↑ 疾患リストへ ← 戻る

 97. 潰瘍性大腸炎 [臨床試験数:820,薬物数:887(DrugBank:195),標的遺伝子数:101,標的パスウェイ数:56] 

Searched query = "Ulcerative colitis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 11/21/2019, 11/20/2019. Trials are sorted by Date_enrolment from most recent to oldest in the table.

Search in Page    e.g. "Phase 3", "Not recruiting", "Japan"    Synonyms (DrugBank) were also searched for.
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03996369June 202015 July 2019Etrasimod Versus Placebo as Induction Therapy in Moderately to Severely Active Ulcerative ColitisA Phase 3, Randomized, Double-Blind, Placebo-Controlled, 12-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects With Moderately to Severely Active Ulcerative ColitisUlcerative ColitisDrug: Etrasimod;Drug: PlaceboArena PharmaceuticalsNot recruiting16 Years80 YearsAll330Phase 3
2NCT04096573April 202030 September 2019Efficacy and Safety of LC51-0255 in Subjects With Ulcerative ColitisA Phase 2, Multi Center, Randomized, Placebo Controlled Parallel Group Study to Evaluate the Clinical Efficacy and Safety of LC51 0255 in Subjects With Moderately to Severely Active Ulcerative ColitisUlcerative ColitisDrug: LC51-0255;Drug: PlaceboLG ChemNot recruiting18 Years80 YearsAll240Phase 2
3NCT04074590December 13, 20194 November 2019Study of Efficacy, Safety, and Tolerability of LYS006, in Patients With Mild to Moderate Ulcerative ColitisA Randomized, Multi-center, Subject and Investigator-blinded, Placebo-controlled, Parallel-group Study to Assess the Efficacy Safety and Tolerability of LYS006 in Patients With Mild to Moderate Ulcerative ColitisColitis, UlcerativeDrug: LYS006;Drug: PlaceboNovartis PharmaceuticalsNot recruiting18 Years65 YearsAll60Phase 2
4NCT04004611December 12, 201911 November 2019A Study of Mirikizumab (LY3074828) in Children and Teenagers With Ulcerative Colitis (UC)Multicenter, Open-Label PK Study of Mirikizumab in Pediatric Patients With Moderately to Severely Active Ulcerative ColitisUlcerative ColitisDrug: MirikizumabEli Lilly and CompanyNot recruiting2 Years17 YearsAll30Phase 2
5JPRN-JapicCTI-19498002/12/20197 October 2019A Study of Guselkumab in Participants with Moderately to Severely Active Ulcerative ColitisA Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative ColitisUlcerative ColitisIntervention name : Guselkumab
INN of the intervention : Guselkumab
Dosage And administration of the intervention : Induction Study 1: Guselkumab Dose 1, Induction Study 1: Guselkumab Dose 2, Induction Study 1: Guselkumab Dose 3, Induction Study 2: Guselkumab IV; Maintenance Study: Maintenance Dose Regimen 1, Maintenance Study: Maintenance Dose Regimen 2; Participants will receive guselkumab IV or SC.
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : Induction Study 1: Placebo IV Induction, Study 2: Placebo IV Maintenance Study: Placebo SC; Participants will receive matching placebo IV or SC.
Janssen Pharmaceutical K.K.Not Recruiting18BOTH1000Phase 2-3Japan, Asia except Japan, North America, Europe
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6ChiCTR19000259002019-12-0116 September 2019Efficacy of Herbal enema prescriptionII(DHEP II) in the treatment of mild or moderate active symptoms of ulcerative colitis:A multicenter prospective randomized control clinical trial.Efficacy of Herbal enema prescriptionII(DHEP II) in the treatment of mild or moderate active symptoms of ulcerative colitis:A multicenter prospective randomized control clinical trial.Ulcerative colitisExperimental group:Mesalazine+DHEP II;control group:Mesalazine+Compound Huangbai lotion;Nanjing Hospital of Chinese MedicineNot RecruitingBothExperimental group:200;control group:100;Phase 3China
7NCT02277223December 1, 201930 September 2019Curcumin in Pediatric Ulcerative ColitisCurcumin for Induction and Maintenance Therapy in Pediatric Ulcerative ColitisUlcerative ColitisDietary Supplement: Curcumin;Drug: PlaceboSchneider Children's Medical Center, IsraelNot recruiting6 Years18 YearsAll60Phase 3
8NCT03998488December 201911 November 2019Examining the Efficacy of Fecal Microbiota Transplantation (FMT) and Dietary Fiber in Patients With Ulcerative ColitisA Randomized, Placebo-controlled Clinical Trial Examining the Efficacy of Fecal Microbiota Transplantation (FMT) and Subsequent Dietary Fiber in Patients With Moderate Ulcerative ColitisUlcerative Colitis;Inflammatory Bowel DiseasesDrug: Fecal Microbiota Transplantation;Dietary Supplement: Psyllium Husk PowderWeill Medical College of Cornell UniversityCrohn's and Colitis FoundationRecruiting18 Years89 YearsAll135Phase 2United States
9NCT04090411November 22, 201930 September 2019A Study to Evaluate the Efficacy and Safety of PF-06480605 in Adult Participants With Moderate to Severe Ulcerative ColitisA PHASE 2B, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED DOSE-RANGING STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF PF-06480605 IN ADULT PARTICIPANTS WITH MODERATE TO SEVERE ULCERATIVE COLITISModerate to Severe Ulcerative ColitisDrug: 50 mg;Drug: 450 mg;Drug: 150 mg;Other: 0 mgPfizerNot recruiting18 Years75 YearsAll240Phase 2
10NCT04133194November 1, 20194 November 2019Adherence of a 1.600 mg Single Tablet 5-ASA Treatment of Ulcerative ColitisAdherence of a 1.600 mg Single Tablet 5-ASA Treatment of Ulcerative Colitis (EASI-trial)Ulcerative ColitisDrug: MesalazineCopenhagen University Hospital, HvidovreNot recruiting18 Years60 YearsAll200Phase 4
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11NCT04156984November 201911 November 2019Comparison of Two Different Golimumab Dosing Regimens for Ulcerative ColitisExposure-response of Golimumab During Maintenance in Ulcerative Colitis: An Exploratory Pharmacokinetics/Pharmacodynamics Comparison of Different Dose RegimensUlcerative ColitisDrug: Golimumab Prefilled SyringeDavid DrobneNot recruiting18 Years65 YearsAll30Phase 4Slovenia
12NCT03414788October 15, 201915 July 2019Distribution of a Single IV Dose Of [124I]-Pf 06687234 and Pf 06687234 Assessed With PET-CT Imaging In Moderate To Severe Ulcerative ColitisPHASE 1B, OPEN LABEL STUDY TO CHARACTERIZE THE DISTRIBUTION OF A SINGLE INTRAVENOUS DOSE OF [124I]-IODOBENZOYL (IB) PF 06687234 WITH CONCURRENT ADMINISTRATION OF NON-RADIOLABELED PF 06687234 AS ASSESSED WITH POSITRON EMISSION TOMOGRAPHY AND COMPUTED TOMOGRAPHY (PET-CT) IMAGING IN MODERATE TO SEVERE ULCERATIVE COLITIS SUBJECTSUlcerative ColitisBiological: PF 06687234;Biological: [124I]IB PF 06687234PfizerNot recruiting18 Years75 YearsAll5Phase 1United States
13NCT03802214October 14, 201922 October 2019Ulcerative Colitis - Vedolizumab- With/Without Prior Exposure to Anti-TNF(Tumor Necrosis Factor)TherapyA Case-control Study to Evaluate the Immunoinflammatory Effect of Prior Exposure to Anti-TNF Therapy in Patients With Ulcerative Colitis Starting Vedolizumab TherapyUlcerative ColitisDrug: VedolizumabStanford UniversityTakeda;University of Western Ontario, Canada;University of California, San DiegoNot recruiting18 YearsN/AAll20Phase 3
14NCT03920254October 20194 November 2019TD-1473 Long-Term Safety (LTS) Ulcerative Colitis (UC) StudyA 3-Year, Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects With Ulcerative Colitis (UC)Ulcerative Colitis (UC)Drug: TD-1473 Dose A;Drug: TD-1473 Dose B;Drug: TD-1473 Dose CTheravance BiopharmaNot recruiting18 YearsN/AAll500Phase 2/Phase 3United States;Bulgaria;Georgia;Greece;Hungary;Israel;Poland;Portugal;Serbia;Slovakia;South Africa;Spain;Taiwan;Ukraine
15NCT04006977October 201930 September 2019Multistrain Probiotics Reduces UC Depression and Anxiety ScoresMultistrain Probiotic Product (De Simone Formulation) Reduces Depression and Anxiety Scores: a Randomized Pilot Study in Patients With Ulcerative ColitisUlcerative ColitisDietary Supplement: a multistrain probiotic product (DSF);Dietary Supplement: PlaceboXijing Hospital of Digestive DiseasesMENDES SANot recruiting18 Years65 YearsAll60N/AChina
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16NCT04023396October 201929 July 2019Efficacy and Safety Study of ABX464 as Maintenance Therapy in Patients With Moderate to Severe Ulcerative ColitisA Phase 2b, Open-label, Efficacy and Safety Study of ABX464 as Maintenance Therapy in Patients With Moderate to Severe Ulcerative ColitisUlcerative ColitisDrug: ABX464Abivax S.A.Not recruiting18 Years75 YearsAll210Phase 2
17NCT04130919October 201928 October 2019Study to Evaluate the Efficacy and Safety of GS-4875 in Adults With Moderately to Severely Active Ulcerative ColitisA Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of GS-4875 in Subjects With Moderately to Severely Active Ulcerative ColitisUlcerative ColitisDrug: GS-4875;Drug: PlaceboGilead SciencesNot recruiting18 YearsN/AAll180Phase 2
18NCT04131322October 201928 October 2019Loss of Response of Adalimumab Biosimilar vs Adalimumab Original, in Inflammatory Bowel Disease.Loss of Response of Adalimumab Biosimilar Compared With the Loss of Response of Adalimumab Original: Controlled, Randomized, Non-inferiority Open Study. ADA-SWITCH StudyCrohn Disease;Ulcerative ColitisDrug: Amgevita 40Mg Solution for Injection;Drug: HUMIRA 40Mg Solution for InjectionFundación Pública Andaluza para la gestión de la Investigación en SevillaNot recruiting18 YearsN/AAll216Phase 4
19NCT04102852September 30, 20197 October 2019Lactobacillus Rhamnosus GG (ATCC 53103) in Mild-moderately Active UC PatientsThe Role of Lactobacillus Rhamnosus GG (ATCC 53103) in the Modulation of the Inflammatory Process in the Mucosa of Ulcerative Colitis (UC) Patients With Mild-moderate Clinical ActivityUlcerative Colitis Chronic Mild;Ulcerative Colitis Chronic ModerateDietary Supplement: Lactobacillus rhamnosus GG ATCC 53103San Giovanni Addolorata HospitalOnlus S. AndreaNot recruiting18 Years65 YearsAll80Phase 1/Phase 2Italy
20NCT04033445September 26, 201922 October 2019A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative ColitisA Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Ulcerative ColitisUlcerative ColitisDrug: Guselkumab;Drug: PlaceboJanssen Research & Development, LLCRecruiting18 YearsN/AAll1000Phase 2/Phase 3United States;Argentina;Australia;Belgium;Bulgaria;Canada;China;Czechia;France;Germany;Hungary;Italy;Japan;Korea, Republic of;Netherlands;Poland;Portugal;Spain;Sweden;Turkey;Ukraine;United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21NCT03847467September 20, 201922 October 2019Pilot and Feasibility Study of 2'-FL as a Dietary Supplement in IBD Patients Receiving Stable Maintenance Anti-TNF TherapyPilot and Feasibility Study of 2'-FL as a Dietary Supplement in Pediatric and Young Adult IBD Patients Receiving Stable Maintenance Anti-TNF TherapyInflammatory Bowel Diseases;Crohn Disease;Ulcerative ColitisDrug: 2'-Fucosyllactose;Other: PlaceboChildren's Hospital Medical Center, CincinnatiBroad Institute;University of Cincinnati;Connecticut Children's Medical CenterRecruiting11 Years25 YearsAll216Phase 1/Phase 2United States
22NCT03950232September 20, 201911 November 2019An Extension Study for Treatment of Moderately to Severely Active Ulcerative ColitisAn Open-Label Extension Study of Etrasimod in Subjects With Moderately to Severely Active Ulcerative ColitisUlcerative ColitisDrug: EtrasimodArena PharmaceuticalsRecruiting16 Years80 YearsAll702Phase 3United States
23NCT03885713September 10, 20194 November 2019Identification of Predictive Biomarkers for Response to Biologic Therapies in Inflammatory Bowel DiseaseIdentification of Predictive Biomarkers for Response to Biologic Therapies in Inflammatory Bowel Disease by Proteomic and Mass Cytometry ApproachesInflammatory Bowel Diseases;Crohn Disease;Ulcerative ColitisBiological: Infliximab or adalimumab or golimumab or vedolizumab or ustekinumabFundación de Investigación Biomédica - Hospital Universitario de La PrincesaRecruiting18 YearsN/AAll180Phase 4Spain
24NCT03980405September 201917 June 2019Combination of Diet and 5ASA ( 5-aminosalicylic Acid) for Ulcerative ColitisCombination Therapy With Drug and Diet for Induction of Remission in Mild to Moderate Active Pediatric Ulcerative Colitis: A Single Blinded, International Randomized Controlled TrialUlcerative ColitisDietary Supplement: Group 1- Control Diet;Dietary Supplement: Group 2- UCD DietProf. Arie LevineNot recruiting10 Years19 YearsAll62N/A
25NCT04064697September 201916 September 2019Impact of Anti-cytomegalovirus (Valganciclovir) Treatment in the Management of Relapsing Ulcerative Colitis (UC) Requiring Vedolizumab TherapyImpact of Anti-cytomegalovirus (Valganciclovir) Treatment in the Management of Relapsing Ulcerative Colitis (UC) Requiring Vedolizumab Therapy: a Randomized Clinical Trial Comparing a Strategy With or Without Antiviral Therapy. CYTOVEDO StudyUlcerative Colitis, UnspecifiedDrug: ValganciclovirCentre Hospitalier Universitaire de Saint EtienneMinistry of Health, FranceNot recruiting18 YearsN/AAll120Phase 3France
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26NCT03724175August 26, 20194 November 2019The Role of Secondary Bile Acids in Intestinal InflammationThe Role of Secondary Bile Acids in Intestinal InflammationUlcerative Colitis;PouchitisDrug: ursodiol (ursodeoxycholic acid, UDCA)Stanford UniversityRecruiting18 Years70 YearsAll15Phase 2/Phase 3United States
27NCT03861143August 14, 20192 September 2019Efficacy and Safety of Oral BT-11 in Mild to Moderate Ulcerative ColitisA Randomized , Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Mild to Moderate Ulcerative ColitisUlcerative ColitisDrug: BT-11 (500 mg);Drug: BT-11 (1000 mg);Drug: PlaceboLandos Biopharma Inc.Recruiting18 Years65 YearsAll195Phase 2United States
28NCT03869905August 8, 201926 August 2019Aquamin® as an Adjuvant Intervention for Ulcerative Colitis In RemissionAquamin®, a Multi-mineral Natural Product From Red Marine Algae, as an Adjuvant Intervention for Ulcerative Colitis in RemissionUlcerative ColitisDrug: Aquamin®;Drug: Placebo first then Aquamin®James VaraniRecruiting18 Years80 YearsAll40Phase 2United States
29ChiCTR19000240862019-08-011 July 2019Modified Chinese Medicine Granule in the Treatment of Ulcerative Colitis in the Remission Phase: Study Protocol for a Series of N-of-1 Randomized, Double-Blind, Controlled TrialsModified Chinese Medicine Granule in the Treatment of Ulcerative Colitis in the Remission Phase: Study Protocol for a Series of N-of-1 Randomized, Double-Blind, Controlled TrialsUlcerative Colitisintervention period:Modified Chinese Medicine Granule and Mesalazine placebo;control period:Mesalazine and Modified Chinese Medicine Granule placebo;The First Affiliated Hospital of Guangzhou University of Chinese MedicineNot Recruiting1875Bothintervention period:10;control period:10;N/AChina
30NCT04029649August 201929 July 2019Beta-1,3/1,6-D-Glucan Ganoderma Lucidum on Ulcerative ColitisThe Role of Beta-1,3/1,6-D-Glucan From Mycelium Extract of Ganoderma Lucidum on Ulcerative Colitis: A Double-Blind Randomized Controlled TrialUlcerative ColitisDrug: Beta-1,3/1,6-D-Glucan;Drug: PlaceboFakultas Kedokteran Universitas IndonesiaNot recruiting18 YearsN/AAll204Phase 2/Phase 3Indonesia
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31NCT03591770July 31, 201926 August 2019Shingrix Vaccine in Patients With Moderate to Severe Ulcerative Colitis on TofacitinibThe Immunogenicity and Safety of Shingrix Vaccine in Patients With Moderate to Severe Ulcerative Colitis on TofacitinibInflammatory Bowel DiseasesBiological: SHINGRIXBoston Medical CenterRecruiting50 YearsN/AAll100Phase 4United States
32NCT03948919July 31, 201926 August 2019Low Sulfur Fecal Transplant for Ulcerative ColitisLow Sulfur Fecal Transplant for Ulcerative ColitisUlcerative ColitisDrug: Fecal microbiota;Other: PlaceboUniversity of Minnesota - Clinical and Translational Science InstituteRecruiting18 Years89 YearsAll20Phase 1United States
33ChiCTR19000245912019-07-2222 July 2019Clinical evaluation for traditional Chinese medicine in the treatment of severe active ulcerative colitisClinical evaluation for traditional Chinese medicine in the treatment of severe active ulcerative colitisUlcerative colitisTCM Group:Prednisone+New Wumeiwan Formula;Convenience medicine Group:Prednisone+Mesalazine Enteric-coated tablets (Salofalk);Combined Group:Prednisone+New Wumeiwan Formula+Mesalazine Enteric-coated tablets(Salofalk);Peking University First HospitalNot Recruiting1865BothTCM Group:40;Convenience medicine Group:40;Combined Group:40;Phase 0China
34NCT04030676July 17, 201929 July 2019QuantiFERON-CMV Test in a Prediction for Colic Cytomegalovirus Reactivation During Ulcerative ColitisPlace of the QuantiFERON-CMV (QF-CMV) Test in a Prediction for Colic Cytomegalovirus Reactivation During Ulcerative Colitis (UC)Cytomegalovirus InfectionsProcedure: Biopsies;Biological: Blood samplesCentre Hospitalier Universitaire de Saint EtienneRecruiting18 YearsN/AAll196N/AFrance
35NCT03937609July 15, 201922 July 2019TITRATE (inducTIon for acuTe ulceRATivE Colitis)Randomized, Multicenter Study to Investigate the Efficacy of Dashboard Driven Individualized Dosing of Infliximab Compared To Standard Dosing During the Induction in Patients With Acute Severe Ulcerative ColitisColitis, UlcerativeDrug: InfliximabAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)PfizerRecruiting18 YearsN/AAll120Phase 4Netherlands
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36NCT04018599July 15, 201930 September 2019Comparison of PK and Tolerability of MSB11022 Administered by AI or PFSA Phase I, Randomized, Open-label, Parallel-group Study to Determine the Pharmacokinetics, Safety, and Tolerability of MSB11022 (Proposed Adalimumab Biosimilar) Following a Single Subcutaneous Injection by an Auto-injector or by a Pre-filled Syringe in Healthy SubjectsRheumatoid Arthritis;Polyarticular Juvenile Idiopathic Arthritis;Psoriatic Arthritis;Ankylosing Spondylitis;Crohn Disease;Ulcerative Colitis;Plaque Psoriasis;Pediatric Plaque Psoriasis;Pediatric Crohns Disease;Hidradenitis Suppurativa;Non-infectious UveitisDrug: 40 mg MSB11022Fresenius Kabi SwissBioSim GmbHPRA Health SciencesRecruiting18 Years55 YearsAll216Phase 1United States
37NCT03935451July 1, 201913 May 2019Postoperative Extended Venous Thromboprophylaxis in Inflammatory Bowel DiseaseA Randomized Controlled Trial on the Use of Postoperative Extended Venous Thromboprophylaxis in Patients With Inflammatory Bowel Disease: A Pilot StudyIBD;Venous Thromboembolism;Crohn Disease;Ulcerative Colitis;Pulmonary Embolism;Colorectal DisordersDrug: Apixaban 2.5 milligram;Drug: Placebo Oral TabletMcMaster UniversityNot recruiting18 YearsN/AAll180Early Phase 1
38NCT04006080July 1, 201915 July 2019Investigation of the Faecal Loss of Vedolizumab and Its Role in Influencing Serum Drug Levels, Outcomes and Response in Ulcerative ColitisInvestigation of the Faecal Loss of Vedolizumab and Its Role in Influencing Serum Drug Levels, Outcomes and Response in Ulcerative ColitisUlcerative ColitisBiological: VedolizumabGuy's and St Thomas' NHS Foundation TrustTakedaRecruiting18 YearsN/AAll30Phase 4United Kingdom
39NCT03986996July 201924 June 2019Antimicrobial Therapy for Ulcerative Colitis (UC)Antimicrobial Therapy for Ulcerative Colitis : Evaluation of Two Antibiotic Combinations for Refractory Ulcerative ColitisUlcerative ColitisDrug: amoxicillin, metronidazole and tetracycline;Drug: amoxicillin and tetracyclineWolfson Medical CenterNot recruiting13 Years60 YearsAll40Phase 2Israel
40NCT03656627June 27, 201922 October 2019Nivolumab in Patients With Advanced Non-Small Cell Lung Cancer and Pre-existing Autoimmune DiseaseSafety, Activity, and Pharmacology of Nivolumab in Patients With Advanced Non-Small Cell Lung Cancer and Pre-existing Autoimmune DiseaseAutoimmune Diseases;Non-small Cell Lung Cancer;Rheumatoid Arthritis;Psoriasis;Giant Cell Arteritis;Polymyalgia Rheumatica;Systemic Lupus Erythematosus;Crohn Disease;Multiple Sclerosis;Ulcerative ColitisDrug: NivolumabAlliance Foundation Trials, LLC.Bristol-Myers SquibbRecruiting18 YearsN/AAll72Phase 1United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41NCT03923478June 24, 20192 September 2019ABI-M201 in Adult Subjects With Mildly-to-Moderately Active Ulcerative ColitisA Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase 1b Study to Evaluate the Safety, Efficacy and Mircobiological Response of Oral ABI-M201 in Subjects With Mildly-to-Moderately Active UC With Ongoing Mesalamine TreatmentUlcerative Colitis Chronic Mild;Ulcerative Colitis Chronic ModerateDrug: ABI-M201;Drug: PlaceboAssembly BiosciencesAllerganRecruiting18 Years70 YearsAll44Phase 1United States
42NCT03483246June 18, 201914 October 2019Impact of Fecal Microbiota Transplantation in Ulcerative ColitisImpact of Fecal Microbiota Transplantation in Ulcerative Colitis: a Randomized, Sham Controlled TrialUlcerative ColitisDrug: Fecal Microbiota Transplantation (FMT);Drug: Sham-transplantation PlaceboAssistance Publique - Hôpitaux de ParisCRB-HUEP;Institut National de la Santé Et de la Recherche Médicale, FranceRecruiting18 Years75 YearsAll150Phase 3France
43NCT03945188June 13, 201911 November 2019Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative ColitisA Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects With Moderately to Severely Active Ulcerative ColitisUlcerative ColitisDrug: Etrasimod;Drug: PlaceboArena PharmaceuticalsRecruiting16 Years80 YearsAll372Phase 3United States;Belgium;Croatia;Estonia;Georgia;Hungary;Korea, Republic of;Latvia;Lithuania;Moldova, Republic of;Slovakia;South Africa
44NCT03760003June 11, 201924 June 2019Dose-Ranging Phase 2b Study of ABX464 in Moderate to Severe Ulcerative ColitisA Randomized, Double Blind, Placebo Controlled, Parallel Group, Multiple Dose, Induction Study to Evaluate the Safety, Tolerability and Optimal Dose of ABX464 Compared With Placebo in Patients With Moderate to Severe Ulcerative Colitis Who Have Inadequate Response, Loss of Response, or Intolerance With at Least One of the Following Agents: Immunosuppressant Treatment (i.e. Azathioprine, 6-mercaptopurine, Methotrexate), Tumor Necrosis Factor Alpha [TNF-a] Inhibitors, Vedolizumab, JAK Inhibitors and/or Corticosteroid TreatmentUlcerative ColitisDrug: ABX464 25mg;Drug: ABX464 50mg;Drug: ABX464 100mg;Drug: PlaceboAbivax S.A.Recruiting18 Years75 YearsAll252Phase 2Poland
45NCT03915769June 3, 201928 October 2019To Evaluate Efficacy and Long-term Safety of Ozanimod in Japanese Subjects With Moderately to Severely Active Ulcerative ColitisA Phase 2/3, Multicenter, Randomized, Double-blind, Placebo-controlled Study of Oral Ozanimod to Evaluate Efficacy and Long-term Safety in Japanese Subjects With Moderately to Severely Active Ulcerative ColitisColitis, UlcerativeDrug: Ozanimod;Other: PlaceboCelgeneRecruiting18 Years75 YearsAll195Phase 3Japan
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46NCT03941418June 1, 201911 June 2019Impact of Additional Treatment With Saccharomyces Boulardii on Quality of Life in Patients With Mild Forms of Ulcerative Colitis and Crohn DiseaseImpact of Additional Treatment With Saccharomyces Boulardii on Quality of Life in Patients With Mild Forms of Ulcerative Colitis and Crohn DiseaseUlcerative Colitis;Crohn DiseaseDietary Supplement: Boulardii;Dietary Supplement: PlaceboUniversity Clinic Dr Dragisa Misovic-DedinjeUniversity Clinic ZvezdaraNot recruiting18 Years80 YearsAll150N/A
47NCT03977480June 1, 201917 June 2019Phase II Study of Hemay007 in Patients With Active Ulcerative ColitisA Multicenter, Randomized, Double-blind, Placebo Parallel Controlled Clinical Study on the Effecacy and Safety of Different Dosing Regimens of Hemay007 in Patients With Active Ulcerative ColitisUlcerative ColitisDrug: Hemay007;Drug: PlaceboTianjin Hemay Pharmaceutical Co.,LtdNot recruiting18 Years70 YearsAll288Phase 2China
48NCT03798691May 28, 201915 July 2019Immunogenicity of Herpes Zoster Subunit Vaccine in Inflammatory Bowel Disease Patients Treated With VedolizumabA Pilot Study Evaluating Immunogenicity of Herpes Zoster Subunit Vaccine in Inflammatory Bowel Disease Patients Treated With VedolizumabInflammatory Bowel Diseases;Crohn Disease;Ulcerative Colitis;Herpes ZosterBiological: ShingrixUniversity of Wisconsin, MadisonBoston Medical CenterRecruiting50 Years70 YearsAll30Phase 4United States
49ChiCTR19000231582019-05-2020 May 2019Clinical evaluation of traditional Chinese medicine on mild active ulcerative colitis: a multi-center, randomized, double-blind, controlled trialClinical evaluation of traditional Chinese medicine on mild active ulcerative colitis: a multi-center, randomized, double-blind, controlled trialUlcerative colitisTCM Group:Hudi Enteric-coated Capsules+Mesalazine Enteric-coated Tablets(Salofalk)Simulator;Medical Group:Mesalazine Enteric-coated Tablets(Salofalk)+Hudi Enteric-coated Capsules Simulator;Jiangsu Province Hospital of Chinese MedicineRecruiting1865BothTCM Group:120;Medical Group:120;Phase 4China
50ChiCTR19000231592019-05-2020 May 2019Clinical evaluation of traditional Chinese medicine on moderate active ulcerative colitis: a multi-center, randomized, double-blind, controlled trialClinical evaluation of traditional Chinese medicine on moderate active ulcerative colitis: a multi-center, randomized, double-blind, controlled trialUlcerative colitis?????????+???????(???)???:Qingchang Wenzhong Granules+Mesalazine Enteric-coated Tablets(Salofalk)Simulator;Medical Group:Mesalazine Enteric-coated Tablets(Salofalk)+Qingchang Wenzhong Granules Simulator;Combined Group:Qingchang Wenzhong Granules+Mesalazine Enteric-coated Tablets(Salofalk);Dongfang Hospital of Beijing University of Chinese MedicineRecruiting1865Both?????????+???????(???)???:90;Medical Group:90;Combined Group:90;Phase 0China
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51NCT03917095May 15, 201927 May 2019The Safety and Efficacy of TET Enema in the Treatment of UCMesalazine and Compound Glutamin Enema for the Treatment of Ulcerative Colitis Through Colonic Transendoscopic Enteral Tubing: A Multicenter, Randomized, Controlled TrailUlcerative Colitis Chronic Mild;Ulcerative Colitis Chronic ModerateDrug: Mesalazine;Drug: Glutamine;Device: The Colonic Transendoscopic enteral Tubing.The Second Hospital of Nanjing Medical UniversityRecruiting18 Years65 YearsAll75N/AChina
52NCT03943550May 8, 201920 May 2019Double-Blinded, Placebo-Controlled Phase 1b Study for Safety, PK, Efficacy, PD of RO7049665 in Patients With Ulcerative Colitis (UC)A Multicenter, Randomized, Double-Blind, Placebo Controlled Phase Ib Study to Investigate the Safety, Tolerability, Pharmacokinetics, Preliminary Efficacy, and Pharmacodynamics of Subcutaneously Administered RO7049665 in Participants With Active Ulcerative ColitisUlcerative ColitisDrug: RO7049665;Drug: PlaceboHoffmann-La RocheRecruiting18 Years70 YearsAll50Phase 1United States;Georgia;Hungary;Moldova, Republic of;Ukraine
53NCT03893565May 6, 201911 November 2019Safety, Tolerability, Efficacy and Dose-response of GSK2831781 in Ulcerative ColitisA Multicentre Randomized, Double-blind (Sponsor Open), Placebo-controlled Phase 2 Study to Evaluate the Safety, Tolerability, Efficacy, Dose-response, Pharmacokinetics and Pharmacodynamics of Repeat Dosing of an Anti-LAG3 Cell Depleting Monoclonal Antibody (GSK2831781) in Patients With Active Ulcerative ColitisColitis, UlcerativeDrug: Placebo;Biological: GSK2831781GlaxoSmithKlineRecruiting18 YearsN/AAll280Phase 2United States;Bulgaria;Czechia;Estonia;France;Netherlands;Poland;Slovakia;South Africa;United Kingdom
54NCT03843385May 20194 March 2019Transfer of FRozen Encapsulated Multidonor Stool Filtrate for Active Ulcerative COlitisLongterm Transfer of FRozen Encapsulated Multidonor Stool Filtrate or Encapsulated Multidonor Microbiome for Chronic Active Ulcerative COlitisUlcerative Colitis;Inflammatory Bowel DiseasesDrug: encapsulated faecal microbiota filtrate;Drug: encapsulated faecal microbiota;Drug: PlaceboJena University HospitalGerman Federal Ministry of Education and ResearchNot recruiting18 Years75 YearsAll174Phase 2/Phase 3
55NCT03934216April 26, 201911 November 2019Safety and Efficacy of BMS-986165 in Subjects With Moderate to Severe Ulcerative Colitis (UC)A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects With Moderate to Severe Ulcerative ColitisUlcerative ColitisDrug: BMS-986165;Drug: PlaceboBristol-Myers SquibbRecruiting18 Years80 YearsAll120Phase 2United States;Australia;Belgium;Canada;Czechia;Germany;Hungary;Italy;Japan;Korea, Republic of;Poland;Russian Federation;United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
56NCT03860896April 24, 201926 August 2019GB004 in Adult Subjects With Active Ulcerative ColitisA Phase 1b, Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GB004 in Adult Subjects With Active Ulcerative ColitisUlcerative ColitisDrug: GB004;Drug: PlaceboGB004, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.Recruiting18 Years74 YearsAll30Phase 1United States;Georgia;Moldova, Republic of
57NCT03800420April 22, 20194 November 2019Efficacy and Safety of BBT-401-1S in Ulcerative ColitisA Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2a Study to Evaluate the Efficacy and Safety of BBT-401-1S in Patients With Active Ulcerative ColitisUlcerative ColitisDrug: Active group;Drug: Placebo groupBridge Biotherapeutics, Inc.KCRN Research, LLCRecruiting18 YearsN/AAll48Phase 2United States
58NCT03675477April 13, 201914 October 2019A Phase II Study in Patients With Moderate to Severe Active Ulcerative Colitis.A Phase II Randomized, Placebo Controlled, Double-blind, 4 Arms Dose-ranging Study to Evaluate the Efficacy and Safety of SHR0302 Compared to Placebo in Patients With Moderate to Severe Active Ulcerative Colitis.Ulcerative ColitisDrug: SHR0302;Drug: PlacebosReistone Biopharma Company LimitedRecruiting18 Years75 YearsAll152Phase 2United States;China;Poland;Ukraine
59EUCTR2018-002135-19-HU11/04/201930 April 2019A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Ulcerative Colitis (UC)A 3-Year, Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects with Ulcerative Colitis (UC) - TD-1473 LTS UC StudyModerately-to-severely active Ulcerative Colitis (UC)
MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: TD-1473
Product Code: TD-1473
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Not assigned
Current Sponsor code: TD-1473
Other descriptive name: THRX-139060
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Product Name: TD-1473
Product Code: TD-1473
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Not assigned
Current Sponsor code: TD-1473
Other descriptive name: THRX-139060
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Product Name: TD-1473
Product Code: TD-1473
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Not assigned
Current Sponsor code: TD-1473
Other descriptive name: THRX-139060
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Theravance Biopharma Ireland LimitedAuthorised Female: yes
Male: yes
500Phase 3Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;United Kingdom;France;Hungary;Canada;Poland;Croatia;Australia;Georgia;South Africa;Bulgaria;Germany
60NCT03816345April 4, 201911 November 2019Nivolumab in Treating Patients With Autoimmune Disorders or Advanced, Metastatic, or Unresectable CancerA Phase Ib Study of Nivolumab in Patients With Autoimmune Disorders and Advanced Malignancies (AIM-NIVO)Advanced Malignant Neoplasm;Autoimmune Disease;Crohn Disease;Dermatomyositis;Inflammatory Bowel Disease;Metastatic Malignant Neoplasm;Multiple Sclerosis;Rheumatoid Arthritis;Sjogren Syndrome;Systemic Lupus Erythematosus;Systemic Scleroderma;Ulcerative Colitis;Unresectable Malignant NeoplasmBiological: NivolumabNational Cancer Institute (NCI)Recruiting18 YearsN/AAll264Phase 1United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
61ChiCTR19000222432019-04-011 April 2019Effect of curcumin combined with probiotics on prevention and treatment in ileal pouchitis after operation of ulcerative colitis.Effect of curcumin combined with probiotics on prevention and treatment in ileal pouchitis after operation of ulcerative colitis.ileal pouchitis after operation of ulcerative colitisExperimental group:Curcumin+Probiotics;Control group:Probiotics;Tianjin Medical University General HospitalRecruitingBothExperimental group:20;Control group:10;Phase 0China
62NCT03794765April 1, 201915 April 2019Antibiotics as an Adjuvant in Patients With Acute Severe Ulcerative ColitisUse of Antibiotics as an Adjuvant in Patients With Acute Severe Ulcerative Colitis: A Randomised TrialUlcerative Colitis;Inflammatory Bowel Diseases;Acute Severe ColitisDrug: Ceftriaxone;Drug: Metronidazole;Other: Placebo infusionPostgraduate Institute of Medical Education and ResearchRecruiting13 YearsN/AAll50Phase 2India
63NCT04000139April 1, 201928 October 2019Anthocyanin Rich Extract (ACRE) in Patients With Ulcerative ColitisA Multi-center, Multi-national, Randomized, Double-blind, Placebo Controlled, Parallel Group, Phase IIa Study to Evaluate the Efficacy, Safety and Tolerability of an Anthocyanin-rich Extract (ACRE) in Patients With Ulcerative ColitisUlcerative ColitisDrug: Standardized anthocyanin-rich extract;Drug: PlaceboUniversity of ZurichSwiss National Science Foundation;The Broad FoundationRecruiting18 YearsN/AAll120Phase 2Switzerland
64NCT04057547April 1, 201928 October 2019Efficacy and Safety of Modified Gegen Qinlian Decoction for Ulcerative Colitis With Damp-heat SyndromeThe Correlation Within Dampness-heat Syndrome of Ulcerative Colitis(UC) and Intestinal Microbiota Via C1orf106/Cytohesin-1(CYTH-1) /Adenosine Diphosphate-ribosylation Factor 6(ARF6) Signal Pathway and the Intervention Mechanism of Classic Chinese Compound Formula With Clearing Heat and Promoting DieresisUlcerative ColitisDrug: Modified Gegen Qinlian DecoctionXiyuan Hospital of China Academy of Chinese Medical SciencesRecruiting18 Years75 YearsAll60Early Phase 1China
65NCT03695185March 26, 20194 November 2019A Study to Investigate How Well ABBV-323 Works and How Safe it is in Participants With Moderate to Severe Ulcerative Colitis Who Failed Prior TherapyA Multicenter, Single Arm, Open-label Study to Investigate the Efficacy and Safety of ABBV-323 in Subjects With Moderate to Severe Ulcerative Colitis Who Failed Prior TherapyUlcerative Colitis (UC)Drug: ABBV-323 Dose B;Drug: ABBV-323 Dose AAbbVieRecruiting18 Years75 YearsAll60Phase 2United States;Canada;France;Germany;Italy;Korea, Republic of;Netherlands;Spain;United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
66EUCTR2018-002136-24-PT18/03/201930 April 2019A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Ulcerative ColitisA Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with TD-1473 in Subjects with Moderately-to-Severely Active Ulcerative Colitis - Rhea: Efficacy and Safety of TD-1473 in Ulcerative ColitisModerately-to-Severely Active Ulcerative Colitis
MedDRA version: 20.1 Level: LLT Classification code 10066678 Term: Acute ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: TD-1473
Product Code: TD-1473
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Not assigned
Current Sponsor code: TD-1473
Other descriptive name: THRX-139060
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Coated tablet
Route of administration of the placebo: Oral use
Product Name: TD-1473
Product Code: TD-1473
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Not assigned
Current Sponsor code: TD-1473
Other descriptive name: THRX-139060
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Pharmaceutical form of the placebo: Coated tablet
Route of administration of the placebo: Oral use
Product Name: TD-1473
Product Code: TD-1473
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Not assigned
Current Sponsor code: TD-1473
Other descriptive name: THRX-139060
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Coated tablet
Route of administration of the placebo: Oral use
Theravance Biopharma Ireland LimitedAuthorised Female: yes
Male: yes
880Phase 2;Phase 3Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;United Kingdom;India;France;Hungary;Canada;Poland;Croatia;Australia;Georgia;South Africa;Bulgaria;Germany
67NCT03768219March 18, 201922 October 2019Study to Evaluate APVO210 in Healthy Subjects, Patients With Psoriasis, and Patients With Ulcerative ColitisPhase 1 Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of APVO210 in Healthy Subjects, Patients With Psoriasis, and Patients With Ulcerative ColitisPsoriasis;Ulcerative ColitisBiological: APVO210;Biological: PlaceboAptevo TherapeuticsNot recruiting18 Years65 YearsAll144Phase 1Australia
68NCT03884439March 18, 20194 November 2019Infliximab Biosimilar Pfizer Drug Use Investigation (Crohn's Disease or Ulcerative Colitis)Infliximab BS for Intravenous Drip Infusion 100 mg Pfizer General Investigation (Crohn's Disease or Ulcerative Colitis)Crohn's Disease;Ulcerative ColitisDrug: Infliximab [infliximab biosimilar 3]PfizerRecruitingN/AN/AAll300Phase 3Japan
69EUCTR2017-004576-57-HU11/03/201930 April 2019Novel budesonide capsules vs. budesonide tables in patients with ulcerative colitis refractory to standard treatment with mesalazineRandomised, double-blind, double-dummy, active-controlled, phase III clinical trial on the efficacy and safety of an 8-week add-on treatment with budesonide 9 mg capsules vs. budesonide 6 mg capsules vs. budesonide-MMX® 9 mg tablets in patients with ulcerative colitis refractory to standard treatment with mesalazine - TOPICAL-2Patients with active ulcerative colitis refractory to standard treatment with mesalazine
MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Budesonide 9 mg capsules, hard (BUX-PVII prototype)
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: BUDESONIDE
CAS Number: 51333-22-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 9-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Product Name: Budesonide 6 mg capsules, hard (BUX-PVII prototype)
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: BUDESONIDE
CAS Number: 51333-22-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 6-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Trade Name: CortimentMMX 9 mg
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: BUDESONIDE
CAS Number: 51333-22-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 9-
Pharmaceutical form of the placebo: Prolonged-release tablet
Route of administration of the placebo: Oral use
Dr. Falk Pharma GmbHAuthorised Female: yes
Male: yes
777Phase 3Czech Republic;Hungary;Slovakia;Poland;Ukraine;Lithuania;Russian Federation;Latvia;Germany
70NCT03758443March 11, 201930 September 2019Efficacy & Safety of TD-1473 in Ulcerative ColitisA Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy With TD-1473 in Subjects With Moderately-to-Severely Active Ulcerative ColitisUlcerative Colitis (UC)Drug: TD-1473 Dose A;Drug: TD-1473 Dose B;Drug: TD-1473 Dose C;Drug: PlaceboTheravance BiopharmaRecruiting18 YearsN/AAll880Phase 2/Phase 3United States;Bulgaria;Georgia;Greece;Hungary;Israel;Poland;Portugal;Serbia;Slovakia;South Africa;Spain;Taiwan;Ukraine
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
71NCT03773445March 1, 201925 March 2019Golimumab Trough Levels in Patients With Ulcerative ColitisAssociation of Golimumab Trough Levels With Endoscopic and Histologic Healing in Patients With Ulcerative ColitisUlcerative ColitisDiagnostic Test: Golimumab trough levels;Diagnostic Test: Antibodies to golimumab;Diagnostic Test: Histology;Diagnostic Test: ColonoscopyHospital San Carlos, MadridHospital Universitario La Fe;Hospital Universitario 12 de Octubre;Hospital Universitario Ramon y Cajal;Gregorio Marañón Hospital;Complejo Hospitalario de Navarra;Hospital Universitario Fundación Alcorcón;Hospital Infanta Sofia;Hospital Clínico Universitario de Valencia;Puerta de Hierro University Hospital;Hospital Universitario La Paz;Hospital Universitario de Fuenlabrada;Merck Sharp & Dohme Corp.Recruiting18 YearsN/AAll100Phase 3Spain
72EUCTR2017-000574-11-GR26/02/201928 February 2019Research 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) - AIDAUlcerative 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
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Anti-MAdCAM antibody
Current Sponsor code: SHP647
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 75-
Product Code: SHP647
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Anti-MAdCAM antibody
Current Sponsor code: SHP647
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 25-
Shire Human Genetic Therapies, Inc.Authorised Female: yes
Male: yes
2453Phase 3Serbia;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
73NCT03942861February 21, 201920 May 2019Sonographic Assessment in Severe Ulcerative Colitis Patients Admitted for Intravenous Corticosteroids and Eligible for Infliximab Rescue Therapy; a Prospective Clinician-blinded Observational Study Protocol.Sonographic Assessment in Severe Ulcerative Colitis Patients Admitted for Intravenous Corticosteroids and Eligible for Infliximab Rescue Therapy; a Prospective Clinician-blinded Observational Study Protocol.Ulcerative Colitis;Ultrasound Therapy; ComplicationsDrug: Solu-MedrolCopenhagen University Hospital at HerlevRecruiting18 Years70 YearsAll50Phase 3Denmark
74EUCTR2018-003349-41-HU19/02/201928 February 2019Clinical trial to evaluate the benefit and safety of ST-0529 in subjects who are suffering from active ulcerative colitisA Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of ST-0529 in Subjects with Moderately to Severely Active Ulcerative ColitisActive ulcerative colitis
MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: ST-0529
Product Code: FP-CYA-050
Pharmaceutical Form: Capsule
INN or Proposed INN: CICLOSPORIN
CAS Number: 59865-13-3
Other descriptive name: cyclosporine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 37.5-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Product Name: ST-0529
Product Code: FP-CYA-053
Pharmaceutical Form: Capsule
INN or Proposed INN: CICLOSPORIN
CAS Number: 59865-13-3
Other descriptive name: cyclosporine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 18.75-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Sublimity Therapeutics (Hold Co) Ltd.Authorised Female: yes
Male: yes
280Phase 2Serbia;United States;Belarus;Spain;Ukraine;Ireland;Turkey;Russian Federation;Israel;United Kingdom;France;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Germany
75ChiCTR19000212292019-02-184 February 2019The role of fecal calprotectin in the treatment of patients with clinically quiescent ulcerative colitisThe role of fecal calprotectin in the treatment of patients with clinically quiescent ulcerative colitisUlcerative colitisIntervention group:Increasing the dose of mesalamine according to fecal calprotectin levels;Control group:Maintaining current dosage of mesalamine;Beijing Friendship Hospital, Capital Medical UniversityNot RecruitingBothIntervention group:74;Control group:74;OtherChina
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
76NCT03832400February 4, 201925 February 2019Safety and Efficacy of Microbial Ecosystem Therapeutic-2 (MET-2) in Patients With Ulcerative Colitis (UC)A Phase 1b, Placebo-controlled, Study of the Safety and Efficacy of MET-2 in Patients With Ulcerative ColitisUlcerative ColitisBiological: MET-2;Drug: Placebo oral capsuleNuBiyotaRecruiting18 YearsN/AAll30Phase 1Canada
77NCT03824561February 1, 201925 February 2019Specified Drug-Use Survey on Vedolizumab for IV Infusion 300 mg [Ulcerative Colitis]Specified Drug-Use Survey on Entyvio for IV Infusion 300 mg [Ulcerative Colitis]Ulcerative ColitisDrug: VedolizumabTakedaRecruitingN/AN/AAll1000Phase 2Japan
78EUCTR2017-003229-14-DE31/01/201928 February 2019AN INDUCTION STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITISA Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 1) - LUCENT 1Ulcerative Colitis
MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: mirikizumab
Product Code: LY3074828
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: MIRIKIZUMAB
Current Sponsor code: LY3074828
Other descriptive name: MIRIKIZUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
Eli Lilly and CompanyAuthorised Female: yes
Male: yes
1160Phase 3Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan
79NCT03844932January 24, 201911 November 2019A Study Evaluating the Efficacy and Safety of ST-0529 in Subjects With Moderately to Severely Active Ulcerative ColitisA Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of ST-0529 in Subjects With Moderately to Severely Active Ulcerative ColitisColitis, UlcerativeDrug: ST-0529Sublimity Therapeutics Holdco LimitedDr. Falk Pharma GmbHRecruiting18 Years75 YearsAll280Phase 2United States;Belarus;Bulgaria;Canada;France;Germany;Hungary;Ireland;Italy;Poland;Romania;Russian Federation;Serbia;Spain;Ukraine;United Kingdom
80NCT03804931January 20, 201928 January 2019Fecal Microbiota Transplantation for Ulcerative ColitisEfficacy and Safety of Fecal Microbiota Transplantation for Ulcerative ColitisUlcerative Colitis;Fecal Microbiota TransplantationProcedure: Fecal microbiota transplantation;Procedure: Infusion of Saline;Drug: 5-Aminosalicylic acid(5-ASA) and/or PrednisoneGuangzhou First People's HospitalRecruiting18 Years65 YearsAll120Phase 2/Phase 3China
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
81NCT04114292January 17, 201914 October 2019TUDCA as a Therapy for Ulcerative Colitis (UC)A Phase I Open Label Study of the Efficacy and Safety of Tudca in Ulcerative ColitisUlcerative ColitisDrug: Tauroursoursodeoxycholic acid, brand name TudcabilWashington University School of MedicineCrohn's and Colitis FoundationRecruiting18 Years65 YearsAll12Phase 1United States
82NCT03650413January 14, 201911 November 2019An Extension Study to Evaluate the Long-Term Safety and Tolerability of UTTR1147A in Participants With Moderate to Severe Ulcerative Colitis or Crohn's DiseaseA Phase II Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of UTTR1147A in Patients With Moderate to Severe Ulcerative Colitis or Crohn's DiseaseUlcerative Colitis;Crohn's DiseaseDrug: UTTR1147AGenentech, Inc.Recruiting18 Years80 YearsAll320Phase 2United States;Bulgaria;France;Germany;Greece;Hungary;Ireland;Israel;Italy;Netherlands;Poland;Russian Federation;Serbia;Spain;Ukraine;United Kingdom
83NCT03679546January 4, 201911 November 2019EFFICACI : EFFicacy of Intravenous Infliximab Versus Vedolizumab After Failure of subCutaneous Anti-TNF in Patients With UlCerative ColitisEFFICACI : EFFicacy of Intravenous Infliximab Versus Vedolizumab After Failure of subCutaneous Anti-TNF in Patients With UlCerative Colitis : A Double Blinded Randomized Clinical TrialUlcerative ColitisDrug: Infliximab;Drug: Vedolizumab InjectionRennes University HospitalRecruiting18 Years75 YearsAll150Phase 4France
84EUCTR2018-002925-47-ES28/12/201828 February 2019prediction of response to therapy in inflammatory bowel diseaseIdentification of predictive biomarkers for response to biologic therapies in inflammatory bowel disease by proteomic and mass cytometry approachesInflammatory bowel disease
MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Adalimumab
Pharmaceutical Form: Injection
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Trade Name: Infliximab
Pharmaceutical Form: Infusion
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: equal
Concentration number: 5-
Trade Name: Golimumab
Pharmaceutical Form: Injection
INN or Proposed INN: GOLIMUMAB
CAS Number: 476181-74-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Trade Name: Ustekinumab
Pharmaceutical Form: Injection
INN or Proposed INN: USTEKINUMAB
CAS Number: 815610-63-0
Other descriptive name: USTEKINUMAB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 90-
Trade Name: Vedolizumab
Pharmaceutical Form: Infusion
INN or Proposed INN: VEDOLIZUMAB
CAS Number: 943609-66-3
Other descriptive name: VEDOLIZUMAB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
Fundación de Investigación Biomédica del Hospital Universitario de La PrincesaAuthorised Female: yes
Male: yes
180Phase 4Spain
85NCT03765450December 21, 201815 July 2019Pharmacokinetics of IFX and TNF Concentrations in Serum, Stool, and Colonic Mucosa in Acute Severe Ulcerative ColitisPharmacokinetics of Infliximab and Tumor Necrosis Factor Concentrations in Serum, Stool, and Colonic Mucosa in Acute Severe Ulcerative ColitisUlcerative ColitisDrug: InfliximabRobarts Clinical Trials Inc.Recruiting18 YearsN/AAll30Phase 3United States;Canada
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
86NCT03759041December 19, 201828 October 2019A Study to Assess Efficacy and Safety of SER-287 in Adults With Active Mild-to-Moderate Ulcerative ColitisECO-RESET: A Phase 2B, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Multicenter Study to Assess Efficacy and Safety of SER-287 in Adults With Active Mild-to-Moderate Ulcerative ColitisUlcerative ColitisDrug: Vancomycin Pre-Treatment;Drug: Placebo for Vancomycin Pre-Treatment;Drug: SER-287;Drug: Placebo for SER-287Seres Therapeutics, Inc.Recruiting18 Years80 YearsAll201Phase 2United States;Canada
87EUCTR2016-000642-62-LV13/12/201828 February 2019A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative ColitisM14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative ColitisUlcerative Colitis
MedDRA version: 20.0 Level: PT Classification code 10009900 Term: Colitis ulcerative System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Upadacitinib
Product Code: ABT-494
Pharmaceutical Form: Tablet
INN or Proposed INN: Upadacitinib
CAS Number: 1310726-60-3
Current Sponsor code: ABT-494
Other descriptive name: ABT-494
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 45-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
AbbVie Deutschland GmbH & Co. KGAuthorised Female: yes
Male: yes
462Phase 3Portugal;Serbia;Belarus;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Singapore;Croatia;Germany;Norway;Japan
88NCT03574948December 6, 201811 June 20195-HTP in Patients With IBD in Clinical and Biologic Remission:Effect on Fatigue ScoresMulticentric, Double-blind, Placebo Controlled Clinical Trial With 5-hydroxytryptophan (5-HTP) in Patients With Inflammatory Bowel Disease in Clinical and Biologic Remission: Effect on Fatigue ScoresCrohn Disease;Ulcerative Colitis;Fatigue;RemissionDrug: 5-HTP;Drug: Placebo oral capsuleUniversity Hospital, GhentRecruiting18 Years60 YearsAll180Phase 2Belgium
