

1217

EUCTR2008-002784-14-LV
(EUCTR)

19/12/2008

31/10/2008

An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease

A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease

Ulcerative Colitis and Crohn’s Disease
MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Takeda Development Centre Europe Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

2200

Phase 3

1218

EUCTR2008-004564-40-ES
(EUCTR)

15/12/2008

17/10/2008

ESTUDIO ALEATORIZADO, DOBLE CIEGO, CONTROLADO CON PLACEBO, CON GRUPOS PARALELOS, MULTICÉNTRICO, PARA INVESTIGAR LA SEGURIDAD Y LA EFICACIA DE CP 690,550 EN SUJETOS CON COLITIS ULCEROSA DE MODERADA A GRAVEA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

CP 690,550 es un fármaco en desarrollo para el tratamiento de los pacientes con colitis ulcerosa de moderada a grave.CP-690,550 is being developed for the treatment of patients with moderate-to-severe ulcerative colitis.
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Code: CP -690,550
Product Code: CP -690,550
Product Code: CP -690,550

Pfizer S.A

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

200

Hungary;Czech Republic;Slovakia;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Sweden

1219

EUCTR2007-004157-28-NL
(EUCTR)

09/12/2008

10/12/2008

Long-term open-label safety and efficacy study of Adalimumab in subjects with Ulcerative Colitis.

Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: Adalimumab
Other descriptive name: ABT-Humira

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

592

Phase 3

Portugal;Slovakia;Spain;Austria;Israel;Italy;Switzerland;France;Czech Republic;Hungary;Puerto Rico;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden

1220

EUCTR2008-004610-27-BE
(EUCTR)

02/12/2008

24/07/2008

A double-blind, randomised, placebo and mesalazine controlled phase II study to explore the safety and activity of dersalazine in patients with mild to moderate active colitis

Mild to moderate active ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Palau Pharma S.A.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Hungary;Belgium;Spain

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1221

EUCTR2008-004610-27-ES
(EUCTR)

25/11/2008

26/09/2008

Estudio fase II doble ciego, aleatorizado, controlado con placebo y mesalazina de seguridad y actividad de dersalazina en pacientes con colitis activa leve o moderada.A double-blind, randomised, placebo and mesalazine controlled phase II study to explore the safety and activity of dersalazine in patients with mild to moderate active colitis

Colitis ulcerosa de leve a moderadaMild to moderate ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: Dersalazina sodica
INN or Proposed INN: dersalazine sodium
Trade Name: LIXACOL
Product Name: LIXACOL
INN or Proposed INN: MESALAZINA
Other descriptive name: MESALAZINE
Trade Name: LIXACOL
Product Name: LIXACOL
INN or Proposed INN: MESALAZINA
Other descriptive name: MESALAZINE

Palau Pharma S.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Hungary;Belgium;Spain

1222

EUCTR2008-004564-40-HU
(EUCTR)

20/11/2008

17/10/2008

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

CP-690,550 is being developed for the treatment of patients with moderate-to-severe ulcerative colitis.
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Code: CP -690,550
Product Code: CP -690,550
Product Code: CP -690,550

Pfizer limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK

NULL

Not Recruiting

Female: yes
Male: yes

200

Hungary;Czech Republic;Slovakia;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Sweden

1223

EUCTR2008-004564-40-SK
(EUCTR)

11/11/2008

24/10/2008

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

CP-690,550 is being developed for the treatment of patients with moderate-to-severe ulcerative colitis.
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Code: CP -690,550
Product Code: CP -690,550
Product Code: CP -690,550

Pfizer limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 2

France;Czech Republic;Hungary;Slovakia;Belgium;Spain;Netherlands;United Kingdom;Italy;Sweden

1224

EUCTR2008-000967-40-NL
(EUCTR)

03/11/2008

30/05/2008

A Phase 2a Randomised, Placebo-Controlled, Double-Blind, Multi-Center Dose Escalation Study, to Evaluate the Safety, Tolerability, Pharmacodynamics and Efficacy of AG011, in Subjects with Moderatley Active Ulcerative Colitis

Moderately Active Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: AG011 - Enema
Product Code: AG011
Product Name: AG011 - Capsules
Product Code: AG011
Product Name: AG011 - Enema
Product Code: AG011
Product Name: AG011 - Enema
Product Code: AG011
Product Name: AG011 - Capsules
Product Code: AG011

ActoGeniX NV.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2a

Netherlands;Belgium;Sweden

1225

EUCTR2006-003397-94-SE
(EUCTR)

23/10/2008

21/12/2007

A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Intravenous

Ulcerative Colitis (UC)
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: Golimumab Liquid in Vial
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

676

Phase 2;Phase 3

Hungary;Germany;Netherlands;Belgium;Bulgaria;France;Latvia;Austria;Lithuania;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1226

EUCTR2007-002544-25-CZ
(EUCTR)

21/10/2008

07/01/2008

A Phase 2, Multi-dose, Double-blind, Placebo-controlled, Randomized, Multicenter Study of MDX-1100 (anti-CXCL10 Human Monoclonal Antibody) in Subjects with Active Ulcerative Colitis

Active Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: MDX-1100
Product Code: MDX-1100

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

106

Phase 2

Hungary;Czech Republic;Latvia

1227

EUCTR2006-004776-12-IT
(EUCTR)

15/10/2008

20/03/2009

Efficacy and Safety of Oral Budesonide-MMX? (CB 01 02) 6 mg and 9 mg Extended Release Tablets in Patients with Mild or Moderate Active Ulcerative Colitis. A Multicentre, Randomised, Double-Blind, Double-Dummy, Comparative Study Versus Placebo with an Additional Reference Arm Evaluating EntocortEC. - CB-01-02/02

Patients with mild or moderate active ulcerative colitis.
MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative

Product Name: Budesonide -MMX
Product Code: CB-01-02
INN or Proposed INN: Budesonide
Trade Name: ENTOCORT CR
INN or Proposed INN: Budesonide
Product Name: Budesonide MMX
Product Code: CB-01-02
INN or Proposed INN: Budesonide

COSMO TECHNOLOGIES LTD

NULL

Not Recruiting

Female: yes
Male: yes

492

United Kingdom;Belgium;Estonia;France;Italy;Latvia;Lithuania;Sweden

1228

EUCTR2007-004867-22-CZ
(EUCTR)

07/10/2008

26/02/2008

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AVONEX® in Subjects with Moderate to Severe Ulcerative Colitis.

Moderate to Severe Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Trade Name: Avonex
Product Name: Avonex

Biogen Idec Ltd

NULL

Not Recruiting

Female: yes
Male: yes

120

Hungary;Czech Republic

1229

EUCTR2008-000045-59-NL
(EUCTR)

06/10/2008

13/08/2008

Multicentre, controlled, randomized, investigator-blinded, comparative study of oral Mesalazine 4g per day Once daily versus 4g per day in Two divided doses in patients with active Ulcerative colitiS - MOTUS

Patients with mild to moderate ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10058816;Term: Colitis ulcerative acute episode

Product Name: Pentasa 2g sachet prolonged release granules (95%)
INN or Proposed INN: MESALAZINE

Ferring SAS

NULL

Not Recruiting

Female: yes
Male: yes

398

United Kingdom;Netherlands;Belgium;France

1230

EUCTR2007-005520-32-NL
(EUCTR)

01/10/2008

05/08/2008

An open label, 7-day repeat dose study to evaluate the pharmacodynamics of SB-656933-AAA in patients with Ulcerative Colitis.

ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: SB-656933 Tablets
Product Code: SB-656933

GlaxoSmithKline R&D Ltd

NULL

Not Recruiting

Female: yes
Male: yes

Netherlands

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1231

EUCTR2006-003398-28-DK
(EUCTR)

25/09/2008

04/12/2007

Ulcerative Colitis (UC)
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

676

Phase 2;Phase 3

Hungary;Czech Republic;Germany;Netherlands;Belgium;Denmark;Bulgaria;France;Latvia;Austria;Sweden;Lithuania

1232

EUCTR2006-003399-37-DK
(EUCTR)

25/09/2008

10/12/2007

The purpose of this study is to assess the effects (good and bad) of CNTO 148 (golimumab) therapy in patients with ulcerative colitis

Janssen Biologics B.V.

NULL

Not Recruiting

Female: yes
Male: yes

1350

Phase 3

United States;Serbia;Slovakia;Ukraine;Russian Federation;Israel;India;France;Australia;Denmark;South Africa;Latvia;Netherlands;Lithuania;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden

1233

EUCTR2006-004776-12-SK
(EUCTR)

18/09/2008

16/07/2008

Efficacy and safety of oral budesonide-MMX™ (CB-01-02) 6 mg and 9 mg extended release tablets in patients with mild or moderate active ulcerative colitis. A multicentre, randomised, double-blind, double-dummy, comparative study versus placebo with an additional reference arm evaluating entocort®EC

Mild or moderate active ulcerative colitis.
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: Budesonide -MMX ™
Product Code: CB-01-02
INN or Proposed INN: budesonide
Other descriptive name: CB-01-02
Trade Name: Entocort® CR
INN or Proposed INN: budesonide
Product Name: Budesonide -MMX
Product Code: CB-01-02
INN or Proposed INN: budesonide
Other descriptive name: CB-01-02

COSMO Technologies Ltd

NULL

Not Recruiting

Female: yes
Male: yes

492

Phase 3

France;Estonia;Slovakia;Belgium;Lithuania;Latvia;Italy;United Kingdom;Sweden

1234

EUCTR2008-000967-40-SE
(EUCTR)

29/08/2008

04/06/2008

Moderately Active Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

ActoGeniX NV.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2a

Netherlands;Belgium;Sweden

1235

EUCTR2008-001968-36-GB
(EUCTR)

27/08/2008

15/07/2008

Comparison of infliximab and ciclosporin in steroid resistant ulcerative colitis: a Trial - CONSTRUCT

Acute severe steroid resistant ulcerative colitis
MedDRA version: 14.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders

Swansea University

NULL

Not Recruiting

Female: yes
Male: yes

250

Phase 3

United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1236

EUCTR2006-003398-28-SE
(EUCTR)

26/08/2008

21/12/2007

Ulcerative Colitis (UC)
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

1002

Phase 2;Phase 3

Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;Bulgaria;France;Latvia;Austria;Lithuania;Sweden

1237

EUCTR2006-003399-37-SE
(EUCTR)

26/08/2008

21/12/2007

The purpose of this study is to assess the effects (good and bad) of CNTO 148 (golimumab) therapy in patients with ulcerative colitis

Janssen Biologics B.V.

NULL

Not Recruiting

Female: yes
Male: yes

1350

Phase 3

United States;Serbia;Slovakia;Ukraine;Russian Federation;Israel;India;France;Australia;Denmark;South Africa;Latvia;Netherlands;Lithuania;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden

1238

EUCTR2007-004157-28-DE
(EUCTR)

07/08/2008

25/03/2008

Long-term open-label safety and efficacy study of Adalimumab in subjects with Ulcerative Colitis.

Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: Adalimumab
Other descriptive name: ABT-Humira

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

592

Phase 3

Portugal;Slovakia;Spain;Austria;Israel;Italy;Switzerland;France;Hungary;Czech Republic;Puerto Rico;Canada;Poland;Belgium;Denmark;Australia;Netherlands;Germany;Norway;New Zealand;Sweden

1239

EUCTR2007-004157-28-SK
(EUCTR)

04/08/2008

09/04/2008

Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative

Trade Name: Humira 40 mg solution for injection in pre-filled syringe
INN or Proposed INN: Adalimumab
Other descriptive name: ABT-Humira

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

800

Phase 3

Portugal;France;Czech Republic;Hungary;Slovakia;Spain;Belgium;Austria;Netherlands;Germany;Italy;Sweden

1240

EUCTR2006-004776-12-EE
(EUCTR)

04/08/2008

11/06/2008

Mild or moderate active ulcerative colitis.
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

COSMO Technologies Ltd

NULL

Not Recruiting

Female: yes
Male: yes

492

United Kingdom;Belgium;France;Estonia;Italy;Latvia;Lithuania;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1241

EUCTR2007-005166-12-DE
(EUCTR)

29/07/2008

15/01/2008

A Phase II, Randomized, Multi-Centre, Double-Blind, Placebo-Controlled Trial of HMPL-004 in Patients with Mild to Moderate Active Ulcerative Colitis with or without Mesalamine

active mild to moderate ulcerative colitis defined as a Mayo clinical score of 4-10 points
MedDRA version: 9.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis

Product Name: HMPL-004
Other descriptive name: ANDROGRAPHIS PANICULATA (ethanol extract)
Product Name: HMPL-004
Other descriptive name: ANDROGRAPHIS PANICULATA (ethanol extract)

Hutchison MediPharma Enterprises Limited

NULL

Not Recruiting

Female: yes
Male: yes

210

Phase 2

Germany

1242

EUCTR2006-004776-12-GB
(EUCTR)

23/07/2008

25/04/2008

Mild or moderate active ulcerative colitis.
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

COSMO Technologies Ltd

NULL

Not Recruiting

Female: yes
Male: yes

492

Phase 3

France;Estonia;Slovakia;Belgium;Lithuania;Latvia;Italy;United Kingdom;Sweden

1243

EUCTR2007-004157-28-FR
(EUCTR)

10/07/2008

14/04/2008

Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

800

Phase 3

Portugal;France;Czech Republic;Hungary;Slovakia;Spain;Belgium;Austria;Netherlands;Germany;Italy;Sweden

1244

EUCTR2007-004157-28-HU
(EUCTR)

09/07/2008

28/03/2008

Long-term open-label safety and efficacy study of Adalimumab in subjects with Ulcerative Colitis.

Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: Adalimumab
Other descriptive name: ABT-Humira

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

592

Phase 3

Spain;Austria;Israel;Italy;Switzerland;France;Czech Republic;Hungary;Puerto Rico;Canada;Poland;Belgium;Denmark;Australia;Netherlands;Germany;Norway;New Zealand;Sweden;Portugal;Slovakia

1245

EUCTR2006-004776-12-FR
(EUCTR)

07/07/2008

09/05/2008

Mild or moderate active ulcerative colitis.
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

COSMO Technologies Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

492

United Kingdom;Belgium;Estonia;France;Italy;Latvia;Lithuania;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1246

EUCTR2006-004776-12-BE
(EUCTR)

01/07/2008

18/06/2008

Mild or moderate active ulcerative colitis.
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

COSMO Technologies Ltd

NULL

Not Recruiting

Female: yes
Male: yes

492

United Kingdom;Belgium;Estonia;France;Italy;Latvia;Lithuania;Sweden

1247

EUCTR2005-003471-20-LT
(EUCTR)

26/06/2008

12/02/2008

Phase II, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter Study to investigate the efficacy of Two Dosages of Propionyl-L-carnitine ST 261 Colon Release Tablets in Patients Affected by Ulcerative Colitis under Oral Stable Treatment

Ulcerative Colitis
MedDRA version: 9.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative

Product Name: Propionyl-L-carnitine
Product Code: ST261
INN or Proposed INN: Propionyl-L-Carnitine

SIGMA-TAU

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 2

Italy;Lithuania

1248

EUCTR2007-004157-28-BE
(EUCTR)

23/06/2008

13/12/2007

Long-term open-label safety and efficacy study of Adalimumab in subjects with Ulcerative Colitis.

Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: Adalimumab
Other descriptive name: ABT-Humira

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

592

Phase 3

Germany;Norway;New Zealand;Sweden;Portugal;Slovakia;Spain;Austria;Israel;Italy;Switzerland;France;Hungary;Czech Republic;Puerto Rico;Canada;Belgium;Poland;Denmark;Australia;Netherlands

1249

EUCTR2007-004867-22-HU
(EUCTR)

18/06/2008

21/02/2008

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AVONEX® in Subjects with Moderate to Severe Ulcerative Colitis.

Moderate to Severe Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Trade Name: Avonex
Product Name: Avonex

Biogen Idec Ltd

NULL

Not Recruiting

Female: yes
Male: yes

120

Hungary;Czech Republic

1250

EUCTR2007-004157-28-IT
(EUCTR)

17/06/2008

01/10/2008

Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

800

Phase 3

Portugal;France;Czech Republic;Hungary;Slovakia;Spain;Belgium;Austria;Netherlands;Germany;Italy;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1251

EUCTR2006-004776-12-LT
(EUCTR)

17/06/2008

22/04/2008

Mild or moderate active ulcerative colitis.
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: Budesonide -MMX™
Product Code: CB-01-02
INN or Proposed INN: budesonide
Other descriptive name: CB-01-02
Trade Name: Entocort® CR
INN or Proposed INN: budesonide
Product Name: Budesonide -MMX™
Product Code: CB-01-02
INN or Proposed INN: budesonide
Other descriptive name: CB-01-02

COSMO Technologies Ltd

NULL

Not Recruiting

Female: yes
Male: yes

492

United Kingdom;Belgium;Estonia;France;Italy;Latvia;Sweden;Lithuania

1252

EUCTR2008-000967-40-BE
(EUCTR)

13/06/2008

05/08/2008

A Phase 2a Randomized, Placebo-Controlled, Double-Blind, Multi-Center Dose Escalation Study, to Evaluate the Safety, Tolerability, Pharmacodynamics and Efficacy of AG011, in Subjects with Moderately Active Ulcerative Colitis

Moderately Active Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

ActoGeniX N.V

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2a

Netherlands;Belgium;Sweden

1253

EUCTR2006-002670-22-GB
(EUCTR)

11/06/2008

01/08/2007

Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1). Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS

Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Schering-Plough Research Institute, a division of Schering Corporation

NULL

Not Recruiting

Female: yes
Male: yes

600

Phase 3

Portugal;France;Czech Republic;Hungary;Slovakia;Spain;Belgium;Germany;Italy;United Kingdom

1254

EUCTR2006-003398-28-BG
(EUCTR)

10/06/2008

30/04/2008

Ulcerative Colitis (UC)
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

1002

Phase 2;Phase 3

Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;France;Bulgaria;Latvia;Austria;Sweden;Lithuania

1255

EUCTR2007-004157-28-CZ
(EUCTR)

09/06/2008

10/04/2008

Long-term open-label safety and efficacy study of Adalimumab in subjects with Ulcerative Colitis.

Ulcerative Colitis
MedDRA version: 17.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: Adalimumab
Other descriptive name: ABT-Humira

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

592

Phase 3

Portugal;Slovakia;Spain;Austria;Israel;Italy;Switzerland;France;Czech Republic;Hungary;Puerto Rico;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1256

EUCTR2008-000045-59-FR
(EUCTR)

04/06/2008

22/04/2008

Patients with mild to moderate ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10058816;Term: Colitis ulcerative acute episode

Product Name: Pentasa 2g sachet prolonged release granules (95%)
INN or Proposed INN: MESALAZINE

Ferring SAS

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

398

United Kingdom;Netherlands;Belgium;France

1257

EUCTR2007-007928-18-DE
(EUCTR)

04/06/2008

12/11/2008

Evaluation of efficacy and safety of the herbal drug Myrrhinil-Intest vs. mesalazine in maintaining clinical remission of ulcerative colitis - a 12-month, multicenter, randomized, prospective, double-blind, double-dummy, active-controlled and parallel group phase IV-trial - MIRCU

ulcerative colitis patients in clinical remission
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Trade Name: Myrrhinil-Intest®
INN or Proposed INN: MATRICARIA FLOWER
Other descriptive name: MATRICARIA FLOWER
INN or Proposed INN: MYRRH
Other descriptive name: MYRRH
INN or Proposed INN: COFFEE COAL
Other descriptive name: COFFEE COAL
Trade Name: Salofalk® 500mg
INN or Proposed INN: MESALAZINE

REPHA GmbH

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4-

Germany

1258

EUCTR2006-004776-12-SE
(EUCTR)

02/06/2008

10/04/2008

Mild or moderate active ulcerative colitis.
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

COSMO Technologies Ltd

NULL

Not Recruiting

Female: yes
Male: yes

492

United Kingdom;Belgium;Estonia;France;Italy;Latvia;Lithuania;Sweden

1259

EUCTR2006-003399-37-BG
(EUCTR)

30/05/2008

30/04/2008

A Study of the Safety and Effectiveness of CNTO 148 (golimumab) in Patients with Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis (UC)
MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Janssen Biologics B.V.

NULL

Not Recruiting

Female: yes
Male: yes

1228

Phase 3

United States;Serbia;Slovakia;Ukraine;Israel;Russian Federation;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;Lithuania;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan;New Zealand;Sweden

1260

EUCTR2006-003397-94-BG
(EUCTR)

30/05/2008

30/04/2008

Ulcerative Colitis (UC)
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: Golimumab Liquid in Vial
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

676

Phase 2;Phase 3

Hungary;Germany;Netherlands;Belgium;France;Bulgaria;Latvia;Austria;Sweden;Lithuania

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1261

EUCTR2006-004776-12-LV
(EUCTR)

29/05/2008

29/04/2008

Mild or moderate active ulcerative colitis.
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

COSMO Technologies Ltd

NULL

Not Recruiting

Female: yes
Male: yes

492

United Kingdom;Belgium;Estonia;France;Italy;Latvia;Lithuania;Sweden

1262

EUCTR2007-002544-25-LV
(EUCTR)

29/05/2008

18/02/2008

A Phase 2, Multi-dose, Double-blind, Placebo-controlled, Randomized, Multicenter Study of MDX-1100 (anti-CXCL10 Human Monoclonal Antibody) in Subjects with Active Ulcerative Colitis

Active Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: MDX-1100
Product Code: MDX-1100

Bristol-Myers Squibb Company

NULL

Not Recruiting

Female: yes
Male: yes

106

Phase 2

Hungary;Czech Republic;Latvia

1263

EUCTR2006-002781-20-SE
(EUCTR)

23/05/2008

04/03/2008

A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis.

Moderately to severely active ulcerative colitis.
MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Trade Name: Humira
INN or Proposed INN: Adalimumab

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

575

Hungary;Germany;Czech Republic;Italy;Austria;Sweden

1264

EUCTR2007-002544-25-HU
(EUCTR)

23/05/2008

07/01/2008

A Phase 2, Multi-dose, Double-blind, Placebo-controlled, Randomized, Multicenter Study of MDX-1100 (anti-CXCL10 Human Monoclonal Antibody) in Subjects with Active Ulcerative Colitis

Active Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: MDX-1100
Product Code: MDX-1100

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

106

Phase 2

Hungary;Czech Republic;Latvia

1265

EUCTR2006-005299-42-BE
(EUCTR)

20/05/2008

07/03/2008

A randomized, multicenter open label study comparing cyclosporine with infliximab in steroid-refractory severe attacks of ulcerative colitis (CYSIF Study) - CYSIF

- Diagnosis of UC according to Lennard-Jones criteria - Endoscopically demonstrated colorectal lesions localized above the anal margin and extending at least up to 15cm proximally.- Severe acute flare of UC with a Lichtiger Index score > 10.- Refractoriness to high dose intravenous steroid therapy (= 0.8 mg/kg/d of methylprednisolone or equivalent) given for at least 5 days.
MedDRA version: 9.1;Level: LLT;Classification code 10045282;Term: UC

Trade Name: REMICADE
INN or Proposed INN: INFLIXIMAB
INN or Proposed INN: CICLOSPORIN
Other descriptive name: SANDINUM
INN or Proposed INN: CICLOSPORIN
Other descriptive name: NEORAL
Trade Name: CYCLOSPORIN
Trade Name: CYCLOSPORIN

GETAID

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

100

Finland;Belgium;France;Spain

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1266

EUCTR2006-005299-42-ES
(EUCTR)

19/05/2008

03/03/2008

Estudio multicéntrico abierto randomizado que compara ciclosporina e infliximab para el tratamiento de la colitis ulcerosa grave corticorrefractaria.A randomized multicenter open label study comparing cyclosporine with infliximab in steroid-refractory severe attacks of ulcerative colitis - CYSIF

Brote grave de colitis ulcerosa (Severe flare of ulcerative colitis)

Trade Name: Sandimmum
Product Name: ciclosporina
Trade Name: Remicade
Product Name: infliximab

GETECCU (Grupo Español para el estudio de la enfermedad de Crohn y la colitis ulcerosa)

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

100

Finland;Belgium;France;Spain

1267

EUCTR2007-004732-23-PL
(EUCTR)

05/05/2008

12/05/2008

A MULTICENTER, RANDOMIZED, BLINDED, PLACEBO CONTROLLED, PARALLEL DESIGN, THREE-ARM, BIOEQUIVALENCE STUDY WITH CLINICAL ENDPOINTS COMPARING MESALAMINE DELAYED RELEASE TABLETS 400mg TO THE REFERENCE LISTED DRUG ASACOL® DELAYED RELEASE TABLETS 400mg IN PATIENTS WITH MILD TO MODERATELY ACTIVE ULCERATIVE COLITIS.)

Mild to moderately active ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative

Product Name: Mesalamine
INN or Proposed INN: MESALAZINE
Trade Name: Asacol
Product Name: Asacol Delayed-Release Tablets
INN or Proposed INN: MESALAZINE

EMET Pharmaceuticals, LLC

NULL

Not Recruiting

Female: yes
Male: yes

435

Estonia;Latvia;Poland

1268

EUCTR2008-001467-10-GB
(EUCTR)

30/04/2008

28/03/2008

Trial of Adjuvant Vitamin D with Standard Maintenance Therapy in Preventing Relapse of Inflammatory Bowel Disease - IBDVit3

Ulcerative colitis - in remissionCrohn's Disease - in remission
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease

Trade Name: Vigantol Oel
Product Name: Vigantol Oel TM

Imperial College London

NULL

Not Recruiting

Female: yes
Male: yes

120

United Kingdom

1269

EUCTR2007-004157-28-AT
(EUCTR)

30/04/2008

08/04/2008

Long-term open-label safety and efficacy study of Adalimumab in subjects with Ulcerative Colitis.

Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: Adalimumab
Other descriptive name: ABT-Humira

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

592

Phase 3

Portugal;Slovakia;Spain;Austria;Israel;Italy;Switzerland;France;Hungary;Czech Republic;Puerto Rico;Canada;Poland;Belgium;Denmark;Australia;Netherlands;Germany;Norway;New Zealand;Sweden

1270

EUCTR2007-006692-37-GB
(EUCTR)

10/04/2008

25/01/2008

The Immunomodulatory Role of Vitamin D in Inflammatory Bowel Disease (IBDVit): IBDVit1 - Trial of Adjuvant Vitamin D with Corticosteroids in Active Crohn’s Disease; IBDVit2 - Trial of Adjuvant Vitamin D with Infliximab in Active Crohn's Disease; IBDVit3 - Trial of Adjuvant Vitamin D with standard maintenance therapy in preventing relapse of Inflammatory Bowel Disease. - IBDVit

IBDVit1 - Active Crohn's Disease IBDVit2 - Active Crohn's Disease IBDVit3 - Crohn's Disease in remission / Ulcerative Colitis in remission
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
MedDRA version: 9.1;Classification code 10045365;Term: Ulcerative colitis

Imperial College London

NULL

Not Recruiting

Female: yes
Male: yes

210

Phase 4

United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1271

EUCTR2007-007702-30-IT
(EUCTR)

03/04/2008

08/07/2008

Feasibility and safety of Infliximab enema treatment in patients with active left-sided ulcerative colitis. An open-label, non comparative, pilot study. - ND

Ulcerative colitis
MedDRA version: 9.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders

Trade Name: REMICADE
INN or Proposed INN: INFLIXIMAB

COSMO TECHNOLOGIES LTD

NULL

Not Recruiting

Female: no
Male: yes

Italy

1272

EUCTR2006-002782-40-AT
(EUCTR)

16/03/2008

20/03/2007

Moderately to severely active ulcerative colitis.
MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Trade Name: Humira
INN or Proposed INN: Adalimumab

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

500

Portugal;Hungary;Germany;Czech Republic;Denmark;France;Austria

1273

EUCTR2006-002781-20-AT
(EUCTR)

27/02/2008

23/02/2007

Moderately to severely active ulcerative colitis.
MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Trade Name: Humira
INN or Proposed INN: Adalimumab

