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	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
2	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
3	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
4	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
5	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
6	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
7	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
8	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
9	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
10	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
No.	TrialID	Date_ enrollment	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	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
12	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
13	NCT03290781 (ClinicalTrials.gov)	April 4, 2018	6/9/2017	An Efficacy and Safety Study of Ontamalimab as Maintenance Therapy in Participants With Moderate to Severe Ulcerative Colitis	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)	Ulcerative Colitis	Drug: Ontamalimab;Other: Placebo	Shire	NULL	Active, not recruiting	16 Years	81 Years	All	366	Phase 3	United States;Argentina;Australia;Austria;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Colombia;Croatia;Czechia;Estonia;Germany;Greece;Hungary;Ireland;Israel;Italy;Japan;Korea, Republic of;Lebanon;Lithuania;Mexico;Netherlands;New Zealand;Poland;Portugal;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Switzerland;Turkey;Ukraine;United Kingdom;France
14	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
15	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
16	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
17	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
18	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
19	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
20	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
No.	TrialID	Date_ enrollment	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	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
22	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
23	NCT03283085 (ClinicalTrials.gov)	February 27, 2018	12/9/2017	A Safety Extension Study of Ontamalimab in Participants With 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)	Crohn's Disease;Ulcerative Colitis	Drug: 25 mg Ontamalimab;Drug: 75 mg Ontamalimab	Shire	NULL	Recruiting	16 Years	80 Years	All	451	Phase 3	United States;Argentina;Australia;Austria;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Colombia;Croatia;Czechia;Estonia;France;Germany;Greece;Hungary;Ireland;Israel;Italy;Japan;Korea, Republic of;Lebanon;Lithuania;Mexico;Netherlands;New Zealand;Poland;Portugal;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Switzerland;Turkey;Ukraine;United Kingdom
24	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
25	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
No.	TrialID	Date_ enrollment	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	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
27	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
28	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
29	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
30	NCT03259334 (ClinicalTrials.gov)	February 9, 2018	21/8/2017	Efficacy and Safety Study of SHP647 as Induction Therapy in Participants With Moderate to Severe Ulcerative Colitis	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	Drug: Ontamalimab;Other: Placebo	Shire	NULL	Completed	16 Years	80 Years	All	380	Phase 3	United States;Australia;Austria;Brazil;Croatia;Czechia;Germany;Israel;Italy;Japan;Lithuania;Netherlands;Poland;Romania;Russian Federation;Serbia;South Africa;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
31	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
32	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
33	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
34	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
35	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
No.	TrialID	Date_ enrollment	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	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
37	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
38	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
39	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
40	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
No.	TrialID	Date_ enrollment	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	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
42	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
43	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
44	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
45	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
No.	TrialID	Date_ enrollment	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	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
47	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
48	NCT03259308 (ClinicalTrials.gov)	December 5, 2017	21/8/2017	Efficacy and Safety Study of SHP647 as Induction Therapy in Participants With Moderate to Severe Ulcerative Colitis	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	Drug: Ontamalimab;Drug: Placebo	Shire	NULL	Terminated	16 Years	80 Years	All	279	Phase 3	United States;Argentina;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Colombia;Estonia;Greece;Hungary;Ireland;Japan;Korea, Republic of;Lebanon;Mexico;New Zealand;Portugal;Slovakia;Spain;Switzerland;Turkey;Ukraine;France
49	NCT01771809 (ClinicalTrials.gov)	March 18, 2013	8/1/2013	Long-Term Safety Of PF-00547659 In Ulcerative Colitis	A Multicenter Open-Label Extension Study To Assess Long-Term Safety Of PF-00547659 In Subjects With Ulcerative Colitis (TURANDOT II)	Ulcerative Colitis	Drug: 75mg SHP647 (PF-00547659);Drug: 225mg SHP647 (PF-00547659)	Shire	NULL	Completed	18 Years	66 Years	All	330	Phase 2	United States;Australia;Austria;Belgium;Bulgaria;Canada;Czechia;France;Germany;Hungary;Israel;Italy;Korea, Republic of;Netherlands;New Zealand;Poland;Russian Federation;Serbia;Slovakia;South Africa;Spain;Czech Republic;Switzerland
50	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	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	NA			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
No.	TrialID	Date_ enrollment	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	EUCTR2017-000573-37-BE (EUCTR)		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 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	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
52	EUCTR2017-000599-27-PL (EUCTR)		04/12/2017	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 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	NA			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;New Zealand;Japan
53	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	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	NA			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
54	EUCTR2017-000572-28-IE (EUCTR)		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 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;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Turkey;Colombia;Switzerland;France;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Bosnia and Herzegovina;Korea, Republic of
55	EUCTR2017-000573-37-PL (EUCTR)		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: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	NA			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

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

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

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

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

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

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

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

EUCTR2017-000573-37-HR
(EUCTR)

23/04/2018

07/12/2018

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]

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

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

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)

Ulcerative colitis
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

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)