89JPRN-UMIN0000340162018/12/017 October 2019The investigation for maintenance therapy by mesalazine enema after remission induction by budesonide form enema in patients with ulcerative colitis: Multicenter randomized controlled studyThe investigation for maintenance therapy by mesalazine enema after remission induction by budesonide form enema in patients with ulcerative colitis: Multicenter randomized controlled study - STABILITY studyulcerative colitisAdditional remission maintenance therapy by mesalazine enema with continuation of concomitant treatment at the remission induction by budesonide form enema
The continuation of concomitant treatment at the remission induction by budesonide form enema (control group)
Hyogo College of MedicineRecruiting16years-oldNot applicableMale and Female84Not selectedJapan
90NCT03716388December 1, 201825 February 2019Fecal Microbiota Therapy Vs 5-aminosalicylates for Induction of Remission in Newly Diagnosed Mild-moderately Active UCFecal Microbiota Therapy Vs 5-aminosalicylates for Induction of Remission in Newly Diagnosed Mild-moderately Active UC : a Pilot StudyUlcerative Colitis Chronic Mild;Ulcerative Colitis Chronic ModerateBiological: Fecal Microbiota Transplantation;Drug: Mesalamine Granules;Other: Placebo infusion;Other: Placebo granulesDayanand Medical College and HospitalColitis & Crohn's Foundation (India)Recruiting18 Years75 YearsAll20Phase 3India
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
91NCT03944447December 1, 20187 October 2019Outcomes Mandate National Integration With Cannabis as MedicineOutcomes Mandate National Integration With Cannabis as MedicineChronic Pain;Chronic Pain Syndrome;Chronic Pain Due to Injury;Chronic Pain Due to Trauma;Fibromyalgia;Seizures;Hepatitis C;Cancer;Crohn Disease;HIV/AIDS;Multiple Sclerosis;Traumatic Brain Injury;Sickle Cell Disease;Post Traumatic Stress Disorder;Tourette Syndrome;Ulcerative Colitis;Glaucoma;Epilepsy;Inflammatory Bowel Diseases;Parkinson Disease;Amyotrophic Lateral Sclerosis;Chronic Traumatic Encephalopathy;Anxiety;Depression;Insomnia;Autism;Opioid-use Disorder;Bipolar DisorderDrug: Cannabis, MedicalOMNI Medical Services, LLCRecruiting7 YearsN/AAll100000Phase 2United States
92NCT02201758December 201825 June 2018Flaxseed Lignan-Enriched Complex (FLC) for the Treatment of Patients With Ulcerative Colitis (UC): A Pilot AssessmentFlaxseed Lignan-enriched Complex (FLC) for the Treatment of Patients With Mild to Moderately Severe Ulcerative Colitis (UC): A Pilot Assessment.Ulcerative ColitisDietary Supplement: Flaxseed lignan-enriched complex (FLC);Other: PlaceboUniversity of SaskatchewanRoyal University Hospital FoundationNot recruiting18 YearsN/AAll56Phase 2Canada
93NCT03729674November 26, 20183 December 2018Comparative Effectiveness and Safety of Biosimilar and Legacy DrugsComparative Effectiveness and Safety of Biosimilar and Legacy DrugsRheumatoid Arthritis;Ankylosing Spondylitis;Ulcerative Colitis;Crohn's DiseaseDrug: Biosimilar;Drug: Originator (legacy) drugMcGill University Health CenterUniversité de Sherbrooke;Institut de rhumatologie de Montréal;Hospital for Special Surgery, New York;University of Manitoba;University of Toronto;University of Alberta;University of British Columbia;Alberta Health Services;McMaster University;The Arthritis Program Research GroupNot recruiting18 YearsN/AAll800Phase 3
94NCT03662542November 20, 201811 November 2019A Study of Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative ColitisA Phase 2a Randomized, Double-blind, Active-controlled, Parallel-group, Multicenter, Proof-of-concept Clinical Study to Evaluate the Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative ColitisColitis, UlcerativeDrug: Guselkumab Dose 1;Drug: Guselkumab Dose 2;Drug: Golimumab Dose 1;Drug: Golimumab Dose 2;Drug: PlaceboJanssen Research & Development, LLCRecruiting18 Years65 YearsAll210Phase 2United States;Argentina;Australia;Brazil;Germany;Mexico;Poland;Russian Federation;Ukraine
95EUCTR2016-004676-22-DK15/11/201828 February 2019A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Product Name: Risankizumab
Product Code: ABBV-006
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: RISANKIZUMAB
Current Sponsor code: ABBV-066
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 90-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
Product Name: Risankizumab
Product Code: ABBV-066
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: RISANKIZUMAB
Current Sponsor code: ABBV-066
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 90-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use
AbbVie Deutschland GmbH & Co. KGAuthorised Female: yes
Male: yes
760Phase 3Serbia;Portugal;United States;Belarus;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
96NCT03596645October 29, 201811 November 2019A Study to Assess the Efficacy and Safety of Golimumab in Pediatric Participants With Moderately to Severely Active Ulcerative ColitisA Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety, and Pharmacokinetics of Golimumab Treatment, a Human Anti-TNFa Monoclonal Antibody, Administered Subcutaneously in Pediatric Participants With Moderately to Severely Active Ulcerative ColitisColitis, UlcerativeDrug: Golimumab;Drug: InfliximabJanssen Research & Development, LLCRecruiting2 Years17 YearsAll125Phase 3United States;Belgium;Brazil;France;Israel;Italy;Korea, Republic of;Netherlands;Poland;Spain;Taiwan
97NCT03648541October 29, 20184 November 2019BI 655130 Long-term Treatment in Patients With moderate-to Severe Ulcerative ColitisAn Open Label, Long Term Safety Trial of BI 655130 Treatment in Patients With Moderate to Severely Active Ulcerative Colitis Who Have Completed Previous BI 655130 TrialsColitis, UlcerativeDrug: Spesolimab IV infusion;Drug: Spesolimab SC solution for injectionBoehringer IngelheimRecruiting18 YearsN/AAll535Phase 2United States;Austria;Belgium;Canada;Germany;Italy;Japan;Korea, Republic of;Russian Federation;Spain;United Kingdom
98NCT03558152October 26, 201811 November 2019A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared With Placebo and With Vedolizumab in Participants With Moderate to Severe Ulcerative Colitis (UC)A Phase II, Randomized, Parallel-Group, Double-Blind, Double-Dummy, Placebo-Controlled, Multicenter Study To Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared With Placebo and Compared With Vedolizumab in Patients With Moderate to Severe Ulcerative ColitisUlcerative ColitisDrug: UTTR1147A;Drug: UTTR1147A Placebo;Drug: Vedolizumab;Drug: Vedolizumab PlaceboGenentech, Inc.Recruiting18 Years80 YearsAll270Phase 2United States;Bulgaria;China;France;Germany;Greece;Hungary;Ireland;Israel;Italy;Netherlands;Poland;Russian Federation;Serbia;Spain;Ukraine;United Kingdom
99EUCTR2018-000334-35-BE22/10/20187 January 2019BI 655130 long-term treatment in patients with moderate-to-severe ulcerative colitisAn open label, long term safety trial of BI 655130 treatment in patients with moderate to severely active ulcerative colitis who have completed previous BI 655130 trialsModerate-to-severely active ulcerative colitis
MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
Product Code: BI 655130
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: BI 655130
Current Sponsor code: BI 655130
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Product Code: BI 655130
Pharmaceutical Form: Solution for injection
INN or Proposed INN: BI 655130
Current Sponsor code: BI 655130
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 150-
SCS Boehringer Ingelheim Comm V.AuthorisedFemale: yes
Male: yes
160Phase 2United States;Spain;Austria;Russian Federation;United Kingdom;Italy;Canada;Belgium;Poland;Germany;Netherlands;Japan;Korea, Republic of
100NCT03524092October 19, 201811 November 2019A Maintenance Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative ColitisA Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm, Placebo-Controlled Maintenance Study of Mirikizumab in Patients With Moderately to Severely Active Ulcerative Colitis (LUCENT 2)Ulcerative ColitisDrug: Mirikizumab;Drug: PlaceboEli Lilly and CompanyRecruiting18 Years80 YearsAll1044Phase 3United States;Argentina;Australia;Austria;Belgium;Canada;China;Croatia;Czechia;Denmark;France;Germany;Hungary;India;Ireland;Israel;Italy;Japan;Korea, Republic of;Latvia;Lithuania;Malaysia;Mexico;Netherlands;Poland;Romania;Russian Federation;Saudi Arabia;Serbia;Slovakia;Spain;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom;Brazil
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
101EUCTR2017-003238-96-DE15/10/201828 February 2019A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITISA PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-ARM, PLACEBO-CONTROLLED MAINTENANCE STUDY OF MIRIKIZUMAB IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS (LUCENT 2) - LUCENT 2Moderately to Severely Active Ulcerative Colitis
MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: mirikizumab
Product Code: LY3074828
Pharmaceutical Form: Solution for injection
INN or Proposed INN: MIRIKIZUMAB
Current Sponsor code: LY3074828
Other descriptive name: MIRIKIZUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Product Name: mirikizumab
Product Code: LY3074828
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: MIRIKIZUMAB
Current Sponsor code: LY3074828
Other descriptive name: MIRIKIZUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Eli Lilly and CompanyAuthorised Female: yes
Male: yes
1044Phase 3Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan
102NCT02921555October 11, 201822 July 2019Endovenous Corticosteroid Pulses in Moderate Ulcerative ColitisEfficacy of High-dose Corticosteroid Pulses Added to Conventional Oral Corticosteroid Course for Moderate Flares of Ulcerative Colitis.Ulcerative ColitisDrug: Methylprednisolone;Drug: PrednisoneGrupo Espanol de Trabajo en Enfermedad de Crohn y Colitis UlcerosaRecruiting18 YearsN/AAll148Phase 4Spain
103NCT03653026October 4, 201811 November 2019A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Ulcerative ColitisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative ColitisUlcerative Colitis (UC)Drug: Upadacitinib (ABT-494);Drug: PlaceboAbbVieRecruiting16 Years75 YearsAll462Phase 3United States;Argentina;Australia;Austria;Belgium;Bosnia and Herzegovina;Brazil;Canada;Chile;China;Colombia;Croatia;Czechia;Egypt;Estonia;Finland;France;Germany;Greece;Hungary;Ireland;Israel;Italy;Japan;Korea, Republic of;Latvia;Lithuania;Malaysia;Mexico;Netherlands;Norway;Poland;Portugal;Puerto Rico;Romania;Russian Federation;Serbia;Singapore;Slovakia;South Africa;Spain;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom;Belarus;Sweden
104NCT03669029October 1, 201824 September 2018Optimization of Golimumab Treatment in Ulcerative ColitisOptimization of Golimumab Treatment in Ulcerative ColitisColitis, UlcerativeDrug: Golimumab 50 mg in patients <80 kg and Golimumab 100 mg in patients >80 kg;Drug: Golimumab treatment optimization.Hospital de ManisesValencia University General Hospital;Hospital Clínico Universitario de Valencia;Hospital de Sagunt;Hospital Universitario La Fe;Hospital General Universitario de Alicante;Hospital Universitario Doctor Peset;Hospital Arnau de Vilanova;Hospital Provincial de Castellon;Merck Sharp & Dohme Corp.Not recruiting18 Years80 YearsAll50Phase 4Spain
105NCT03627052September 20, 20187 October 2019A Study to Evaluate the Safety and Efficacy of Itacitinib in Moderate to Severe Ulcerative ColitisA Phase 2, Double-Blind, Dose-Ranging, Placebo-Controlled Study With Open-Label Extension to Evaluate the Safety and Efficacy of Itacitinib in Moderate to Severe Ulcerative ColitisModerate to Severe Ulcerative ColitisDrug: Itacitinib;Drug: PlaceboIncyte CorporationRecruiting18 Years74 YearsAll206Phase 2United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
106EUCTR2018-000334-35-ES17/09/201810 October 2018BI 655130 long-term treatment in patients with moderate-to-severe ulcerative colitisAn open label, long term safety trial of BI 655130 treatment in patients with moderate to severely active ulcerative colitis who have completed previous BI 655130 trialsModerate-to-severely active ulcerative colitis
MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
Product Code: BI 655130
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: BI 655130
Current Sponsor code: BI 655130
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Product Code: BI 655130
Pharmaceutical Form: Solution for injection
INN or Proposed INN: BI 655130
Current Sponsor code: BI 655130
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 150-
Boehringer Ingelheim España, S.A.AuthorisedFemale: yes
Male: yes
160Phase 2United States;Spain;Austria;Russian Federation;United Kingdom;Italy;Canada;Belgium;Poland;Germany;Netherlands;Japan;Korea, Republic of
107JPRN-JapicCTI-18413110/9/201816 July 2019A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative ColitisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative ColitisUlcerative ColitisIntervention name : ABT-494
INN of the intervention : upadacitinib
Dosage And administration of the intervention : Will be orally administered
Control intervention name : Placebo
Dosage And administration of the control intervention : Will be orally administered
AbbVie GKRecruiting1875BOTHPhase 3
108EUCTR2018-001051-12-FR07/09/201824 September 2018VEDO - PREDIRESPUC project - Vedolizumab and anti-vedolizumab antibody in the prediction of therapeutic response in Ulcerative ColitisVEDO - PREDIRESPUC project - Value of pharmacokinetic assays (Vedolizumab and anti-vedolizumab antibody) in the prediction of induction and maintenance therapeutic response in Ulcerative ColitisUlcerative Colitis
MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856
MedDRA version: 20.1 Level: LLT Classification code 10066678 Term: Acute ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: ENTYVIO
Product Name: ENTYVIO
Product Code: 1
Pharmaceutical Form: Powder for concentrate and solution for solution for infusion
CHU Saint-EtienneAuthorisedFemale: yes
Male: yes
125Phase 4France
109EUCTR2018-002673-21-FR04/09/201810 October 2018EFFICACI : EFFicacy of intravenous Infliximab versus vedolizumab after failure of subCutaneous Anti-TNF in patients with UlCerative colitis : A double blinded Randomized Clinical Trial.EFFICACI : EFFicacy of intravenous Infliximab versus vedolizumab after failure of subCutaneous Anti-TNF in patients with UlCerative colitis : A double blinded Randomized Clinical Trial. - EFFICACIUlcerative colitis
MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
Trade Name: Remicade
Product Name: infliximab
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: equal
Concentration number: 5-
Trade Name: Inflectra
Product Name: infliximab
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: equal
Concentration number: 5-
Trade Name: Flixabi
Product Name: infliximab
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: equal
Concentration number: 5-
Trade Name: Remsima
Product Name: infliximab
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: equal
Concentration number: 5-
Trade Name: Entyvio
Product Name: Vedolizumab
Pharmaceutical Form: Powder for solution for infusion
CAS Number: 943609-66-3
Other descriptive name: VEDOLIZUMAB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
Centre Hospitalier Universitaire de RennesAuthorisedFemale: yes
Male: yes
150Phase 4France
110EUCTR2017-002350-36-NL28/08/20181 October 2018A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared with Placebo and Compared with Vedolizumab in Patients with Moderate to Severe Ulcerative Colitis.A PHASE II, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF UTTR1147A COMPARED WITH PLACEBO AND COMPARED WITH VEDOLIZUMAB IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITISUlcerative colitis (UC)
MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856
MedDRA version: 20.1 Level: LLT Classification code 10033007 Term: Other ulcerative colitis System Organ Class: 100000004856
MedDRA version: 20.1 Level: LLT Classification code 10045366 Term: Ulcerative colitis, unspecified System Organ Class: 100000004856
MedDRA version: 20.1 Level: LLT Classification code 10066678 Term: Acute ulcerative colitis System Organ Class: 100000004856
MedDRA version: 20.0 Level: LLT Classification code 10075635 Term: Acute hemorrhagic ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: UTTR1147A/RO7021610 (Active)
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: n.a.
Current Sponsor code: RO7021610
Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
Trade Name: Entyvio 300mg
Product Code: RO7246311
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: Vedolizumab
CAS Number: 943609-66-3
Current Sponsor code: RO7246311
Other descriptive name: VEDOLIZUMAB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
Genentech, Inc.AuthorisedFemale: yes
Male: yes
330Phase 2Bulgaria;Netherlands;Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;United Kingdom;Italy;Hungary;Poland;Germany
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
111NCT03398135August 28, 20184 November 2019A Study to Assess the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065Ulcerative Colitis (UC)Drug: risankizumab;Drug: placebo for risankizumabAbbVieRecruiting16 Years80 YearsAll760Phase 3United States;Argentina;Austria;Belgium;Brazil;Bulgaria;Canada;Chile;China;Colombia;Croatia;Denmark;Egypt;France;Germany;Greece;Hungary;Israel;Italy;Japan;Korea, Republic of;Latvia;Lithuania;Malaysia;Mexico;Netherlands;New Zealand;Poland;Portugal;Puerto Rico;Romania;Russian Federation;Serbia;Singapore;Slovakia;Slovenia;South Africa;Spain;Sweden;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom;American Samoa;Australia;Czechia
112EUCTR2018-000334-35-AT20/08/20183 September 2018BI 655130 long-term treatment in patients with moderate-to-severe ulcerative colitisAn open label, long term safety trial of BI 655130 treatment in patients with moderate to severely active ulcerative colitis who have completed previous BI 655130 trialsModerate-to-severely active ulcerative colitis
MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
Product Code: BI 655130
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: BI 655130
Current Sponsor code: BI 655130
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Product Code: BI 655130
Pharmaceutical Form: Solution for injection
INN or Proposed INN: BI 655130
Current Sponsor code: BI 655130
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 150-
Boehringer Ingelheim RCV GmbH&Co. KGAuthorisedFemale: yes
Male: yes
160Phase 2United States;Spain;Austria;Russian Federation;United Kingdom;Italy;Canada;Belgium;Poland;Germany;Netherlands;Japan;Korea, Republic of
113NCT03546868August 14, 20183 September 2018Diagnostic Validity of [18F]FSPG PET for the Assessment of Disease Activity in Inflammatory Bowel DiseasePhase 2, Open-label, Non-randomized, Single Center Study to Explore Diagnostic Validity of [18F]FSPG PET for the Assessment of Disease Activity in Subjects With Inflammatory Bowel Disease.Inflammatory Bowel Diseases;Ulcerative Colitis;Crohn DiseaseDrug: [18F]FSPGAsan FoundationRecruiting19 Years79 YearsAll20Phase 2Korea, Republic of
114NCT03616821August 7, 20189 September 2019An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis [EXPEDITION]A 54-Week Treatment, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo and Active-Controlled, Parallel-Group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants With Moderately to Severely Active Ulcerative ColitisColitis;Ulcerative;IBDDrug: Brazikumab;Drug: Vedolizumab;Drug: PlaceboAllerganRecruiting18 Years80 YearsAll375Phase 2United States;Canada
115NCT03196427July 30, 201815 July 2019Long-term Safety With Vedolizumab Intravenous (IV) in Pediatric Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD)A Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn's DiseaseUlcerative Colitis;Crohn's DiseaseDrug: VedolizumabTakedaRecruiting2 Years17 YearsAll80Phase 2United States;Belgium;Canada;France;Hungary;Israel;Netherlands;Poland;Ukraine;United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
116NCT03519945July 18, 201811 November 2019A Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 3)A Phase 3, Multicenter, Open-Label Extension Study to Evaluate the Long Term Efficacy and Safety of Mirikizumab in Patients With Moderately to Severely Active Ulcerative Colitis LUCENT 3Ulcerative ColitisDrug: MirikizumabEli Lilly and CompanyRecruiting18 Years80 YearsAll840Phase 3United States;Argentina;Australia;Austria;Belgium;Canada;Croatia;Czechia;Denmark;France;Georgia;Germany;Hungary;India;Ireland;Israel;Italy;Japan;Korea, Republic of;Latvia;Lithuania;Malaysia;Mexico;Moldova, Republic of;Netherlands;Poland;Romania;Russian Federation;Saudi Arabia;Serbia;Slovakia;Spain;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom
117NCT03860571July 6, 201811 March 2019Safety, Tolerability, and Pharmacokinetics of Oral BT-11 in Healthy Adult Male and Female VolunteersA Randomized, Placebo-Controlled, Sequential Single and Multiple Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral BT-11 in Healthy Adult Male and Female VolunteersUlcerative Colitis;Crohn DiseaseDrug: BT-11 Placebo;Drug: BT-11 ActiveLandos Biopharma Inc.Not recruiting18 Years65 YearsAll70Phase 1United States
118NCT02469220July 1, 201820 May 2019Diet Treatment of Patients With Ulcerative Colitis in RemissionDiet Treatment of Patients With Ulcerative Colitis in RemissionUlcerative ColitisDietary Supplement: Low FODMAP;Dietary Supplement: Standardized FODMAPVendsyssel HospitalRecruiting18 Years70 YearsAll45N/ADenmark
119NCT03609905July 1, 201820 August 2018Adipose Mesenchymal Stem Cells (AMSC) for Treatment of Ulcerative ColitisA Phase I/II Randomized, Controlled, Clinical Trial for Assessment of the Safety and Efficacy of Allogeneic Adipose Mesenchymal Stem Cells in Moderate to Severe Ulcerative Colitis PatientsUlcerative Colitis (UC)Biological: Adipose-cord mesenchymal stromal cells (A-MSCs);Other: Conventional drugsLiaocheng People's HospitalRecruiting18 Years65 YearsAll50Phase 1/Phase 2China
120NCT03773952July 1, 201818 December 2018Safety and Efficacy of PBF-677 in Ulcerative Colitis PatientsA Phase IIa (Proof of Concept), Randomized, Double Blind, Placebo Controlled, Multicenter Clinical Trial to Evaluate the Safety and Efficacy of Oral Treatment With PBF-677 in Patients With Mild to Moderate Ulcerative ColitisUlcerative ColitisDrug: PBF-677;Drug: Placebo oral capsulePalobiofarma SLQualitecfarmaRecruiting18 Years75 YearsAll50Phase 2Spain
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
121ChiCTR18000164382018-06-305 June 2018Clinical research of flupentixol-melitracen and mesalazine on ulcerative colitisClinical research of flupentixol-melitracen and mesalazine on ulcerative colitisulcerative colitiscontrol:mesalazine 1 po qid;observation group:mesalazine 1 po qid; flupentixol-melitracen 1pill po tid;Guiyang 1st People's HospitalNot Recruiting1575Bothcontrol:30;observation group:30;Pilot studyChina
122EUCTR2017-004967-11-FR26/06/201810 October 2018Prospective multicenter randomized controlled double-blind label study of the prophylaxis of recurrent pouchitis after fecal microbiota transplant in UC with ileo-anal anastomosis.Poca - PocaPatients operated with an IPAA for Ulcerative Colitis with active recurrent pouchitis, who respond after 4 weeks of an antibiotherapy, will be randomized
MedDRA version: 20.1 Level: LLT Classification code 10000638 Term: Active ileal inflammation System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: suspension de microbiote fécal
Product Code: PRD5973697
Pharmaceutical Form: Solution for injection
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Rectal use
CHU NantesAuthorisedFemale: yes
Male: yes
42Phase 3France
123NCT03518086June 18, 201811 November 2019An Induction Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 1)A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients With Moderately to Severely Active Ulcerative Colitis (LUCENT 1)Ulcerative ColitisDrug: Mirikizumab;Drug: PlaceboEli Lilly and CompanyRecruiting18 Years80 YearsAll1160Phase 3United States;Argentina;Australia;Austria;Belgium;Canada;China;Croatia;Czechia;Denmark;France;Germany;Hungary;India;Ireland;Israel;Italy;Japan;Korea, Republic of;Latvia;Lithuania;Malaysia;Mexico;Netherlands;Poland;Romania;Russian Federation;Saudi Arabia;Serbia;Slovakia;Spain;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom;Brazil
124EUCTR2017-002350-36-HU14/06/201820 August 2018A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared with Placebo and Compared with Vedolizumab in Patients with Moderate to Severe Ulcerative Colitis.A PHASE II, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF UTTR1147A COMPARED WITH PLACEBO AND COMPARED WITH VEDOLIZUMAB IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITISUlcerative colitis (UC)
MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856
MedDRA version: 20.1 Level: LLT Classification code 10033007 Term: Other ulcerative colitis System Organ Class: 100000004856
MedDRA version: 20.1 Level: LLT Classification code 10045366 Term: Ulcerative colitis, unspecified System Organ Class: 100000004856
MedDRA version: 20.1 Level: LLT Classification code 10066678 Term: Acute ulcerative colitis System Organ Class: 100000004856
MedDRA version: 20.0 Level: LLT Classification code 10075635 Term: Acute hemorrhagic ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: n.a.
Product Code: UTTR1147A/RO7021610 (Active)
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: n.a.
Current Sponsor code: RO7021610
Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
Trade Name: Entyvio 300mg
Product Code: RO7246311
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: Vedolizumab
CAS Number: 943609-66-3
Current Sponsor code: RO7246311
Other descriptive name: VEDOLIZUMAB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
Genentech, Inc.AuthorisedFemale: yes
Male: yes
270Phase 2Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;United Kingdom;Italy;Hungary;Poland;Bulgaria;Germany;Netherlands
125NCT03531892June 6, 201822 July 2019A Study to Evaluate the Safety and Efficacy of AJM300 in Participants With Active Ulcerative ColitisPhase III Study of AJM300 in Patients With Active Ulcerative ColitisColitis, UlcerativeDrug: AJM300;Drug: PlaceboEA Pharma Co., Ltd.Kissei Pharmaceutical Co., Ltd.Recruiting16 Years74 YearsAll198Phase 3Japan
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
126EUCTR2017-003284-35-ES05/06/201818 June 2018Investigate the efficacy and safety of study drug ABX464 50 mg once daily in patients with moderate to severe Active Ulcerative Colitis.A follow-up Phase IIa study to evaluate the long-term safety and efficacy profile of ABX464 given at 50 mg once daily in subjects with Moderate to Severe Active Ulcerative Colitis - A follow-up study in patients with moderate to severe active ulcerative colitis.Moderate to severe Ulcerative Colitis.
MedDRA version: 20.1 Level: LLT Classification code 10066678 Term: Acute ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: ABX464
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: ABX464
Current Sponsor code: ABX464
Other descriptive name: ABX464
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
ABIVAXAuthorisedFemale: yes
Male: yes
30Phase 2Hungary;Spain
127EUCTR2017-004230-28-DE04/06/20187 January 2019BI 655130 induction treatment in patients with moderate-tosevere ulcerative colitisA Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI 655130 Induction Therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapyModerate-to-severely active ulcerative colitis
MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
Product Name: BI 655130
Product Code: BI 655130
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: BI 655130
Current Sponsor code: BI 655130
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
Boehringer Ingelheim Pharma GmbH & Co. KGAuthorisedFemale: yes
Male: yes
550Phase 2;Phase 3United States;Taiwan;Spain;Austria;Russian Federation;United Kingdom;Italy;Canada;Belgium;Poland;Germany;Netherlands;Japan;Korea, Republic of
128NCT03477032June 1, 201811 June 2019FMT in Inflammatory Bowel DiseaseFaecal Transplantation in Inflammatory Bowel DiseaseFaecal Microbiota Transplantation;Crohn Disease;Ulcerative Colitis;Microscopic ColitisBiological: Faecal Microbiota TransplantationSt Vincent's Hospital MelbourneRecruiting18 Years65 YearsAll50Phase 2Australia
129NCT03504930June 201811 June 2018COLISURG Prospective, Multicentric CohortCOLISURG Prospective, Multicentric Cohort of Ulcerative Colitis Requiring Surgical Treatment With Ileal Pouch-anal Anastomosis. Impact of Biotherapies on Sexual Function and Postoperative Morbidity.Ulcerative ColitisOther: Impact of biotherapy on postoperative morbidity in ulcerative colitisHospices Civils de LyonNot recruiting18 YearsN/AAll330Phase 3France
130JPRN-JapicCTI-18399729/5/20187 October 2019A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy [M16-067]A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy [M16-067]Ulcerative Colitis (UC)Intervention name : Risankizumab (Genetical Recombination)
INN of the intervention : risankizumab
Dosage And administration of the intervention : SC/IV
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -
AbbVie GKRecruiting1680BOTH65Phase 2-3Japan, Asia except Japan, North America, South America, Europe, Oceania, Africa
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
131EUCTR2017-003228-54-ES28/05/201818 June 2018A clinical trial to evaluate the safety and efficacy of oral treatment with PBF-677 in patients with mild to moderate ulcerative colitis.A Phase IIa (proof of concept), randomized, double blind, placebo controlled, multicenter clinical trial to evaluate the safety and efficacy of oral treatment with PBF-677 in patients with mild to moderate ulcerative colitis.Inflammatory Bowel disease, mild to moderate Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Product Code: PBF-677
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: PBF-677
Current Sponsor code: PBF-677
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
PaloBiofarma S.L.AuthorisedFemale: yes
Male: yes
30Phase 2Spain
132NCT03521232May 15, 201826 August 2019A Study of Niclosamide Enemas in Subjects With Active Ulcerative Proctitis or Ulcerative ProctosigmoiditisA Phase I/IIA, Open-Label, Three-Stage Study to Investigate the Safety, the Efficacy and the Pharmacokinetics of Niclosamide Enemas in Subjects With Active Ulcerative Proctitis or Ulcerative Procto-SigmoiditisUlcerative Colitis;Ulcerative Proctitis;Ulcerative ProctosigmoiditisDrug: NiclosamideFirst Wave Bio, Inc.Recruiting18 YearsN/AAll51Phase 1/Phase 2Italy
133NCT03565939May 4, 201830 September 2019Probiotic Treatment of Ulcerative Colitis With Trichuris Suis Ova (TSO)Probiotic Treatment of Ulcerative Colitis With Trichuris Suis Ova (TSO)Ulcerative Colitis Chronic ModerateBiological: Trichuris suis ova;Biological: PlaceboParaTech A/SRecruiting18 Years75 YearsAll120Phase 2Denmark
134EUCTR2017-003649-10-DE30/04/201828 February 2019A Pharmacokinetic, Pharmacodynamic, and Safety Study of Etrolizumab Followed by Open-Label Extension and Safety Monitoring in Pediatric Patients From 4 Years to Less Than 18 Years of Age with Moderate to Severe Ulcerative Colitis or Moderate to Severe Crohn’s DiseaseA PHASE I, OPEN–LABEL, RANDOMIZED, PHARMACOKINETIC, PHARMACODYNAMIC, AND SAFETY STUDY OF ETROLIZUMAB FOLLOWED BY OPEN–LABEL EXTENSION AND SAFETY MONITORING IN PEDIATRIC PATIENTS FROM 4 YEARS TO LESS THAN 18 YEARS OF AGE WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR MODERATE TO SEVERE CROHN’S DISEASEModerate to severe ulcerative colitis (UC); moderate to severe Crohn’s disease (CD)
MedDRA version: 20.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0 Level: PT Classification code 10009900 Term: Colitis ulcerative System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Etrolizumab
Product Code: 549-0261/F02-01
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ETROLIZUMAB
CAS Number: 1044758-60-2
Current Sponsor code: RO5490261/F02-01
Other descriptive name: ETROLIZUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 150-
F. Hoffmann-La Roche LtdNot RecruitingFemale: yes
Male: yes
60Phase 1United States;Poland;Belgium;Spain;Germany;United Kingdom
135NCT03594708April 30, 201823 July 2018Immunonutrition in Ulcerative ColitisImpact of Immunonutrition Supplementation Combining Fermentable Fiber, Omega-3 Fatty Acids, Vitamin D, Vitamin E, and Zinc on Intestinal Inflammation, Gut Microbial Activity, and Severity of Symptoms in Ulcerative Colitis PatientsUlcerative ColitisDietary Supplement: Nutrition supplement;Dietary Supplement: Placebo supplementBaptist Memorial Health Care CorporationRecruiting18 YearsN/AAll30N/AUnited States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
136EUCTR2017-003703-22-ES29/04/201814 May 2018Phase 2 Dose-finding IMU-838 for Ulcerative Colitis (CALDOSE-1)A phase 2, multicenter, randomized, double-blind, placebo controlled, dose-finding study to evaluate the efficacy and safety of IMU 838 for induction and maintenance therapy in moderate-to-severe ulcerative colitis CALDOSE-1Ulcerative Colitis
MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: vidofludimus calcium
Product Code: IMU-838
Pharmaceutical Form: Tablet
INN or Proposed INN: Vidofludimus calcium
Current Sponsor code: IMU-838
Other descriptive name: IM90838
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: vidofludimus calcium
Product Code: IMU-838
Pharmaceutical Form: Tablet
INN or Proposed INN: Vidofludimus calcium
Current Sponsor code: IMU-838
Other descriptive name: IM90838
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 15-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: vidofludimus calcium
Product Code: IMU-838
Pharmaceutical Form: Tablet
INN or Proposed INN: Vidofludimus calcium
Current Sponsor code: IMU-838
Other descriptive name: IM90838
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 22.5-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Immunic AGAuthorisedFemale: yes
Male: yes
210Phase 2Serbia;United States;Czech Republic;Slovakia;Poland;Belgium;Spain;Ukraine;Russian Federation;Netherlands;Germany;United Kingdom
137NCT03209232April 16, 201830 September 2019Infliximab Accelerated Induction in Moderate to Severe Pediatric UCInfliximab Accelerated Induction for Moderate to Severe Ulcerative Colitis in Children (INDUCE) TrialUlcerative ColitisDrug: InfliximabSchneider Children's Medical Center, IsraelRecruiting6 Years18 YearsAll84N/AIsrael
138EUCTR2017-002350-36-ES15/04/201811 June 2018A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared with Placebo and Compared with Vedolizumab in Patients with Moderate to Severe Ulcerative Colitis.A PHASE II, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF UTTR1147A COMPARED WITH PLACEBO AND COMPARED WITH VEDOLIZUMAB IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITISUlcerative colitis (UC)
MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856
MedDRA version: 20.1 Level: LLT Classification code 10033007 Term: Other ulcerative colitis System Organ Class: 100000004856
MedDRA version: 20.1 Level: LLT Classification code 10045366 Term: Ulcerative colitis, unspecified System Organ Class: 100000004856
MedDRA version: 20.1 Level: LLT Classification code 10066678 Term: Acute ulcerative colitis System Organ Class: 100000004856
MedDRA version: 20.0 Level: LLT Classification code 10075635 Term: Acute hemorrhagic ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: UTTR1147A/RO7021610 (Active)
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: n.a.
Current Sponsor code: RO7021610
Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
Trade Name: Entyvio 300mg
Product Code: RO7246311
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: Vedolizumab
CAS Number: 943609-66-3
Current Sponsor code: RO7246311
Other descriptive name: VEDOLIZUMAB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
Roche Farma, S.A por delegación de Genentech, Inc.AuthorisedFemale: yes
Male: yes
330Phase 2Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;United Kingdom;Italy;Hungary;Poland;Bulgaria;Germany;Netherlands
139EUCTR2017-000574-11-DE10/04/20187 January 2019Research 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) - AIDAUlcerative 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
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Anti-MAdCAM antibody
Current Sponsor code: SHP647
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 75-
Product Code: SHP647
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Anti-MAdCAM antibody
Current Sponsor code: SHP647
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 25-
Shire Human Genetic Therapies, Inc.AuthorisedFemale: yes
Male: yes
2453Phase 3Serbia;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
140NCT03298022April 10, 20189 September 2019Efficacy and Safety of AbGn-168H in Patients With Moderate to Severe Active, Anti-TNF Alpha and/or Anti-integrin Refractory Ulcerative ColitisEfficacy and Safety of AbGn-168H in Patients With Moderate to Severe Active, Anti-TNF Alpha and/or Anti-integrin Refractory Ulcerative Colitis: a 26-week, Open-label, Multi-center, Phase II Proof of Principle TrialUlcerative ColitisBiological: AbGn-168HAbGenomics International, Inc.Recruiting18 Years75 YearsAll40Phase 2United States;Puerto Rico
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
141EUCTR2017-003284-35-PL06/04/201822 October 2018A follow-up study in patients with moderate to severe active ulcerative colitis.A follow-up Phase IIa study to evaluate the long-term safety and efficacy profile of ABX464 given at 50 mg once daily in subjects with Moderate to Severe Active Ulcerative Colitis. - Follow-up study in Moderate to Severe Active Ulcerative Colitis subjects.Moderate to severe Ulcerative Colitis.
MedDRA version: 20.1 Level: LLT Classification code 10066678 Term: Acute ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: ABX464
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: ABX464
Current Sponsor code: ABX464
Other descriptive name: ABX464
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
ABIVAXAuthorisedFemale: yes
Male: yes
30Phase 2Hungary;Spain;Belgium;Poland
142JPRN-jRCTs04119001006/04/201810 September 2019The usefulness of kestose for ulcerative colitisThe usefulness of kestose for ulcerative colitisInflammatory Bowel Diseasearm A Kestose(10g) every day 8 weeksar
arm B Maltose(5g) every day 8 weeks
Takashi HondaRecruiting>= 20age old<= 80age oldBoth40N/Anone
143EUCTR2016-004112-35-SE04/04/201830 April 2018A comparison between standard treatment with azathioprine and a modified treatment with a lower dose of azathioprine in combination with allopurinol for patients with inflammatory bowel diseaseLow-dose azathioprine and allopurinol- versus azathioprine monotherapy in patients with Inflammatory Bowel Disease: An investigator-initiated, open, multicentre, parallel-arm, randomized controlled trial A SOIBD (The Swedish Organisation for the study of Inflammatory Bowel Diseases) studyPatients with inflammatory bowel diseae (Ulcerative colitis or Crohns disease) wh do not responding to first line therapy;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Imurel
Product Name: Azathioprine
Product Code: NA
Pharmaceutical Form: Tablet
Trade Name: Allopurinol
Product Name: Allopurinol
Product Code: NA
Pharmaceutical Form: Tablet
SOIBD (The Swedish Organisation for the study of Inflammatory Bowel Diseases)AuthorisedFemale: yes
Male: yes
120Phase 4Sweden
144NCT03452501April 201811 June 2018Safety and Effectiveness Study of Remsima® in the Treatment of Inflammatory Bowel Diseases Among Saudi Arabia PatientsAn Observational, Prospective Cohort Study to Evaluate the Safety and Effectiveness of Remsima® in the Treatment of Inflammatory Bowel Disease Among Saudi Arabia Patients Diagnosed With Crohn's Disease, Ulcerative Colitis, or Fistulizing CDInflammatory Bowel Diseases Including Crohn's Disease, Fistulizing Crohn's Disease and Ulcerative ColitisDrug: InfliximabHikma Pharmaceuticals LLCNot recruiting18 YearsN/AAll150Phase 3Saudi Arabia
145EUCTR2017-003524-75-NL27/03/201830 April 2018Mesenchymal Stromal Cells for the treatment of Ulcerative ColitisAllogeneic Bone Marrow Derived Mesenchymal Stromal Cells for the Treatment of Refractory Proctitis in Ulcerative Colitis - BMMSCproctitisUlcerative Colitis
MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Mesenchymal stromal cells
Product Code: MSC
Pharmaceutical Form: Suspension for injection in pre-filled syringe
INN or Proposed INN: n.a.
CAS Number: n.a.
Current Sponsor code: Freshly harvested_BMMSC_P3
Other descriptive name: MESENCHYMAL CELLS
Concentration unit: Other
Concentration type: equal
Concentration number: 10000000 -
Leiden University Medical CenterAuthorisedFemale: yes
Male: yes
14Phase 2Netherlands
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
146NCT03478956March 27, 201828 October 2019A Phase I Study Of Etrolizumab Followed By Open-Label Extension And Safety Monitoring In Pediatric Patients With Moderate To Severe Ulcerative Colitis Or Moderate To Severe Crohn's DiseaseA Phase I, Open-Label, Randomized, Pharmacokinetic, Pharmacodynamic, And Safety Study Of Etrolizumab Followed By Open-Label Extension And Safety Monitoring In Pediatric Patients From 4 Years To Less Than 18 Years Of Age With Moderate To Severe Ulcerative Colitis Or Moderate To Severe Crohn's DiseaseUlcerative Colitis;Crohn's DiseaseDrug: EtrolizumabHoffmann-La RocheNot recruiting4 Years17 YearsAll24Phase 1United States;Belgium;Germany;Poland;Spain;United Kingdom
147NCT03581149March 26, 201830 September 2019Tolerability and Efficacy of Sodium Picosulfate/Magnesium Citrate Versus PEG/Ascorbic Acid in Ulcerative Colitis PatientsTolerability and Efficacy of Low-Volume Sodium Picosulfate/Magnesium Citrate Versus 2L Polyethylene Glycol/Ascorbic Acid in Patients With Ulcerative Colitis Undergoing Colonoscopy: A Randomized Controlled TrialUlcerative ColitisDrug: Sodium Picosulfate/Magnesium Citrate Laxative;Drug: 2L polyethylene glycol/ascorbic acidAmerican University of Beirut Medical CenterRecruiting18 Years65 YearsAll68Phase 4Lebanon
148NCT03482648March 20, 201811 June 2018First-In-Human Study of BBT-401-1S Following Single and Multiple Ascending Doses in Healthy VolunteersA Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability and Pharmacokinetics of Novel Oral Peptide BBT-401-1S Following Single and Multiple Ascending Doses in Healthy Adult SubjectsUlcerative ColitisDrug: BBT-401-1S, Single dose;Drug: BBT-401-1S, Multiple doses;Drug: PlaceboBridge Biotherapeutics, Inc.KCRN Research, LLCRecruiting19 Years55 YearsAll80Phase 1United States
149NCT03597971March 20, 201820 August 2018HMPL004-6599 Phase I Dose-escalating StudyA Phase I, Randomized, Double Blind, Placebo-controlled, Dose-escalating Study of the Safety, Tolerability and Pharmacokinetics of Single and Repeat Doses of HMPL004-6599 in Healthy Male VolunteersUlcerative Colitis;Crohn DiseaseDrug: HMPL004-6599;Drug: PlaceboNutrition Science Partners LimitedHutchison Medipharma Limited;NestléRecruiting18 Years45 YearsMale56Phase 1Australia
150NCT03341962March 15, 201825 March 2019Phase 2 Dose-finding IMU-838 for Ulcerative ColitisA Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-finding Study to Evaluate the Efficacy and Safety of IMU-838 for Induction and Maintenance Therapy in Moderate-to-severe Ulcerative ColitisUlcerative ColitisDrug: IMU-838;Drug: PlaceboImmunic AGRecruiting18 Years80 YearsAll150Phase 2United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
151EUCTR2017-000574-11-IE13/03/201823 July 2018Research 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) - AIDAUlcerative 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
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Anti-MAdCAM antibody
Current Sponsor code: SHP647
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 75-
Product Code: SHP647
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Anti-MAdCAM antibody
Current Sponsor code: SHP647
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 25-
Shire Human Genetic Therapies, Inc.AuthorisedFemale: yes
Male: yes
2453Phase 3Serbia;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
152EUCTR2017-004230-28-BE09/03/201817 September 2018BI 655130 induction treatment in patients with moderate-tosevere ulcerative colitisA Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI 655130 Induction Therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapyModerate-to-severely active ulcerative colitis;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]Product Code: BI 655130
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: BI 655130
Current Sponsor code: BI 655130
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
SCS Boehringer Ingelheim Comm. VAuthorisedFemale: yes
Male: yes
550Phase 2;Phase 3United States;Taiwan;Spain;Austria;Russian Federation;United Kingdom;Italy;Canada;Belgium;Poland;Germany;Netherlands;Japan;Korea, Republic of
153NCT03444311March 8, 201811 June 2018Combined Nutritional Therapies for the Treatment of Ulcerative ColitisDevelopment of Combined Nutritional Therapies for the Treatment of Ulcerative Colitis Through the Increase of the Biodiversity of the Microbiota.Colitis, UlcerativeDietary Supplement: A: 1 dosis;Dietary Supplement: B: 2 dosisAB Biotics, SARecruiting18 Years65 YearsAll40N/ASpain
154NCT03398148March 7, 20184 November 2019A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic TherapyA Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic TherapyUlcerative Colitis (UC)Drug: risankizumab IV;Drug: placebo for risankizumab;Drug: risankizumab SCAbbVieRecruiting16 Years80 YearsAll720Phase 2/Phase 3United States;Argentina;Austria;Belgium;Brazil;Bulgaria;Canada;Chile;China;Colombia;Croatia;Denmark;Egypt;France;Germany;Greece;Israel;Italy;Japan;Korea, Republic of;Latvia;Lithuania;Malaysia;Mexico;Netherlands;New Zealand;Poland;Portugal;Puerto Rico;Romania;Russian Federation;Serbia;Singapore;Slovakia;Slovenia;South Africa;Spain;Sweden;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom;American Samoa;Australia;Czechia;Hungary
155NCT03412682March 2, 201830 September 2019To Evaluate the Efficacy and Safety of FE 999315 in Japanese Subjects With Mild to Moderate Active Ulcerative ColitisA Phase 3, Multi-centre, Randomised, Double-blind, Active-controlled, Parallel-group Trial Investigating the Efficacy and Safety of FE 999315 Following 8 Weeks of Treatment for Mild to Moderate Active Ulcerative Colitis in Japanese SubjectsColitis, UlcerativeDrug: Budesonide (6 mg);Drug: Budesonide (9 mg);Drug: Mesalazine (3,600 mg)Ferring PharmaceuticalsRecruiting16 Years75 YearsAll273Phase 3Japan
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
156NCT03460847March 1, 201815 July 2019Fecal Microbiota Alterations in Steroid Refractory Active Colitis UlcerosaCan Fecal Microbiota Alterations Predict a Refractory Disease Course to Standard Steroid Therapy in Patients With Active Ulcerative Colitis?Colitis, UlcerativeDrug: SteroidsMedical University of GrazRecruiting18 YearsN/AAll200N/AAustria
157NCT03378921February 27, 20183 December 2018Fecal Microbiota Transplantation in the Treatment of PouchitisDouble-blinded Randomized Placebo Controlled Study: Fecal Microbiota Transplantation in the Treatment of Chronic PouchitisPouchitis;Ulcerative ColitisBiological: Fecal microbiota transplantation;Biological: PlaceboHelsinki University Central HospitalNot recruiting18 Years75 YearsAll26Phase 2Finland
158NCT03801928February 23, 201821 January 2019Observational, Real World Study Of Inflectra In Patients With Inflammatory Bowel DiseaseOBSERVATIONAL, REAL WORLD STUDY OF INFLECTRA IN PATIENTS WITH INFLAMMATORY BOWEL DISEASE (IBD) IN THE UNITED STATES AND CANADAInflammatory Bowel Disease (IBD);Crohn's Disease (CD);Ulcerative Colitis (UC)Drug: InflectraPfizerRecruiting18 YearsN/AAll300Phase 2United States
159NCT03849599February 21, 201825 March 2019A Study to Evaluate the Safety of PRV-300 in Adult Subjects With Moderately to Severely Active Ulcerative ColitisA Phase 1b Study to Evaluate the Safety of PRV-300 Therapy in Subjects With Moderately to Severely Active Ulcerative ColitisUlcerative ColitisBiological: PRV-300;Biological: PlaceboProvention Bio, Inc.Not recruiting18 Years75 YearsAll37Phase 1Georgia;Moldova, Republic of;Ukraine
160NCT03259334February 9, 201811 November 2019Efficacy and Safety Study of SHP647 as Induction Therapy in Participants With Moderate to Severe Ulcerative ColitisA 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 ColitisDrug: SHP647;Other: PlaceboShireRecruiting16 Years80 YearsAll825Phase 3United States;Australia;Austria;Brazil;Croatia;Czechia;Germany;Israel;Italy;Japan;Lithuania;Netherlands;Poland;Romania;Russian Federation;Serbia;South Africa;United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
161NCT03235752February 6, 201815 July 2019Safety and Efficacy of TJ301 IV in Participants With Active Ulcerative ColitisA Phase II, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of TJ301 (FE 999301) Administered Intravenously in Patients With Active Ulcerative ColitisActive Ulcerative ColitisDrug: TJ301 300mg;Drug: TJ301 600mg;Drug: PlaceboI-Mab Biopharma HongKong LimitedRecruiting18 Years70 YearsAll90Phase 2Australia;China;Korea, Republic of;Taiwan
162EUCTR2017-004772-65-DK05/02/201830 April 2019Probiotic Treatment of Ulcerative Colitis with Trichuris suis ova (TSO)Probiotic Treatment of Ulcerative Colitis with Trichuris suis ova (TSO) - PROCTOUlcerative Colitis
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: TSO
Pharmaceutical Form: Suspension for oral suspension
INN or Proposed INN: TSO
Other descriptive name: SUSPENSION CONTAINING 7500 EMBRYONATED VIABLE TRICHURIS SUIS OVA/15ML
Concentration unit: IU/ml international unit(s)/millilitre
Concentration type: range
Concentration number: 450-550
Pharmaceutical form of the placebo: Suspension for oral suspension
Route of administration of the placebo: Oral use
ParaTech A/SAuthorised Female: yes
Male: yes
120Phase 2Denmark
163JPRN-JapicCTI-18385801/2/201816 July 2019Prospective, Post Marketing Surveillance of RECTABUL2mg rectal formProspective, Post Marketing Surveillance of RECTABUL2mg rectal formUlcerative colitis (except for severe disease)Intervention name : RECTABUL2mg rectal form
INN of the intervention : Budesonide
Dosage And administration of the intervention : Usually, this drug is administered 2 times (1time 2mg) daily through rectal.