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

475

Hungary;Germany;Czech Republic;Italy;Austria;Sweden

1274

EUCTR2006-003604-19-PL
(EUCTR)

27/02/2008

07/11/2007

ULCERATIVE COLITIS,NOS
MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

978

Phase 3

Czech Republic;United Kingdom;Germany;Belgium;France;Ireland;Italy;Poland

1275

EUCTR2007-004732-23-LV
(EUCTR)

27/02/2008

28/02/2008

A Multicenter, Randomized, Partially Blinded, Placebo Controlled, Parallel Design, Three-Arm, Bioequivalence Study With Clinical Endpoints Comparing Mesalamine Delayed Release Tablets 400mg To The Reference Listed Drug Asacol Delayed Release Tablets 400mg In Patients With Mild To Moderately Active Ulcerative Colitis

Mild to moderately active ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative

Product Name: Mesalamine Delayed Release Tablets 400mg
INN or Proposed INN: MESALAZINE
Trade Name: Asacol
Product Name: Asacol Delayed-Release Tablets
INN or Proposed INN: MESALAZINE

EMET Pharmaceuticals LLC

NULL

Not Recruiting

Female: yes
Male: yes

435

Estonia;Latvia;Poland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1276

EUCTR2006-005299-42-FI
(EUCTR)

25/02/2008

27/12/2007

A randomized, multicentre, open label study comparing cyclosporine with infliximab in steroid-refractory severe attacks of ulcerative colitisSatunnaistettu, avoin, vertaileva monikeskustutkimus siklosporiinista ja infliximabista kortikosteroidille reagoimattoman vaikean haavaisen paksusuolitulehduksen hoidossa. - CYSIF STUDY

Tutkimuksessa verrataan kortikosteroidihoidolle reagoimattoman haavaisen paksusuolitulehduksen hoitoa käyttämällä suonensisäistä siklosporiinihoitoa 2 mg/kg/vrk 7 vrk:n ajan ja siklosporiini (Sandimmun Neoral) 4 mg/kg/vrk suun kautta tämän jälkeen 3 kk:n ajan verrattuna infliximabi (Remicade) 5 mg/kg iv viikoilla 0, 2 ja 6.
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Trade Name: Sandimmun 50 mg/ml, infuusiokonsentraatti
INN or Proposed INN: CICLOSPORIN
Trade Name: Sandimmun Neoral
INN or Proposed INN: CICLOSPORIN
Trade Name: Remicade 100 mg infuusiokuiva-aine, konsentraattiliuosta varten
INN or Proposed INN: INFLIXIMAB

Groupe d'Etude Thérapeutique des Affections Inflammatoires Digestives (G.E.T.A.I.D.)

NULL

Not Recruiting

Female: yes
Male: yes

100

France;Finland;Belgium;Spain

1277

EUCTR2006-002782-40-DE
(EUCTR)

20/02/2008

18/04/2007

Moderately to severely active ulcerative colitis.
MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Trade Name: Humira
INN or Proposed INN: Adalimumab

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

500

Portugal;Hungary;Czech Republic;Germany;Denmark;France;Austria

1278

EUCTR2006-002670-22-SK
(EUCTR)

08/02/2008

15/04/2008

Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Schering-Plough Research Institute, a division of Schering Corporation

NULL

Not Recruiting

Female: yes
Male: yes

600

Phase 3

Portugal;France;Czech Republic;Hungary;Slovakia;Spain;Belgium;Germany;Italy;United Kingdom

1279

EUCTR2006-003398-28-LT
(EUCTR)

29/01/2008

30/08/2007

Ulcerative Colitis (UC)
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

676

Phase 2;Phase 3

Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania

1280

EUCTR2006-003397-94-LT
(EUCTR)

29/01/2008

30/08/2007

Ulcerative Colitis (UC)
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: Golimumab Liquid in Vial
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

676

Phase 2;Phase 3

Hungary;Germany;Netherlands;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1281

EUCTR2006-003399-37-LT
(EUCTR)

29/01/2008

30/08/2007

Ulcerative Colitis (UC)
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

1350

Phase 3

Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania

1282

EUCTR2006-003399-37-NL
(EUCTR)

17/01/2008

08/10/2007

The purpose of this study is to assess the effects (good and bad) of CNTO 148 (golimumab) therapy in patients with ulcerative colitis

Janssen Biologics BV

NULL

Not Recruiting

Female: yes
Male: yes

1350

Phase 3

United States;Serbia;Slovakia;Ukraine;Russian Federation;Israel;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Lithuania;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden

1283

EUCTR2006-003397-94-NL
(EUCTR)

17/01/2008

07/08/2007

Ulcerative Colitis (UC)
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: Golimumab Liquid in Vial
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

676

Phase 2;Phase 3

Hungary;Germany;Netherlands;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania

1284

EUCTR2006-003398-28-NL
(EUCTR)

17/01/2008

08/10/2007

Ulcerative Colitis (UC)
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

676

Phase 2;Phase 3

Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania

1285

EUCTR2004-004184-29-NL
(EUCTR)

15/01/2008

17/10/2007

Ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Shire Pharmaceutical Development Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

826

Phase 3

Portugal;Hungary;Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Spain;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1286

EUCTR2006-004230-32-BE
(EUCTR)

21/12/2007

04/12/2007

Efficacy and safety of Beclomethasone dipropionate, gastro-resistant, prolonged release tablets (CHF1514) compared to oral prednisone, in a 8-week treatment period, in patients with active ulcerative colitis. An international, multicentre, randomized, double blind, parallel group study. - Beta study

Ulcerative colitis extending proximally beyond the rectum.
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Trade Name: Clipper 30 cpr 5mg R.M.
INN or Proposed INN: BECLOMETASONE DIPROPIONATE
Trade Name: Deltacortene 20 cpr 5mg
INN or Proposed INN: PREDNISONE
Trade Name: Deltacortene 10 cpr 25mg
INN or Proposed INN: PREDNISONE

CHIESI Farmaceutici S.p.A.

NULL

Not Recruiting

Female: yes
Male: yes

300

Belgium;Spain;Italy;Poland

1287

EUCTR2004-004184-29-PT
(EUCTR)

14/12/2007

11/10/2007

Ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Shire Pharmaceutical Development Ltd

NULL

Not Recruiting

Female: yes
Male: yes

826

Phase 3

Hungary;Portugal;Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Spain;Sweden

1288

EUCTR2006-005377-22-ES
(EUCTR)

12/12/2007

29/10/2007

Estudio clínico fase III, de doble ciego, doble simulación, aleatorizado, multicéntrico, que compara la eficacia y la tolerancia de 8 semanas de tratamiento oral con 9 mg de budesonida frente a 3 g de mesalazina en pacientes con colitis ulcerosa activa - Budesonida en cápsulas frente a mesalazina en gránulos en la CU activa

Tratamiento de colitis ulcerosa
MedDRA version: 9.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis

Dr. Falk Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

360

Phase 3

Czech Republic;Slovakia;Poland;Spain;Lithuania;Latvia;Germany

1289

EUCTR2006-003398-28-BE
(EUCTR)

10/12/2007

18/07/2007

Ulcerative Colitis (UC)
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

1002

Phase 2;Phase 3

Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania

1290

EUCTR2006-004230-32-PL
(EUCTR)

07/12/2007

05/09/2007

EFFICACY AND SAFETY OF BECLOMETHASONE DIPROPIONATE GASTRO-RESISTANT, PROLONGED RELEASE TABLETS (CHF 1514) COMPARED WITH ORAL PREDNISONE, IN A 8-WEEK TREATMENT PERIOD, IN PATIENTS WITH ACTIVE ULCERATIVE COLITIS. AN INTERNATIONAL, MUTICENTRE, RANDOMISED, DOUBLE BLIND, PARALLEL GROUP STUDY - Beta study

Ulcerative Colitis extending proximally beyond the rectum with bleeding, verified by endoscopic examination
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Trade Name: Clipper
INN or Proposed INN: Beclomethasone diproprionate
Trade Name: Deltacortene
INN or Proposed INN: Prednisone
Trade Name: Deltacortene
INN or Proposed INN: Prednisone

Chiesi Farmaceutici SpA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

300

Belgium;Spain;Italy;Poland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1291

EUCTR2007-002542-38-DK
(EUCTR)

28/11/2007

08/11/2007

A clinical study to explore the safe and effective use of the drug sotrastaurin in patients with ulcerative colitis

A randomized, double blind, placebo controlled, parallel group design study to explore the efficacy, safety and tolerability of AEB071 in patients with active, moderate to severe ulcerative colitis. - A2210

Product Name: Sotrastaurin
Product Code: AEB071
INN or Proposed INN: Sotrastaurin (INN) acetate
Product Name: Vitamin B2
INN or Proposed INN: Riboflavin

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Denmark;Germany

1292

EUCTR2006-002670-22-IT
(EUCTR)

27/11/2007

04/10/2007

Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1) Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-Up of Efficacy and Safety (Part 2)

moderately to severely active Ulcerative Colitis
MedDRA version: 14.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Remicade
INN or Proposed INN: Infliximab
Trade Name: imuran
INN or Proposed INN: azathioprine

SCHERING-PLOUGH

NULL

Not Recruiting

Female: yes
Male: yes

600

Portugal;France;Czech Republic;Hungary;Spain;Belgium;Germany;United Kingdom;Italy

1293

EUCTR2006-003399-37-DE
(EUCTR)

27/11/2007

03/07/2007

The purpose of this study is to assess the effects (good and bad) of CNTO 148 (golimumab) therapy in patients with ulcerative colitis

Janssen Biologics B.V.

NULL

Not Recruiting

Female: yes
Male: yes

1350

Phase 3

Serbia;United States;Slovakia;Ukraine;Russian Federation;Israel;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Lithuania;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden

1294

EUCTR2007-003815-30-ES
(EUCTR)

27/11/2007

24/10/2007

Estudio abierto, randomizado, multicéntrico para comparar la eficacia y la seguridad de la prednisona y granulocitoféresis con Adacolumn® versus la prednisona sola en el tratamiento de pacientes con colitis ulcerosa activa corticodependiente leve a moderada.

Colitis ulcerosa corticodependiente leve o moderada
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Trade Name: DACORTIN
Product Name: PREDNISONE
INN or Proposed INN: PREDNISONE
Other descriptive name: N/A

GETECCU (Grupo Español de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa)

NULL

Not Recruiting

Female: yes
Male: yes

Portugal;Spain

1295

EUCTR2004-004184-29-SE
(EUCTR)

22/11/2007

27/09/2007

Ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Shire Pharmaceutical Development Ltd

NULL

Not Recruiting

Female: yes
Male: yes

830

Phase 3

Portugal;Hungary;Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Spain;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1296

EUCTR2006-003397-94-AT
(EUCTR)

15/11/2007

16/07/2007

Ulcerative Colitis (UC)
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: Golimumab Liquid in Vial
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

676

Phase 2;Phase 3

Hungary;Germany;Netherlands;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania

1297

EUCTR2006-003399-37-BE
(EUCTR)

15/11/2007

18/07/2007

The purpose of this study is to assess the effects (good and bad) of CNTO 148 (golimumab) therapy in patients with ulcerative colitis

Janssen Biologics B.V.

NULL

Not Recruiting

Female: yes
Male: yes

1350

Phase 3

1298

EUCTR2006-003398-28-DE
(EUCTR)

15/11/2007

03/07/2007

Ulcerative Colitis (UC)
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

1002

Phase 2;Phase 3

Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania

1299

EUCTR2006-003397-94-BE
(EUCTR)

15/11/2007

18/07/2007

Ulcerative Colitis (UC)
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: Golimumab Liquid in Vial
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

676

Phase 2;Phase 3

Hungary;Germany;Netherlands;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania

1300

EUCTR2006-005377-22-LT
(EUCTR)

13/11/2007

14/08/2007

Double-blind, double-dummy, randomised, multi-centre, comparative phase III clinical study on the efficacy and tolerability of an 8 week oral treatment with 9 mg budesonide or 3 g mesalazine in patients with active ulcerative colitis - Budesonide capsules versus mesalazine granules in active UC

Treatment of ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis

Trade Name: Budenofalk 3mg
INN or Proposed INN: BUDESONIDE
Trade Name: Salofalk 1000mg Granu-Stix
INN or Proposed INN: MESALAZINE

Dr. Falk Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

360

Phase 3

Czech Republic;Germany;Spain;Latvia;Poland;Lithuania

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1301

EUCTR2006-000410-20-NL
(EUCTR)

13/11/2007

09/08/2007

A Phase 3, Randomized, Open-label, Parallel-group, Multicenter Trial to Evaluate the Safety and Efficacy of Infliximab (REMICADE®) in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis

Ulcerative colitis
MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Trade Name: Remicade

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

Netherlands;Belgium;Denmark;Italy

1302

EUCTR2006-002670-22-DE
(EUCTR)

31/10/2007

12/06/2007

Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1).Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS

Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: Infliximab
Trade Name: Imuran
Product Name: Overencapsulated Azathioprine (Imuran) 50 mg Tablet
Product Code: SCH 900050
INN or Proposed INN: azathioprine

Schering-Plough Research Institute, a division of Schering Corporation

NULL

Not Recruiting

Female: yes
Male: yes

600

Portugal;Hungary;United Kingdom;Czech Republic;Germany;Belgium;France;Spain;Italy

1303

EUCTR2006-003397-94-HU
(EUCTR)

30/10/2007

10/07/2007

Ulcerative Colitis (UC)
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: Golimumab Liquid in Vial
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa

Centocor BV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

700

Phase 2;Phase 3

Hungary;Germany;Netherlands;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania

1304

EUCTR2006-003399-37-HU
(EUCTR)

30/10/2007

10/07/2007

A Study of the Safety and Effectiveness of CNTO 148 (golimumab) in Patients with Moderately to Severely Active Ulcerative Colitis

Janssen Biologics B.V.

