97. 潰瘍性大腸炎 Ulcerative colitis Clinical trials / Disease details
臨床試験数 : 2,630 / 薬物数 : 1,459 - (DrugBank : 265) / 標的遺伝子数 : 144 - 標的パスウェイ数 : 202
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05442567 (ClinicalTrials.gov) | May 2, 2023 | 30/6/2022 | A Study of Vedolizumab in Pediatric Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD) | A Phase 3b Extension Study to Evaluate the Long-term Safety of Vedolizumab Intravenous in Pediatric Patients With Ulcerative Colitis or Crohn's Disease | Ulcerative Colitis;Crohn's Disease | Drug: Vedolizumab IV;Other: No Intervention | Takeda | NULL | Not yet recruiting | 3 Years | 17 Years | All | 240 | Phase 3 | NULL |
| 2 | NCT05771155 (ClinicalTrials.gov) | May 2023 | 1/3/2023 | Efficacy, Safety and Immunogenicity of the Proposed Biosimilar Vedolizumab PB016 in Comparison With Entyvio® | A Randomized, Double-blind, Multicenter Phase 3 Study in Patients With Moderately to Severely Active Ulcerative Colitis (UC) to Compare the Efficacy, Safety and Immunogenicity of PB016 and Entyvio® for the Induction and Maintenance of Clinical Response and Remission | Ulcerative Colitis | Biological: Intravenous (IV) infusions | Polpharma Biologics S.A. | NULL | Not yet recruiting | 18 Years | 75 Years | All | 750 | Phase 3 | NULL |
| 3 | NCT05370885 (ClinicalTrials.gov) | May 2023 | 30/3/2022 | VE202 in Patients With Mild-to-Moderate Ulcerative Colitis | Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of VE202 in Patients With Mild-to-Moderate Ulcerative Colitis | Ulcerative Colitis;Colitis, Ulcerative | Biological: VE202;Drug: Vancomycin Oral Capsule;Other: VE202 Placebo;Other: Vancomycin Placebo | Vedanta Biosciences, Inc. | NULL | Not yet recruiting | 18 Years | 75 Years | All | 100 | Phase 2 | NULL |
| 4 | NCT05117749 (ClinicalTrials.gov) | May 2023 | 21/10/2021 | Saffron and Ulcerative Colitis | The Effect of Saffron in Patients With Ulcerative Colitis: A Randomized Double-blind Clinical Trial | Ulcerative Colitis | Drug: Saffron 100;Drug: Saffron 50;Drug: Placebo | Shiraz University of Medical Sciences | NULL | Not yet recruiting | 18 Years | 80 Years | All | 60 | Phase 2 | NULL |
| 5 | NCT05672199 (ClinicalTrials.gov) | April 26, 2023 | 3/1/2023 | Long-term Safety and Efficacy of Efavaleukin Alfa in Participants With Moderately to Severely Active Ulcerative Colitis | A Phase 2 Long-Term Extension (LTE) Study to Evaluate The Safety and Efficacy of Efavaleukin Alfa in Subjects With Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Drug: Efavaleukin alfa;Drug: Placebo | Amgen | NULL | Not yet recruiting | 18 Years | 80 Years | All | 200 | Phase 2 | NULL |
| 6 | NCT05767021 (ClinicalTrials.gov) | April 21, 2023 | 8/2/2023 | A Study of Mirikizumab (LY3074828) in Participants With Moderately to Severely Active Ulcerative Colitis | A Multicenter, Phase 3b, Open-Label, Single-Arm Study to Investigate Bowel Urgency and Its Relationship With Other Outcome Measures in Adults With Moderately to Severely Active Ulcerative Colitis Treated With Mirikizumab | Ulcerative Colitis Chronic;Ulcerative Colitis | Drug: Mirikizumab | Eli Lilly and Company | NULL | Not yet recruiting | 18 Years | N/A | All | 160 | Phase 3 | NULL |
| 7 | NCT05702879 (ClinicalTrials.gov) | April 1, 2023 | 18/1/2023 | Combined Microbiota and Metabolic Signature in Ulcerative Colitis Predicts Anti-Inflammatory Therapy Success | An Early Combined Microbiota and Metabolic Signature in Ulcerative Colitis Patients Predict the Clinical Success of Anti-inflammatory Therapy | Ulcerative Colitis | Drug: Ozanimod;Drug: TNF Inhibitor;Drug: Steroids;Drug: Vedolizumab;Drug: Ustekinumab | University Hospital Inselspital, Berne | Bristol-Myers Squibb | Not yet recruiting | 18 Years | 80 Years | All | 240 | NULL | |
| 8 | NCT05715099 (ClinicalTrials.gov) | March 30, 2023 | 19/1/2023 | Saffron as Anti Inflammatory In Patients With Inflammatory Bowel Disease | Efficacy of Nutritional Saffron Supplement as an Anti-inflammatory Agent in Egyptian Patients With Inflammatory Bowel Disease | Ulcerative Colitis | Drug: Saffron;Drug: Placebo | Minia University | NULL | Not yet recruiting | 18 Years | 60 Years | All | 90 | Phase 4 | Egypt |
| 9 | NCT05770609 (ClinicalTrials.gov) | March 15, 2023 | 5/3/2023 | A Study of SPH3127 in the Treatment of Mild to Moderate Ulcerative Colitis | A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel, Dose-finding Phase II Clinical Study to Evaluate the Efficacy and Safety of SPH3127 Tablets in the Treatment of Mild to Moderate Ulcerative Colitis | Mild to Moderate Ulcerative Colitis | Drug: SPH3127 Tablets with Dose A;Drug: SPH3127 Tablets with Dose B;Drug: SPH3127 Tablets placebo | Shanghai Pharmaceuticals Holding Co., Ltd | NULL | Not yet recruiting | 18 Years | 75 Years | All | 108 | Phase 2 | China |
| 10 | NCT04314375 (ClinicalTrials.gov) | March 2023 | 17/3/2020 | Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Extended-release Tablets in Pediatric Subjects Aged 5 to 17 Years With Active, Mild to Moderate Ulcerative Colitis | A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Extended-release Tablets n Pediatric Subjects Aged 5 to 17 Years With Active, Mild to Moderate Ulcerative Colitis | Ulcerative Colitis | Drug: Low Dose Budesonide;Drug: High Dose Budesonide;Drug: Placebo | Bausch Health Americas, Inc. | NULL | Not yet recruiting | 5 Years | 17 Years | All | 70 | Phase 4 | NULL |
| 11 | NCT05202990 (ClinicalTrials.gov) | March 2023 | 10/1/2022 | Oral Fecal Microbiota Transplantation in Pediatric Ulcerative Colitis | Pilot Study of a New Technique of Oral Fecal Transplantation Using Frozen Stool Capsules for the Maintenance Treatment of Pediatric Ulcerative Colitis. | Pediatric Ulcerative Colitis in Remission | Drug: Fecal Microbiota Transplantation by Stool capsules;Drug: Fecal Microbiota Transplantation by Intra-rectal enemas | Assistance Publique - Hôpitaux de Paris | MRSU 938 - Research Center of Saint Antoine | Not yet recruiting | 8 Years | 17 Years | All | 26 | Phase 2 | France |
| 12 | NCT05753267 (ClinicalTrials.gov) | February 28, 2023 | 22/2/2023 | Fenofibrate in Ulcerative Colitis | Clinical Study to Evaluate the Possible Efficacy of Fenofibrate in Patient With Ulcerative Colitis | Inflammatory Bowel Diseases | Drug: Mesalamine;Drug: Fenofibrate 160mg | Tanta University | Eman Ibrahim Elberri, Faculty of Pharmacy, Tanta University;Hend El-Said Abo Mansour, Faculty of Pharmacy, Menoufia University;Monir Hussein Bahgat, Faculty of Medicine, Mansura University;Eman Maamoun Ali El-Khateeb, Lecturer of Clinical Pharmacy, Faculty of Pharmacy, Tanta University | Recruiting | 18 Years | 75 Years | All | 60 | Phase 2/Phase 3 | Egypt |
| 13 | NCT05666960 (ClinicalTrials.gov) | February 27, 2023 | 1/12/2022 | R-3750 in Patients With Mild to Moderate Ulcerative Colitis | A Single and Repeat Dosing Study of the Safety, Drug Exposure, and Clinical Activity of R-3750 in Patients With Mild to Moderate Ulcerative Colitis | Ulcerative Colitis Chronic Mild;Ulcerative Colitis Chronic Moderate;Ulcerative Colitis Chronic;Ulcerative Colitis | Drug: R-3750 | Rise Therapeutics LLC | Mayo Clinic;University of Colorado, Denver | Recruiting | 18 Years | 65 Years | All | 36 | Phase 1 | United States |
| 14 | EUCTR2022-001686-12-BE (EUCTR) | 13/02/2023 | 05/12/2022 | Long-term Safety and Efficacy of Efavaleukin Alfa in Subjects With Moderately to Severely Active Ulcerative Colitis | A Phase 2 Long-Term Extension (LTE) Study to Evaluate The Safety and Efficacy of Efavaleukin Alfa in Subjects with Moderately to Severely Active Ulcerative Colitis | Moderate to Severe Active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Efavaleukin Alfa Product Code: AMG 592 INN or Proposed INN: Efavaleukin alfa | Amgen Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 2 | Russian Federation;United States;Czechia;Greece;Austria;Netherlands;Korea, Republic of;Poland;Bulgaria;Argentina;Romania;Hungary;Japan;Ukraine;Switzerland;Spain;Canada;Turkey;Belgium;Taiwan;Finland;Denmark;Mexico;Italy;Germany | ||
| 15 | NCT05739864 (ClinicalTrials.gov) | February 13, 2023 | 13/2/2023 | Superdonor FMT in Patients With Ulcerative Colitis | Evaluation of the Efficacy of Superdonor Fecal Microbiota Transplantation in Patients With Mild-to-moderate Ulcerative Colitis: a Double-blind Randomized Controlled Trial | Active Ulcerative Colitis | Biological: FMT;Other: Placebo FMT | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | NULL | Recruiting | 18 Years | 75 Years | All | 42 | Phase 1/Phase 2 | Italy |
| 16 | NCT05575505 (ClinicalTrials.gov) | February 2, 2023 | 8/10/2022 | Phosphodiesterase Inhibitors, Pentoxifylline, as Adjunctive Therapy in Patients With Ulcerative Colitis. | Phosphodiesterase Inhibitors, Pentoxifylline, as Adjunctive Therapy in Patients With Ulcerative Colitis. | Inflammatory Bowel Diseases | Drug: Pentoxifylline 400 MG | Tanta University | NULL | Recruiting | 18 Years | 75 Years | All | 44 | Phase 2 | Egypt |
| 17 | NCT05567068 (ClinicalTrials.gov) | February 1, 2023 | 1/10/2022 | Atorvastatin Efficacy and Safety in Patients With Ulcerative Colitis | Repurposing Atorvastatin in Patients With Ulcerative Colitis Treated With Mesalamine by Modulation of mTOR/NLRP3 Pathway. | Inflammatory Bowel Diseases | Drug: Atorvastatin 80mg;Drug: Mesalamine | Tanta University | NULL | Not yet recruiting | 18 Years | 75 Years | All | 44 | Phase 2 | NULL |
| 18 | NCT05684484 (ClinicalTrials.gov) | February 1, 2023 | 26/12/2022 | Role of Roflumilast in Ulcerative Colitis | Clinical Study to Evaluate the Possible Efficacy and Safety of Roflumilast in Patients With Ulcerative Colitis. | Ulcerative Colitis | Drug: Roflumilast 500 Ug ORAL TABLET [Daliresp];Drug: corticosteroids +immune suppressive +amino salicylic acid | Tanta University | NULL | Not yet recruiting | 15 Years | 80 Years | All | 52 | Phase 4 | NULL |
| 19 | NCT05507931 (ClinicalTrials.gov) | February 2023 | 17/8/2022 | Broccoli Sprouts for Mild Ulcerative Colitis | A Pilot Feasibility Study to Develop a Broccoli Sprouts-enriched Diet in the Management of Ulcerative Colitis | Ulcerative Colitis;Ulcerative Colitis Chronic Mild | Dietary Supplement: 1 Serving of broccoli sprouts;Dietary Supplement: 3 Servings of broccoli sprouts | University of Michigan | University of Maine | Not yet recruiting | 18 Years | N/A | All | 40 | N/A | United States |
| 20 | NCT05743374 (ClinicalTrials.gov) | February 2023 | 14/2/2023 | Micronutrient and Additive Modifications May Optimize Diet To Health | Micronutrient and Additive Modifications May Optimize Diet To Health | Ulcerative Colitis;Diet Habit;Microbial Colonization | Other: Normal diet;Dietary Supplement: E400 elimination | Region Skane | NULL | Not yet recruiting | 18 Years | N/A | All | 70 | N/A | Sweden |
| 21 | NCT05743010 (ClinicalTrials.gov) | February 2023 | 15/11/2022 | A Phase 1b Study to Evaluate APL-1401 in Patients With Moderately to Severely Active Ulcerative Colitis | A Phase 1b Randomized, Double-blind Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of APL-1401 in Patients With Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Drug: APL-1401;Drug: Placebo | Jiangsu Yahong Meditech Co., Ltd aka Asieris | NULL | Not yet recruiting | 18 Years | 65 Years | All | 36 | Phase 1 | United States |
| 22 | EUCTR2022-002593-89-CZ (EUCTR) | 23/01/2023 | 28/12/2022 | A Study to Evaluate the Long-Term Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn's Disease | A 24-Week, Phase 2b, Randomized, Double-Blind Long-Term Extension Study to Evaluate Pharmacokinetics, Efficacy Safety, and Tolerability ofTEV-48574 in Adult Patients with Moderate to Severe Ulcerative Colitis or Crohn's Disease who completed the treatment phase of the Dose-Ranging Study - RELIEVE UCCD LTE | Moderate to severe Ulcerative colitis or moderate to severe Crohn'sdisease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10011400;Term: Crohn's colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TEV-48574 Product Code: TEV-48574 INN or Proposed INN: TEV-48574 Other descriptive name: Fully human IgG1 monoclonal antibody specific for TL1A | Teva Branded Pharmaceutical Products R&D, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 128 | Phase 2 | United States;Czechia;Slovakia;Spain;Austria;Israel;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Poland;Belgium;Bulgaria;Norway;Germany | ||
| 23 | NCT05574387 (ClinicalTrials.gov) | January 20, 2023 | 6/10/2022 | Metformin as Added on Therapy in Patients With Ulcerative Colitis | Metformin, The Biguanide Derivative, as Adjuvant Therapy in Patients With Ulcerative Colitis Treated With Mesalamine | Inflammatory Bowel Diseases | Drug: Metformin | Tanta University | Principal Investigator Sahar El-Haggar, Prof Clinical pharmacy Department- Tanta University;Principal Investigator Sahar Hegazy, Prof Clinical pharmacy Department- Tanta University;Principal Investigator Mostafa Mahmoud Bahaa El-Dien Pharmacy Practice Department- Horus University | Recruiting | 18 Years | 75 Years | All | 46 | Phase 2 | Egypt |
| 24 | NCT05535946 (ClinicalTrials.gov) | January 16, 2023 | 7/9/2022 | ABTECT - Maintenance | A Randomized, Double-blind, Multicenter Phase III Study to Evaluate the Long-term Efficacy and Safety of ABX464 25 mg or 50 mg Once Daily as a Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Drug: ABX464;Drug: Placebo | Abivax S.A. | NULL | Recruiting | 16 Years | N/A | All | 1050 | Phase 3 | United States |
| 25 | EUCTR2021-000630-34-GR (EUCTR) | 13/01/2023 | 11/11/2022 | A study to evaluate the long term safety of Vedolizumab in Pediatric Patients With Ulcerative Colitis or Crohn’s Disease | A Phase 3b Extension Study to Evaluate the Long-term Safety of Vedolizumab Intravenous in Pediatric Patients With Ulcerative Colitis or Crohn’s Disease | Active Ulcerative Colitis (UC) or Crohn's disease (CD);Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: ENTYVIO Product Name: Vedolizumab INN or Proposed INN: Vedolizumab Other descriptive name: MLN0002 | Takeda Development Center Americas, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 93 | Phase 3 | United States;Czechia;Slovakia;Greece;Spain;Ukraine;Lithuania;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Australia;China;Japan;Korea, Republic of | ||
| 26 | NCT05731128 (ClinicalTrials.gov) | January 12, 2023 | 3/2/2023 | A Study to Investigate the Efficacy and Safety of Dupilumab Therapy Compared With Placebo in Participants Aged =18 Years With Moderately to Severely Active Ulcerative Colitis With an Eosinophilic Phenotype (LIBERTY-UC SUCCEED (Study in UC for Clinical Efficacy Evaluation of Dupilumab)) | A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled Parallel-group Study to Evaluate the Efficacy and Safety of Dupilumab Therapy in Patients With Moderately to Severely Active Ulcerative Colitis With an Eosinophilic Phenotype | Colitis Ulcerative | Drug: Dupilumab;Drug: Placebo | Sanofi | Regeneron Pharmaceuticals | Recruiting | 18 Years | N/A | All | 100 | Phase 2 | United States |
| 27 | NCT05668013 (ClinicalTrials.gov) | January 11, 2023 | 12/12/2022 | A Study to Evaluate the Long-Term Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn's Disease | A 24-Week Phase 2b Long-Term Extension, RandomizEd, Double-BLind, Study to Determine the Long-Term PharmacokInetics, Efficacy, Safety, and Tolerability of TEV-48574 in Adult PatiEnts With Moderate to Severe Ulcerative Colitis or Crohn's Disease Who Completed the Main Phase of the Dose-Ranging Study (RELIEVE UCCD LTE) | Crohn Disease;Colitis, Ulcerative | Drug: TEV-48574 Dose Regimen A;Drug: TEV-48574 Dose Regiment B | Teva Branded Pharmaceutical Products R&D, Inc. | NULL | Recruiting | 18 Years | 75 Years | All | 128 | Phase 2 | United States |
| 28 | EUCTR2021-006881-19-CZ (EUCTR) | 06/01/2023 | 06/01/2023 | A Study to Test the Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn’s Disease | A 14-Week Phase 2b, RandomizEd, Double-BLind, Dose-Ranging Study to Determine the PharmacokInetics, Efficacy, Safety, and Tolerability of TEV-48574 in Adult PatiEnts with Moderate to Severe Ulcerative Colitis or Crohn’s Disease (RELIEVE UCCD) - RELIEVE UCCD | Moderate to severe Ulcerative colitis or moderate to severe Crohn's disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10011400;Term: Crohn's colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TEV-48574 Product Code: TEV-48574 INN or Proposed INN: TEV-48574 Other descriptive name: Fully human IgG1 monoclonal antibody specific for TL1A | Teva Branded Pharmaceutical Products R&D, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 280 | Phase 2 | United States;Czechia;Slovakia;Spain;Austria;Israel;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Poland;Bulgaria;Norway;Germany;Japan | ||
| 29 | NCT05561738 (ClinicalTrials.gov) | January 1, 2023 | 13/9/2022 | Nicotinamide Riboside in Ulcerative Colitis | Nicotinamide Riboside in Ulcerative Colitis | Ulcerative Colitis | Dietary Supplement: Nicotinamide Riboside Chloride;Dietary Supplement: Placebo;Other: Standard of Care | University of Pittsburgh | Crohn's and Colitis Foundation | Not yet recruiting | N/A | 18 Years | All | 40 | N/A | United States |
| 30 | NCT05112263 (ClinicalTrials.gov) | January 1, 2023 | 26/10/2021 | Tofacitinib Versus Cyclosporine for Steroid Refractory Acute Severe Ulcerative Colitis | Tofacitinib Versus Cyclosporine for Steroid Refractory Acute Severe Ulcerative Colitis: An Open Label Randomized Study | Ulcerative Colitis | Drug: Tofacitinib;Drug: Cyclosporine | Postgraduate Institute of Medical Education and Research | All India Institute of Medical Sciences, New Delhi | Not yet recruiting | 18 Years | 65 Years | All | 96 | N/A | NULL |
| 31 | NCT05316220 (ClinicalTrials.gov) | December 31, 2022 | 31/3/2022 | A Study to Assess Adverse Events and Change in Disease Condition of Mesalamine Capsules in Children Aged 5 to 17 Years With Ulcerative Colitis | A Randomized, Double-blind Study to Assess the Safety and Efficacy of Mesalamine Delayed-release Capsules in Children Aged 5 to 17 Years for the Maintenance of Remission of Ulcerative Colitis | Ulcerative Colitis (UC) | Drug: Mesalamine;Drug: Placebo | AbbVie | NULL | Not yet recruiting | 5 Years | 17 Years | All | 80 | Phase 3 | United States;Puerto Rico |
| 32 | NCT05121402 (ClinicalTrials.gov) | December 30, 2022 | 5/11/2021 | Safety and Efficacy Study of TLL018 in the Treatment of Ulcerative Colitis | A Phase 2 Multicenter, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Safety and Efficacy of TLL018 for Induction Therapy in Subjects With Moderate to Severe Ulcerative Colitis | Ulcerative Colitis | Drug: TLL018;Other: Placebo | TLL Pharmaceutical, LLC | NULL | Withdrawn | 18 Years | 75 Years | All | 0 | Phase 2 | United States |
| 33 | EUCTR2021-000630-34-HR (EUCTR) | 27/12/2022 | 05/01/2023 | A study to evaluate the long term safety of Vedolizumab in Pediatric Patients With Ulcerative Colitis or Crohn’s Disease | A Phase 3b Extension Study to Evaluate the Long-term Safety of Vedolizumab Intravenous in Pediatric Patients With Ulcerative Colitis or Crohn’s Disease | Active Ulcerative Colitis (UC) or Crohn's disease (CD);Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: ENTYVIO Product Name: Vedolizumab INN or Proposed INN: Vedolizumab Other descriptive name: MLN0002 | Takeda Development Center Americas, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 93 | Phase 3 | United States;Czechia;Slovakia;Greece;Spain;Ukraine;Lithuania;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Australia;China;Japan;Korea, Republic of | ||
| 34 | NCT05507216 (ClinicalTrials.gov) | December 21, 2022 | 17/8/2022 | ABTECT-2 - ABX464 Treatment Evaluation for Ulcerative Colitis Therapy -2 | A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Study to Evaluate the Efficacy and Safety of ABX464 Once Daily for Induction Treatment in Subjects With Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Drug: ABX464;Drug: Placebo | Abivax S.A. | NULL | Recruiting | 16 Years | N/A | All | 612 | Phase 3 | United States |