EA Pharma Co.,Ltd.KISSEI Pharmaceutical Co., Ltd.RecruitingBOTH600NA
164JPRN-UMIN0000309882018/02/012 April 2019Open-label, randomized, two-parallel-arm, single center study to designed to evaluate azathioprine versus adalimumab after induction of tacrolimus in refractory ulcerative colitis therapyUlcerative ColitisInduce azathioprine and continue maintenance therapy by azathioprine
Induce adalimumab and continue maintenance therapy by adalimumab
Sakura Medical Center, Toho universityNot Recruiting15years-oldNot applicableMale and Female53Not applicableJapan
165EUCTR2017-000599-27-LT30/01/201828 February 2019Research 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
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Anti-MAdCAM antibody
Current Sponsor code: SHP647
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 75-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Product Code: SHP647
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Anti-MAdCAM antibody
Current Sponsor code: SHP647
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Shire Human Genetic Therapies, Inc.Authorised Female: yes
Male: yes
825Phase 3Serbia;United States;Slovakia;Greece;Lithuania;Austria;Russian Federation;Israel;Italy;United Kingdom;Czech Republic;Poland;Brazil;Romania;Croatia;Australia;South Africa;Netherlands;Germany;New Zealand;Japan
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
166EUCTR2017-000402-38-DE23/01/201828 February 2019A clinical trail to evaluate the testicular safety of Filgotinib in adult males with Ulcerative ColitisA Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Testicular Safety of Filgotinib in Adult Males with Moderately to Severely Active Ulcerative ColitisTo evaluate the testicular safety of filgotinib in adult males with ulcerative colitis
MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: GS-6034
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: FILGOTINIB
Current Sponsor code: GS-6034
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Gilead Sciences, Inc.Authorised Female: no
Male: yes
250Phase 2Portugal;United States;Spain;Ukraine;Austria;Russian Federation;Sri Lanka;Switzerland;United Kingdom;Italy;India;France;Canada;Belgium;Poland;Australia;Germany;Netherlands;New Zealand;Sweden
167NCT03368118January 20, 201815 April 2019Study Evaluating the Long-term Safety and Efficacy of ABX464 in Active Ulcerative ColitisA Follow-up Phase IIa Study to Evaluate the Long-term Safety and Efficacy Profile of ABX464 Given at 50 mg Once Daily in Subjects With Moderate to Severe Active Ulcerative Colitis.Ulcerative ColitisDrug: ABX464Abivax S.A.Orion Corporation, Orion PharmaNot recruiting18 Years70 YearsAll30Phase 2Belgium
168EUCTR2017-002231-41-BE10/01/201820 August 2018A study to investigate how the body responds to the study drug Vedolizumab in child patients with Ulcerative Colitis or Crohn’s DiseaseA Phase 2, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease (A Phase 2, Randomized, Double-Blind, Dose-Ranging Study With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease) - HubbleUlcerative Colitis and Crohn’s Disease
MedDRA version: 20.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: Vedolizumab
CAS Number: 943609-66-3
Current Sponsor code: MLN0002
Other descriptive name: VEDOLIZUMAB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: Vedolizumab
CAS Number: 943609-66-3
Current Sponsor code: MLN0002
Other descriptive name: VEDOLIZUMAB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: Vedolizumab
CAS Number: 943609-66-3
Current Sponsor code: MLN0002
Other descriptive name: VEDOLIZUMAB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: Vedolizumab
CAS Number: 943609-66-3
Current Sponsor code: MLN0002
Other descriptive name: VEDOLIZUMAB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Takeda Development Centre Europe, Ltd.AuthorisedFemale: yes
Male: yes
80Phase 2United Kingdom;Germany;Netherlands;Israel;Ukraine;Belgium;Poland;Canada;Hungary;United States;France
169EUCTR2017-003284-35-HU03/01/201828 February 2019A follow-up study in patients with moderate to severe active ulcerative colitis.A follow-up Phase IIa study to evaluate the long-term safety and efficacy profile of ABX464 given at 50 mg once daily in subjects with Moderate to Severe Active Ulcerative Colitis. - A Follow-up study in Moderate to Severe Active Ulcerative Colitis subjectsModerate to severe Ulcerative Colitis.
MedDRA version: 20.1 Level: LLT Classification code 10066678 Term: Acute ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: ABX464
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: ABX464
Current Sponsor code: ABX464
Other descriptive name: ABX464
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
ABIVAXAuthorised Female: yes
Male: yes
30Phase 2Hungary;Spain;Poland;Belgium
170JPRN-UMIN0000300002018/01/012 April 2019The efficacy and safety of topical budezonide for pouchitis after restorative proctocolectomy in patients with ulcerative colitis.ulcerative colitis pouchitisTopical budesonido
2weeks of 2mg daily
Topical prednisolone
2weeks 20mg daily
Topical aminosalicylate
2weeks 1g daily
Department of Inflammatory Bowel Disease Hyogo College of MedicineNot RecruitingNot applicableNot applicableMale and Female30Phase 1Japan
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
171NCT03394586January 1, 201822 January 2018Real-world Data Regarding Treatment of Ulcerative Colitis Patients With GolimumabReal-world Data Regarding Treatment of Ulcerative Colitis Patients With GolimumabUlcerative Colitis;Flare Up, SymptomDrug: Exposure to golimumabUniversity of ZurichRecruitingN/AN/AAll100N/ASwitzerland
172NCT03309865December 25, 20171 October 2018Evaluating the Combined Effect of Vedolizumab and Semi-Vegetarian Diet on Ulcerative Colitis.A Pilot Study Evaluating the Synergistic Effect of Vedolizumab in Conjunction With Structured Semi-Vegetarian Diet on the Treatment of Ulcerative Colitis.Ulcerative Colitis;Dietary ModificationDietary Supplement: semi-vegetarian diet;Drug: Vedolizumab InjectionMayo ClinicNot recruiting18 YearsN/AAll0Early Phase 1United States
173NCT03269695December 20, 201711 November 2019Efficacy, Safety and Tolerability of PF-06687234 as Add-on Therapy to Infliximab in Active UC Subjects Not in Remission.A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06687234 AS ADD-ON THERAPY TO INFLIXIMAB IN ACTIVE ULCERATIVE COLITIS SUBJECTS WHO ARE NOT IN REMISSION (BUILD UC)Ulcerative ColitisDrug: PF-06687234;Drug: PlaceboPfizerRecruiting18 Years75 YearsAll76Phase 2United States;Australia;Belgium;Germany;Israel;Italy;Korea, Republic of;Saudi Arabia;Serbia;Spain
174EUCTR2014-001594-14-DE19/12/201723 July 2018Can FITC-Adalimumab predict the efficacy of Adalimumab in patients with colitis ulcerosa, when it is applied to the intestinal mucosa during an endoscopic examination? Is FITC-Adalimumab safe and tolerable in this setting? Open-label, one-arm clinical trial in one study siteProspective, single-centre, open-label, one-arm clinical trial, phase I/IIa, to assess the safety and tolerability and to investigate the predictive power of FITC-Adalimumab, when topically applied twice to the intestinal mucosa as an in-vitro diagnostic in the framework of a confocal laser-endomicroscopic examination of colitis ulcerosa patients with an indication for Adalimumab treatment - MAgICUlcerative colitis
MedDRA version: 20.1 Level: LLT Classification code 10066678 Term: Acute ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: FITC-Adalimumab
Product Code: FITC-Adalimumab
Pharmaceutical Form: Gastroenteral solution
INN or Proposed INN: FITC-Adalimumab
Other descriptive name: FITC-ADALIMUMAB
Concentration unit: µg/µl microgram(s)/microlitre
Concentration type: equal
Concentration number: 2.5-
Universitätsklinikum ErlangenAuthorisedFemale: yes
Male: yes
25Phase 1;Phase 2Germany
175EUCTR2017-003284-35-BE19/12/20177 January 2019A follow-up study in patients with moderate to severe active ulcerative colitis.A follow-up Phase IIa study to evaluate the long-term safety and efficacy profile of ABX464 given at 50 mg once daily in subjects with Moderate to Severe Active Ulcerative Colitis. - Follow-up study in Moderate to Severe Active Ulcerative Colitis subjectsModerate to severe Ulcerative Colitis.
MedDRA version: 20.1 Level: LLT Classification code 10066678 Term: Acute ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: ABX464
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: ABX464
Current Sponsor code: ABX464
Other descriptive name: ABX464
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
ABIVAXAuthorisedFemale: yes
Male: yes
30Phase 2Hungary;Spain;Poland;Belgium
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
176JPRN-UMIN0000322502017/12/152 April 2019Dual center study of usefulness of probe-based confocal laser endomicroscopy for suspected ulcerative colitis-associated neoplasiaDual center study of usefulness of probe-based confocal laser endomicroscopy for suspected ulcerative colitis-associated neoplasia - Dual center study of pCLE for UCANsuspected ulcerative colitis-associated neoplasiapCLE after intravenous administration of fluoresceinFujita Health University School of Medicine, Department of GastroenterologyCenter for Diagnostic and Therapeutic Endoscopy, School of Medicine Keio UniversityRecruiting20years-old85years-oldMale and Female40Not applicableJapan
177JPRN-jRCTs04118003515/12/201710 September 2019Dual center study of pCLE for UCANDual center study of usefulness of probe-based confocal laser endomicroscopy for suspected ulcerative colitis-associated neoplasiasuspected ulcerative colitis-associated neoplasiapCLE after intravenous administration of fluoresceinNaoki OhmiyaRecruiting20years old or olderUnder 80 years oldBoth40N/Anone
178NCT03259308December 5, 201711 November 2019Efficacy and Safety Study of SHP647 as Induction Therapy in Participants With Moderate to Severe Ulcerative ColitisA 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 ColitisDrug: SHP647;Drug: PlaceboShireRecruiting16 Years80 YearsAll825Phase 3United States;Argentina;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Colombia;Estonia;France;Greece;Hungary;Ireland;Japan;Korea, Republic of;Mexico;New Zealand;Portugal;Slovakia;Spain;Switzerland;Ukraine
179NCT02559713November 29, 201711 March 2019Postmarketing Vedolizumab Milk-Only Lactation Study in Lactating Women With Active Ulcerative Colitis or Crohn's DiseaseAn Open-Label, Multicenter and Open Enrollment Model, Postmarketing, Milk-Only Lactation Study to Assess Concentration of Vedolizumab in Breast Milk of Lactating Women With Active Ulcerative Colitis or Crohn's Disease Who Are Receiving Vedolizumab TherapeuticallyColitis, Ulcerative;Crohn DiseaseDrug: VedolizumabTakedaNot recruiting18 YearsN/AFemale11Phase 4United States
180NCT03182166November 21, 201715 July 2019Golimumab in Ulcerative Colitis (UC) Patients With Loss of Response (LOR) Followed by Dose OptimizationPharmacokinetic and Pharmacodynamic Study of Golimumab in Ulcerative Colitis (UC) Patients With Loss of Response (LOR) Followed by Dose OptimizationUlcerative ColitisDrug: Golimumab (Optimization);Diagnostic Test: Rectosigmoidoscopy;Biological: Blood samplesCentre Hospitalier Universitaire de Saint EtienneMerck Sharp & Dohme Corp.Recruiting18 YearsN/AAll80Phase 2France
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
181NCT03408847November 20, 201719 February 2018Monocultivar Coratina Extra Virgin Olive Oil in UC PatientsSupplementation of Extra Virgin Olive Oil Monocultivar Coratina in Patients With Active Ulcerative ColitisUlcerative Colitis Chronic MildCombination Product: Beclomethasone dipropionate in addition to MC-EVOO;Combination Product: Beclomethasone dipropionate in addition to refined oilCasa Sollievo della Sofferenza IRCCSFondazione SchenaRecruiting18 Years70 YearsAll30N/AItaly
182NCT03281304November 16, 201722 October 2019A Study of Tofacitinib in Patients With Ulcerative Colitis in Stable RemissionA PHASE 3B/4,MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP STUDY OF TOFACITINIB (CP-690,550) IN SUBJECTS WITH ULCERATIVE COLITIS IN STABLE REMISSIONUlcerative ColitisDrug: CP-690,500 5 mg;Drug: CP-690,550 10 mgPfizerRecruiting18 YearsN/AAll130Phase 4United States;Belgium;Canada;Czechia;France;Germany;Hungary;Italy;Japan;Korea, Republic of;Netherlands;New Zealand;Poland;Russian Federation;Serbia;Slovakia;South Africa;Spain;Ukraine;United Kingdom
183NCT03266484November 13, 201718 March 2019Effect of a Probiotic Mixture on the Gut Microbiome and Fatigue in Patients With Quiescent Inflammatory Bowel DiseaseEffect of Dietary Therapy With a Probiotic Mixture on the Gut Microbiome and Fatigue Symptoms in Patients With Quiescent Inflammatory Bowel Disease - A Clinical TrialInflammatory Bowel Diseases;Crohn Disease;Ulcerative ColitisDietary Supplement: Probiotic Mixture;Dietary Supplement: PlaceboMassachusetts General HospitalWinclove Bio Industries BVRecruiting18 Years75 YearsAll100N/AUnited States
184JPRN-JapicCTI-17380201/11/201716 July 2019Active phase study of MD-0901 in pediatric ulcerative colitis.The clinical study to evaluate the efficacy, safety, and pharmacokinetics of MD-0901 in pediatric patients with mildly to moderately active ulcerative colitis.Mildly to moderately active ulcerative colitisIntervention name : MD-0901
INN of the intervention : mesalazine
Dosage And administration of the intervention : Mesalazine 80 mg/day are administrated orally once daily after breakfast for 8 weeks.
MOCHIDA PHARMACEUTICAL CO., LTDRecruiting16BOTH26Phase 2-3
185JPRN-JapicCTI-17380301/11/201716 July 2019Maintenance phase study of MD-0901 in pediatric ulcerative colitis.The clinical study to evaluate the efficacy, safety, and pharmacokinetics of MD-0901 in pediatric patients with ulcerative colitis in remission.Ulcerative colitis in remissionIntervention name : MD-0901
INN of the intervention : mesalazine
Dosage And administration of the intervention : Mesalazine 40 mg/day are administrated orally once daily after breakfast for 48 weeks.
MOCHIDA PHARMACEUTICAL CO., LTDRecruiting16BOTH26Phase 2-3
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
186EUCTR2016-002691-27-NL19/10/20176 November 2017An open label study to study changes in the structure of the mucosa of the bowel in subjects during treatment with tofacitinib for moderate to severe ulcerative colitisAn open label exploratory analysis of the histological, immunological and microbiome changes of the colonic mucosa during treatment with tofacitinib for moderate-severe ulcerative colitis - TOFA-histoUlcerative colitis
MedDRA version: 20.0 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Xeljanz 5 mg film-coated tabletsAcademic Medical CenterAuthorisedFemale: yes
Male: yes
40Phase 3Netherlands
187NCT03172195October 11, 20171 October 2018Detection of Herpesvirus DNA (CMV, EBV, HHV-6 and HSV) in Colonic Tissue: Impact on Ulcerative Colitis Flare-upDetection of Herpesvirus DNA (CMV, EBV, HHV-6 and HSV) in Colonic Tissue: Impact on Ulcerative Colitis Flare-upColitis, UlcerativeProcedure: rectosigmoidoscopy;Biological: biopsies;Biological: blood sampleCentre Hospitalier Universitaire de Saint EtienneRecruiting18 YearsN/AAll100N/AFrance
188NCT03093259October 1, 201718 December 2018ABX464 in Subjects With Moderate to Severe Active Ulcerative ColitisPhase IIa Study to Evaluate the Safety and Efficacy of ABX464 Versus Placebo in Subjects With Moderate to Severe Active Ulcerative Colitis Who Have Failed or Are Intolerant to Immunomodulators, Anti-TNFa, Vedolizumab and/or CorticosteroidsUlcerative ColitisDrug: ABX464;Drug: Placebo oral capsuleAbivax S.A.Not recruiting18 Years70 YearsAll32Phase 2Belgium
189EUCTR2017-000937-30-BE29/09/201720 August 2018Investigate the efficacy and safety of study drug ABX464 50 mg once daily versus placebo with patients with moderate to severe Active Ulcerative Colitis.A Phase IIa study to evaluate the safety and efficacy of ABX464 50 mg once daily versus Placebo in subjects with Moderate to Severe Active Ulcerative Colitis who have failed or are intolerant to immunomodulators, Anti-TNFa, vedolizumab and/or corticosteroids. - Safety and efficacy study of ABX464 in patients with moderate to severe Active Ulcerative Colitis.Moderate to severe Ulcerative Colitis.
MedDRA version: 20.1 Level: LLT Classification code 10066678 Term: Acute ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: ABX464
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: ABX464
Current Sponsor code: ABX464
Other descriptive name: ABX464
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
ABIVAXAuthorisedFemale: yes
Male: yes
30Phase 2Germany;Austria;Belgium;Poland;Spain;Hungary
190NCT03494764September 7, 201711 November 2019Hyperbaric Oxygen Therapy for Ulcerative Colitis FlaresHyperbaric Oxygen Therapy for Moderate to Severe Ulcerative Colitis Flares: A Multi-Center Randomized TrialColitis, UlcerativeOther: Hyperbaric Oxygen TherapyDartmouth-Hitchcock Medical CenterFoundation for Clinical Research in IBD;The Eli and Edythe Broad Foundation;University of California, San Diego;Mayo Clinic;University of Pittsburgh Medical Center;Virginia Mason Memorial Hospital;University of Texas Southwestern Medical CenterRecruiting18 YearsN/AAll30Phase 2United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
191NCT03124121September 5, 201726 August 2019Study of the Golimumab Exposure-Response Relationship Using Serum Trough LevelsStudy of the Golimumab Exposure-Response Relationship Using Serum Trough LevelsUlcerative ColitisDrug: GolimumabGuy's and St Thomas' NHS Foundation TrustMerck Sharp & Dohme Corp.Recruiting18 YearsN/AAll84Phase 4United Kingdom
192NCT03221036August 3, 201729 April 2019Efficacy and Safety of Vedolizumab IV in Chinese Participants With Ulcerative ColitisA Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Examine the Efficacy and Safety of Intravenous Vedolizumab (300 mg) Infusion Treatment in Chinese Subjects With Moderately to Severely Active Ulcerative ColitisModerately to Severely Active Ulcerative ColitisDrug: Vedolizumab IV;Drug: PlaceboTakedaRecruiting18 Years80 YearsAll302Phase 3China
193NCT03162432August 1, 201730 September 2019High Dose Interval Vitamin D Supplementation in Patients With IBD Receiving RemicadeHigh Dose Interval Vitamin D Supplementation in Patients With IBD Receiving RemicadeIBD;Ulcerative Colitis;Crohn DiseaseDrug: Vitamin D3Boston Children’s HospitalRecruiting7 Years25 YearsAll50Phase 3United States
194NCT03237260July 1, 201715 July 2019An Open Label Single-arm Phase 4 Study of Vedolizumab in Subjects With Newly Diagnosed Active Ulcerative ColitisAn Open Label Single-arm Phase 4 Study of Vedolizumab in Subjects With Newly Diagnosed Active Ulcerative ColitisUlcerative ColitisDrug: VedolizumabUniversity of PennsylvaniaTakeda;Corporal Michael J. Crescenz VA Medical CenterNot recruiting18 Years80 YearsAll0Phase 4United States
195JPRN-UMIN0000261752017/06/232 April 2019Comparison of concentration of 5-ASA and acetyl 5-ASA in mucosa in time-dependent mesalazine granule preparation and pH-dependent mesalazine tablet for patients with ulcerative colitisComparison of concentration of 5-ASA and acetyl 5-ASA in mucosa in time-dependent mesalazine granule preparation and pH-dependent mesalazine tablet for patients with ulcerative colitis - Comparison of concentration of 5-ASA and acetyl 5-ASA in mucosa in time-dependent mesalazine granule preparation and pH-dependent mesalazine tablet for patients with ulcerative colitisUlcerative colitisTime dependent mesalazine granule formulation After bottom of the 8th week from the start of administration, the lower endoscopy was performed and the mucous membrane was collected from the cecum and rectum by biopsy and the concentration of 5-ASA and acetyl 5-ASA in the mucosa was measured in the mucosa .

PH dependent mesalazine granule preparation Lower endoscopy was performed 8 weeks after the start of administration, mucosa was collected from the cecum and rectum by biopsy, and the concentration of 5-ASA and acetyl 5-ASA in the mucosa was measured at the drug part .
Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu UniversityNot Recruiting20years-old99years-oldMale and Female60Not applicableJapan
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
196NCT03178669June 21, 201726 August 2019The Efficacy of Cobitolimod in Patients With Moderate to Severe Active Ulcerative ColitisA Randomised Dose-Optimisation Study to Evaluate the Efficacy and Safety of Cobitolimod in Moderate to Severe Active Ulcerative Colitis PatientsUlcerative ColitisDrug: cobitolimod;Drug: PlaceboInDex PharmaceuticalsNot recruiting18 YearsN/AAll213Phase 2Czechia;France;Germany;Hungary;Poland;Russian Federation;Serbia;Spain;Sweden;Ukraine
197NCT03104036June 19, 201711 November 2019Faecal Bacteriotherapy for Ulcerative ColitisFaecal Bacteriotherapy for Ulcerative ColitisUlcerative ColitisOther: Faecal bacterial transplantation;Drug: Mesalazine 4G EnemaInstitute for Clinical and Experimental MedicineInstitute of Animal Physiology and Genetics Academy of Science Czech RepublicRecruiting18 Years70 YearsAll60Phase 2Czechia;Czech Republic
198NCT03122613June 19, 201715 July 2019Curcumin for Prevention of Relapse in Patients With Ulcerative ColitisA Double-blind, Randomized, Placebo-Controlled Trial of Curcumin Versus Placebo for Prevention of Relapse in Patients With Ulcerative ColitisUlcerative Colitis in RemissionDietary Supplement: Curcumin;Drug: PlaceboChinese University of Hong KongRecruiting18 YearsN/AAll172N/AHong Kong
199EUCTR2016-004572-21-DK07/06/201730 April 2019A study in patients with mild or moderate ulcerative colitis who take a TNF inhibitor. The study investigates whether bowel inflammation improves when patients take BI 655130 in addition to their current therapy.Proof-of-concept study of BI 655130 add-on treatment in patients with mild-to-moderately active ulcerative colitis during TNF inhibitor therapyMild-to-moderately active ulcerative colitis on TNF inhibitor therapy
MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: BI 655130
Product Code: BI 655130
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: BI 655130
Current Sponsor code: BI 655130
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
Boehringer Ingelheim Pharma GmbH & Co. KGAuthorised Female: yes
Male: yes
30Phase 2United Kingdom;Norway;Germany;Netherlands;Denmark;Spain
200NCT03123120June 7, 201728 October 2019A Study in Patients With Mild or Moderate Ulcerative Colitis Who Take a TNF Inhibitor. The Study Investigates Whether Bowel Inflammation Improves When Patients Take BI 655130 in Addition to Their Current TherapyProof-of-concept Study of BI 655130 add-on Treatment in Patients With Mild-to-moderately Active Ulcerative Colitis During TNF Inhibitor TherapyColitis, UlcerativeDrug: Spesolimab;Drug: PlaceboBoehringer IngelheimRecruiting18 Years75 YearsAll30Phase 2Denmark;Germany;Netherlands;Norway;Spain;United Kingdom;Ireland
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
201EUCTR2017-000100-20-DE06/06/201720 August 2018This study tests how BI 655130 works in patients with active ulcerative colitis. The study also tests how well BI 655130 is tolerated and whether it helps the patients.Exploratory Trial to Assess Mechanism of Action, Clinical Effect, Safety and Tolerability of 12 Weeks of Treatment with BI 655130 in Patients with Active Ulcerative Colitis (UC)Active ulcerative colitis
MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: BI 655130
Product Code: BI 655130
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: BI 655130
Current Sponsor code: BI 655130
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1200-
Boehringer Ingelheim Pharma GmbH & Co. KGAuthorisedFemale: yes
Male: yes
10Phase 2Belgium;Germany;United Kingdom
202NCT03299413June 5, 201723 April 2019Use of Mesenchymal Stem Cells in Inflammatory Bowel DiseaseUlcerative Colitis Stem Cell TherapyInflammatory Bowel DiseasesBiological: Wharton Jelly Mesenchymal stem cellsHanan JafarScientific Research Support fundNot recruiting18 Years75 YearsAll20Phase 1/Phase 2Jordan
203JPRN-UMIN0000274652017/05/292 April 2019Efficacy and safety of the biosimilar Infliximab in the patients with ulcerative colitisEfficacy and safety of the biosimilar Infliximab in the patients with ulcerative colitis - Efficacy and safety of IFX-BS in UC patientsulcerative colitisInfliximab (5mg/kg, every 8 weeks, for 12 months)
Biosimilar Infliximab (5mg/kg, every 8 weeks, for 12 months)
University of ToyamaNot Recruiting20years-oldNot applicableMale and Female20Not selectedJapan
204NCT02954159May 18, 20173 June 2019Vedolizumab Monotherapy Vs Combination Therapy With Tacrolimus in UCInduction of Response and Remission of Vedolizumab Monotherapy Vs Combination Therapy With Tacrolimus in Patients With Moderately to Severely Active Ulcerative ColitisUlcerative ColitisDrug: Tacrolimus;Drug: Vedolizumab;Other: PlaceboMedical College of WisconsinTakedaNot recruiting18 Years65 YearsAll4Phase 3United States
205EUCTR2017-000330-61-ES16/05/20173 July 2017Effect of Beclometasone dipropionate (BDP) on faecal Calprotectin levels in patients with clinically inactive Ulcerative Colitis at risk of relapse. BeCalCU studyEffect of Beclometasone dipropionate (BDP) on faecal Calprotectin levels in patients with clinically inactive Ulcerative Colitis at risk of relapse. BeCalCU study - BeCalCUClinically inactive Ulcerative Colitis at risk of relapse
MedDRA version: 19.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Clipper
Product Name: Beclometasone dipropionate
Pharmaceutical Form: Tablet
INN or Proposed INN: BECLOMETASONE DIPROPIONATE
CAS Number: 5534-09-8
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
CHIESI ESPAÑA S.A.U.AuthorisedFemale: yes
Male: yes
Phase 3Spain
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
206NCT03327558May 15, 201711 June 2018Randomized,Study of APRISO 375 mg Versus the Approved APRISO 375 mg Capsules in Healthy Male and Female SubjectsFull-replicate Study of APRISO 375 mg Extended-release Capsules Versus the Approved APRISO 375 mg Extended-release Capsules in Healthy Male and Female SubjectsUlcerative ColitisDrug: Apriso 0.375G ER CAP;Drug: APRISO 375 mg extended-release capsulesValeant Pharmaceuticals International, Inc.Not recruiting18 YearsN/AAll60Phase 1United States
207NCT03151525May 8, 201716 December 2017Two Therapeutic Strategies for the Maintenance of Remission in Patients With Ulcerative ColitisComparison Between Two Therapeutic Strategies for the Maintenance of Clinical and Endoscopic Remission in Patients With Ulcerative Colitis Treated by InfliximabColitis, UlcerativeDrug: Azathioprine;Drug: InfliximabIstituto Clinico HumanitasAgenzia Italiana del FarmacoRecruiting18 Years65 YearsAll100Phase 4Italy
208NCT03103412May 4, 201716 December 2017TD-3504 SAD in Healthy Subjects and Subjects With Ulcerative Colitis (UC)Study 0146: A Phase 1a, Double-Blinded, Randomized, Placebo Controlled, Single Ascending Dose (SAD) Study to Evaluate the Safety, Tolerability, and Systemic Exposure of TD-3504 in Healthy Subjects and Subjects With Ulcerative Colitis (UC)Active Mild Ulcerative Colitis, Active Moderate Ulcerative Colitis, Healthy SubjectsDrug: TD-3504;Drug: 15N2-tofacitinib;Drug: PlaceboTheravance Biopharma R & D, Inc.Not recruiting18 Years55 YearsAll32Phase 1United States
209NCT03059849May 1, 201716 December 2017Brief Escalation of Adalimumab Treatment for Prevention of Clinical Relapse in IBDBrief Escalation of Adalimumab Treatment for Prevention of Clinical Relapse in IBDCrohn Disease;Ulcerative ColitisDrug: AdalimumabMcMaster UniversityNot recruiting18 Years80 YearsAll290Phase 4
210NCT03110198May 201716 December 2017Mesalazine With Hydrocortisone Sodium Succinate Enema for 4-Week Treatment in Patients With Ulcerative ColitisA Randomized, Double-blind Study Investigating the Efficacy and Safety of Mesalazine With Hydrocortisone Sodium Succinate (100mg QD) Enema for 4-Week Treatment in Patients With Ulcerative Colitis (UC)Ulcerative Colitis, UnspecifiedDrug: Mesalazine;Drug: hydrocortisone sodium succinate;Drug: Mesalazine with hydrocortisone sodium succinateXijing Hospital of Digestive DiseasesShanghai Tongji Hospital, Tongji University School of Medicine;First Affiliated Hospital of Zhongshan Medical UniversityRecruiting18 Years70 YearsAll528Phase 4China
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
211NCT03415711April 28, 20175 February 2018PRObiotic VSL#3® for Maintenance of Clinical and Endoscopic REMission in Ulcerative ColitisA Double-blind, Randomized, Placebo-controlled, Single-center, Dose-finding, Pilot Study Evaluating the Efficacy of VSL#3® in the Maintenance of Clinical and Endoscopic Remission of Mild-to-moderate UCUlcerative ColitisDietary Supplement: VSL#3®;Drug: Mesalamine;Drug: PlaceboVSL PharmaceuticalsActial Farmaceutica S.r.l.Recruiting18 Years85 YearsAll39N/AItaly
212EUCTR2016-004217-26-DE21/04/201724 September 2018A Randomised Dose-Optimisation Study to Evaluate the Efficacy and Safety of Cobitolimod in Moderate to Severe Active Ulcerative Colitis PatientsA Randomised Dose-Optimisation Study to Evaluate the Efficacy and Safety of Cobitolimod in Moderate to Severe Active Ulcerative Colitis Patients - CONDUCTModerate to Severe left-sided Active Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Product Name: Cobitolimod
Product Code: DIMS0150
Pharmaceutical Form: Rectal solution
INN or Proposed INN: Cobitolimod
CAS Number: 1527479-55-5
Current Sponsor code: DIMS0150
Other descriptive name: DIMS0150
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 31-
Pharmaceutical form of the placebo: Rectal solution
Route of administration of the placebo: Rectal use
Product Name: Cobitolimod
Product Code: DIMS0150
Pharmaceutical Form: Rectal solution
INN or Proposed INN: Cobitolimod
CAS Number: 1527479-55-5
Current Sponsor code: DIMS0150
Other descriptive name: DIMS0150
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 125-
Pharmaceutical form of the placebo: Rectal solution
Route of administration of the placebo: Rectal use
Product Name: Cobitolimod
Product Code: DIMS0150
Pharmaceutical Form: Rectal solution
INN or Proposed INN: Cobitolimod
CAS Number: 1527479-55-5
Current Sponsor code: DIMS0150
Other descriptive name: DIMS0150
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 250-
Pharmaceutical form of the placebo: Rectal solution
Route of administration of the placebo: Rectal use
InDex Pharmaceuticals ABAuthorisedFemale: yes
Male: yes
215Phase 2Sweden;Italy;Germany;Russian Federation;Romania;Ukraine;Spain;Poland;Czech Republic;Hungary;France;Serbia
213NCT02994836April 21, 201727 May 2019GIS-SUSANTI-TNF-2015 (Anti-TNF Discontinuation )Anti-TNF Discontinuation in Patients With Inflammatory Bowel Disease: Multicentre, Prospective, Randomized Clinical Trial and Economic EvaluationCrohn's Disease;Inflammatory Bowel Disease;Ulcerative ColitisDrug: Anti-TNF discontinuation: Physiological saline solution;Biological: Anti-TNF:Adalimumab (Subcutaneus);Biological: Anti-TNF: Infliximab (Infusion)Fundación de Investigación Biomédica - Hospital Universitario de La PrincesaRecruiting18 YearsN/AAll194Phase 4Spain
214EUCTR2016-001392-78-BE31/03/201728 February 2019A study to assess a new treatment in patients with moderately to Severely active Ulcerative ColitisCombined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Ulcerative ColitisModerately to Severely Active Ulcerative Colitis (UC)
MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Filgotinib
Product Code: GS-6034
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Product Name: Filgotinib
Product Code: GS-6034
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Gilead Sciences, Inc.Authorised Female: yes
Male: yes
1300Phase 2;Phase 3Serbia;Portugal;United States;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Iceland;Germany;New Zealand;Japan;Sweden
215NCT03029143March 29, 201711 November 2019Vedolizumab Intravenous (IV) Dose Optimization in Ulcerative ColitisA Phase 4 Open-Label Study to Evaluate Vedolizumab IV Dose Optimization on Treatment Outcomes In Nonresponders With Moderately to Severely Active Ulcerative Colitis (ENTERPRET)Colitis, UlcerativeDrug: Vedolizumab IVTakedaNot recruiting18 Years85 YearsAll250Phase 4United States;Canada
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
216NCT03090139March 28, 20172 July 2018Sub-optimal Response to Anti-Tumor Necrosis Factor's in Inflammatory Bowel Disease in Emerging MarketsIndicators of Sub-Optimal Response to Anti-Tumor Necrosis Factor (TNF) Therapy in Patients With Crohn's Disease (CD) and Ulcerative Colitis (UC): A Retrospective Chart Review in the Emerging Market (EM) Region (EXPLORE)Colitis, Ulcerative;Crohn Disease;Inflammatory Bowel DiseasesDrug: Anti-TNF TherapyTakedaNot recruiting18 YearsN/AAll1731Phase 3Argentina;China;Colombia;Korea, Republic of;Mexico;Russian Federation;Saudi Arabia;Singapore;Taiwan;Turkey
217NCT03006809March 2, 201726 November 2018Optimal Fecal Microbiota Transplant Dosing for Mild to Moderate Ulcerative ColitisOptimal Fecal Microbiota Transplant Dosing for Mild to Moderate Ulcerative ColitisUlcerative ColitisBiological: Fecal Microbiota Transplantation (FMT), OpenBiome;Other: pretreatment antibioticsNajwa ElnachefRecruiting18 Years64 YearsAll40Phase 1United States
218EUCTR2016-003797-40-BE23/02/201723 October 2017A clinical study to investigate the effectiveness and safety of treatment with the drug APD334 in ulcerative colitis and crohn's disease patients with skin conditionsA Phase 2a, Proof of Concept, Open-label Study Evaluating the Efficacy and Safety of Etrasimod (APD334) in Inflammatory Bowel Disease Patients with active Skin Extra-intestinal ManifestationsActive Skin Extra-Intestinal Manifestations in Inflammatory Bowel Disease.;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Product Name: APD334
Pharmaceutical Form: Tablet
INN or Proposed INN: Not yet available
CAS Number: 1206123 97 8
Current Sponsor code: APD334
Other descriptive name: APD334
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-
Arena Pharmaceuticals, Inc.Not RecruitingFemale: yes
Male: yes
20Phase 2United States;Belgium;Germany
219NCT02914535February 23, 201711 November 2019Filgotinib in Long-Term Extension Study of Adults With Ulcerative ColitisA Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects With Ulcerative ColitisUlcerative ColitisDrug: Filgotinib;Drug: PlaceboGilead SciencesGalapagos NVRecruiting18 YearsN/AAll1000Phase 3United States;Argentina;Australia;Austria;Belgium;Bulgaria;Canada;Croatia;Czechia;France;Georgia;Germany;Greece;Hong Kong;Hungary;Iceland;India;Ireland;Israel;Italy;Japan;Korea, Republic of;Malaysia;Mexico;Netherlands;New Zealand;Poland;Portugal;Romania;Russian Federation;Serbia;Singapore;Slovakia;South Africa;Spain;Sweden;Switzerland;Taiwan;Ukraine;United Kingdom;Czech Republic
220EUCTR2016-003797-40-DE21/02/201715 October 2018A clinical study to investigate the effectiveness and safety of treatment with the drug APD334 in ulcerative colitis and crohn's disease patients with skin conditionsA Phase 2a, Proof of Concept, Open-label Study Evaluating the Efficacy and Safety of Etrasimod (APD334) in Inflammatory Bowel Disease Patients with active Skin Extra-intestinal ManifestationsActive Skin Extra-Intestinal Manifestations in Inflammatory Bowel Disease.;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Product Name: APD334
Pharmaceutical Form: Tablet
INN or Proposed INN: Not yet available
CAS Number: 1206123 97 8
Current Sponsor code: APD334
Other descriptive name: APD334
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-
Arena Pharmaceuticals, Inc.Not RecruitingFemale: yes
Male: yes
20Phase 2United States;Belgium;Germany
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
221EUCTR2016-003452-75-LV20/02/201730 April 2018A study to examine the safety and effect of the study drug PTG-100 in patients with inflammation of the colonA PHASE 2B RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL ADAPTIVE 2-STAGE, MULTI-CENTRE STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ORAL PTG-100 INDUCTION IN SUBJECTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITISModerate to Severe Active Ulcerative Colitis
MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: PTG-100
Product Code: PTG-100
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: -
Current Sponsor code: PTG-100
Other descriptive name: PN-10884A
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Product Name: PTG-100
Product Code: PTG-100
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: -
Current Sponsor code: PTG-100
Other descriptive name: PN-10884A
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Protagonist Therapeutics, IncNot RecruitingFemale: yes
Male: yes
240Phase 2Serbia;United States;Slovenia;Greece;Ukraine;Russian Federation;United Kingdom;Czech Republic;Hungary;Poland;Belgium;Croatia;Latvia;Germany;Netherlands;Bosnia and Herzegovina
222NCT03071081February 8, 20171 October 2018Study for Safety and Tolerability of TOP1288 Administered Orally in Healthy SubjectsA Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of TOP1288 Oral Single Ascending and Multiple Doses in Healthy VolunteersUlcerative ColitisDrug: TOP1288;Drug: Placebo to TOP1288Topivert Pharma LtdNot recruiting18 Years55 YearsMale37Phase 1United Kingdom
223NCT02958865February 3, 201711 November 2019Study to Compare Oral PF-06651600, PF-06700841 and Placebo in Subjects With Moderate to Severe Ulcerative ColitisA PHASE 2B, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP, DOSE RANGING STUDY OF ORAL PF-06651600 AND PF-06700841 AS INDUCTION AND CHRONIC THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITISUlcerative ColitisDrug: PF-06651600 or Placebo;Drug: PF-06700841 or Placebo;Drug: PF-06700841;Drug: PF-06651600PfizerRecruiting18 Years75 YearsAll360Phase 2United States;Austria;Bulgaria;Canada;Czechia;Denmark;Georgia;Germany;Hungary;Israel;Italy;Korea, Republic of;Netherlands;Poland;Romania;Russian Federation;Serbia;Slovakia;Spain;Turkey;Ukraine
224ChiCTR-IPR-170103062017-02-0118 April 2017Effects of probiotics on intestinal microecological reconstruction in patients with ulcerative colitisEffects of probiotics on intestinal microecological reconstruction in patients with ulcerative colitisUlcerative colitisGroup A:Mesalazine combined with placebo; Group B:Methalazine combined with probiotics;Group C:Probiotics combined with placebo;Normal control group:Blank control;Affiliated Hospital of Inner Mongolia Medical UniversityNot Recruiting18BothGroup A:30; Group B:30;Group C:30;Normal control group:30;Post-marketChina
225JPRN-UMIN0000258462017/02/012 April 2019A trial of a combination therapy of fecal microbial transplantation and antibiotics for inflammatory bowel diseaseulcerative colitis, Crohn's diseaseAdministration of the fecal material from healthy donors to patients after taking three kinds of antibiotics (Amoxicillin, fosmycin, metronidazole) for two weeksJuntendo university school of medicine Department of gastroenterologyRecruiting16years-oldNot applicableMale and Female60Not selectedJapan
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
226JPRN-jRCTs03118041501/02/201722 July 2019A trial of a combination therapy of fecal microbial transplantation and antibiotics for inflammatory bowel diseaseSingle center non-randomized study: A trial of a combination therapy of fecal microbial transplantation and antibiotics for inflammatory bowel diseaseInflammatory Bowel Disease (Ulcerative Colitis, Crohn's Disease)
Inflammatory Bowel Disease (Ulcerative Colitis, Crohn's Disease)
AFM therapy arm : three antibiotics, amoxicillin (1500 mg/day), fosfomycin (3000 mg/day) and metronidazole (750 mg/day) are administered orally to patients for 2 weeks. For pediatric patients, amoxicillin (50mg/kg), fosfomycin (120mg/kg) and metronidazole (20mg/kg) are administered orally for 2 weeks (the upper limit is the same amount as adults).
FMT arm : Approximately 150 to 250 g of donor stool is diluted with saline (500 mL) and filtered to remove crude components. The diluted and filtered fecal suspension is transferred into the patients colon from cecum to rectum during total colonoscopy. As usual examinations, the patient undergoes biopsy of inflammatory site.
A-FMT arm : Patient undergoes FMT two days after AFM therapy.
Dai IshikawaRecruiting>=6 age oldBoth120N/Anone
227NCT03038711February 1, 201711 February 2019A Multiple Dose Study to Assess the Safety and Tolerability of BMS-986166 in Healthy VolunteersA Randomized, Double Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986166 in Healthy SubjectsUlcerative ColitisDrug: BMS-986166;Other: Placebo matching BMS-986166Bristol-Myers SquibbNot recruiting18 Years55 YearsAll213Phase 1United States
228NCT03006068January 31, 201727 May 2019A Study to Evaluate the Long-Term Safety and Efficacy of Upadacitinib (ABT-494) in Subjects With Ulcerative Colitis (UC)A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects With Ulcerative ColitisUlcerative Colitis (UC)Drug: Upadacitinib (ABT-494);Drug: PlaceboAbbVieRecruiting16 Years75 YearsAll950Phase 3United States;Argentina;Australia;Austria;Belarus;Belgium;Bosnia and Herzegovina;Brazil;Canada;Chile;China;Colombia;Croatia;Czechia;Estonia;Finland;France;Germany;Greece;Hungary;Ireland;Israel;Italy;Japan;Korea, Republic of;Latvia;Lithuania;Malaysia;Mexico;Netherlands;Norway;Poland;Portugal;Puerto Rico;Romania;Russian Federation;Serbia;Singapore;Slovakia;South Africa;Spain;Sweden;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom
229NCT03000101January 19, 201721 January 2019Study of the Role of Pomegranate Juice Ellagitannins in the Modulation of Inflammation in Inflammatory Bowel DiseaseNew Insight and Knowledge on Anti-inflammatory Effectiveness of Dietary Phenolics (NIKE)Crohn's Disease;Ulcerative ColitisOther: placebo beverage;Other: 100% pomegranate juiceAzienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola MalpighiUniversity of Bologna;Conserve Italia;GAT FoodsNot recruiting18 Years80 YearsAll18N/AItaly
230NCT03798210January 1, 201721 January 2019Lactobacillus Reuteri ATCC PTA 4659 in Ulcerative ColitisThe Effect of Lactobacillus Reuteri ATCC PTA 4659 in Patients With Ulcerative ColitisUlcerative Colitis FlareDietary Supplement: Lactobacillus reuteri;Dietary Supplement: PlaceboUppsala UniversityRecruiting18 Years80 YearsAll40Phase 2Sweden
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
231NCT02862132January 201728 January 2019Predicting Response to Vedolizumab in Pediatric Inflammatory Bowel DiseasesPredicting Response to Vedolizumab in Pediatric Inflammatory Bowel Diseases (IBD) Including Drug Levels: a Multi-center Prospective Cohort Study, From the Pediatric IBD Porto Group of European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN)Crohn's Disease;Ulcerative Colitis;Inflammatory Bowel DiseaseDrug: VedolizumabShaare Zedek Medical CenterRecruitingN/A18 YearsAll120N/AUnited States;Denmark;Finland;Ireland;Israel;Slovenia;United Kingdom
232NCT02878083January 201711 June 2018Development of a Biomarker of Efficacy of Vedolizumab (EnTyvio®) in Patients With ulcErative ColiTis (DETECT)Development of a Biomarker of Efficacy of Vedolizumab (EnTyvio®) in Patients With ulcErative ColiTis (DETECT)ULCERATIVE COLITISDrug: VEDOLIZUMAB;Drug: ADALIMUMABNantes University HospitalTakeda;Mauna Kea Technologies;Institut national de la santé et de la recherche médicale unité U1235 FRANCE;Institut national de la santé et de la recherche médicale unité1064 FRANCERecruiting18 YearsN/AAll25N/AFrance
233EUCTR2017-000573-37-IE13 November 2017Research 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 303Ulcerative colitis
MedDRA version: 20.0 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000016670 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: SHP647
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Anti-MAdCAM antibody
Current Sponsor code: SHP647
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 75-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Product Code: SHP647
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Anti-MAdCAM antibody
Current Sponsor code: SHP647
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Shire Human Genetic Therapies, Inc.Not AvailableFemale: yes
Male: yes
772Phase 3Serbia;Portugal;United States;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Japan;New Zealand;Germany;Bulgaria;Croatia;Romania;Brazil;Belgium;Poland;Argentina;Canada;Mexico;Hungary;Czech Republic;United Kingdom;Austria;Lithuania;Bosnia and Herzegovina;Korea, Republic of
234EUCTR2017-003649-10-PL28 February 2019A Pharmacokinetic, Pharmacodynamic, and Safety Study of Etrolizumab Followed by Open-Label Extension and Safety Monitoring in Pediatric Patients From 4 Years to Less Than 18 Years of Age with Moderate to Severe Ulcerative Colitis or Moderate to Severe Crohn’s DiseaseA PHASE I, OPEN–LABEL, RANDOMIZED, PHARMACOKINETIC, PHARMACODYNAMIC, AND SAFETY STUDY OF ETROLIZUMAB FOLLOWED BY OPEN–LABEL EXTENSION AND SAFETY MONITORING IN PEDIATRIC PATIENTS FROM 4 YEARS TO LESS THAN 18 YEARS OF AGE WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR MODERATE TO SEVERE CROHN’S DISEASEModerate to severe ulcerative colitis (UC); moderate to severe Crohn’s disease (CD)
MedDRA version: 20.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0 Level: PT Classification code 10009900 Term: Colitis ulcerative System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Etrolizumab
Product Code: 549-0261/F02-01
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ETROLIZUMAB
CAS Number: 1044758-60-2
Current Sponsor code: RO5490261/F02-01
Other descriptive name: ETROLIZUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 150-
F. Hoffmann-La Roche LtdNot Available Female: yes
Male: yes
60Phase 1United States;Belgium;Spain;Poland;Germany;United Kingdom
235JPRN-UMIN0000245202016/12/152 April 2019Exploratory study of antibiotics combination therapy for moderate to severe ulcerative colitisulcerative colitisplacebo
metronidazole
metronidazole,amoxicillin
metronidazole,amoxicillin,tetracycline
Hokkaido University HospitalNot Recruiting16years-old80years-oldMale and Female212Not selectedJapan
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
236NCT03101800December 14, 201627 August 2018Beneficial and Harmful Effects of Azathioprine and Allopurinol Versus Standard Azathioprine Therapy for Patients With Ulcerative ColitisLow-dose Azathioprine and Allopurinol- Versus Azathioprine Monotherapy in Patients With Ulcerative Colitis: An Investigator-initiated, Open, Multicentre, Parallel-arm, Randomised Controlled TrialColitis, Ulcerative;Colitis Ulcerative ExacerbationDrug: Azathioprine and Allopurinol;Drug: AzathioprineHvidovre University HospitalAalborg Universitetshospital;Zealand University Hospital;University of Copenhagen;Odense University Hospital;Aarhus University Hospital;Regional Hospital Viborg;Vejle Hospital;Sydvestjysk Hospital EsbjergRecruiting18 Years80 YearsAll84Phase 3Denmark
237EUCTR2016-001684-36-SK12/12/201621 August 2017EFFICACY AND SAFETY STUDY OF GED-0507-34-LEVO (GED0507) FOR TREATMENT OF PATIENTS WITH ACTIVE ULCERATIVE COLITISA PHASE 2, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF GED-0507-34-LEVO (GED0507) FOR TREATMENT OF SUBJECTS WITH ACTIVE ULCERATIVE COLITISUlcerative Colitis
MedDRA version: 20.0 Level: LLT Classification code 10021184 Term: IBD System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0 Level: LLT Classification code 10045366 Term: Ulcerative colitis, unspecified System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0 Level: SOC Classification code 10017947 Term: Gastrointestinal disorders System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GED-0507-34-Levo
Product Code: GED0507
Pharmaceutical Form: Gastro-resistant tablet
INN or Proposed INN: (S)-(-)-3-(4-Aminophenyl)-2-methoxypropionic Acid
Current Sponsor code: GED-0507-34-Levo
Other descriptive name: GED-0507-34-LEVO
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 80-
Pharmaceutical form of the placebo: Gastro-resistant tablet
Route of administration of the placebo: Oral use
PPM SERVICES SANot RecruitingFemale: yes
Male: yes
207Phase 2France;United States;Hungary;Slovakia;Canada;Poland;Spain;Ukraine;Bulgaria;Latvia;Italy;United Kingdom
238EUCTR2016-001409-18-NO06/12/201612 December 2016A study to evaluate the safety of stopping versus continuing anti TNF therapy in ulcerative colitis patients in remission, and to evaluate the safety and efficacy of restarting anti TNF therapy in patients with disease recurrenceA prospective, open randomized, parallel-group study to evaluate the outcome of discontinuing or continuing anti-tumor necrosis factor treatment in patients with ulcerative colitis in sustained clinical remission. - The Biostop studyUlcerative colitis
MedDRA version: 19.0 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: 1.Remicade
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: range
Concentration number: 5-10
Trade Name: Humira
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Trade Name: Simponi
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: GOLIMUMAB
CAS Number: 476181-74-5
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration number: 100-
Helse More og Romsdal Hospital TrustAuthorisedFemale: yes
Male: yes
Phase 4Norway
239NCT02425852December 201611 February 2019A Randomized, Multicenter Open Label Study Comparing Early Administration of Azathioprine Plus IFX to Steroids Plus Azathioprine for Acute Severe ColitisA Randomized, Multicenter Open Label Study Comparing Early Administration of Azathioprine Plus Infliximab to Corticosteroids Plus Azathioprine for Acute Severe ColitisUlcerative ColitisDrug: Azathioprine;Drug: Infliximab;Drug: Prednisolone;Drug: HydrocortisoneGroupe d'Etude Therapeutique des Affections Inflammatoires DigestivesRecruiting18 YearsN/AAll146Phase 4France
240NCT02425865December 20163 June 2019Intensive Treatment to Reach the Target With Golimumab in ulcErative coliTis - In-TARGETIntensive Treatment to Reach the Target With Golimumab in ulcErative coliTis- In-TARGETULCERATIVE COLITISDrug: GOLIMUMABGroupe d'Etude Therapeutique des Affections Inflammatoires DigestivesRecruiting18 Years75 YearsAll200Phase 4Belgium;France
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
241NCT02895100December 201618 March 2019Safety and Efficacy Study of PTG-100 in the Treatment of Moderate to Severe Ulcerative ColitisA Phase 2b Randomised, Double-blind, Placebo-controlled, Parallel, Adaptive 2-Stage, Multi-Centre Study to Evaluate the Safety and Efficacy of Oral PTG-100 Induction in Subjects With Moderate to Severe Active Ulcerative ColitisUlcerative ColitisDrug: PTG-100;Drug: PlaceboProtagonist TherapeuticsNot recruiting18 Years80 YearsAll100Phase 2United States;Australia;Belgium;Bosnia and Herzegovina;Canada;Croatia;Czechia;Germany;Hungary;Korea, Republic of;Latvia;Netherlands;New Zealand;Poland;Russian Federation;Serbia;Ukraine
242NCT02985593December 201611 June 2018A Phase 1 Study of KHK4083 in Healthy Volunteers and Subjects With Ulcerative ColitisA Phase 1, Single-Blind, Randomized, Placebo-Controlled, Single-Dose or Open-Label Multiple-Dose Study of KHK4083 in Healthy Adults and Subjects With Ulcerative ColitisHealthy Men and Subjects With Ulcerative ColitisDrug: KHK4083;Drug: PlaceboKyowa Hakko Kirin Co., LtdNot recruiting20 YearsN/AAll155Phase 1Japan
243NCT02998112December 20169 January 2017Fecal Microbiota Transplantation for Ulcerative Colitis Through Colonic Transendoscopic Enteral TubingUlcerative ColitisDrug: fecal microbiota transplantation;Drug: SalineThe Second Hospital of Nanjing Medical UniversityFourth Military Medical University;First Hospital of Guangzhou;Daping Hospital and the Research Institute of Surgery of the Third Military Medical University;Zhongshan Hospital Xiamen UniversityRecruiting18 Years65 YearsBoth188Phase 4China
244JPRN-UMIN0000249362016/11/302 April 2019Efficacy of additional Calcineurin inhibitors in anti TNF-alfa antibody refractory Ulcerative colitisUlcerative colitispatients who received Infliximab continued to treat every 8 week and who received Adalimumab continued to treat every 2 week. Patients received Tacrolimus 0.5mg2Cap par day at day0. Day0 is day of first anti TNF-alfa antibody treat after participate this study. We control Tacrolimus trough levels 3 to 5 mg/ml.Keio University Gastroenterology and HepatologyRecruiting16years-old150years-oldMale and Female30Not selectedJapan
245NCT02808390November 28, 201616 December 2017Efficacy and Safety Study of GED-0507-34-Levo for Treatment of UCA Phase 2, Randomized, Placebo-controlled, Multicenter Study to Investigate the Efficacy and Safety of GED-0507-34-Levo (GED0507) for Treatment of Subjects With Active Ulcerative ColitisUlcerative ColitisDrug: GED-0507-34-Levo 80 mg;Drug: GED-0507-34-Levo 160 mg;Drug: PlaceboPPM Services S.A.Not recruiting18 YearsN/AAll19Phase 2United States;Bulgaria;Canada;France;Hungary;Italy;Latvia;Poland;Slovakia;Ukraine
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
246NCT02903966November 15, 201626 August 2019GSK2982772 Study in Subjects With Ulcerative ColitisA Multicentre, Randomised, Double-blind (Sponsor Unblinded), Placebo-controlled Study With Open Label Extension to Investigate the Safety and Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of GSK2982772 in Subjects With Active Ulcerative ColitisColitis, UlcerativeDrug: GSK2982772;Drug: PlaceboGlaxoSmithKlineNot recruiting18 Years75 YearsAll36Phase 2United States;Germany;Netherlands;Poland;Russian Federation;Sweden;United Kingdom
247NCT02914522November 14, 201626 August 2019Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Ulcerative ColitisCombined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects With Moderately to Severely Active Ulcerative ColitisUlcerative ColitisDrug: Filgotinib;Drug: Placebo to match filgotinibGilead SciencesGalapagos NVNot recruiting18 Years75 YearsAll1351Phase 3United States;Argentina;Australia;Austria;Belgium;Bulgaria;Canada;Croatia;Czechia;France;Georgia;Germany;Greece;Hong Kong;Hungary;India;Ireland;Israel;Italy;Japan;Korea, Republic of;Malaysia;Mexico;Netherlands;New Zealand;Norway;Poland;Portugal;Romania;Russian Federation;Serbia;Singapore;Slovakia;South Africa;Spain;Sweden;Switzerland;Taiwan;Ukraine;United Kingdom;Iceland
248NCT02760615November 1, 201610 December 2018Phase 4, Vedolizumab-4002 Post-marketing, Disease-Drug-Drug Interaction StudyAn Open-Label, 2-Part, Multicenter, Post-marketing Study to Evaluate the Effect of Moderately or Severely Active Ulcerative Colitis or Crohn's Disease on Cytochrome P-450 Enzyme Substrates Compared to Healthy Subjects and the Effect of Vedolizumab Treatment on Cytochrome P-450 Enzyme Substrates in Subjects With Ulcerative Colitis or Crohn's DiseaseColitis, Ulcerative;Crohn DiseaseDrug: Caffeine;Drug: Losartan;Drug: Omeprazole;Drug: Dextromethorphan;Drug: Midazolam;Drug: VedolizumabTakedaRecruiting18 Years55 YearsAll60Phase 4United States
249NCT02291523November 201611 February 2019The Effect of Therapeutic Fecal Transplant on the Gut Microbiome in Children With Ulcerative ColitisThe Effect of Therapeutic Fecal Transplant on the Gut Microbiome in Children With Ulcerative ColitisUlcerative ColitisBiological: Fecal Microbial TransplantChildren's Hospital Los AngelesRecruiting7 Years21 YearsAll101Phase 1United States
250NCT02962245November 201621 November 2016Efficacy of Treatment With Berberine to Maintain Remission in Ulcerative ColitisEfficacy of Treatment With Berberine to Maintain Remission in Ulcerative Colitis: An Open-label,Randomized,Phase IV Clinical TrialUlcerative ColitisDrug: berberine;Drug: regular treatmentXijing Hospital of Digestive DiseasesNot recruiting18 Years70 YearsBoth238Phase 4
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
251NCT03136419October 31, 201616 December 2017Microbiota and Immune microEnvironment in PouchitisMicrobiota and Immune microEnvironment in Pouchitis: Randomized Controlled Trial Oral Administration of Lactobacillus Casei DG After Ileostomy Closure in Ileal Pouch MucosaPouchitis;Ulcerative Colitis;Ileal PouchDietary Supplement: Lactobacillus casei DG;Dietary Supplement: PlaceboUniversity of PadovaRecruiting18 Years100 YearsAll32N/AItaly
252EUCTR2016-000509-35-BG27/10/201630 April 2018Drug OPRX-106 in Patients with Ulcerative ColitisAn Open Label, Proof of Concept Study to Assess the Safety, PK and Explore Efficacy of OPRX-106 in Patients with Active Mild to Moderate Ulcerative ColitisActive mild to moderate ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Product Name: OPRX-106 (plant cells expressing TNFR-Fc) 8mg
Product Code: OPRX-106
Pharmaceutical Form: Powder for oral suspension
Product Name: OPRX-106 (plant cells expressing TNFR-Fc) 2mg
Product Code: OPRX-106
Pharmaceutical Form: Powder for oral suspension
Protalix Biotherapeutics Ltd.Not RecruitingFemale: yes
Male: yes
20Phase 2Serbia;Israel;Bulgaria
253NCT02840721October 26, 201611 March 2019Safety, Efficacy, and Tolerability Study of PF-06480605 in Subjects With Moderate to Severe Ulcerative Colitis.A PHASE 2A, MULTICENTER, SINGLE ARM, OPEN- LABEL, TWO-STAGE, STUDY TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06480605 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITISColitis, UlcerativeDrug: PF-06480605PfizerNot recruiting18 Years75 YearsAll50Phase 2United States;Belgium;Italy;Korea, Republic of;Netherlands;Poland;France
254EUCTR2015-005260-41-NL13/10/201631 October 2016Efficacy of optimized thiopurine therapy in ulcerative colitis.Efficacy of optimized thiopurine therapy in ulcerative colitis. - OPTICUlcerative Colitis
MedDRA version: 19.0 Level: SOC Classification code 10017947 Term: Gastrointestinal disorders System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Mercaptopurine (Puri-Nethol)
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Academic Medical CentreAuthorisedFemale: yes
Male: yes
Phase 3Netherlands
255EUCTR2016-002061-54-IT13/10/20167 January 2019Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®) in the treatment of rheumatoid arthritis, spondyloarthritis and chronic inflammatory bowel diseases.Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®) in the treatment of rheumatoid arthritis, spondyloarthritis and chronic inflammatory bowel diseases. Evaluation of immunogenicity and clinical response - Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®)Rheumatoid arthritis, seronegative spondylo arthritis, Crohn's Disease, Ulcerative Colitis
MedDRA version: 20.0 Level: PT Classification code 10002556 Term: Ankylosing spondylitis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0 Level: PT Classification code 10075634 Term: Acute haemorrhagic ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: REMSIMA - 100 MG POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLANCONCINO (VETRO) - 1 FLACONCINO
Product Name: Remsima
Product Code: 42942019
Pharmaceutical Form: Powder for solution for infusion
UNIVERSITÀ CATTOLICA DEL SACRO CUORE- POLICLINICO A. GEMELLINot RecruitingFemale: yes
Male: yes
250Phase 4Italy
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
256EUCTR2016-000420-26-CZ06/10/201626 November 2018A study to test the effectiveness of bimekizumab as a treatment for ulcerative colitis to look for unwanted side effects and to measure how the drug is distributed, modified and cleared from the body.A MULTICENTER, SUBJECT-BLIND, INVESTIGATOR-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY, SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF AN IV LOADING DOSE FOLLOWED BY SC ADMINISTRATION OF BIMEKIZUMAB (UCB4940) IN SUBJECTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITISSEVERE ACTIVE ULCERATIVE COLITIS
MedDRA version: 20.0 Level: SOC Classification code 10017947 Term: Gastrointestinal disorders System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Bimekizumab
Product Code: UCB4940
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: Bimekizumab
CAS Number: 1418205-77-2
Current Sponsor code: CDP4940
Other descriptive name: UCB4940
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 160-
Pharmaceutical form of the placebo: Solution for injection/infusion
Route of administration of the placebo: Intravenous use
UCB Biopharma SPRLNot RecruitingFemale: yes
Male: yes
60Phase 2France;Czech Republic;Poland;Spain;Romania;Bulgaria;Georgia;South Africa;Moldova, Republic of;Italy;United Kingdom
257NCT02516384October 1, 20165 March 2018Fecal Microbiota Transplantation (FMT) in the Management of Ulcerative Colitis (UC)Fecal Microbiota Transplantation (FMT) in the Management of Ulcerative Colitis (UC)Ulcerative ColitisBiological: Fecal Microbiota TransplantationWeill Medical College of Cornell UniversityNot recruiting18 YearsN/AAll20Phase 1United States
258NCT03018925October 201616 December 2017Golimumab Effect in the Modulation of Gut Microbiota in Ulcerative ColitisGolimumab Effect in the Modulation of Gut Microbiota in Ulcerative Colitis: Pilot StudyUlcerative ColitisDrug: GolimumabInstitut d'Investigació Biomèdica de Girona Dr. Josep TruetaRecruiting18 YearsN/AAll15N/ASpain
259EUCTR2016-003073-18-GB29/09/20163 April 2017A study designed to investigate how radiolabelled RPC1063 is taken up, broken down and removed from the bodyA Phase I, Single-Centre, Single Dose Oral Excretion Balance Study of [14C]-RPC1063 in Healthy Male Adults - ADME study of [14C]-RPC1063 in healthy male subjects (QCL117686)The drug is a potential treatment for adult patients with relapsing multiple sclerosis (RMS) and for adult patients with moderately to severely active inflammatory bowel disease (IBD), including ulcerative colitis (UC) and Crohn’s disease (CD).