NULL

Not Recruiting

Female: yes
Male: yes

1228

Phase 3

Serbia;Saudi Arabia;Slovakia;Finland;Ukraine;Lithuania;Austria;Israel;Russian Federation;India;France;Czech Republic;Hungary;Poland;Belgium;Romania;Denmark;Australia;Bulgaria;Netherlands;Latvia;Germany;New Zealand;Sweden

1305

EUCTR2006-003398-28-HU
(EUCTR)

29/10/2007

10/07/2007

Ulcerative Colitis (UC)
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

1002

Phase 2;Phase 3

Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1306

EUCTR2007-002542-38-DE
(EUCTR)

29/10/2007

22/02/2008

A clinical study to explore the safe and effective use of the drugsotrastaurin in patients with ulcerative colitis

A randomized, double blind, placebo controlled, parallel group design study to explore the efficacy, safety and tolerability of AEB071 in patients with active, moderate to severe ulcerative colitis.

Product Code: AEB071A
Trade Name: B2-ASmedic
Product Name: B2-ASmedic
INN or Proposed INN: RIBOFLAVIN

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

Denmark;Germany

1307

EUCTR2006-005377-22-DE
(EUCTR)

23/10/2007

16/07/2007

Treatment of ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis

Trade Name: Budenofalk 3mg
INN or Proposed INN: BUDESONIDE
Trade Name: Salofalk 1000mg Granu-Stix
INN or Proposed INN: MESALAZINE

Dr. Falk Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

360

Phase 3

Czech Republic;Poland;Spain;Lithuania;Latvia;Germany

1308

EUCTR2007-004732-23-EE
(EUCTR)

22/10/2007

23/10/2007

Mild to moderately active ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative

Product Name: Mesalamine Delayed Release Tablets 400mg
INN or Proposed INN: MESALAZINE
Trade Name: Asacol
Product Name: Asacol Delayed-Release Tablets
INN or Proposed INN: MESALAZINE

EMET Pharmaceuticals LLC

NULL

Not Recruiting

Female: yes
Male: yes

435

Estonia;Latvia;Poland

1309

EUCTR2006-002670-22-PT
(EUCTR)

12/10/2007

20/07/2007

Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1).Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS

Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Schering-Plough Research Institute, a division of Schering Corporation

NULL

Not Recruiting

Female: yes
Male: yes

600

Hungary;Portugal;United Kingdom;Czech Republic;Germany;Belgium;France;Spain;Italy

1310

EUCTR2006-003399-37-SK
(EUCTR)

04/10/2007

23/12/2009

A Study of the Safety and Effectiveness of CNTO 148 (golimumab) inPatients with Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis (UC)
MedDRA version: 14.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Janssen Biologics BV

NULL

Not Recruiting

Female: yes
Male: yes

1228

Phase 3

Slovakia;Lithuania;Austria;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1311

EUCTR2006-003398-28-SK
(EUCTR)

04/10/2007

23/12/2009

Ulcerative Colitis (UC)
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

1002

Phase 2;Phase 3

Slovakia;Lithuania;Austria;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Sweden

1312

EUCTR2006-003397-94-SK
(EUCTR)

04/10/2007

16/04/2008

Ulcerative Colitis (UC)
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: Golimumab Liquid in Vial
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

676

Phase 2;Phase 3

France;Hungary;Slovakia;Belgium;Lithuania;Austria;Bulgaria;Latvia;Netherlands;Germany;Sweden

1313

EUCTR2006-003399-37-AT
(EUCTR)

27/09/2007

17/07/2007

The purpose of this study is to assess the effects (good and bad) of CNTO 148 (golimumab) therapy in patients with ulcerative colitis

Janssen Biologics B.V.

NULL

Not Recruiting

Female: yes
Male: yes

1350

Phase 3

United States;Serbia;Slovakia;Ukraine;Russian Federation;Israel;India;France;Australia;Denmark;South Africa;Latvia;Netherlands;Lithuania;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden

1314

EUCTR2006-005377-22-LV
(EUCTR)

27/09/2007

12/09/2007

Treatment of ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis

Trade Name: Budenofalk 3mg
INN or Proposed INN: BUDESONIDE
Trade Name: Salofalk 1000mg Granu-Stix
INN or Proposed INN: MESALAZINE

Dr. Falk Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

360

Phase 3

Czech Republic;Germany;Spain;Latvia;Poland;Lithuania

1315

EUCTR2006-003398-28-FR
(EUCTR)

21/09/2007

23/07/2007

Ulcerative Colitis (UC)
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Centocor BV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

676

Phase 2;Phase 3

Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1316

EUCTR2006-003397-94-FR
(EUCTR)

21/09/2007

23/07/2007

Ulcerative Colitis (UC)
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: Golimumab Liquid in Vial
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa

Centocor BV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

676

Phase 2;Phase 3

Hungary;Germany;Netherlands;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania

1317

EUCTR2006-003399-37-FR
(EUCTR)

21/09/2007

23/07/2007

Ulcerative Colitis (UC)
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Centocor BV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1350

Phase 3

Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania

1318

EUCTR2006-002670-22-ES
(EUCTR)

20/09/2007

26/07/2007

Comparación de la eficacia y la seguridad del infliximab, en monoterapia o en combinación con azatioprina, y la azatioprina en monoterapia en la colitis ulcerosa activa de moderada a grave (1.ª parte). Comparación del tratamiento de mantenimiento y el tratamiento intermitente con infliximab en la conservación de la remisión: seguimiento de la eficacia y la seguridad (2.ª parte).

Colitis Ulcerosa
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Schering-Plough Research Institute, a division of Schering Corporation

NULL

Not Recruiting

Female: yes
Male: yes

600

Phase 3

Portugal;France;Czech Republic;Hungary;Slovakia;Belgium;Spain;Germany;Italy;United Kingdom

1319

EUCTR2006-005377-22-CZ
(EUCTR)

17/09/2007

14/09/2007

Treatment of ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis

Trade Name: Budenofalk 3mg
INN or Proposed INN: BUDESONIDE
Trade Name: Salofalk 1000mg Granu-stix®
INN or Proposed INN: MESALAZINE
Trade Name: Budenofalk 3mg
INN or Proposed INN: BUDESONIDE

Dr. Falk Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

360

Phase 3

Germany;Czech Republic;Spain;Latvia;Poland;Lithuania

1320

EUCTR2006-005377-22-SK
(EUCTR)

14/09/2007

16/04/2008

Treatment of ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis

Trade Name: Budenofalk 3mg
INN or Proposed INN: BUDESONIDE
Trade Name: Salofalk 1000mg Granu-Stix®
INN or Proposed INN: MESALAZINE
Trade Name: Budenofalk 3mg
INN or Proposed INN: BUDESONIDE

Dr. Falk Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

360

Phase 3

Czech Republic;Slovakia;Poland;Spain;Lithuania;Latvia;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1321

EUCTR2006-002782-40-PT
(EUCTR)

07/09/2007

18/06/2007

Moderately to severely active ulcerative colitis.
MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Trade Name: Humira
INN or Proposed INN: Adalimumab

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

500

Hungary;Portugal;Germany;Czech Republic;Denmark;France;Austria

1322

EUCTR2006-002670-22-FR
(EUCTR)

07/09/2007

14/06/2007

Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1).Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2)

Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: Infliximab
Trade Name: Imuran
Product Name: Azathioprine (Imuran) 50 mg Overencapsulated Tablet
Product Code: SCH 900050
INN or Proposed INN: azathioprine

Schering-Plough Research Institute, a division of Schering Corporation

NULL

Not Recruiting

Female: yes
Male: yes

600

Phase 3

Portugal;France;Czech Republic;Hungary;Slovakia;Spain;Belgium;Germany;Italy;United Kingdom

1323

EUCTR2006-003398-28-AT
(EUCTR)

06/09/2007

17/07/2007

Ulcerative Colitis (UC)
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

1002

Phase 2;Phase 3

Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania

1324

EUCTR2006-003397-94-DE
(EUCTR)

05/09/2007

03/07/2007

Ulcerative Colitis (UC)
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: Golimumab Liquid in Vial
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

676

Phase 2;Phase 3

Hungary;Germany;Netherlands;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania

1325

EUCTR2006-003399-37-LV
(EUCTR)

03/09/2007

04/09/2007

The purpose of this study is to assess the effects (good and bad) of CNTO 148 (golimumab) therapy in patients with ulcerative colitis

Janssen Biologics B.V.

NULL

Not Recruiting

Female: yes
Male: yes

1350

Phase 3

Germany;France;Bulgaria;Austria;Australia;South Africa;Sweden;Czech Republic;Canada;Serbia;Belgium;United States;Poland;Hungary;Netherlands;Latvia;Lithuania;Israel;India;Russian Federation;Slovakia;Ukraine;Denmark;Romania;Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1326

EUCTR2006-003397-94-LV
(EUCTR)

03/09/2007

04/09/2007

Ulcerative Colitis (UC)
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: Golimumab Liquid in Vial
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

676

Phase 2;Phase 3

Hungary;Germany;Netherlands;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania

1327

EUCTR2006-003398-28-LV
(EUCTR)

03/09/2007

04/09/2007

Ulcerative Colitis (UC)
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

676

Phase 2;Phase 3

Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania

1328

NCT00488631
(ClinicalTrials.gov)

September 2007

18/6/2007

An Efficacy and Safety Study of Golimumab (CNTO 148) in Participants With Moderately to Severely Active Ulcerative Colitis

A Phase 3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects With Moderately to Severely Active Ulcerative Colitis

Colitis, Ulcerative

Biological: Placebo;Biological: Golimumab 50 mg;Biological: Golimumab 100 mg;Biological: Golimumab 200 mg

Janssen Research & Development, LLC

Merck Sharp & Dohme Corp.

Completed

18 Years

N/A

All

1228

Phase 3

United States;Australia;Austria;Belgium;Bulgaria;Canada;Czech Republic;Denmark;France;Germany;Hungary;India;Israel;Japan;Latvia;Lithuania;Netherlands;New Zealand;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Sweden;Ukraine;Former Serbia and Montenegro;Nauru;United Kingdom

1329

EUCTR2006-002670-22-CZ
(EUCTR)

29/08/2007

20/07/2007

Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1).Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS

Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Schering-Plough Research Institute, a division of Schering Corporation

NULL

Not Recruiting

Female: yes
Male: yes

600

Portugal;Hungary;United Kingdom;Germany;Czech Republic;Belgium;France;Spain;Italy

1330

EUCTR2006-004230-32-ES
(EUCTR)

22/08/2007

26/09/2007

EFICACIA Y SEGURIDAD DE COMPRIMIDOS DE BECLOMETASONA DIPROPIONATO (CHF1514) GASTRORRESISTENTES DE LIBERACIÓN PROLONGADA, FRENTE A PREDNISONA ORAL, DURANTE UN PERIODO DE TRATAMIENTO DE 8 SEMANAS EN PACIENTES CON COLITIS ULCEROSA ACTIVA. ESTUDIO INTERNACIONAL, MULTICÉNTRICO, ALEATORIZADO, DOBLE CIEGO DE GRUPOS PARALELOS. - Estudio BETA

Colitis ulcerosa activa, extendiéndose en sentido proximal más allá del recto.
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Trade Name: Clipper
INN or Proposed INN: BECLOMETASONE DIPROPIONATE
Trade Name: Deltacortene
INN or Proposed INN: PREDNISONE
Trade Name: Deltacortene
INN or Proposed INN: PREDNISONE

Chiesi Farmaceutici SpA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

300

Belgium;Spain;Italy;Poland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1331

EUCTR2006-003604-19-GB
(EUCTR)

16/08/2007

09/03/2007

A Phase III, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate theClinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept inSubjects with Active Ulcerative Colitis (UC) who have had an Inadequate ClinicalResponse and/or Intolerance to Medical Therapy.Revised Protocol 03 incorporating Amendments 02 (v1.0, Date 06-Dec-2006), 03 (v1.0, Date 05-Mar-2007), 08 (v1.0, Date 22-Dec-2008) and Administrative Letters 01, 02 & 03. + Protocol Amendment 06 - Site specific - U.K. (Version 1.0, Date: 26-Jun-2007).+ Protocol amendment 04 - Biopsy substudy - Site specific+ Pharmacogenetics Blood Sample Amendment 01 - Site Specific (v2.0, Date: 02-Nov-2006).

ULCERATIVE COLITIS,NOS
MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Trade Name: Orencia
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

978

Phase 3

Italy;United Kingdom;France;Czech Republic;Poland;Belgium;Ireland;Germany

1332

EUCTR2006-003604-19-CZ
(EUCTR)

15/08/2007

11/05/2007

ULCERATIVE COLITIS,NOS
MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Trade Name: Orencia
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

978

Phase 3

United Kingdom;Germany;Czech Republic;Belgium;France;Ireland;Italy;Poland

1333

EUCTR2006-000410-20-DK
(EUCTR)

13/08/2007

09/01/2007

Ulcerative colitis
MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Trade Name: Remicade
INN or Proposed INN: infliximab

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

Netherlands;Belgium;Denmark;Italy

1334

EUCTR2006-002670-22-HU
(EUCTR)

09/08/2007

04/07/2007

Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1).Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS

Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Schering-Plough Research Institute, a division of Schering Corporation

NULL

Not Recruiting

Female: yes
Male: yes

600

Portugal;Hungary;United Kingdom;Czech Republic;Germany;Belgium;France;Spain;Italy

1335

EUCTR2006-006052-35-IT
(EUCTR)

08/08/2007

15/05/2007

An open label study to determine the safety and tolerability oftwo dose escalation treatment regimens with an oral, delayed release preparation of nicotine in patients with stable ulcerative colitismaintained by steroid therapy. - ND

Ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative

Product Name: Nicolon

S.L.A. PHARMA (UK) LTD

NULL

Not Recruiting

Female: yes
Male: yes

Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1336

EUCTR2006-003604-19-DE
(EUCTR)

06/08/2007

15/12/2006

A Phase III, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate theClinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept inSubjects with Active Ulcerative Colitis (UC) who have had an Inadequate ClinicalResponse and/or Intolerance to Medical Therapy.Revised Protocol 03 incorporating Amendments 02 (v1.0, Date 06-Dec-2006), 03 (v1.0, Date 05-Mar-2007), 08 (v1.0, Date 22-Dec-2008) and Administrative Letters 01, 02 & 03. And Pharmacogenetics Blood Sample Amendment 01 - Site Specific (v2.0, Date: 02-Nov-06). + Protocol amendment 04 (Biopsy substudy) - Site specific

ULCERATIVE COLITIS,NOS
MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Trade Name: Orencia
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

978

Phase 3

Czech Republic;United Kingdom;Germany;Belgium;France;Ireland;Italy;Poland

1337

EUCTR2006-000410-20-IT
(EUCTR)

02/08/2007

08/08/2007

A Phase 3, Randomized, Open-label, Parallel-group, MulticenterTrial to Evaluate the Safety and Efficacy of Infliximab(REMICADE) in Pediatric Subjects with Moderately to SeverelyActive Ulcerative Colitis - Protocol C0168T72

Moderately to severely active Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative

Trade Name: REMICADE
INN or Proposed INN: Infliximab

CENTOCOR

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

Netherlands;Belgium;Denmark;Italy

1338

NCT00487539
(ClinicalTrials.gov)

August 2007

14/6/2007

An Efficacy and Safety Study of Golimumab (CNTO 148) in Participants With Moderately to Severely Active Ulcerative Colitis

A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects With Moderately to Severely Active Ulcerative Colitis

Colitis, Ulcerative

Biological: Placebo;Biological: Golimumab 100 mg;Biological: Golimumab 200 mg;Biological: Golimumab 400 mg;Biological: Golimumab 50 mg

Janssen Research & Development, LLC

Merck Sharp & Dohme Corp.