| 35 | EUCTR2021-002537-41-FR (EUCTR) | 20/12/2022 | 03/01/2023 | Safety and Efficacy of Efavaleukin Alfa in Subjects with Moderately to Severely Active Ulcerative Colitis | A Phase 2, Dose-finding, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Efavaleukin Alfa Induction Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis | Moderate to Severe Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Efavaleukin Alfa Product Code: AMG 592 INN or Proposed INN: EFAVALEUKIN ALFA | Amgen Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Phase 2 | United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Switzerland;Italy;France;Denmark;Latvia;Netherlands;Korea, Republic of;Czechia;Finland;Turkey;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Germany;Japan | ||
| 36 | NCT05176366 (ClinicalTrials.gov) | December 19, 2022 | 17/11/2021 | Study of ExoFlo for the Treatment of Medically Refractory Ulcerative Colitis | A Phase I Study of ExoFlo, an ex Vivo Culture-expanded Adult Allogeneic Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicle Isolate Product, for the Treatment of Medically Refractory Ulcerative Colitis | Ulcerative Colitis;Inflammatory Bowel Diseases | Biological: ExoFlo | Direct Biologics, LLC | NULL | Recruiting | 18 Years | 75 Years | All | 10 | Phase 1 | United States |
| 37 | NCT05287126 (ClinicalTrials.gov) | December 16, 2022 | 10/3/2022 | A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis | An Open-Label, Single-Arm Study to Evaluate the Efficacy, Pharmacokinetics, and Safety of Etrasimod in Adolescent Subjects With Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Drug: Etrasimod | Pfizer | Arena is a wholly owned subsidiary of Pfizer | Recruiting | 12 Years | 17 Years | All | 36 | Phase 2 | United States |
| 38 | NCT05369832 (ClinicalTrials.gov) | December 16, 2022 | 6/5/2022 | An Open-label Study of Ozanimod in Moderate to Severe Ulcerative Colitis in Clinical Practice | A Phase 4, Prospective, Open-label Study of Ozanimod to Explore the Safety, Efficacy, Quality of Life, and Biomarker Response in Participants With Moderate to Severe Ulcerative Colitis in Clinical Practice | Colitis, Ulcerative | Drug: Ozanimod | Bristol-Myers Squibb | NULL | Recruiting | 18 Years | N/A | All | 415 | Phase 4 | United States;Puerto Rico |
| 39 | EUCTR2021-005528-39-NL (EUCTR) | 14/12/2022 | 12/09/2022 | Efficacy and Safety of Combination Therapy with Guselkumab and Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 2b Randomized, Double-blind, Active-and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Induction and Maintenance Combination Therapy with Guselkumab and Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis - DUET-UC | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: JNJ-78934804 INN or Proposed INN: Guselkumab Other descriptive name: Guselkumab INN or Proposed INN: Golimumab Other descriptive name: Golimumab Product Name: Guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Other descriptive name: Guselkumab Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: Golimumab Other descriptive name: Golimumab | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 550 | Phase 2 | Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Chile;Italy;India;France;Jordan;Denmark;Latvia;Korea, Republic of;Bosnia and Herzegovina;Turkey;Mexico;Canada;Brazil;Croatia;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Switzerland;Malaysia;Australia;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Bulgaria;Georgia;Germany;Norway;New Zealand;Japan | ||
| 40 | NCT05644665 (ClinicalTrials.gov) | December 9, 2022 | 1/12/2022 | A Study to Evaluate Efficacy and Long-term Safety of Oral Ozanimod in Chinese Participants With Moderately to Severely Active Ulcerative Colitis (UC) | A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study of Oral Ozanimod to Evaluate Efficacy and Long-term Safety in Chinese Participants With Moderately to Severely Active Ulcerative Colitis (UC) | Ulcerative Colitis | Drug: Ozanimod;Drug: Placebo | Bristol-Myers Squibb | NULL | Recruiting | 18 Years | 75 Years | All | 240 | Phase 3 | China;Taiwan |
| 41 | EUCTR2022-000837-17-NL (EUCTR) | 07/12/2022 | 29/09/2022 | Lengthening of vedolizumab injections based on drug concentrations in patients with inflammatory bowel disease | Subcutaneous vedolizumab drug de-escalation using therapeutic drug monitoring in inflammatory bowel disease: a randomized controlled pilot study - SILVER-study | Inflammatory bowel diseases (Crohn's disease, ulcerative colitis);Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Vedolizumab, Entyvio | Amsterdam UMC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 4 | Netherlands | ||
| 42 | NCT05561062 (ClinicalTrials.gov) | December 1, 2022 | 27/9/2022 | Atorvastatin in Patients With Ulcerative Colitis | Combination of Atorvastatin and Mesalazine to Enhance Anti-inflammatory Effects and Attenuates Progression of Ulcerative Colitis | Inflammatory Bowel Diseases | Drug: Atorvastatin 80mg | Tanta University | NULL | Not yet recruiting | 18 Years | 75 Years | All | 50 | Phase 2 | NULL |
| 43 | NCT05610956 (ClinicalTrials.gov) | December 1, 2022 | 31/10/2022 | Evaluate the Possible Efficacy and Safety of Empagliflozin in Patient With Ulcerative Colitis | Clinical Study to Evaluate the Possible Efficacy and Safety of Empagliflozin in Patients With Ulcerative Colitis | Ulcerative Colitis | Drug: Empagliflozin;Drug: conventional treatment | Tanta University | NULL | Not yet recruiting | 18 Years | 70 Years | All | 60 | Early Phase 1 | NULL |
| 44 | NCT05579483 (ClinicalTrials.gov) | December 2022 | 4/10/2022 | Prediction of Dietary Intervention Efficacy in Mild Ulcerative Colitis Patients Based on Fecal Microbiome Signatures | Prediction of Dietary Intervention Efficacy in Mild Ulcerative Colitis Patients Based on Fecal Microbiome Signatures | Ulcerative Colitis | Dietary Supplement: Prebiotics;Dietary Supplement: Placebo | Wageningen University | Winclove Probiotics B.V.;China Scholarship Council | Not yet recruiting | 18 Years | 65 Years | All | 60 | N/A | Netherlands |
| 45 | NCT05588843 (ClinicalTrials.gov) | November 25, 2022 | 17/10/2022 | Dose-finding Study of SAR443122 in Adult Participants With Ulcerative Colitis | A Randomized, Double-blind, Placebo Controlled, Dose-finding Study to Assess the Efficacy and Safety of SAR443122 in Adult Patients With Moderate to Severe Ulcerative Colitis | Colitis Ulcerative | Drug: SAR443122;Drug: Placebo | Sanofi | NULL | Recruiting | 18 Years | 75 Years | All | 182 | Phase 2 | United States;Argentina;Chile;United Kingdom |
| 46 | NCT05549323 (ClinicalTrials.gov) | November 7, 2022 | 17/9/2022 | A Study to Learn About the Safety, Effects and Pharmacokinetics of Study Medication (PF-07054894) for the Treatment of Ulcerative Colitis | A PHASE 1B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF ORAL PF-07054894 IN ADULT PARTICIPANTS AGED 18-75 YEARS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative Colitis | Drug: PF-07054894;Drug: Placebo | Pfizer | NULL | Recruiting | 18 Years | 75 Years | All | 27 | Phase 1 | United States |
| 47 | NCT05570006 (ClinicalTrials.gov) | November 1, 2022 | 5/10/2022 | Study of ABBV-668 Oral Capsules to Assess Adverse Events and Change in Disease Activity in Adult Participants With Moderate to Severe Ulcerative Colitis | A Single-Arm, Open-Label Study to Evaluate the Efficacy and Safety of ABBV-668 in Subjects With Moderate to Severe Ulcerative Colitis | Ulcerative Colitis | Drug: ABBV-668 | AbbVie | NULL | Not yet recruiting | 18 Years | N/A | All | 40 | Phase 2 | United States;Belgium |
| 48 | JPRN-jRCT2031220308 | 01/11/2022 | 01/09/2022 | A Study of Combination Therapy with Guselkumab and Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 2b Randomized, Double-blind, Active-and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Induction and Maintenance Combination Therapy with Guselkumab and Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis - DUET-UC | Colitis, Ulcerative | Guselkumab Guselkumab will be administered as subcutaneous injection. Participants will receive guselkumab dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension. Golimumab Golimumab will be administered as subcutaneous injection. Participants will receive golimumab dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension. JNJ-78934804 (High-dose) JNJ-78934804 will be administered subcutaneously as per defined regimen. Participants will receive JNJ-78934804 dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension. JNJ-78934804 (Mid-dose) JNJ-78934804 will be administered subcutaneously as per defined regimen. Participants will receive JNJ-78934804 dose regimen 2 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension. JNJ-78934804 (Low-dose) JNJ-78934804 will be administered subcutaneously as per defined regimen. Participants will receive JNJ-78934804 dose regimen 3 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Particip | Nishikawa Kazuko | NULL | Pending | >= 18age old | <= 65age old | Both | 550 | Phase 2 | Argentina;Australia;Austria,;Belgium;Bulgaria;Brazil;Canada;Switzerland;Chile;Czechia;Germany;Denmark;Spain;Estonia;France;United Kingdom Of Great Britain;Greece;Hungary;India;Israel;Italy;Korea;Republic Of Lithuania;Mexico;Netherlands;Norway;NewZealand;Poland;Portugal;Serbia;Japan |
| 49 | NCT05553704 (ClinicalTrials.gov) | November 1, 2022 | 20/9/2022 | Metformin in Patients With Ulcerative Colitis Treated With Mesalamine | Clinical Study to Compare the Possible Efficacy of Metformin in Patients With Ulcerative Colitis Treated With Mesalamine | Inflammatory Bowel Diseases | Drug: Metformin | Tanta University | NULL | Recruiting | 18 Years | 75 Years | All | 52 | Phase 2 | Egypt |
| 50 | NCT05626166 (ClinicalTrials.gov) | November 2022 | 9/11/2022 | the Efficacy and Safety of Diosmin in Patients With Ulcerative Colitis | Clinical Study Evaluating the Efficacy and Safety of Diosmin in Patients With Ulcerative Colitis Treated With Mesalamine | Ulcerative Colitis | Drug: Placebo;Drug: Diosmin | Tanta University | NULL | Not yet recruiting | 18 Years | N/A | All | 60 | Phase 3 | NULL |
| 51 | NCT05611671 (ClinicalTrials.gov) | October 31, 2022 | 31/10/2022 | A Study to Evaluate MORF-057 in Adults With Moderately to Severely Active UC | A Phase 2b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of 3 Active Dose Regimens of MORF-057 in Adults With Moderately to Severely Active Ulcerative Colitis (EMERALD-2) | Inflammatory Bowel Diseases;Colitis, Ulcerative | Drug: MORF-057;Drug: Placebo | Morphic Therapeutic, Inc | NULL | Recruiting | 18 Years | 85 Years | All | 280 | Phase 2 | United States;Australia |
| 52 | NCT05558761 (ClinicalTrials.gov) | October 10, 2022 | 25/9/2022 | Pentoxifylline as Adjunctive Therapy in Patients With Ulcerative Colitis | Clinical Study to Evaluate the Possible Efficacy of Pentoxifylline in Patients With Ulcerative Colitis Treated With Mesalamine | Inflammatory Bowel Diseases | Drug: Pentoxifylline 400 MG | Tanta University | NULL | Recruiting | 18 Years | 75 Years | All | 50 | Phase 2 | Egypt |
| 53 | NCT05507203 (ClinicalTrials.gov) | October 10, 2022 | 17/8/2022 | ABTECT-1 - ABX464 Treatment Evaluation for Ulcerative Colitis Therapy -1 | A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Study to Evaluate the Efficacy and Safety of ABX464 Once Daily for Induction Treatment in Subjects With Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Drug: ABX464;Drug: Placebo | Abivax S.A. | NULL | Recruiting | 16 Years | N/A | All | 612 | Phase 3 | United States |
| 54 | NCT05587673 (ClinicalTrials.gov) | October 6, 2022 | 14/10/2022 | High Dose Steroid Therapy to Treat Flares in Patients With Inflammatory Bowel Disease (IBD) | A Pilot Study Investigating the Feasibility and Efficacy of Locoregional Intra-arterial Administration of Methylprednisolone as a Bridge Therapy to Treat Symptomatic Flares in Inflammatory Bowel Disease. | Inflammatory Bowel Diseases;Crohn Disease;Ulcerative Colitis;Indeterminate Colitis | Drug: Methylprednisolone | Stanford University | NULL | Recruiting | 4 Years | 25 Years | All | 30 | Phase 1 | United States |
| 55 | NCT04991324 (ClinicalTrials.gov) | September 21, 2022 | 27/7/2021 | Cholecalciferol Comedication in IBD - the 5C-study | Cholecalciferol Comedication in Patients With Chronic Inflammatory Bowel Diseases (Crohn's Disease or Ulcerative Colitis) - the 5C-study | Inflammatory Bowel Diseases | Drug: Vitamin D3 | University Hospital, Basel, Switzerland | NULL | Recruiting | 18 Years | N/A | All | 150 | Phase 3 | Switzerland |
| 56 | NCT05242484 (ClinicalTrials.gov) | September 19, 2022 | 15/2/2022 | A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis | A Phase 2b Randomized, Double-blind, Active-and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Induction and Maintenance Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis | Colitis, Ulcerative | Biological: Guselkumab;Biological: Golimumab;Biological: JNJ-78934804;Drug: Placebo | Janssen Research & Development, LLC | NULL | Recruiting | 18 Years | 65 Years | All | 550 | Phase 2 | United States;Argentina;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;Chile;Croatia;Czechia;Denmark;Estonia;France;Germany;Greece;Hungary;India;Israel;Italy;Japan;Jordan;Korea, Republic of;Mexico;Netherlands;New Zealand;Norway;Poland;Portugal;Serbia;Slovakia;Slovenia;South Africa;Spain;Sweden;Switzerland;Taiwan;Turkey;United Kingdom;Lithuania |
| 57 | NCT05466890 (ClinicalTrials.gov) | September 15, 2022 | 25/5/2022 | Phase 2a To Evaluate PL-8177 in Subjects With Active Ulcerative Colitis (UC) | Phase 2a, Double-Blind, Randomized Adaptive Design, Placebo-Controlled, Parallel Group Study to Evaluate the Safety, Tolerability, Efficacy, PK and Biomarkers With Oral Colon Delivery PL8177 in Adult Subjects With Active Ulcerative Colitis | Ulcerative Colitis;Ulcerative Colitis Acute;Ulcerative;Ulcerative Colitis Flare | Drug: PL8177 Placebo;Drug: PL8177 | Palatin Technologies, Inc | NULL | Recruiting | 18 Years | 75 Years | All | 28 | Phase 2 | United States |
| 58 | NCT05528510 (ClinicalTrials.gov) | September 13, 2022 | 19/8/2022 | A Study of Guselkumab Therapy in Participants With Moderately to Severely Active Ulcerative Colitis | A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab Subcutaneous Induction Therapy in Participants With Moderately to Severely Active Ulcerative Colitis | Colitis, Ulcerative | Drug: Guselkumab Dose 1;Drug: Guselkumab Dose 2;Drug: Guselkumab Dose 3;Other: Placebo | Janssen Research & Development, LLC | NULL | Recruiting | 18 Years | N/A | All | 400 | Phase 3 | United States;Argentina;Australia;Belgium;Brazil;Bulgaria;Canada;China;Czechia;France;Germany;Hungary;India;Israel;Japan;Jordan;Korea, Republic of;Mexico;New Zealand;Poland;Slovakia;Spain;Taiwan;Turkey;Italy;Malaysia;Portugal;Serbia;Sweden |
| 59 | NCT05624801 (ClinicalTrials.gov) | September 1, 2022 | 14/11/2022 | Cholecalciferol in Chronic Inflammatory Bowel Diseases | Cholecalciferol Comedication in Patients With Chronic Inflammatory Bowel Diseases (Crohn's Disease or Ulcerative Colitis) - the 5C-study | IBD | Drug: D3 VitaCaps® | University Hospital, Basel, Switzerland | NULL | Recruiting | 18 Years | N/A | All | 150 | Phase 3 | Switzerland |
| 60 | NCT05539625 (ClinicalTrials.gov) | September 2022 | 4/8/2022 | Mini-MARVEL - Mitochondrial Antioxidant Therapy in Ulcerative Colitis | Mitochondrial Antioxidant Therapy to Resolve Inflammation in Ulcerative Colitis (Mini-MARVEL): A Phase 2b Feasibility Randomised Placebo Controlled Trial of Oral MitoQ in Mild-tomoderately Active Paediatric UC | Ulcerative Colitis | Dietary Supplement: MitoQ;Other: Placebo | University of Edinburgh | The Jon Moulton Charity Trust;MitoQ | Not yet recruiting | 6 Years | 17 Years | All | 120 | Phase 2 | NULL |
| 61 | NCT05499130 (ClinicalTrials.gov) | August 29, 2022 | 11/8/2022 | A Study to Test the Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn's Disease | A 14 Week Phase 2b, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Efficacy, Safety and Tolerability of TEV-48574 in Adult Patients With Ulcerative Colitis or Crohn's Disease (RELIEVE UCCD) | Crohn Disease;Colitis, Ulcerative | Drug: TEV-48574;Drug: Placebo | Teva Branded Pharmaceutical Products R&D, Inc. | NULL | Recruiting | 18 Years | 75 Years | All | 280 | Phase 2 | United States |
| 62 | JPRN-jRCT2031220186 | 10/08/2022 | 06/07/2022 | A Basket Long-term Extension Study of Ustekinumab in Pediatric Participants | A Phase 3, Multicenter, Open-label, Basket, Long-term Extension Study of Ustekinumab in Pediatric Clinical Study Participants (2 to <18 Years of Age) | Crohn Disease, Ulcerative Colitis, Psoriatic Arthritis | Participants will have continued access to ustekinumab for primary study (CNTO1275CRD1001, CNTO1275PUC3001, CNTO1275CRD3004 & CNTO1275JPA3001) participants who in the opinion of the investigator will continue to benefit from ustekinumab therapy. All blinded participants who enroll in the long-term extension (LTE) from blinded primary studies with both every 8 weeks (q8w) and every 12 weeks (q12w) dosing groups just prior to the end of the primary study will be assigned to the q8w dosing regimen. Participants enrolling in the LTE from an unblinded primary study will remain on the final dosing regimen that they were receiving in the primary study. Ustekinumab will be administered as a SC injection. | Nishikawa Kazuko | NULL | Pending | >= 2age old | < 18age old | Both | 151 | Phase 3 | France;Poland;United States Of America;Japan |
| 63 | JPRN-jRCT2011210047 | 09/08/2022 | 29/10/2021 | Open-label Extension Study of Brazikumab in Ulcerative Colitis | A Phase 2 Open-label, Long-term Extension Safety Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis - EXPEDITION OLE | Ulcerative Colitis | Completers in the lead-in study will receive a maintenance dose of brazikumab 240 mg administered SC every 4 weeks (Group A). The 240 mg SC dose of brazikumab will be administered to all responders/completers in the lead-in study regardless of the prior treatment administered. Participants in the lead-in study who have not responded to treatment and have met criteria for rescue treatment are considered inadequate/non-responders (Group B). In these eligible participants, IV induction dosing with 1440 mg of brazikumab at Week 0, Week 4, and Week 8 will be administered, followed by brazikumab 240 mg SC-administered every 4 weeks thereafter (up to Week 52). | Ageishi Yuji | NULL | Recruiting | >= 18age old | <= 80age old | Both | 21 | Phase 2 | India;South Africa;South Korea;Taiwan;Canada;United States;Czech Republic;France;Germany;Austria;Hungary;Israel;Italy;Poland;Russia;Spain;Ukraine;United Kingdom;Japan |
| 64 | EUCTR2021-002549-13-PT (EUCTR) | 02/08/2022 | 27/10/2021 | A Phase III Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis | A Randomised Double-Blind Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis - CONCLUDE | Moderate to Severe left-sided 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: Cobitolimod INN or Proposed INN: COBITOLIMOD Product Name: Cobitolimod INN or Proposed INN: COBITOLIMOD | InDex Pharmaceuticals AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 440 | Phase 3 | Serbia;United States;Portugal;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;France;Denmark;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Czechia;Korea, Democratic People's Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Croatia;Romania;Georgia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 65 | NCT05652621 (ClinicalTrials.gov) | July 31, 2022 | 9/9/2022 | Efficacy of Probiotics in Patients With IBD | Clinical Efficacy and Mechanism of Probiotics in the Adjuvant Treatment of Ulcerative Colitis and Irritable Bowel Syndrome | Ulcerative Colitis;Irritable Bowel Syndrome | Dietary Supplement: probiotics | The First Affiliated Hospital of Xinxiang Medical College | NULL | Recruiting | 18 Years | 80 Years | All | 200 | N/A | China |