MedDRA version: 19.0 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 19.0 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856
MedDRA version: 19.0 Level: LLT Classification code 10013099 Term: Disease Crohns System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: [14C]-RPC1063 Solution (0.1 mg/mL) for Oral Administration
Pharmaceutical Form: Oral solution
INN or Proposed INN: Ozanimod hydrochloride
CAS Number: 1618636-37-5
Current Sponsor code: RPC1063HCL
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 0.1-
Celgene International II SàrlAuthorisedFemale: no
Male: yes
6Phase 1United Kingdom
260NCT02819635September 26, 201622 October 2019A Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis (UC)A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative ColitisUlcerative Colitis (UC)Drug: Placebo;Drug: Updacitinib (ABT-494)AbbVieRecruiting16 Years75 YearsAll844Phase 3United States;Argentina;Australia;Austria;Belarus;Belgium;Bosnia and Herzegovina;Brazil;Canada;Chile;China;Colombia;Croatia;Czechia;Egypt;Estonia;Finland;France;Germany;Greece;Hungary;Ireland;Israel;Italy;Japan;Korea, Republic of;Latvia;Lithuania;Malaysia;Mexico;Netherlands;Norway;Poland;Portugal;Puerto Rico;Romania;Russian Federation;Serbia;Singapore;Slovakia;South Africa;Spain;Sweden;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
261EUCTR2016-001158-16-PL23/09/201610 December 2018Study to test whether PF-06480605 is safe and improves symptoms in patients with ulcerative colitisA PHASE 2A, MULTICENTER, SINGLE ARM, OPEN-LABEL, TWO-STAGE, STUDY TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06480605 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITISUlcerative colitis (UC)
MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: PF-06480605
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: PF-06480605
Current Sponsor code: PF-06480605
Other descriptive name: PF-06480605
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: range
Concentration number: 42.5-57.5
Pfizer Inc. 235 East 42nd Street, New York, NY 10017Not RecruitingFemale: yes
Male: yes
50Phase 2France;United States;Belgium;Poland;Netherlands;Italy;Korea, Republic of
262EUCTR2014-004904-31-BE21/09/201620 August 2018A clinical study to investigate the infliximab serum concentration of Remsima™ (infliximab biosimilar) after switching from Remicade (infliximab) in subjects with Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA) in stable remission.An open-label, multicentre, phase IV study to investigate the infliximab serum concentration of Remsima™ (infliximab biosimilar) after switching from Remicade (infliximab) in subjects with Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA) in stable remission.Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA).;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Trade Name: Remsima (infliximab)
Pharmaceutical Form: Powder for concentrate for solution for injection/infusion
Mundipharma Pharmaceuticals B.V.Not RecruitingFemale: yes
Male: yes
156Phase 4Belgium;Netherlands
263EUCTR2016-000641-31-SK20/09/201623 January 2017Efficacy and Safety of ABT-494 in Subjects With Moderately to Severely Active Ulcerative ColitisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABT-494 for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative ColitisUlcerative Colitis
MedDRA version: 19.1 Level: PT Classification code 10009900 Term: Colitis ulcerative System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ABT-494
Pharmaceutical Form: Tablet
INN or Proposed INN: ABT-494
CAS Number: 1310726-60-3
Other descriptive name: ABT-494
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 7.5-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: ABT-494
Pharmaceutical Form: Tablet
INN or Proposed INN: ABT-494
CAS Number: 1310726-60-3
Other descriptive name: ABT-494
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 15-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: ABT-494
Pharmaceutical Form: Tablet
INN or Proposed INN: ABT-494
CAS Number: 1310726-60-3
Other descriptive name: ABT-494
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
AbbVie Deutschland GmbH & Co. KGAuthorisedFemale: yes
Male: yes
1055Phase 2;Phase 3Serbia;Belarus;United States;Estonia;Saudi Arabia;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Austria;Egypt;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Singapore;Kazakhstan;Norway;Japan;New Zealand
264EUCTR2016-000674-38-SK20/09/20161 October 2018Long Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis.A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects with Ulcerative Colitis (UC)Ulcerative Colitis
MedDRA version: 20.0 Level: PT Classification code 10009900 Term: Colitis ulcerative System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Upadacitinib
Product Code: ABT-494
Pharmaceutical Form: Tablet
INN or Proposed INN: Upadacitinib
CAS Number: 1310726-60-3
Current Sponsor code: ABT-494
Other descriptive name: ABT-494
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 15-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: Upadacitinib
Product Code: ABT-494
Pharmaceutical Form: Tablet
INN or Proposed INN: Upadacitinib
CAS Number: 1310726-60-3
Current Sponsor code: ABT-494
Other descriptive name: ABT-494
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: Upadacitinib
Product Code: ABT-494
Pharmaceutical Form: Tablet
INN or Proposed INN: Upadacitinib
CAS Number: 1310726-60-3
Current Sponsor code: ABT-494
Other descriptive name: ABT-494
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 7.5-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
AbbVie Deutschland GmbH & Co. KGAuthorisedFemale: yes
Male: yes
950Phase 3Portugal;Serbia;Belarus;United States;Estonia;Saudi Arabia;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Singapore;Croatia;Kazakhstan;Norway;Japan;New Zealand;Sweden
265NCT02864264September 14, 201616 December 2017Single Ascending Dose and Multiple Ascending Dose Study in Healthy Participants and Proof of Mechanism Study in Patients With Ulcerative ColitisDouble-Blind, Randomized, Placebo-Controlled, Single Ascending and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Target Engagement of BMS-986184 in Healthy Subjects and to Evaluate the Safety, Efficacy, Pharmacokinetics, Target Engagement, and Pharmacodynamics of BMS-986184 in Patients With Moderate to Severe Ulcerative ColitisHealthy Volunteers;Ulcerative ColitisDrug: BMS-986184;Drug: Placebo matching BMS-986184Bristol-Myers SquibbNot recruiting18 Years75 YearsAll7Phase 1Australia;Georgia;Moldova, Republic of;Romania
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
266NCT02883452September 12, 201626 August 2019A Phase I Study to Evaluate PK, Efficacy and Safety of CT-P13 SC in Patients With Active CD and UCAn Open-label, Randomized, Parallel-Group, Phase I Study to Evaluate Pharmacokinetics, Efficacy and Safety Between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients With Active Crohn's Disease and Active Ulcerative ColitisCrohn's Disease;Ulcerative ColitisBiological: InfliximabCelltrionNot recruiting18 Years75 YearsAll170Phase 1Korea, Republic of
267EUCTR2016-001833-29-SE07/09/201619 March 2018A multicentre, randomised, double-blind (sponsor-unblinded), placebo-controlled study with open label extension to investigate the safety and tolerability, pharmacokinetics, pharmacodynamics, and efficacy of GSK2982772 in subjects with active ulcerative colitisA multicentre, randomised, double-blind (sponsor-unblinded), placebo-controlled study with open label extension to investigate the safety and tolerability, pharmacokinetics, pharmacodynamics, and efficacy of GSK2982772 in subjects with active ulcerative colitis.Active ulcerative colitis
MedDRA version: 20.0 Level: HLGT Classification code 10017969 Term: Gastrointestinal inflammatory conditions System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: GSK2982772
Product Code: GSK2982772
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Not Available
CAS Number: Not Availabl
Current Sponsor code: GSK2982772
Other descriptive name: GSK2982772A, where A denotes the free base
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
GlaxoSmithKline Research & Development LtdAuthorisedFemale: yes
Male: yes
48Phase 2Poland;Netherlands;Germany;United Kingdom;Sweden
268JPRN-UMIN0000225882016/09/012 April 2019Assessment of indication and efficacy of anti-viral therapy based on mucosal PCR assay in active UC patients with CMV infection.Ulcerative colitisAdditional immunosuppressive therapies combined with anti-viral therapy (Ganciclovir 5mg/kg, twice a day, 2weeks)
Additional immunosuppressive therapies without administration of ganciclovir
Department of Gastroenterology and Hepatology, Kyoto University HospitalNot Recruiting20years-oldNot applicableMale and Female120Not applicableJapan
269NCT02825914September 1, 20167 October 2019CAsein GLycomacropeptide in Ulcerative Colitis - Anti-Inflammatory and Microbiome Modulating Effects (CAGLUCIM)CAsein GLycomacropeptide in Ulcerative Colitis - Anti-Inflammatory and Microbiome Modulating Effects (CAGLUCIM)Colitis, Ulcerative;Inflammatory Bowel DiseasesDietary Supplement: Casein glycomacropeptide (CGMP);Dietary Supplement: PlaceboUniversity of AarhusNot recruiting18 YearsN/AAll80N/ADenmark
270NCT02764229September 201611 June 2018Open-label Extension Study to Assess Safety and Tolerability of LYC-30937-EC in Subjects With Active Ulcerative ColitisA Multicenter Open-label Extension Study to Assess the Safety and Tolerability of LYC-30937-EC in Subjects With Active Ulcerative ColitisColitis, UlcerativeDrug: LYC-30937-ECLycera Corp.Not recruiting18 Years75 YearsAll120Phase 2United States;Czechia;Hungary;Netherlands;Poland;Serbia
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
271NCT02768974September 201610 October 2016Open Label Study to Assess Safety, PK and Explore Efficacy of OPRX-106 in Patients With Active Mild to Moderate Ulcerative ColitisAn Open Label, Proof of Concept Study to Assess the Safety, PK and Explore Efficacy of OPRX-106 in Patients With Active Mild to Moderate Ulcerative ColitisUlcerative ColitisDrug: OPRX-106ProtalixRecruiting18 Years70 YearsBoth20Phase 2Israel
272NCT02888379September 201616 December 2017Phase 2a Study to Evaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks in Ulcerative ColitisA Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patients With Moderate to Severe Disease ActivityUlcerative ColitisDrug: TOP1288;Drug: Placebo (for TOP1288)Topivert Pharma LtdNot recruiting18 Years75 YearsAll77Phase 2Bulgaria;Czechia;Hungary;Latvia;Lithuania;Poland;Ukraine;United Kingdom;Czech Republic
273EUCTR2016-002433-30-DK25/08/20167 January 2019Effect of azathioprine and allopurinol compared to azaothioprine monotherapy in ulcerative colitisLow-dose azathioprine and allopurinol versus azathioprine monotherapy for patients with ulcerative colitis: protocol for an investigator initiated, open, multicentre, parallel arm, randomised controlled trial - AAUCUlcerative Colitis
MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Imurel
Pharmaceutical Form: Tablet
INN or Proposed INN: Azathioprine
CAS Number: 446-86-6
Other descriptive name: AZATHIOPRINE
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 25-50
Trade Name: Allopurinol
Pharmaceutical Form: Tablet
INN or Proposed INN: ALLOPURINOL
CAS Number: 315-30-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Hvidovre HospitalAuthorisedFemale: yes
Male: yes
84Phase 3Denmark
274EUCTR2015-001346-29-BE22/08/201617 October 2016A Multi-Center, Open-Label Study of Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Ulcerative Colitis Who Completed the Study M11-290A Multi-Center, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Ulcerative Colitis Who Completed the Study M11-290Ulcerative Colitis
MedDRA version: 18.0 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use
Product Name: Adalimumab
Product Code: 331731-18-1
Pharmaceutical Form: Injection
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Current Sponsor code: Humira
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
AbbVie Deutschland GmbH & Co. KGAuthorisedFemale: yes
Male: yes
93Phase 3United States;Hungary;Canada;Spain;Belgium;Australia;Israel;United Kingdom;New Zealand;Japan
275JPRN-UMIN0000264852016/08/012 April 2019Research on the Efficacy of Fecal Microbiota Transplantation and Microbiota in Japanese Children with Ulcerative Colitis.ulcerative colitisFecal Microbiota Transplantation(on Day1, 2 and 3, week 2, 3 and 5) after antibiotic pretreatment using amoxicillin 40mg/kg/day, fosfomycin 100mg/kg/day and metronidazole 16mg/kg/day.National Center for Child Health and Development10Probiotics Research Laboratory, Juntendo University Graduate School of Medicine, Tokyo, Japan. Yakult Central Institute, Tokyo, JapanRecruiting2years-old18years-oldMale and Female12Not selectedJapan
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
276NCT02743806August 1, 201611 November 2019Extended Access Program of Vedolizumab IV in Ulcerative Colitis and Crohn's DiseaseEntyvio (Vedolizumab IV) Extended Access Program in Ulcerative Colitis and Crohn's DiseaseColitis, Ulcerative;Crohn DiseaseDrug: VedolizumabTakedaNot recruiting18 Years90 YearsAll331Phase 4Australia;Bulgaria;Czechia;Estonia;Hungary;India;Italy;Korea, Republic of;Latvia;Malaysia;New Zealand;Poland;Romania;Russian Federation;Serbia;South Africa;Turkey;Ukraine;Czech Republic;Slovakia;Taiwan
277NCT02818686August 201620 August 2018TD-1473 for Active Ulcerative Colitis (UC)A Phase 1b Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Plasma Exposure of TD-1473 in Subjects With Moderately-to-Severely Active Ulcerative ColitisUlcerative Colitis, Active Moderate;Ulcerative Colitis, Active SevereDrug: TD-1473;Drug: PlaceboTheravance Biopharma R & D, Inc.Not recruiting18 Years75 YearsAll40Phase 1United States
278NCT02865707August 20163 June 2019Ulcerative Colitis Relapse Prevention by PrebioticsPrevention of Ulcerative Colitis by Prebiotics: Efficacy and Protective MechanismsUlcerative ColitisDietary Supplement: Synergy-1;Dietary Supplement: MaltodextrinUniversity of AlbertaUniversity of British ColumbiaRecruiting18 Years75 YearsAll100N/ACanada
279EUCTR2016-000235-40-SE29/07/20168 August 2016Stopping anti-TNF treatment in Crohn’s and Colitis patients in remissionStopping anti-TNF treatment in Crohn’s and Colitis patients in remission - The StatiC studyCrohn´s disease Ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Remicade
Pharmaceutical Form: Concentrate and solvent for solution for infusion
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Trade Name: Remsima
Pharmaceutical Form: Concentrate and solvent for solution for infusion
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Trade Name: Inflectra
Pharmaceutical Form: Concentrate and solvent for solution for infusion
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Trade Name: Humira
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Region SkåneAuthorisedFemale: yes
Male: yes
Phase 4Sweden
280EUCTR2016-000205-36-DE11/07/201614 November 2016A Clinical Trial to Evaluate Activity, Safety and Tolerability of FE 999301 by Intravenous Infusions in Patients with Active Inflammatory Bowel Disease (IBD).A Single-Centre, Exploratory Trial to Assess the Mechanisms of Molecular Activity, Safety and Tolerability of One Dose Level of FE 999301 by Intravenous Infusions in Patients with Active Inflammatory Bowel Disease (IBD) - FUTUREInflammatory Bowel Disease (Crohn`s Disease and Ulcerative Colitis)
MedDRA version: 19.0 Level: PT Classification code 10009900 Term: Colitis ulcerative System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 19.0 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: FE 999301
Pharmaceutical Form: Concentrate for solution for infusion
University Hospital Schleswig-Holstein (UKSH)AuthorisedFemale: yes
Male: yes
Phase 2Germany
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
281JPRN-UMIN0000199582016/07/022 April 2019Research for biomarkers of inflammatory bowel disease. - Investigation of the usefulness of LRG for evaluation of disease condition after adalimumab treatmentsCrohn's disease, ulcerative colitisPatients with Crohn's disease or ulcerative colitis

Adalimumab administration subcutaneously for 52 weeks using the recommended dosing regimens.
Iwate Medical University Kochi Medical School Hospital Keio University School of MedicineNot Recruiting15years-oldNot applicableMale and Female100Not applicableJapan
282NCT02762500July 201625 June 2018An Efficacy and Safety Study of LYC-30937-EC in Subjects With Active Ulcerative ColitisA Randomized, Double-Blind, Placebo-Controlled Parallel Group Study to Assess the Efficacy and Safety of Induction Therapy With LYC-30937-EC in Subjects With Active Ulcerative ColitisColitis, UlcerativeDrug: LYC-30937-EC;Drug: PlaceboLycera Corp.Not recruiting18 Years75 YearsAll124Phase 2United States;Canada;Czechia;Hungary;Netherlands;Poland;Serbia;Czech Republic
283NCT02770040July 201621 July 2016Optimising Infliximab Induction Therapy for Acute Severe Ulcerative ColitisPREDICT UC: Optimising Infliximab Induction Therapy for Acute Severe Ulcerative Colitis - A Randomised Controlled TrialUlcerative ColitisDrug: InfliximabAustin HealthUniversity of MelbourneRecruiting18 Years80 YearsBoth138Phase 4Australia
284NCT02849951July 201616 December 2017A Study to Investigate the Safety and Efficacy of LT-02 in Patients With Mesalamine Refractory Ulcerative Colitis (UC)A Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of a 12-week Add-on Treatment With LT-02 vs. Placebo in Subjects With Ulcerative Colitis Refractory to Standard Treatment With MesalamineUlcerative ColitisDrug: LT-02;Drug: LT-02 PlaceboPrometheus LaboratoriesNestlé Health Science Spain;INC ResearchNot recruiting18 Years70 YearsAll25Phase 3United States
285EUCTR2016-000678-40-CZ27/06/201628 February 2019Program to allow continuation of treatment with Entyvio (Vedolizumab IV) for patients with ulcerative colitis and Chron´s disease who previously participated in a clinical trial with this same treatmentEntyvio (Vedolizumab IV) Extended Access Program in Ulcerative Colitis and Crohn’s DiseaseUlcerative Colitis and Crohn’s Disease
MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856
MedDRA version: 20.0 Level: LLT Classification code 10013099 Term: Disease Crohns System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Entyvio
Product Name: vedolizumab IV
Product Code: MLN002
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: vedolizumab
CAS Number: 943609-66-3
Current Sponsor code: MLN0002
Other descriptive name: VEDOLIZUMAB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
Takeda Development Centre Europe LimitedAuthorised Female: yes
Male: yes
385Phase 4Serbia;Taiwan;Estonia;Slovakia;Ukraine;Turkey;Russian Federation;Italy;India;Czech Republic;Hungary;Poland;Malaysia;Romania;Australia;South Africa;Bulgaria;Latvia;New Zealand;Korea, Republic of
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
286NCT02365480June 16, 201622 October 2019Berberine Chloride in Preventing Colorectal Cancer in Patients With Ulcerative Colitis in RemissionPhase I Trial of Berberine in Subjects With Ulcerative ColitisUlcerative ColitisDrug: Berberine Chloride;Other: Laboratory Biomarker Analysis;Other: PlaceboNational Cancer Institute (NCI)Not recruiting18 Years70 YearsAll18Phase 1United States;China
287NCT02665845June 13, 20164 November 2019Combination Corticosteroids+5-aminosalicylic Acids Compared to Corticosteroids Alone (for Ulcerative Colitis).Combination Corticosteroids+5-aminosalicylic Acids Compared to Corticosteroids Alone in the Treatment of Moderate-severe Active Ulcerative Colitis: A Protocol of a Multi-center Prospective Randomized Investigator Blinded Trial.Ulcerative ColitisDrug: 5-ASA;Drug: CorticosteroidsCentre Hospitalier Universitaire de Saint EtienneRecruiting18 YearsN/AAll160Phase 3France;Greece;Israel;Italy;Korea, Republic of;Serbia
288EUCTR2016-000390-20-GB10/06/201623 January 2017A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease ActivityA Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease ActivitySymptomatic Ulcerative Colitis Patients with Moderate Disease Activity
MedDRA version: 19.0 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: TOP1288 Rectal solution
Pharmaceutical Form: Rectal solution
INN or Proposed INN: Not Applied for
CAS Number: 1630202-02-6
Current Sponsor code: TOP1288
Other descriptive name: TOP1288 rectal solution
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Rectal solution
Route of administration of the placebo: Rectal use
TOPIVERT Pharma LimitedAuthorisedFemale: yes
Male: yes
60Phase 2Hungary;Czech Republic;Poland;Ukraine;Lithuania;Bulgaria;Latvia;United Kingdom
289EUCTR2016-001278-13-FI08/06/201627 June 2016Immunologic, genetic and bowel microbes as predictors of the treatment response for TNFalpha-blocking drugs in patients with Crohn’s disease or ulcerative colitisImmunologic, genetic and microbiomic predictors of the treatment response for TNFalpha-blocking drugs – prospective follow-up cohort of patients with Crohn’s disease or ulcerative colitis - PROSIBDUlcerative colitis and Crohn's disease
MedDRA version: 19.0 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 19.0 Level: LLT Classification code 10013099 Term: Disease Crohns System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 19.0 Level: LLT Classification code 10058815 Term: Crohn's disease acute episode System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 19.0 Level: LLT Classification code 10057035 Term: Crohn's ileocolitis System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 19.0 Level: LLT Classification code 10011405 Term: Crohn's enteritis System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 19.0 Level: LLT Classification code 10011406 Term: Crohn's ileitis System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 19.0 Level: LLT Classification code 10076318 Term: Crohn's disease relapse System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 19.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 19.0 Level: LLT Classification code 10011402 Term: Crohn's disease (colon) System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 19.0 Level: LLT Classification code 10075466 Term: Fistulising Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 19.0 Level: LLT Classification code 10066678 Term: Acute ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 19.0 Level: LLT Classification code 10075465 Term: Fistulizing Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 19.0 Level: LLT Classification code 10011400 Term: Crohn's colitis System Organ Class: 10017947 - Gastrointe;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Remsima
Product Name: Remsima
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3
Taina SipponenAuthorisedFemale: yes
Male: yes
Phase 4Finland
290NCT02687724June 201620 August 2018Golimumab (GLM) Dose Optimisation to Adequate Levels to Achieve Response in ColitisGLM Dose Optimisation to Adequate Levels to Achieve Response in Colitis (GOAL-ARC). A Nationwide Multi-centred Randomised Controlled Trial (RCT) Investigating the Use of GLM Dose Adjustment in Ulcerative Colitis (UC).ColitisDrug: Golimumab (GLM)University College DublinRecruiting18 YearsN/AAll136Phase 4Ireland
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
291NCT02606032May 201618 March 2019Trial of Antimicrobials Versus Placebo in Addition to Fecal Transplant Therapy in Ulcerative ColitisRandomized Trial of Antimicrobials Versus Placebo in Addition to Fecal Microbiota Therapy in for the Induction of Remission in Active Ulcerative ColitisUlcerative ColitisDrug: Metronidazole;Drug: Doxycycline;Drug: Terbinafine;Drug: PlaceboHamilton Health Sciences CorporationHamilton Academic Health Sciences OrganizationRecruiting18 YearsN/AAll80Phase 2Canada
292EUCTR2015-004618-10-BE19/04/20168 August 2016PhArmaCo-kinetics of InFliximab during treatment InductionStudy of the inter-individual variation of PhArmaCo-kinetics of InFliximab during treatment Induction in patients with Crohn’s disease and Ulcerative ColitisPatients with Crohn disease or Ulcerative Colitis which need biotherapy (antibody against TNF-a);Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Remsima
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3
Other descriptive name: Remsima
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: range
Concentration number: 5-10
Trade Name: Remicade
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3
Other descriptive name: Remicade
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: range
Concentration number: 5-10
Trade Name: Inflectra
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3
Other descriptive name: Inflectra
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: range
Concentration number: 5-10
CUB- Hopital ErasmeAuthorisedFemale: yes
Male: yes
Phase 4Belgium
293NCT02620046April 15, 201620 May 2019Vedolizumab Subcutaneous Long-Term Open-Label Extension StudyA Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects With Ulcerative Colitis and Crohn's DiseaseColitis, Ulcerative;Crohn DiseaseDrug: Vedolizumab SCTakedaRecruiting18 Years80 YearsAll692Phase 3Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Sweden;Taiwan;Turkey;Ukraine;United Kingdom;United States;Colombia;Czech Republic;Argentina;Australia;Belgium;Bosnia and Herzegovina;Brazil;Bulgaria;Canada;Croatia;Czechia;Denmark;Estonia;Germany;Hungary;Israel;Italy;Japan;Korea, Republic of;Lithuania;Mexico;Netherlands;Poland
294NCT02749630April 11, 201611 November 2019A Safety Study of Intravenously Administered UTTR1147A in Healthy Volunteers (HVs), Participants With Ulcerative Colitis (UC), and Participants With Crohn's Disease (CD)An Observer-Blinded, Placebo-Controlled, Multiple-Ascending, Dose-Escalation Study to Explore the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Repeat Intravenous Administrations of UTTR1147A in Healthy Volunteers and Patients With Ulcerative Colitis and Crohn's DiseaseUlcerative Colitis;Crohn's DiseaseDrug: Placebo;Drug: UTTR1147AGenentech, Inc.Not recruiting18 Years80 YearsAll90Phase 1Germany;United Kingdom;Canada
295JPRN-UMIN0000200292016/04/0122 July 2019The significance of serum HBs-antigen as a monitoring examination for viral reactivation during immunesuppressive therapy in patients with previously resolved hepatitis B virus infectionThe significance of serum HBs-antigen as a monitoring examination for viral reactivation during immunesuppressive therapy in patients with previously resolved hepatitis B virus infection - Monitoring by HBs antigen for HBV ReactivationCollagen disease, collagen disease related disease, ulcerative colitis, Crohn's disease, intestinal Behcet's disease (simple ulcers included), psoriasis, and diseases that require other immunosuppressive therapies.Entecavir administration is initiated when serum HBV-DNA levels increased up to 3.0 Log/IU/mL and/or serum HBs-antigen becomes detectable.Saitama Medical UniversityRecruiting16years-oldNot applicableMale and Female300Not selectedJapan
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
296EUCTR2015-002109-12-GB14/03/201628 February 2019A study that continues from APD334-003 which investigates the safety and effectiveness of treatment with the drug APD334 in patients with ulcerative colitis (a form of inflammatory bowel disease)An Extension Study of APD334-003 in Patients with Moderately to Severely Active Ulcerative ColitisUlcerative colitis
MedDRA version: 20.0 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: APD334
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Not yet available
Other descriptive name: APD334
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-
Arena Pharmaceuticals, Inc.Not Recruiting Female: yes
Male: yes
240Phase 2United States;Spain;Ukraine;Lithuania;Austria;Russian Federation;Israel;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Germany;Latvia;New Zealand
297NCT02818543March 20169 January 2017Safety and Pharmacokinetic Study of LYC-30937 in Subjects With Active Ulcerative ColitisAn Open-Label, Single Ascending Dose Study To Evaluate The Pharmacokinetic Profile, Safety and Tolerability of Orally Administered LYC-30937 in Subjects With Active Ulcerative ColitisUlcerative ColitisDrug: LYC-30937Lycera Corp.Not recruiting18 Years75 YearsBoth6Phase 1Hungary
298EUCTR2015-003123-57-BE09/02/20167 May 2018An investigational study to assess the safety and effectiveness of an investigational drug in people with moderate to severe ulcerative colitisA Phase 2, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study of LY3074828 in Subjects with Moderate to Severe Ulcerative Colitis - AMACUlcerative colitis
MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mirikizumab
Product Code: LY3074828
Pharmaceutical Form: Powder for solution for injection/infusion
INN or Proposed INN: Not assigned
Current Sponsor code: LY3074828
Other descriptive name: LY3074828
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-
Pharmaceutical form of the placebo: Solution for injection/infusion
Route of administration of the placebo: Intravenous use
Eli Lilly and CompanyAuthorisedFemale: yes
Male: yes
240Phase 2United States;Ukraine;Lithuania;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Denmark;Georgia;Netherlands;Moldova, Republic of;Japan
299EUCTR2015-003364-36-HU09/02/20162 October 2017A study using a new drug (GED-0301) to investigate if the new drug works and is safe in subjects suffering ulcerative colitis.A Phase 2, Open-label, Multicenter Study to Explore the Efficacy and Safety of Mongersen (GED-0301) in Subjects with Active Ulcerative Colitis.Ulcerative Colitis.
MedDRA version: 18.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Mongersen
CAS Number: 1443994-86-6
Current Sponsor code: GED-0301
Other descriptive name: GED-0301
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Celgene CorporationNot RecruitingFemale: yes
Male: yes
40Phase 2United States;Hungary;Slovakia;Canada;Poland;Bulgaria
300EUCTR2015-001346-29-GB08/02/20169 October 2017A Multi-Center, Open-Label Study of Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Ulcerative Colitis Who Completed the Study M11-290A Multi-Center, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Ulcerative Colitis Who Completed the Study M11-290Ulcerative Colitis
MedDRA version: 20.0 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000016670 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use
Product Name: Adalimumab
Product Code: 331731-18-1
Pharmaceutical Form: Injection
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Current Sponsor code: Humira
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
AbbVie Deutschland GmbH & Co. KGNot RecruitingFemale: yes
Male: yes
93Phase 3United States;Czech Republic;Hungary;European Union;Canada;Spain;Belgium;Israel;New Zealand;Japan;United Kingdom;Sweden
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
301JPRN-UMIN0000208402016/02/022 April 2019A multi-Center, prospective study for maintenance of remission after discontinuation of adalimumab therapy in ulcerative colitis patientsulcerative colitisdiscontinuation of adalimumab therapyFukuyama Medical CenterRecruiting15years-oldNot applicableMale and Female50Not selectedJapan
302NCT02522780February 1, 201616 September 2019Mesalamine 2 g Sachet for the Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis (UC)A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 2 g Extended Release Granules (Sachet) for Maintenance of Clinical and Endoscopic Remission in Ulcerative ColitisUlcerative ColitisDrug: Mesalamine;Drug: PlaceboFerring PharmaceuticalsNot recruiting18 Years75 YearsAll276Phase 3United States;Bulgaria;Canada;Hungary;Latvia;Mexico;Poland;Russian Federation;Serbia;Switzerland;Ukraine;Belgium
303NCT02579733February 1, 201626 August 2019Azathioprine Based on Endoscopy After Clinical Remission in Moderate to Severe Ulcerative ColitisUlcerative ColitisDrug: Azathioprine;Drug: PlaceboKyungpook National UniversityCelltrionNot recruiting18 Years80 YearsAll16Phase 4Korea, Republic of
304NCT02683733February 201614 March 2016Bio-enhanced Curcumin as an Add-On Treatment in Mild to Moderate Ulcerative ColitisThe Efficacy and Tolerability of Bio-enhanced Curcumin (Diferuloylmethane) in the Induction of Remission in Patients With Mild to Moderate Ulcerative ColitisUlcerative ColitisDietary Supplement: Bio-enhanced Curcumin Soft Gelatin Capsule;Drug: 5-Aminosalicylic acidAsian Institute of Gastroenterology, IndiaRecruiting18 Years70 YearsBoth50Phase 3India
305NCT02683759February 201614 March 2016Bio-enhanced Curcumin as an Add-on Treatment in Maintaining Remission of Ulcerative ColitisThe Efficacy and Tolerability of Bio-Enhanced Curcumin in Maintaining Remission in Patients With Ulcerative ColitisUlcerative ColitisDietary Supplement: Bio-enhanced Curcumin Soft Gelatin Capsule;Drug: 5-Aminosalicyclic acidAsian Institute of Gastroenterology, IndiaRecruiting18 Years70 YearsBoth50Phase 3India
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
306EUCTR2015-000319-41-NL26/01/201628 February 2019The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC).A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Induction and Maintenance Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of RPC1063 in Ulcerative Colitisulcerative colitis
MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: 0.25mg RPC103
Product Code: RPC1063
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Ozanimod
Current Sponsor code: RPC1063
Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.25-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Product Name: 1.0 mg RPC103
Product Code: RPC1063
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Ozanimod
Current Sponsor code: RPC1063
Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Celgene International II Sàrl (CIS II)Authorised Female: yes
Male: yes
900Phase 3Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;New Zealand
307EUCTR2015-001555-69-HU15/01/201626 November 2018A clinical study to test the safety and possible benefits of an investigational study drug, KHK4083, in patients with ulcerative colitis.A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Multiple Ascending Dose Study (Induction Therapy) and Long-term Extension Therapy of an Anti-OX40 Monoclonal Antibody (KHK4083) in Subjects with Moderately Active Ulcerative ColitisModerately Active Ulcerative Colitis, defined as: •Total Mayo Clinic score of 4 to 9 (range: 0 to 12, with higher scores indicating more disease activity); •Endoscopy subscore (mMES determined by a central reader) of at least 2; and •Disease that extends = 15 cm from the anal verge.
MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: KHK4083
Product Code: KHK4083
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Not available
Current Sponsor code: KHK4083
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
Kyowa Kirin Pharmaceutical Development, Inc.Not RecruitingFemale: yes
Male: yes
60Phase 2Serbia;United States;Czech Republic;Hungary;Poland;Russian Federation
308JPRN-UMIN0000229542016/01/152 April 2019A study related to usability of Mesalazine Controlled-Release Tablets and Granules.ulcerative colitisPatients take Mesalazine Controlled-release tablets at first, 3-12 weeks, then take granules, 3-12 weeks
Patients take Mesalazine Controlled-release granules at first, 3-12 weeks, then take tablets, 3-12 weeks
Kitasato University Kitasato Institute HospitalRecruitingNot applicable100years-oldMale and Female60Not applicableJapan
309NCT02618187January 13, 20163 September 2018A Study to Evaluate the Safety, Tolerability and Microbiome Dynamics of SER-287 in Subjects With Mild-to-Moderate Ulcerative ColitisA Phase 1B Multiple Dose Study to Evaluate the Safety, Tolerability and Microbiome Dynamics of SER-287 in Subjects With Mild-to-Moderate Ulcerative ColitisUlcerative ColitisDrug: Eubacterial Spores, Purified Suspension, Encapsulated;Drug: Placebo;Drug: Placebo Pre-Treat;Drug: Vancomycin Pre-TreatSeres Therapeutics, Inc.Not recruiting18 Years75 YearsAll58Phase 1United States
310NCT02742597January 12, 20168 January 2018Patient-Centred Innovations for Persons With Multimorbidity - OntarioPatient-Centred Innovations for Persons With Multimorbidity - OntarioHypertension;Depression;Anxiety;Musculoskeletal Pain;Arthritis;Rheumatoid Arthritis;Osteoporosis;Chronic Obstructive Pulmonary Disease (COPD);Asthma;Chronic Bronchitis;Cardiovascular Disease;Heart Failure;Stroke;Transient Ischemic Attacks;Ulcer;Gastroesophageal Reflux;Irritable Bowel;Crohn's Disease;Ulcerative Colitis;Diverticulosis;Chronic Hepatitis;Diabetes;Thyroid Disorder;Cancer;Kidney Disease;Urinary Tract Problem;Dementia;Alzheimer's Disease;Hyperlipidemia;HIV;MultimorbidityBehavioral: TIP / IMPACT Plus Care CoordinationLawson Health Research InstituteWestern University, Canada;Université de Sherbrooke;Canadian Institutes of Health Research (CIHR);Sunnybrook Health Sciences Centre;St. Michael's Hospital, Toronto;University Health Network, Toronto;Toronto East General Hospital;Providence HealthCare;Mount Sinai Hospital, Canada;Toronto Central Community Care Access Centre;Women's College HospitalNot recruiting18 Years80 YearsAll1980N/ACanada
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
311EUCTR2015-002109-12-LV08/01/201626 November 2018A study that continues from APD334-003 which investigates the safety and effectiveness of treatment with the drug APD334 in patients with ulcerative colitis (a form of inflammatory bowel disease)An Extension Study of APD334-003 in Patients with Moderately to Severely Active Ulcerative ColitisUlcerative colitis
MedDRA version: 19.0 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: APD334
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Not yet available
Other descriptive name: APD334
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Arena Pharmaceuticals, Inc.Not RecruitingFemale: yes
Male: yes
240Phase 2United States;Spain;Ukraine;Lithuania;Austria;Russian Federation;Israel;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Latvia;Germany;New Zealand
312NCT02611830January 8, 201610 September 2018Efficacy and Safety of Vedolizumab Subcutaneously (SC) as Maintenance Therapy in Ulcerative ColitisA Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, With a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous TherapyColitis, UlcerativeDrug: Vedolizumab IV 300 mg;Drug: Placebo IV;Drug: Vedolizumab SC 108 mg;Drug: Placebo SCTakedaNot recruiting18 Years80 YearsAll384Phase 3United States;Argentina;Australia;Belgium;Bosnia and Herzegovina;Brazil;Bulgaria;Canada;Croatia;Czechia;Denmark;Estonia;Germany;Hungary;Israel;Italy;Japan;Korea, Republic of;Lithuania;Mexico;Netherlands;Poland;Romania;Russian Federation;Serbia;Slovakia;Spain;Sweden;Turkey;Ukraine;United Kingdom;Colombia;Czech Republic
313NCT02493712January 201626 August 2019A Phase 2a, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Trial of IBD98-MA Phase 2a, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Trial of IBD98-M Delayed-release Capsules to Induce Remission in Patients With Active, Mild to Moderate Ulcerative ColitisColitis, UlcerativeDrug: High dose;Drug: Low dose;Drug: PlaceboHoly Stone Healthcare Co., LtdinVentiv Health ClinicalNot recruiting18 Years75 YearsAll51Phase 2Italy;Taiwan
314EUCTR2015-004724-62-IE22/12/201523 July 2018Golimumab dose variation to achieve response in ColitisGolimumab (GLM) dose Optimisation to Adequate Levels to Achieve Response in Colitis. (GOAL-ARC)Ulcerative Colitis
MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Simponi
Product Name: Simponi
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: GOLIMUMAB
CAS Number: 476181-74-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
INN or Proposed INN: GOLIMUMAB
CAS Number: 476181-74-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
UCDAuthorisedFemale: yes
Male: yes
136Phase 4Ireland
315EUCTR2015-001942-28-CZ10/12/20153 April 2017A study to investigate the safety and effectiveness of treatment with the drug APD334 in patients with ulcerative colitis (a form of inflammatory bowel disease)A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study to Investigate the Safety and Efficacy of APD334 in Patients with Moderately to Severely Active Ulcerative ColitisUlcerative colitis
MedDRA version: 19.0 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: APD334
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Not yet available
Current Sponsor code: APD334
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Product Code: APD334
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Not yet available
Current Sponsor code: APD334
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Arena Pharmaceuticals, Inc.Not RecruitingFemale: yes
Male: yes
240Phase 2United States;Spain;Ukraine;Lithuania;Austria;Israel;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Latvia;Germany;New Zealand
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
316NCT02531126December 2, 20154 November 2019Open-Label Extension of RPC1063 as Therapy for Moderate to Severe Ulcerative ColitisA Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative ColitisUlcerative ColitisDrug: RPC1063CelgeneRecruiting12 YearsN/AAll890Phase 3United States;Argentina;Australia;Austria;Belarus;Belgium;Bulgaria;Canada;Croatia;Czechia;Georgia;Germany;Greece;Hungary;Israel;Italy;Korea, Republic of;Latvia;Moldova, Republic of;Netherlands;New Zealand;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Ukraine;United Kingdom;Czech Republic
317EUCTR2015-001022-42-IT01/12/201530 April 2019A Phase 2a, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Trial of IBD98-M Delayed-release Capsules to Induce Remission in Patients with Active, Mild to Moderate Ulcerative ColitisA Phase 2a, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Trial of IBD98-M Delayed-release Capsules to Induce Remission in Patients with Active, Mild to Moderate Ulcerative ColitisActive, Mild to Moderate Ulcerative Colitis
MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: IBD98-M Delayed-release Capsules
Product Code: IBD98-M
Pharmaceutical Form: Capsule
INN or Proposed INN: SODIUM HYALURONATE
CAS Number: 9067-32-7
Other descriptive name: SODIUM HYALURONATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 23-
INN or Proposed INN: MESALAZINE
CAS Number: 89-57-6
Other descriptive name: Mesalamine, 5-ASA
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Holy Stone Healthcare Co., Ltd.Not Recruiting Female: yes
Male: yes
51Phase 2Italy
318NCT02368743December 201516 July 2018QUality of Life in pAtients With Mild to modeRate Active procTitis Treated by mesalaZine (Pentasa®)QUality of Life in pAtients With Mild to modeRate Active procTitis Treated by mesalaZine (Pentasa®)Distal Ulcerative ColitisDrug: mesalazineFerring PharmaceuticalsNot recruiting18 YearsN/AAll117Phase 2France
319NCT02390726December 201516 July 2018Fecal Microbiota Transplant in the Treatment of Ulcerative ColitisFecal Microbiota Transplant in the Treatment of Ulcerative ColitisUlcerative Colitis, Active ModerateBiological: Fecal Microbiota Transplant;Biological: PlaceboUniversity of VermontNot recruiting18 Years75 YearsAll20Early Phase 1United States
320NCT02586259December 201526 August 2019Effectiveness of Cortiment® in Patients With Ulcerative ColitisA Prospective Multi-centre Observational Cohort Study Assessing the Effectiveness of Cortiment® for the Treatment of Mild-to-moderate Active Ulcerative Colitis in Routine Clinical PracticeUlcerative ColitisDrug: budesonide MMX®Ferring PharmaceuticalsNot recruiting18 YearsN/AAll378Phase 2/Phase 3Canada;Germany;Ireland;Italy;Netherlands;Poland;Sweden;United Kingdom;Israel;Switzerland
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
321NCT02636517December 201518 December 2018Fecal Microbiome TransplantFecal Microbiome Transplant in Pediatric C. DifficileClostridium Difficile;Inflammatory Bowel Disease;Crohn's Disease;Ulcerative ColitisBiological: Fecal Microbiota TransplantChildren's Hospital of PhiladelphiaRecruiting3 Years21 YearsAll50N/AUnited States
322NCT02632175November 26, 201518 March 2019Long-term Safety and Efficacy Study of Adalimumab in Pediatric Subjects With Ulcerative ColitisA Multi-Center, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects With Ulcerative Colitis Who Completed the Study M11-290Ulcerative Colitis (UC)Biological: AdalimumabAbbVieRecruiting5 Years18 YearsAll93Phase 3United States;Japan;Poland;Slovakia;Spain;United Kingdom
323NCT02330653November 20153 June 2019Fecal Microbiota Transplant (FMT) in Pediatric Active Ulcerative ColitisA Phase I/II, Double Blinded, Placebo Controlled, Single-center Study of Fecal Microbiota Transplant (FMT) for the Treatment of Active Pediatric Ulcerative ColitisInflammatory Bowel Diseases;Ulcerative ColitisBiological: Fecal Microbiota Transplant;Biological: PlaceboStacy A. KahnNot recruiting5 Years30 YearsAll11Phase 1/Phase 2United States
324NCT02487238November 201511 February 2019Pediatric FEcal Microbiota Transplant for Ulcerative ColitisA Single-Blind, Randomized, Placebo-Controlled Trial of Human Fecal Microbiota Transplantation for the Therapy of Pediatric Ulcerative Colitis and Inflammatory Bowel Disease UnclassifiedInflammatory Bowel Disease;Ulcerative ColitisBiological: Fecal Microbiota Enema;Biological: Normal Saline EnemaMcMaster Children's HospitalLondon Health Sciences Centre;St. Justine's HospitalNot recruiting3 Years17 YearsAll35Phase 1Canada
325NCT02536404November 201511 November 2019Extension Study of APD334-003 in Patients With Moderately to Severely Active Ulcerative ColitisExtension Study of APD334-003 in Patients With Moderately to Severely Active Ulcerative ColitisUlcerative ColitisDrug: Etrasimod;Drug: PlaceboArena PharmaceuticalsNot recruiting18 Years80 YearsAll118Phase 2United States;Australia;Austria;Belgium;Bulgaria;Canada;Czechia;France;Germany;Hungary;Israel;Latvia;Lithuania;New Zealand;Poland;Romania;Spain;Ukraine;United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
326JPRN-UMIN0000214602015/10/202 April 2019Chromoendoscopic method using an acetic acid indigocarmine mixture for diagnostic accuracy in delineating margin of colitic cancer.patients with ulcerative colitis had high risk of colitic cancer. A:patients suspected dysplasia(low/high grade) or cancer. B:patients had plan of treatment of the dysplasia or cancer.40mL AIM solution (0.6% acetic acid with 0.4% IC) was sprinkled onto the lesions and images were recorded.Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical SciencesRecruiting20years-old80years-oldMale and Female30Not selectedJapan
327EUCTR2015-001600-64-CZ14/10/201523 July 2018The purpose of this study is to determine whether long-term RPC1063 is safe and effective in the treatment of ulcerative colitis (UC).A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of long-term RPC1063 in Ulcerative ColitisUlcerative colitis
MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: 0.25 mg RPC1063
Product Code: RPC1063
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Ozanimod
Current Sponsor code: RPC1063
Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.25-
Product Name: 1.0 mg RPC1063
Product Code: RPC1063
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Ozanimod
Current Sponsor code: RPC1063
Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1.0-
Celgene International II SàrlAuthorisedFemale: yes
Male: yes
1200Phase 3United States;Belarus;Slovakia;Ukraine;Russian Federation;Israel;Italy;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Croatia;Australia;South Africa;Bulgaria;Latvia;Netherlands;Germany;New Zealand;Korea, Republic of
328ChiCTR-IOR-150071942015-10-1018 April 2017The randomized, controlled, double blind clinical trial of Qingchang Wenzhongs in the treatment of ulcerative colitis.The randomized, controlled, double blind clinical trial of Qingchang Wenzhongs in the treatment of ulcerative colitis.Ulreative colitisQing chang wen zhong: Qing chang wen zhong of traditional Chinese medicine;Mesalazine:Mesalazine;Dongfang hospital, Beijing univetsity of Chinese MedicineRecruiting1665BothQing chang wen zhong:36;Mesalazine:36;OtherChina
329ChiCTR-ICR-150071882015-10-0918 April 2017Percutaneous endoscopic mini-colostomy anddrug delivery system for the treatment of ulcerative colitis: A randomized, controlled clinical trialPercutaneous endoscopic mini-colostomy anddrug delivery system for the treatment of ulcerative colitis: A randomized, controlled clinical trialUlcerative colitisPercutaneous endoscopic mini-colostomy group:Oral steroids (prednisone 1mg.kg-1d-1) +Percutaneous endoscopic mini-colostomy andsubsequent drug delivery (mesalazine 3g / d);Control Group:Oral steroids (prednisone 1mg.kg-1d-1) andmesalazine 3g / d;Southern Medical University, Nanfang Hospital, Department of GastroenterologyRecruitingBothPercutaneous endoscopic mini-colostomy group:21;Control Group:21;New Treatment Measure Clinical StudyChina
330NCT02522767October 20158 April 2019Mesalamine 4 g Sachet for the Induction of Remission in Active, Mild to Moderate Ulcerative Colitis (UC)A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 4 g Extended Release Granules (Sachet) for the Induction of Clinical and Endoscopic Remission in Active, Mild to Moderate Ulcerative ColitisUlcerative ColitisDrug: Mesalamine;Drug: PlaceboFerring PharmaceuticalsNot recruiting18 Years75 YearsAll228Phase 3United States;Bulgaria;Canada;Hungary;Latvia;Mexico;Poland;Russian Federation;Serbia;Switzerland;Ukraine;Belgium
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
331NCT02550418October 201516 December 2017Budesonide 9 mg Capsules in Active UCOpen-label, Multi-centre, Proof of Concept Phase IIa Clinical Trial on the Efficacy and Tolerability of an 8 Week Oral Treatment With Once Daily 9 mg Budesonide in Patients With Active Ulcerative ColitisColitis, UlcerativeDrug: BudesonideDr. Falk Pharma GmbHNot recruiting18 Years75 YearsAll60Phase 2Germany
332JPRN-UMIN0000190662015/09/252 April 2019An open label randomized controlled trial of combination therapy of Adalimumab and GMA for intractable ulcerative colitisUlcerative colitisAdministration of Adalimumab 160 mg at baseline, 80 mg at 2 weeks and 40 mg every 2 weeks.