Completed

18 Years

N/A

All

1065

Phase 2;Phase 3

United States;Australia;Austria;Belgium;Bulgaria;Canada;Czech Republic;Denmark;France;Germany;Hungary;India;Israel;Japan;Lithuania;Netherlands;New Zealand;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Sweden;Ukraine;Latvia;United Kingdom

1339

EUCTR2006-002670-22-BE
(EUCTR)

25/07/2007

15/06/2007

Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Schering-Plough Research Institute, a division of Schering Corporation

NULL

Not Recruiting

Female: yes
Male: yes

600

Phase 3

Portugal;France;Czech Republic;Hungary;Slovakia;Spain;Belgium;Germany;Italy;United Kingdom

1340

EUCTR2006-002781-20-BE
(EUCTR)

16/07/2007

10/01/2007

Moderately to severely active ulcerative colitis.
MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Trade Name: Humira
INN or Proposed INN: Adalimumab

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

475

Hungary;Czech Republic;Belgium;Austria;Germany;Italy;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1341

EUCTR2006-002782-40-DK
(EUCTR)

09/07/2007

07/03/2007

Moderately to severely active ulcerative colitis.
MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Trade Name: Humira
INN or Proposed INN: Adalimumab

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

500

Portugal;Hungary;Germany;Czech Republic;Denmark;France;Austria

1342

EUCTR2006-002781-20-DE
(EUCTR)

27/06/2007

04/04/2007

Moderately to severely active ulcerative colitis.
MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Trade Name: Humira
INN or Proposed INN: Adalimumab

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

575

Hungary;Czech Republic;Germany;Italy;Austria;Sweden

1343

EUCTR2006-003604-19-IE
(EUCTR)

26/06/2007

13/02/2007

ULCERATIVE COLITIS,NOS
MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

978

Phase 3

Czech Republic;United Kingdom;Germany;Belgium;France;Ireland;Italy;Poland

1344

EUCTR2006-002782-40-FR
(EUCTR)

19/06/2007

06/03/2007

Moderately to severely active ulcerative colitis.
MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Trade Name: Humira
INN or Proposed INN: Adalimumab

Abbott GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

500

Portugal;Hungary;Germany;Czech Republic;Denmark;France;Austria

1345

EUCTR2006-002782-40-BE
(EUCTR)

19/06/2007

05/01/2007

Moderately to severely active ulcerative colitis.
MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Trade Name: Humira
INN or Proposed INN: Adalimumab

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

500

Portugal;France;Czech Republic;Hungary;Spain;Belgium;Austria;Denmark;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1346

EUCTR2006-002782-40-CZ
(EUCTR)

18/06/2007

10/04/2007

Moderately to severely active ulcerative colitis.
MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Trade Name: Humira
INN or Proposed INN: Adalimumab

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

500

Portugal;Hungary;Germany;Czech Republic;Denmark;France;Austria

1347

EUCTR2006-004303-19-BE
(EUCTR)

08/06/2007

07/02/2007

A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of Basiliximab, with Concomitant Corticosteroids, in Steroid-Refractory Ulcerative Colitis - BSX-001

Steroid-refractory ulcerative colitis
MedDRA version: 8.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative

Trade Name: Simulect
Product Name: Basiliximab
Other descriptive name: Basiliximab

Cerimon Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

135

Czech Republic;United Kingdom;Belgium

1348

EUCTR2006-004230-32-IT
(EUCTR)

06/06/2007

12/11/2007

Efficacy and safety of beclometasone dipropionate (BDP) gastro-resistant prolonged release tablets (CHF1514) compared to oral steroid (prednisone) in an 8-week treatment period in patients with active moderate ulcerative colitis. A multicentre, randomised, controlled, double blind, parallel group study. Beta study - BETA

Mild moderate active ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative

Trade Name: CLIPPER*30CPR 5MG R.M.
INN or Proposed INN: Beclometasone
Trade Name: DELTACORTENE*20CPR 5MG
INN or Proposed INN: Prednisone
Trade Name: DELTACORTENE FORTE*10CPR 25MG
INN or Proposed INN: Prednisone

CHIESI

NULL

Not Recruiting

Female: yes
Male: yes

300

Belgium;Spain;Italy;Poland

1349

EUCTR2005-003707-37-BE
(EUCTR)

25/05/2007

18/12/2006

A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis

Intravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC)
MedDRA version: 9.0;Level: LLT;Classification code 10045365

Product Name: Visilizumab (Nuvion)
Product Code: HuM291
INN or Proposed INN: Visilizumab
Other descriptive name: anti-CD3 monoclonal antibody

PDL BioPharma, Inc

NULL

Not Recruiting

Female: yes
Male: yes

150

Phase 3

Belgium;Austria

1350

EUCTR2006-006319-54-BE
(EUCTR)

24/05/2007

08/02/2007

An Open Label Evaluation of the Safety and Efficacy of Basiliximab Maintenance in Ulcerative Colitis - BSX-002

Steroid-refractory ulcerative colitis
MedDRA version: 8.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative

Trade Name: Simulect
Product Name: Basiliximab
Other descriptive name: Basiliximab

Cerimon Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

135

United Kingdom;Belgium

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1351

EUCTR2006-005299-42-FR
(EUCTR)

16/05/2007

06/03/2007

A randomized, multicenter open label study comparing cyclosporine with infliximab in steroid-refractory severe attacks of ulcerative colitis (CYSIF Study) - CYSIF

GETAID

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

100

Finland;Belgium;France;Spain

1352

EUCTR2006-006319-54-CZ
(EUCTR)

14/05/2007

20/02/2007

An Open Label Evaluation of the Safety and Efficacy of Basiliximab Maintenance in Ulcerative Colitis - BSX-002

Steroid-refractory ulcerative colitis
MedDRA version: 8.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative

Trade Name: Simulect
Product Name: Basiliximab
Other descriptive name: Basiliximab

Cerimon Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

135

Phase 2

Czech Republic;Belgium;United Kingdom

1353

EUCTR2006-003604-19-BE
(EUCTR)

10/05/2007

20/02/2007

A Phase III, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate theClinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept inSubjects with Active Ulcerative Colitis (UC) who have had an Inadequate ClinicalResponse and/or Intolerance to Medical Therapy.Revised Protocol 03 incorporating Amendments 02 (v1.0, Date 06-Dec-2006), 03 (v1.0, Date 05-Mar-2007), 08 (v1.0, Date 22-Dec-2008) and Administrative Letters 01, 02 & 03. And Pharmacogenetics Blood Sample Amendment 01 - Site Specific (v2.0, Date: 02-Nov-06). + Protocol amendment 04 (Biopsy substudy) - Site specific

ULCERATIVE COLITIS,NOS
MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Trade Name: Orencia
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

978

Phase 3

Czech Republic;United Kingdom;Germany;Belgium;France;Ireland;Italy;Poland

1354

EUCTR2005-003707-37-AT
(EUCTR)

09/05/2007

03/01/2007

A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis

Intravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC)
MedDRA version: 9.0;Level: LLT;Classification code 10045365

Product Name: Visilizumab (Nuvion)
Product Code: HuM291
INN or Proposed INN: Visilizumab
Other descriptive name: anti-CD3 monoclonal antibody

PDL BioPharma, Inc

NULL

Not Recruiting

Female: yes
Male: yes

150

Phase 3

Belgium;Austria

1355

EUCTR2006-004303-19-CZ
(EUCTR)

09/05/2007

20/02/2007

Steroid-refractory ulcerative colitis
MedDRA version: 8.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative

Trade Name: Simulect
Product Name: Basiliximab
Other descriptive name: Basiliximab

Cerimon Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

181

United Kingdom;Czech Republic;Belgium

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1356

EUCTR2006-006319-54-SK
(EUCTR)

07/05/2007

08/03/2007

An Open Label Evaluation of the Safety and Efficacy of Basiliximab Maintenance in Ulcerative Colitis - BSX-002

Steroid-refractory ulcerative colitis
MedDRA version: 8.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative

Trade Name: Simulect
Product Name: Basiliximab
Other descriptive name: Basiliximab

Cerimon Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

135

Phase 2

Czech Republic;Slovakia;Belgium;United Kingdom

1357

EUCTR2006-004303-19-SK
(EUCTR)

04/05/2007

08/03/2007

Steroid-refractory ulcerative colitis
MedDRA version: 8.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative

Trade Name: Simulect
Product Name: Basiliximab
Other descriptive name: Basiliximab

Cerimon Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

181

Phase 2

Czech Republic;Slovakia;Belgium;United Kingdom

1358

EUCTR2006-002781-20-CZ
(EUCTR)

04/05/2007

16/02/2007

Moderately to severely active ulcerative colitis.
MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Trade Name: Humira
INN or Proposed INN: Adalimumab

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

250

Hungary;Germany;Czech Republic;Italy;Austria;Sweden

1359

EUCTR2005-004105-28-FR
(EUCTR)

26/04/2007

23/02/2007

An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis - RESTORE™ S

Intravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC)
MedDRA version: 9.0;Level: LLT;Classification code 10045365

Product Name: Visilizumab (Nuvion)
Product Code: HuM291
INN or Proposed INN: Visilizumab
Other descriptive name: anti CD3 monoclonal antibody

PDL BioPharma, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

300

Hungary;Germany;United Kingdom;Netherlands;France;Ireland;Greece

1360

EUCTR2006-004303-19-GB
(EUCTR)

25/04/2007

06/12/2006

Steroid-refractory ulcerative colitis
MedDRA version: 8.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative

Trade Name: Simulect
Product Name: Basiliximab
Other descriptive name: Basiliximab

Cerimon Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

135

Phase 2

Czech Republic;Slovakia;Belgium;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1361

EUCTR2006-006319-54-GB
(EUCTR)

25/04/2007

07/12/2006

An Open Label Evaluation of the Safety and Efficacy of Basiliximab Maintenance in Ulcerative Colitis - BSX-002

Steroid-refractory ulcerative colitis
MedDRA version: 8.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative

Cerimon Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

135

Phase 2

Czech Republic;Slovakia;Belgium;United Kingdom

1362

EUCTR2006-002782-40-HU
(EUCTR)

18/04/2007

20/03/2007

Moderately to severely active ulcerative colitis.
MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Trade Name: Humira
INN or Proposed INN: Adalimumab

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

500

Portugal;France;Czech Republic;Hungary;Spain;Belgium;Austria;Denmark;Germany

1363

EUCTR2006-000410-20-BE
(EUCTR)

18/04/2007

11/01/2007

Ulcerative colitis
MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Trade Name: Remicade
INN or Proposed INN: infliximab

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

Netherlands;Denmark;Belgium;Italy

1364

EUCTR2006-002781-20-IT
(EUCTR)

17/04/2007

07/03/2007

A multicenter,randomized, double-blind, placebo-controlled Study of Adalimumab for the Induction of clinical remission in subjects with moderately to severely active Ulcerative Colitis - ND

Moderately to severely active Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative

Trade Name: HUMIRA

Abbott GmbH Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

250

Hungary;Germany;Czech Republic;Italy;Austria;Sweden

1365

EUCTR2006-002781-20-HU
(EUCTR)

26/03/2007

28/02/2007

Moderately to severely active ulcerative colitis.
MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Trade Name: Humira
INN or Proposed INN: Adalimumab

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

575

Hungary;Germany;Czech Republic;Italy;Austria;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1366

EUCTR2006-002782-40-ES
(EUCTR)

23/03/2007

05/02/2007

A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis.Ensayo Multicéntrico, Aleatorizado, Doble ciego y controlado con Placebo del Anticuerpo Monoclonal Anti-TNF Adalimumab para la Induccción y el Mantenimiento de la Remisión Clínica en Sujetos con Colitis Ulcerosa Activa de Intensidad Moderada a Severa.