| 66 | NCT05479058 (ClinicalTrials.gov) | July 26, 2022 | 26/7/2022 | A Study Evaluating the Effect of Filgotinib Dose De-escalation in Participants With Ulcerative Colitis (UC) in Remission | A Randomized, Double-blind, Controlled, Multi-center Study to Evaluate the Efficacy and Safety of Dose De-escalation of Orally Administered Filgotinib in Subjects With Ulcerative Colitis in Clinical Remission | Ulcerative Colitis | Drug: Filgotinib;Drug: Placebo | Galapagos NV | NULL | Recruiting | 18 Years | N/A | All | 80 | Phase 3 | United States;Belgium;Czechia;France;Germany;Hungary;Italy;Korea, Republic of;Poland;South Africa;Spain;United Kingdom |
| 67 | EUCTR2021-002308-11-ES (EUCTR) | 21/07/2022 | 21/07/2022 | A phase 2/3, multicenter, randomized, double-blind study to evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of oral ozanimod (RPC1063) in pediatric subjects with moderately to severely active ulcerative colitis with an inadequate response to conventional therapy. | A phase 2/3, multicenter, randomized, double-blind study to evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of oral ozanimod (RPC1063) in pediatric subjects with moderately to severely active ulcerative colitis with an inadequate response to conventional therapy. | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Ozanimod HCL Product Code: RPC1063 INN or Proposed INN: Ozanimod HCL Other descriptive name: RPC1063 Product Name: Ozanimod HCL Product Code: RPC1063 INN or Proposed INN: Ozanimod HCL Other descriptive name: RPC1063 Product Name: Ozanimod HCL Product Code: RPC1063 INN or Proposed INN: Ozanimod HCL Other descriptive name: RPC1063 | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 2;Phase 3 | France;United States;Canada;Belgium;Poland;Spain;Russian Federation;Israel;Germany;Netherlands;United Kingdom;Japan | ||
| 68 | EUCTR2021-005288-31-PL (EUCTR) | 04/07/2022 | 19/05/2022 | A Phase 2a study to evaluate the Efficacy, Safety, and Tolerability of MORF-057 in Ulcerative Colitis | A Phase 2a, Open-label, Single-arm Study to Evaluate the Efficacy, Safety, and Tolerability of MORF-057 in Adults with Moderately to Severely Active Ulcerative Colitis | Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MORF-057 Product Code: MORF-057 INN or Proposed INN: MORF-057 Other descriptive name: MORF-057 | Morphic Therapeutic, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 35 | Phase 2 | United States;Poland | ||
| 69 | NCT05218850 (ClinicalTrials.gov) | July 1, 2022 | 20/1/2022 | The Use of Butyrate Therapy in Pediatric Ulcerative Colitis | Butyrate Therapy in Pediatric Ulcerative Colitis | Ulcerative Colitis | Drug: Butyrate | Children's Hospital Los Angeles | NULL | Not yet recruiting | 7 Years | 21 Years | All | 10 | Phase 1 | United States |
| 70 | NCT05377580 (ClinicalTrials.gov) | July 1, 2022 | 6/5/2022 | A Study to Evaluate IBI112 in the Treatment of Moderate to Severe Active Ulcerative Colitis | A Multicenter, Randomized, Double-blind, Parallel, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of IBI112 in Patients With Moderate to Severe Active Ulcerative Colitis | Ulcerative Colitis (UC) | Drug: Placebo;Drug: IBI112 | Innovent Biologics (Suzhou) Co. Ltd. | NULL | Recruiting | 18 Years | 75 Years | All | 150 | Phase 2 | China |
| 71 | JPRN-jRCT2021220013 | 01/07/2022 | 18/06/2022 | A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis | A Phase 2/3, Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Oral Ozanimod (RPC1063) in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis with an Inadequate Response to Conventional Therapy | Ulcerative Colitis (UC) | Ozanimod High Dose Ozanimod Low Dose | Liu W. Jerry | NULL | Pending | >= 2age old | <= 17age old | Both | 120 | Phase 2-3 | France;United States;Japan |
| 72 | NCT05119140 (ClinicalTrials.gov) | June 10, 2022 | 20/10/2021 | HCQ for Non Europeans With Mild to Severe UC | Administration of Hydroxychloroquine (Plaquenil) to Individuals of Non-European Ancestry for the Treatment of Mild to Severe Ulcerative Colitis. | Ulcerative Colitis (Disorder) | Drug: Hydroxychloroquine;Drug: Mesalamine | Icahn School of Medicine at Mount Sinai | Crohn's and Colitis Foundation | Recruiting | 18 Years | N/A | All | 20 | Phase 1/Phase 2 | United States |
| 73 | ITMCTR2200006063 | 2022-06-05 | 2022-06-05 | A systematic study on the syndrome differentiation standard of lingnan wet syndrome - ulcerative colitis | A systematic study on the syndrome differentiation standard of lingnan wet syndrome - ulcerative colitis | Ulcerative colitis | No intervention:No intervention;Pure western medicine intervention:Mesalazine ;Intervention of integrated Chinese and Western medicine:Mesalazine + invigorating spleen and removing dampness;Simple Chinese medicine intervention:Shenling Baizhu powder + special prescription; | Guangdong Provincial Hospital of Chinese Medicine | NULL | Pending | 18 | 75 | Both | No intervention:25;Pure western medicine intervention:25;Intervention of integrated Chinese and Western medicine:25;Simple Chinese medicine intervention:25; | Phase 1 | China |
| 74 | NCT05761327 (ClinicalTrials.gov) | June 3, 2022 | 11/2/2023 | Investigation of the Effects of Curcumin and Resveratrol Supplements Added to the Mediterranean Diet on Disease Severity and Inflammatory Biomarkers in Patients With Ulcerative Colitis | Investigation of the Effects of Curcumin and Resveratrol Supplements Added to the Mediterranean Diet on Disease Severity and Inflammatory Biomarkers in Patients With Ulcerative Colitis | Ulcerative Colitis | Other: Mediterranean Diet;Dietary Supplement: Curcumin Supplementation;Dietary Supplement: Resveratrol Supplementation | Ardahan University | NULL | Recruiting | 18 Years | 70 Years | All | 45 | N/A | Turkey |
| 75 | NCT05427942 (ClinicalTrials.gov) | June 3, 2022 | 17/6/2022 | Yuflyma® (Adalimumab), Patient Experience After Switching | YUflyma® (Adalimumab), Patient Experience After Switching to adaliMumab biosimilAr High concenTration, Low Volume (40mg/0.4mL) (Yuflyma®) by Taking Patient pERception of Treatment Into Account: The YU-MATTER Study | Rheumatoid Arthritis;Ankylosing Spondylarthritis;Axial Spondyloarthritis Without Radiographic Evidence of Ankylosing Spondylitis;Psoriatic Arthritis;Crohn Disease;Ulcerative Colitis | Drug: Adalimumab | Celltrion HealthCare France | NULL | Recruiting | 18 Years | N/A | All | 300 | France | |
| 76 | NCT05341401 (ClinicalTrials.gov) | June 2022 | 21/3/2022 | Budesonide Multimatrix(MMX) Versus Prednisolone in Management of Mild to Moderate Ulcerative Colitis | Budesonide MMX Versus Prednisolone in Management of Mild to Moderate Ulcerative Colitis | Ulcerative Colitis Chronic | Drug: Budesonide MMX;Drug: Prednisolone | Assiut University | NULL | Not yet recruiting | 18 Years | 60 Years | All | 100 | Phase 2/Phase 3 | NULL |
| 77 | NCT04276740 (ClinicalTrials.gov) | May 31, 2022 | 12/2/2020 | MARVEL: Mitochondrial Anti-oxidant Therapy to Resolve Inflammation in Ulcerative Colitis | Mitochondrial Anti-oxidant Therapy to Resolve Inflammation in Ulcerative Colitis (MARVEL): A Randomised Placebo-controlled Trial on Oral MitoQ in Moderate UC | Ulcerative Colitis Flare | Dietary Supplement: MitoQ;Other: Placebo | University of Edinburgh | JP Moulton Charitable Foundation;MitoQ | Not yet recruiting | 18 Years | N/A | All | 206 | Phase 2 | NULL |
| 78 | NCT05076175 (ClinicalTrials.gov) | May 30, 2022 | 4/10/2021 | A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis | A Phase 2/3, Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Oral Ozanimod (RPC1063) in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis With an Inadequate Response to Conventional Therapy | Colitis, Ulcerative | Drug: Ozanimod | Bristol-Myers Squibb | NULL | Recruiting | 2 Years | 17 Years | All | 120 | Phase 2/Phase 3 | United States;Belgium;France;Germany;Israel;Japan;Poland;Russian Federation;Spain;United Kingdom |
| 79 | NCT05291689 (ClinicalTrials.gov) | May 24, 2022 | 10/3/2022 | A Phase 2a Open-Label Study to Evaluate the Efficacy and Safety of MORF-057 in Adults With UC | A Phase 2a, Open-label, Single-arm Study to Evaluate the Efficacy, Safety, and Tolerability of MORF-057 in Adults With Moderately to Severely Active Ulcerative Colitis (EMERALD-1) | Inflammatory Bowel Diseases;Colitis, Ulcerative | Drug: MORF-057 | Morphic Therapeutic, Inc | NULL | Recruiting | 18 Years | 85 Years | All | 40 | Phase 2 | United States;Poland |
| 80 | EUCTR2020-004457-76-HU (EUCTR) | 17/05/2022 | 10/03/2022 | A Long-term Extension Study of Ustekinumab in Pediatric Participants with different medical conditions. | A Phase 3, Multicenter, Open-label, Basket, Long-term Extension Study of Ustekinumab in Pediatric Clinical Study Participants (2 to <18 Years of Age) - UNITED | Paediatric conditions in - Moderately to Severely Active Crohn's Disease - Moderately to Severely Active Ulcerative Colitis - Juvenile Psoriatic Arthritis 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 MedDRA version: 20.0;Classification code 10076674;Term: Juvenile psoriatic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 151 | Phase 3 | United States;Spain;Turkey;Russian Federation;Italy;United Kingdom;France;Hungary;Argentina;Belgium;Poland;Germany;Japan | ||
| 81 | EUCTR2021-003702-42-ES (EUCTR) | 17/05/2022 | 12/05/2022 | A Phase 3 Placebo-controlled Efficacy and Safety Study with Ritlecitinib (PF-06651600) in Adults with Moderately to Severely Active UC | AN INTERVENTIONAL PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, PARALLEL GROUP STUDY OF THE EFFICACY AND SAFETY OF RITLECITINIB (PF-06651600) IN ADULT PARTICIPANTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS | Moderate to Severe Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Ritlecitinib Product Code: PF-06651600 INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600 Product Name: Ritlecitinib Product Code: PF-06651600 INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600 | Pfizer Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 432 | Phase 3 | Serbia;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Bulgaria;Norway;Germany;Japan;Sweden | ||
| 82 | ChiCTR2200059150 | 2022-05-05 | 2022-04-26 | Study on the mechanism of Qingchangxiaopi Decoction and UC large intestine damp-heat syndrome from the activation of LPDC through TLR5-IRF4 pathway to mediate intestinal inflammation | Study on the mechanism of Qingchangxiaopi Decoction and UC large intestine damp-heat syndrome from the activation of LPDC through TLR5-IRF4 pathway to mediate intestinal inflammation | Ulcerative colitis (UC) | Intervention group:Qingchangxiaopi Decoction;Control group:Mesalazine; | Dongguan Hospital of Guangzhou University of Chinese Medinine | NULL | Pending | 18 | 70 | Both | Intervention group:30;Control group:30; | China | |
| 83 | EUCTR2021-002549-13-DK (EUCTR) | 21/04/2022 | 24/01/2022 | A Phase III Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis | A Randomised Double-Blind Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis - CONCLUDE | Moderate to Severe left-sided 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: Cobitolimod INN or Proposed INN: COBITOLIMOD Product Name: Cobitolimod INN or Proposed INN: COBITOLIMOD | InDex Pharmaceuticals | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 440 | Phase 3 | Portugal;Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;France;Australia;Denmark;South Africa;Netherlands;Bosnia and Herzegovina;Czechia;Korea, Democratic People's Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Norway;Germany;New Zealand;Sweden | ||
| 84 | EUCTR2021-002537-41-DK (EUCTR) | 20/04/2022 | 08/10/2021 | Safety and Efficacy of Efavaleukin Alfa in Subjects with Moderately to Severely Active Ulcerative Colitis | A Phase 2, Dose-finding, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Efavaleukin Alfa Induction Therapy in Subjects with Moderately to Severely Active UlcerativeColitis | Moderate to Severe Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Efavaleukin Alfa Product Code: AMG 592 INN or Proposed INN: EFAVALEUKIN ALFA | Amgen Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Phase 2 | Denmark;Netherlands;Korea, Republic of;United States;Taiwan;Greece;Spain;Ukraine;Russian Federation;Italy;Switzerland;Czechia;Finland;Turkey;Austria;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Japan | ||
| 85 | EUCTR2018-002378-30-DE (EUCTR) | 14/04/2022 | 13/12/2021 | OPEN LABEL, MAINTENANCE STUDY OF ORAL TOFACITINIB IN CHILDREN WITH MODERATE TO SEVERE ULCERATIVE COLITIS | OPEN-LABEL INDUCTION AND MAINTENANCE STUDY OF ORAL CP-690,550 (TOFACITINIB) IN CHILDREN WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS | MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: XELJANZ Product Name: Tofacitinib citrate Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: XELJANZ Product Name: Tofacitinib citrate Product Code: CP-690,550-10 INN or Proposed INN: TOFACITINIB Other descriptive name: TOFACITINIB CITRATE | Pfizer Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 3 | United States;Slovakia;Finland;Spain;Israel;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Australia;Germany;Netherlands;Japan;Sweden | ||
| 86 | EUCTR2021-002537-41-GR (EUCTR) | 11/04/2022 | 08/02/2022 | Safety and Efficacy of Efavaleukin Alfa in Subjects with Moderately to Severely Active Ulcerative Colitis | A Phase 2, Dose-finding, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Efavaleukin Alfa Induction Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis | Moderate to Severe Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Efavaleukin Alfa Product Code: AMG 592 INN or Proposed INN: EFAVALEUKIN ALFA | Amgen Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Phase 2 | United States;Taiwan;Greece;Spain;Ukraine;Russian Federation;Italy;Switzerland;Denmark;Netherlands;Czechia;Finland;Korea, Democratic People's Republic of;Turkey;Austria;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Japan | ||
| 87 | NCT05728008 (ClinicalTrials.gov) | April 5, 2022 | 30/1/2023 | Retrospective Observational Comparison Study Between Ustekinumab and Tofacitinib as Third Line Therapy in a Multicenter Cohort of Patients With Refractory Ulcerative Colitis. | Retrospective Observational Comparison Study Between Ustekinumab and Tofacitinib as Third Line Therapy in a Multicenter Cohort of Patients With Refractory Ulcerative Colitis. | Ulcerative Colitis | Drug: Ustekinumab;Drug: Tofacitinib | IRCCS San Raffaele | NULL | Completed | 18 Years | N/A | All | 100 | Italy | |
| 88 | NCT05578508 (ClinicalTrials.gov) | April 2022 | 1/11/2019 | Stem Cells for the Treatment of Pouchitis | A Phase I Study of Bone Marrow Derived Mesenchymal Stem Cells (MSCs) for the Treatment of Medically Refractory Pouchitis | Pouchitis;Crohn's Disease;Ulcerative Colitis Chronic;Inflammatory Bowel Diseases;Pouch, Ileal | Drug: Mesenchymal Stem Cells (MSCs) | The Cleveland Clinic | Case Western Reserve University | Withdrawn | 18 Years | 75 Years | All | 0 | Phase 1 | United States |
| 89 | EUCTR2021-002549-13-AT (EUCTR) | 31/03/2022 | 25/10/2021 | A Phase III Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis | A Randomised Double-Blind Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis - CONCLUDE | Moderate to Severe left-sided 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: Cobitolimod INN or Proposed INN: COBITOLIMOD Product Name: Cobitolimod INN or Proposed INN: COBITOLIMOD | InDex Pharmaceuticals | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 440 | Phase 3 | Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;France;Australia;Denmark;South Africa;Netherlands;Bosnia and Herzegovina;Czechia;Korea, Democratic People's Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;New Zealand;Sweden;United States;Taiwan;Portugal;Serbia | ||
| 90 | JPRN-jRCTs052210199 | 22/03/2022 | 22/03/2022 | Comparison of GI tract pH and motility between patients with ulcerative colitis and healthy controls | Comparison of total gastrointestinal pH and motility between healthy subjects and patients with ulcerative colitis using wireless motility/pH capsule | Ulcerative colitis | arm UC arm Health control In each case, the SmartPill motility capsule is orally taken with 50 ml of water. The temperature, pH and pressure of the entire digestive tract are measured in real time. Also, the transit time of each of the stomach, small intestine, and large intestine is calculated from the transit time of the capsule. | Nakamura Shiro | Higuchi Kazuhide | Pending | >= 20age old | <= 79age old | Both | 25 | N/A | Japan |
| 91 | NCT05019742 (ClinicalTrials.gov) | March 21, 2022 | 13/8/2021 | Evaluation of SPH3127 in Patients With Mild-to-Moderate Ulcerative Colitis | A Double-Blind, Placebo-Controlled Trial to Investigate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of SPH3127 in Patients With Mild-to-Moderate Ulcerative Colitis | Ulcerative Colitis | Drug: SPH3127;Drug: Placebo | Shanghai Pharma Biotherapeutics USA Inc. | NULL | Recruiting | 18 Years | 70 Years | All | 30 | Phase 2 | United States |
| 92 | EUCTR2021-002537-41-FI (EUCTR) | 16/03/2022 | 28/10/2021 | Safety and Efficacy of Efavaleukin Alfa in Subjects with Moderately to Severely Active Ulcerative Colitis | A Phase 2, Dose-finding, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Efavaleukin Alfa Induction Therapy in Subjects with Moderately to Severely Active UlcerativeColitis | Moderate to Severe Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Efavaleukin Alfa Product Code: AMG 592 INN or Proposed INN: EFAVALEUKIN ALFA | Amgen Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Phase 2 | United States;Taiwan;Greece;Spain;Ukraine;Russian Federation;Italy;Switzerland;Denmark;Netherlands;Korea, Republic of;Czechia;Finland;Turkey;Austria;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Japan | ||
| 93 | JPRN-jRCT2051210183 | 09/03/2022 | 02/03/2022 | Single Dose Study of MK-6194 in Healthy Japanese Participants | A Single Dose Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-6194 in Healthy Japanese Participants | Ulcerative colitis | - Drug: MK-6194 MK-6194 1-7.5 mg subcutaneously administered in sterile solution form once - Drug: Placebo 5% glucose subcutaneously administered in sterile solution form once | Tanaka Yoshiyuki | NULL | Recruiting | >= 20age old | <= 55age old | Male | 48 | Phase 1 | Japan |
| 94 | EUCTR2021-002537-41-ES (EUCTR) | 08/03/2022 | 09/03/2022 | Safety and Efficacy of Efavaleukin Alfa in Subjects with Moderately to Severely Active Ulcerative Colitis | A Phase 2, Dose-finding, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Efavaleukin Alfa Induction Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis | Moderate to Severe Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Efavaleukin Alfa Product Code: AMG 592 INN or Proposed INN: EFAVALEUKIN ALFA | Amgen Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Phase 2 | United States;Taiwan;Greece;Spain;Ukraine;Russian Federation;Italy;Switzerland;Denmark;Netherlands;Czechia;Finland;Korea, Democratic People's Republic of;Turkey;Austria;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Japan | ||
| 95 | JPRN-jRCTs021210073 | 08/03/2022 | 08/03/2022 | Ustekinumab withdrawal for UC in remission | Ustekinumab withdrawal for ulcerative colitis in remission | Ulcerative colitis | No maintenance subcutaneous Ustekinumab therapy for UC patients in remission with Ustekinumab. | Shimodaira Yosuke | NULL | Recruiting | >= 15age old | < 75age old | Both | 30 | Phase 4 | Japan |