In addition to Adalimumab Therapy, co-treatment of GMA 3times a week up to 2 weeks
Sakura Medical Center,Toho universityNot Recruiting20years-oldNot applicableMale and Female58Not applicableJapan
333JPRN-UMIN0000187452015/09/012 April 2019The Efficacy of Enternal Nutrition in Active Ulcerative Colitis Patients with Hypoalbuminemia ,during Infliximab Therapyulcerative colitisAdministration of Infliximab and enteral nutrition
Administration of Infliximab
Nagoya University Graduate School of Medicine, Department of Gastroentrology and hepatologyNot Recruiting15years-old75years-oldMale and Female40Not selectedJapan
334NCT02084550September 201516 December 2017Amino Acids in Ileal Pouch-anal Anastomosis for Ulcerative ColitisAmino Acids in Ileal Pouch-anal Anastomosis for Ulcerative Colitis: a Randomized, Assessor-blinded, Placebo-controlled TrialUlcerative ColitisDietary Supplement: Vaminolac;Other: SalineAarhus University HospitalNot recruiting18 Years50 YearsAll8N/ADenmark
335NCT02520284September 201516 December 2017Safety and Efficacy of GS-5745 in Adults With Moderately to Severely Active Ulcerative ColitisA Combined Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Induction and Maintenance Study Evaluating the Safety and Efficacy of GS-5745 in Subjects With Moderately to Severely Active Ulcerative ColitisUlcerative ColitisBiological: GS-5745;Biological: PlaceboGilead SciencesNot recruiting18 Years75 YearsAll165Phase 2/Phase 3United States;Australia;Belgium;Bulgaria;Canada;Czech Republic;France;Hungary;Ireland;Italy;Korea, Republic of;Latvia;Netherlands;New Zealand;Poland;Romania;Russian Federation;Slovakia;South Africa;Switzerland;Taiwan;Ukraine;United Kingdom;Austria;Croatia;Germany;Hong Kong;Iceland;Israel;Serbia;Spain;Sweden
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
336NCT02537210September 201520 August 2018Aminosalicylic Acid Withdrawal Study in Long Standing Inactive Ulcerative ColitisOral 5-aminosalicylic Acid Withdrawal in Long Standing Inactive Ulcerative Colitis: A Double-blind, Randomized, Placebo-controlled TrialColitis, Ulcerative;Aminosalicylic AcidDrug: Mesalazine;Drug: Placebo oral capsuleChinese University of Hong KongQueen Elizabeth Hospital, Hong Kong;Alice Ho Miu Ling Nethersole Hospital;Tseung Kwan O Hospital, Hong KongRecruiting18 YearsN/AAll194N/AHong Kong;China
337JPRN-UMIN0000188012015/08/272 April 2019Efficasy of colonosocopy using carbon dioxide insufflation for the patients with ulcerative colitisulcerative colitisColonosocopy using carbon dioxide insufflation
Colonosocopy using air insufflation
Osaka University, Graduate School of Medicine, Department of Gastroenterology and HepatologyRecruiting16years-oldNot applicableMale and Female250Not selectedJapan
338JPRN-UMIN0000186422015/08/122 April 2019A trial of fecal microbiota transplantation and / or antibiotics therapy for ulcerative colitisulcerative colitisAntibiotics therapy:Taking three kinds of antibiotics (Amoxicillin, fosmycin, metronidazole) for two weeks.
FMT:Administration of the fecal material from healthy donors to patients.
Juntendo university school of medicine Department of gastroenterologyRecruiting6years-oldNot applicableMale and Female50Not selectedJapan
339EUCTR2014-005443-40-NL15/07/20154 August 2015An open label study to Evaluate Efficacy, Safety and Mucosal Healing of early versus late use of vedolizumab in ulcerative colitis: the LOVE-UC study (LOw countries VEdolizumab in UC study) LOVE-UCAn open label observational phase 4 study to Evaluate Efficacy, Safety and Mucosal Healing of early versus late use of vedolizumab in ulcerative colitis: the LOVE-UC study (LOw countries VEdolizumab in UC study) LOVE-UC - LOVE-UCUlcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Entyvio
Pharmaceutical Form: Powder for solution for infusion
Academic Medical Center/ GastroenterologyAuthorisedFemale: yes
Male: yes
120Phase 4Netherlands
340NCT02497469July 15, 201523 April 2019An Efficacy and Safety Study of Vedolizumab Intravenous (IV) Compared to Adalimumab Subcutaneous (SC) in Participants With Ulcerative ColitisA Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative ColitisColitis, UlcerativeDrug: Vedolizumab;Drug: Adalimumab placebo;Drug: Adalimumab;Drug: Vedolizumab placeboTakedaNot recruiting18 Years85 YearsAll770Phase 3United States;Argentina;Australia;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Colombia;Croatia;Czechia;Denmark;Estonia;France;Germany;Hong Kong;Hungary;Israel;Italy;Korea, Republic of;Latvia;Lithuania;Mexico;Netherlands;Poland;Portugal;Romania;Russian Federation;Serbia;Slovakia;Spain;Taiwan;Turkey;Ukraine;United Kingdom;Chile;Czech Republic;Finland;Norway;South Africa;Sweden
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
341EUCTR2014-005635-14-LV10/07/20153 July 2017Open-label, multi-centre, proof of concept phase IIa clinical trial on the efficacy and tolerability of an 8 week oral treatment with once daily 9 mg budesonide in patients with active ulcerative colitisOpen-label, multi-centre, proof of concept phase IIa clinical trial on the efficacy and tolerability of an 8 week oral treatment with once daily 9 mg budesonide in patients with active ulcerative colitis - Budesonide 9 mg capsules in active UCPatients with active ulcerative colitis
MedDRA version: 18.0 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Budesonide 9 mg capsules, hard (BUX-PV)
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: BUDESONIDE
CAS Number: 51333-22-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 9-
Dr. Falk Pharma GmbHNot RecruitingFemale: yes
Male: yes
60Phase 2Hungary;Lithuania;Latvia
342NCT02407236July 10, 201511 November 2019A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative ColitisA Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative ColitisColitis, Ulcerative;Inflammatory Bowel DiseasesDrug: Placebo IV;Drug: Placebo SC;Drug: Ustekinumab IV;Drug: Ustekinumab SCJanssen Research & Development, LLCNot recruiting18 YearsN/AAll972Phase 3United States;Australia;Austria;Belgium;Bulgaria;Canada;Czechia;Denmark;France;Germany;Hungary;Israel;Japan;Korea, Republic of;Netherlands;New Zealand;Poland;Romania;Russian Federation;Serbia;Slovakia;Ukraine;United Kingdom;Czech Republic;South Africa
343NCT01671956July 201518 January 2018Evaluation of Safety, Efficacy, Pharmacokinetic and Pharmacodynamic of Bertilimumab in Patients With Active Moderate to Severe Ulcerative ColitisA Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study Designed to Evaluate the Safety, Efficacy, Pharmacokinetic and Pharmacodynamic Profile of Bertilimumab in Patients With Active Moderate to Severe Ulcerative ColitisUlcerative Colitis, Active Moderate;Ulcerative Colitis, Active SevereBiological: Bertilimumab;Biological: PlaceboImmune PharmaceuticalsRecruiting18 Years70 YearsAll42Phase 2Israel
344NCT02426372July 201516 December 2017Safety and Efficacy of QBECO in Moderate to Severe Ulcerative ColitisAn Open Label, Dose Ranging, Exploratory Study to Evaluate the Safety, Tolerability, Compliance, Mechanism of Action and Efficacy of QBECO Site Specific Immunomodulation for the Induction of Clinical Response and Remission in Subjects With Moderate to Severe Ulcerative ColitisUlcerative ColitisBiological: QBECO SSIQu Biologics Inc.Not recruiting19 YearsN/AAll11Phase 2Canada
345NCT02447302July 201525 February 2019Safety and Efficacy of Etrasimod (APD334) in Patients With Ulcerative ColitisA Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study to Investigate the Safety and Efficacy of APD334 in Patients With Moderately to Severely Active Ulcerative ColitisUlcerative ColitisDrug: Etrasimod;Drug: PlaceboArena PharmaceuticalsNot recruiting18 Years80 YearsAll156Phase 2United States;Australia;Austria;Belgium;Bulgaria;Canada;Czechia;France;Germany;Hungary;Israel;Korea, Republic of;Latvia;Lithuania;New Zealand;Poland;Romania;Russian Federation;Spain;Ukraine;United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
346NCT02646657July 201513 May 2019An Open Label Phase 4 Study to Evaluate Efficacy of Early Versus Late Use of Vedolizumab in Ulcerative ColitisAn Open Label Interventional Phase 4 Study to Evaluate Efficacy, Safety and Mucosal Healing of Early Versus Late Use of Vedolizumab in Ulcerative Colitis: the LOVE-UC Study (LOw Countries VEdolizumab in UC Study)Colitis, UlcerativeDrug: Vedolizumab 300 mgGeert D'HaensTakedaRecruiting18 Years80 YearsAll120Phase 4Belgium;Hungary;Netherlands
347JPRN-UMIN0000178442015/06/222 April 2019Antibiotic combination therapy for ulcerative colitisulcerative colitisamoxicillin, tetracycline, and metronidazoleShiga University of Medical ScienceNot Recruiting20years-old80years-oldMale and Female20Not selectedJapan
348NCT02435992June 17, 20154 November 2019Safety and Efficacy Trial of RPC1063 for Moderate to Severe Ulcerative ColitisA Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Induction and Maintenance Therapy for Moderate to Severe Ulcerative ColitisUlcerative ColitisDrug: RPC1063;Drug: PlaceboCelgeneRecruiting12 Years75 YearsAll900Phase 3United States;Argentina;Australia;Austria;Belarus;Belgium;Bulgaria;Canada;Croatia;Czechia;Georgia;Germany;Greece;Hungary;Israel;Italy;Korea, Republic of;Latvia;Moldova, Republic of;Netherlands;New Zealand;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Ukraine;United Kingdom;Czech Republic
349JPRN-JapicCTI-16312228/5/201516 July 2019A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Participants with Moderately to Severely Active Ulcerative ColitisA Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative ColitisColitis, Ulcerative, Inflammatory Bowel DiseasesIntervention name : Ustekinumab
Dosage And administration of the intervention : week 0: Participants will be randomized to receive single dose of placebo, Ustekinumab 130mg or Ustekinumab 6 mg/kg as Intravenous (IV: into the vein) infusion at Week 0. At week 8: Participants without clinical response to placebo will receive a single IV infusion of ustekinumab approximating 6mg/kg along with matching subcutaneous (SC) placebo. Participants without clinical response to ustekinumab (130 mg or 6 mg/kg [IV]) will receive a single dose of ustekinumab 90 mg SC along with matching placebo IV. Participants in clinical response at Week 16 will be eligible to enter Maintenance study and will be randomized. Participants in clinical response will be randomized to receive placebo SC, ustekinumab 90 mg SC every 12 weeks or 90 mg subcutaneously every 8 weeks beginning Week 0 of Maintenance study through Week 44.
Janssen Pharmaceutical K.K.Not Recruiting18BOTH92Phase 3
350EUCTR2014-004904-31-NL19/05/20155 September 2016A clinical study to investigate the infliximab serum concentration of Remsima™ (infliximab biosimilar) after switching from Remicade (infliximab) in subjects with Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA) in stable remission.An open-label, multicentre, phase IV study to investigate the infliximab serum concentration of Remsima™ (infliximab biosimilar) after switching from Remicade (infliximab) in subjects with Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA) in stable remission.Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA).;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Trade Name: Remsima (infliximab)
Pharmaceutical Form: Powder for concentrate for solution for injection/infusion
Mundipharma Pharmaceuticals B.V.AuthorisedFemale: yes
Male: yes
Phase 4Netherlands
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
351NCT02413047May 201516 December 2017Evaluate if Response to Infliximab or Adalimumab May be Regained With an ImmunomodulatorA Pilot Study to Evaluate if Response to Infliximab or Adalimumab May be Regained With the Addition of an ImmunomodulatorInflammatory Bowel Disease;Ulcerative Colitis;Crohn's DiseaseDrug: Azathioprine;Drug: 6 mercaptopurine;Drug: MethotrexateIndiana UniversityRecruiting18 Years80 YearsAll20N/AUnited States
352NCT02423460May 201519 November 2018Threonine Requirement in IBD Adults and Healthy Adult ControlsThreonine Requirement in Healthy Adult Subjects and in Patients With Crohn's Disease and With Ulcerative Colitis Using the Indicator Amino Acid Oxidation (IAAO) MethodologyUlcerative Colitis;Crohn's Disease;HealthyOther: ThreonineNestléThe Hospital for Sick Children;Mount Sinai Hospital, CanadaNot recruiting18 Years40 YearsMale86N/ACanada
353NCT02435160May 201525 May 2015The Study of Efficacy and Mechanism in Fecal Microbiota Transplantation in the Treatment of Ulcerative ColitisUlcerative Colitis;Fecal Microbiota TransplantationBiological: Fecal Microbiota TransplantationJun LiuNot recruiting25 Years60 YearsMale20Phase 2/Phase 3
354NCT02442037May 201525 May 2015Human Umbilical-Cord-Derived Mesenchymal Stem Cell Therapy in Active Ulcerative ColitisSafety and Efficacy of Human Umbilical-Cord-derived Mesenchymal Stem Cell Transplantation in Active Ulcerative Colitis.Ulcerative ColitisBiological: UCMSC group;Other: Control group(Normal saline)Affiliated Hospital to Academy of Military Medical SciencesIvy Institute of Stem Cells Co. LtdRecruiting18 Years65 YearsBoth30Phase 1/Phase 2China
355NCT02463045May 201516 December 2017Study for Safety and Tolerability of TOP1288 Administered Rectally in Healthy and Ulcerative Colitis SubjectsA Phase I Study to Evaluate the Safety/Tolerability and Pharmacokinetics of TOP1288 Rectal Single and Multiple Ascending Doses in Healthy Subjects and Multiple Doses in Subjects With Ulcerative ColitisUlcerative ColitisDrug: TOP1288Topivert Pharma LtdNot recruiting18 Years55 YearsAll67Phase 1United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
356NCT02575040May 201526 October 2015Efficacy of Fecal Microbiota Transplantation for Inflammatory Bowel DiseaseEfficacy of Fecal Microbiota Transplantation for Refractory Inflammatory Bowel DiseaseUlcerative Colitis;Crohn Disease;Constipation (Excl Faecal Impaction)Biological: Fecal microbiota transplantationGulhane Military Medical AcademyRecruiting18 YearsN/ABoth60Phase 3Turkey
357NCT02539368April 22, 201526 August 2019Post-Marketing Use Of CT-P13 (Infliximab) For Standard Of Care Treatment Of Inflammatory Bowel DiseasePOST-MARKETING OBSERVATIONAL COHORT STUDY OF PATIENTS WITH INFLAMMATORY BOWEL DISEASE (IBD) TREATED WITH CT-P13 IN USUAL CLINICAL PRACTICE (CONNECT-IBD)Inflammatory Bowel Diseases;Ulcerative Colitis;Crohn's DiseaseDrug: CT-P13;Drug: RemicadePfizerHospira, now a wholly owned subsidiary of PfizerNot recruiting18 YearsN/AAll2565Phase 3Belgium;Czechia;Finland;France;Germany;Greece;Hungary;Italy;Netherlands;Portugal;Slovakia;Spain;United Kingdom;Czech Republic;Ireland
358EUCTR2014-000784-41-DK15/04/20158 January 2018Amino acids in j-pouch surgery for ulcerative colitisAmino acids in ileal pouch-anal anastomosis for ulcerative colitis: a randomized, double-blind placebo-controlled trial - Amino acids in ileal pouch-anal anastomosisIleal pouch-anal anastomosis for ulcerative colitis
MedDRA version: 18.0 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Vaminolac, komb.
Product Name: Vaminolac, komb.
Pharmaceutical Form: Infusion
INN or Proposed INN: Vaminolac, komb.
Other descriptive name: Vaminolac, komb.
Concentration unit: g/l gram(s)/litre
Concentration type: equal
Concentration number: 65-
Pharmaceutical form of the placebo: Infusion
Route of administration of the placebo: Intravenous use
Department of Medicine and EndocrinologyNot RecruitingFemale: yes
Male: yes
24Phase 3Denmark
359NCT02674308March 31, 201514 October 2019Entyvio (Vedolizumab) Long Term Safety StudyEntyvio (Vedolizumab) Long-term Safety Study: An International Observational Prospective Cohort Study Comparing Vedolizumab to Other Biologic Agents in Patients With Ulcerative Colitis or Crohn's DiseaseUlcerative Colitis and Crohn's DiseaseDrug: Vedolizumab;Other: Other Biologic AgentsTakedaNot recruiting18 YearsN/AAll5302N/AUnited States;Austria;Belgium;Canada;Croatia;Denmark;Estonia;France;Germany;Greece;Ireland;Israel;Italy;Netherlands;Norway;Portugal;Slovenia;Spain;Sweden;Switzerland;United Kingdom
360EUCTR2014-002579-27-IT03/03/20157 January 2019Pilot study on the efficacy of golimumab in normalizing the symptoms and lesions of the colon-rectum in patients with ulcerative colitis who only respond to therapy with cortisonePilot study on the efficacy of golimumab in the induction and maintenance of clinical and endoscopic remission in patients with steroid-dependent ulcerative colitis. - UC-GOLactive steroid-dependent ulcerative colitis
MedDRA version: 17.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: SIMPONI
Product Name: SIMPONI
Product Code: NA
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: GOLIMUMAB
CAS Number: 476181-74-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Istituto Clinico HumanitasNot RecruitingFemale: yes
Male: yes
100Phase 4Italy
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
361NCT02368717March 201516 December 2017An Efficacy and Safety Study of PENTASA in Chinese Patients With Left-sided Active Ulcerative Colitis Followed by a 24-Week Open-Label Extension PhaseA Randomized, Double-blind, Placebo-controlled, Multi-centre, Superiority Study Investigating the Efficacy and Safety of PENTASA Enema Compared With Placebo Enema for 4-Week Treatment in Chinese Patients With Left-sided Active Ulcerative Colitis (UC) Followed by a Maximal 28-Week Open-Label Extension Phase of PENTASA Enema and/or PENTASA TabletsUlcerative ColitisDrug: Mesalazine Enema;Drug: Placebo EnemaFerring PharmaceuticalsNot recruiting18 Years70 YearsAll281Phase 3China
362NCT02412085March 201520 April 2015Golimumab in Steroid-dependent Ulcerative Colitis: Induction and Maintenance of Clinical and Endoscopic RemissionPilot Study to Evaluate the Efficacy of Golimumab for Induction and Maintenance of Clinical and Endoscopic Remission in Patients With Steroid-dependent Ulcerative ColitisColitis, UlcerativeDrug: GolimumabIstituto Clinico HumanitasRecruiting18 Years65 YearsBoth100Phase 4Italy
363NCT02318667February 27, 201524 June 2019Correlation of Soluble Suppression of Tumorigenicity 2 (ST2) With Golimumab (MK-8259) Response in Participants With Ulcerative Colitis (UC) (MK-8529-022).An Open Label, Single Group Assignment Design Study to Correlate Soluble ST2 With Clinical, Endoscopic and Histological Activity in Moderate to Severe Ulcerative Colitis Patients Under Golimumab.Colitis, UlcerativeBiological: GolimumabMerck Sharp & Dohme Corp.Not recruiting18 Years65 YearsAll38Phase 4Portugal
364NCT02200445February 20151 April 2019Low Dose IL-2 for Ulcerative ColitisA Phase I Study of Low Dose Subcutaneous Interleukin-2 (IL-2) For The Treatment of Ulcerative Colitis.Ulcerative ColitisDrug: Interleukin-2 (aldesleukin).Scott SnapperRecruiting18 Years70 YearsAll28Phase 1United States
365NCT02465385February 20158 August 2016Single-dose Linaclotide for Capsule Endoscopy PreparationSingle-dose Linaclotide for Capsule Endoscopy PreparationCrohn's;Ulcerative Colitis;Gastrointestinal BleedingDrug: LinaclotideUniversity of VirginiaNot recruiting18 YearsN/ABoth30Phase 4United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
366EUCTR2013-001205-84-DE13/01/20154 December 2018LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo vs. mesalamine for maintenance of remission in patients with ulcerative colitisRandomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 48-weeks treatment with gastro-resistant phosphatidylcholine (LT-02) versus placebo versus mesalamine for maintenance of remission in patients with ulcerative colitis - Phosphatidylcholine (LT-02) vs. placebo vs. mesalamine for maintenance of remission in UCMaintenance of remission in ulcerative colitis (UC)
MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: gastro-resistant phosphatidylcholine granules
Product Code: LT-02
Pharmaceutical Form: Gastro-resistant granules
INN or Proposed INN: Phosphatidylcholine
CAS Number: 97281-47-5
Current Sponsor code: LT-02
Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 800-
Pharmaceutical form of the placebo: Gastro-resistant granules
Route of administration of the placebo: Oral use
Trade Name: Salofalk Granu-Stix 500 mg
Pharmaceutical Form: Gastro-resistant granules
INN or Proposed INN: MESALAZINE
CAS Number: 89-57-6
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Pharmaceutical form of the placebo: Gastro-resistant granules
Route of administration of the placebo: Oral use
Dr. Falk Pharma GmbHNot RecruitingFemale: yes
Male: yes
400Phase 3Slovakia;Ukraine;Lithuania;Austria;Russian Federation;Israel;Switzerland;Czech Republic;Hungary;Belgium;Poland;Germany;Latvia;Netherlands
367ChiCTR-IPR-150057602015-01-1218 April 2017Steroid-dependent ulcerative colitis pathogenesis of complex multi-center alternative medicine therapy, randomized, controlled clinical studySteroid-dependent ulcerative colitis pathogenesis of complex multi-center alternative medicine therapy, randomized, controlled clinical studyulcerative colitisTCM Group:Oral Chinese medicine Qinchang Lianyang Granule + Guanchang Fang granule;Control:Azathioprine;Affiliated Hospital of Nanjing University of Chinese MedicineNot Recruiting1865BothTCM Group:60;Control:60;Phase 1 studyChina
368NCT03441893January 1, 201520 August 2018Role of Intestinal Protozoa and Helminths in the Course of Ulcerative ColitisRole of Intestinal Protozoa and Helminths in the Course of Ulcerative ColitisUlcerative Colitis;Ulcerative Colitis Exacerbation;Protozoan Infections;Helminth InfectionDiagnostic Test: parasitological diagnostics (coproscopy);Drug: Nitazoxanide 500Mg Oral Tablet;Drug: Mesalazine 250Mg Tablet and nitazoxanide 500Mg Oral Tablet;Drug: Mesalazine 250MgResearch Institute of Epidemiology, Microbiology and Infectious Diseases, UzbekistanNot recruiting18 Years90 YearsAll300Phase 1/Phase 2
369NCT02261636January 201525 February 2019Induction and Maintenance of Remission With Pentasa as Ulcerative Colitis TreatmentUlcerative ColitisDrug: mesalazineFerring PharmaceuticalsNot recruiting18 Years70 YearsAll150Phase 1Netherlands
370NCT02335281January 201519 February 2015Standardized Fecal Microbiota Transplantation for Inflammatory Bowel DiseaseEfficacy, Durability and Safety of Standardized Fecal Microbiota Transplantation for Severe Inflammatory Bowel DiseaseInflammatory Bowel Disease;Ulcerative Colitis;Crohn's DiseaseProcedure: FMT;Drug: MesalazineYanling WeiRecruiting16 Years70 YearsBoth40Phase 2China
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
371NCT02136069December 24, 201420 May 2019A Study Comparing the Efficacy and Safety of Etrolizumab to Infliximab in Participants With Moderate to Severe Ulcerative Colitis Who Are Naïve to Tumor Necrosis Factor (TNF) InhibitorsPhase III, Randomized, Multicenter Double-Blind, Double Dummy Study to Evaluate the Efficacy and Safety of Etrolizumab Compared With Infliximab in Patients With Moderate to Severe Active Ulcerative Colitis Who Are Naive to TNF InhibitorsUlcerative ColitisDrug: etrolizumab;Drug: infliximab;Other: placebo (IV);Other: placebo (injection)Hoffmann-La RocheNot recruiting18 Years80 YearsAll390Phase 3Romania;Singapore;South Africa;Spain;Sweden;Switzerland;United Kingdom;Czech Republic;Vietnam;Austria;Belgium;Canada;Czechia;France;Germany;Hungary;Israel;Italy;Korea, Republic of;Netherlands;Norway;Philippines;Portugal
372JPRN-JapicCTI-14264922/12/20147 October 2019Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative ColitisA Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis [M11-290]Ulcerateive ColotisIntervention name : abalimumab
INN of the intervention : Adalimumab
Dosage And administration of the intervention : subcutaneous injection
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : subcutaneous injection
AbbVie GKNot Recruiting417BOTH9Phase 3Japan
373JPRN-UMIN0000159122014/12/152 April 2019Efficacy of maintenance therapy with adalimumab in ulcerative colitis achieving remission with tacrolimusulcerative colitisTacrolimus will be decreased gradually three months after it was administered.
Adalimumab will be administrated three months after tacrolimus was administered, and tacrolimus will be decreased gradually.
Osaka Medical CollegeRecruiting16years-old70years-oldMale and Female50Not applicableJapan
374EUCTR2014-003262-25-PT12/12/201411 December 2017Study to correlate a new biomarker (ST2) with clinical activity in Ulcerative Colitis patients under golimumabAn open label, single group assignment design study to correlate soluble ST2 with clinical, endoscopic and histological activity in moderate to severe Ulcerative Colitis patients under golimumab - EVOLUTIONUlcerative Colitis
MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Simponi
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: GOLIMUMAB
CAS Number: 476181-74-5
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.Not RecruitingFemale: yes
Male: yes
37Phase 4Portugal
375NCT02093663December 12, 201410 December 2018Safety and Efficacy of MMX Mesalamine/Mesalazine in Pediatric Subjects With Mild to Moderate Ulcerative ColitisA Phase 3, Multicenter, Randomized, Double-blind Study to Determine the Safety and Efficacy of MMX Mesalamine/Mesalazine in Pediatric Subjects With Mild to Moderate Ulcerative Colitis, in Both Acute and Maintenance PhasesUlcerative ColitisDrug: MMX Mesalamine/Mesalazine (Low Dose);Drug: MMX Mesalamine/Mesalazine (High Dose)ShireNot recruiting5 Years17 YearsAll167Phase 3United States;Canada;Hungary;Israel;Poland;Slovakia;United Kingdom;Belgium;Germany;Netherlands
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
376NCT02289417December 10, 201426 August 2019Efficacy and Safety Study of Apremilast to Treat Active Ulcerative ColitisA Phase 2, Randomized, Placebo-controlled, Multicenter Study to Investigate the Efficacy and Safety of Apremilast (CC-10004) for Treatment of Subjects With Active Ulcerative ColitisUlcerative ColitisDrug: Apremilast;Drug: PlaceboCelgeneNot recruiting18 YearsN/AAll170Phase 2United States;Australia;Bulgaria;Canada;Czechia;France;Germany;Hungary;Italy;Netherlands;New Zealand;Poland;Russian Federation;Ukraine;Czech Republic
377EUCTR2014-001893-32-HU08/12/201416 November 2015Placebo-controlled study to assess efficicay, safety and tolerability and to investigate the pharmacokinetics of GLPG1205 in subjects with moderate to severe Ulcerative ColitisPhase II, Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of GLPG1205 in Patients with Moderate to Severe Ulcerative ColitisUlcerative Colitis
MedDRA version: 18.0 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GLPG1205
Product Code: G321605
Pharmaceutical Form: Capsule, hard
Current Sponsor code: G321605
Other descriptive name: GLPG1205
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Galapagos NVNot RecruitingFemale: yes
Male: yes
60Phase 2Czech Republic;Hungary;Poland;Belgium;Russian Federation;Germany
378NCT02442960December 201413 May 2019Evaluating Safety and Efficacy of Herbal Treatment in Ulcerative ColitisAn Open-Label, Dose-Escalation Phase Ib Study Evaluating the Safety and Preliminary Efficacy of Oral SA100 in the Treatment of Patients With Mild, Moderate or Severe Ulcerative ColitisUlcerative ColitisDrug: Herbal treatment (SA100)Stanford UniversityNot recruiting13 Years75 YearsAll15Phase 1United States
379EUCTR2013-004280-31-DE24/11/201428 February 2019A study to investigate the effectiveness (efficacy) and safety of etrolizumab treatment in maintaining disease remission in ulcerative colitis patients who have not previously been treated with TNF inhibitorsPHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (MAINTENANCE OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - LAURELUlcerative colitis (UC)
MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: etrolizumab
Product Code: Ro 549-0261/F04
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Etrolizumab
CAS Number: 1044758-60-2
Current Sponsor code: RO5490261
Other descriptive name: ETROLIZUMAB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 105-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use
F. Hoffmann-La Roche LtdAuthorised Female: yes
Male: yes
350Phase 3United States;Slovakia;Ukraine;Israel;Italy;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Denmark;South Africa;Germany
380NCT02171429November 14, 201411 November 2019A Study Comparing the Efficacy and Safety of Etrolizumab With Adalimumab and Placebo in Participants With Moderate to Severe Ulcerative Colitis (UC) in Participants Naive to Tumor Necrosis Factor (TNF) Inhibitors (Study #2)Phase III, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy (Induction of Remission) and Safety of Etrolizumab Compared With Adalimumab and Placebo in Patients With Moderate to Severe Ulcerative Colitis Who Are Naive to TNF InhibitorsUlcerative ColitisDrug: Adalimumab;Other: Adalimumab Placebo;Drug: Etrolizumab;Other: Etrolizumab PlaceboHoffmann-La RocheRecruiting18 Years80 YearsAll350Phase 3United States;Argentina;Australia;Brazil;Bulgaria;Colombia;Croatia;Czechia;Greece;Hungary;Latvia;Lithuania;Malaysia;New Zealand;Poland;Russian Federation;Turkey;Ukraine
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
381EUCTR2013-004282-14-DE10/11/201428 February 2019A study to evaluate the effectiveness (efficacy) and safety of etrolizumab compared with infliximab in patients with moderate to severe ulcerative colitis who have not previously received TNF inhibitorsPHASE III, RANDOMIZED, MULTICENTER DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ETROLIZUMAB COMPARED WITH INFLIXIMAB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - GARDENIAUlcerative Colitis
MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Etrolizumab
Product Code: Ro 549-0261/F04
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Etrolizumab
CAS Number: 1044758-60-2
Current Sponsor code: RO5490261
Other descriptive name: ETROLIZUMAB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 105-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use
Trade Name: Remicade
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3
Current Sponsor code: RO6897845
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
F. Hoffmann-La Roche LtdAuthorised Female: yes
Male: yes
390Phase 3Portugal;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Singapore;Romania;South Africa;Norway;Netherlands;Germany;Korea, Republic of;Sweden
382NCT02163759November 4, 201411 November 2019A Study Comparing the Efficacy and Safety of Etrolizumab With Adalimumab and Placebo in Participants With Moderate to Severe Ulcerative Colitis (UC) in Participants Naive to Tumor Necrosis Factor (TNF) Inhibitors (Study #1)Phase III, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy (Induction of Remission) and Safety of Etrolizumab Compared With Adalimumab and Placebo in Patients With Moderate to Severe Ulcerative Colitis Who Are Naive to TNF InhibitorsUlcerative ColitisDrug: Adalimumab;Other: Adalimumab Placebo;Drug: Etrolizumab;Other: Etrolizumab PlaceboHoffmann-La RocheRecruiting18 Years80 YearsAll350Phase 3Russian Federation;Serbia;Slovakia;Ukraine;Argentina;Australia;Brazil;Bulgaria;United States;Estonia;France;Hong Kong;Mexico;Poland
383JPRN-JapicCTI-14270401/11/20142 April 2019Phase III study of AJG511 in patients with active ulcerative colitisPhase III study of AJG511 in patients with active ulcerative colitisulcerative colitisIntervention name : AJG511
INN of the intervention : budesonide
Dosage And administration of the intervention : intrarectal
Control intervention name : Placebo
Dosage And administration of the control intervention : intrarectal
EA Pharma Co.,Ltd.16BOTH120Phase 3
384NCT02361957November 20147 September 2015The Effect of the Multispecies Probiotic Ecologic 825 Versus Placebo in Ulcerative Colitis PatientsThe Effect of the Multispecies Probiotic Ecologic 825 Versus Placebo in Ulcerative Colitis PatientsUlcerative ColitisDietary Supplement: Ecologic 825;Dietary Supplement: PlaceboWageningen UniversityNot recruiting18 Years65 YearsBoth40N/ANetherlands
385EUCTR2013-003032-77-GB30/10/201412 February 2018A Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Ulcerative Colitis.A Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Ulcerative Colitis.Ulcerative colitis
MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use
Product Name: ADALIMUMAB
Product Code: 331731-18-1
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Current Sponsor code: Humira
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
AbbVie Deutschland GmbH & Co. KGAuthorisedFemale: yes
Male: yes
85Phase 3United States;Slovakia;Spain;Austria;Israel;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Poland;New Zealand
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
386ChiCTR18000166682014-10-2218 June 2018A randomized, double-blind, double-dummy, positive controlled clinical trial of Hudi enteric-coated capsules, mesalazine, and combination therapy for active ulcerative colitis (damp-heat syndrome)A randomized, double-blind, double-dummy, positive controlled clinical trial of Hudi enteric-coated capsules, mesalazine, and combination therapy for active ulcerative colitis (damp-heat syndrome)Active ulcerative colitistest group:Hudi enteric-coated capsules+Mesalazine enteric-coated tablets Simulator;Positive control group:Mesalazine enteric-coated tablets+Hudi Enteric-coated Capsule Simulator;Combined group:Hudi enteric-coated capsules+Mesalazine enteric-coated tablets;Affiliated Hospital of Nanjing University of Traditional Chinese Medicine (Jiangsu Province Traditional Chinese Medicine Hospital)Not Recruiting1865Bothtest group:120;Positive control group:120;Combined group:120;Post-marketChina
387EUCTR2013-004278-88-DE20/10/201428 February 2019A study to investigate the effectiveness (efficacy) and safety of etrolizumab in ulcerative colitis patients who have been previously exposed to TNF inhibitors.PHASE III, DOUBLE BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF THE EFFICACY AND SAFETY OF ETROLIZUMAB DURING INDUCTION AND MAINTENANCE IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO HAVE BEEN PREVIOUSLY EXPOSED TO TNF INHIBITORS - HICKORYUlcerative colitis (UC)
MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: etrolizumab
Product Code: Ro 549-0261/F04
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ETROLIZUMAB
CAS Number: 1044758-60-2
Current Sponsor code: RO5490261
Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 105-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use
F. Hoffmann-La Roche LtdAuthorised Female: yes
Male: yes
605Phase 3United States;Greece;Spain;Lithuania;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Denmark;Netherlands;Germany;Korea, Republic of
388NCT02065557October 13, 201415 July 2019Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative ColitisA Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative ColitisUlcerative Colitis (UC)Biological: AdalimumabAbbVieNot recruiting4 Years17 YearsAll100Phase 3United States;Australia;Austria;Belgium;Canada;Czechia;Hungary;Israel;Japan;New Zealand;Poland;Slovakia;Spain;United Kingdom;Czech Republic;Italy;Sweden
389NCT02148640October 201416 December 2017The NOR-SWITCH StudyA RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SWITCHING FROM INNOVATOR INFLIXIMAB TO BIOSIMILAR INFLIXIMAB COMPARED WITH CONTINUED TREATMENT WITH INNOVATOR INFLIXIMAB IN PATIENTS WITH RHEUMATOID ARTHRITIS, SPONDYLOARTHRITIS, PSORIATIC ARTHRITIS, ULCERATIVE COLITIS, CROHN'S DISEASE AND CHRONIC PLAQUE PSORIASIS THE NOR-SWITCH STUDYRheumatoid Arthritis;Spondyloarthritis;Psoriatic Arthritis;Ulcerative Colitis;Crohn's Disease;Psoriasis ChronicDrug: Innovator infliximab;Drug: Biosimilar infliximabDiakonhjemmet HospitalSouth-Eastern Norway Regional Health AuthorityNot recruiting18 YearsN/AAll482Phase 4Norway
390NCT02217722October 201422 August 2016Use of the Ulcerative Colitis Diet for Induction of RemissionAn Open Label Non Randomized Pilot Study: Use of the Ulcerative Colitis Diet for Induction of Remission.Ulcerative Colitis (UC)Other: Ulcerative Colitis Diet;Drug: Antibiotic cocktailProf. Arie LevineNot recruiting5 Years18 YearsBoth9N/AIsrael
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
391NCT02266849October 201417 October 2016Loperamide vs. Placebo's Effect on Ileostomy Output: A Clinical Randomized Blinded Cross-over StudyLoperamide vs. Placebo's Effect on Ileostomy Output: A Clinical Randomized Blinded Cross-over StudyRectal Cancer;Ulcerative Colitis;Short Bowel SyndromeDrug: Loperamide;Drug: PlaceboOdense University HospitalNot recruiting18 YearsN/ABoth12Phase 3Denmark
392NCT02280629October 201411 June 2018Phosphatidylcholine (LT-02) vs. Placebo vs. Mesalamine for Maintenance of Remission in Ulcerative Colitis (PROTECT-2)Randomized, Double-blind, Double-dummy, Placebo-controlled, Phase III Clinical Trial on the Efficacy and Safety of a 48-weeks Treatment With Gastro-resistant Phosphatidylcholine (LT-02) Versus Placebo Versus Mesalamine for Maintenance of Remission in Patients With Ulcerative ColitisUlcerative ColitisDrug: LT-02;Drug: Placebo;Drug: MesalamineDr. Falk Pharma GmbHNot recruiting18 Years70 YearsAll150Phase 3Germany
393EUCTR2013-004282-14-GB29/09/201428 February 2019A study to evaluate the effectiveness (efficacy) and safety of etrolizumab compared with infliximab in patients with moderate to severe ulcerative colitis who have not previously received TNF inhibitorsPHASE III, RANDOMIZED, MULTICENTER DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ETROLIZUMAB COMPARED WITH INFLIXIMAB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - GARDENIAUlcerative Colitis
MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Etrolizumab
Product Code: Ro 549-0261/F04
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Etrolizumab
CAS Number: 1044758-60-2
Current Sponsor code: RO5490261
Other descriptive name: ETROLIZUMAB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 105-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use
Trade Name: Remicade
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3
Current Sponsor code: RO6897845
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
F. Hoffmann-La Roche LtdAuthorisedFemale: yes
Male: yes
390Phase 3Portugal;Spain;Austria;Israel;Italy;United Kingdom;Switzerland;France;Czech Republic;Hungary;Canada;Belgium;Singapore;Romania;South Africa;Norway;Netherlands;Germany;Korea, Republic of;Sweden
394NCT02118584September 15, 201411 November 2019Study for Participants With Ulcerative Colitis Previously Enrolled in Etrolizumab Phase II/III StudiesAn Open-Label Extension and Safety Monitoring Study of Moderate to Severe Ulcerative Colitis Patients Previously Enrolled in Etrolizumab Phase II/III StudiesUlcerative ColitisDrug: EtrolizumabHoffmann-La RocheRecruiting18 YearsN/AAll2100Phase 3Malaysia;Mexico;Netherlands;New Zealand;Norway;Philippines;Poland;Portugal;Romania;Russian Federation;Serbia;Singapore;Slovakia;South Africa;Spain;Sweden;Switzerland;Turkey;Ukraine;United Kingdom;Vietnam;Argentina;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;Colombia;Croatia;Czechia;Denmark;Estonia;Lithuania;Latvia;Korea, Republic of;Italy;Israel;India;Hungary;Hong Kong;Greece;Germany;France;United States;Czech Republic
395JPRN-UMIN0000150682014/09/052 April 2019An open label randomized controlled trial of GMA and Infliximab in intractable ulcerative colitisUlcerative colitisInfliximab will be administered intravenously at the dose of 5 mg/kg at 0, 2, 6 weeks
GMA will be administrated 10 times
Hiroshima University Hospital, Department of EndoscopyRecruiting20years-oldNot applicableMale and Female150Not applicableJapan
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
396EUCTR2013-004282-14-AT03/09/201428 February 2019A study to evaluate the effectiveness (efficacy) and safety of Etrolizumab compared with Infliximab in patients with moderate to severe ulcerative colitis who have not previously received TNF inhibitorsPHASE III, RANDOMIZED, MULTICENTER DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ETROLIZUMAB COMPARED WITH INFLIXIMAB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - GARDENIAUlcerative Colitis
MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Etrolizumab
Product Code: Ro 549-0261/F04
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Etrolizumab
CAS Number: 1044758-60-2
Current Sponsor code: RO5490261
Other descriptive name: ETROLIZUMAB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 105-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use
Trade Name: Remicade
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3
Current Sponsor code: RO6897845
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
F. Hoffmann-La Roche LtdAuthorised Female: yes
Male: yes
390Phase 3Portugal;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Singapore;Romania;South Africa;Norway;Netherlands;Germany;Korea, Republic of;Sweden
397NCT02108821September 201416 December 2017Fecal Microbiota Transplantation in Pediatric PatientsA Study of Fecal Microbiota Transplantation in Pediatric Patients With Relapsed Inflammatory Bowel Disease.Inflammatory Bowel Diseases (IBD);Crohn's Disease (CD);Ulcerative Colitis (UC)Biological: Fecal Microbiota Transplantation (FMT)Children's Mercy Hospital Kansas CityUniversity of PittsburghNot recruiting2 Years22 YearsAll23Phase 1United States
398NCT02165215August 12, 20144 November 2019A Study of the Efficacy and Safety of Etrolizumab Treatment in Maintenance of Disease Remission in Ulcerative Colitis (UC) Participants Who Are Naive to Tumor Necrosis Factor (TNF) InhibitorsPhase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy (Maintenance of Remission) and Safety of Etrolizumab Compared With Placebo in Patients With Moderate to Severe Active Ulcerative Colitis Who Are Naive to TNF InhibitorsColitis, UlcerativeDrug: Etrolizumab;Drug: PlaceboHoffmann-La RocheNot recruiting18 Years80 YearsAll359Phase 3United States;Brazil;Canada;Czechia;Denmark;Germany;Hungary;India;Israel;Italy;Mexico;Poland;Slovakia;South Africa;Ukraine;Czech Republic
399NCT02209987August 201419 February 2015Absolute Bioavailability, Safety, and Tolerability of Subcutaneous GS-5745 in Healthy AdultsA Phase 1 Study to Evaluate the Absolute Bioavailability, Safety, and Tolerability of Subcutaneous GS-5745 in Healthy SubjectsUlcerative ColitisDrug: GS-5745 SC;Drug: GS-5745 IVGilead SciencesNot recruiting18 Years45 YearsBoth28Phase 1New Zealand
400JPRN-JapicCTI-14264822/7/201416 July 2019Study to Evaluate the Safety and Efficacy of Two Drug Regimens in Subjects with Moderate to Severe Ulcerative ColitisA Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis [M14-033]Ulcerative ColitisIntervention name : adalimumab
INN of the intervention : adalimumab
Dosage And administration of the intervention : subcutaneous injection
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : subcutaneous injection
AbbVie GKNot Recruiting1875BOTH100Phase 3Japan, North America, Europe
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
401EUCTR2013-000891-13-DE21/07/201412 October 2015Study with the herbal preparation STW5-II in patients with mild to moderate ulcerative colitis (chronic inflammatory bowel disease)A randomised, double-blind, placebo-controlled multi-centre study to investigate the effectiveness and safety of STW5-II as add-on treatment for induction of remission in patients with mild to moderate ulcerative colititsUlcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Iberogast N
Product Name: Iberogast N
Product Code: STW5-II
Pharmaceutical Form: Oral drops, liquid
INN or Proposed INN: Bitterschleifenblume-ganzpflanze 1,5ml/10ml
Other descriptive name: BITTER CANDYTUFT FRESH PLANT EXTRACT
Concentration unit: ml millilitre(s)
Concentration type: equal
Concentration number: 15-
INN or Proposed INN: Kümmel 2ml/10ml
Other descriptive name: CARVI EXTRACTUM FLUIDUM
Concentration unit: ml millilitre(s)
Concentration type: equal
Concentration number: 20-
INN or Proposed INN: Pfefferminzblätter 1ml/10ml
Other descriptive name: MENTHA × PIPERITA L. FOLIUM
Concentration unit: ml millilitre(s)
Concentration type: equal
Concentration number: 10-
INN or Proposed INN: Süßholzwurzel 1ml/10ml
Other descriptive name: GLYCYRRHIZA GLABRA ROOT
Concentration unit: ml millilitre(s)
Concentration type: equal
Concentration number: 10-
INN or Proposed INN: Kamillenblüten 3ml/10ml
Other descriptive name: MATRICARIA RECUTITA L. FLOS
Concentration unit: ml millilitre(s)
Concentration type: equal
Concentration number: 30-
INN or Proposed INN: Melissenblätter 15ml/10ml
Other descriptive name: MELISSAE FOLII DRY AQUEOUS EXTRACT
Concentration unit: ml millilitre(s)
Concentration type: equal
Concentration number: 15-
Pharmaceutical form of the placebo: Oral drops, liquid
Route of administration of the placebo: Oral use
Steigerwald Arzneimittelwerk GmbHNot RecruitingFemale: yes
Male: yes
Germany
402NCT02049502July 20141 April 2019FMT in Ulcerative Colitis-Associated PouchitisThe Use of Fecal Microbiota Transplantation in Patients With Ulcerative Colitis-associated PouchitisUlcerative Colitis Associated PouchitisBiological: biologically active human fecal microbiota;Procedure: sigmoidoscopyVirginia O. ShafferNot recruiting18 Years65 YearsAll8Phase 2United States
403NCT02227342July 20149 January 2017Fecal Microbiota Transplantation (FMT) in the Management of Active Ulcerative ColitisA Prospective, Single Center, Open Label Trial of Fecal Microbiota Transplantation (FMT) in the Management of Active Ulcerative ColitisUlcerative ColitisBiological: Fecal Microbiota TransplantUniversity of AlbertaNot recruiting18 Years65 YearsBoth3Phase 1/Phase 2Canada
404JPRN-UMIN0000142752014/06/242 April 2019Efficacy of infliximab for refractory pouchitis with complexed anal fistulaulcerative colitisinfliximabHyogo College of MedicineNot RecruitingNot applicableNot applicableMale and Female10Phase 1Japan
405EUCTR2014-000656-29-BE13/06/201424 November 2014Study to evaluate delivery preference of Simponi (golimumab) by Ulcerative Colitis patients: delivery using a prefilled syringe or the Smartject™ devicePreference for a prefilled syringe or Smartject™ device for delivering SIMPONI (golimumab) in patients suffering from moderate to severe ulcerative colitis - SMARTUlcerative Colitis
MedDRA version: 17.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
Trade Name: Simponi® (Golimumab)
Product Name: Simponi (Golimumab)
Product Code: MK-8259
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: GOLIMUMAB
CAS Number: 476181-74-5
Current Sponsor code: MK-8259
Other descriptive name: Simponi
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Trade Name: Simponi® (Golimumab)
Product Name: Simponi (Golimumab)
Product Code: MK-8259
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: GOLIMUMAB
CAS Number: 476181-74-5
Current Sponsor code: MK-8259
Other descriptive name: Simponi
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
MSD Belgium BVBA/SPRLAuthorisedFemale: yes
Male: yes
Belgium
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
406JPRN-UMIN0000141522014/06/042 April 2019A trial of a combination therapy of fecal microbiota transplantation and antibiotics or simple fecal microbiota therapy for ulcerative colitisulcerative colitisAdministration of the fecal material from healthy donors to patients after taking three kinds of antibiotics (Amoxicillin, fosmycin, metronidazole) for two weeksJuntendo university school of medicine Department of gastroenterologyRecruiting20years-oldNot applicableMale and Female30Not selectedJapan
407JPRN-UMIN0000135462014/06/012 April 2019The effect ofgrepefruit juice on the patients with autoimmune diseases taking tacrolimusrheumatoid arthritis, lupus nephritis, polymyositis/dermatomyositis with interstitial pneumonia, ulcerative colitistake a glass of grapefruit juice every day
do not take grapefruit juice
Department of Rheumatology and Clinical Immunology, Kyoto University HospitalNot Recruiting16years-old80years-oldMale and Female20Not applicableJapan
408NCT02179372June 201412 December 2016Eicosapentaenoic Free Fatty Acid and Fecal Calprotectin in Inflammatory Bowel DiseasesModulation of Fecal Calprotectin by Eicosapentaenoic Free Fatty Acid in Inflammatory Bowel DiseasesUlcerative Colitis;Crohn's DiseaseDietary Supplement: Eicosapentaenoic acid;Dietary Supplement: Medium chain fatty acid (placebo)Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola MalpighiNot recruiting18 Years80 YearsBoth60N/AItaly
409NCT02186886June 201419 February 2015Physiological Intermolecular Modification Spectroscopy (PIMS) in Ulcerative Colitis With GolimumabPersonalised Medicine: a Break Through Approach for Early Determination of Anti Tumor Necrosis Factor (TNF) Responders and Non Responders Among Patients With Ulcerative Colitis in a Prospective Study With Golimumab (Simponi)Ulcerative ColitisDrug: GolimumabKliniken im Naturpark AltmuehltalRecruiting18 YearsN/ABoth50Phase 4Germany
410NCT02100696May 21, 20144 November 2019A Study of the Efficacy and Safety of Etrolizumab in Participants With Ulcerative Colitis Who Have Been Previously Exposed to Tumor Necrosis Factor (TNF) InhibitorsPhase III, Double-Blind, Placebo-Controlled, Multicenter Study of the Efficacy and Safety of Etrolizumab During Induction and Maintenance in Patients With Moderate to Severe Active Ulcerative Colitis Who Have Been Previously Exposed to TNF InhibitorsUlcerative ColitisDrug: Etrozulimab;Drug: PlaceboHoffmann-La RocheNot recruiting18 Years80 YearsAll609Phase 3United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;Czechia;Denmark;France;Germany;Greece;Hungary;Israel;Italy;Korea, Republic of;Lithuania;Mexico;Netherlands;Poland;Romania;Spain;Switzerland;United Kingdom;Czech Republic;New Zealand
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
411ChiCTR-OCH-140046152014-05-1218 April 2017Prospective cohort study of Qing Chang Wen Zhong decoction in the treatment of patients with mild and moderate ulcerative colitis.Prospective cohort study of qingchangwenzhong decoction in the treatment of patients with mild and moderate ulcerative colitis.ulcerative colitisclinical group:Qing Chang Wen Zhong decoction;control:Mesalazine Enteric-coated Tablets or Medichemie Ettingen;Dongfang Hospital Affiliated to Beijing University of Traditional Chinese MedicineNot Recruiting1865Bothclinical group:60;control:60;OtherChina
412EUCTR2012-003702-27-DE08/05/201411 December 2017LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitisRandomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 12-weeks add-on treatment with LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis refractory to standard treatment with mesalamine - Phosphatidylcholine (LT-02) vs. placebo for induction of remission in mesalamine-refractory UCAcute Ulcerative Colitis (UC)
MedDRA version: 19.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: gastro-resistant phosphatidylcholine granules
Product Code: LT-02
Pharmaceutical Form: Gastro-resistant granules
INN or Proposed INN: Phosphatidylcholine
CAS Number: 97281-47-5
Current Sponsor code: LT-02
Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 800-
Pharmaceutical form of the placebo: Gastro-resistant granules
Route of administration of the placebo: Oral use
Dr. Falk Pharma GmbHNot RecruitingFemale: yes
Male: yes
762Phase 3Slovakia;Ukraine;Lithuania;Austria;Russian Federation;Israel;Switzerland;Czech Republic;Hungary;Belgium;Poland;Germany;Latvia;Netherlands
413JPRN-UMIN0000136942014/05/012 April 2019Individualized tacrolimus therapy for ulcerative colitis based on CYP3A5 SNPsulcerative colitisdetermine CYP3A5 SNP status
increase the initial dosage of tacrolimus
Kitasato University Kitasato Institute HospitalRecruiting18years-oldNot applicableMale and Female30Not selectedJapan
414EUCTR2013-004599-36-DE23/04/201430 October 2017SB012 for the treatment of active ulcerative colitis: a clinical study in early development (phase IIa), conducted in several study centres, with random assignment of patients to active treatment or placebo, to investigate the efficacy, pharmacokinetics, tolerability, and safety of SB012 enema administered once dailySB012 for the treatment of active ulcerative colitis (SECURE): a prospective, multi-centre, randomised, double-blind, placebo-controlled phase IIa clinical trial to evaluate the efficacy, pharmacokinetics, tolerability, and safety of SB012 enema administered once daily - SECUREActive ulcerative colitis;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]Product Name: SB012
Pharmaceutical Form: Enema
INN or Proposed INN: hgd40
Current Sponsor code: hgd40
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 7.5-
Pharmaceutical form of the placebo: Enema
Route of administration of the placebo: Rectal use
sterna biologicals GmbH & Co. KGNot RecruitingFemale: yes
Male: yes
18Phase 2Germany
415JPRN-UMIN0000137162014/04/152 April 2019A study of infliximab administration method for tacrolimus-resistant active ulcerative colitisulcerative colitisAfter administrating tacrolimus and infliximab for 6 weeks,tacrolimus is tapered to 0mg.