Moderately to severely active ulcerative colitis.Colitis Ulcerosa Activa de Intensidad Moderada a Severa
MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Trade Name: Humira
INN or Proposed INN: Adalimumab

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

500

Portugal;France;Czech Republic;Hungary;Belgium;Spain;Austria;Denmark;Germany

1367

EUCTR2006-002781-20-SK
(EUCTR)

19/03/2007

01/02/2007

Moderately to severely active ulcerative colitis.
MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Trade Name: Humira
INN or Proposed INN: Adalimumab

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

575

Phase 3

Hungary;Czech Republic;Slovakia;Belgium;Austria;Germany;Italy;Sweden

1368

EUCTR2005-004105-28-GR
(EUCTR)

15/03/2007

15/02/2007

An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis - RESTORE™ S

Intravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC)
MedDRA version: 9.0;Level: LLT;Classification code 10045365

Product Name: Visilizumab (Nuvion)
Product Code: HuM291
INN or Proposed INN: Visilizumab
Other descriptive name: anti CD3 monoclonal antibody

PDL BioPharma, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

300

Hungary;Germany;United Kingdom;Netherlands;France;Ireland;Greece

1369

EUCTR2006-003604-19-IT
(EUCTR)

09/03/2007

14/07/2008

ulcerative colitis, NOS
MedDRA version: 14.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Orencia
INN or Proposed INN: abatacept

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

978

Phase 3

France;Czech Republic;Poland;Belgium;Ireland;Germany;United Kingdom;Italy

1370

EUCTR2006-004162-13-DE
(EUCTR)

27/02/2007

06/10/2006

Randomized, double-blind, placebo-controlled phase II pilot study of the impact of mesalazine enemas on the mucosal gut flora in patients with inflammatory bowel disease - Impact of mesalazine vs placebo on mucosal gut flora in IBD patients

Active inflammatory bowel disease, i.e. either left-sided ulcerative colitis or Crohn´s Disease (Colon) with signs of inflammation within 40 cm ab ano.
MedDRA version: 8.1;Level: LLT;Classification code 10021972;Term: Inflammatory bowel disease

Trade Name: Salofalk 4g/60ml Klysma
INN or Proposed INN: MESALAZINE

Charité Universitätsmedizin, Campus Charité Mitte

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1371

EUCTR2005-003482-17-GB
(EUCTR)

26/02/2007

01/02/2006

A Phase 2, Randomized, Double-blind, Multicenter, Dose-exploration Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis

Intravenous steroid-refractory ulcerative colitis (IVSR-UC)
MedDRA version: 9.0;Level: LLT;Classification code 10045365

Product Name: Visilizumab (Nuvion)
Product Code: HuM291
INN or Proposed INN: Visilizumab
Other descriptive name: anti-CD3 monoclonal antibody

PDL BioPharma, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

165

Phase 2

United Kingdom;Spain;Ireland;Italy;Greece

1372

EUCTR2006-003604-19-FR
(EUCTR)

14/02/2007

29/12/2006

ULCERATIVE COLITIS,NOS
MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept

Bristol-Myers Squibb International Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

978

Phase 3

Czech Republic;United Kingdom;Germany;Belgium;France;Ireland;Italy;Poland

1373

EUCTR2005-003482-17-GR
(EUCTR)

30/01/2007

24/11/2006

A Phase 2, Randomized, Double-blind, Multicenter, Dose-exploration Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis - RESTORE™ D

Intravenous steroid-refractory ulcerative colitis (IVSR-UC)
MedDRA version: 9.0;Level: LLT;Classification code 10045365

Product Name: Visilizumab (Nuvion)
Product Code: HuM291
INN or Proposed INN: Visilizumab
Other descriptive name: anti-CD3 monoclonal antibody

PDL BioPharma, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

100

Phase 2

United Kingdom;Spain;Ireland;Italy;Greece

1374

EUCTR2005-003481-42-GR
(EUCTR)

30/01/2007

24/11/2006

Intravenous steroid-refractory ulcerative colitis (IVSR-UC)
MedDRA version: 9.0;Level: LLT;Classification code 10045365

Product Name: Visilizumab (Nuvion)
Product Code: HuM291
INN or Proposed INN: Visilizumab
Other descriptive name: anti-CD3 monoclonal antibody

PDL BioPharma, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Hungary;Germany;Czech Republic;Slovakia;Spain;Ireland;Italy;Greece

1375

EUCTR2006-001782-42-HU
(EUCTR)

20/12/2006

16/08/2006

Efficacy and tolerability of a new oral extended-release formulation containing Low Molecular Weight Heparin (CB-01-05-MMX), administered as add-on therapy to oral mesalazine or other 5-ASA derivatives, in patients with active, left-sided, mild to moderate ulcerative colitis. A multicentre randomized, double-blind, comparative study versus placebo.

Active left-sided, mild to moderate ulcerative colitis
MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: CB-01-05-MMX
Product Code: CB-01-05-MMX
Other descriptive name: PARNAPARIN SODIUM

Cosmo Technologies Ltd

NULL

Not Recruiting

Female: yes
Male: yes

120

Hungary;United Kingdom;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1376

EUCTR2006-001782-42-IT
(EUCTR)

03/11/2006

20/12/2006

Efficacy and tolerability of a new oral extended-release formulation containing Low Molecular Weight Heparin CB-01-05-MMXTM , administered as add-on therapy to oral mesalazine or other 5-ASA derivatives, in patients with active, left-sided, mild to moderate ulcerative colitis. A multicentre randomized, double-blind, comparative study versus placebo. - ND

Patients with mild to moderate active ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative

Product Name: CB-01-05-MMX

COSMO TECHNOLOGIES LTD

NULL

Not Recruiting

Female: yes
Male: yes

120

Hungary;United Kingdom;Italy

1377

EUCTR2006-001782-42-GB
(EUCTR)

17/10/2006

29/09/2006

Active left-sided, mild to moderate ulcerative colitis
MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Cosmo Technologies Ltd

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 2

Hungary;Italy;United Kingdom

1378

EUCTR2005-004105-28-DE
(EUCTR)

11/10/2006

10/04/2006

An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis - RESTORE™ S

Intravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC)
MedDRA version: 9.0;Level: LLT;Classification code 10045365

Product Name: Visilizumab (Nuvion)
Product Code: HuM291
INN or Proposed INN: Visilizumab
Other descriptive name: anti CD3 monoclonal antibody

PDL BioPharma, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

300

Hungary;United Kingdom;Germany;Netherlands;France;Ireland;Greece

1379

EUCTR2005-004105-28-NL
(EUCTR)

28/09/2006

10/08/2006

An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis

Intravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC)
MedDRA version: 9.0;Level: LLT;Classification code 10045365

Product Name: Visilizumab (Nuvion)
Product Code: HuM291
INN or Proposed INN: Visilizumab
Other descriptive name: anti CD3 monoclonal antibody

PDL BioPharma, Inc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

300

Hungary;Germany;United Kingdom;Netherlands;France;Ireland;Greece

1380

EUCTR2006-001310-32-LT
(EUCTR)

17/07/2006

15/05/2006

A double-blind, randomized, 6-week, parallel-group clinicaltrial to assess the safety and efficacy of Asacol 4.8 g/day(800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mgmesalamine tablet) for the treatment of moderately activeulcerative colitis (ASCEND III) - ASCEND III

Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative

Product Name: Asacol 800 mg tablet
INN or Proposed INN: mesalazine
Other descriptive name: 5-aminosalicylic acid (5-ASA)
Product Name: Asacol 400 mg tablet
INN or Proposed INN: mesalazine
Other descriptive name: 5-aminosalicylic acid (5-ASA)

Procter & Gamble Technical Centres Limited

NULL

Not Recruiting

Female: yes
Male: yes

770

Hungary;Czech Republic;Estonia;Latvia;Lithuania

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1381

EUCTR2006-001310-32-HU
(EUCTR)

29/06/2006

23/05/2006

Ulcerative Colitis
MedDRA version: 8.1;Classification code 10009900

Procter & Gamble Technical Centres Limited

NULL

Not Recruiting

Female: yes
Male: yes

770

Hungary;Czech Republic;Estonia;Latvia;Lithuania

1382

EUCTR2006-001310-32-CZ
(EUCTR)

26/06/2006

17/05/2006

Ulcerative Colitis
MedDRA version: 8.1;Classification code 10009900

Procter & Gamble Technical Centres Limited

NULL

Not Recruiting

Female: yes
Male: yes

770

Hungary;Czech Republic;Estonia;Latvia;Lithuania

1383

EUCTR2005-004105-28-GB
(EUCTR)

20/06/2006

07/03/2006

An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis.

Intravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC).
MedDRA version: 8.0;Level: LLT;Classification code 10045265

Product Name: Visilizumab (Nuvion)
Product Code: HuM291
INN or Proposed INN: Visilizumab
Other descriptive name: anti CD3 monoclonal antibody

PDL BioPharma, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

300

Hungary;Germany;United Kingdom;Netherlands;France;Ireland;Greece

1384

EUCTR2005-004105-28-IE
(EUCTR)

20/06/2006

10/02/2006

An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis.

Intravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC).
MedDRA version: 8.0;Level: LLT;Classification code 10045265

Product Name: Visilizumab (Nuvion)
Product Code: HuM291
INN or Proposed INN: Visilizumab
Other descriptive name: anti CD3 monoclonal antibody

PDL BioPharma, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 2

France;Hungary;Greece;Ireland;Netherlands;Germany;United Kingdom

1385

EUCTR2006-001310-32-EE
(EUCTR)

16/06/2006

27/04/2006

Ulcerative Colitis
MedDRA version: 8.1;Classification code 10009900

Procter & Gamble Technical Centres Limited

NULL

Not Recruiting

Female: yes
Male: yes

770

Hungary;Czech Republic;Estonia;Latvia;Lithuania

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1386

EUCTR2005-003482-17-IT
(EUCTR)

08/06/2006

04/12/2006

A Phase 2, Randomized, Double-Blind, Multicenter, Dose-Exploration Study of Visilizumab in Subjects with Intraveneous Steroid-Refractory Ulcerative Colitis.

Subjects with Intraveneous Steroid-Refractory Ulcerative Colitis
MedDRA version: 6.1;Level: PT;Classification code 10009900

Product Name: visilizumab
Product Code: HuM291
Product Name: visilizumab
Product Code: HuM291
Product Name: visilizumab
Product Code: HuM291

PDL BioPharma , Inc.

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 2

United Kingdom;Spain;Ireland;Italy;Greece

1387

EUCTR2005-003481-42-IT
(EUCTR)

08/06/2006

11/07/2007

A Randomized, Double-Blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intraveneous Steroid-Refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study - ND

subjects with IVSR-UC
MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative

Product Name: visilizumab
INN or Proposed INN: visilizumab

PDL BioPharma, Inc;

NULL

Not Recruiting

Female: yes
Male: yes

Hungary;Germany;Czech Republic;Slovakia;Spain;Ireland;Italy;Greece

1388

EUCTR2005-003482-17-ES
(EUCTR)

26/05/2006

15/03/2006

A Phase 2, Randomized, Double-blind, Multicenter, Dose-Exploration Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative ColitisEstudio fase 2, aleatorizado, doble ciego, multicéntrico, de exploración de dosis de Visilizumab en sujetos con colitis ulcerosa refractaria a esteróides intravenosos.

Intravenous steroid-refractory ulcerative colitis (IVSR-UC)
MedDRA version: 8.0;Level: LLT;Classification code 10045265

Product Name: Visilizumab (Nuvion)
Product Code: HuM291
INN or Proposed INN: Visilizumab
Other descriptive name: anti-CD3 monoclonal antibody

PDL BioPharma, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

100

Phase 2

United Kingdom;Ireland;Spain;Italy;Greece

1389

EUCTR2005-003481-42-ES
(EUCTR)

26/05/2006

15/03/2006

A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab StudyEstudio aleatorizado, doble ciego y multicéntrico de Visilizumab frente a placebo en sujetos con colitis ulcerosa refractaria a esteroides intravenosos que hayan respondido previamente en un estudio con Visilizumab.

Intravenous steroid-refractory ulcerative colitis (IVSR-UC)Colitis ulcerosa refractaria a esteróides intravenonsos
MedDRA version: 8.0;Level: LLT;Classification code 10045265

Product Name: Visilizumab (Nuvion)
Product Code: HuM291
INN or Proposed INN: Visilizumab
Other descriptive name: anti-CD3 monoclonal antibody

PDL BioPharma, Inc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Hungary;Germany;Czech Republic;Slovakia;Ireland;Spain;Italy;Greece

1390

EUCTR2004-005032-35-IT
(EUCTR)

10/05/2006

19/01/2007

A Phase III, Multicentre, Pan-European, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of Targeted Release Prednisolone in Treatment of Moderate, Acute Ulcerative Colitis

Ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative

Product Name: COLAL PRED
Product Code: ATL-2502
INN or Proposed INN: Prednisolone
Product Name: COLAL PRED
Product Code: ATL-2502
INN or Proposed INN: Prednisolone
Product Name: COLAL PRED
Product Code: ATL-2502
INN or Proposed INN: Prednisolone
Trade Name: PREDNISOLONE
INN or Proposed INN: Prednisolone

ALIZYME

NULL

Not Recruiting

Female: yes
Male: yes

890

Phase 3

Hungary;Czech Republic;United Kingdom;Belgium;Denmark;Spain;Italy;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1391

EUCTR2005-003481-42-HU
(EUCTR)

04/04/2006

28/11/2005

Intravenous steroid-refractory ulcerative colitis (IVSR-UC)
MedDRA version: 9.0;Level: LLT;Classification code 10045365

Product Name: Visilizumab (Nuvion)
Product Code: HuM291
INN or Proposed INN: Visilizumab
Other descriptive name: anti-CD3 monoclonal antibody

PDL BioPharma, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Hungary;Germany;Czech Republic;Slovakia;Spain;Ireland;Italy;Greece

1392

EUCTR2005-003481-42-DE
(EUCTR)

22/03/2006

29/11/2005

Intravenous steroid-refractory ulcerative colitis (IVSR-UC)
MedDRA version: 9.0;Level: LLT;Classification code 10045365

Product Name: Visilizumab (Nuvion)
Product Code: HuM291
INN or Proposed INN: Visilizumab
Other descriptive name: anti-CD3 monoclonal antibody

PDL BioPharma, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Hungary;Czech Republic;Slovakia;Germany;Spain;Ireland;Italy;Greece

1393

EUCTR2005-002063-87-DE
(EUCTR)

22/03/2006

29/11/2005

A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis

Intravenous steroid-refractory ulcerative colitis (IVSR-UC)
MedDRA version: 9.0;Level: LLT;Classification code 10045365

Product Name: Visilizumab (Nuvion)
Product Code: HuM291
INN or Proposed INN: visilizumab
Other descriptive name: anti-CD3 monoclonal antibody

PDL BioPharma, Inc

NULL

Not Recruiting

Female: yes
Male: yes

150

Phase 2;Phase 3

Hungary;Czech Republic;Germany;Belgium

1394

EUCTR2006-000197-69-IT
(EUCTR)

16/03/2006

05/06/2006

A pilot, open-label, multi-center clinical trial to investigate the safety and efficacy of Bovine-Calf Intestinal Alkaline Phosphatase in patients with moderate to severe ulcerative colitis - AP IBD 02-02

Inflammatory Blowel Disease
MedDRA version: 6.1;Level: PT;Classification code 10009900

Product Name: Bovine-Calf Alkaline Phosphatase BIAP
Product Code: BIAP

AM PHARMA B.V.