| 96 | EUCTR2021-002549-13-NO (EUCTR) | 07/03/2022 | 24/11/2021 | A Phase III Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis | A Randomised Double-Blind Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis - CONCLUDE | Moderate to Severe left-sided 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: Cobitolimod INN or Proposed INN: COBITOLIMOD Product Name: Cobitolimod INN or Proposed INN: COBITOLIMOD | InDex Pharmaceuticals | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 440 | Phase 3 | United States;Portugal;Serbia;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;France;Australia;Denmark;South Africa;Netherlands;Bosnia and Herzegovina;Czechia;Korea, Democratic People's Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 97 | EUCTR2018-002378-30-HU (EUCTR) | 01/03/2022 | 15/12/2021 | OPEN LABEL, MAINTENANCE STUDY OF ORAL TOFACITINIB IN CHILDREN WITH MODERATE TO SEVERE ULCERATIVE COLITIS | OPEN-LABEL INDUCTION AND MAINTENANCE STUDY OF ORAL CP-690,550 (TOFACITINIB) IN CHILDREN WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS | MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: XELJANZ Product Name: Tofacitinib citrate Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: XELJANZ Product Name: Tofacitinib citrate Product Code: CP-690,550-10 INN or Proposed INN: TOFACITINIB Other descriptive name: TOFACITINIB CITRATE | Pfizer Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 3 | United States;Slovakia;Finland;Spain;Israel;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Australia;Germany;Netherlands;Japan;Sweden | ||
| 98 | NCT05239702 (ClinicalTrials.gov) | February 28, 2022 | 1/12/2021 | Clinical Study of Targeting CD7 CAR-T Cells in the Treatment of Autoimmune Diseases | A Clinical Study on the Safety and Effectiveness of Targeting CD7 Chimeric Antigen Receptor T Cells in the Treatment of Autoimmune Diseases | Crohn Disease;Ulcerative Colitis;Dermatomyositis;Still Disease;Autoimmune Diseases | Biological: CD7 CAR T-cells | Zhejiang University | Yake Biotechnology Ltd. | Recruiting | N/A | N/A | All | 75 | Early Phase 1 | China |
| 99 | JPRN-jRCT2031210352 | 28/02/2022 | 28/09/2021 | A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Parallel Group Study Evaluating the Efficacy and Safety of Amiselimod (MT-1303) in Subjects with Mild to Moderate Ulcerative Colitis (UC) | A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Parallel Group Study Evaluating the Efficacy and Safety of Amiselimod (MT-1303) in Subjects with Mild to Moderate Ulcerative Colitis (UC) | Ulcerative Colitis | Double-blinded Treatment Period : Oral administration of 2 capsules of 0.2 mg or 0.4 mg amiselimod or placebo once a day for 2 weeks, and oral administration of one cupsule once a day for 10 weeks. Open Label Extension Period: Oral administration of 0.4 mg amiselimod once a day for up to 36 weeks. | Kagiyama Shoji | NULL | Recruiting | >= 18age old | <= 75age old | Both | 35 | Phase 2 | USA;Australia;Taiwan;S. Korea;Belarus;Russia;Ukraine;Moldova;Georgia;Germany;Hungary;Czech Republic;Slovakia,;Serbia;Italy;Estonia;Bulgaria;Poland;Japan |
| 100 | JPRN-jRCTs031210326 | 28/02/2022 | 21/09/2021 | Evaluation of biomarkers in BF treatment | A multicenter study to evaluate the effectiveness of budesonide enema foam treatment and the usefulness ofserum biomarker measurement for active ulcerative colitis - BF-LRG | Ulcerative colitis Ulcerative colitis | Budesonide foam was administered as a study drug | Matsuoka Katsuyoshi | EA Pharma Co., Ltd. | Recruiting | >= 16age old | Not applicable | Both | 20 | N/A | Japan |
| 101 | EUCTR2021-002549-13-HR (EUCTR) | 24/02/2022 | 28/02/2022 | A Phase III Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis | A Randomised Double-Blind Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis - CONCLUDE | Moderate to Severe left-sided 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: Cobitolimod INN or Proposed INN: COBITOLIMOD Product Name: Cobitolimod INN or Proposed INN: COBITOLIMOD | InDex Pharmaceuticals | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 440 | Phase 3 | Portugal;Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;France;Australia;Denmark;South Africa;Netherlands;Bosnia and Herzegovina;Czechia;Korea, Democratic People's Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 102 | EUCTR2021-004398-30-SI (EUCTR) | 24/02/2022 | 02/02/2022 | Effects of ABX464 during long-term treatment in patients with moderate to severe ulcerative colitis. | A follow-up Phase II open-label study to evaluate the long-term safety and efficacy profile of ABX464 given at 25 mg once daily in subjects with Moderate to Severe Active Ulcerative Colitis | Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | ABIVAX | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 203 | Phase 2 | Serbia;Czechia;Slovenia;Slovakia;Spain;Ukraine;Austria;Italy;France;Hungary;Canada;Belgium;Poland;Germany | ||
| 103 | NCT05194007 (ClinicalTrials.gov) | February 19, 2022 | 18/11/2021 | Investigating the Anti-inflammatory Effects of Frondanol in Adults With Inflammatory Bowel Disease | A Pilot Randomized, Double-blind, Placebo-controlled Trial to Investigate the Anti-inflammatory Effects of Frondanol in Adults With Inflammatory Bowel Disease | Ulcerative Colitis Chronic Mild;Ulcerative Colitis Chronic Moderate;Crohn Colitis | Drug: Frondanol;Drug: Placebo | Mohammed Bin Rashid University of Medicine and Health Sciences | Mediclinic Middle East;Rashid Hospital;Dubai Health Authority | Recruiting | 18 Years | N/A | All | 100 | Phase 2/Phase 3 | United Arab Emirates |
| 104 | EUCTR2020-000311-71-FR (EUCTR) | 11/02/2022 | 17/09/2021 | Pilot study of a new technique of Oral Fecal Transplantation using frozen stool capsules for the maintenance treatment of UC with pediatric onset | Pilot study of a new technique of Oral Fecal Transplantation using frozen stool capsules for the maintenance treatment of UC with pediatric onset | ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Microbiote fécal | AP-HP/DRCD | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 2 | France | ||
| 105 | NCT05118919 (ClinicalTrials.gov) | February 9, 2022 | 26/10/2021 | A Safety Study of Lactobacillus Reuteri BGP-014 in Patients With Ulcerative Colitis | A Randomised Placebo-controlled Safety Study of Lactobacillus Reuteri BGP-014 in Patients With Mild to Moderate Ulcerative Colitis | Ulcerative Colitis | Biological: BGP-014;Biological: Placebo | BioGaia Pharma AB | NULL | Recruiting | 18 Years | N/A | All | 50 | Phase 1/Phase 2 | Sweden |
| 106 | NCT05180175 (ClinicalTrials.gov) | February 7, 2022 | 17/12/2021 | The Nordic IBD Treatment Strategy Trial | The Nordic IBD Treatment Strategy Trial- a Randomised Controlled Trial of Access to a Protein Profile | Inflammatory Bowel Diseases;Ulcerative Colitis;Crohn Disease | Drug: Top down treatment if patient at high risk | Region Örebro County | NULL | Recruiting | 18 Years | 70 Years | All | 250 | Phase 4 | Denmark;Iceland;Norway;Sweden |
| 107 | NCT05186623 (ClinicalTrials.gov) | February 5, 2022 | 22/12/2021 | Prediction Model for Response to Biologics and Small Molecular Agent for UC | Establishment of Prediction Model of Biologics and Small Molecular Agent for Patients With Ulcerative Colitis Using Longitudinal Data | Ulcerative Colitis | Drug: Vedolizumab, Ustekinumab, or Tofacitinib | Asan Medical Center | NULL | Recruiting | 18 Years | 79 Years | All | 300 | Korea, Republic of | |
| 108 | EUCTR2021-001644-10-HU (EUCTR) | 04/02/2022 | 15/12/2021 | Open-label Extension Study of Brazikumab in Ulcerative Colitis | A Phase 2 Open-label, Long-term Extension Safety Study of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis (EXPEDITION OLE) - EXPEDITION OLE | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Brazikumab Product Code: MEDI2070 INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as 'MEDI2070' Product Name: Brazikumab Product Code: MEDI2070 INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as 'MEDI2070' | AstraZeneca AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 2 | United States;Czechia;Taiwan;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Hungary;Canada;Poland;South Africa;Germany;Japan;Korea, Republic of | ||
| 109 | EUCTR2021-002537-41-BG (EUCTR) | 02/02/2022 | 19/01/2022 | Safety and Efficacy of Efavaleukin Alfa in Subjects with Moderately to Severely Active Ulcerative Colitis | A Phase 2, Dose-finding, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Efavaleukin Alfa Induction Therapy in Subjects with Moderately to Severely Active UlcerativeColitis | Moderate to Severe Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Efavaleukin Alfa Product Code: AMG 592 INN or Proposed INN: EFAVALEUKIN ALFA | Amgen Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Phase 2 | United States;Czechia;Taiwan;Finland;Spain;Ukraine;Korea, Democratic People's Republic of;Turkey;Austria;Russian Federation;Switzerland;Italy;Hungary;Mexico;Canada;Argentina;Poland;Romania;Denmark;Bulgaria;Germany;Netherlands;Japan;Sweden | ||
| 110 | NCT04987307 (ClinicalTrials.gov) | January 31, 2022 | 26/7/2021 | Safety and Efficacy of Efavaleukin Alfa in Participants With Moderately to Severely Active Ulcerative Colitis | A Phase 2, Dose-finding, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Efavaleukin Alfa Induction Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Drug: Efavaleukin alfa;Drug: Placebo | Amgen | NULL | Recruiting | 18 Years | 80 Years | All | 320 | Phase 2 | United States;Argentina;Austria;Belgium;Bulgaria;Canada;Czechia;Denmark;Finland;Germany;Greece;Hungary;Italy;Japan;Korea, Republic of;Mexico;Netherlands;Poland;Romania;Spain;Switzerland;Taiwan;Turkey |
| 111 | JPRN-jRCT2041220001 | 31/01/2022 | 07/04/2022 | Safety and Efficacy of Efavaleukin Alfa in Participants With Moderately to Severely Active Ulcerative Colitis | A Phase 2, Dose-finding, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Efavaleukin Alfa Induction Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Experimental: Efavaleukin alfa Drug: Efavaleukin alfa Efavaleukin alfa will be administered by subcutaneous (SC) injection. Other Name: AMG 592 Placebo Comparator: Placebo Drug: Placebo Placebo will be administered by SC injection. | Hama Yoriko | NULL | Recruiting | >= 18age old | <= 80age old | Both | 320 | Phase 2 | United States;Austria;Bulgaria;Korea;Poland;Japan |
| 112 | EUCTR2021-003050-23-LT (EUCTR) | 25/01/2022 | 11/10/2021 | VTX002 versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis | A Phase 2, Multicenter, Randomized, Double-Blind,Placebo-Controlled, Parallel-Group Study to Evaluate the Clinical Efficacy and Safety of VTX002 in Subjects with Moderately to Severely Active Ulcerative Colitis | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: VTX002 INN or Proposed INN: not yet available Other descriptive name: VTX002 is not biologic Product Code: VTX002 INN or Proposed INN: not yet available Other descriptive name: VTX002 is not biologic Product Code: VTX002 INN or Proposed INN: not yet available Other descriptive name: VTX002 is not biologic Product Code: VTX002 INN or Proposed INN: not yet available Other descriptive name: VTX002 is not biologic | Oppilan Pharma Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 2 | Belarus;United States;Czechia;Ukraine;Lithuania;Israel;Russian Federation;Italy;Hungary;Czech Republic;Poland;Georgia;Germany | ||
| 113 | EUCTR2019-004878-26-PL (EUCTR) | 18/01/2022 | 12/10/2021 | A Study of the Safety, Efficacy, and Biomarker Response of BMS-986165 in Participants with Moderate to Severe Ulcerative Colitis | A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Efficacy, and Biomarker Response of BMS-986165 in Subjects with Moderate to Severe Ulcerative Colitis. | Moderate to Severe Ulcerative Colitis. MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BMS-986165 Product Code: BMS-986165 INN or Proposed INN: TYK2 Inhibitor Other descriptive name: BMS-986165 Product Name: BMS-986165 Product Code: BMS-986165 INN or Proposed INN: TYK2 Inhibitor Other descriptive name: BMS986165 | Bristol-Myers Squibb International Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 2 | United States;Canada;Poland;Australia;Netherlands;Germany;United Kingdom | ||
| 114 | NCT04898348 (ClinicalTrials.gov) | January 14, 2022 | 13/5/2021 | A Study to Investigate Efficacy and Safety of KBL697 in Patients With Mild to Moderate Active Ulcerative Colitis | A Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of KBL697 in Patients With Mild to Moderate Active Ulcerative Colitis | Ulcerative Colitis | Drug: KBL697;Drug: Placebo | KoBioLabs | NULL | Recruiting | 18 Years | 75 Years | All | 30 | Phase 2 | Australia |
| 115 | JPRN-jRCT2011210030 | 11/01/2022 | 30/08/2021 | Phase 2 Dose-finding UC Study | A 54-Week, Multicenter, Randomized, Double-blind, Placebocontrolled, Parallel-group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis - Expedition Lead-in | Ulcerative Colitis, Colitis, Ulcerative, IBD | - Brazikumab low dose: IV brazikumab 720 mg at Week 0 (Day 1), Week 2, and Week 6 followed by SC brazikumab 120 mg or 240 mg every 4 weeks beginning at Week 10 - Brazikumab high-dose: IV brazikumab 1440 mg at Week 0 (Day 1), Week 2, and Week 6 followed by SC brazikumab 120 mg or 240 mg every 4 weeks beginning at Week 10 - Placebo: IV placebo at Week 0 (Day 1), Week 2, and Week 6 followed by SC placebo every 4 weeks beginning at Week 10 | Ageishi Yuji | NULL | Recruiting | >= 18age old | <= 80age old | Both | 21 | Phase 2 | Australia;Austria;Belgium;Bulgaria;Canada;Czechia;France;Germany;Hungary;India;Israel;Italy;Korea, Republic of;Poland;Puerto Rico;Romania;Russian Federation;South Africa;Spain;Taiwan;Ukraine;United Kingdom;United States;Japan |
| 116 | EUCTR2021-003050-23-PL (EUCTR) | 02/01/2022 | 29/09/2021 | VTX002 versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis | A Phase 2, Multicenter, Randomized, Double-Blind,Placebo-Controlled, Parallel-Group Study to Evaluate the Clinical Efficacy and Safety of VTX002 in Subjects with Moderately to Severely Active Ulcerative Colitis | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: VTX002 INN or Proposed INN: not yet available Other descriptive name: VTX002 Product Code: VTX002 INN or Proposed INN: not yet available Other descriptive name: VTX002 Product Code: VTX002 INN or Proposed INN: not yet available Other descriptive name: VTX002 Product Code: VTX002 INN or Proposed INN: not yet available Other descriptive name: VTX002 | Oppilan Pharma Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 2 | United States;Belarus;Czechia;Ukraine;Lithuania;Israel;Russian Federation;Italy;Hungary;Czech Republic;Poland;Georgia;Germany | ||
| 117 | NCT04924270 (ClinicalTrials.gov) | January 2022 | 7/6/2021 | Safety and Efficacy of Faecal Microbiota Transplantation in Treatment-naïve Patients With Newly Diagnosed Chronic Inflammatory Diseases | Safety and Clinical Efficacy Associated With Faecal Microbiota Transplantation Performed in Treatment-naïve Patients With Newly Diagnosed Rheumatoid Arthritis, Reactive Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis, Gouty Arthritis, Psoriasis, Hidradenitis Suppurativa, Pulmonary Sarcoidosis, Crohn's Disease, and Ulcerative Colitis: a 52-week, Double-blind, Randomised, Placebo-controlled, Exploratory Trial | Rheumatoid Arthritis;Reactive Arthritis;Ankylosing Spondylitis;Psoriatic Arthritis;Gouty Arthritis;Psoriasis;Hidradenitis Suppurativa;Pulmonary Sarcoidosis;Crohn Disease;Ulcerative Colitis | Biological: Faecal microbiota transplantation;Other: Placebo | Torkell Ellingsen | Region of Southern Denmark;University of Southern Denmark | Not yet recruiting | 18 Years | 70 Years | All | 200 | Phase 2 | NULL |
| 118 | NCT04804540 (ClinicalTrials.gov) | December 29, 2021 | 15/3/2021 | A Study of Vedolizumab in People With Ulcerative Colitis and Crohn's Disease | A Multicenter, Single-arm, Open-label, Phase 4 Study to Evaluate the Safety and Efficacy of Vedolizumab in Indian Patients With Ulcerative Colitis and Crohn's Disease | Ulcerative Colitis;Crohn Disease | Drug: Vedolizumab IV | Takeda | NULL | Active, not recruiting | 18 Years | 65 Years | All | 150 | Phase 4 | India |
| 119 | JPRN-jRCT1051210145 | 28/12/2021 | 28/12/2021 | Efficacy of therapeutic intervention with vedolizumab for ulcerative colitis patients with no or mild symptom and uncontrolled endoscopic activity: A multicenter- non-randomized trial | Efficacy of therapeutic intervention with vedolizumab for ulcerative colitis patients with no or mild symptom and uncontrolled endoscopic activity: A multicenter- non-randomized trial | ulcerative colitis ulcerative colitis;D003093 | Administration of vedolizumab 300mg/day at 0,2, and 6 weeks, then at 8-week intervals for up to 54 weeks | ooi makoto | NULL | Recruiting | >= 18age old | <= 80age old | Both | 150 | Phase 3 | Japan |
| 120 | EUCTR2018-002378-30-FI (EUCTR) | 22/12/2021 | 20/12/2021 | OPEN-LABEL MAINTENANCE STUDY OF ORAL TOFACITINIB IN CHILDREN WITH MODERATE TO SEVERE ULCERATIVE COLITIS | OPEN-LABEL INDUCTION AND MAINTENANCE STUDY OF ORAL CP-690,550 (TOFACITINIB) IN CHILDREN WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS | MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: XELJANZ Product Name: Tofacitinib citrate Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: TOFACITINIB CITRATE Product Name: Tofacitinib citrate Product Code: CP-690,550-10 INN or Proposed INN: TOFACITINIB Other descriptive name: TOFACITINIB CITRATE | Pfizer Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 3 | United States;Slovakia;Finland;Spain;Israel;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Australia;Netherlands;Germany;Japan;Sweden | ||
| 121 | EUCTR2021-001644-10-IT (EUCTR) | 21/12/2021 | 17/09/2021 | Open-label Extension Study of Brazikumab in Ulcerative Colitis | A Phase 2 Open-label, Long-term Extension Safety Study of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis(EXPEDITION OLE) - EXPEDITION OLE | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Brazikumab Product Code: [MEDI2070] INN or Proposed INN: ( L ) ASCORBATO DI CALCIO Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as 'MEDI2070' Product Name: Brazikumab Product Code: [MEDI2070] INN or Proposed INN: ( L ) ASCORBATO DI CALCIO Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as 'MEDI2070' | ASTRAZENECA AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 2 | United States;Czechia;Taiwan;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Hungary;Canada;Poland;South Africa;Germany;Japan;Korea, Republic of | ||
| 122 | EUCTR2021-002537-41-DE (EUCTR) | 15/12/2021 | 13/10/2021 | Safety and Efficacy of Efavaleukin Alfa in Subjects with Moderately to Severely Active Ulcerative Colitis | A Phase 2, Dose-finding, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Efavaleukin Alfa Induction Therapy in Subjects with Moderately to Severely Active UlcerativeColitis | Moderate to Severe Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Efavaleukin Alfa Product Code: AMG 592 INN or Proposed INN: EFAVALEUKIN ALFA | Amgen Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Phase 2 | United States;Czechia;Taiwan;Finland;Ukraine;Korea, Democratic People's Republic of;Turkey;Austria;Russian Federation;Switzerland;Italy;Hungary;Mexico;Canada;Argentina;Poland;Romania;Denmark;Bulgaria;Germany;Netherlands;Japan;Sweden | ||
| 123 | EUCTR2021-004398-30-SK (EUCTR) | 14/12/2021 | 27/10/2021 | Effects of ABX464 during long-term treatment in patients with moderate to severe ulcerative colitis. | A follow-up Phase II open-label study to evaluate the long-term safety and efficacy profile of ABX464 given at 25 mg once daily in subjects with Moderate to Severe Active Ulcerative Colitis | Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | ABIVAX | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 203 | Phase 2 | Serbia;Czechia;Slovakia;Slovenia;Spain;Ukraine;Austria;Italy;France;Hungary;Canada;Belgium;Poland;Germany | ||