Ulcerative colitis
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

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

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

EUCTR2017-000573-37-DE
(EUCTR)

10/04/2018

24/10/2017

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]

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

NCT03290781
(ClinicalTrials.gov)

April 4, 2018

6/9/2017

An Efficacy and Safety Study of Ontamalimab as Maintenance Therapy in Participants With Moderate to Severe Ulcerative Colitis

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)

Ulcerative Colitis

Drug: Ontamalimab;Other: Placebo

Shire

NULL

Active, not recruiting

16 Years

81 Years

All

366

Phase 3

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

EUCTR2017-000573-37-NL
(EUCTR)

15/03/2018

02/11/2017

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]

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

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

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)

Ulcerative Colitis
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

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

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

EUCTR2017-000573-37-IE
(EUCTR)

13/03/2018

04/09/2017

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]

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

EUCTR2017-000573-37-PT
(EUCTR)

13/03/2018

21/12/2017

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

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)

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

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2017-000573-37-GB
(EUCTR)

07/03/2018

25/09/2017

Shire Human Genetic Therapies, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

772

Phase 3

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

NCT03283085
(ClinicalTrials.gov)

February 27, 2018

12/9/2017

A Safety Extension Study of Ontamalimab in Participants With 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)

Crohn's Disease;Ulcerative Colitis

Drug: 25 mg Ontamalimab;Drug: 75 mg Ontamalimab

Shire

NULL

Recruiting

16 Years

80 Years

All

451

Phase 3

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

EUCTR2017-000573-37-CZ
(EUCTR)

27/02/2018

01/11/2017

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]

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

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)

Ulcerative colitis
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

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2017-000573-37-ES
(EUCTR)

16/02/2018

19/12/2017

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]

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

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)

Ulcerative Colitis
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

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

Ulcerative Colitis
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

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

NCT03259334
(ClinicalTrials.gov)

February 9, 2018

21/8/2017

Efficacy and Safety Study of SHP647 as Induction Therapy in Participants With Moderate to Severe Ulcerative Colitis

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

Drug: Ontamalimab;Other: Placebo

Shire

NULL

Completed

16 Years

80 Years

All

380

Phase 3

United States;Australia;Austria;Brazil;Croatia;Czechia;Germany;Israel;Italy;Japan;Lithuania;Netherlands;Poland;Romania;Russian Federation;Serbia;South Africa;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

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

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)

Ulcerative colitis
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

EUCTR2017-000573-37-LT
(EUCTR)

30/01/2018

31/10/2017

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]

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

EUCTR2017-000573-37-BG
(EUCTR)

24/01/2018

22/11/2017

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]

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

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

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2017-000573-37-HU
(EUCTR)

22/01/2018

23/01/2018

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

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)

Ulcerative Colitis
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

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)

Ulcerative Colitis
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

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

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)

Ulcerative colitis
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

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

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

EUCTR2017-000573-37-AT
(EUCTR)

22/12/2017

30/10/2017

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]

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

EUCTR2017-000573-37-SK
(EUCTR)

13/12/2017

21/11/2017

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]

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

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)

Ulcerative Colitis
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

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

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2017-000573-37-GR
(EUCTR)

11/12/2017

01/12/2017

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]

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

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)

Ulcerative Colitis
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

NCT03259308
(ClinicalTrials.gov)

December 5, 2017

21/8/2017

Efficacy and Safety Study of SHP647 as Induction Therapy in Participants With Moderate to Severe Ulcerative Colitis

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

Drug: Ontamalimab;Drug: Placebo

Shire

NULL

Terminated

16 Years

80 Years

All

279

Phase 3

United States;Argentina;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Colombia;Estonia;Greece;Hungary;Ireland;Japan;Korea, Republic of;Lebanon;Mexico;New Zealand;Portugal;Slovakia;Spain;Switzerland;Turkey;Ukraine;France

NCT01771809
(ClinicalTrials.gov)

March 18, 2013

8/1/2013

Long-Term Safety Of PF-00547659 In Ulcerative Colitis

A Multicenter Open-Label Extension Study To Assess Long-Term Safety Of PF-00547659 In Subjects With Ulcerative Colitis (TURANDOT II)

Ulcerative Colitis

Drug: 75mg SHP647 (PF-00547659);Drug: 225mg SHP647 (PF-00547659)

Shire

NULL

Completed

18 Years

66 Years

All

330

Phase 2

United States;Australia;Austria;Belgium;Bulgaria;Canada;Czechia;France;Germany;Hungary;Israel;Italy;Korea, Republic of;Netherlands;New Zealand;Poland;Russian Federation;Serbia;Slovakia;South Africa;Spain;Czech Republic;Switzerland

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

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2017-000573-37-BE
(EUCTR)

14/12/2017

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]

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

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)

Ulcerative colitis
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

Female: yes
Male: yes

825

Phase 3

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

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)

Ulcerative Colitis
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

EUCTR2017-000573-37-PL
(EUCTR)

01/12/2017

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]

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