Infliximab monotherapy
Yokohama City University Medical CenterNot Recruiting16years-oldNot applicableMale and Female40Phase 2Japan
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
416EUCTR2013-005013-13-LT08/04/201416 November 2015A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate TherapyA Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate TherapySubjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis.
MedDRA version: 16.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: SB5
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Current Sponsor code: SB5
Other descriptive name: SB5
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Trade Name: Humira®
Product Name: Humira®
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Current Sponsor code: not applicable
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Samsung Bioepis Co., Ltd.Not RecruitingFemale: yes
Male: yes
490Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina
417ChiCTR-IOR-150068122014-04-0118 April 2017Effect of dispelling wind and eliminating dampness therapy in mucosal healing of ulcerative colitisEffect of dispelling wind and eliminating dampness therapy in mucosal healing of ulcerative colitisulcerative colitisintervetion group:wind-dispelling and damp-eliminating glanules;control group:Mesalazine;Department of anorectal surgery, Dongzhimen Hospital, Beijing University of Chinese MedicineRecruiting1870Bothintervetion group:30;control group:30;OtherChina
418NCT01960426April 201423 May 2016Evaluation of Health Costs and Resource UtilizationA Randomized Evaluation of Health Costs and Resource Utilization Comparing Testing-Based Therapy to Empiric Dose Intensification for the Management of Inflammatory Bowel Disease.Ulcerative Colitis;Crohn's DiseaseOther: Measurement of drug (Adalimumab/Infliximab);Other: Intensify treatment with the existing drugUniversity of Western Ontario, CanadaPrometheus LaboratoriesNot recruiting18 YearsN/ABoth51Phase 4United States
419NCT02129439April 201411 June 2018Efficacy, Pharmacokinetics, Tolerability, Safety of SB012 Intrarectally Applied in Active Ulcerative Colitis PatientsSB012 for Treatment of Active Ulcerative Colitis: Prospective Multi-centre Randomised Double-blind Placebo-controlled Phase IIa Clinical Trial to Evaluate Efficacy, Pharmacokinetics, Tolerability and Safety of SB012 Enema Administered ODColitis, UlcerativeDrug: SB012;Drug: PlaceboSterna Biologicals GmbH & Co. KGNot recruiting18 Years75 YearsAll20Phase 1/Phase 2Germany
420NCT02913508April 20143 October 2016Vedolizumab Subcutaneous (SC) Versus Intravenous (IV) in Ulcerative Colitis or Crohn's DiseaseA Randomized, Open Label Phase 2 Study to Assess Pharmacokinetics, Pharmacodynamics, Immunogenicity, Safety and Exploratory Efficacy of Vedolizumab Subcutaneous Compared to Vedolizumab Intravenous in Subjects With Moderately to Severely Active Ulcerative Colitis or Crohn's DiseaseUlcerative Colitis;Crohn's DiseaseDrug: Vedolizumab subcutaneous injection;Drug: Vedolizumab intravenous injectionTakedaNot recruiting18 Years80 YearsBoth0Phase 2
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
421NCT02065622March 27, 201428 October 2019Study to Evaluate the Safety and Efficacy of Two Drug Regimens in Subjects With Moderate to Severe Ulcerative ColitisA Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative ColitisUlcerative Colitis (UC)Drug: Adalimumab;Other: PlaceboAbbVieNot recruiting18 Years75 YearsAll952Phase 3United States;Austria;Belgium;Canada;Czechia;Denmark;France;Germany;Hungary;Israel;Italy;Japan;Netherlands;Poland;Romania;Slovakia;Spain;Switzerland;Ukraine;United Kingdom;Czech Republic
422JPRN-UMIN0000142052014/03/2516 July 2019Examination of the medical treatment by the pancrelipase to the refractory inflammatory bowel disease patientExamination of the medical treatment by the pancrelipase to the refractory inflammatory bowel disease patient - Validity of pancrelipase in patients with inflammatory bowel diseaseCrohn's disease Ulcerative colitisAdministration of pancrelipaseDepartment of Gastroenterology Osaka City University Graduate School of MedicineNot Recruiting20years-oldNot applicableMale and Female30Not selectedJapan
423EUCTR2013-003060-31-LV17/02/20147 October 2014A Placebo Controlled Trial of HMPL-004 in Subjects with Mild to Moderate Active Ulcerative ColitisA Phase III Double Blind, Multi-Center Placebo Controlled Maintenance Trial of HMPL-004 in Subjects with Mild to Moderate Ulcerative Colitis with Clinical Remission or Response from Induction Therapy. (NATRUL-4)Ulcerative Colitis (UC)
MedDRA version: 17.0 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: HMPL-004
Pharmaceutical Form: Tablet
CAS Number: 8000051-24-3
Current Sponsor code: HMPL-004
Other descriptive name: ANDROGRAPHIS PANICULATA
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 400-
CAS Number: 5508-58-7
Other descriptive name: AND (Andrographolide)
CAS Number: 27215-14-1
Other descriptive name: NAND (Neoandrographolide)
CAS Number: 4176-97-0
Other descriptive name: DAND (14-Deoxyandrographolide)
CAS Number: 42895-58-9
Other descriptive name: DDAND (14-deoxy-11,12-didehydroandrographolide)
CAS Number: 327-97-9
Other descriptive name: CLA (Chlorogenic acid)
CAS Number: 29741-09-1
Other descriptive name: AODG (Apigenin-7-O-glucuronide)
Product Code: HMPL-004
Pharmaceutical Form: Tablet
CAS Number: 8000051-24-3
Current Sponsor code: HMPL-004
Other descriptive name: ANDROGRAPHIS PANICULATA
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 600-
CAS Number: 5508-58-7
Other descriptive name: AND (Andrographolide)
CAS Number: 27215-14-1
Other descriptive name: NAND (Neoandrographolide)
CAS Number: 4176-97-0
Other descriptive name: DAND (14-Deoxyandrographolide)
CAS Number: 42895-58-9
Other descriptive name: DDAND (14-deoxy-11,12-didehydroandrographolide)
CAS Number: 327-97-9
Other descriptive name: CLA (Chlorogenic acid)
CAS Number: 29741-09-1
Other descriptive name: AODG (Apigenin-7-O-glucuronide)
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Nutrition Science Partners LimitedNot RecruitingFemale: yes
Male: yes
460Phase 3United States;Hungary;Czech Republic;Poland;Ukraine;Lithuania;Bulgaria;Latvia
424JPRN-JapicCTI-14240304/2/201416 July 2019Phase 3 study of MLN0002 (300 mg) in treatment of ulcerative colitisPhase 3, multicenter, randomized, double-blinded, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and pharmacokinetics of intravenous MLN0002 (300 mg) infusion in induction and maintenance therapy in Japanese subjects with moderate or severe ulcerative colitisUlcerative colitisIntervention name : MLN0002 (Vedolizumab)
INN of the intervention : Vedolizumab
Dosage And administration of the intervention : Induction Phase: Cohort 1/Cohort 2: Vedolizumab 300 mg; Vedolizumab 300 mg, IV intravenous (IV) infusion, once at Weeks 0, 2, and 6 in the induction phase.
Intervention name : MLN0002 (Vedolizumab)
INN of the intervention : Vedolizumab
Dosage And administration of the intervention : Maintenance Phase: Vedolizumab 300 mg; Vedolizumab 300 mg, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved clinical response at Week 10 and were randomized to receive vedolizumab in maintenance phase.
Intervention name : MLN0002 (Vedolizumab)
INN of the intervention : Vedolizumab
Dosage And administration of the intervention : Maintenance Phase: Placebo; Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved clinical response at Week 10 and were randomized to receive placebo in maintenance phase.
Intervention name : MLN0002 (Vedolizumab)
INN of the intervention : Vedolizumab
Dosage And administration of the intervention : Open-Label Cohort: Vedolizumab 300 mg Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 and then every 8 weeks thereafter up to Week 94 in open-label cohort.
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : Induction Phase: Cohort 1, Placebo; Vedolizumab placebo-matching, IV infusion, once at Weeks 0, 2 and 6 in the induction phase.
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : Maintenance Phase: Placebo continuation Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab placebo-matching in
TAKEDA PHARMACEUTICAL COMPANY LTD.Not Recruiting1580BOTH292Phase 3Japan
425NCT02039505February 4, 20148 April 2019Phase III Study of MLN0002 (300 mg) in the Treatment of Ulcerative ColitisPhase III, Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Intravenous MLN0002 (300 mg) Infusion in Induction and Maintenance Therapy in Japanese Subjects With Moderate or Severe Ulcerative ColitisUlcerative ColitisDrug: Vedolizumab;Drug: Vedolizumab placeboTakedaNot recruiting15 Years80 YearsAll292Phase 3Japan
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
426JPRN-UMIN0000130332014/02/012 April 2019Examination of the early clinical and endoscopic views change after infliximab administration in the ulcerative colitis.Ulcerative colitisStudy start - 14 weeks:5mg/kg of Infliximab for 0.2.6.14 week, respectively ( initial administration day with 0 weeks)Department of Internal Medicine,Juntendo UniversityNot Recruiting20years-oldNot applicableMale and Female30Not selectedJapan
427NCT01765439February 201420 August 2018The Effect of VSL#3 Probiotic Preparation on the Bile Acid Metabolism in Patients With Inflammatory Bowel DiseaseThe Effect of VSL#3 (Original De Simone Formulation) Probiotic Preparation on the Bile Acid Metabolism in Patients With Inflammatory Bowel DiseaseCrohn Disease;Ulcerative ColitisDietary Supplement: VSL#3 (Original De Simone formulation)Charles University, Czech RepublicIscare i.v.f., Czech Republic;CD Investments srl;University Of Perugia;University of Roma La SapienzaRecruitingN/AN/AAll80N/ACzechia;Czech Republic
428NCT01947101February 201420 June 2016Fecal Microbiota Transplantation (FMT) for Treatment of Ulcerative Colitis in ChildrenA Phase I Study of Fecal Microbiota Transplantation (FMT) in Immunomodulator Dependent Pediatric Ulcerative Colitis (UC)Ulcerative ColitisBiological: Fecal Microbiota TransplantBaylor College of MedicineNot recruiting12 Years20 YearsBoth6Phase 1United States
429EUCTR2013-004583-56-GB28/01/20143 April 2017Go-colitis: Golimumab: A Phase 4 UK Study on its Utilisation and Impact in Ulcerative ColitisGolimumab: A Phase 4, UK Open Label, Single arm Study on its Utilization and Impact in Ulcerative Colitis - Go-colitisUlcerative colitis
MedDRA version: 16.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Simponi
Product Name: Simponi
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: golimumab
CAS Number: 476181-74-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-200
MSDNot RecruitingFemale: yes
Male: yes
200Phase 4United Kingdom
430NCT01988506January 6, 201427 August 2018Induction of Regulatory t Cells by Low Dose il2 in Autoimmune and Inflammatory DiseasesInduction of Regulatory t Cells by Low Dose IL2 in Autoimmune and Inflammatory Diseases: a Transnosographic ApproachRheumatoid Arthritis;Ankylosing Spondylitis;Systemic Lupus Erythematosus;Psoriasis;Behcet's Disease;Wegener's Granulomatosis;Takayasu's Disease;Crohn's Disease;Ulcerative Colitis;Autoimmune Hepatitis;Sclerosing Cholangitis;Gougerot-sjögren;Idiopathic Thrombocytopenic Purpura;Systemic SclerosisDrug: Interleukin 2Assistance Publique - Hôpitaux de ParisIltoo PharmaRecruiting18 YearsN/AAll132Phase 2France
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
431NCT02033408January 201423 April 2019Manipulating the Microbiome in IBD by Antibiotics and FMTManipulating the Microbiome in IBD by Antibiotics and Fecal Microbiota Transplantation (FMT): a Randomized Controlled TrialExacerbation of Ulcerative Colitis;Ulcerative Colitis, Active Severe;Crohn's ColitisDrug: AB (antibiotics);Drug: CS (corticosteroids) OnlyShaare Zedek Medical CenterNot recruiting2 Years75 YearsAll28Phase 4Canada;Finland;Israel;Italy;Poland;Spain
432NCT02069561January 201428 September 2015Effects of Eicosapentaenoic Acid on Subjects at High Risk for Colorectal CancerEffects of Eicosapentaenoic Acid on Molecular, Metabonomics and Intestinal Microbiota Changes, in Subjects With Long-standing Inflammatory Bowel DiseaseUlcerative ColitisDietary Supplement: Eicosapentaenoic AcidAzienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola MalpighiNot recruiting18 Years70 YearsBoth25N/AItaly
433JPRN-JapicCTI-14247524/12/20132 April 2019Phase 3 Clinical Trial with MD-0901Phase 3 Clinical Trial with MD-0901Mild to moderate active ulcerative colitisIntervention name : MD-0901
INN of the intervention : Mesalazine
Dosage And administration of the intervention : Mesalazine 4.8 g/d are administrated orally once daily after breakfast for 8 weeks.
Control intervention name : Asacol tablet
INN of the control intervention : Mesalazine
Dosage And administration of the control intervention : Mesalazine 3.6 g/d are administrated orally 3 times daily after each meal for 8 weeks.
MOCHIDA PHARMACEUTICAL CO., LTD.16BOTH250Phase 3
434NCT02000453December 20, 201316 December 2017Safety and Tolerability Study of GSK2586184 in Patients With Moderate to Severely Active Ulcerative Colitis.An Open Label, Experimental Medicine Investigation of the Safety and Tolerability of 400 mg b.i.d. GSK2586184 in Patients With Moderate to Severely Active Ulcerative Colitis.Colitis, UlcerativeDrug: GSK2586184 400mgGlaxoSmithKlineProf Geert D'Haens, AMC, AmsterdamNot recruiting18 Years75 YearsAll2Phase 1Netherlands
435EUCTR2011-001332-29-AT02/12/201327 October 2014The degradation and elimination of InfliximabPharmacokinetics of InfliximabInflammatory bowel disease (Ulcerative Colitis, Crohn's disease)
MedDRA version: 17.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 17.0 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Remicade
Product Name: Remicade
Pharmaceutical Form: Powder for solution for injection/infusion
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3
Other descriptive name: Remicade
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Universitätsklinik für Innere Medizin III, Klinische Abteilung für Gastroenterologie und HepatologieAuthorisedFemale: yes
Male: yes
Austria
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
436JPRN-UMIN0000042012013/12/022 April 2019The evaluation of efficacy for remission maintenance with immunomodulator following remission induction with tacrolimus in patients with moderate to severe active refractory ulcerative colitis.:mucosal healing for prognosisThe patients with moderate to severe active refractory ulcerative colitisGroup of remission maintenance therapy for 48 weeks with immunomodulator at from 2 to 4 weeks following remission induction with tacrolimus,
Group of no remission maintenance therapy with immunomodulator following remission induction with tacrolimus,
Osaka City University, Graduate School of Medicine,Department of GastroenterologyNot Recruiting16years-old65years-oldMale and Female50Not selectedJapan
437NCT01988961December 201316 December 2017A Study to Evaluate the Accuracy of a Subset of the Length-109 Probe Set Panel (a Genetic Test) in Predicting Response to Golimumab in Participants With Moderately to Severely Active Ulcerative ColitisA Phase 2a Open-Label Study to Evaluate Prediction of Response to Golimumab Using a Transcriptomic Profile in Subjects With Moderately to Severely Active Ulcerative ColitisColitis, UlcerativeBiological: GolimumabJanssen Research & Development, LLCNot recruiting18 YearsN/AAll103Phase 2United States;Belgium;Bulgaria;Canada;Czech Republic;France;Germany;Hungary;Netherlands;Poland;Russian Federation;Ukraine
438NCT01959165November 21, 201311 June 2018MEDI7183 Phase 2 Study in Japanese Ulcerative Colitis PatientsUlcerative ColitisDrug: MEDI7183 low dose;Drug: MEDI7183 medium dose;Drug: MEDI7183 high dose;Drug: Matching PlaceboAstraZenecaNot recruiting18 Years65 YearsAll44Phase 2Japan
439NCT01959282November 15, 201314 January 2019A Study of Safety and Effectiveness of JNJ-54781532 in Patients With Moderately to Severely Active Ulcerative ColitisA Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Dose-response Study Evaluating the Efficacy and Safety of JNJ-54781532 in Subjects With Moderately to Severely Active Ulcerative ColitisColitis, UlcerativeDrug: Placebo;Drug: JNJ-54781532 25 mg once daily;Drug: JNJ-54781532 75 mg once daily;Drug: JNJ-54781532 150 mg once daily;Drug: JNJ-54781532 75 mg twice dailyJanssen Research & Development, LLCNot recruiting18 YearsN/AAll219Phase 2United States;Australia;Belgium;Bulgaria;Canada;France;Germany;Hungary;Israel;Netherlands;Poland;Romania;Russian Federation;Ukraine
440NCT01896635November 20137 November 2016Faecal Microbiota Transplantation in Ulcerative ColitisFaecal Microbiota Transplantation for Chronic Active Ulcerative Colitis - A Randomised Double Blind Controlled Study of Efficacy & SafetyUlcerative Colitis;Inflammatory Bowel DiseaseBiological: FMT infusions;Other: Placebo infusionThe University of New South WalesNot recruiting18 Years75 YearsBoth81Phase 2Australia
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
441NCT01953354November 201316 December 2017Trichuris Suis Ova Treatment in Left-sided Ulcerative ColitisA Prospective, Randomized, Double-blind, Placebo-controlled Phase II Clinical Study of Trichuris Suis Ova Treatment in Left-sided Ulcerative Colitis and Its Effects on Mucosal Immune State and MicrobiotaColitis, UlcerativeBiological: Trichuris suis ova (TSO);Biological: PlaceboNational Institute of Allergy and Infectious Diseases (NIAID)Coronado Biosciences, Inc.;Autoimmunity Centers of ExcellenceNot recruiting18 Years70 YearsAll16Phase 2United States
442NCT01971814November 20138 June 2015Early Serum Infliximab Levels in Severe Ulcerative Colitis.Early Serum Infliximab Levels in Severe Ulcerative ColitisUlcerative Colitis (UC);Inflammatory Bowel DiseaseDrug: InfliximabUniversity of California, San FranciscoNot recruiting18 YearsN/ABoth11Phase 1United States
443NCT03268213November 201311 November 2019Fecal Microbial Transplantation for C. Difficile and/or Ulcerative Colitis or Indeterminate ColitisFecal Microbial Transplantation in Patients With Medication Refractory Clostridium Difficile and/or Ulcerative Colitis or Indeterminate ColitisClostridium Difficile Infection;Ulcerative Colitis;Indeterminate ColitisBiological: Fecal Microbial TransplantationStony Brook UniversityNot recruiting7 YearsN/AAll12Early Phase 1United States
444ChiCTR-TRC-130035302013-10-0118 April 2017Effect of hydrogen rich water on ulcerative colitis: a randomized controlled trialEffect of hydrogen rich water on ulcerative colitis: a randomized controlled trialulcerative colitisone:hydrogen rich water;two:pure water;411th Hospital of PLANot Recruiting1860Bothone:20;two:20;Pilot studyChina
445JPRN-UMIN0000101272013/09/242 April 2019Comparative study for mucosal concentration of 5-ASA by once-daily vs divided dosing of oral mesalazine in quiescent ulcerative colitisulcerative colitisEligible patients will be treated with 3g of oral mesalazine once daily for at least two weeks
Eligible patients will be treated with 3g of oral mesalazine twice daily for at least two weeks
Eligible patients will be treated with 3g of oral mesalazine three times daily for at least two weeks
Department of Gastroenterology and Hepatology, Kyoto University HospitalNot Recruiting20years-oldNot applicableMale and Female50Not applicableJapan
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
446NCT01941589September 201316 December 2017Corticosteroids+5-aminosalicylic Acid Compared to Corticosteroids in the Treatment of Moderate-severe Ulcerative ColitisCombination Corticosteroids + 5-aminosalicylic Acids Compared to Corticosteroids Alone in the Treatment of Moderate-severe Active Ulcerative Colitis.Ulcerative ColitisDrug: oral 5-ASA+/-topical 5-ASA+IV corticosteroids / PO Methylprednisolone;Drug: corticosteroids onlySheba Medical CenterRecruiting18 YearsN/AAll160Phase 4China;France;Greece;Israel;Italy;Korea, Republic of;Serbia
447NCT02306798September 201319 February 2015TP0502-B-Pharmaco-Scintigraphic-StudyAn Open Label, Single-site Pharmaco-Scintigraphic Study in Healthy Subjects With Radio-labelled TP05-tablets (Mesalazine) to Evaluate the Gastrointestinal Transit and Release ProfileUlcerative ColitisDrug: TP05Tillotts Pharma AGNot recruiting18 Years55 YearsBoth9Phase 1
448NCT01900574August 9, 201316 September 2019A Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human Anti-TNFa Antibody, in Pediatric Patients With Moderate to Severe Active Ulcerative ColitisA Phase 1b Open-Label Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human Anti-TNFa Antibody, in Pediatric Subjects With Moderately to Severely Active Ulcerative ColitisColitis, UlcerativeDrug: GolimumabJanssen Research & Development, LLCNot recruiting2 Years17 YearsAll35Phase 1United States;Austria;Belgium;Canada;Denmark;France;Germany;Israel;Netherlands;Poland
449NCT01929668August 20139 May 2016Comparison of 4L Polyethylene Glycol and 2L Polyethylene Glycol With Ascorbic Acid in Inactive UC PatientsComparison of 4L Polyethylene Glycol and 2L Polyethylene Glycol With Ascorbic Acid in Patients With Inactive Ulcerative Colitis; Randomized, Single Blind, Multicenter StudyUlcerative ColitisDrug: polyethylene glycol;Drug: Ascorbic AcidKyungpook National UniversityNot recruiting18 Years80 YearsBoth114N/AKorea, Republic of
450NCT02144350August 201311 June 2018Hyperbaric Oxygen for Ulcerative ColitisHyperbaric Oxygen Therapy for Moderate to Severe Ulcerative Colitis Flares: A Multi-center Randomized Double Blind Sham Controlled TrialUlcerative ColitisProcedure: Hyperbaric oxygen;Procedure: Sham Hyperbaric AirDartmouth-Hitchcock Medical CenterMayo Clinic;University of PittsburghNot recruiting18 YearsN/AAll18Phase 2/Phase 3United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
451NCT02267694August 201316 December 2017Study of Freeze-dried Black Raspberry in Maintenance of Ulcerative ColitisA Trial of Freeze-dried Black Raspberry in Maintenance of Remission of Ulcerative ColitisUlcerative ColitisDrug: Freeze-dried black raspberry powderUConn HealthMedical College of WisconsinNot recruiting18 Years90 YearsAll7Phase 1United States
452EUCTR2012-004366-18-AT30/07/20136 October 2015A Study to Assess the Safety and Pharmacokinetics (Serum Levels) of Golimumab in Children With Moderately to Severely Active Ulcerative ColitisA Phase 1b Open-Label Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human anti-TNFa Antibody, in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT PEDS PKUlcerative Colitis in pediatric subjects
MedDRA version: 18.0 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Golimumab
Product Code: CNTO148
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Golimumab
CAS Number: 476181-74-5
Current Sponsor code: CNTO148
Other descriptive name: Human anti-TNF-alpha monoclonal antibody
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Janssen Biologics B.V.AuthorisedFemale: yes
Male: yes
30Phase 1bFrance;United States;Canada;Poland;Belgium;Denmark;Austria;Israel;Netherlands;Germany
453EUCTR2012-001653-13-IT10/07/201310 March 2014New Therapeutic Strategy in Ulcerative ColitisNew Therapeutic Options for the Maintenance of Remission of the Ulcerative Colitis in Pediatric PatientsUlcerative Colitis
MedDRA version: 15.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: AZAFOR 50mg
Product Name: AZATIOPRINA
Product Code: AZA
Pharmaceutical Form: Tablet
INN or Proposed INN: AZATHIOPRINE
CAS Number: 446-86-6
Current Sponsor code: AZA
Other descriptive name: AZATHIOPRINE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Dipartimento di Pediatria Università Federico II di NapoliAuthorisedFemale: yes
Male: yes
130Italy
454NCT01861249July 20138 August 2016Long Term Safety And Tolerability Of SAR339658 In Patients With Ulcerative Colitis (UC)A Multicenter Single-Arm Open Label Extension Study Evaluating The Long Term Safety And Tolerability Of SAR339658 In Patients With Ulcerative Colitis (UC)Ulcerative ColitisDrug: SAR339658SanofiNot recruiting18 YearsN/ABoth6Phase 2United States;Canada
455NCT01903252July 201320 August 2018TP05 for the Treatment of Mild to Moderate Active Ulcerative Colitis (UC)A Randomised, Active-Controlled, Double-Blind and Open Label Extensions Study to Evaluate the Efficacy, Long-Term Safety and Tolerability of TP05 3.2g/Day for the Treatment of Active Ulcerative ColitisAcute Ulcerative ColitisDrug: TP05;Drug: Asacol 400 mgTillotts Pharma AGNot recruiting18 YearsN/AAll817Phase 3Switzerland;Netherlands
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
456EUCTR2013-000366-11-SE28/06/201329 August 2016Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05.A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC)Ulcerative colitis
MedDRA version: 17.0 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: TP05
Pharmaceutical Form: Gastro-resistant tablet
INN or Proposed INN: MESALAZINE
CAS Number: 89-57-6
Current Sponsor code: TP05
Concentration unit: g gram(s)
Concentration type: up to
Concentration number: 4.8-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Trade Name: Asacol
Pharmaceutical Form: Gastro-resistant tablet
INN or Proposed INN: MESALAZINE
CAS Number: 89-57-6
Concentration unit: g gram(s)
Concentration type: up to
Concentration number: 4.8-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Tillotts Pharma AGNot RecruitingFemale: yes
Male: yes
800Phase 3Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden
457EUCTR2012-004768-23-DE12/06/201316 August 2016A Phase 2a Trial of STNM01 by a Single Submucosal Injection to Investigate the Mucosal Healing Efficacy in Patients with Ulcerative ColitisA Phase 2a Trial of STNM01 by a Single Submucosal Injection to Investigate the Mucosal Healing Efficacy in Patients with Ulcerative ColitisUlcerative Colitis with active endoscopic lesion(s), ranging in severity from moderate to severe in endoscopic score not responding sufficiently to conventional treatment
MedDRA version: 19.0 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: STNM01 1.84 mg
Product Code: STNM01
Pharmaceutical Form: Lyophilisate for solution for injection
INN or Proposed INN: STNM01
Current Sponsor code: STNM01
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1.84-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Submucosal use
STELIC INSTITUTE & CO.Not RecruitingFemale: yes
Male: yes
Phase 2Germany
458JPRN-UMIN0000109062013/06/102 April 2019The exploratory randomized controlled trial by high-dose Asacol treatment to patients with ulcerative colitis aiming to maintain remission.Ulcerative ColitisA 24-week administration of 4.8g/day of Asacol
A 24-week administration of the mesalazine which the patients have taken before the treatment of 4.8g/day of Asacol as induction therapy
Chiba University HospitalNot Recruiting15years-old70years-oldMale and Female60Phase 2Japan
459JPRN-UMIN0000133702013/06/072 April 2019Efficacy of infliximab therapy for refractory pouchitisulcerative colitis, pouchitisinfliximabInflammatory bowel disease center, Hyogo college of medicineNot Recruiting18years-old80years-oldMale and Female10Phase 1Japan
460JPRN-UMIN0000133712013/06/052 April 2019Efficacy of infliximab therapy for arthritis after restorative proctocolectomy in patients with ulcerative colitisulcerative colitisinfliximabHyogo college of medicineNot Recruiting20years-old80years-oldMale and Female10Not selectedJapan
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
461JPRN-UMIN0000107762013/06/012 April 2019An open label randomized controlled trial of tacrolimus versus cyclosporine treatment for severe ulcerative colitisUlcerative colitistacrolimus (Prograf)
cyclosporine (Sandimmune)
Chiba University HospitalRecruiting16years-old65years-oldMale and Female40Not selectedJapan
462NCT01716039June 20135 November 2018Pharmacokinetics of Adalimumab With Methotrexate for Treatment of Patients With Ulcerative Colitis (UC)A Study to Evaluate the Pharmacokinetics of Adalimumab in Combination With Methotrexate for the Treatment of Patients With Ulcerative ColitisUlcerative ColitisDrug: MTX 12.5;Drug: MTX 25;Drug: AdalimumabUniversity of Western Ontario, CanadaAbbottNot recruiting18 YearsN/AAll25Phase 4
463NCT01882764June 201311 March 2019HMPL-004 Maintenance Treatment in Subjects With Mild to Moderate Ulcerative ColitisA Phase III Double Blind, Multi-Center Placebo Controlled Maintenance Trial of HMPL-004 in Subjects With Mild to Moderate Ulcerative Colitis With Clinical Remission or Response From Induction Therapy. (NATRUL-4)Ulcerative ColitisDrug: HMPL-004;Drug: PlaceboHutchison Medipharma LimitedNutrition Science Partners LimitedNot recruiting18 YearsN/AAll1Phase 3United States
464NCT02058524June 20135 September 2016A Pilot and Feasibility Study of Fecal Microbiota Transplantation for Ulcerative ColitisA Pilot and Feasibility Study of Fecal Microbiota Transplantation for Ulcerative ColitisUlcerative ColitisBiological: fecal microbiota transplantationUniversity of ChicagoNot recruiting18 Years65 YearsBoth1Phase 1United States
465JPRN-JapicCTI-13213501/5/20132 April 2019Phase III Study of Z-206Phase III Study of Z-206Ulcerative ColitisIntervention name : Z-206
INN of the intervention : Mesalazine
Dosage And administration of the intervention : Mesalazine at the dose 2.4g/day is administered once a day or three times a day.
Control intervention name : null
Zeria Pharmaceutical Co., Ltd.Kyowa Hakko Kirin Co., Ltd.1664BOTH600Phase 3
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
466JPRN-UMIN0000103402013/05/012 April 2019Comparison of rectal with oral mesalazine in the treatment of Ulcerative Proctitis (CORRECT Study)Ulcerative colitisRandomized treatment with mesalazine suppository or oral mesalazine for 2 weeks
Switch from oral mesalazine to mesalazine suppository for 2 weeks
Saitama Medical Center, Saitama Medical UniversityNot Recruiting18years-oldNot applicableMale and Female60Not selectedJapan
467JPRN-UMIN0000106122013/05/012 April 2019A comparative study of the efficacy of tacrolimus with infliximab in intractable ulcerative colitisUlcerative colitisTacrolimus will be administered orally for 10 weeks at the trough level of 10-15 ng/ml for the first 2 weeks following that of 5-10 ng/ml for the rest of the study period.
Infliximab will be administered intravenously at the dose of 5 mg/kg at 0, 2, 6 weeks.
Department of Internal Medicine, Division of Gastroenterology and Hepatology, Keio University School of MedicineNot Recruiting20years-oldNot applicableMale and Female130Phase 4Japan
468JPRN-UMIN0000132662013/05/012 April 2019Randomized controlled study comparing 1% of Dermacrin A ointmentwith 0.033% of Guaiazulene ointment for patients with perianal delmatitis after total colectomyulcerative colitis, familial adenomatous polyposis1% of Dermacrin A ointment
0.033% of Guaiazulene ointment
Mie University Graduate School of Medicine, Gastrointestinal and Pediatric SurgeryNot Recruiting20years-oldNot applicableMale and Female30Not applicableJapan
469NCT02073526May 20139 January 2017Anti-TNF-alpha Trough Level Measurements in Inflammatory Bowel DiseaseAnti-TNF-alpha Trough Level Measurements in Inflammatory Bowel DiseaseInflammatory Bowel Disease;Crohn's Disease;Ulcerative ColitisDrug: Infliximab, adalimumab, certolizumab pegolOslo University HospitalNot recruiting18 YearsN/ABoth1230N/ANorway
470NCT01804166March 21, 201330 September 2019A Research Study to Bank Samples for Future Evaluation to Identify Biomarkers That Predispose Crohn's Disease and Ulcerative Colitis Patients to Develop Hepatosplenic T-Cell Lymphoma (HSTCL)A Research Study to Bank Samples for Future Evaluation to Identify Biomarkers That Predispose Crohn's Disease and Ulcerative Colitis Patients to Develop Hepatosplenic T-Cell Lymphoma (HSTCL)Hepatosplenic T-Cell LymphomaDrug: Infliximab;Drug: GolimumabJanssen Scientific Affairs, LLCRecruitingN/AN/AAll40Phase 4United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
471EUCTR2012-005521-73-BE20/03/201321 August 2017Placebo-controlled, proof-of-concept oral dose study to explore the safety, pharmacokinetics and pharmacodynamics in subjects with mild to moderate ulcerative colitisExploratory, Phase II, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept study to evaluate the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of GLPG0974 in subjects with mild to moderate Ulcerative Colitis - Proof-of-concept oral dose, safety, tolerability, efficacy, PK and PD studyMild to moderate Ulcerative Colitis
MedDRA version: 16.0 Level: PT Classification code 10009900 Term: Colitis ulcerative System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GLPG0974
Pharmaceutical Form: Capsule
INN or Proposed INN: GLPG0974
Current Sponsor code: G279874
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Galapagos NVNot RecruitingFemale: yes
Male: yes
45Phase 2Czech Republic;Belgium;Latvia
472NCT01863771March 15, 201316 December 2017A Safety and Effectiveness Study of Golimumab in Japanese Patients With Moderately to Severely Active Ulcerative Colitis.A Phase 3 Multicenter, Placebo-controlled, Double-blind, Randomized-withdrawal Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Japanese Subjects With Moderately to Severely Active Ulcerative ColitisColitis, UlcerativeDrug: Golimumab;Other: PlaceboJanssen Pharmaceutical K.K.Not recruiting18 Years70 YearsAll144Phase 3Japan
473NCT01771809March 1, 201329 January 2018Long-Term Safety Of PF-00547659 In Ulcerative ColitisA Multicenter Open-Label Extension Study To Assess Long-Term Safety Of PF-00547659 In Subjects With Ulcerative Colitis (TURANDOT II)Ulcerative ColitisDrug: 75mg PF-00547659;Drug: 225mg PF-00547659ShireNot recruiting18 Years66 YearsAll270Phase 2United 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
474NCT01805791March 201320 August 2018A Phase III Trial of HMPL-004 in Patients With Mild to Moderate Active Ulcerative ColitisA Phase III, Randomized, Multi-Centre, Double-Blind, Placebo-Controlled Trial of HMPL-004 in Patients With Mild to Moderate Active Ulcerative ColitisUlcerative ColitisDrug: HMPL-004 tablet;Drug: PlaceboHutchison Medipharma LimitedNot recruiting18 Years75 YearsAll201Phase 3United States
475NCT01810185March 201319 February 2015Low Dose Naltrexone in Symptomatic Inflammatory Bowel DiseaseLow Dose Naltrexone in Symptomatic Inflammatory Bowel DiseaseInflammatory Bowel Disease;Crohn's Disease;Ulcerative ColitisDrug: Low dose naltrexone;Drug: PlaceboSanta Barbara Cottage HospitalNot recruiting18 YearsN/ABoth0Phase 2United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
476NCT01831427March 201326 August 2019Evaluating the Safety, Pharmacokinetics and Efficacy of GS-5745 in Adults With Moderately to Severely Active Ulcerative ColitisA Phase 1 Double-blind, Randomized, Placebo-Controlled, Staggered, Single and Multiple Ascending Dose, Multicenter Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of GS-5745 in Subjects With Moderate to Severe Ulcerative ColitisUlcerative ColitisDrug: GS-5745;Drug: Placebo to match GS-5745Gilead SciencesNot recruiting18 Years65 YearsAll74Phase 1United States;Belgium;Canada;Hungary;Moldova, Republic of;Netherlands;Romania
477NCT01768858February 5, 201311 February 2019Assessment of Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Plaque Psoriasis, Crohn's Disease and Ulcerative Colitis Patients´ Adherence Attitudes to Maintenance Therapy With a Scheduled Adalimumab Treatment in Routine Clinical PracticeAssessment of Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Plaque Psoriasis, Crohn's Disease and Ulcerative Colitis Patients´ Adherence Attitudes to Maintenance Therapy With a Scheduled Adalimumab Treatment in Routine Clinical PracticeCrohn´s Disease;Ulcerative Colitis;Plaque Psoriasis;Rheumatoid Arthritis;Ankylosing Spondylitis;Psoriatic ArthritisDrug: AdalimumabAbbVieRaffeiner GmbHNot recruiting18 Years99 YearsAll96Phase 2Austria
478NCT01658605February 201319 February 2015A Study to Investigate the Efficacy and Safety of GSK1605786 for Treatment of Patients With Active Ulcerative ColitisA Phase II, 20-week, Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Proof of Concept Study to Investigate the Efficacy and Safety of GSK1605786 for Treatment of Patients With Active Ulcerative ColitisColitis, UlcerativeDrug: GSK1605786;Other: PlaceboGlaxoSmithKlineNot recruiting18 YearsN/ABoth0Phase 2Belgium;Netherlands;United Kingdom
479NCT01759056February 201319 February 2015Evaluation of an Oral Anti-TNF Antibody in Patients With Active Ulcerative ColitisA Multicenter, Double-Blind, Placebo-Controlled, Ascending-Dose, Repeat-Dose Safety and Pharmacokinetic Investigation of a Delayed-Release, Enteric-Coated Capsule Formulation of AVX 470 [Anti-TNF (Tumor Necrosis Factor) Globulin (Bovine)] in Patients With Active Ulcerative ColitisUlcerative ColitisDrug: AVX 470;Drug: PlaceboAvaxia Biologics, IncorporatedNot recruiting18 Years75 YearsBoth33Phase 1United States;Belgium;Canada;Hungary
480JPRN-UMIN0000098112013/01/232 April 2019Comparison of randomized trials of antibiotic combination therapies for patients with ulcerative colitisComparison of randomized trials of antibiotic combination therapies for patients with ulcerative colitis - Antibiotics trials for ulcerative colitisUlcerative colitisOne group is to receive two-week combination therapy consisting of amoxicillin (Sawacillin) 500 mg t.i.d, tetracycline (Acromycin) 500 mg t.i.d, and metronidazole (Flagyl) 250 mg t.i.d. with an inhibitor of gastric acid secretion. Patients are to be followed for 3 months (first endpoint).
Another group will receive two week combination therapy consisting of amoxicillin (Sawacillin) 500 mg t.i.d, fosfomycin (Fosmicin) 1000mg t.i.d, and metrozole (Flagyl) 250 mg t.i.d, with an inhibitor of gastric acid secretion. Patients are to be followed for 3 months.