| 124 | EUCTR2021-000091-11-BE (EUCTR) | 09/12/2021 | 27/07/2021 | A study of PRA023 in patients with Ulcerative Colitis | A Phase 2, Multi-Center, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Induction Therapy with PRA023 in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PRA023 INN or Proposed INN: Not yet assigned Other descriptive name: PRA023 | Prometheus Biosciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 170 | Phase 2 | United States;Czechia;Ukraine;Israel;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Georgia | ||
| 125 | EUCTR2021-002537-41-NL (EUCTR) | 08/12/2021 | 13/10/2021 | Safety and Efficacy of Efavaleukin Alfa in Subjects with Moderately to Severely Active Ulcerative Colitis | A Phase 2, Dose-finding, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Efavaleukin Alfa Induction Therapy in Subjects with Moderately to Severely Active UlcerativeColitis | Moderate to Severe Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Efavaleukin Alfa Product Code: AMG 592 INN or Proposed INN: EFAVALEUKIN ALFA | Amgen Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Phase 2 | United States;Taiwan;Greece;Spain;Ukraine;Russian Federation;Italy;Switzerland;Denmark;Netherlands;Korea, Republic of;Czechia;Finland;Turkey;Austria;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Japan | ||
| 126 | EUCTR2021-001280-24-LT (EUCTR) | 07/12/2021 | 19/08/2021 | Study of VE202 in Patients with Ulcerative Colitis | Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of VE202 in Patients with Mild-to-Moderate Ulcerative Colitis | Mild-to-moderate 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: VE202 Product Code: VE202 INN or Proposed INN: Not applicable Other descriptive name: JNJ-64841829 INN or Proposed INN: Not applicable Other descriptive name: JNJ-64841842 INN or Proposed INN: Not applicable Other descriptive name: JNJ-64841855 INN or Proposed INN: Not applicable Other descriptive name: JNJ-64841894 INN or Proposed INN: Not applicable Other descriptive name: JNJ-64841907 INN or Proposed INN: Not applicable Other descriptive name: JNJ-64841920 INN or Proposed INN: Not applicable Other descriptive name: JNJ-64841933 INN or Proposed INN: Not applicable Other descriptive name: JNJ-64841946 | Vedanta Biosciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 2 | Serbia;United States;Czechia;Hungary;Poland;Ukraine;Lithuania;Bulgaria;Netherlands;United Kingdom | ||
| 127 | EUCTR2021-002537-41-HU (EUCTR) | 06/12/2021 | 25/10/2021 | Safety and Efficacy of Efavaleukin Alfa in Subjects with Moderately to Severely Active Ulcerative Colitis | A Phase 2, Dose-finding, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Efavaleukin Alfa Induction Therapy in Subjects with Moderately to Severely Active UlcerativeColitis | Moderate to Severe Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Efavaleukin Alfa Product Code: AMG 592 INN or Proposed INN: EFAVALEUKIN ALFA | Amgen Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Phase 2 | United States;Czechia;Taiwan;Finland;Korea, Democratic People's Republic of;Ukraine;Turkey;Austria;Russian Federation;Switzerland;Italy;Hungary;Mexico;Canada;Argentina;Poland;Romania;Denmark;Bulgaria;Netherlands;Germany;Japan;Sweden | ||
| 128 | NCT05177835 (ClinicalTrials.gov) | December 3, 2021 | 15/12/2021 | Long-term Safety and Efficacy Profile of ABX464 in Subjects With Moderate to Severe Active Ulcerative Colitis | A Follow-up Phase II Open-label Study to Evaluate the Long-term Safety and Efficacy Profile of ABX464 Given at 25 mg Once Daily in Subjects With Moderate to Severe Active Ulcerative Colitis | Ulcerative Colitis | Drug: ABX464 | Abivax S.A. | NULL | Recruiting | 18 Years | N/A | All | 203 | Phase 2 | Belgium;Czechia;Hungary;Poland |
| 129 | EUCTR2021-002549-13-SK (EUCTR) | 02/12/2021 | 24/08/2021 | A Phase III Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis | A Randomised Double-Blind Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis - CONCLUDE | Moderate to Severe left-sided 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: Cobitolimod INN or Proposed INN: COBITOLIMOD Product Name: Cobitolimod INN or Proposed INN: COBITOLIMOD | InDex Pharmaceuticals AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 440 | Phase 3 | Portugal;Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;France;Australia;Denmark;South Africa;Netherlands;Bosnia and Herzegovina;Czechia;Korea, Democratic People's Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 130 | EUCTR2021-002549-13-LT (EUCTR) | 02/12/2021 | 06/09/2021 | A Phase III Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis | A Randomised Double-Blind Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis - CONCLUDE | Moderate to Severe left-sided 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: Cobitolimod INN or Proposed INN: COBITOLIMOD Product Name: Cobitolimod INN or Proposed INN: COBITOLIMOD | InDex Pharmaceuticals | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 440 | Phase 3 | Portugal;Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;France;Australia;Denmark;South Africa;Netherlands;Bosnia and Herzegovina;Czechia;Korea, Democratic People's Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 131 | EUCTR2021-004398-30-HU (EUCTR) | 01/12/2021 | 08/10/2021 | Effects of ABX464 during long-term treatment in patients with moderate to severe ulcerative colitis. | A follow-up Phase II open-label study to evaluate the long-term safety and efficacy profile of ABX464 given at 25 mg once daily in subjects with Moderate to Severe Active Ulcerative Colitis | Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | ABIVAX | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 203 | Phase 2 | Serbia;Czechia;Slovakia;Slovenia;Spain;Ukraine;Austria;Italy;France;Hungary;Canada;Belgium;Poland;Germany | ||
| 132 | EUCTR2021-001644-10-ES (EUCTR) | 30/11/2021 | 12/08/2021 | Open-label Extension Study of Brazikumab in Ulcerative Colitis | A Phase 2 Open-label, Long-term Extension Safety Study of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis (EXPEDITION OLE) - EXPEDITION OLE | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Brazikumab Product Code: MEDI2070 INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as 'MEDI2070' Product Name: Brazikumab Product Code: MEDI2070 INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as 'MEDI2070' | AstraZeneca AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 2 | United States;Czechia;Taiwan;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Hungary;Canada;Poland;South Africa;Germany;Japan;Korea, Republic of | ||
| 133 | NCT05156125 (ClinicalTrials.gov) | November 30, 2021 | 1/12/2021 | VTX002 Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Clinical Efficacy and Safety of VTX002 in Subjects With Moderately to Severely Active Ulcerative Colitis | Colitis, Ulcerative | Drug: VTX002;Drug: Placebo | Oppilan Pharma Ltd | NULL | Recruiting | 18 Years | 80 Years | All | 180 | Phase 2 | United States;Bulgaria;Czechia;France;Georgia;Germany;Hungary;Italy;Lithuania;Poland;Serbia;Slovakia;Ukraine |
| 134 | NCT05084261 (ClinicalTrials.gov) | November 30, 2021 | 20/9/2021 | An Investigation of Oral BT051 in Subjects With Moderately to Severely Active Ulcerative Colitis (UC) | A Multicenter, Randomized, Placebo-Controlled, Multiple-Ascending-Dose Investigation of the Oral Anti-Inflammatory Agent BT051 in Subjects With Moderately to Severely Active Ulcerative Colitis (UC) | Ulcerative Colitis | Drug: BT051 200 mg;Drug: BT051 800 mg;Drug: BT051 3200 mg;Drug: Matching Placebo | Adiso Therapeutics | NULL | Completed | 18 Years | 75 Years | All | 24 | Phase 1 | United States;Georgia;Moldova, Republic of;Poland;Ukraine |
| 135 | EUCTR2021-004398-30-IT (EUCTR) | 29/11/2021 | 01/10/2021 | Effects of ABX464 during long-term treatment in patients with moderate to severe ulcerative colitis. | A follow-up Phase II open-label study to evaluate the long-term safety and efficacy profile of ABX464 given at 25 mg once daily in subjects with Moderate to Severe Active Ulcerative Colitis - Long-term safety and efficacy follow-up of ABX464 in 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 Name: ABX464 Product Code: [ABX464] INN or Proposed INN: ABX464 | Abivax | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 203 | Phase 2 | Serbia;Czechia;Slovakia;Slovenia;Spain;Ukraine;Austria;Italy;France;Hungary;Canada;Belgium;Poland;Germany | ||
| 136 | EUCTR2021-001644-10-PL (EUCTR) | 24/11/2021 | 14/10/2021 | Open-label Extension Study of Brazikumab in Ulcerative Colitis | A Phase 2 Open-label, Long-term Extension Safety Study of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis (EXPEDITION OLE) - EXPEDITION OLE | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Brazikumab Product Code: MEDI2070 INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as 'MEDI2070' Product Name: Brazikumab Product Code: MEDI2070 INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as 'MEDI2070' | AstraZeneca AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 2 | India;France;Hungary;Canada;Poland;South Africa;Germany;Japan;United States;Czechia;Taiwan;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;Korea, Republic of | ||
| 137 | NCT04985968 (ClinicalTrials.gov) | November 24, 2021 | 22/7/2021 | The Efficacy and Safety of Cobitolimod in Participants With Moderate to Severe Active Left-Sided Ulcerative Colitis | A Randomised Double-Blind Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants With Moderate to Severe Active Left-Sided Ulcerative Colitis | Ulcerative Colitis | Drug: Cobitolimod 250 mg;Drug: Cobitolimod 500 mg;Drug: Placebo | InDex Pharmaceuticals | NULL | Recruiting | 18 Years | N/A | All | 440 | Phase 3 | United States;Australia;Austria;Belgium;Bosnia and Herzegovina;Brazil;Canada;Croatia;Denmark;France;Georgia;Germany;Hungary;Israel;Italy;Korea, Republic of;Lithuania;Mexico;Netherlands;Norway;Poland;Portugal;Romania;Serbia;Slovakia;Sweden;Turkey;United Kingdom;Korea, Democratic People's Republic of |
| 138 | NCT05404074 (ClinicalTrials.gov) | November 22, 2021 | 17/5/2022 | Pharmacokinetics of Cobitolimod Enemas in Participants With Active Ulcerative Colitis | Pharmacokinetics of Cobitolimod Enemas in Participants With Active Ulcerative Colitis | Ulcerative Colitis | Drug: Cobitolimod 500mg | InDex Pharmaceuticals | NULL | Recruiting | 18 Years | N/A | All | 6 | Phase 1 | Sweden |
| 139 | EUCTR2021-002549-13-IT (EUCTR) | 22/11/2021 | 19/10/2021 | A Phase III Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis | A Randomised Double-Blind Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis - CONCLUDE | Moderate to Severe left-sided 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: Cobitolimod Product Code: [-] INN or Proposed INN: Cobitolimod Product Name: Cobitolimod Product Code: [-] INN or Proposed INN: Cobitolimod | INDEX PHARMACEUTICALS AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 440 | Phase 3 | Portugal;Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 140 | EUCTR2018-001605-93-HU (EUCTR) | 22/11/2021 | 05/05/2020 | Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis | A 54-Week, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis (Expedition Lead-in) - Phase 2 Dose-finding UC Study | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Brazikumab Product Code: MEDI2070 INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as MEDI2070 Product Name: Brazikumab Product Code: MEDI2070 INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as MEDI2070 | AstraZeneca AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 255 | Phase 2 | United States;Czechia;Taiwan;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;South Africa;Germany;Japan;Korea, Republic of | ||
| 141 | EUCTR2021-003050-23-HU (EUCTR) | 22/11/2021 | 01/10/2021 | VTX002 versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis | A Phase 2, Multicenter, Randomized, Double-Blind,Placebo-Controlled, Parallel-Group Study to Evaluate the Clinical Efficacy and Safety of VTX002 in Subjects with Moderately to Severely Active Ulcerative Colitis | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: VTX002 INN or Proposed INN: not yet available Other descriptive name: VTX002 is not biologic Product Code: VTX002 INN or Proposed INN: not yet available Other descriptive name: VTX002 is not biologic Product Code: VTX002 INN or Proposed INN: not yet available Other descriptive name: VTX002 is not biologic Product Code: VTX002 INN or Proposed INN: not yet available Other descriptive name: VTX002 is not biologic | Oppilan Pharma Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 2 | Belarus;United States;Czechia;Ukraine;Lithuania;Israel;Russian Federation;Italy;Hungary;Czech Republic;Poland;Georgia;Germany | ||
| 142 | EUCTR2020-004355-33-CZ (EUCTR) | 18/11/2021 | 01/07/2021 | First-in-human Study of MH002 in Subjects with Mild to Moderate Ulcerative Colitis | Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety, Mechanistic Effects, and Effects on Disease Activity of MH002 in Subjects with Mild to Moderate Ulcerative Colitis: A First-in-human Study - First-in-human Study of MH002 in Subjects with Mild to Moderate Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MH002 Product Code: MH002 | MRM Health NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 45 | Phase 1;Phase 2 | Czech Republic;Belgium | ||
| 143 | EUCTR2020-001811-26-BE (EUCTR) | 18/11/2021 | 22/07/2021 | IBD under control with less medication | De-escalation of anti-TNF therapy in adolescents and young adults with IBD with tight faecal calprotectin and trough level monitoring - FREE-study | Crohn's disease, ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remicade INN or Proposed INN: INFLIXIMAB Trade Name: Flixabi INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra INN or Proposed INN: INFLIXIMAB Trade Name: Remsima INN or Proposed INN: INFLIXIMAB Trade Name: Zessly INN or Proposed INN: INFLIXIMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Amgevita INN or Proposed INN: ADALIMUMAB Trade Name: Hulio INN or Proposed INN: ADALIMUMAB | University Medical Center Groningen | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 148 | Phase 4 | Belgium;Netherlands | ||
| 144 | NCT05088369 (ClinicalTrials.gov) | November 11, 2021 | 12/10/2021 | Assessment of the Safety, Tolerability, and Pharmacokinetic of HM201 | A First-in-human, Double-blind, Placebo-controlled, Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Intravenous Doses of HM201 (Pegylated Human Adrenomedullin) in Healthy Subjects (Adults) | Ulcerative Colitis;Crohn's Disease | Drug: HM201;Drug: Placebo | Syneos Health | Himuka AM Pharma Corp. | Completed | 18 Years | 55 Years | All | 53 | Phase 1 | Australia |
| 145 | NCT04968951 (ClinicalTrials.gov) | November 10, 2021 | 9/7/2021 | Refined Fecal Microbiota Transplantation (FMT) for Ulcerative Colitis (UC) | REFOCUS: Refined Fecal Microbiota Transplantation (FMT) Delivered by Oral Capsules for Induction of Remission in Mild to Moderate Ulcerative Colitis - a Phase I Study | Ulcerative Colitis;FMT;Fecal Microbiota Transplant | Drug: Metronidazole;Drug: Placebo;Drug: Vancomycin;Biological: Fecal Microbiota Transplantation | Ari M Grinspan | NULL | Recruiting | 18 Years | 75 Years | All | 20 | Early Phase 1 | United States |
| 146 | EUCTR2021-000091-11-IT (EUCTR) | 08/11/2021 | 02/09/2021 | A study of efficacy of PRA023 in patients with Ulcerative Colitis | A Phase 2, Multi-Center, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Induction Therapy with PRA023 in Subjects with Moderately to Severely Active Ulcerative Colitis - ARTEMIS-UC Study | Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PRA023 Product Code: [PRA023] Other descriptive name: PRA023 | Prometheus Biosciences Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 170 | Phase 2 | Belarus;United States;Czechia;Ukraine;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Georgia;Bulgaria | ||
| 147 | NCT05181137 (ClinicalTrials.gov) | November 5, 2021 | 10/12/2021 | A Phase 3 Study to Investigate the Efficacy and Safety of SHR0302 With Moderately to Severely Active Ulcerative Colitis | A Phase 3 Study to Evaluate the Efficacy and Long-term Safety of SHR0302 Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Drug: SHR0302;Drug: Placebo | Reistone Biopharma Company Limited | NULL | Recruiting | 18 Years | 75 Years | All | 368 | Phase 3 | United States;China;Georgia;Poland;Ukraine |
| 148 | NCT04855799 (ClinicalTrials.gov) | November 2, 2021 | 20/4/2021 | GI Permeability Change in Response to Aquamin® | Direct Measurement of Gastrointestinal Permeability Change in Response to Aquamin® | Ulcerative Colitis;Healthy;Irritable Bowel Syndrome With Diarrhea | Drug: Aquamin | James Varani | NULL | Recruiting | 18 Years | 80 Years | All | 30 | Phase 2 | United States |
| 149 | NCT04999228 (ClinicalTrials.gov) | November 1, 2021 | 5/8/2021 | Top Down Versus Step up in Pediatric Ulcerative Colitis | First-line Treatment With Infliximab Versus Corticosteroids in Children With Newly Diagnosed Moderate to Severe Ulcerative Colitis | Ulcerative Colitis;Infliximab;Children | Drug: Infliximab;Drug: Corticosteroids | Children's Hospital of Fudan University | NULL | Recruiting | 6 Years | 18 Years | All | 40 | Phase 4 | China |
| 150 | NCT04626947 (ClinicalTrials.gov) | October 30, 2021 | 29/9/2020 | Prevention of Recurrent Clostridium Difficile Infection (CDI) in Patients With Inflammatory Bowel Disease (IBD). | Prevention of Recurrent Clostridium Difficile Infection (CDI) in Patients With Inflammatory Bowel Disease (IBD). | Inflammatory Bowel Diseases;Ulcerative Colitis;Crohn Disease;C. Diff. Infections | Biological: Bezlotoxumab | David Binion, MD | Merck Sharp & Dohme LLC | Recruiting | 18 Years | N/A | All | 50 | Phase 4 | United States |
| 151 | EUCTR2020-004457-76-PL (EUCTR) | 28/10/2021 | 15/09/2021 | A Long-term Extension Study of Ustekinumab in Pediatric Participants with different medical conditions. | A Phase 3, Multicenter, Open-label, Basket, Long-term Extension Study of Ustekinumab in Pediatric Clinical Study Participants (2 to <18 Years of Age) - UNITED | Paediatric conditions in - Moderately to Severely Active Crohn's Disease - Moderately to Severely Active Ulcerative Colitis - Juvenile Psoriatic Arthritis 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 MedDRA version: 20.0;Classification code 10076674;Term: Juvenile psoriatic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 3 | United States;Spain;Turkey;Russian Federation;Italy;United Kingdom;France;Hungary;Argentina;Poland;Belgium;Germany;Japan | ||
| 152 | JPRN-jRCT2041200098 | 28/10/2021 | 02/02/2021 | A Study of Ustekinumab in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis (UC) | A Phase 3 Study of the Efficacy, Safety and Pharmacokinetics of Ustekinumab as Openlabel Intravenous Induction Treatment Followed by Randomized Double-blind Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis | Colitis, Ulcerative | -Ustekinumab Dose Based on BSA and Body Weight As per BSA and body weight Ustekinumab will be administered SC and IV. Induction Period (I):Ustekinumab Maintenance (M) Period: Ustekinumab once every 8 Week (q8w) Maintenance (M) Period: Ustekinumab once every 12 Week (q12w) -Matching Placebo Placebo will be administered subcutaneously. Maintenance (M) Period: Ustekinumab once every 8 Week (q8w) Maintenance (M) Period: Ustekinumab once every 12 Week (q12w) | Nishikawa Kazuko | NULL | Recruiting | >= 2age old | < 18age old | Both | 100 | Phase 3 | United States Of America;Belgium;Germany;Hungary;Poland;Russian Federation;United Kingdom Of Great Britain And Northern Irela;Japan |