NULL

Not Recruiting

Female: yes
Male: yes

Italy

1395

EUCTR2005-002063-87-SK
(EUCTR)

16/03/2006

23/11/2005

A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis

Intravenous steroid-refractory ulcerative colitis (IVSR-UC)
MedDRA version: 9.0;Level: LLT;Classification code 10045365

Product Name: Visilizumab (Nuvion)
Product Code: HuM291
INN or Proposed INN: visilizumab
Other descriptive name: anti-CD3 monoclonal antibody

PDL BioPharma, Inc

NULL

Not Recruiting

Female: yes
Male: yes

150

Phase 2;Phase 3

Hungary;Czech Republic;Slovakia;Belgium;Austria;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1396

EUCTR2005-005414-20-IT
(EUCTR)

06/03/2006

31/01/2006

Randomized controlled double-blind Vs. placebo multicentre study on the safety and effectiveness of thalidomide in the treatment of refractory Crohn s disease and ulcerative colitis. - Thalidomide and IBD

Inflammatory Bowel Disease Crohn Disease, Ulcerative Colitis
MedDRA version: 6.1;Level: PT;Classification code 10021972

Trade Name: Thalidomide Pharmion
INN or Proposed INN: Thalidomide

ISTITUTO PER L INFANZIA BURLO GAROFOLO

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

124

Italy

1397

EUCTR2005-003482-17-IE
(EUCTR)

03/03/2006

10/01/2006

A Phase 2, Randomized, Double-blind, Multicenter, Dose-Exploration Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis

Intravenous steroid-refractory ulcerative colitis (IVSR-UC)
MedDRA version: 8.0;Level: LLT;Classification code 10045265

Product Name: Visilizumab (Nuvion)
Product Code: HuM291
INN or Proposed INN: Visilizumab
Other descriptive name: anti-CD3 monoclonal antibody

PDL BioPharma, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 2

Greece;Spain;Ireland;Italy;United Kingdom

1398

EUCTR2005-003481-42-CZ
(EUCTR)

16/02/2006

28/11/2005

Intravenous steroid-refractory ulcerative colitis (IVSR-UC)
MedDRA version: 9.0;Level: LLT;Classification code 10045365

Product Name: Visilizumab (Nuvion)
Product Code: HuM291
INN or Proposed INN: Visilizumab
Other descriptive name: anti-CD3 monoclonal antibody

PDL BioPharma, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Hungary;Germany;Slovakia;Czech Republic;Spain;Ireland;Italy;Greece

1399

EUCTR2004-001216-31-SI
(EUCTR)

22/12/2005

26/10/2005

Double-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UC

Therapy of active ulcerative colitis
MedDRA version: 7.1;Level: LLT;Classification code 10058816

Trade Name: Salofalk® 1000mg Granu-Stix®
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Product Name: 1500mg mesalazine pellets
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Product Name: 500mg mesalazine pellets
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid

Dr. Falk Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

320

Estonia;Czech Republic;Hungary;Slovenia;Lithuania;Latvia;Germany

1400

EUCTR2005-003471-20-IT
(EUCTR)

07/12/2005

17/01/2007

Phase II, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter Study to investigate the efficacy of Two Dosages of Propionyl-L-carnitine (ST 261) Colon Release Tablets in Patients Affected by Ulcerative Colitis under Oral Stable Treatment

ULCERATIVE COLITIS
MedDRA version: 14.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Propionyl-L-carnitine
Product Code: ST261
INN or Proposed INN: Levocarnitine

SIGMA-TAU

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Lithuania;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1401

EUCTR2005-003724-19-CZ
(EUCTR)

21/11/2005

05/10/2005

A Phase 3, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-arm Study of the Efficacy and Safety of OPC-6535 Tablets in the Treatment of Subjects with Active Ulcerative Colitis - 197-02-218 Protocol

Active Ulcerative Colitis
MedDRA version: 8.0;Level: LLT;Classification code 10058816

Product Name: OPC-6535
Product Code: OPC-6535
INN or Proposed INN: Not applicable
Other descriptive name: OPC-6535

Otsuka Maryland Research Institute, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

375

Phase 3

Hungary;Czech Republic

1402

EUCTR2005-003724-19-HU
(EUCTR)

24/10/2005

07/09/2005

Active Ulcerative Colitis
MedDRA version: 8.0;Level: LLT;Classification code 10058816

Product Name: OPC-6535
Product Code: OPC-6535
INN or Proposed INN: Not applicable
Other descriptive name: OPC-6535

Otsuka Maryland Research Institute, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

375

Phase 3

Hungary

1403

EUCTR2004-004565-15-FI
(EUCTR)

26/08/2005

28/04/2005

Pentasa® Once Daily In Ulcerative colitis for Maintenance of remission: PODIUM An International multi-centre investigator blinded randomised controlled study of Pentasa ® Sachet comparing one gram twice with two gram once daily - PODIUM

Ulcerative collitis (UC)
MedDRA version: 4.1;Level: PT;Classification code 10009900

Trade Name: Pentasa
Product Name: Pentasa
INN or Proposed INN: mesalazine
Other descriptive name: 5-AminoSalicylic Acid
Trade Name: NA
Product Name: Pentasa prolonged release granules 2g
INN or Proposed INN: mesalazine

Ferring BV

NULL

Not Recruiting

Female: yes
Male: yes

360

Finland;Germany;Czech Republic;Denmark;Norway;Sweden

1404

EUCTR2004-001216-31-CZ
(EUCTR)

17/08/2005

Therapy of active ulcerative colitis
MedDRA version: 7.1;Level: LLT;Classification code 10058816

Dr. Falk Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

320

Hungary;Germany;Czech Republic;Estonia;Latvia;Lithuania

1405

EUCTR2004-001216-31-SK
(EUCTR)

28/07/2005

23/05/2005

Therapy of active ulcerative colitis
MedDRA version: 7.1;Level: LLT;Classification code 10058816

Dr. Falk Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

320

Phase 3

Estonia;Czech Republic;Hungary;Slovenia;Slovakia;Lithuania;Latvia;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1406

EUCTR2004-001216-31-HU
(EUCTR)

28/07/2005

20/06/2005

Therapy of active ulcerative colitis
MedDRA version: 7.1;Level: LLT;Classification code 10058816

Dr. Falk Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

320

Hungary;Czech Republic;Germany;Estonia;Latvia;Lithuania

1407

EUCTR2004-001216-31-LV
(EUCTR)

25/07/2005

Therapy of active ulcerative colitis
MedDRA version: 7.1;Level: LLT;Classification code 10058816

Dr. Falk Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

320

Hungary;Czech Republic;Germany;Estonia;Latvia;Lithuania

1408

EUCTR2004-001677-26-IT
(EUCTR)

06/06/2005

15/02/2006

Nolpitantium Besylate in patients with mild to moderate Ulcerative Colitis a double-blind, placebo controlled efficacy and safety, 8-week study

Patients with 5-aminosalicylic 5-ASA or sulphasalazine resistant ulcerative colitis
MedDRA version: 6.1;Level: PT;Classification code 10009900

Product Name: Nolpitantium Besylate
Product Code: SR140333B

SANOFI-SYNTHELABO

NULL

Not Recruiting

Female: yes
Male: yes

300

Hungary;Czech Republic;Estonia;Spain;Italy;Sweden

1409

EUCTR2004-001216-31-LT
(EUCTR)

06/06/2005

28/04/2005

Therapy of active ulcerative colitis
MedDRA version: 7.1;Level: LLT;Classification code 10058816

Dr. Falk Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

320

Hungary;Czech Republic;Germany;Estonia;Latvia;Lithuania

1410

EUCTR2004-004565-15-CZ
(EUCTR)

03/06/2005

13/04/2005

Ulcerative collitis (UC)
MedDRA version: 4.1;Level: PT;Classification code 10009900

Trade Name: Pentasa sachet 1g
Product Name: Pentasa
INN or Proposed INN: mesalazine
Other descriptive name: 5-AminoSalicylic Acid
Product Name: Pentasa prolonged release granules 2g
INN or Proposed INN: mesalazine

Ferring BV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

360

Finland;Germany;Czech Republic;Denmark;Norway;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1411

EUCTR2004-004184-29-GB
(EUCTR)

31/05/2005

23/02/2005

Ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Shire Pharmaceutical Development Ltd

NULL

Not Recruiting

Female: yes
Male: yes

826

Phase 3

Portugal;Czech Republic;Hungary;Spain;Denmark;Netherlands;Germany;United Kingdom;Sweden

1412

EUCTR2004-001216-31-DE
(EUCTR)

30/05/2005

04/04/2005

Therapy of active ulcerative colitis
MedDRA version: 7.1;Level: LLT;Classification code 10058816

Dr. Falk Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

320

Hungary;Czech Republic;Germany;Estonia;Latvia;Lithuania

1413

EUCTR2004-004565-15-SE
(EUCTR)

24/05/2005

09/03/2005

Ulcerative collitis (UC)
MedDRA version: 4.1;Level: PT;Classification code 10009900

Trade Name: Pentasa Sachet 1g
Product Name: Pentasa Sachet 1 g
INN or Proposed INN: mesalazine
Other descriptive name: 5-AminoSalicylic Acid
Product Name: Pentasa Sachet 2 g
INN or Proposed INN: mesalazine

Ferring BV

NULL

Not Recruiting

Female: yes
Male: yes

360

Finland;Germany;Czech Republic;Denmark;Norway;Sweden

1414

EUCTR2004-004184-29-ES
(EUCTR)

05/05/2005

03/04/2006

Ulcerative colitis
MedDRA version: 3.2;Level: LLT;Classification code 10045365

Product Code: SPD476
INN or Proposed INN: Mesalazine
Other descriptive name: 5-amino salicylic acid
Trade Name: Asacol Delayed Release Tablets
Product Name: Asacol
INN or Proposed INN: Mesalazine
Other descriptive name: 5-aminosalicylic acid

Shire Pharmaceutical Development Ltd

NULL

Not Recruiting

Female: yes
Male: yes

410

Phase 3

Portugal;Hungary;Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Spain;Sweden

1415

EUCTR2004-004184-29-CZ
(EUCTR)

13/04/2005

11/04/2005

Ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Trade Name: Mezavant XL 1200 mg gastro-resistant, prolonged release tablets .
Product Name: Mezavant XL 1200 mg gastro-resistant, prolonged release tablets
Product Code: SPD476
INN or Proposed INN: Mesalazine
Other descriptive name: 5-amino salicylic acid
Trade Name: Asacol Delayed Release Tablets
Product Name: Asacol
INN or Proposed INN: Mesalazine
Other descriptive name: 5-aminosalicylic acid

Shire Pharmaceutical Development Ltd

NULL

Not Recruiting

Female: yes
Male: yes

826

Phase 3

Portugal;Hungary;Germany;United Kingdom;Czech Republic;Netherlands;Denmark;Spain;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1416

EUCTR2004-004565-15-NO
(EUCTR)

06/04/2005

14/02/2005

Ulcerative collitis (UC)
MedDRA version: 4.1;Level: PT;Classification code 10009900

Trade Name: Pentasa sachet 1g
Product Name: Pentasa
INN or Proposed INN: mesalazine
Other descriptive name: 5-AminoSalicylic Acid
Trade Name: NA
Product Name: Pentasa prolonged release granules 2g
INN or Proposed INN: mesalazine

Ferring BV

NULL

Not Recruiting

Female: yes
Male: yes

360

Finland;Germany;Czech Republic;Denmark;Norway;Sweden

1417

EUCTR2004-004565-15-DK
(EUCTR)

31/03/2005

24/02/2005

Ulcerative collitis (UC)
MedDRA version: 4.1;Level: PT;Classification code 10009900

Product Name: Pentasa Sachet
INN or Proposed INN: mesalazine
Other descriptive name: 5-AminoSalicylic Acid
Product Name: Pentasa Sachet
INN or Proposed INN: mesalazine

Ferring BV

NULL

Not Recruiting

Female: yes
Male: yes

360

Finland;Germany;Czech Republic;Denmark;Norway;Sweden

1418

EUCTR2004-004184-29-HU
(EUCTR)

30/03/2005

10/02/2005

Ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Shire Pharmaceutical Development Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

826

Phase 3

Portugal;Hungary;Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Spain;Sweden

1419

EUCTR2004-001677-26-EE
(EUCTR)

23/03/2005

Nolpitantium Besylate In patients with mild to moderate Ulcerative Colitis: a double-blind, placebo-controlled Efficacy and safety, 8-week study. - NICE

Patients with 5-aminosalicylic acid (5-ASA) or sulphasalazine resistant ulcerative colitis.
MedDRA version: 7.0;Level: LLT;Classification code 10045365

Product Name: Nolpitantium besylate
Product Code: SR140333B
INN or Proposed INN: Nolpitantium besylate

Sanofi-Synthelabo Recherche

NULL

Not Recruiting

Female: yes
Male: yes

300

Hungary;Czech Republic;Estonia;Spain;Italy;Sweden

1420

EUCTR2004-001677-26-SE
(EUCTR)

07/02/2005

23/12/2004

Nolpitantium Besylate In patients with mild to moderate Ulcerative Colitis: a double-blind, placebo-controlled Efficacy and safety, 8-week study. - NICE

Patients with 5-aminosalicylic acid (5-ASA) or sulphasalazine resistant ulcerative colitis.
MedDRA version: 7.0;Level: LLT;Classification code 10045365

Product Name: Nolpitantium besylate
Product Code: SR140333B
INN or Proposed INN: Nolpitantium besylate

Sanofi-Synthelabo Recherche

NULL

Not Recruiting

Female: yes
Male: yes

300

Hungary;Czech Republic;Estonia;Spain;Italy;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1421