Division of General Medicine, Department of Internal Medicine, Nihon University School of MedicineNot Recruiting16years-old75years-oldMale and Female40Phase 3Japan
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
481EUCTR2011-001568-22-HU15/01/201329 July 2013A placebo-controlled trial with rFXIII administered to subjects with mild to moderate active ulcerative colitisA multicenter, randomised, double-blind, placebo-controlled, multiple-dose trial with rFXIII administered to subjects with mild to moderate active ulcerative colitisMild to moderate Ulcerative Colitis
MedDRA version: 14.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Recombinant Factor XIII (rFXIII)
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Catridecacog
Current Sponsor code: Recombinant factor XIII (rFXIII)
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 2500-
Pharmaceutical form of the placebo: Powder and solvent for solution for injection
Route of administration of the placebo: Intravenous use
Novo Nordisk A/SNot RecruitingFemale: yes
Male: yes
90Hungary;European Union;Ukraine;Croatia;Denmark;Bulgaria;Russian Federation
482NCT01745770January 201313 June 2016TID 1000 mg Mesalazine Versus TID 2x500 mg Mesalazine in Active Ulcerative Colitis (UC)Double-blind, Double-dummy, Randomised, Multi-centre, Comparative Phase III Clinical Study on the Efficacy and Tolerability of an 8 Week Oral Treatment With Three Times Daily 1000 mg Mesalazine Versus Three Times Daily 2x500 mg Mesalazine in Patients With Active Ulcerative ColitisActive Ulcerative ColitisDrug: Mesalazine - TID 1000 mg;Drug: Mesalazine - TID 2x 500 mgDr. Falk Pharma GmbHNot recruiting18 Years75 YearsBoth306Phase 3Germany
483NCT01771224January 201319 February 2015Effect of FAn-7 in UC ActivityEffect of Palmitoleic Acid (FAn-7) on Expression of HNF4? and Ulcerative Colitis (UC) ActivityInflammatory Bowel Disease;Ulcerative ColitisDietary Supplement: Palmitoleic acidNational Institute of Medical Sciences and Nutrition, Salvador ZubiranRecruiting18 Years59 YearsBoth20Phase 0Mexico
484NCT01839214January 20137 April 2015A Study to Evaluate the Efficacy and Safety of VB-201 in Patients With Ulcerative ColitisA Randomized, Double-Blind, 12-Week, Placebo-Controlled Study Followed by a 12-Week Extension Phase Without Placebo to Evaluate the Efficacy and Safety of Oral VB-201 in Subjects With Mild to Moderate Ulcerative ColitisUlcerative ColitisDrug: VB-201 160mg;Drug: PlaceboVascular Biogenics Ltd. operating as VBL TherapeuticsNot recruiting18 YearsN/ABoth112Phase 2Bulgaria;Hungary;Poland
485NCT02922374January 201331 October 2016Ulcerative Colitis Endoscopic Index of Severity and Fecal Calprotectin to Predict the Reaction to Corticosteroids of Acute Severe Ulcerative ColitisUlcerative Colitis Endoscopic Index of Severity and Fecal Calprotectin to Predict the Reaction to Corticosteroids of Acute Severe Ulcerative Colitis: A Prospective Observational StudyAcute Severe Colitis (ASC)Drug: corticosteroidsJinling Hospital, ChinaNot recruiting18 YearsN/ABoth117Phase 1/Phase 2China
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
486NCT01647516December 12, 201222 July 2019Efficacy and Safety Study of RPC1063 in Ulcerative ColitisA Phase 2, Multi-Center, Randomized, Double-Blind, Placebo Controlled Parallel-Group Study to Evaluate the Clinical Efficacy and Safety of Induction Therapy With RPC1063 in Patients With Moderately to Severely Active Ulcerative ColitisUlcerative ColitisDrug: RPC1063;Drug: placeboCelgeneNot recruiting18 Years75 YearsAll197Phase 2United States;Belgium;Bulgaria;Greece;Hungary;Israel;Korea, Republic of;Netherlands;New Zealand;Poland;Russian Federation;Slovakia;Ukraine;Australia;Canada
487EUCTR2012-003123-38-BE11/12/201228 February 2019A CLINICAL EFFICACY AND SAFETY STUDY TO EVALUATE IN A BLINDED WAY THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITISA PHASE 2, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PARALLEL-GROUP STUDY TO EVALUATE THE CLINICAL EFFICACY AND SAFETY OF INDUCTION THERAPY WITH RPC1063 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITISModerately to severely active Ulcerative Colitis
MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: 0.25 mg RPC1063
Pharmaceutical Form: Capsule
INN or Proposed INN: RPC1063
Current Sponsor code: RPC1063
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.25-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Product Name: 0.5 mg RPC1063
Pharmaceutical Form: Capsule
INN or Proposed INN: RPC1063
Current Sponsor code: RPC1063
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Product Name: 1 mg RPC1063
Pharmaceutical Form: Capsule
INN or Proposed INN: RPC1063
Current Sponsor code: RPC1063
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Celgene International II Sàrl (CIS II)Authorised Female: yes
Male: yes
86Phase 2United States;Hungary;Slovakia;Greece;Poland;Belgium;Ukraine;Russian Federation;Israel;Bulgaria;Netherlands;Korea, Republic of
488EUCTR2012-003974-18-HU10/12/201210 July 2015Study to Evaluate the Efficacy and Safety of Oral VB-201 in Subjects with Mild to Moderate Ulcerative ColitisA Randomized, Double-Blind, 12-Week, Placebo-Controlled Study Followed by a 12-Week Extension Phase Without Placebo to Evaluate the Efficacy and Safety of Oral VB-201 in Subjects with Mild to Moderate Ulcerative ColitisMild to Moderate Ulcerative Colitis
MedDRA version: 16.0 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: VB-201
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Not applicable
CAS Number: 630112-41-3
Current Sponsor code: VB-201
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Vascular Biogenics Ltd.Not RecruitingFemale: yes
Male: yes
110Hungary;Bulgaria
489NCT01078935December 201219 February 2015The Effect of Probiotics on the Rate of Recovery of Inflammatory Bowel Disease Exacerbation, Endothelial Function, and Markers of InflammationThe Effect of Probiotics on Bowel DiseaseCrohn's Disease;Ulcerative ColitisDietary Supplement: probiotics;Dietary Supplement: placeboThe Baruch Padeh Medical Center, PoriyaMinistry of Health, IsraelNot recruiting18 Years80 YearsBoth100Phase 4
490NCT01757964December 201216 December 2017Bacteriotherapy in Pediatric Inflammatory Bowel DiseaseBacteriotherapy in Pediatric Inflammatory Bowel DiseaseInflammatory Bowel Disease;Crohn's Disease;Ulcerative Colitis;CDBiological: BacteriotherapyDavid SuskindSeattle Children's HospitalNot recruiting12 Years21 YearsAll13Phase 1United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
491NCT04032652December 201229 July 2019Use of Rectal Dialysis Technique to Measure Rectal 5-ASA Levels in Healthy Volunteers Receiving AsacolMeasurement of Rectal Levels of 5-aminosalicylic Acid (5-ASA) Using a Novel In-vivo Rectal Dialysis Technique in Healthy Volunteers on AsacolUlcerative ColitisProcedure: Rectal dialysis;Drug: Rectal dialysisNorthShore University HealthSystemNot recruiting18 Years45 YearsAll2Phase 2
492EUCTR2010-023798-20-ES29/11/201221 January 2013A CLINICAL TRIAL WITH FAT-DERIVED ADULT STEM CELLS TO TREAT ULCERATIVE COLITISA PHASE I/IIA CLINICAL TRIAL TO EVALUATE SAFETY AND EFFICACY OF ADIPOSE TISSUE-DERIVED MESENCHYMAL STEM CELLS (ASC) ON INDUCTION TO REMISSION IN ULCERATIVE COLITIS - ALOASCUMedDRA version: 14.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Product Name: ASC
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: adipose tissue-derived mesenchymal stem cells
Other descriptive name: aloASC
Concentration unit: million organisms/ml million organisms/millilitre
Concentration type: equal
Concentration number: 5-
Fundacion para la Investigacion Biomedica Hospital Universitario La PazAuthorisedFemale: yes
Male: yes
Phase 1/2ASpain
493JPRN-UMIN0000093642012/11/242 April 2019Long-term administration of fermented brown rice by Aspergillus oryzae in patients with ulcerative colitisulcerative colitisPatients receive 6 sachets (21 g) of FBRA, brown rice fermented by Aspergillus oryzae, daily (after every meal, 3 times daily) for 2 years.Graduate School of Medical Science, Kyoto Prefectural University of MedicineNot Recruiting20years-oldNot applicableMale and Female20Phase 2Japan
494NCT01620255November 201216 December 2017A Study Of PF-00547659 In Patients With Moderate To Severe Ulcerative ColitisA Double-blind, Randomized, Placebo-controlled, Parallel, Dose-ranging Study To Evaluate The Efficacy And Safety Of Pf-00547659 In Subjects With Moderate To Severe Ulcerative Colitis (Turandot)Ulcerative ColitisDrug: Placebo;Drug: PF-00547659 SC InjectionShireNot recruiting18 Years65 YearsAll357Phase 2United 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;Croatia;Czech Republic;Norway;Sweden;United Kingdom
495NCT01790061November 201218 January 2018Standardized Fecal Microbiota Transplantation for Ulcerative ColitisEfficacy, Durability and Safety of Standardized Fecal Microbiota Transplantation in Patients With Moderate to Severe Ulcerative ColitisBacteria;Microbiota;Fecal Microbiota Transplantation;Inflammatory Bowel Disease;Ulcerative ColitisProcedure: Standardized FMT;Drug: Traditional treatmentsThe Second Hospital of Nanjing Medical UniversityFourth Military Medical UniversityRecruiting6 Years80 YearsAll500Phase 2/Phase 3China
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
496EUCTR2011-006084-22-GB04/10/201216 October 2012Usefulness of the measurement of blood levels of infliximab and adalimumab in inflammatory bowel disease patients in predicting response to treatmentUtilising drug levels and anti-drug antibodies to predict response to treatment in patients with Inflammatory Bowel Disease - Trough levels of anti-TNF agents in inflammatory bowel diseaseInflammatory bowel disease
MedDRA version: 14.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Remicade
Product Name: Infliximab
Pharmaceutical Form: Infusion
INN or Proposed INN: Infliximab
CAS Number: 170277-31-3
Current Sponsor code: Centocor
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration number: 10mg/kg body wt-
Trade Name: Humira
Product Name: adalimumab
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Adalimumab
CAS Number: 331731-18-1
Current Sponsor code: EU/1/03/256/001
Concentration unit: mg milligram(s)
Concentration type: not less then
Concentration number: 40-mg
Royal Liverpool University HospitalAuthorisedFemale: yes
Male: yes
0United Kingdom
497EUCTR2012-001830-32-HU04/10/201226 November 2018A comparative study on the efficacy and tolerability of an 8 week oral treatment with three times daily 1000 mg mesalazine versus three times daily 2x500 mg mesalazine in patients with active ulcerative colitisDouble-blind, double-dummy, randomised, multi-centre, comparative phase III clinical study on the efficacy and tolerability of an 8 week oral treatment with three times daily 1000 mg mesalazine versus three times daily 2x500 mg mesalazine in patients with active ulcerative colitis - TID 1000 mg mesalazine versus TID 2x500 mg mesalazine in active UCActive ulcerative colitis
MedDRA version: 17.0 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mesalazine 1000 mg gastro-resistant tablets
Product Code: Mesalazine 1000 mg gastro-resistant tablets
Pharmaceutical Form: Gastro-resistant tablet
INN or Proposed INN: Mesalazine
CAS Number: 89-57-6
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3000-
Pharmaceutical form of the placebo: Gastro-resistant tablet
Route of administration of the placebo: Oral use
Trade Name: Salofalk® 500 mg gastro-resistant tablet
Product Name: Mesalazine 500 mg gastro-resistant tablets (Salofalk® 500 mg)
Product Code: Salofalk® 500 mg tablets
Pharmaceutical Form: Gastro-resistant tablet
INN or Proposed INN: Mesalazine
CAS Number: 89-57-6
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3000-
Pharmaceutical form of the placebo: Gastro-resistant tablet
Route of administration of the placebo: Oral use
Dr. Falk Pharma GmbHNot RecruitingFemale: yes
Male: yes
400Phase 3Hungary;Poland;Ukraine;Lithuania;Russian Federation;Latvia
498NCT01470612October 1, 201222 October 2019Long-Term Study Of CP-690,550 In Subjects With Ulcerative ColitisA MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITISUlcerative ColitisDrug: CP-690,550PfizerNot recruiting18 YearsN/AAll944Phase 3United States;Australia;Austria;Belgium;Brazil;Canada;Colombia;Croatia;Czechia;Denmark;Estonia;France;Germany;Hungary;Israel;Italy;Japan;Korea, Republic of;Latvia;Netherlands;New Zealand;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Taiwan;Ukraine;United Kingdom;Czech Republic;India
499NCT01418131October 20129 January 2017Rectal Tacrolimus in the Treatment of Resistant Ulcerative ProctitisA Multi-centre Double Blind Randomised Placebo-controlled Study of the Use of Rectal Tacrolimus in the Treatment of Resistant Ulcerative ProctitisUlcerative ColitisDrug: Rectal tacrolimus;Drug: PlaceboThe University of Western AustraliaRoyal Brisbane and Women's Hospital;Royal Adelaide Hospital, Australia;Liverpool Hospital, Australia;Fremantle Hospital and Health ServiceNot recruiting18 YearsN/ABoth21Phase 4Australia
500NCT02306785October 201219 February 2015TP0502-Pharmaco-Scintigraphic-Study and AmendmentAn Open Label, Single-site Pharmaco-Scintigraphic Study in Healthy Subjects and Patients With Active Ulcerative Colitis With Radio-labelled TP05-tablets to Evaluate the Gastrointestinal Transit and Release Profiles of Two Different Formulations (and Amendment)Ulcerative ColitisDrug: TP05 Coating D;Drug: TP05 Coating E;Drug: TP05 Coating HTillotts Pharma AGNot recruiting18 Years55 YearsBoth26Phase 1
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
501EUCTR2012-002023-15-AT21/09/201210 September 2018Mesacol: The effect of mesalazine on molecular pathways of cell adhesion in ulcerative colitisMesacol: The effect of mesalazine on molecular pathways of cell adhesion in ulcerative colitis - MesacolUlcerative colitis
MedDRA version: 14.1 Level: LLT Classification code 10045366 Term: Ulcerative colitis, unspecified System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Mezavant 1200 mg magensaftresistente Retardtabletten
Pharmaceutical Form: Gastro-resistant tablet
INN or Proposed INN: MESALAZINE
CAS Number: 89-57-6
Current Sponsor code: 5-ASA
Other descriptive name: 5-aminosalicylic acid
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1200-
Medizinische Universität Wien, Universitätsklinik für Innere Medizin 3, Abteilung für Gastroenterologie und HepatologieNot RecruitingFemale: yes
Male: yes
12Phase 2Austria
502JPRN-UMIN0000152972012/09/1923 April 2019The feasibility study of accelated infliximab infusion from initial administrationThe feasibility study of accelated infliximab infusion from initial administration - The feasibility study of accelated infliximab infusion from initial administrationpatient in whom infliximab is indicated(rheumatoid arthritis, Crohn's disease, Ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis)Administration of intravenous infliximab infusion with 60 min accelated procedure for patients who are already successfully treated with usual 2hr infuion without infusion reaction. The tolerable patient continue to receive more five treatment with 60min procedure.Chiba University HospitalRecruiting20years-old70years-oldMale and Female54Phase 2Japan
503NCT01697670September 201219 February 2015Photodynamic Therapy for Ulcerative ColitisA Multicenter, Open Phase II Study to Assess the Effect and Safety of Low Dose Photodynamic Therapy in Patients With Moderate to Severe Active Distal Ulcerative ColitisUlcerative ColitisDrug: Photodynamic therapy with GliolanUniversity of ZurichSwiss National Science FoundationRecruiting18 YearsN/ABoth7Phase 1Switzerland
504JPRN-UMIN0000083522012/08/012 April 2019Switch Trial from Several Times to Once Daily Oral Mesalazine Administration in Patients with Quiescent Ulcerative ColitisUlcerative ColitisSwitch from several times to once daily oral mesalazine administrationSaitama Medical Center, Saitama Medical UniversityNot Recruiting15years-old70years-oldMale and Female50Not selectedJapan
505NCT03079700August 1, 201216 December 2017Immune Modulation From Trichuris SuisMucosal and Systemic Immune Modulation From Trichuris Suis in a Self-infected IndividualCrohn Disease;Ulcerative Colitis;Intestinal HelminthiasisBiological: Trichuris suis eggsUniversity of AarhusNot recruiting18 Years70 YearsMale1N/A
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
506NCT01433471August 201219 October 2017Mucosal Immunity of Ulcerative Colitis Patients Undergoing Therapy With Trichuris Suis OvaMucosal Immunity of Ulcerative Colitis Patients Undergoing Therapy With Trichuris Suis OvaUlcerative ColitisDrug: Trichuris suis ovaNew York University School of MedicineNot recruiting18 Years72 YearsAll4N/AUnited States
507NCT01659138August 20128 August 2016Efficacy and Safety of SAR339658 in Patients With Moderate to Severe Ulcerative ColitisA Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating Efficacy and Safety of SAR339658 in Patients With Active Moderate to Severe Ulcerative Colitis (UC)Ulcerative ColitisDrug: SAR339658;Other: PlaceboSanofiNot recruiting18 Years70 YearsBoth28Phase 2United States;Austria;Canada;France;Germany;Italy;Poland;Belgium
508NCT01678911August 201219 October 2017Efficacy of Gralise® for Chronic Pelvic PainEfficacy of Gralise® for Chronic Pelvic PainIrritable Bowel Syndrome;Ulcerative Colitis;Interstitial Cystitis;Prostatitis;Pelvic PainDrug: GraliseShirley Ryan AbilityLabNot recruiting18 YearsN/AAll11Phase 4United States
509NCT01783119August 201219 February 2015Effect of Aloe Vera in the Inflammation of Patients With Mild Ulcerative ColitisEffect of Aloe Vera in the Inflammation of Patients With Mild Ulcerative ColitisUlcerative ColitisDietary Supplement: Aloe Barbadensis Miller;Dietary Supplement: placebo waterNational Institute of Medical Sciences and Nutrition, Salvador ZubiranRecruiting18 Years59 YearsBoth60Phase 0Mexico
510NCT01458574July 20, 201216 December 2017A Study Of Oral CP-690,550 As A Maintenance Therapy For Ulcerative ColitisA Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Of Oral Cp-690,550 As A Maintenance Therapy In Subjects With Ulcerative ColitisUlcerative ColitisDrug: Placebo;Drug: CP690,550;Drug: CP-690,550PfizerNot recruiting18 YearsN/AAll593Phase 3United States;Australia;Austria;Belgium;Brazil;Canada;Colombia;Croatia;Czech Republic;Denmark;Estonia;France;Germany;Hungary;Israel;Italy;Japan;Korea, Republic of;Latvia;Netherlands;New Zealand;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Taiwan;Ukraine;United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
511NCT01612039July 201210 October 2016Safety, Efficacy, and Tolerability Study of ASP3291 in Patients With Active Ulcerative ColitisA Phase 2, Randomized, Double-Blind, Parallel, Placebo-Controlled, Proof-of-Concept Study to Assess the Efficacy, Safety, and Tolerability of ASP3291 in Patients With Active Ulcerative ColitisUlcerative ColitisDrug: ASP3291;Drug: PlaceboTelsar Pharma Inc.Not recruiting18 Years65 YearsBoth112Phase 2United States
512NCT01640496July 201219 February 2015Vitamin D Treatment in Ulcerative ColitisVitamin D Treatment in Ulcerative ColitisUlcerative Colitis;Inflammatory Bowel DiseaseDrug: Vitamin D3;Other: PlaceboUniversity of ChicagoNorth Shore University HospitalNot recruiting18 YearsN/ABoth0N/AUnited States
513EUCTR2011-005251-13-GR05/06/201228 May 2018A study to find out more about the effect of AMG 181 in people with moderate to severe ulcerative colitisA Randomized, Double blind, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Ulcerative ColitisModerate to severe Ulcerative Colitis
MedDRA version: 14.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: AMG 181
Product Code: AMG 181
Pharmaceutical Form: Solution for injection
INN or Proposed INN: AMG 181
Current Sponsor code: AMG 181
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 70-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Amgen IncNot RecruitingFemale: yes
Male: yes
315Phase 2United States;Estonia;Greece;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Latvia;Germany;Norway
514JPRN-UMIN0000078062012/06/012 April 2019The feasibility study of accelated infliximab infusion during maintenance phasepatient in whom infliximab is indicated(rheumatoid arthritis, Crohn's disease, Ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis)Administration of intravenous infliximab infusion with 60 min accelated procedure for patients who are already successfully treated with usual 2hr infuion without infusion reaction. The tolerable patient continue to receive more five treatment with 60min procedure.Chiba University HospitalNot RecruitingNot applicableNot applicableMale and Female54Phase 2Japan
515NCT01458951June 201219 October 2017A Study To Evaluate Both The Efficacy and Safety Profile of CP-690,550 In Patients With Moderately to Severely Active Ulcerative ColitisA Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Of Oral Cp-690,550 As An Induction Therapy In Subjects With Moderate To Severe Ulcerative Colitis.Ulcerative ColitisDrug: tofacitinib;Drug: PlaceboPfizerNot recruiting18 YearsN/AAll547Phase 3United States;Australia;Austria;Belgium;Brazil;Canada;Colombia;Croatia;Czech Republic;Denmark;Estonia;France;Germany;Hungary;Israel;Korea, Republic of;Latvia;Netherlands;New Zealand;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Taiwan;Ukraine;United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
516NCT01586533June 201219 February 2015Study of the Safety and Efficacy of Zoenasa® Versus Mesalamine Enema in Subjects With Left-Sided Ulcerative ColitisA Phase II Double-blind, Randomized, Comparator-controlled Study of the Safety and Efficacy of Zoenasa™ Rectal Gel (Mesalamine Plus N-acetylcysteine) in Subjects With Left-sided Ulcerative ColitisUlcerative Colitis;Left-sided Ulcerative Colitis;Distal Ulcerative ColitisDrug: Zoenasa-1:4;Drug: Mesalamine EnemaAltheus Therapeutics, Inc.Not recruiting18 Years64 YearsBoth120Phase 2United States
517NCT01536535May 1, 20129 October 2018Predicting Response to Standardized Pediatric Colitis TherapyMulticenter Open-label Study Evaluating the Safety and Efficacy of Standardized Initial Therapy Using Either Mesalamine or Corticosteroids Then Mesalamine to Treat Children and Adolescents With Newly Diagnosed Ulcerative Colitis.Ulcerative ColitisDrug: Mesalamine;Drug: Corticosteroid;Drug: Corticosteroids then mesalamineConnecticut Children's Medical CenterNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Not recruiting4 Years17 YearsAll467Phase 4United States;Canada
518NCT01387594May 201216 December 2017Evaluate PF-00547659 On Cerebrospinal Fluid Lymphocytes In Volunteers With Crohn's Disease Or Ulcerative Colitis Who Failed Or Did Not Tolerate Anti-TNFsA Multi-Center, Phase 1, Open-Label Evaluation Of The Effect Of PF-00547659 (Anti Madcam Monoclonal Antibody) On Cerebrospinal Fluid (CSF) Lymphocytes In Volunteers With Crohns Disease Or Ulcerative Colitis Who Are Anti-TNFInadequate Responders (TOSCA)Crohn's Disease;Ileitis;Ileo-colonic and Colonic Crohn's Disease;Granulomatous Colitis;Regional Enteritis;Ulcerative ColitisProcedure: lumbar puncture;Drug: lumbar punctureShireNot recruiting18 Years75 YearsAll49Phase 1Austria;Belgium;France;Germany;Netherlands
519EUCTR2011-002411-29-SE26/04/201214 March 2016A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis.An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/AUlcerative Colitis
MedDRA version: 14.1 Level: SOC Classification code 10017947 Term: Gastrointestinal disorders System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
AbbVie Deutschland GmbH & Co. KGNot RecruitingFemale: yes
Male: yes
455Sweden;Norway;Germany;Denmark;Belgium;Poland;Canada;Czech Republic;France;United Kingdom;Switzerland;Italy;Israel;Austria;Turkey;Ireland;Spain;Finland;Greece;Slovakia;Portugal
520EUCTR2011-004581-14-EE26/04/201228 February 2019A multi-center, open-label study of CP-690,550 in subjects with moderate to severe ulcerative colitisA MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITISUlcerative colitis
MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Tofacitinib citrate (clinical trial image)
Product Code: CP-690,550-10
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: tofacitinib
CAS Number: 540737-29-9
Current Sponsor code: CP-690,550-10
Other descriptive name: tofacitinib
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Product Name: Tofacitinib citrate (Proposed commercial formulation – debossed)
Product Code: CP-690,550-10
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: tofacitinib
CAS Number: 540737-29-9
Current Sponsor code: CP-690,550-10
Other descriptive name: tofacitinib
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pfizer Inc, 235 East 42nd Street, New York, New York 10017AuthorisedFemale: yes
Male: yes
900Phase 3Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
521NCT01465763April 201219 October 2017A Study Evaluating The Efficacy And Safety Of CP-690,550 In Patients With Moderate To Severe Ulcerative ColitisA Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Of Oral Cp-690,550 As An Induction Therapy In Subjects With Moderate To Severe Ulcerative ColitisUlcerative ColitisDrug: tofacitinib;Drug: PlaceboPfizerNot recruiting18 YearsN/AAll614Phase 3United States;Australia;Austria;Belgium;Canada;Colombia;Croatia;Czech Republic;Denmark;Estonia;France;Germany;Hungary;Israel;Italy;Japan;Latvia;Netherlands;New Zealand;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Ukraine;United Kingdom;Brazil
522NCT01551290April 201217 November 2015A Study to Evaluate the Effectiveness and Safety of Infliximab in Chinese Patients With Active Ulcerative ColitisA Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Infliximab in Chinese Subjects With Active Ulcerative ColitisUlcerative ColitisDrug: Infliximab;Drug: PlaceboXian-Janssen Pharmaceutical Ltd.Not recruiting18 Years65 YearsBoth99Phase 3China
523NCT01877577April 201219 February 2015Supplementation of Vitamin D3 in Patients With Inflammatory Bowel Diseases and Hypovitaminosis DSupplementation of Vitamin D3 (Cholecalciferol) in Patients With Inflammatory Bowel Diseases (IBD) and Hypovitaminosis D: A Prospective Randomized Controlled Trial.Crohn's Disease (CD);Ulcerative Colitis (UC)Dietary Supplement: Vitamin D3University of California, San FranciscoNot recruiting18 YearsN/ABoth30N/AUnited States
524EUCTR2011-005115-82-HU26/03/20129 December 2013An 8 week study to compare budesonide MMX 9 mg versus placebo in patients with mild to moderate ulcerative colitis who experience a flare of their disease while taking an existing 5 aminosalicylic acid.A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Budesonide MMX® 9 mg Extended-release Tablets as Add-on Therapy in Patients with Active, Mild or Moderate Ulcerative Colitis not Adequately Controlled on a Background Oral 5-ASA RegimenUlcerative Colitis
MedDRA version: 14.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Budesonide-MMX®
Pharmaceutical Form: Film coated gastro-resistant tablet
INN or Proposed INN: BUDESONIDE
CAS Number: 51333-22-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 9-
Pharmaceutical form of the placebo: Film coated gastro-resistant tablet
Route of administration of the placebo: Oral use
Santarus, Inc.Not RecruitingFemale: yes
Male: yes
500United States;Estonia;Czech Republic;Hungary;Canada;Poland;Ukraine;Lithuania;Bulgaria;Latvia
525NCT01506362March 201219 October 2017Efficacy, Pharmacodynamics, Safety and Tolerability of Oral BL-7040 in Patients With Moderately Active Ulcerative ColitisAn Open-Label Study to Evaluate the Efficacy, Pharmacodynamics, Safety and Tolerability of Oral BL-7040 in Patients With Moderately Active Ulcerative ColitisUlcerative ColitisDrug: BL-7040BioLineRx, Ltd.Not recruiting18 Years70 YearsAll22Phase 2Israel
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
526EUCTR2011-004770-28-ES28/02/201225 September 2012Investigation of the potential side effects and effects on the large bowel of Propionyl-L-carnitine Hydrochloride (ST 261) (given as tablets that release the active ingredient only in the large bowel) in Patients with Mild Ulcerative Colitis that are concomitantly treated with a Stable dose of aminosalicylatesPhase III, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter International Study to Investigate the Safety and Efficacy of Propionyl-L-Carnitine (ST261) Modified Release Tablets in Patients Affected by Mild Ulcerative Colitis under Oral Stable Treatment. - Propionyl-L-Carnitine in Ulcerative ColitisMild ulcerative colitis
MedDRA version: 14.1 Level: LLT Classification code 10066678 Term: Acute ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: PROPIONYL L-CARNITINE
Product Code: ST 261
Pharmaceutical Form: Tablet
INN or Proposed INN: Levocarnitine propyl hydrochloride
CAS Number: 119793-66-7
Current Sponsor code: (ST261) Propionyl-L-carnitine hydrochloride
Other descriptive name: (R)-3-(1-oxo-propoxy)-4-(N,N,N-trimethyl amonium chloride)-butanoic acid
Concentration unit: mg milligram(s)
Concentration type: not less then
Concentration number: 500-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.AuthorisedFemale: yes
Male: yes
444Phase 3Hungary;Germany;France;Spain;Latvia;Poland;Austria;Lithuania
527EUCTR2011-002818-37-BE15/02/201221 August 2017A Phase II study to investigate GSK1605786 fo the treatment of patients with Ulcerative Colitis.A phase II, 20-week, multi-centre, randomised, double-blind, placebo-controlled, parallel group proof of concept study to investigate the efficacy and safety of GSK1605786 for treatment of patients with active Ulcerative Colitis.Subjects with Active Ulcerative Colitis.
MedDRA version: 14.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GSK1605786A
Product Code: GSK1605786A
Pharmaceutical Form: Capsule, hard
Current Sponsor code: GSK1605786A
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 250-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
GlaxoSmithKline Research & Development LtdNot RecruitingFemale: yes
Male: yes
45Phase 2United Kingdom;Netherlands;Belgium
528EUCTR2011-003532-32-LT14/02/201226 November 2013A Pilot Study to Evaluate Safety and Efficacy of LX1606 in Subjects With Acute, Mild to Moderate Ulcerative ColitisPhase 2 Assessment of the Relationship between Serotonin and Efficacy in Ulcerative Colitis: A Multi-Center Randomized, Double Blind, Placebo-Controlled, Pilot Study to Evaluate Safety and Preliminary Efficacy of Orally Administered LX1606 in Subjects with Acute, Mild to Moderate Ulcerative ColitisAcute mild to moderate ulcerative colitis
MedDRA version: 14.1 Level: LLT Classification code 10066678 Term: Acute ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: LX1606
Product Code: LX1606
Pharmaceutical Form: Capsule
INN or Proposed INN: Telotristat etiprate
CAS Number: 1137608-69-5
Current Sponsor code: LX1606, LX1032
Other descriptive name: telotristat etiprate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 250-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Lexicon Pharmaceuticals, Inc.Not RecruitingFemale: yes
Male: yes
60Phase 2Lithuania;Belgium;Poland;Slovakia;United States
529NCT01453491February 13, 201216 December 2017A Phase 1b Study to Assess the Safety and Anti-inflammatory Effects of Two Different Doses of SRT2104 in Patients With Ulcerative ColitisA Phase 1b, Exploratory Study to Assess the Safety, Tolerability, Colonic Tissue Exposure, and Anti-Inflammatory Effects of Two Different Doses of SRT2104 in Subjects With Mild to Moderate Ulcerative ColitisColitis, UlcerativeDrug: SRT2104Sirtris, a GSK CompanyGlaxoSmithKlineNot recruiting18 Years75 YearsAll17Phase 1United States
530JPRN-UMIN0000073412012/02/0110 September 2019The study of the effectiveness of maintenance treatment with infliximab for ulcerative colitis patients who respond to induction treatment with infliximabThe study of the effectiveness of maintenance treatment with infliximab for ulcerative colitis patients who respond to induction treatment with infliximab - The study of the effectiveness of maintenance treatment with infliximab for ulcerative colitis patients who respond to induction treatment with infliximabulcerative colitisPatients in maintenance group receive intravenous infusion of infliximab (5mg/kg) at week 0, 2, and 6 and then every 8 weeks (up to week 54).
Patients in discontinuation group receive intravenous infusion of infliximab (5mg/kg) at week 0, 2, and 6 (not receiving infliximab at week 14, 22, 30, 38, 46 and 54).
Tohoku University Graduate School of Medicine (Tohoku University Hospital)Not Recruiting20years-oldNot applicableMale and Female90Not applicableJapan
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
531NCT01393405February 201211 June 2018Methotrexate in Induction and Maintenance of Steroid Free Remission in Ulcerative ColitisRandomized, Double Blind, Prospective Trial Investigating the Efficacy of Methotrexate in Induction and Maintenance of Steroid Free Remission in Ulcerative Colitis (MEthotrexate Response In Treatment of UC - MERIT-UC)Ulcerative ColitisDrug: MethotrexateUniversity of North Carolina, Chapel HillNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Not recruiting18 Years70 YearsAll179Phase 2United States
532NCT01517607February 201212 October 2015Mesalazine (PENTASA®) in Ulcerative ColitisMesalazine (PENTASA®) in Ulcerative Colitis: Correlation of the Information Level With Patient's Compliance in Everyday PracticeUlcerative ColitisOther: MesalazineFerring PharmaceuticalsFerring Arzneimittel GmbHNot recruiting18 YearsN/ABoth506N/AGermany
533NCT01532648February 201219 February 2015Randomized Placebo Controlled Trial of Budesonide Multi-Matrix System (MMX®) 9 mg in Patients With Ulcerative Colitis Currently on a 5-Aminosalicylic Acid (5-ASA).Ulcerative ColitisDrug: Budesonide;Drug: Placebo;Procedure: Procedure/Surgery: Blood sampling, endoscopySalix PharmaceuticalsNot recruiting18 Years75 YearsBoth509Phase 3United States;Bulgaria;Canada;Czech Republic;Estonia;Hungary;Latvia;Lithuania;Poland;Russian Federation;Ukraine
534NCT01562314February 201219 October 2017A Pilot Study of GWP42003 in the Symptomatic Treatment of Ulcerative Colitis (GWID10160)A Randomised, Double-blind, Placebo-controlled Parallel Group, Pilot Study of GWP42003 in the Symptomatic Treatment of Ulcerative Colitis.Ulcerative ColitisDrug: GWP42003;Drug: PlaceboGW Research LtdNot recruiting18 YearsN/AAll60Phase 2Czech Republic;United Kingdom
535NCT01585155February 201225 May 2015Clinical Study of TA-650 in Pediatric Patients With Ulcerative ColitisClinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of TA-650 in Pediatric Patients With Moderate to Severe Ulcerative Colitis.Pediatric Ulcerative ColitisDrug: TA-650Mitsubishi Tanabe Pharma CorporationNot recruiting6 Years17 YearsBoth21Phase 3Japan
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
536NCT01456052January 30, 201216 December 2017A Study to Evaluate Safety and Efficacy of LX1606 in Subjects With Acute, Mild to Moderate Ulcerative ColitisPhase 2 Assessment of the Relationship Between Serotonin and Efficacy in Ulcerative Colitis: A Multi-Center Randomized, Double Blind, Placebo-Controlled, Pilot Study to Evaluate Safety and Preliminary Efficacy of Orally Administered LX1606 in Subjects With Acute, Mild to Moderate Ulcerative ColitisUlcerative ColitisDrug: 500 mg LX1606 QD;Drug: 500 mg LX1606 TID;Drug: PlaceboLexicon PharmaceuticalsNot recruiting18 Years70 YearsAll59Phase 2United States;Lithuania;Poland;Slovakia
537EUCTR2011-004812-40-DE26/01/201214 October 2013Evaluation of efficacy and safety of tralokinumab in patients with active, moderate-to-severe ulcerative colitis.A phase IIa, randomised, double-blind, placebo-controlled, parallel-arm, multicenter study to evaluate the efficacy and safety of tralokinumab (CAT-354), a recombinant human monoclonal antibody directed against interleukin-13 (IL-13), as add-on therapy, on clinical response in patients with active, moderate-to-severe, ulcerative colitisUlcerative Colitis
MedDRA version: 14.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: tralokinumab
Product Code: CAT-354
Pharmaceutical Form: Solution for injection
INN or Proposed INN: tralokinumab
CAS Number: 1044515-88-9
Current Sponsor code: CAT-354
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
AstraZeneca ABNot RecruitingFemale: yes
Male: yes
110Phase 2aItaly;United Kingdom;Germany;Netherlands;Czech Republic
538EUCTR2011-004765-32-BE10/01/201221 August 2017Investigation of the potential side effects and effects on the large bowel of Propionyl-L-carnitine Hydrochloride (ST 261) (given as tablets that release the active ingredient only in the large bowel) in Patients with Mild Ulcerative Colitis that are concomitantly treated with a Stable dose of aminosalicylatesPhase III, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter International Study to Investigate the Safety and Efficacy of Propionyl-L-carnitine Hydrochloride (ST261) Modified Release Tablets in Patients Affected by Mild Ulcerative Colitis under Oral Stable Treatment - Propionyl-L-carnitine in Ulcerative ColitisMild ulcerative colitis
MedDRA version: 14.1 Level: LLT Classification code 10066678 Term: Acute ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: PROPIONYL L-CARNITINE
Product Code: ST 261
Pharmaceutical Form: Tablet
INN or Proposed INN: Levocarnitine propyl hydrochloride
CAS Number: 119793-66-7
Current Sponsor code: (ST261) Propionyl-L-carnitine
Other descriptive name: (R)-3-(1-oxo-propoxy)-4-(N,N,N-trimethyl amonium chloride)-butanoic acid
Concentration unit: mg milligram(s)
Concentration type: not less then
Concentration number: 500-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.Not RecruitingFemale: yes
Male: yes
444Phase 3Czech Republic;Slovakia;Belgium;Netherlands;Italy
539EUCTR2011-003283-78-IT09/01/201227 January 2014A PROOF-OF-CONCEPT CLINICAL STUDY, TO ASSESS THE EFFECT OF GED-0507-34-Levo 80 mg Tablets IN INDUCTION OF REMISSION OF ACTIVE ULCERATIVE COLITISA PROOF-OF-CONCEPT CLINICAL STUDY, TO ASSESS THE EFFECT OF GED-0507-34-Levo 80 mg Tablets IN INDUCTION OF REMISSION OF ACTIVE ULCERATIVE COLITISActive Ulcerative Colitis Patients
MedDRA version: 14.1 Level: LLT Classification code 10021184 Term: IBD System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: NA
Product Code: GED-0507-34-Levo
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: (-)-3-(4-Aminophenyl)-2-methoxypropionic acid
CAS Number: NA
Current Sponsor code: GED-0507-34-Levo
Other descriptive name: NA
Concentration unit: mg/g milligram(s)/gram
Concentration type: up to
Concentration number: 160-
GIULIANINot RecruitingFemale: yes
Male: yes
Italy
540EUCTR2011-005693-36-IT09/01/20129 October 2012Evaluation of the number of colon intraephitelial tumours in patients with ulcerative colitis after oral administration of the vital dye methylene blueIntraepithelial neoplasia detection rate after single oral dose of methylene blue MMX modified release tablets administered to patients with long standing ulcerative colitis undergoing colonoscopy - NAPatients affecetd by Long standing ulcerative colitis
MedDRA version: 14.1 Level: SOC Classification code 10017947 Term: Gastrointestinal disorders System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Methylene blue 25mg tablets
Product Code: NA
Pharmaceutical Form: Modified-release tablet
INN or Proposed INN: METHYLENE BLUE
Current Sponsor code: NA
Other descriptive name: NA
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
COSMO TECHNOLOGIES LTDNot RecruitingFemale: yes
Male: yes
Italy
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
541NCT01494857January 201219 February 2015Efficacy and Safety of Adalimumab for the Induction of Clinical Response in Ulcerative ColitisOpen-Label, Non-Randomized, Single Patient Group, Multi-Center Study to Evaluate the Efficacy and Safety of Adalimumab for the Induction of Clinical Response in Moderately to Severely Active Ulcerative ColitisUlcerative ColitisDrug: AdalimumabClalit Health ServicesRecruiting18 YearsN/ABoth200Phase 3Israel
542NCT01534312January 201228 November 2016Casein Glycomacropeptide in Active Distal Ulcerative Colitis (Pilot Study)Casein Glycomacropeptide in Active Distal Ulcerative Colitis (Pilot Study)Colitis, Ulcerative;Inflammatory Bowel DiseasesDrug: CGMP protein;Drug: Maximal oral 5ASAUniversity of AarhusArla FoodsNot recruiting18 YearsN/ABoth24N/ADenmark
543EUCTR2010-020448-37-NL21/12/20114 August 2015Randomized placebo-controlled multicenter exploratory Phase IIA study to assess the safety and efficacy of PEG-liposomal prednisolone sodium phosphate (Nanocort) in subjects with active ulcerative colitis.Randomized placebo-controlled multicenter exploratory Phase IIA study to assess the safety and efficacy of PEG-liposomal prednisolone sodium phosphate (Nanocort) in subjects with active ulcerative colitis.Active Ulcerative Colitis
MedDRA version: 14.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: PEG-liposomal prednisolone sodium phosphate
Product Code: Nanocort
Pharmaceutical Form: Concentrate and diluent for solution for infusion
INN or Proposed INN: Prednisolone Sodium Phosphate
CAS Number: 125-02-0
Current Sponsor code: Nanocort
Other descriptive name: PREDNISOLONE SODIUM PHOSPHATE
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: range
Concentration number: 1.0 -3.2
Pharmaceutical form of the placebo: Infusion
Route of administration of the placebo: Intravenous use
Enceladus PharmaceuticalsNot RecruitingFemale: yes
Male: yes
20Phase 2ABelgium;Netherlands
544EUCTR2011-003532-32-SK19/12/201127 January 2014A Pilot Study to Evaluate Safety and Efficacy of LX1606 in Subjects With Acute, Mild to Moderate Ulcerative ColitisPhase 2 Assessment of the Relationship between Serotonin and Efficacy in Ulcerative Colitis: A Multi-Center Randomized, Double Blind, Placebo-Controlled, Pilot Study to Evaluate Safety and Preliminary Efficacy of Orally Administered LX1606 in Subjects with Acute, Mild to Moderate Ulcerative ColitisAcute mild to moderate ulcerative colitis
MedDRA version: 14.0 Level: LLT Classification code 10066678 Term: Acute ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: LX1606
Product Code: LX1606
Pharmaceutical Form: Capsule
INN or Proposed INN: Non as of yet
CAS Number: 1137608-69-5
Current Sponsor code: LX1606, LX1032
Other descriptive name: telotristat etiprate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 250-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Lexicon Pharmaceuticals, Inc.Not RecruitingFemale: yes
Male: yes
60Phase 2Lithuania;Poland;Belgium;Slovakia;United States
545EUCTR2011-004268-31-DK13/12/201117 August 2015Adalimumab (Humira) in the treatment of chronic pouchitisAdalimumab (Humira) in the treatment of chronic pouchitisChronic pouchitis after proctocolectomy and reconstruction with a J-pouch and with ulcerative colitis as primary diagnosis
MedDRA version: 14.0 Level: PT Classification code 10036463 Term: Pouchitis System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg solution for injection in pre-filled syringes
Product Name: Humira
Product Code: EMEA/H/C/000481
Pharmaceutical Form: Solution for injection
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Odense University HospitalNot RecruitingFemale: yes
Male: yes
24Denmark
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
546NCT01434576December 201119 February 2015Study to Evaluate the Pharmacodynamics and Safety of HGS1025 in Patients With Ulcerative ColitisA Phase 1b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Pharmacodynamics and Safety of HGS1025, a Human Monoclonal Anti-CCR5 Antibody, in Subjects With Ulcerative ColitisUlcerative ColitisBiological: HGS1025;Drug: PlaceboHuman Genome Sciences Inc.Not recruiting18 YearsN/ABoth0Phase 1
547NCT01496053December 201128 April 2015Anti-inflammatory Effect of Agaricus Blazei Murill in Inflammatory Bowel Disease (IBD)Anti-inflammatory Effect of a Mushroom Extract (AndoSan)in Patients With Inflammatory Bowel Disease. A Prospective StudyUlcerative Colitis;Crohn's Disease;Inflammatory Bowel DiseaseDietary Supplement: AndoSan;Dietary Supplement: Sugar ExtractOslo University HospitalImmunoPharmaRecruiting18 Years60 YearsBoth100Phase 2/Phase 3Norway
548NCT02306772December 201119 February 2015TP0501 - Pharmaco-Scintigraphic-StudyAn Open Label, Single-site Pharmaco-Scintigraphic Study in Healthy Subjects With Radio-labelled TP05-tablets (Mesalazine) to Evaluate the Gastrointestinal Transit and Release Profiles of Two Different Formulations.Ulcerative ColitisDrug: TP05 Coating A;Drug: TP05 Coating BTillotts Pharma AGNot recruiting18 Years55 YearsBoth18Phase 1
549NCT01461317November 30, 201116 December 2017Study to Evaluate the Long-term Safety of Etrolizumab in Participants With Moderate to Severe Ulcerative ColitisA Phase II Open-Label Extension Study to Evaluate the Long-Term Safety of Etrolizumab in Patients With Moderate to Severe Ulcerative ColitisUlcerative ColitisDrug: EtrolizumabGenentech, Inc.Not recruiting18 Years75 YearsAll121Phase 2United States;Australia;Belgium;Canada;Czech Republic;Germany;Hungary;Israel;New Zealand;Spain;United Kingdom
550EUCTR2011-003208-19-GB16/11/201128 February 2019GWP42003 symptomatic treatment of ulcerative colitis.A randomised, double-blind, placebo-controlled parallel group, pilot study of GWP42003 in the symptomatic treatment of ulcerative colitis.Symptoms of diarrhoea, rectal bleeding, stool frequency and inflammation in subjects with ulcerative colitis
MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: GWP42003
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Not applicable
CAS Number: 13956-29-1
Current Sponsor code: GWP42003
Other descriptive name: CANNABIDIOL
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
GW Pharma Ltd.Not Recruiting Female: yes
Male: yes
62Phase 2Czech Republic;United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
551EUCTR2011-002462-20-DE25/10/201129 April 2013Clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitisRandomised, double-blind, placebo-controlled prospective clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitis - K(D)PT in ulcerative colitis: proof of concept studyAcute mild to moderate ulcerative colitis.
MedDRA version: 14.1 Level: LLT Classification code 10066678 Term: Acute ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: KdPT
Product Code: 20 mg
Pharmaceutical Form: Powder and solvent for oral solution
Current Sponsor code: K(D)PT Acetate
Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Powder and solvent for oral solution
Route of administration of the placebo: Oral use
Product Name: KdPT
Product Code: 50 mg
Pharmaceutical Form: Powder and solvent for oral solution
Current Sponsor code: K(D)PT Acetate
Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Powder and solvent for oral solution
Route of administration of the placebo: Oral use
Product Name: KdPT
Product Code: 100 mg
Pharmaceutical Form: Powder and solvent for oral solution
Current Sponsor code: K(D)PT Acetate
Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Powder and solvent for oral solution
Route of administration of the placebo: Oral use
Dr August Wolff GmbH & Co KG ArzneimittelNot RecruitingFemale: yes
Male: yes
160Italy;Germany;Poland;Czech Republic;Hungary
552EUCTR2011-003130-14-GB06/10/201125 September 2012A study to see how effective and safe the drug Kappaproct is in patients with refractory ulcerative colitis when added to their standard care of treatmentA placebo-controlled, double-blind, randomised study to assess the efficacy and safety of Kappaproct as an add-on to current practice in chronic active treatment refractory ulcerative colitis patients -Chronic active treatment refractory ulcerative colitis
MedDRA version: 14.1 Level: PT Classification code 10009900 Term: Colitis ulcerative System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Kappaproct
Pharmaceutical Form: Rectal solution
Current Sponsor code: DIMS0150
Other descriptive name: DIMS0150
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 15.6-
Pharmaceutical form of the placebo: Rectal capsule
Route of administration of the placebo: Rectal use
InDex Pharmaceuticals ABAuthorisedFemale: yes
Male: yes
120Hungary;Czech Republic;Germany;United Kingdom;Italy;Poland
553JPRN-UMIN0000061412011/10/012 April 2019Comparative study of Infliximab monotherapy vs combined therapy with azathiopurine for inducing and maintaining clinical remission in steroid-dependent or -resistant ulcerative colitisulcerative colitisPatients in Infliximab monotherapy receive intravenous infusion of IFX at week 0, 2, and 6, and then every 8 weeks (up to week 54).
Patients in the combination therapy of Infliximab and azathiopurine receive intravenous infusion of IFX (at week 0, 2, 6, and then every 8 weeks) and oral azathiopurine (up to week 54).
Department of Gastroenterology and Hepatology, Kyoto University HospitalNot Recruiting16years-old75years-oldMale and Female50Not applicableJapan
554NCT01336465September 201122 August 2016Evaluate the Efficacy and Safety of rhuMAb Beta7 in Patients With Moderate to Severe Ulcerative ColitisPhase II Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of rhuMAb Beta7 in Patients With Moderate to Severe Ulcerative ColitisUlcerative ColitisDrug: rhuMAb Beta7;Drug: placeboGenentech, Inc.Not recruiting18 Years75 YearsBoth124Phase 2United States;Australia;Belgium;Canada;Czech Republic;Germany;Hungary;Israel;New Zealand;Spain;United Kingdom
555EUCTR2011-000897-80-BE16/08/201116 August 2016A clinical study to investigate the safety and efficacy of the product rhuMAb BETA7 in treating patients with ulcerative colitis, a form of inflammatory bowel diseasePHASE II RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF rhuMAb BETA7 IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITISUlcerative colitis
MedDRA version: 14.0 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: rhuMAb Beta7
Product Code: PRO145223 (RO5490261)
Pharmaceutical Form: Solution for injection
INN or Proposed INN: n.a.
Current Sponsor code: PRO145223 (RO5490261)
Other descriptive name: rhuMAb Beta7
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Genentech, Inc.Not RecruitingFemale: yes
Male: yes
120Phase 2United States;Hungary;Czech Republic;Canada;Spain;Belgium;Australia;Israel;Germany;United Kingdom;New Zealand
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
556EUCTR2010-023797-39-GB12/08/201128 January 2013TREATMENT OF IRON DEFICIENCY ANAEMIA IN ADOLESCENTS WITH INFLAMMATORY BOWEL DISEASETREATMENT OF IRON DEFICIENCY ANAEMIA IN ADOLESCENTS WITH INFLAMMATORY BOWEL DISEASE USING FERROUS SULPHATE OR COSMOFER: TOLERANCE AND EFFECTS ON HAEMOGLOBIN, DISEASE ACTIVITY, MOOD, QUALITY OF LIFE AND AUTONOMIC NERVOUS SYSTEM ACTIVITY. AN OPEN LABEL PHASE IV NON-INFERIORITY STUDY. - TREATMENT OF IRON DEFICIENCY ANAEMIA IN ADOLESCENTS WITH IBD.Inflammatory bowel disease
MedDRA version: 14.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders
Trade Name: Iron sulphate 200mg coated tablets
Product Name: Ferrous sulphate
Product Code: Ferrous sulphate
Pharmaceutical Form: Tablet
INN or Proposed INN: Iron sulphate
CAS Number: 7720-78-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Trade Name: CosmoFer
Product Name: CosmoFer 50mg/ml solution for infusion or injection
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: iron(III)- hydroxide dextran complex
CAS Number: 9004-66-4
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Barts Health NHS TrustAuthorisedFemale: yes
Male: yes
Phase 4United Kingdom
557NCT01340872August 201112 September 2016Safety and Efficacy Study of Oral Ferric Iron To Treat Iron Deficiency Anaemia in Quiescent Ulcerative Colitis (AEGIS-1)A Prospective, Multicentre, Randomised, Double-blind, Placebo Controlled Study With Oral ST10-021 for the Treatment of Iron Deficiency Anaemia in Subjects With Quiescent Ulcerative Colitis Where Oral Ferrous Preparations Have Failed or Cannot be Used (AEGIS 1)Iron Deficiency Anaemia;Inflammatory Bowel Disease;Ulcerative ColitisDrug: ST10-021;Drug: Placebo ComparatorIron TherapeuticsNot recruiting18 YearsN/ABoth58Phase 3Austria;United Kingdom
558JPRN-UMIN0000058242011/07/012 April 2019Examination of efficacy and safety of tacrolimus, immunomodulator for an outpatient with moderate to severe ulcerative colitisulcerative colitisTacrolimus (12weeks)Juntendo UniversityRecruiting16years-old65years-oldMale and Female20Not applicableJapan
559NCT01320436July 201123 February 2016Curcumin + Aminosalicylic Acid (5ASA) Versus 5ASA Alone in the Treatment of Mild to Moderate Ulcerative ColitisRandomized, Double-blind, Placebo-controlled Study to Evaluated the Efficacy of Combining Curcumin+5ASA Medication Versus 5ASA Medication Alone on Active Mild to Moderate Ulcerative Colitis PatientsUlcerative ColitisDietary Supplement: Curcumin;Drug: 5-aminosalicylic acidSheba Medical CenterNot recruiting18 Years70 YearsBoth50Phase 3Israel
560EUCTR2011-002061-38-BE29/06/201121 August 2017Treating patients with infliximab based on their trough levelsA randomised prospective trough level monitoring study with real-time therapeutic adaptations: Trough level Adapted infliXImab Treatment scheme (TAXIT). - TAXIT2) Crohn's disease and ulcerative colitis
MedDRA version: 13.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 13.1 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Remicade
Product Name: Remicade
Product Code: Remicade
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Katholieke Universiteit LeuvenNot RecruitingFemale: yes
Male: yes
Phase 4Belgium
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
561JPRN-UMIN0000112362011/05/022 April 2019Evaluation of efficacy of mesalazine suppository in ulcerative colitis with rectal inflammation -Efficacy of on-demand therapy for induction and maintenance of remission -Ulcerative colitisUpon appearance of rectal bleeding, once daily administration of a 500 mg mesalazine suppository until disappearance of rectal bleeding.Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of MedicineNot Recruiting15years-old65years-oldMale and Female200Not selectedJapan
562NCT01346826May 20118 August 2016Safety of Accelerated Infliximab Infusions in Patients With Inflammatory Bowel Disease (IBD)Safety of Accelerated Infliximab Infusions in Patients With Inflammatory Bowel Disease: A Prospective, Randomized, Double-Blind, Controlled TrialCrohn's Disease;Ulcerative ColitisDrug: Standard 2 hours-infusion;Drug: Accelerated 1 hour-infusion;Drug: Accelerated 30 minutes-infusionAsan Medical CenterNot recruiting16 Years80 YearsBoth145Phase 4Korea, Republic of
563NCT01772615May 201119 February 2015Treatment of Ulcerative Colitis With Ciprofloxacin and E. Coli NissleActive Ulcerative Colitis; Placebo Controlled Treatment Trial With Ciprofloxacin and E. Coli NissleUlcerative ColitisDrug: Ciprofloxacin;Dietary Supplement: E. coli NissleHvidovre University HospitalNot recruiting18 YearsN/ABoth100Phase 4Denmark
564JPRN-UMIN0000053582011/04/012 April 2019Rapid LeukocyAPheresis InDuction for Ulcerative Colitisulcerative colitisLCAP is determined to apply if patient does not obtain a significant improvement (higher than 50%) in spite of recieving sufficient steroid therapy (higher than 30mg/day of prednisolone) for 3 days.
LCAP is determined to apply if patient does not obtain a significant improvement (higher than 50%) in spite of recieving sufficient steroid therapy (higher than 30mg/day of prednisolone) for 14 days.
Lower Gastroenterology, Hyogo College of MedicineDepartment of Gastroenterology, Osaka City University and Department of Gastroenterology, Osaka Medical CollegeNot Recruiting12years-old81years-oldMale and Female40Phase 2,3Japan
565NCT01341808April 201119 February 2015Immunogenicity of Hepatitis A Vaccine in Inflammatory Bowel Disease (IBD) PatientsImmunogenicity of Hepatitis A Vaccine in Patients With Inflammatory Bowel DiseaseInflammatory Bowel Disease;Crohn's Disease;Ulcerative Colitis;Hepatitis ABiological: Epaxal Berna (virosomal hepatitis A vaccine)Asan Medical CenterNot recruiting18 Years40 YearsBoth493Phase 4Korea, Republic of
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
566JPRN-UMIN0000050332011/03/012 April 2019Open-labeled prospective randomized study between tacrolimus only and tacrolimus with intensive (twice a week) GMA (granulocyte and monocyte absorptive apheresis) for ulcerative colitisulcerative colitisPatients in tacrolimus only receive tacrolimus twice a day (at initial dose of 0.0025mg/kg, optimal serum traff level 10-15ng/ml (until 2 weeks) , 5-10ng/ml (after 2 weeks))
Patiens in tacrolimus with GMA receive tacrolimus twice a day and two GMA treatments per week.