| 153 | EUCTR2021-003050-23-CZ (EUCTR) | 25/10/2021 | 18/08/2021 | VTX002 versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis | A Phase 2, Multicenter, Randomized, Double-Blind,Placebo-Controlled, Parallel-Group Study to Evaluate the Clinical Efficacy and Safety of VTX002 in Subjects with Moderately to Severely Active Ulcerative Colitis | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: VTX002 INN or Proposed INN: not yet available Other descriptive name: VTX002 is not biologic Product Code: VTX002 INN or Proposed INN: not yet available Other descriptive name: VTX002 is not biologic Product Code: VTX002 INN or Proposed INN: not yet available Other descriptive name: VTX002 is not biologic Product Code: VTX002 INN or Proposed INN: not yet available Other descriptive name: VTX002 is not biologic | Oppilan Pharma Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 2 | Belarus;United States;Czechia;Ukraine;Lithuania;Israel;Russian Federation;Italy;Czech Republic;Hungary;Poland;Georgia;Germany | ||
| 154 | EUCTR2021-001644-10-AT (EUCTR) | 22/10/2021 | 13/08/2021 | Open-label Extension Study of Brazikumab in Ulcerative Colitis | A Phase 2 Open-label, Long-term Extension Safety Study of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis (EXPEDITION OLE) - EXPEDITION OLE | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Brazikumab Product Code: MEDI2070 INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as 'MEDI2070' Product Name: Brazikumab Product Code: MEDI2070 INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as 'MEDI2070' | AstraZeneca AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 2 | United States;Czechia;Taiwan;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Hungary;Canada;Poland;South Africa;Germany;Japan;Korea, Republic of | ||
| 155 | EUCTR2021-002537-41-IT (EUCTR) | 21/10/2021 | 26/01/2022 | Safety and Efficacy of Efavaleukin Alfa in Subjects with Moderately to Severely Active Ulcerative Colitis | A Phase 2, Dose-Finding, Randomized, Double-Blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Efavaleukin Alfa Induction Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis. - - | Moderate to Severe Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Efavaleukin Alfa Product Code: [AMG 592] INN or Proposed INN: EFAVALEUKIN ALFA | AMGEN INC. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Phase 2 | United States;Czechia;Taiwan;Finland;Ukraine;Korea, Democratic People's Republic of;Turkey;Austria;Russian Federation;Switzerland;Italy;Hungary;Mexico;Canada;Argentina;Poland;Romania;Denmark;Bulgaria;Germany;Netherlands;Japan;Sweden | ||
| 156 | EUCTR2021-000091-11-CZ (EUCTR) | 20/10/2021 | 22/04/2021 | A study of PRA023 in patients with Ulcerative Colitis | A Phase 2, Multi-Center, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Induction Therapy with PRA023 in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PRA023 INN or Proposed INN: Not yet assigned Other descriptive name: PRA023 | Prometheus Biosciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 170 | Phase 2 | United States;Czechia;Ukraine;Russian Federation;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Bulgaria;Georgia | ||
| 157 | EUCTR2021-002549-13-DE (EUCTR) | 20/10/2021 | 28/06/2021 | A Phase III Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis | A Randomised Double-Blind Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis - CONCLUDE | Moderate to Severe left-sided 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: Cobitolimod INN or Proposed INN: COBITOLIMOD Product Name: Cobitolimod INN or Proposed INN: COBITOLIMOD | InDex Pharmaceuticals | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 440 | Phase 3 | Portugal;Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;France;Australia;Denmark;South Africa;Netherlands;Bosnia and Herzegovina;Czechia;Korea, Democratic People's Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Norway;Germany;New Zealand;Sweden | ||
| 158 | JPRN-jRCT2071210030 | 19/10/2021 | 31/05/2021 | A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Ulcerative Colitis | A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy | Colitis, Ulcerative | Induction Period: Participants >=30 kg, Vedolizumab 300 mg Vedolizumab 300 mg, intravenous (IV) infusion, at Day 1, Weeks 2 and 6 in the Induction Period. Participants with UC having Baseline weight of >=30 kg were included in this arm. Induction Period: Participants >15 to <30 kg, Vedolizumab 200 mg Vedolizumab 200 mg, IV infusion, at Day 1, Weeks 2 and 6 in the Induction Period. Participants with UC having Baseline weight of >15 to <30 kg were included in this arm. Induction Period: Participants 10 to 15 kg, Vedolizumab 150 mg Vedolizumab 150 mg, IV infusion, at Day 1, Weeks 2 and 6 in the Induction Period. Participants with UC having Baseline weight of 10 to 15 kg were included in this arm. Maintenance Period: Participants >=30 kg, Vedolizumab 300 mg Vedolizumab 300 mg, IV infusion, once every 8 weeks (Q8W) from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of >=30 kg who achieved clinical response at Week 14 randomized to this high dose arm group will receive vedolizumab 300 mg. Maintenance Period: Participants >=30 kg, Vedolizumab 150 mg Vedolizumab 150 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of >=30 kg who achieved clinical response at Week 14 randomized to this low dose arm group will receive vedolizumab 150 mg. Maintenance Period: Participants >15 to <30 kg, Vedolizumab 200 mg Vedolizumab 200 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of >15 to <30 kg who achieved clinical response at Week 14 randomized to this high dose arm group will receive vedolizumab 200 mg. Maintenance Period: Participants >15 to <30 kg, Vedolizumab 100 mg Vedolizumab 100 mg, IV infusion, Q8W from Week 14 up to Wee | Shikamura Mitsuhiro | NULL | Recruiting | >= 2age old | <= 17age old | Both | 120 | Phase 3 | United States;Belgium;Bosnia;Croatia;Australia;Canada;Czech Republic;Germany;Hungary;Italy;Lithuania;Poland;New Zealand;Romania;Russia;Slovakia;Spain;United Kingdom;Israel;China;Ukraine;Japan |
| 159 | JPRN-jRCT2071210052 | 16/10/2021 | 19/08/2021 | Etrasimod Dose-Ranging Versus Placebo as Induction Therapy inModerately to Severely Active Ulcerative Colitis | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, 12-WeekDose-Ranging Study to Assess the Efficacy and Safety of Etrasimod inJapanese Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative colitis | Eligible subjects will be randomized (1:1:1ratio) to receive either etrasimod (dose A), etrasimod (dose B), or matching placebo (once daily) in a double-blind fashion for 12 weeks | Tanabe Masakazu | NULL | Recruiting | >= 20age old | <= 80age old | Both | 96 | Phase 2 | Japan |
| 160 | NCT04924114 (ClinicalTrials.gov) | October 14, 2021 | 26/2/2021 | A Study of MK-6194 (PT101) in Participants With Active Ulcerative Colitis (UC) (MK-6194-002) | A Phase 1b, Randomized, Adaptive, Double-Blind, Placebo-Controlled, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of PT101 in Subjects With Active Ulcerative Colitis | Ulcerative Colitis | Drug: MK-6194;Drug: MK-6194-matching placebo | Merck Sharp & Dohme LLC | NULL | Recruiting | 18 Years | 80 Years | All | 30 | Phase 1 | United States;Georgia;Germany;Hungary;Moldova, Republic of;Poland;Ukraine;United Kingdom |
| 161 | EUCTR2020-004300-34-IT (EUCTR) | 13/10/2021 | 30/08/2021 | A study to evaluate efficacy and safety of Vedolizumab in pediatric subjects with moderately to severely active Ulcerative Colitis | A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open–Label Vedolizumab Intravenous Therapy - NA | Moderately to severely active Ulcerative Colitis (UC) 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 - 300 MG - POLVERE PE RCONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO (VETRO) (20ML) - 1 FLACONCINO Product Name: Vedolizumab Product Code: [NA] INN or Proposed INN: Vedolizumab Other descriptive name: MLN0002 | TAKEDA DEVELOPMENT CENTER AMERICAS INC. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 3 | United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;China;Bosnia and Herzegovina;Czechia;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Romania;Germany;New Zealand;Japan | ||
| 162 | EUCTR2021-001280-24-HU (EUCTR) | 13/10/2021 | 18/08/2021 | Study of VE202 in Patients with Ulcerative Colitis | Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of VE202 in Patients with Mild-to-Moderate Ulcerative Colitis | Mild-to-moderate 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: VE202 Product Code: VE202 INN or Proposed INN: Not applicable Other descriptive name: JNJ-72537634 | Vedanta Biosciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 2 | United States;Czechia;Hungary;Poland;Ukraine;Lithuania;Russian Federation;Netherlands | ||
| 163 | NCT05058417 (ClinicalTrials.gov) | October 1, 2021 | 16/9/2021 | Assessment of Empagliflozin as Adjuvant Therapy in Patients With Ulcerative Colitis | Assessment of Empagliflozin as Adjuvant Therapy in Patients With Ulcerative Colitis | Ulcerative Colitis | Drug: Empagliflozin 10 MG;Drug: Placebo | Sadat City University | NULL | Recruiting | 18 Years | 60 Years | All | 50 | Phase 2 | Egypt |
| 164 | NCT03843385 (ClinicalTrials.gov) | October 2021 | 14/2/2019 | Transfer of FRozen Encapsulated Multidonor Stool Filtrate for Active Ulcerative COlitis | Longterm Transfer of FRozen Encapsulated Multidonor Stool Filtrate or Encapsulated Multidonor Microbiome for Chronic Active Ulcerative COlitis | Ulcerative Colitis;Inflammatory Bowel Diseases | Drug: encapsulated faecal microbiota filtrate;Drug: encapsulated faecal microbiota;Drug: Placebo | Jena University Hospital | German Federal Ministry of Education and Research | Not yet recruiting | 18 Years | 75 Years | All | 174 | Phase 2/Phase 3 | NULL |
| 165 | NCT04857112 (ClinicalTrials.gov) | September 29, 2021 | 19/4/2021 | Study Evaluating Efficacy and Safety of Amiselimod (MT-1303) in Mild to Moderate Ulcerative Colitis | A Phase 2, Randomized, Double-Blinded, Placebo Controlled, Parallel Group Study Evaluating the Efficacy and Safety of Amiselimod (MT-1303) in Subjects With Mild to Moderate Ulcerative Colitis (UC) | Ulcerative Colitis | Drug: Low Dose MT-1303;Drug: High Dose MT-1303;Drug: Placebo | Bausch Health Americas, Inc. | NULL | Recruiting | 18 Years | 75 Years | All | 336 | Phase 2 | United States |
| 166 | EUCTR2021-002549-13-HU (EUCTR) | 24/09/2021 | 23/07/2021 | A Phase III Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis | A Randomised Double-Blind Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis - CONCLUDE | Moderate to Severe left-sided 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: Cobitolimod INN or Proposed INN: COBITOLIMOD Product Name: Cobitolimod INN or Proposed INN: COBITOLIMOD | InDex Pharmaceuticals | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 440 | Phase 3 | Portugal;Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;France;Australia;Denmark;South Africa;Netherlands;Bosnia and Herzegovina;Czechia;Korea, Democratic People's Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 167 | NCT04767984 (ClinicalTrials.gov) | September 24, 2021 | 23/2/2021 | Testing Atorvastatin to Lower Colon Cancer Risk in Longstanding Ulcerative Colitis | A Randomized and Placebo-Controlled Phase II Trial Targeting Dominant-Negative Missense Mutant P53 by Atorvastatin for Reducing the Risk of Longstanding Ulcerative Colitis-Associated Cancer | Colorectal Carcinoma;Ulcerative Colitis | Drug: Atorvastatin Calcium;Procedure: Biopsy of Colon;Procedure: Biospecimen Collection;Drug: Placebo Administration;Other: Questionnaire Administration | National Cancer Institute (NCI) | NULL | Recruiting | 18 Years | 70 Years | All | 70 | Phase 2 | United States |
| 168 | EUCTR2019-002485-12-IT (EUCTR) | 23/09/2021 | 22/10/2020 | Determination of the Optimal Treatment Target in Ulcerative Colitis | VERDICT: In actiVE ulcerative colitis, a RanDomIzed Controlled Trial for determination of the optimal treatment target - VERDICT | Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entyvio Product Name: Entyvio Product Code: [NA] Other descriptive name: VEDULIZUMAB Trade Name: Entyvio Product Name: Entyvio Product Code: [NA] Other descriptive name: VEDOLIZUMAB | ALIMENTIV INC. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 660 | Phase 4 | United States;France;Belarus;Canada;Poland;Belgium;Ukraine;Russian Federation;Netherlands;United Kingdom;Italy | ||
| 169 | EUCTR2020-004355-33-BE (EUCTR) | 23/09/2021 | 08/06/2021 | First-in-human Study of MH002 in Subjects with Mild to Moderate Ulcerative Colitis | Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety, Mechanistic Effects, and Effects on Disease Activity of MH002 in Subjects with Mild to Moderate Ulcerative Colitis: A First-in-human Study - First-in-human Study of MH002 in Subjects with Mild to Moderate Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MH002 Product Code: MH002 | MRM Health NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 45 | Phase 1;Phase 2 | Belgium | ||
| 170 | EUCTR2020-004300-34-SK (EUCTR) | 18/09/2021 | 28/04/2021 | A study to evaluate efficacy and safety of Vedolizumab in pediatric subjects with moderately to severely active Ulcerative Colitis | A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open–Label Vedolizumab Intravenous Therapy | Moderately to severely active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: ENTYVIO INN or Proposed INN: Vedolizumab Other descriptive name: MLN0002 | Takeda Development Center Americas, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 3 | United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;China;Bosnia and Herzegovina;Czechia;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Romania;Germany;New Zealand;Japan | ||
| 171 | JPRN-jRCT2051210087 | 17/09/2021 | 22/09/2021 | Safety and pharmacokinetics study in healthy Japanese volunteers | A Phase 1 study to assess the safety, tolerability and pharmacokinetics after single and multiple doses of ABX464 capsules in healthy Japanese volunteers. - Safety and pharmacokinetics study in healthy Japanese volunteers | Ulcerative colitis | Part A Part A includes the following two dose regimen groups: - 25 mg dose regimen group: ABX464 25 mg or placebo - 50 mg dose regimen group: ABX464 50 mg or placebo In each dose regimen group, 12 subjects will be randomly assigned, according to a 3:1 ratio, to receive either ABX464 (9 subjects) or its matching placebo (3 subjects). Enrolment will start with the 25 mg dose regimen group. Following a blinded review of available safety data by the DSMB after the subjects of the first dose regimen have received the study treatment (ABX464, 9 subjects and placebo, 3 subjects), the 50 mg dose regimen group will open for enrolment and receive the study treatment. For each dose regimen group, subjects will be admitted to the study center on D?1, administered the study treatment on D1, orally in the morning in the standardized fed conditions, and discharged from the study center on D4 after completion of study assessments. Subjects will visit the study center on D8 and D15 (End of Study [EoS] visit) for PK and safety assessments. Body weight, vital signs, laboratory parameters including renal and hepatic markers, will be evaluated at screening and at each visit to the study center. Part B Following a blinded review of available safety and PK data by the DSMB after the subjects of part A have received the study treatment (ABX464 or placebo), the part B will start for enrolment. Part B includes the following two dose regimen groups: - 25 mg dose regimen group: ABX464 25 mg or placebo for 28 days - 50 mg dose regimen group: ABX464 50 mg or placebo for 28 days In each dose regimen group, 12 subjects will be randomly assigned, according to a 3:1 ratio, to receive either ABX464 (9 subjects) or its matching placebo (3 subjects). Enrolment will start with the 25 mg dose regimen. | Owada Yasuko | NULL | Pending | >= 20age old | <= 45age old | Male | 48 | Phase 1 | Japan |
| 172 | EUCTR2020-004461-40-IT (EUCTR) | 15/09/2021 | 18/10/2021 | Long-term Safety and Efficacy of BMS-986165 in Participants with Crohn's Disease or Ulcerative Colitis | An Open-label, Multi-center Extension Study to Evaluate the Long-term Safety and Efficacy of BMS-986165 in Participants with Moderate to Severe Crohn's Disease or Moderate to Severe Ulcerative Colitis - - | moderate to severe Crohn's Disease (CD), moderate to severe Ulcerative Colitis (UC) 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] - Immune System Diseases [C20] | Product Name: deucravacitinib Product Code: [BMS-986165] INN or Proposed INN: deucravacitinib | BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 2 | United States;Portugal;Taiwan;Spain;Ireland;Russian Federation;Israel;Italy;Switzerland;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;United Kingdom;Hungary;Mexico;Canada;Belgium;Brazil;Poland;Romania;Germany;Japan | ||
| 173 | EUCTR2021-000091-11-HU (EUCTR) | 13/09/2021 | 17/04/2021 | A study of PRA023 in patients with Ulcerative Colitis | A Phase 2, Multi-Center, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Induction Therapy with PRA023 in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PRA023 INN or Proposed INN: Not yet assigned Other descriptive name: PRA023 | Prometheus Biosciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 170 | Phase 2 | Belarus;United States;Czechia;Ukraine;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Australia;Georgia | ||
| 174 | EUCTR2021-001940-86-PL (EUCTR) | 11/09/2021 | 09/08/2021 | A phase 3 Study to Evaluate the Efficacy and Safety of SHR0302 in Ulcerative Colitis. | A Phase 3 Study to Evaluate the Efficacy and Long-term Safety of SHR0302 for Induction, Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis | Moderately to severely active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: SHR0302 tablets Product Code: SHR0302 INN or Proposed INN: SHR0302 | Reistone Biopharma Company Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 368 | Phase 3 | United States;Poland;Ukraine;Georgia;China | ||
| 175 | NCT05061446 (ClinicalTrials.gov) | September 10, 2021 | 20/9/2021 | Etrasimod Dose-Ranging Versus Placebo as Induction Therapy Study in Adult Japanese Subjects With Moderately to Severely Active Ulcerative Colitis | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, 12-Week Dose-Ranging Study to Assess the Efficacy and Safety of Etrasimod in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Drug: Etrasimod;Drug: Placebo | Pfizer | Arena is a wholly owned subsidiary of Pfizer | Recruiting | 18 Years | 80 Years | All | 96 | Phase 2 | Japan |
| 176 | NCT05030064 (ClinicalTrials.gov) | September 10, 2021 | 9/8/2021 | Clinical Study on the Fecal Microbiota Transplantation in the Treatment of Ulcerative Colitis With Depression | Clinical Study on the Efficacy and Safety of Fecal Microbiota Transplantation in the Treatment of Ulcerative Colitis With Depression | Ulcerative Colitis | Drug: Intestinal flora capsule;Procedure: placebo capsule | Third Military Medical University | NULL | Recruiting | 18 Years | 65 Years | All | 54 | N/A | China |