EUCTR2004-001677-26-HU
(EUCTR)

25/01/2005

03/11/2004

Nolpitantium Besylate In patients with mild to moderate Ulcerative Colitis: a double-blind, placebo-controlled Efficacy and safety, 8-week study. - NICE

Patients with 5-aminosalicylic acid (5-ASA) or sulphasalazine resistant ulcerative colitis.
MedDRA version: 7.0;Level: LLT;Classification code 10045365

Product Name: Nolpitantium besylate
Product Code: SR140333B
INN or Proposed INN: Nolpitantium besylate

Sanofi-Synthelabo Recherche

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

300

Hungary;Czech Republic;Estonia;Spain;Italy;Sweden

1422

EUCTR2004-001677-26-ES
(EUCTR)

14/01/2005

01/06/2005

Nolpitantium Besylate In patients with mild to moderate Ulcerative Colitis: a double-blind, placebo-controlled Efficacy and safety, 8-week study.Estudio doble ciego, controlado con placebo de 8 semanas de duración, de eficacia y seguridad de besilato de nolpitantium en pacientes con colitis ulcerosa leve a moderada. - NICE

Patients with 5-aminosalicylic acid (5-ASA) or sulphasalazine resistant ulcerative colitis.
MedDRA version: 7.0;Level: LLT;Classification code 10045365

Product Name: Nolpitantium besylate
Product Code: SR140333B
INN or Proposed INN: Nolpitantium besylate

Sanofi-Synthelabo Recherche

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

300

Hungary;Czech Republic;Estonia;Spain;Italy;Sweden

1423

EUCTR2004-001216-31-EE
(EUCTR)

11/01/2005

20/09/2005

Therapy of active ulcerative colitis
MedDRA version: 7.1;Level: LLT;Classification code 10058816

Dr. Falk Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

320

Hungary;Czech Republic;Germany;Estonia;Latvia;Lithuania

1424

EUCTR2004-000916-25-IT
(EUCTR)

28/09/2004

18/05/2005

A PHASE III PROSPECTIVE, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUPS, STUDY, TO ASSESS THE EFFECT OF 5-ASA MMx 1.2 g Tablets IN MAINTENANCE OF REMISSION OF LEFT-SIDED ULCERATIVE COLITIS

TREATMENT OF ULCERATIVE COLITIS IN ACTIVE PHASE AND IN THE MAINTENANCE OF CLINICAL REMISSION
MedDRA version: 6.1;Level: PT;Classification code 10021972

Product Name: 5-ASA MMx
INN or Proposed INN: Mesalazine

GIULIANI

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

Italy

1425

EUCTR2004-001677-26-CZ
(EUCTR)

09/03/2004

10/02/2005

Nolpitantium Besylate In patients with mild to moderate Ulcerative Colitis: a double-blind, placebo-controlled Efficacy and safety, 8-week study. - NICE

Patients with 5-aminosalicylic acid (5-ASA) or sulphasalazine resistant ulcerative colitis.
MedDRA version: 7.0;Level: LLT;Classification code 10045365

Product Name: Nolpitantium besylate
Product Code: SR140333B
INN or Proposed INN: Nolpitantium besylate

sanofi-aventis recherche & developpement

NULL

Not Recruiting

Female: yes
Male: yes

300

Hungary;Czech Republic;Estonia;Spain;Italy;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1426

EUCTR2017-002231-41-FR
(EUCTR)

15/12/2017

A study to investigate how the body responds to the study drug Vedolizumab in child patients with Ulcerative Colitis or Crohn’s Disease

Takeda Development Centre Europe, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;France;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom

1427

EUCTR2006-005377-22-PL
(EUCTR)

14/02/2008

Treatment of ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis

Dr. Falk Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

360

Phase 3

Czech Republic;Slovakia;Spain;Poland;Lithuania;Latvia;Germany

1428

EUCTR2018-003986-33-EE
(EUCTR)

19/09/2019

A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis

A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Arena Pharmaceuticals, Inc.

NULL

Female: yes
Male: yes

330

Phase 3

1429

EUCTR2017-000574-11-PL
(EUCTR)

05/12/2017

Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn's Disease (AIDA)

A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA) - AIDA

Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab

Shire Human Genetic Therapies, Inc.

NULL

Female: yes
Male: yes

2453

Phase 3

Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Lebanon;Ireland;Russian Federation;Israel;Colombia;Italy;Switzerland;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan

1430

EUCTR2018-003985-15-DE
(EUCTR)

01/07/2019

A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52

Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine

Arena Pharmaceuticals Inc.

NULL

Female: yes
Male: yes

372

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1431

EUCTR2018-003985-15-BE
(EUCTR)

08/05/2019

A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52

Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine

Arena Pharmaceuticals Inc.

NULL

Female: yes
Male: yes

372

Phase 3

1432

EUCTR2013-003032-77-FR
(EUCTR)

19/06/2015

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Ulcerative Colitis.

Ulcerative colitis
MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Abbvie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

225

Phase 3

United States;Slovakia;Spain;Austria;Israel;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;New Zealand

1433

EUCTR2015-001346-29-SE
(EUCTR)

30/09/2015

Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use
Product Name: Adalimumab
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Female: yes
Male: yes

Phase 3

United States;Czech Republic;Hungary;European Union;Canada;Spain;Belgium;Israel;United Kingdom;New Zealand;Japan;Sweden

1434

EUCTR2018-003986-33-CZ
(EUCTR)

20/09/2019

A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis

A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Arena Pharmaceuticals, Inc.

NULL

Female: yes
Male: yes

330

Phase 3

1435

EUCTR2019-004224-38-GB
(EUCTR)

25/11/2020

Janssen-Cilag International NV

NULL

Female: yes
Male: yes

Phase 3

United States;Hungary;Poland;Belgium;Russian Federation;Germany;Japan;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1436

EUCTR2007-005702-49-PL
(EUCTR)

17/06/2009

A Randomized, Double-blind, Parallel-group Study to Assess the Safety and Efficacy ofAsacol® (1.2 to 4.8 g/day) Administered as 400 mg Delayed-release Tablets Given Every 12 Hours for 6 Weeks to Children and Adolescents with Mildly-to-Moderately Active Ulcerative Colitis. - CAMP II

Mildly-to-Moderately Active Ulcerative Colitis in Children and Adolescents
MedDRA version: 11.0;Level: LLT;Classification code 10045365;Term:

Trade Name: Asacol
Product Name: Asacol
Product Code: NA
INN or Proposed INN: MESALAZINE

Procter & Gamble Pharmaceuticals

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 3

Poland

1437

EUCTR2017-000573-37-PL
(EUCTR)

01/12/2017

Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab

Shire Human Genetic Therapies, Inc.

NULL

Female: yes
Male: yes

772

Phase 3

United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan

1438

EUCTR2015-001346-29-AT
(EUCTR)

12/01/2016

Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use
Product Name: Adalimumab
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Female: yes
Male: yes

Phase 3

United States;Spain;Austria;Israel;United Kingdom;Hungary;Czech Republic;European Union;Canada;Belgium;Japan;New Zealand;Sweden

1439

EUCTR2016-000674-38-DE
(EUCTR)

28/09/2016

Long Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis.

A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects with Ulcerative Colitis (UC)

Product Name: Upadacitinib - Direct compression-yellow
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib -Direct compression-yellow
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib -Direct compression-yellow
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib - Wet Granulation-Yellow
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib - Wet Granulation-Yellow
Product Code: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Female: yes
Male: yes

950

Phase 3

Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Turkey;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan

1440

EUCTR2015-000319-41-PL
(EUCTR)

16/09/2015

The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC).

Celgene International II Sàrl (CIS II)

NULL

Not Recruiting

Female: yes
Male: yes

900

Phase 3

United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Slovenia;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1441

EUCTR2018-003985-15-CZ
(EUCTR)

31/07/2019

A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Arena Pharmaceuticals Inc.

NULL

Female: yes
Male: yes

372

Phase 3

1442

EUCTR2018-003987-29-CZ
(EUCTR)

10/09/2019

An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis

An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Arena Pharmaceuticals Inc.

NULL

Female: yes
Male: yes

702

Phase 3

1443

EUCTR2016-000641-31-DE
(EUCTR)

06/10/2016

Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis

AbbVie Deutschland GmbH & Co. KG

NULL

Female: yes
Male: yes

1055

Phase 2;Phase 3

Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan

1444

EUCTR2018-003986-33-DE
(EUCTR)

19/09/2019

A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis

A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12

Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine

Arena Pharmaceuticals, Inc.

NULL

Female: yes
Male: yes

330

Phase 3

1445

EUCTR2018-003987-29-EE
(EUCTR)

12/09/2019

An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis

An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Arena Pharmaceuticals Inc.

NULL

Female: yes
Male: yes

702

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1446

EUCTR2015-001346-29-PL
(EUCTR)

21/03/2016

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Female: yes
Male: yes

Phase 3

United States;Slovakia;Spain;Israel;United Kingdom;Czech Republic;Hungary;European Union;Canada;Poland;Belgium;Australia;New Zealand;Sweden

1447

EUCTR2017-003649-10-PL
(EUCTR)

11/12/2017

Moderate to severe ulcerative colitis (UC); moderate to severe Crohn’s disease (CD)
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

F. Hoffmann-La Roche Ltd

NULL

Female: yes
Male: yes

Phase 1

United States;Belgium;Spain;Poland;Germany;United Kingdom

1448

EUCTR2017-000573-37-BE
(EUCTR)

14/12/2017

Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody
Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody

Baxalta Innovations GmbH

NULL

Not Recruiting

Female: yes
Male: yes

772

Phase 3

United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Japan;New Zealand

1449

EUCTR2017-000574-11-CZ
(EUCTR)

01/11/2017

Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn’s Disease (AIDA)

A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn’s Disease (AIDA) - AIDA

Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab

Shire Human Genetic Therapies, Inc.

NULL

Female: yes
Male: yes

2453

Phase 3

Bosnia and Herzegovina;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands

1450

EUCTR2014-004559-29-Outside-EU/EEA
(EUCTR)

12/11/2014

A Multi-Center, Randomized, Double-Blind, Placebo-controlled Study of Adalimumab in Japanese Subjects with Moderately to Severely Active Ulcerative Colitis

Trade Name: Humira 40 mg/0.8 ml solution for injection
Product Name: Adalimumab
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB

AbbVie Inc.

NULL

Female: yes
Male: yes

274

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1451

EUCTR2017-000599-27-PL
(EUCTR)

04/12/2017

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 301)

Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab

Shire Human Genetic Therapies, Inc.

NULL

Female: yes
Male: yes

825

Phase 3

1452

EUCTR2015-001346-29-SK
(EUCTR)

30/10/2015

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Female: yes
Male: yes

Phase 3

United States;Slovakia;Spain;Israel;United Kingdom;Czech Republic;Hungary;European Union;Canada;Belgium;Poland;Japan;New Zealand;Sweden

1453

EUCTR2018-003986-33-PL
(EUCTR)

15/11/2019

A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis

A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12

Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine

Arena Pharmaceuticals, Inc.

NULL

Female: yes
Male: yes

330

Phase 3

United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Georgia;Germany

1454

EUCTR2015-000319-41-BG
(EUCTR)

12/08/2015

The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC).

Celgene International II Sàrl (CIS II)

NULL

Not Recruiting

Female: yes
Male: yes

1050

Phase 3

Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Romania;Croatia;Bulgaria;Georgia;Germany;New Zealand

1455

EUCTR2012-004366-18-FR
(EUCTR)

28/09/2015

A Study to Assess the Safety and Pharmacokinetics (Serum Levels) of Golimumab in Children With Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis in pediatric subjects
MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti-TNF-alpha monoclonal antibody

Janssen Biologics B.V.

NULL

Female: yes
Male: yes

Phase 1

United States;France;Canada;Poland;Belgium;Denmark;Austria;Israel;Netherlands;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1456

EUCTR2018-003985-15-PL
(EUCTR)

02/08/2019

A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52

Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine

Arena Pharmaceuticals Inc.

NULL

Female: yes
Male: yes

372

Phase 3

United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Japan

1457

EUCTR2018-003987-29-PL
(EUCTR)

24/10/2019

An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis

An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Arena Pharmaceuticals Inc.

NULL

Female: yes
Male: yes

702

Phase 3

1458

EUCTR2015-001600-64-PL
(EUCTR)

03/12/2015

The purpose of this study is to determine whether long-term RPC1063 is safe and effective in the treatment of ulcerative colitis (UC).

A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of long-term RPC1063 in Ulcerative Colitis

Celgene International II Sàrl (CIS II)

NULL

Female: yes
Male: yes

1350

Phase 3

Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;Korea, Republic of;Slovenia;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;New Zealand

1459

EUCTR2004-004565-15-DE
(EUCTR)

15/09/2005

Ulcerative collitis (UC)
MedDRA version: 4.1;Level: PT;Classification code 10009900

Product Name: Pentasa
INN or Proposed INN: mesalazine
Other descriptive name: 5-AminoSalicylic Acid
Product Name: Pentasa prolonged release granules 2g
INN or Proposed INN: mesalazine

Ferring BV

NULL

Not Recruiting

Female: yes
Male: yes

360

Finland;Czech Republic;Germany;Denmark;Norway;Sweden

1460

EUCTR2017-000572-28-IE
(EUCTR)

04/09/2017

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 302)

Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab

Shire Human Genetic Therapies, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

825

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1461

EUCTR2016-000674-38-NO
(EUCTR)

01/11/2016

Long Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis.

A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects with Ulcerative Colitis (UC)

AbbVie Deutschland GmbH & Co. KG

NULL

Female: yes
Male: yes

950

Phase 3

1462

EUCTR2016-000641-31-NO
(EUCTR)

07/11/2016

Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis

AbbVie Deutschland GmbH & Co. KG

NULL

Female: yes
Male: yes

1055

Phase 2;Phase 3

Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan;Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico

1463

EUCTR2019-004224-38-DE
(EUCTR)

20/10/2020

Janssen-Cilag International NV

NULL

Female: yes
Male: yes

Phase 3

United States;Hungary;Poland;Belgium;Russian Federation;Germany;United Kingdom;Japan