Saitama Medical Center, Saitama Medical UniversityNot Recruiting12years-old75years-oldMale and Female50Not applicableJapan
567NCT00895336March 201116 December 2017Lactobacillus GG in Pediatric Ulcerative Colitis (UC)An Open Label Pilot Study of Lactobacillus GG in Pediatric Ulcerative ColitisUlcerative ColitisBiological: Lactobacillus GGChildren's Hospital Medical Center, CincinnatiNot recruiting5 Years18 YearsAll0Phase 2United States
568NCT01284062March 201119 October 2017Pharmacokinetics/Pharmacodynamics Biomarker Study in Active Ulcerative Colitis PatientsA Phase 2a, Randomized, Double-blind, Sponsor Unblinded, Placebo-controlled, Multiple Dose Study To Evaluate The Pharmacodynamics, Pharmacokinetics And Safety Of Anrukinzumab In Subjects With Active Ulcerative ColitisColitis, UlcerativeBiological: Anrukinzumab;Other: placeboPfizerNot recruiting18 Years65 YearsAll84Phase 2United States;Austria;Bulgaria;Canada;France;Germany;Hungary;Netherlands;Poland;Romania;Spain;Belgium
569NCT01294410March 20113 August 2015Induction and Maintenance Study of BMS-936557 Patients With Moderate to Severe Ulcerative ColitisA Phase IIb Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy With BMS-936557 in Subjects With Active Ulcerative Colitis (UC)Colitis, UlcerativeDrug: Placebo;Drug: Anti-IP-10 AntibodyBristol-Myers SquibbNot recruiting18 YearsN/ABoth305Phase 2United States;Australia;Austria;Belgium;Brazil;Canada;France;Germany;Hungary;Italy;Mexico;Netherlands;Poland;South Africa
570EUCTR2010-023494-19-SE10/02/201123 September 2013A Phase IIa, Multi-Centre, Double-blind, Randomised, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of K(D)PT after Multiple Ascending Doses in Patients with Active Mild to Moderate Ulcerative ColitisA Phase IIa, Multi-Centre, Double-blind, Randomised, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of K(D)PT after Multiple Ascending Doses in Patients with Active Mild to Moderate Ulcerative ColitisUlcerative colitis
MedDRA version: 12.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis
Product Name: Lysine-D-Proline-Threonine
Product Code: K(D)PT
Pharmaceutical Form: Powder for oral solution
Pharmaceutical form of the placebo: Oral liquid
Route of administration of the placebo: Oral use
Dr. August Wolff GmbH & Co. KG ArzneimittelNot RecruitingFemale: yes
Male: yes
12Phase 2aSweden
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
571NCT01240915February 201119 October 2017A Study To Investigate The Safety And Possible Clinical Benefit Of Multistem(r) In Patients With Moderate To Severe Ulcerative ColitisA Phase 2 Randomized, Double-blind, Placebo-controlled, Parallel Group, Multi-center Study To Investigate The Safety And Efficacy Of Multistem (Pf-05285401) In Subjects With Moderate To Severe Ulcerative ColitisColitis, UlcerativeDrug: placebo;Drug: MultiStem low dose;Drug: MultiStem high dosePfizerAthersys, IncNot recruiting18 YearsN/AAll105Phase 2United States;Belgium;Canada;Germany;Hungary;Italy;Slovakia;Sweden
572NCT01290042February 201123 March 2015Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 181.A Phase 1, Randomized, Double-Blind, Placebo-controlled, Ascending Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 181 in Healthy Subjects, in Subjects With Active Ulcerative Colitis, and in Subjects With Active Crohn's Disease.Ulcerative Colitis;Crohn's DiseaseDrug: AMG 181;Other: Placebo for AMG 181AmgenNot recruiting18 Years65 YearsBoth43Phase 1United States;Australia
573NCT01408810February 201119 February 2015Evaluation of Histologic and Endoscopic Remission Induced by Infliximab in Moderate to Severe Ulcerative ColitisHistological and Endoscopic Evaluation of Remission Induced by Infliximab in Moderately to Severely Active Ulcerative Colitis PatientsUlcerative ColitisDrug: InfliximabGrupo de Estudo da Doença Inflamatória IntestinalNot recruiting18 Years64 YearsBoth21Phase 4Portugal
574EUCTR2010-019558-42-BE23/12/201019 March 2012A Multicenter, Randomized, Double-Blind, Placebo-Controlled Pilot Study to Assess the Efficacy, Safety, and Tolerability of Baminercept in Subjects With Moderate to Severe Ulcerative ColitisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Pilot Study to Assess the Efficacy, Safety, and Tolerability of Baminercept in Subjects With Moderate to Severe Ulcerative ColitisUlcerative Colitis
MedDRA version: 12.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis
Product Name: Baminercept
Product Code: BG9924
Pharmaceutical Form: Solution for injection
INN or Proposed INN: N/A
CAS Number: N/A
Current Sponsor code: BG9924
Other descriptive name: Baminercept
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Biogen Idec Ltd.Not RecruitingFemale: yes
Male: yes
100Hungary;Czech Republic;Belgium
575JPRN-JapicCTI-10138015/11/20102 April 2019Active Phase Study with MD-0901 -Phase 3 Clinical Trial in Patients with Mild to Moderate Active Ulcerative Colitis-Active Phase Study with MD-0901 -Phase 3 Clinical Trial in Patients with Mild to Moderate Active Ulcerative Colitis-Mild to moderate active ulcerative colitisIntervention name : MD-0901
INN of the intervention : Mesalazine
Dosage And administration of the intervention : Mesalazine 2.4 g/d or 4.8 g/d are administrated orally once daily after breakfast for 8 weeks.
Control intervention name : Mesalazine tablet
INN of the control intervention : Mesalazine
Dosage And administration of the control intervention : Mesalazine 2.25 g/d are administrated orally 3 times daily after each meal for 8 weeks.
MOCHIDA PHARMACEUTICAL CO., LTD.16BOTH228Phase 3
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
576JPRN-JapicCTI-10138115/11/20102 April 2019Remission Phase Study with MD-0901 -Phase 3 Clinical Trial in Patients with Ulcerative Colitis in Remission Phase-Remission Phase Study with MD-0901 -Phase 3 Clinical Trial in Patients with Ulcerative Colitis in Remission Phase-Ulcerative colitis in remission phaseIntervention name : MD-0901
INN of the intervention : Mesalazine
Dosage And administration of the intervention : Mesalazine 2.4 g/d are administrated orally once daily after breakfast for 48 weeks.
Control intervention name : Mesalazine tablet
INN of the control intervention : Mesalazine
Dosage And administration of the control intervention : Mesalazine 2.25g/d are administrated orally 3 times daily after each meal for 48 weeks.
MOCHIDA PHARMACEUTICAL CO., LTD.16BOTH190Phase 3
577EUCTR2010-019970-33-HU11/11/201025 September 2012A multi-centre, double-blind, placebo controlled, parallel group, proof of concept study to evaluate the efficacy, safety and tolerability of KRP203 in subjects with moderately active refractory ulcerative colitis -Ulcerative colitis
MedDRA version: 12.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis
Product Name: n.a.
Product Code: KRP203A
Pharmaceutical Form: Capsule*
Current Sponsor code: KRP203A
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.1-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
Product Name: n.a
Product Code: KRP203A
Pharmaceutical Form: Capsule*
Current Sponsor code: KRP203A
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.4-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
Product Name: n.a
Product Code: KRP203A
Pharmaceutical Form: Capsule*
Current Sponsor code: KRP203A
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1.0-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
Novartis Services AGNot RecruitingFemale: yes
Male: yes
72Hungary;Germany;United Kingdom;Belgium;Sweden
578EUCTR2010-018557-35-NL08/11/201019 March 2012Desensitisation of ulcerative colitis patients intolerant for mesalazine treatment. - Desensitisation for mesalazineDesensitisation of ulcerative colitis patients intolerant for mesalazine treatment. - Desensitisation for mesalazineUlcerative colitisTrade Name: Mesalazine
Product Name: Mesalazine
Product Code: Salofalk
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
University Medical Center GroningenAuthorisedFemale: yes
Male: yes
20Netherlands
579NCT01257386November 201019 February 2015Comparative Efficacy and Safety Study in Patients With Active Ulcerative ColitisComparative Efficacy and Safety Study in Patients With Active Ulcerative ColitisActive Ulcerative ColitisDrug: Asacol®;Drug: MesalazineTillotts Pharma AGZeria PharmaceuticalNot recruiting18 Years64 YearsBoth251Phase 3China
580NCT01257399November 201019 February 2015Comparative Efficacy and Safety Study in Patients With Ulcerative Colitis in Remission PhaseComparative Efficacy and Safety Study in Patients With Ulcerative Colitis in Remission PhaseUlcerative Colitis in RemissionDrug: Asacol®;Drug: MesalazineTillotts Pharma AGZeria PharmaceuticalNot recruiting18 Years64 YearsBoth251Phase 3China
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
581NCT01090154October 201018 December 2018Study of Cimzia for the Treatment of Ulcerative ColitisCertolizumab Pegol for the Treatment of Moderate to Severe Ulcerative Colitis: An Open Label StudyUlcerative ColitisDrug: CimziaUniversity of WashingtonUCB Pharma;University of PennsylvaniaNot recruiting18 Years75 YearsAll25Phase 2United States
582NCT01111292October 201019 October 2017Inositol in Preventing Colorectal Cancer in Patients With Colitis-Associated DysplasiaMyo-Inositol Chemoprevention in Colitis-Associated DysplasiaColon Carcinoma;Dysplasia in Crohn Disease;Low Grade Dysplasia in Ulcerative Colitis;Rectal CarcinomaDrug: Inositol;Other: PlaceboNational Cancer Institute (NCI)Not recruiting18 YearsN/AAll5Phase 1/Phase 2United States
583NCT01130844October 201019 October 2017Safety and Pharmacokinetics of MMX Mesalamine in Children and Adolescents With Ulcerative ColitisA Phase 1, Multicenter, Open-label Study to Determine the Safety and Pharmacokinetics of MMX Mesalamine Following Administration in Children and Adolescents With Ulcerative ColitisUlcerative ColitisDrug: MMX MesalamineShireNot recruiting5 Years17 YearsAll52Phase 1United States;Australia;Poland;Slovakia;United Kingdom
584NCT01201122September 201021 December 2015Once Versus Twice Daily Mesalamine to Induce Remission in Pediatric Ulcerative ColitisMulti Center Ulcerative Colitis Pediatric Pentasa Intervention Trial (MUPPIT). A Randomized, Single-blinded, Controlled, Parallel, Induction Therapy With Once vs. Twice Daily Dosing of Pentasa in Pediatric UC.Mild to Moderate Ulcerative ColitisDrug: MesalamineWolfson Medical CenterNot recruiting6 Years18 YearsBoth86Phase 4Israel
585NCT01221428September 201019 February 2015Umbilical Cord Mesenchymal Stem Cells Infusion for Ulcerative ColitisSafety and Efficacy of Umbilical Cord Mesenchymal Stem Cells Infusion for Ulcerative ColitisUlcerative Colitis;Mesenchymal Stem Cells;Umbilical CordBiological: Umbilical Cord Mesenchymal Stem CellsQingdao UniversityNot recruiting18 Years70 YearsBoth50Phase 1/Phase 2China
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
586NCT01320332August 201019 February 2015A Study of a Single Dose of ASP3291 in Subjects With Ulcerative ColitisA Phase 1, Randomized, Double-Blind, Placebo Controlled Study to Assess the Pharmacokinetics, Safety, and Tolerability of ASP3291 Following a Single Oral Dose in Subjects With Ulcerative ColitisUlcerative ColitisDrug: ASP3291;Drug: PlaceboTelsar Pharma Inc.Not recruiting18 Years65 YearsBoth16Phase 1United States
587JPRN-UMIN0000037852010/07/012 April 2019Remission maintenance treatment of ulcerative colitis with tacrolimus in azathioprine-intolerant patients: a randomized comparative trial of 5-aminosalicylic acid (5-ASA) monotherapy versus 5-ASA and tacrolimus combination therapy.Ulcerative colitis5-aminosalicylic acid monotherapy arm:
5-aminosalicylic acid is administered to subjects during the study period (for 48 weeks).

5-aminosalicylic acid monotherapy and tacrolimus arm:
5-aminosalicylic acid is administered to subjects during the study period (for 48 weeks). Tacrolimus is administered to subjects for 12 weeks after the start of protocol treatment as a rule.
Department of Internal medicine, Division of Lower Gastroenterology, Hyogo College of MedicineNot Recruiting16years-old65years-oldMale and Female80Phase 3Japan
588JPRN-UMIN0000039522010/07/012 April 2019A multicenter, randomised, open-label study to evaluate the clinical efficacy and pharmacokinetics of oral tacrolimus (FK506) therapy under fasting and fed conditions in refractory ulcerative colitisulcerative colitisFasting condition group: Tacrolimus ingestion 1 hour before meal
Fed condition group: Tacrolimus ingestion immediately following consumption of meal
Department of lower gastroenterology, Hyogo College of MedicineOsaka Medical College Osaka City UniversityNot Recruiting16years-oldNot applicableMale and Female40Phase 4Japan
589NCT01164904July 201019 February 2015Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 181 in Healthy Subjects and Subjects With Mild to Moderate Ulcerative ColitisA Phase 1, Randomized, Double-blind, Placebo-controlled, Ascending Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 181 in Healthy Subjects and Subjects With Mild to Moderate Ulcerative ColitisUlcerative ColitisDrug: Amg 181AmgenNot recruiting18 Years55 YearsBoth72Phase 1United States;Australia;New Zealand
590NCT01216280July 201019 February 2015Efficacy and Tolerability Study of Natura-Alpha in the Treatment of Patients With Active Ulcerative ColitisEfficacy and Tolerability Study of Natura-Alpha in the Treatment of Patients With Active Ulcerative ColitisUlcerative ColitisDrug: placebo capsule;Drug: 10 mg Natura-alpha capsule and 10 mg placebo capsule;Drug: 2 x 10 mg Natura-alpha capsulesNatrogen Therapeutics International, IncNot recruiting18 Years70 YearsBoth75Phase 2United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
591EUCTR2009-017044-13-GB30/06/201016 October 2012A study to Evaluate the Ability to Maintain Clinical and Endoscopic Remission During a 12-Month period with 2.4g/day of drug given once a day in adults with ulcerative colitisA Phase 3b/4, Open-label, Multicenter, Prospective Study to Evaluate the Effect of Remission Status on the Ability to Maintain or Achieve Clinical and Endoscopic Remission During a 12-Month, Long-term Maintenance Phase With 2.4g/day MMX® Mesalamine/mesalazine Once Daily in Adult Subjects With Ulcerative Colitis - MOMENTUMUlcerative Colitis
MedDRA version: 14.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets
Product Name: Mezavant XL
Product Code: SPD476
Pharmaceutical Form: Gastro-resistant tablet
INN or Proposed INN: MESALAZINE
CAS Number: 89-57-6
Current Sponsor code: SPD476
Other descriptive name: MMX Mesalamine/Mesalazine
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 1.2-
Shire Development LLCAuthorisedFemale: yes
Male: yes
1000Phase 3b/4United States;Spain;Ireland;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Canada;Poland;South Africa;Germany
592NCT01149707June 1, 201011 June 2018Safety, Tolerability, Efficacy Study of PUR 0110 Rectal Enema in Mild-to-Moderate Distal Ulcerative ColitisA 2-Week Exploratory Randomized, Double-Blind, Parallel-Group, Dose-Ranging, Placebo-Controlled Safety, Tolerability, Biomarker and Efficacy Clinical Study of PUR 0110 Rectal Enema in Mild-to-Moderate Distal Ulcerative ColitisLeft-Sided Ulcerative Colitis;ProctosigmoiditisDrug: PUR 0110 Rectal Enema 250 mg;Drug: PUR 0110 Rectal Enema 500 mg;Drug: PUR 0110 Rectal Enema 1000 mg;Drug: Placebo EnemaPurGenesis Technologies Inc.Not recruiting18 Years75 YearsAll34Phase 2Germany
593EUCTR2009-013890-16-PT28/05/201019 August 2013Herica - Histological and Endoscopic evaluation of Remission induced by Infliximab in moderately to severely active ulcerative Colitis Patients - HericaHerica - Histological and Endoscopic evaluation of Remission induced by Infliximab in moderately to severely active ulcerative Colitis Patients - HericaThis national, multi-centre, open-label pilot study will assess the histologic remission in patients with moderate to severe active ulcerative colitis under infliximab treatment who have had an inadequate response to conventional therapy. Biopsies will be analyzed throughout the study in order to assess histological disease modifying effects in those patients.
MedDRA version: 16.0 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856
Trade Name: Remicade
Product Name: Remicade
Pharmaceutical Form: Powder for concentrate for solution for infusion
GEDII - Grupo de Estudo da Doença inflamatória IntestinalNot RecruitingFemale: yes
Male: yes
20Portugal
594EUCTR2009-017839-18-DE14/05/20103 April 2012A 2-WEEK EXPLORATORY RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP, DOSE-RANGING, PLACEBO-CONTROLLED SAFETY, TOLERABILITY, BIOMARKER AND EFFICACY CLINICAL STUDY OF PUR 0110 RECTAL ENEMA IN MILD-TO-MODERATE DISTAL ULCERATIVE COLITISA 2-WEEK EXPLORATORY RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP, DOSE-RANGING, PLACEBO-CONTROLLED SAFETY, TOLERABILITY, BIOMARKER AND EFFICACY CLINICAL STUDY OF PUR 0110 RECTAL ENEMA IN MILD-TO-MODERATE DISTAL ULCERATIVE COLITISActive mild-to-moderate distal ulcerative colitis
MedDRA version: 13.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders
Product Name: PUR 0110
Product Code: PUR 0110
Pharmaceutical Form: Powder for rectal suspension
Current Sponsor code: PUR 0110
Other descriptive name: PCT (PureCell Technologies Complex)
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 250-
Pharmaceutical form of the placebo: Rectal suspension
Route of administration of the placebo: Rectal use
Product Name: PUR 0110
Product Code: PUR 0110
Pharmaceutical Form: Powder for rectal suspension
Current Sponsor code: PUR 0110
Other descriptive name: PCT (PureCell Technologies Complex)
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Pharmaceutical form of the placebo: Rectal suspension
Route of administration of the placebo: Rectal use
Product Name: PUR 0110
Product Code: PUR 0110
Pharmaceutical Form: Powder for rectal suspension
Current Sponsor code: PUR 0110
Other descriptive name: PCT (PureCell Technologies Complex)
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1000-
Pharmaceutical form of the placebo: Rectal suspension
Route of administration of the placebo: Rectal use
PurGenesis Techonologies Inc.Not RecruitingFemale: yes
Male: yes
56Germany
595NCT01033305March 201019 February 2015Oral Ciclosporin for Colonic Release in Ulcerative Colitis (CyCol™)A Phase II, Randomized, Double-blind, Placebo-controlled Study of a Controlled Release Minicapsule Formulation of Ciclosporin (CyCol™) in the Treatment of Mild to Moderate Ulcerative ColitisMild to Moderate Ulcerative ColitisDrug: CyCol™;Drug: PlaceboSigmoid PharmaNot recruiting18 YearsN/ABoth118Phase 2Ireland;United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
596NCT01100112February 201019 October 2017(CB-01-02/06) Oral Budesonide-Multi-Matrix System (MMX) 9mg Extended Release TabletsMulticenter, Open-Label Efficacy and Safety Study of Oral Budesonide-MMX 9mg Extended Release Tablets in Patients With Mild to Moderate, Active Ulcerative ColitisColitis, UlcerativeDrug: BudesonideValeant Pharmaceuticals International, Inc.Cosmo Technologies LtdNot recruiting18 Years75 YearsAll61Phase 3India
597NCT01037322January 201019 February 2015Cannabidiol for Inflammatory Bowel DiseaseUse of Cannabidiol for the Treatment of Inflammatory Bowel DiseaseCrohn's Disease;Ulcerative ColitisDrug: cannabidiol;Drug: placebo in dropsMeir Medical CenterNot recruiting20 Years80 YearsBoth20Phase 1/Phase 2Israel
598NCT01040910January 201019 February 2015Cannabis for Inflammatory Bowel DiseaseA Double Blind Placebo Controlled Study of Cannabis Smoking in Inflammatory Bowel DiseaseCrohn's Disease;Ulcerative ColitisDrug: smoking of cannabis;Drug: smoking cigarettes with placeboMeir Medical CenterRecruiting20 Years70 YearsBoth20Phase 1/Phase 2Israel
599NCT01065571January 201019 February 2015Effects of Carrageenan-Elimination Diet on Ulcerative Colitis Disease ActivityEffects of Carrageenan-Elimination Diet on Ulcerative Colitis Disease ActivityUlcerative ColitisDietary Supplement: carrageenan;Other: dietary intervention with no-carrageenan dietUniversity of Illinois at ChicagoThe Broad Foundation;University of ChicagoRecruiting18 YearsN/ABoth40N/AUnited States
600EUCTR2008-005237-30-NL01/12/20097 December 2015A Multicenter, Prospective, Long-term Registry of children with Crohn's Disease or Ulcerative ColitisA Multicenter, Prospective, Long-term Registry of Pediatric Patients with Crohn's Disease or Ulcerative Colitis - DEVELOPPediatric patients with a confirmed diagnosis of CD or UC .
MedDRA version: 18.1 Level: LLT Classification code 10013099 Term: Disease Crohns System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Remicade
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3
Other descriptive name: Remsima and Inflectra
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Janssen Biologics B.V.AuthorisedFemale: yes
Male: yes
6000United States;Canada;Netherlands;Sweden
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
601NCT01039597December 200919 February 2015Safety and Activity of ORE1001 in Subjects With Ulcerative ColitisA Randomized, Double-Blind, Placebo-Controlled Pilot Study of the Safety and Therapeutic Activity of ORE1001 in Subjects With Ulcerative ColitisMild to Moderate Ulcerative ColitisDrug: ORE1001;Drug: PlaceboOre Pharmaceuticals, Inc.Recruiting18 Years70 YearsBoth50Phase 1/Phase 2Canada;India
602EUCTR2009-015077-12-GB23/11/20099 October 2012The use of corticosteroids (Budenofalk) as a chemopreventative agent in ulcerative colitis associated neoplasiaThe use of corticosteroids (Budenofalk) as a chemopreventative agent in ulcerative colitis associated neoplasia -chronic ulcerative colitis
;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Budenofalk 2mg rectal foam
Product Name: Budenofalk rectal foam
Pharmaceutical Form: Rectal foam
University Hospital Birmingham NHS Foundation TrustAuthorisedFemale: yes
Male: yes
50United Kingdom
603EUCTR2009-015136-14-BE20/11/200919 March 2012Modified release metronidazole for the treatment of pouchitis after colectomy with ileo-anal pouch anastomosis for ulcerative colitis: a pharmacokinetic studyModified release metronidazole for the treatment of pouchitis after colectomy with ileo-anal pouch anastomosis for ulcerative colitis: a pharmacokinetic studyPouchitis
MedDRA version: 12.0 Level: LLT Classification code 10036463 Term: Pouchitis
Product Name: Metronidazole capsule 50 mg
Product Code: FP-110
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Metronidazole
CAS Number: 44-348-1
Current Sponsor code: Fp-110
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Trade Name: Flagyl
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Metronidazole
CAS Number: 443-38-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
FORMAC Pharmaceuticals NVNot RecruitingFemale: yes
Male: yes
Belgium
604EUCTR2008-007952-90-DE17/11/200919 March 2012A randomized, multi-center, doubleblind, parallel group, placebocontrolled, phase IIb, dose ranging study to investigate the efficacy and safety of LT-02 in patients with mesalazine-refractory ulcerative colitis. - Amendment No. 3 (Version 1.0), 16-JUL-2010A randomized, multi-center, doubleblind, parallel group, placebocontrolled, phase IIb, dose ranging study to investigate the efficacy and safety of LT-02 in patients with mesalazine-refractory ulcerative colitis. - Amendment No. 3 (Version 1.0), 16-JUL-2010Patients with ulcerative colitis (UC) according to European Crohn's and Colitis Organisation (ECCO) consensus; Simple Clinical Colitis Activity Index (SCCAI) =5 and SCCAI subscore for “blood in stool” =2 at Baseline Visit.
MedDRA version: 12.0 Level: LLT Classification code 10045365 Term: Ulcerative colitis
Product Name: LT-02 (modified-release PC pellets)
Product Code: LT-02
Pharmaceutical Form: Granules for oral suspension
INN or Proposed INN: Modified-release phosphatidylcholine
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 0.2-
Pharmaceutical form of the placebo: Granules for oral suspension
Route of administration of the placebo: Oral use
Product Name: LT-02 (modified-release PC pellets)
Product Code: LT-02
Pharmaceutical Form: Granules for oral suspension
INN or Proposed INN: Modified-release phosphatidylcholine
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 0.4-
Pharmaceutical form of the placebo: Granules for oral suspension
Route of administration of the placebo: Oral use
Product Name: LT-02 (modified-release PC pellets)
Product Code: LT-02
Pharmaceutical Form: Granules for oral suspension
INN or Proposed INN: Modified-release phosphatidylcholine
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 0.8-
Pharmaceutical form of the placebo: Granules for oral suspension
Route of administration of the placebo: Oral use
Lipid Therapeutics GmbHNot RecruitingFemale: yes
Male: yes
240Phase 2bGermany;Lithuania
605EUCTR2008-003169-19-IE09/11/200911 September 2012A Randomized, Double-blind, Placebo-controlled Study of a Controlled Release Minicapusle Formulation of Ciclosporin (CyCol™) in the Treatment of Ulcerative ColitisA Randomized, Double-blind, Placebo-controlled Study of a Controlled Release Minicapusle Formulation of Ciclosporin (CyCol™) in the Treatment of Ulcerative ColitisUlcerative colitis
MedDRA version: 9.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis ;Ulcerative colitis
MedDRA version: 9.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis
Product Name: CyCol
Pharmaceutical Form: Modified-release capsule, hard
INN or Proposed INN: ciclosporin
CAS Number: 59865-13-3
Current Sponsor code: ciclosporin
Other descriptive name: cyclosporine (USAN)
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Pharmaceutical Form: Modified-release capsule, hard
INN or Proposed INN: ciclosporin
CAS Number: 59865-13-3
Current Sponsor code: ciclosporin
Other descriptive name: cyclosporine (USAN)
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Sigmoid Pharma LtdNot RecruitingFemale: yes
Male: yes
0United Kingdom;Ireland
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
606NCT01020708November 200919 February 2015Study of the Safety and Tolerability of ALTH12 Versus Mesalamine Enema in Subjects With Left-Sided Ulcerative ColitisA Phase I Double-blind, Randomized, Comparator-controlled Study of the Safety and Tolerability of N-acetylcysteine Plus Mesalamine Enema in Subjects With Left-sided Ulcerative ColitisUlcerative ColitisDrug: mesalamine;Drug: ALTH12-1:4;Drug: ALTH12-2:4Altheus Therapeutics, Inc.Not recruiting18 Years64 YearsBoth9Phase 1United States
607NCT01059344November 200916 December 2017Efficacy and Safety of Asacol™ 4.8 g/Day (800 mg Tablets) for the Treatment of Active Ulcerative ColitisA Randomized Placebo-Controlled Double-Blind Study to Evaluate the Efficacy and Safety of Asacol™ 4.8 g/Day (800 mg Tablets) for the Treatment of Active Ulcerative ColitisUlcerative ColitisDrug: MesalaminTillotts Pharma AGNot recruiting18 YearsN/AAll281Phase 3Belarus;India;Turkey;Ukraine
608EUCTR2009-015649-21-NO21/10/200919 March 2012Immunmodulating and clinical effect of vitamin D onthe induction of remission in the patients with moderate to severe ulcerative colitis under the treatment with Infliximab.Immunmodulating and clinical effect of vitamin D onthe induction of remission in the patients with moderate to severe ulcerative colitis under the treatment with Infliximab.Ulcerative colitisTrade Name: Dekristol
Product Name: cholecalciferol
Product Code: na
Pharmaceutical Form: Capsule, soft
Pharmaceutical form of the placebo: Capsule, soft
Route of administration of the placebo: Oral use
Medical clinic, University Hospital of North NorwayAuthorisedFemale: yes
Male: yes
200Norway
609NCT03747068October 9, 20093 December 2018The Influence of Biologcal Treatment on the Short-Term Complications of Surgery in Patients With Inflematory Bowel Disease.Preoperative Use of ANTI-Tumor Necrosis Factor Therapy in Ulcerative Colitis Patients Who Underwent Ileal Pouch-Anal Anastomosis (IPAA) is Not Associated With Histological FibrosisUlcerative Colitis;Anti TNF Therapy;Ileal Pouch Anal Anastomosis (IPAA)Drug: Anti-TNF DrugHaEmek Medical Center, IsraelMount Sinai Hospital, Canada;University of TorontoNot recruitingN/AN/AAll130N/A
610NCT01004185October 200919 October 2017Assessing the Safety/Efficacy of Asacol® Given Every 12 Hours to Children and Adolescents for the Maintenance of Remission of Ulcerative ColitisA Randomized, Double-blind, Parallel-group Study to Assess the Safety and Efficacy of Asacol® (1.2 to 4.8g/Day) 400 mg Delayed-release Tablets Given Twice Daily for 26 Weeks to Children and Adolescents for the Maintenance of Remission of Ulcerative ColitisUlcerative ColitisDrug: Asacol 400 mgWarner ChilcottNot recruiting5 Years17 YearsAll39Phase 3United States;Canada;Croatia;Poland;Romania;Russian Federation
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
611EUCTR2009-010921-38-NL08/09/200919 March 2012Chemopreventive effects of 5-ASA and UDCA in Ulcerative Colitis: A Double-blind, Randomized Placebo-controlled Pilot Study - CRC chemoprevention in UCChemopreventive effects of 5-ASA and UDCA in Ulcerative Colitis: A Double-blind, Randomized Placebo-controlled Pilot Study - CRC chemoprevention in UCUlcerative Colitis and the risk of developing colorectal cancer.
MedDRA version: 13.1 Level: PT Classification code 10021972 Term: Inflammatory bowel disease System Organ Class: 10017947 - Gastrointestinal disorders
Trade Name: Salofalk
Pharmaceutical Form: Granules
INN or Proposed INN: mesalazine
CAS Number: 89-57-6
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: range
Concentration number: 20-25
Pharmaceutical form of the placebo: Granules
Route of administration of the placebo: Oral use
Trade Name: Ursofalk
Pharmaceutical Form: Coated tablet
INN or Proposed INN: ursodeoxycholic acid
CAS Number: 128-13-2
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 4-
Pharmaceutical form of the placebo: Coated tablet
Route of administration of the placebo: Oral use
UMC UtrechtAuthorisedFemale: yes
Male: yes
Netherlands
612NCT01036022September 1, 200916 December 2017Effect of GSK1399686 in Patients With Mild to Moderately Active Ulcerative ColitisA Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-Inflammatory Effects of GSK1399686 in Patients With Mild to Moderately Active Ulcerative ColitisColitis, UlcerativeDrug: GSK1399686GlaxoSmithKlineNot recruiting18 Years65 YearsAll120Phase 2Belgium;Canada;Germany;Norway;Sweden
613NCT02322008September 200919 February 2015Anti-TNF Therapy in Danish Patients With Inflammatory Bowel Diseases in Clinical PracticeAnti-TNF Therapy in Danish Patients With Inflammatory Bowel Diseases in Clinical PracticeCrohn's Disease;Ulcerative Colitis;Inflammatory Bowel DiseaseBiological: infliximab and adalimumabRegionshospitalet Viborg, SkiveNot recruiting18 YearsN/ABoth1035N/A
614EUCTR2009-010065-23-DE17/08/20091 May 2012Conventional Step-Up versus Infliximab Monotherapy in Patients with Active Moderate to Severe Ulcerative Colitis. A Randomized, Open Label, Prospective, Multicenter Study (Phase 3, Protocol No. P05553) - MUNIXConventional Step-Up versus Infliximab Monotherapy in Patients with Active Moderate to Severe Ulcerative Colitis. A Randomized, Open Label, Prospective, Multicenter Study (Phase 3, Protocol No. P05553) - MUNIXActive Moderate to Severe Ulcerative Colitis
MedDRA version: 14.1 Level: LLT Classification code 10066678 Term: Acute ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1 Level: LLT Classification code 10033007 Term: Other ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1 Level: LLT Classification code 10045366 Term: Ulcerative colitis, unspecified System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders
Trade Name: Remicade
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: infliximab
Other descriptive name: 100
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Trade Name: Pentasa 500 mg Retardtabletten
Product Name: 5-Aminosalicylic acid (5-ASA)
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: 5-Aminosalicylic acid
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Trade Name: Imurek 25mg Filmtabletten
Pharmaceutical Form: Coated tablet
INN or Proposed INN: azathioprine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Trade Name: Imurek 50mg Filmtabletten
Pharmaceutical Form: Coated tablet
INN or Proposed INN: azathioprine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Trade Name: Decortin H 1 mg
Pharmaceutical Form: Tablet
INN or Proposed INN: prednisolone
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Trade Name: Decortin H 5mg
Pharmaceutical Form: Tablet
INN or Proposed INN: prednisolone
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Trade Name: Decortin H 10mg
Pharmaceutical Form: Tablet
INN or Proposed INN: prednisolone
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Trade Name: Decortin H 20mg
Pharmaceutical Form: Tablet
INN or Proposed INN: prednisolone
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Trade Name: Decortin H 50 mg
Pharmaceutical Form: Tablet
INN or Proposed INN: prednisolone
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Essex Pharma GmbHNot RecruitingFemale: yes
Male: yes
Phase 3Germany
615EUCTR2009-011608-51-SE17/08/200929 April 2013A Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-Inflammatory Effects of GSK1399686 in Patients with Mild to Moderately Active Ulcerative ColitisA Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-Inflammatory Effects of GSK1399686 in Patients with Mild to Moderately Active Ulcerative ColitisUlcerative colitis
MedDRA version: 9.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis
Product Name: GSK1399686
Product Code: GSK1399686
Pharmaceutical Form: Capsule, hard
Current Sponsor code: GSK1399686
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Trade Name: ASACOL
Product Name: ASACOL
Product Code: ASACOL
Pharmaceutical Form: Over encapsulated tablet
INN or Proposed INN: mesalazine
Current Sponsor code: Asacol
Other descriptive name: Overencapsulated mesalazine tablets
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 400-
Pharmaceutical form of the placebo: Over encapsulated tablet
Route of administration of the placebo: Oral use
Product Name: GSK1399686
Product Code: GSK1399686
Pharmaceutical Form: Capsule, hard
Current Sponsor code: GSK1399686
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Product Name: GSK1399686
Product Code: GSK1399686
Pharmaceutical Form: Capsule, hard
Current Sponsor code: GSK1399686
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Product Name: GSK1399686
Product Code: GSK1399686
Pharmaceutical Form: Capsule, hard
Current Sponsor code: GSK1399686
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
GlaxoSmithKline Research and Development LtdNot RecruitingFemale: yes
Male: yes
60Germany;Sweden
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
616NCT00963287August 20092 May 2016Trial of Chinese Prescription on Ulcerative ColitisUlcerative ColitisDrug: bascial prescription plus or minus herbs depend on symptomsShanghai University of Traditional Chinese MedicineNot recruiting18 Years65 YearsBoth200N/AChina
617NCT01149694June 200919 February 2015A Study to Assess the Safety and Tolerability of PUR 0110 Rectal Enema in Normal Healthy VolunteersA Randomized, Double-Blind, Parallel-Group, Single-Ascending Dose, Placebo-Controlled Safety and Tolerability Study of PUR 0110 Rectal Enema in Normal Healthy VolunteersUlcerative ColitisDrug: PUR 0110 Rectal Enema or Placebo EnemaPurGenesis Technologies Inc.Not recruiting18 Years55 YearsMale24Phase 1Germany
618EUCTR2008-003913-28-IT25/05/200919 March 2012Randomised, double-blind,multicentre,12 months extension study to evaluate the safety and the efficacy of daily Budesonide MMX 6mg vs placebo in the maintenance of remission in subjects with ulcerative colitis. - NDRandomised, double-blind,multicentre,12 months extension study to evaluate the safety and the efficacy of daily Budesonide MMX 6mg vs placebo in the maintenance of remission in subjects with ulcerative colitis. - NDMild to moderate ulcerative colitis.
MedDRA version: 9.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis
Product Name: Budesonide-MMX
Product Code: CB-01-02
Pharmaceutical Form: Tablet
INN or Proposed INN: Budesonide
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 6-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
COSMO TECHNOLOGIES LTDNot RecruitingFemale: yes
Male: yes
150Italy
619NCT00790933May 22, 200926 February 2018An Open-label Study of Vedolizumab (MLN0002) in Participants With Ulcerative Colitis and Crohn's DiseaseA Phase 3, Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab (MLN0002) in Subjects With Ulcerative Colitis and Crohn's DiseaseUlcerative Colitis;Crohn's DiseaseDrug: VedolizumabTakedaNot recruiting18 YearsN/AAll2243Phase 3United States;Australia;Belgium;Canada;Czechia;Germany;Hungary;Israel;Korea, Republic of;Malaysia;Czech Republic
620NCT00889161May 200919 February 2015Curcumin in Pediatric Inflammatory Bowel DiseaseCurcumin in Pediatric Inflammatory Bowel Disease: A Forced Dose Titration StudyInflammatory Bowel Disease;Ulcerative Colitis;Crohn's DiseaseDrug: CurcuminSeattle Children's HospitalNot recruiting8 Years18 YearsBoth11Phase 1United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
621EUCTR2008-002784-14-EE28/04/20095 February 2018An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's DiseaseA Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s DiseaseUlcerative Colitis and Crohn’s Disease
MedDRA version: 14.1 Level: LLT Classification code 10013099 Term: Disease Crohns System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: VEDOLIZUMAB
Product Code: MLN0002
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: VEDOLIZUMAB
CAS Number: 943609-66-3
Current Sponsor code: MLN0002
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
Millennium Pharmaceuticals, Inc.Not RecruitingFemale: yes
Male: yes
2200Phase 3Portugal;Serbia;United States;Hong Kong;Estonia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Austria;Malta;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Iceland;Germany;Norway;New Zealand;Sweden;Israel;Russian Federation;Italy;Switzerland;India;France;Malaysia;Australia
622EUCTR2008-007519-34-SE17/04/200919 March 2012Feasibility of Accelerated infliximab infusions - Safety and Tolerability in patients wit IBD. FAST - FAST VERSIONFeasibility of Accelerated infliximab infusions - Safety and Tolerability in patients wit IBD. FAST - FAST VERSIONThis is a open label, prospective, multicenter trial in patients recieving one hour infusions of infliximab (i.e. Remicade)as part of their daily practice. Main objective: Is to assess the tolerability of Remicade with an infusionsrate of 30 minutes. Patients: eligible patients are those with intestinal fistulas Mb Crohn disease or Ulcerative colitis/IBD. or patietns withTrade Name: Remicade
Pharmaceutical Form: Powder and solvent for solution for infusion
University of Leuven Hospitals, Division of GastroenterologyAuthorisedFemale: yes
Male: yes
200Sweden
623NCT01287195April 7, 200916 December 2017Oral OKT3 for the Treatment of Active Ulcerative ColitisOral Anti-CD3 for the Treatment of Active Ulcerative ColitisUlcerative ColitisDrug: Oral OKT3;Drug: OmeprazoleBrigham and Women's HospitalNot recruiting18 Years65 YearsAll6Phase 1/Phase 2United States
624EUCTR2008-007292-25-IT24/03/200919 March 2012AN OPEN, PILOT PHASE III, RANDOMIZED CLINICAL TRIAL TO ASSESS THE TISSUTAL PHARMAKINETICS OF MESALAZINE TABLETS IN PATIENTS WITH MILD TO MODERATE LEFT-SIDED ULCERATIVE COLITIS IN ACTIVE PHASE - GIU-5-ASA1.2 MMx-02-08AN OPEN, PILOT PHASE III, RANDOMIZED CLINICAL TRIAL TO ASSESS THE TISSUTAL PHARMAKINETICS OF MESALAZINE TABLETS IN PATIENTS WITH MILD TO MODERATE LEFT-SIDED ULCERATIVE COLITIS IN ACTIVE PHASE - GIU-5-ASA1.2 MMx-02-08Patients with established diagnosis of left-sided UC (rectum-sigmoid colon or colon up to the splenic flexure)
MedDRA version: 9.1 Level: LLT Classification code 10024123 Term: Left-sided ulcerative (chronic) colitis
Trade Name: MEZAVANT
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Mesalazine
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 1.2-
Trade Name: ASACOL
Pharmaceutical Form: Gastro-resistant tablet
INN or Proposed INN: Mesalazine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 800-
GIULIANINot RecruitingFemale: yes
Male: yes
Phase 3Italy
625EUCTR2008-002782-32-ES02/03/200928 August 2014A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Ulcerative Colitis Estudio multicéntrico, ciego, controlado con placebo, aleatorizado, de fase 3, sobre la inducción y el mantenimiento de la respuesta clínica y la remisión con MLN0002, en pacientes con colitis ulcerosa moderada o graveA Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Ulcerative Colitis Estudio multicéntrico, ciego, controlado con placebo, aleatorizado, de fase 3, sobre la inducción y el mantenimiento de la respuesta clínica y la remisión con MLN0002, en pacientes con colitis ulcerosa moderada o graveModerate to Severe Ulcerative Colitis Colitis ulcerosa moderada o grave
MedDRA version: 9.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis
Product Name: VEDOLIZUMAB
Product Code: MLN0002
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: VEDOLIZUMAB
CAS Number: 943609-66-3
Current Sponsor code: MLN0002
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
Millennium Pharmaceuticals, Inc.Not RecruitingFemale: yes
Male: yes
826Phase 3Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
626JPRN-JapicCTI-09071801/2/20092 April 2019A Study of Adalimumab in Japanese Subjects with Moderately to Severely Active Ulcerative Colitis.A Multi-Center, Randomized, Double-Blind, Placebo-controlled Study of Adalimumab in Japanese Subjects with Moderately to Severely Active Ulcerative Colitis.Ulcerative colitisIntervention name : adalimumab
INN of the intervention : adalimumab
Dosage And administration of the intervention : 160/80 mg at Week 0/2 and 40 mg eow starting at Week 4 to Week 50, or 80/40 mg at Week 0/2 and 40 mg eow starting at Week 4 to Week 50
Control intervention name : Placebo
Dosage And administration of the control intervention : Placebo eow starting at Week 0 to Week 50
AbbVie GKEisai Co., Ltd.15BOTH255Phase 2-3
627NCT00853099February 200919 October 2017A Study of Adalimumab in Japanese Subjects With Moderately to Severely Active Ulcerative ColitisA Multi-Center, Randomized, Double-Blind, Placebo-controlled Study of Adalimumab in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis.Ulcerative ColitisBiological: adalimumab;Drug: placeboAbbVie (prior sponsor, Abbott)Eisai Co., Ltd.Not recruiting15 YearsN/AAll274Phase 3Japan
628EUCTR2008-004564-40-IT23/01/200928 August 2012A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS - NDA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS - NDCP-690,550 is being developed for the treatment of patients with moderate-to-severe ulcerative colitis.
MedDRA version: 9.1 Level: LLT Classification code 10045282 Term: UC
Product Name: CP-690,550
Pharmaceutical Form: Tablet
CAS Number: 540737-29-9
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: .5-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: CP-690,550
Pharmaceutical Form: Tablet
CAS Number: 540737-29-9
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: CP-690,550
Pharmaceutical Form: Tablet
CAS Number: 540737-29-9
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
PFIZERNot RecruitingFemale: yes
Male: yes
200Hungary;Czech Republic;Slovakia;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Sweden
629EUCTR2008-005903-25-DE08/01/20094 March 2013Exploratory, open-label study to demonstrate efficacy, safety and tolerability of SC12267 (35 mg) in patients with inflammatory bowel disease (Crohn’s disease and ulcerative colitis)Exploratory, open-label study to demonstrate efficacy, safety and tolerability of SC12267 (35 mg) in patients with inflammatory bowel disease (Crohn’s disease and ulcerative colitis)inflammatory bowel disease (Crohn’s disease and ulcerative colitis)
MedDRA version: 12.0 Level: LLT Classification code 10021973 Term: Inflammatory bowel disease NOS
Product Name: SC12267
Product Code: SC12267
Pharmaceutical Form: Film-coated tablet
Current Sponsor code: SC12267
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 35-
Trade Name: Prednisolon Jenapharm
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Prednisolon
CAS Number: 50-24-8
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Trade Name: Prednisolon Jenapharm
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Prednisolon
CAS Number: 50-24-8
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Trade Name: Prednisolon Jenapharm
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Prednisolon
CAS Number: 50-24-8
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
4SC AGNot RecruitingFemale: yes
Male: yes
35Bulgaria;Germany
630JPRN-UMIN0000089672009/01/012 April 2019Efficacy of zinc-carnosine chelate compound, Polaprezinc, enemas in patients with ulcerative colitisUlcerative ColitisPolaprezinc group: Polaprezinc enema contained 150 mg of Polaprezinc suspension in tap water (total volume 100 mL) daily for one week

Placebo group: 100 mL tap water enema daily for one week
The Jikei University School of Medicine Division of Gastroenterology and HepatologyNot Recruiting18years-oldNot applicableMale and Female30Not applicableJapan
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
631NCT00748410January 200916 December 2017Study to Evaluate the Pharmacodynamics of SB-656933 in Patients With Ulcerative ColitisAn Open Label, 7-day Repeat Dose Study to Evaluate the Pharmacodynamics of SB-656933-AAA in Patients With Ulcerative Colitis.Colitis, UlcerativeDrug: SB-656933GlaxoSmithKlineNot recruitingN/AN/AAll3Phase 2Netherlands
632NCT00783718January 200919 October 2017Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Ulcerative ColitisA Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients With Moderate to Severe Ulcerative ColitisUlcerative ColitisDrug: vedolizumab;Other: PlaceboMillennium Pharmaceuticals, Inc.Not recruiting18 Years80 YearsAll895Phase 3United States;Canada;Puerto Rico
633NCT00790478January 200919 February 2015Melatonin & Ulcerative ColitisMelatonin and Ulcerative Colitis: A Pilot Clinical TrialUlcerative ColitisDietary Supplement: Melatonin;Other: PlaceboEmory UniversityRecruiting18 Years69 YearsBoth60Phase 2United States
634JPRN-JapicCTI-09073908/12/200823 April 2019A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative ColitisA Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative ColitisUlcerative ColitisIntervention name : golimumab
Dosage And administration of the intervention : SC
JANSSEN PHARMACEUTICAL K.K18BOTHPhase 2-3
635JPRN-JapicCTI-09074008/12/200823 April 2019A Phase 3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative ColitisA Phase 3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative ColitisUlcerative ColitisIntervention name : golimumab
Dosage And administration of the intervention : SC
JANSSEN PHARMACEUTICAL K.K18BOTHPhase 3
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
636EUCTR2008-004610-27-BE02/12/200819 March 2012A double-blind, randomised, placebo and mesalazine controlled phase II study to explore the safety and activity of dersalazine in patients with mild to moderate active colitisA double-blind, randomised, placebo and mesalazine controlled phase II study to explore the safety and activity of dersalazine in patients with mild to moderate active colitisMild to moderate active ulcerative colitis
MedDRA version: 9.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis
Product Name: Dersalazine sodium
Product Code: UR-12746-S
Pharmaceutical Form: Capsule*
INN or Proposed INN: dersalazine sodium
CAS Number: 367249-56-7
Current Sponsor code: UR-12746-S
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 400-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
Trade Name: Lixacol
Product Name: Lixacol
Pharmaceutical Form: Over encapsulated tablet
INN or Proposed INN: Mesalazine
CAS Number: 89576
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 400-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
Trade Name: Lixacol
Product Name: Lixacol
Pharmaceutical Form: Coated tablet
INN or Proposed INN: mesalazine
CAS Number: 89576
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 400-
Palau Pharma S.A.Not RecruitingFemale: yes
Male: yes
90Phase 2Hungary;Belgium;Spain
637NCT00713310December 200819 October 2017Assessing the Safety/Efficacy of Asacol® Given Every 12 Hours to Children and Adolescents With Active Ulcerative ColitisStudy to Assess the Safety and Efficacy of Asacol® (1.2 to 4.8 g/Day) Administered as 400 mg Delayed-release Tablets Given Every 12 Hours for 6 Weeks to Children and Adolescents With Mildly-to-Moderately Active Ulcerative ColitisUlcerative ColitisDrug: Asacol 400 mgWarner ChilcottNot recruiting5 Years17 YearsAll83Phase 3United States;Canada;Croatia;Poland;Romania
638NCT00787202December 200819 October 2017A Study To Investigate The Safety And Efficacy Of CP- 690,550 In Patients With Moderate And Severe Ulcerative Colitis.A Randomized, Placebo Controlled, Double Blind, Parallel Group Multi-Center Study In Order To Investigate Safety And Efficacy Of CP- 690 550 In Subjects With Moderate To Severe Ulcerative Colitis.Ulcerative ColitisDrug: CP- 690 550;Other: placeboPfizerNot recruiting18 YearsN/AAll195Phase 2Belgium;Brazil;Chile;Czech Republic;Denmark;France;Hungary;Israel;Italy;Mexico;Netherlands;Poland;Slovakia;South Africa;Spain;Sweden;United Kingdom;Turkey
639NCT00801723December 200819 February 2015(CB-01-02/04) Extension Study of Budesonide Multi-Matrix System (MMX) 6 mg in Maintenance Of Remission In Patients With Ulcerative Colitis.Randomised, Double-Blind, Multi-Centre, 12 Month Extension Study to Evaluate the Safety And Efficacy of Daily Budesonide MMX 6 mg Versus Placebo in the Maintenance of Remission in Subjects With Ulcerative Colitis.Ulcerative ColitisDrug: Budesonide MMX 6 mg Tablet;Drug: Placebo TabletSalix PharmaceuticalsNot recruiting18 Years75 YearsBoth123Phase 3United States;Canada
640EUCTR2006-003607-40-NL13/11/200819 March 2012A CONTROLLED, RANDOMISED, DOUBLE-BLIND, MULTICENTER STUDY, COMPARING METHOTREXATE VS PLACEBO IN STEROID-REFRACTORY ULCERATIVE COLITIS - METEORA CONTROLLED, RANDOMISED, DOUBLE-BLIND, MULTICENTER STUDY, COMPARING METHOTREXATE VS PLACEBO IN STEROID-REFRACTORY ULCERATIVE COLITIS - METEORSteroid-dependent ulcerative colitisTrade Name: methotrexate bellon
Product Name: methotrexate bellon 25mg/ml
Pharmaceutical Form: Solution for injection
INN or Proposed INN: methotrexate bellon 25mg/ml
CAS Number: 59 05 2
Current Sponsor code: Sonifi Aventis
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intramuscular use
Besancon University HospitalNot RecruitingFemale: yes
Male: yes
110Finland;Netherlands;Austria
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
641EUCTR2008-000967-40-NL03/11/200819 March 2012A Phase 2a Randomised, Placebo-Controlled, Double-Blind, Multi-Center Dose Escalation Study, to Evaluate the Safety, Tolerability, Pharmacodynamics and Efficacy of AG011, in Subjects with Moderatley Active Ulcerative ColitisA Phase 2a Randomised, Placebo-Controlled, Double-Blind, Multi-Center Dose Escalation Study, to Evaluate the Safety, Tolerability, Pharmacodynamics and Efficacy of AG011, in Subjects with Moderatley Active Ulcerative ColitisModerately Active Ulcerative Colitis
MedDRA version: 9.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis
Product Name: AG011 - Enema
Product Code: AG011
Pharmaceutical Form: Powder for rectal suspension
Current Sponsor code: AG011-DS-01
Concentration unit: CFU/g colony forming unit(s)/gram
Concentration type: range
Concentration number: 0.6 x 10e10-1.0 x 10e10
Pharmaceutical form of the placebo: Powder for rectal suspension
Route of administration of the placebo: Rectal use
Product Name: AG011 - Capsules
Product Code: AG011
Pharmaceutical Form: Gastro-resistant capsule, soft
Current Sponsor code: AG011-DS-01
Concentration unit: CFU/g colony forming unit(s)/gram
Concentration type: range
Concentration number: 1.94 x 10e10-3.2 x 10e10
Pharmaceutical form of the placebo: Gastro-resistant capsule, hard
Route of administration of the placebo: Oral use
Product Name: AG011 - Enema
Product Code: AG011
Pharmaceutical Form: Powder for rectal suspension
Current Sponsor code: AG011-DS-01
Concentration unit: CFU/g colony forming unit(s)/gram
Concentration type: range
Concentration number: 0.6 x 10e11-1.0 x 10e11
Pharmaceu