| 177 | EUCTR2021-002549-13-SE (EUCTR) | 07/09/2021 | 16/06/2021 | A Phase III Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis | A Randomised Double-Blind Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis - CONCLUDE | Moderate to Severe left-sided 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: Cobitolimod INN or Proposed INN: COBITOLIMOD Product Name: Cobitolimod INN or Proposed INN: COBITOLIMOD | InDex Pharmaceuticals | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 440 | Phase 3 | Portugal;Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;France;Australia;Denmark;South Africa;Netherlands;Bosnia and Herzegovina;Czechia;Korea, Democratic People's Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 178 | NCT04979832 (ClinicalTrials.gov) | September 6, 2021 | 30/6/2021 | GM-CSF, Fosfomycin and Metronidazole for Pouchitis in Ulcerative Colitis Patients After Restorative IPAA Surgery | A Combined Treatment With GM-CSF, Fosfomycin and Metronidazole for Pouchitis in Ulcerative Colitis Patients After Restorative Ileal Pouch Anal Anastomosis Surgery | Pouchitis | Drug: GM-CSF, fosfomycin and metronidazole | Zealand University Hospital | NULL | Recruiting | 18 Years | N/A | All | 18 | Phase 1/Phase 2 | Denmark |
| 179 | EUCTR2018-003524-36-NO (EUCTR) | 06/09/2021 | 16/06/2021 | Randomized, mulitcenter study to investigate how infliximab dosing calculated by a computer compares to the standard dosing during the induction of infliximab in patients with severe colitis ulcerosa. | Randomized, Multicenter Study to Investigate the Efficacy of Dashboard Driven Individualized Dosing of Infliximab Compared To Standard Dosing During the Induction in Patients with Acute Severe Ulcerative Colitis - TITRATE | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remicade Trade Name: Metoject Trade Name: Puri-Nethol Trade Name: Remsima Trade Name: Inflectra | UMC Amsterdam location AMC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 124 | Phase 4 | France;Ireland;Netherlands;Norway;United Kingdom | ||
| 180 | EUCTR2021-003023-14-SE (EUCTR) | 02/09/2021 | 23/06/2021 | Pharmacokinetics of Cobitolimod Enemas in Participants with active Ulcerative Colitis | Pharmacokinetics of Cobitolimod Enemas in Participants with active Ulcerative Colitis | Moderate to Severe Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: DIMS0150 INN or Proposed INN: Cobitolimod Other descriptive name: DIMS0150 | InDex Pharmaceuticals AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 1;Phase 2 | Sweden | ||
| 181 | NCT04908644 (ClinicalTrials.gov) | August 18, 2021 | 25/5/2021 | MS-20 on Patients With Ulcerative Colitis(UC) | Study to Evaluate Efficacy and Safety of MS 20 on Patients With Ulcerative Colitis | Ulcerative Colitis | Drug: MS-20 oral solution;Other: Placebo | National Taiwan University Hospital | Microbio Co Ltd | Recruiting | 20 Years | 65 Years | All | 40 | N/A | Taiwan |
| 182 | EUCTR2020-004300-34-HR (EUCTR) | 18/08/2021 | 02/09/2021 | A study to evaluate efficacy and safety of Vedolizumab in pediatric subjects with moderately to severely active Ulcerative Colitis | A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open–Label Vedolizumab Intravenous Therapy | Moderately to severely active Ulcerative Colitis (UC) 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: Vedolizumab INN or Proposed INN: Vedolizumab Other descriptive name: MLN0002 | Takeda Development Center Americas, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 3 | United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;China;Bosnia and Herzegovina;Czechia;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Romania;Germany;New Zealand;Japan | ||
| 183 | EUCTR2020-005232-30-SK (EUCTR) | 17/08/2021 | 09/06/2021 | Effects of Amiselimod in patients with mild to moderate Ulcerative Colitis. | A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Parallel Group Study Evaluating the Efficacy and Safety of Amiselimod (MT-1303) in Subjects with Mild to Moderate Ulcerative Colitis (UC) | 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: Amiselimod Product Code: MT-1303 INN or Proposed INN: amiselimod Other descriptive name: MT-1303 Product Name: Amiselimod Product Code: MT-1303 INN or Proposed INN: amiselimod Other descriptive name: MT-1303 | Salix Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 336 | Phase 2 | Serbia;United States;Belarus;Czechia;Taiwan;Estonia;Slovakia;Ukraine;Russian Federation;Italy;Hungary;Poland;Australia;Georgia;Bulgaria;Germany;Moldova, Republic of;Japan;Korea, Republic of | ||
| 184 | JPRN-jRCT2031210210 | 16/08/2021 | 28/07/2021 | A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease | A master protocol for a Phase 3, multicenter, open-label, long-term extension study to evaluate the long-term efficacy and safety of mirikizumab in children and adolescents with moderate-to-severe ulcerative colitis or Crohn's Disease - I6T-MC-AMAZ | Ulcerative Colitis / Crohn's Disease - | Drug: Mirikizumab Administered SC Other Name: LY3074828 | Yoshimoto Yusuke | NULL | Recruiting | Not applicable | Not applicable | Both | 5 | Phase 3 | United States;Japan |
| 185 | EUCTR2021-002211-65-ES (EUCTR) | 13/08/2021 | 11/06/2021 | EFFECT OF TOFACITINIB ON COAGULATION | EFFECT OF TOFACITINIB ON COAGULATION AND PLATELET FUNCTION, AND ITS ROLE IN THROMBOEMBOLIC EVENTS | ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Level: PT;Classification code 10009790;Term: Coagulation time;System Organ Class: 10022891 - Investigations MedDRA version: 21.0;Classification code 10061684;Term: Platelet function test;System Organ Class: 10022891 - Investigations;Therapeutic area: Body processes [G] - Biological Phenomena [G16] | Trade Name: Adalimumab INN or Proposed INN: ADALIMUMAB Trade Name: Infliximab INN or Proposed INN: INFLIXIMAB Trade Name: Golimumab INN or Proposed INN: GOLIMUMAB Trade Name: Tofacitinib INN or Proposed INN: TOFACITINIB | Fundación Española de Gastroenterología | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 4 | Spain | ||
| 186 | JPRN-jRCT2071210075 | 12/08/2021 | 07/10/2021 | Evaluation of Oral Tofacitinib in Children Aged 2 to 17 Years Old Suffering From Moderate to Severe Ulcerative Colitis | OPEN-LABEL INDUCTION AND MAINTENANCE STUDY OF ORAL CP-690,550 (TOFACITINIB) IN CHILDREN WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS | Ulcerative Colitis | Drug: tofacitinib Open label tofacitinib 5 mg BID weight based adult equivalent with the option for individual dose increase to 10 mg BID weight based adult equivalent for a limited time if dose escalation criteria are met, prior to returning to 5 mg BID. | Kawai Norisuke | NULL | Recruiting | >= 2age old | <= 17age old | Both | 120 | Phase 3 | Australia;Canada;United States;Japan |
| 187 | NCT04624230 (ClinicalTrials.gov) | August 12, 2021 | 26/10/2020 | Evaluation of Oral Tofacitinib in Children Aged 2 to 17 Years Old Suffering From Moderate to Severe Ulcerative Colitis | OPEN-LABEL INDUCTION AND MAINTENANCE STUDY OF ORAL CP-690,550 (TOFACITINIB) IN CHILDREN WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS | Ulcerative Colitis | Drug: tofacitinib | Pfizer | NULL | Recruiting | 2 Years | 17 Years | All | 120 | Phase 3 | United States;Australia;Belgium;Canada;Finland;France;Germany;Hungary;Israel;Italy;Japan;Netherlands;Poland;Slovakia;Spain;Sweden;United Kingdom |
| 188 | EUCTR2020-003420-16-ES (EUCTR) | 11/08/2021 | 23/06/2021 | A study comparing two different therapeutic approaches in the treatment of moderate to severe ulcerative colitis. | SPRINT: AN OPEN-LABEL, MULTICENTER STUDY TO EVALUATE STEP-UP VS TOP-DOWN TREATMENT ALGORITHMS IN MODERATE TO SEVERE ULCERATIVE COLITIS - SPRINT | Moderate to severe ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Amgevita INN or Proposed INN: ADALIMUMAB Other descriptive name: Amgevita | Instituto Clinico Humanitas | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 350 | Phase 4 | Portugal;France;Belgium;Spain;Austria;Germany;United Kingdom;Switzerland;Italy;Sweden | ||
| 189 | EUCTR2021-000091-11-PL (EUCTR) | 06/08/2021 | 20/05/2021 | A study of PRA023 in patients with Ulcerative Colitis | A Phase 2, Multi-Center, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Induction Therapy with PRA023 in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PRA023 INN or Proposed INN: Not yet assigned Other descriptive name: PRA023 | Prometheus Biosciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 170 | Phase 2 | United States;Czechia;Ukraine;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Georgia | ||
| 190 | EUCTR2020-004300-34-HU (EUCTR) | 06/08/2021 | 28/04/2021 | A study to evaluate efficacy and safety of Vedolizumab in pediatric subjects with moderately to severely active Ulcerative Colitis | A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open–Label Vedolizumab Intravenous Therapy | Moderately to severely active Ulcerative Colitis (UC) 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: Vedolizumab INN or Proposed INN: Vedolizumab Other descriptive name: MLN0002 | Takeda Development Center Americas, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 3 | United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;China;Bosnia and Herzegovina;Czechia;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Romania;Germany;New Zealand;Japan | ||
| 191 | EUCTR2020-005232-30-DE (EUCTR) | 05/08/2021 | 29/04/2021 | Effects of Amiselimod in patients with mild to moderate Ulcerative Colitis. | A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Parallel Group Study Evaluating the Efficacy and Safety of Amiselimod (MT-1303) in Subjects with Mild to Moderate Ulcerative Colitis (UC) | 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: Amiselimod Product Code: MT-1303 INN or Proposed INN: amiselimod Other descriptive name: MT-1303 Product Name: Amiselimod Product Code: MT-1303 INN or Proposed INN: amiselimod Other descriptive name: MT-1303 | Salix Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 336 | Phase 2 | Belarus;Serbia;United States;Czechia;Estonia;Taiwan;Slovakia;Ukraine;Russian Federation;Italy;France;Hungary;Poland;Australia;Bulgaria;Georgia;Germany;Japan;Moldova, Republic of;New Zealand;Korea, Republic of | ||
| 192 | EUCTR2020-004461-40-DE (EUCTR) | 04/08/2021 | 12/05/2021 | Long-term Safety and Efficacy of BMS-986165 in Participants with Crohn’s Disease or Ulcerative Colitis | An Open-label, Multi-center Extension Study to Evaluate the Long-term Safety and Efficacy of BMS-986165 in Participants with Moderate to Severe Crohn’s Disease or Moderate to Severe Ulcerative Colitis | moderate to severe Crohn’s Disease (CD), moderate to severe Ulcerative Colitis (UC) 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] - Immune System Diseases [C20] | Product Name: deucravacitinib Product Code: BMS-986165 INN or Proposed INN: deucravacitinib Other descriptive name: BMS986165 | Bristol-Myers Squibb International Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 2 | United States;Portugal;Taiwan;Spain;Ireland;Russian Federation;Israel;Italy;Switzerland;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;United Kingdom;Hungary;Mexico;Canada;Belgium;Brazil;Poland;Romania;Germany;Japan | ||
| 193 | EUCTR2020-003017-35-LV (EUCTR) | 29/07/2021 | 17/03/2021 | A study of LY3471851 in adult participants with moderately to severely active ulcerative colitis (UC) | An Adaptive Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of LY3471851 (NKTR-358) in Patients with Moderately to Severely Active Ulcerative Colitis - INSTRUCT-UC | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: LY3471851 Product Code: LY3471851 INN or Proposed INN: LY3471851 | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 2 | United States;Czechia;Slovakia;Ukraine;Israel;Russian Federation;United Kingdom;India;France;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Georgia;Germany;Latvia;China;Japan;Korea, Republic of | ||
| 194 | EUCTR2020-005232-30-EE (EUCTR) | 27/07/2021 | 26/04/2021 | Effects of Amiselimod in patients with mild to moderate Ulcerative Colitis. | A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Parallel Group Study Evaluating the Efficacy and Safety of Amiselimod (MT-1303) in Subjects with Mild to Moderate Ulcerative Colitis (UC) | 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: Amiselimod Product Code: MT-1303 INN or Proposed INN: amiselimod Other descriptive name: MT-1303 Product Name: Amiselimod Product Code: MT-1303 INN or Proposed INN: amiselimod Other descriptive name: MT-1303 | Salix Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 336 | Phase 2 | Serbia;United States;Belarus;Czechia;Estonia;Taiwan;Slovakia;Ukraine;Russian Federation;Italy;Hungary;Poland;Australia;Bulgaria;Georgia;Germany;Moldova, Republic of;Japan;Korea, Republic of | ||
| 195 | NCT04963725 (ClinicalTrials.gov) | July 18, 2021 | 8/7/2021 | A Study of Symptom Improvement of Ulcerative Colitis After an Induction Dose of Ustekinumab in Japanese Clinical Practice | Symptom Improvement of Ulcerative Colitis After an Induction Dose of Ustekinumab in Japanese Clinical Practice, Measured Using Patient-Reported Outcomes | Ulcerative Colitis | Drug: Ustekinumab | Janssen Pharmaceutical K.K. | NULL | Completed | 16 Years | N/A | All | 122 | Japan | |
| 196 | EUCTR2020-003420-16-BE (EUCTR) | 16/07/2021 | 30/06/2021 | A study comparing two different therapeutic approaches in the treatment of moderate to severe ulcerative colitis | SPRINT: AN OPEN-LABEL, MULTICENTER STUDY TO EVALUATE STEP-UP VS TOP-DOWN TREATMENT ALGORITHMS IN MODERATE TO SEVERE ULCERATIVE COLITIS - SPRINT | Moderate to severe ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Amgevita INN or Proposed INN: Adalimumab 40mg Trade Name: Azathioprine Other descriptive name: AZATHIOPRINE BP | Instituto Clinico Humanitas | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 350 | Phase 4 | Portugal;France;Spain;Belgium;Austria;Germany;United Kingdom;Switzerland;Italy;Sweden | ||
| 197 | EUCTR2018-002135-19-FR (EUCTR) | 16/07/2021 | 02/04/2019 | A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Ulcerative Colitis (UC) | A 3-Year, Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects with Ulcerative Colitis (UC) - TD-1473 LTS UC Study | Moderately-to-severely active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 | Theravance Biopharma Ireland Limited | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;South Africa;Korea, Democratic People's Republic of;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Japan | ||
| 198 | ITMCTR2100005038 | 2021-07-15 | 2021-07-09 | Modified Shenling Baizhu Powder in the Treatment of Ulcerative Colitis in the Remission Phase: a Series of N-of-1 Randomized, Controlled Trials | Modified Shenling Baizhu Powder in the Treatment of Ulcerative Colitis in the Remission Phase: a Series of N-of-1 Randomized, Controlled Trials | Ulcerative Colitis | Experimental group:SLBZP Granule and Mesalazine;Control group:Mesalazine; | The First Affiliated Hospital of Guangzhou University of Chinese Medicine | NULL | Pending | 18 | 75 | Both | Experimental group:3;Control group:3; | N/A | China |
| 199 | ChiCTR2100048502 | 2021-07-15 | 2021-07-09 | Modified Shenling Baizhu Powder in the Treatment of Ulcerative Colitis in the Remission Phase: a Series of N-of-1 Randomized, Controlled Trials | Modified Shenling Baizhu Powder in the Treatment of Ulcerative Colitis in the Remission Phase: a Series of N-of-1 Randomized, Controlled Trials | Ulcerative Colitis | Experimental group:SLBZP Granule and Mesalazine;Control group:Mesalazine; | The First Affiliated Hospital of Guangzhou University of Chinese Medicine | NULL | Pending | 18 | 75 | Both | Experimental group:3;Control group:3; | N/A | China |
| 200 | NCT04996797 (ClinicalTrials.gov) | July 14, 2021 | 2/8/2021 | A Phase 2 Safety and Efficacy Study of PRA023 in Subjects With Moderately to Severely Active Ulcerative Colitis | A Phase 2, Multi-Center, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Induction Therapy With PRA023 in Subjects With Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Drug: PRA023 IV;Device: Companion Diagnostic (CDx) Testing;Other: Placebo | Prometheus Biosciences, Inc. | NULL | Active, not recruiting | 18 Years | N/A | All | 170 | Phase 2 | United States;Australia;Belgium;Canada;Czechia;France;Georgia;Hungary;Israel;Italy;Poland;United Kingdom |
| 201 | ITMCTR2100005012 | 2021-07-12 | 2021-07-04 | A randomized controlled trial of Xuyan decoction in the treatment of ulcerative colitis with spleen deficiency and dampness-blocking syndrome in remission period | A randomized controlled trial of Xuyan decoction in the treatment of ulcerative colitis with spleen deficiency and dampness-blocking syndrome in remission period | Ulcerative colitis | Control group:Mesalazine sustained-release granules;Experimental group:Xuyan Decoction; | Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine | NULL | Pending | 18 | 65 | Both | Control group:44;Experimental group:44; | China | |
| 202 | ChiCTR2100048176 | 2021-07-12 | 2021-07-04 | A randomized controlled trial of Xuyan decoction in the treatment of ulcerative colitis with spleen deficiency and dampness-blocking syndrome in remission period | A randomized controlled trial of Xuyan decoction in the treatment of ulcerative colitis with spleen deficiency and dampness-blocking syndrome in remission period | Ulcerative colitis | Experimental group:Xuyan Decoction;Control group:Mesalazine sustained-release granules; | Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine | NULL | Pending | 18 | 65 | Both | Experimental group:44;Control group:44; | China | |
| 203 | EUCTR2019-004578-25-SE (EUCTR) | 09/07/2021 | 27/12/2019 | A clinical study in patients with mild to moderate ulcerative colitis to test the tolerability of Lactobacillus reuteri BGP-014 | A randomised placebo-controlled safety study of Lactobacillus reuteri BGP-014 in patients with active mild to moderate ulcerative colitis | Mild to moderate ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: BGP-014 Capsules Product Code: BGP-014 INN or Proposed INN: Lactobacillus reuteri Other descriptive name: LACTOBACILLUS REUTERI | BioGaia Pharma AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 50 | Phase 1;Phase 2 | Sweden | ||
| 204 | EUCTR2019-003596-19-RO (EUCTR) | 07/07/2021 | 21/04/2022 | A Three-Arm, Randomized, Placebo-Controlled, Double-Blind Phase 3 Study to Evaluate the Safety and Efficacy of Once-Daily and Twice-Daily Dosing of a Novel Hydrocortisone Acetate 90 mg Suppository Formulation Administered with the Sephure® Suppository Applicator in Subjects with Ulcerative Colitis of the Rectum. | A Three-Arm, Randomized, Placebo-Controlled, Double-Blind Phase 3 Study to Evaluate the Safety and Efficacy of Once-Daily and Twice-Daily Dosing of a Novel Hydrocortisone Acetate 90 mg Suppository Formulation Administered with the Sephure® Suppository Applicator in Subjects with Ulcerative Colitis of the Rectum. - cessa | Ulcerative Colitis of the Rectum MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;Level: HLT;Classification code 10027682;Term: Immune and associated conditions NEC;System Organ Class: 10021428 - Immune system disorders MedDRA version: 20.0;Level: SOC;Classification code 10021428;Term: Immune system disorders;Level: HLGT;Classification code 10027665;Term: Immune disorders NEC;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 90 mg hydrocortisone acetate suppository with Sephure suppository applicator INN or Proposed INN: HYDROCORTISONE ACETATE | Cristcot HCA LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 618 | Phase 3 | United States;Philippines;Hong Kong;Spain;Poland;Ukraine;Romania;Russian Federation;Germany;Italy;India | ||
| 205 | EUCTR2020-000609-10-DK (EUCTR) | 06/07/2021 | 23/09/2020 | A combination of immunesystem stimulating- and antibiotic treatment for inflammation of the pouch in ulcerative colitis patients | A combined treatment with GM-CSF, fosfomycin and metronidazole for pouchitis in ulcerative colitis patients after restorative ileal pouch anal anastomosis surgeryA clinical safety and proof-of-concept study | A combination of GM-CSF and metronidazole/fosfomycin treatment for pouchitis in Ulcerative Colitis patients after ileal-pouch-anal anastomosis surgery given as an enema or spray in the pouch. MedDRA version: 20.0;Level: PT;Classification code 10036463;Term: Pouchitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Repomol INN or Proposed INN: Molgramostim Trade Name: Metronidazole Product Name: Metronidazole INN or Proposed INN: METRONIDAZOLE Other descriptive name: Metronidazole Trade Name: Fosfomycin Product Name: Infectofos INN or Proposed INN: Fosfomycin disodium Other descriptive name: FOSFOMYCIN DISODIUM | Center for Surgical Science | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 26 | Phase 1;Phase 2 | Denmark | ||
| 206 | NCT04828031 (ClinicalTrials.gov) | July 1, 2021 | 29/3/2021 | Vitamin D Regulation of Gut Specific B Cells and Antibodies Targeting Gut Bacteria in Inflammatory Bowel Disease | Vitamin D Regulation of a4ß7+ B Cell Immunophenotypes and Mucosal Antibody Response to Commensal Gut Bacteria in Patients With Inflammatory Bowel Disease | Crohn Disease;Inflammatory Bowel Diseases;Ulcerative Colitis | Drug: Vitamin D | Stanford University | Doris Duke Charitable Foundation | Recruiting | 18 Years | N/A | All | 50 | Phase 1 | United States |
| 207 | ChiCTR2100046446 | 2021-07-01 | 2021-05-15 | Effect of probiotics supplementation combined with WeChat platform health management on nutritional status, inflammatory factors, and quality of life in patients with mild-to-moderate ulcerative colitis | Effect of probiotics supplementation combined with WeChat platform health management on nutritional status, inflammatory factors, and quality of life in patients with mild-to-moderate ulcerative colitis | ulcerative colitis | experimental group:Bifidobacterium triple live bacteria combined with WeChat platform for health management intervention;control group:Mesalazine Oral; | Affiliated Hospital of Jiangnan University | NULL | Recruiting | 18 | 80 | Both | experimental group:70;control group:70; | N/A | China |
| 208 | EUCTR2019-003113-34-SK (EUCTR) | 29/06/2021 | 27/04/2021 | Study of efficacy, safety and tolerability of LYS006 in patients with mild to moderate ulcerative colitis | A randomized, multi-center, subject and investigator blinded, placebo controlled, parallel group study to assess the efficacy, safety and tolerability of LYS006 in patients with mild to moderate ulcerative colitis | Mild to moderate ulcerative colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: LYS006 Product Code: LYS006 INN or Proposed INN: not yet defined Other descriptive name: LYS006 | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 45 | Phase 2 | United States;Czechia;Hungary;Slovakia;Poland;Bulgaria;Russian Federation;Norway;Germany | ||
| 209 | EUCTR2020-004300-34-LT (EUCTR) | 25/06/2021 | 21/04/2021 | A study to evaluate efficacy and safety of Vedolizumab in pediatric subjects with moderately to severely active Ulcerative Colitis | A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open–Label Vedolizumab Intravenous Therapy | Moderately to severely active Ulcerative Colitis (UC) 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: Vedolizumab INN or Proposed INN: Vedolizumab Other descriptive name: MLN0002 | Takeda Development Center Americas, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 3 | United States;Czechia;Slovakia;Greece;Spain;Ukraine;Lithuania;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Hungary;Canada;Poland;Belgium;Croatia;Australia;China;Japan;Korea, Republic of | ||
| 210 | NCT04372108 (ClinicalTrials.gov) | June 24, 2021 | 30/4/2020 | A Study to Assess the Long-Term Safety of Ustekinumab Versus Other Biologics in Patients With Crohn's Disease and Ulcerative Colitis | An Observational Study to Assess the Long-term Safety of Ustekinumab Versus Other Biologic Therapies Among Patients With Crohn's Disease and Ulcerative Colitis: A New-User Cohort Study Using the Department of Defense Electronic Health Records Database | Crohn Disease;Colitis, Ulcerative | Drug: Ustekinumab;Drug: Other Biologic Therapies | Janssen Scientific Affairs, LLC | NULL | Recruiting | 18 Years | N/A | All | 1056 | United States | |
| 211 | EUCTR2020-005232-30-BG (EUCTR) | 22/06/2021 | 02/06/2021 | Effects of Amiselimod in patients with mild to moderate Ulcerative Colitis. | A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Parallel Group Study Evaluating the Efficacy and Safety of Amiselimod (MT-1303) in Subjects with Mild to Moderate Ulcerative Colitis (UC) | 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: Amiselimod Product Code: MT-1303 INN or Proposed INN: amiselimod Other descriptive name: MT-1303 Product Name: Amiselimod Product Code: MT-1303 INN or Proposed INN: amiselimod Other descriptive name: MT-1303 | Salix Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 336 | Phase 2 | Belarus;Serbia;United States;Estonia;Taiwan;Slovakia;Ukraine;Russian Federation;Italy;Hungary;Canada;Poland;Belgium;Australia;Bulgaria;Georgia;Germany;Japan;Moldova, Republic of;Korea, Republic of | ||
| 212 | EUCTR2020-005232-30-HU (EUCTR) | 21/06/2021 | 23/04/2021 | Effects of Amiselimod in patients with mild to moderate Ulcerative Colitis. | A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Parallel Group Study Evaluating the Efficacy and Safety of Amiselimod (MT-1303) in Subjects with Mild to Moderate Ulcerative Colitis (UC) | 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: Amiselimod Product Code: MT-1303 INN or Proposed INN: amiselimod Other descriptive name: MT-1303 Product Name: Amiselimod Product Code: MT-1303 INN or Proposed INN: amiselimod Other descriptive name: MT-1303 | Salix Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 336 | Phase 2 | Belarus;Serbia;United States;Czechia;Estonia;Taiwan;Slovakia;Ukraine;Russian Federation;Italy;Hungary;Poland;Belgium;Australia;Bulgaria;Georgia;Germany;Japan;Moldova, Republic of;Korea, Republic of | ||
| 213 | NCT04596293 (ClinicalTrials.gov) | June 11, 2021 | 15/10/2020 | Efficacy and Safety of Orally Administered BBT-401-1S in Subjects With Ulcerative Colitis | A Randomised, Double-blind, Placebo-controlled Study of Orally Administered BBT-401-1S in Subjects With Moderate to Severe Ulcerative Colitis, Incorporating a Response-adaptive, Double-blind Extension Phase | Ulcerative Colitis | Drug: BBT-401-1S;Drug: Placebo | Bridge Biotherapeutics, Inc. | Covance | Completed | 18 Years | 60 Years | All | 38 | Phase 2 | United States;Korea, Republic of;New Zealand;Poland;Ukraine |
| 214 | JPRN-jRCT2031200371 | 04/06/2021 | 19/02/2021 | A Study of Vedolizumab, given every 4 weeks, in Japanese Participants with Moderate to Severe Ulcerative Colitis or Crohn's Disease | An Open-Label, Phase 3 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Intravenous (IV) Vedolizumab Administered Every 4 Weeks (Q4W) in Japanese Patients with Moderate to Severe Ulcerative Colitis or Crohn's Disease who Experienced Secondary Loss of Response During Maintenance Therapy with Vedolizumab IV Administered Every 8 Weeks (Q8W) | Ulcerative Colitis, Crohn's Disease | Vedolizumab 300 mg, IV infusion, for up to 12 weeks Q4W for Treatment phase, and until the date of marketing approval of vedolizumab IV Q4W or study termination for Extension phase. | Shikamura Mitsuhiro | NULL | Recruiting | >= 18age old | <= 80age old | Both | 158 | Phase 3 | Japan |
| 215 | NCT04738942 (ClinicalTrials.gov) | June 4, 2021 | 2/2/2021 | A Study of Intravenous Vedolizumab Administered Every 4 Weeks in Japanese Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease | An Open-Label, Phase 3 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Intravenous (IV) Vedolizumab Administered Every 4 Weeks (Q4W) in Japanese Patients With Moderate to Severe Ulcerative Colitis or Crohn's Disease Who Experienced Secondary Loss of Response During Maintenance Therapy With Vedolizumab IV Administered Every 8 Weeks (Q8W) | Ulcerative Colitis;Crohn's Disease | Drug: Vedolizumab | Takeda | NULL | Recruiting | 18 Years | 80 Years | All | 158 | Phase 3 | Japan |
| 216 | EUCTR2020-004300-34-ES (EUCTR) | 02/06/2021 | 01/09/2021 | A study to evaluate efficacy and safety of Vedolizumab in pediatric subjects with moderately to severely active Ulcerative Colitis | A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open–Label Vedolizumab Intravenous Therapy | Moderately to severely active Ulcerative Colitis (UC) 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: Vedolizumab INN or Proposed INN: Vedolizumab Other descriptive name: MLN0002 | Takeda Development Center Americas, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 3 | United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;China;Bosnia and Herzegovina;Czechia;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Romania;Germany;New Zealand;Japan | ||
| 217 | NCT04919252 (ClinicalTrials.gov) | June 1, 2021 | 6/4/2021 | Efficacy and Safety of Vedolizumab in Biologic-naïve Korean Patients With Moderate to Severe Inflammatory Bowel Disease | Efficacy and Safety of Vedolizumab in Biologic-naïve Korean Patients With Moderate to Severe Inflammatory Bowel Disease | Crohn's Disease and Ulcerative Colitis | Drug: Vedolizumab | Yonsei University | NULL | Not yet recruiting | 19 Years | 70 Years | All | 60 | Phase 3 | Korea, Republic of |
| 218 | NCT04882683 (ClinicalTrials.gov) | June 1, 2021 | 6/5/2021 | Clinical Study of Cord Blood Mononuclear Cells on Treatment of Hormone-resistant or Hormone-dependent Ulcerative Colitis | Clinical Study of Cord Blood Mononuclear Cells on Treatment of Hormone-resistant or Hormone-dependent Ulcerative Colitis | Ulcerative Colitis | Drug: Prednisone;Drug: Azathioprine;Drug: Adalimumab;Biological: umbilical cord blood mononuclear cells | Shandong Qilu Stem Cells Engineering Co., Ltd. | NULL | Recruiting | 18 Years | 65 Years | All | 50 | N/A | China |
| 219 | NCT04925973 (ClinicalTrials.gov) | June 1, 2021 | 8/6/2021 | Tofacitinib for Hospitalized Acute Severe Ulcerative Colitis Management | Tofacitinib for Hospitalized Acute Severe Ulcerative Colitis Management (the TRIUMPH Study) | Ulcerative Colitis Acute | Drug: Tofacitinib 10 MG [Xeljanz] | McMaster University | University of Manitoba;University of British Columbia;McGill University;University of Alberta | Recruiting | 18 Years | N/A | All | 26 | Phase 2 | Canada |
| 220 | NCT04478825 (ClinicalTrials.gov) | June 1, 2021 | 16/7/2020 | Efficacy and Safety of Rectally Administered BBT-401-1S in Subjects With Ulcerative Colitis | An Open Label, Proof of Mechanism Study to Explore the Efficacy and Safety of Rectally Administered BBT-401-1S in Subjects With Ulcerative Colitis | Ulcerative Colitis | Drug: BBT-401-1S | Bridge Biotherapeutics, Inc. | Covance | Terminated | 18 Years | 60 Years | All | 2 | Phase 1 | New Zealand |
| 221 | EUCTR2020-004300-34-GR (EUCTR) | 01/06/2021 | 29/04/2021 | A study to evaluate efficacy and safety of Vedolizumab in pediatric subjects with moderately to severely active Ulcerative Colitis | A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open–Label Vedolizumab Intravenous Therapy | Moderately to severely active Ulcerative Colitis (UC) 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: Vedolizumab INN or Proposed INN: Vedolizumab Other descriptive name: MLN0002 | Takeda Development Center Americas, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 3 | United States;Czechia;Slovakia;Greece;Spain;Ukraine;Lithuania;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Hungary;Canada;Poland;Belgium;Croatia;Australia;China;Japan;Korea, Republic of | ||
| 222 | EUCTR2018-004002-25-SK (EUCTR) | 28/05/2021 | 13/01/2021 | A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis - QUASAR | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 2;Phase 3 | Serbia;Portugal;United States;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;France;Jordan;Malaysia;Australia;Latvia;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Hungary;Canada;Argentina;Belgium;Brazil;Poland;Bulgaria;Germany;New Zealand;Japan;Sweden | ||
| 223 | EUCTR2018-004002-25-LV (EUCTR) | 27/05/2021 | 02/02/2021 | A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis - QUASAR | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 950 | Phase 2;Phase 3 | Portugal;Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;France;Jordan;Australia;Netherlands;Latvia;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Hungary;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Japan;Sweden | ||
| 224 | NCT04844606 (ClinicalTrials.gov) | May 26, 2021 | 12/4/2021 | A Master Protocol (AMAZ): A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease (SHINE-ON) | A Master Protocol for a Phase 3, Multicenter, Open-label, Long-term Extension Study to Evaluate the Long-term Efficacy and Safety of Mirikizumab in Children and Adolescents With Moderate-to-severe Ulcerative Colitis or Crohn's Disease | Ulcerative Colitis;Ulcerative Colitis Chronic;Inflammatory Bowel Diseases;Crohn's Disease | Drug: Mirikizumab | Eli Lilly and Company | NULL | Recruiting | 2 Years | 19 Years | All | 150 | Phase 3 | Israel;Italy;Japan;United States;Korea, Republic of;Poland |
| 225 | EUCTR2020-003017-35-SK (EUCTR) | 26/05/2021 | 28/12/2020 | A study of LY3471851 in adult participants with moderately to severely active ulcerative colitis (UC) | An Adaptive Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of LY3471851 (NKTR-358) in Patients with Moderately to Severely Active Ulcerative Colitis - INSTRUCT-UC | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: LY3471851 Product Code: LY3471851 INN or Proposed INN: LY3471851 | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | United States;Czechia;Slovakia;Ukraine;Russian Federation;Israel;United Kingdom;India;France;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Brazil;Romania;Australia;Georgia;Germany;Latvia;China;Japan;Korea, Republic of | ||
| 226 | EUCTR2020-003017-35-PL (EUCTR) | 25/05/2021 | 15/02/2021 | A study of LY3471851 in adult participants with moderately to severely active ulcerative colitis (UC) | An Adaptive Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of LY3471851 (NKTR-358) in Patients with Moderately to Severely Active Ulcerative Colitis - INSTRUCT-UC | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: LY3471851 Product Code: LY3471851 INN or Proposed INN: LY3471851 | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 2 | United States;Czechia;Slovakia;Ukraine;Israel;Russian Federation;United Kingdom;India;France;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Brazil;Romania;Australia;Georgia;Latvia;Germany;China;Japan;Korea, Republic of | ||
| 227 | NCT04879966 (ClinicalTrials.gov) | May 17, 2021 | 6/5/2021 | A Cohort Study Comparing IFX to CS for Moderate to Severe UC | A Multicenter Prospective Cohort Study Comparing Infliximab to Corticosteroids for Moderate to Severe Ulcerative Colitis | Moderate to Severe Ulcerative Colitis | Drug: Infliximab;Drug: Corticosteroid | Sixth Affiliated Hospital, Sun Yat-sen University | NULL | Recruiting | 18 Years | 70 Years | All | 342 | China | |
| 228 | EUCTR2018-004002-25-AT (EUCTR) | 12/05/2021 | 21/12/2020 | A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis - QUASAR | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 2;Phase 3 | Japan;New Zealand;Sweden;United States;Serbia;Portugal;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;France;Jordan;Malaysia;Australia;Latvia;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany | ||
| 229 | NCT04877990 (ClinicalTrials.gov) | May 7, 2021 | 4/5/2021 | A Study to Evaluate the Long-term Safety and Efficacy of Deucravacitinib in Participants With Crohn's Disease or Ulcerative Colitis | An Open-label, Multi-center Extension Study to Evaluate the Long-term Safety and Efficacy of Deucravacitinib in Participants With Moderate to Severe Crohn's Disease or Moderate to Severe Ulcerative Colitis | Crohn Disease;Ulcerative Colitis | Drug: Deucravacitinib | Bristol-Myers Squibb | NULL | Recruiting | 18 Years | N/A | All | 300 | Phase 2 | United States;Australia;Brazil;Canada;China;Czechia;Germany;Hungary;Italy;Japan;Netherlands;Poland;Portugal;Romania;Russian Federation;Spain;United Kingdom |
| 230 | ChiCTR2100046284 | 2021-05-06 | 2021-05-12 | Clinical study of cord blood mononuclear cells on treatment of hormone-resistant or hormone-dependent ulcerative colitis | Clinical study of cord blood mononuclear cells on treatment of hormone-resistant or hormone-dependent ulcerative colitis | ulcerative colitis | Control group:Prednisone+Azathioprine/Adalimumab;Test group:Prednisone+Azathioprine/Adalimumab+umbilical cord blood mononuclear cells; | The Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine | NULL | Recruiting | 18 | 65 | Both | Control group:25;Test group:25; | China | |
| 231 | EUCTR2019-002485-12-PL (EUCTR) | 05/05/2021 | 22/09/2020 | Determination of the Optimal Treatment Target in Ulcerative Colitis | VERDICT: In actiVE ulcerative colitis, a RanDomIzed Controlled Trial for determination of the optimal treatment target - VERDICT | Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entyvio INN or Proposed INN: vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio INN or Proposed INN: vedolizumab Other descriptive name: VEDOLIZUMAB | Alimentiv Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 660 | Phase 4 | Belarus;France;United States;Canada;Belgium;Poland;Ukraine;Russian Federation;Netherlands;United Kingdom;Italy | ||
| 232 | NCT04862741 (ClinicalTrials.gov) | May 5, 2021 | 10/3/2021 | Safety, Tolerability, and Pharmacokinetics of Oral NX-13 in Active Ulcerative Colitis | A Randomized, Double-blind Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral NX-13 in Active Ulcerative Colitis | Ulcerative Colitis | Drug: NX-13 250mg IR;Drug: NX-13 500mg IR;Drug: NX-13 500mg MR;Drug: Placebo | Landos Biopharma Inc. | NULL | Completed | 18 Years | 65 Years | All | 39 | Phase 1 | United States;Ukraine |
| 233 | EUCTR2019-003334-16-LV (EUCTR) | 29/04/2021 | 14/01/2021 | Novel budenosid suppository in addition to basic therapy with oral mesalazine compared to basic therapy alone for treatment of ulcerative colitis | Randomised, double-blind, placebo-controlled, multicentre study to compare the efficacy and safety of novel 4 mg budesonide suppository in combination with oral mesalazine versus oral mesalazine monotherapy in patients with acute ulcerative colitis | acute ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Budenofalk® suppositories INN or Proposed INN: BUDESONIDE Other descriptive name: Budenofalk® suppositories (BUS) Trade Name: Salofalk 3g gastro-resistant prolonged-release granules Product Name: Salofalk 3g gastro-resistant prolonged-release granules INN or Proposed INN: MESALAZINE | Dr. Falk Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 360 | Phase 3 | Belarus;Poland;Ukraine;Bulgaria;Russian Federation;Germany;Latvia | ||
| 234 | EUCTR2019-002485-12-NL (EUCTR) | 23/04/2021 | 03/08/2020 | Determination of the Optimal Treatment Target in Ulcerative Colitis | VERDICT: In actiVE ulcerative colitis, a RanDomIzed Controlled Trial for determination of the optimal treatment target - VERDICT | Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entyvio INN or Proposed INN: vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio INN or Proposed INN: vedolizumab Other descriptive name: VEDOLIZUMAB | Alimentiv Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 660 | Phase 4 | France;United States;Belarus;Canada;Poland;Belgium;Ukraine;Russian Federation;Netherlands;United Kingdom;Italy | ||
| 235 | NCT04064697 (ClinicalTrials.gov) | April 22, 2021 | 20/8/2019 | Impact of Anti-cytomegalovirus Treatment in the Management of Relapsing Ulcerative Colitis Requiring Vedolizumab Therapy | Impact of Anti-cytomegalovirus (Valganciclovir) Treatment in the Management of Relapsing Ulcerative Colitis (UC) Requiring Vedolizumab Therapy: a Randomized Clinical Trial Comparing a Strategy With or Without Antiviral Therapy. | Ulcerative Colitis, Unspecified | Drug: Valganciclovir | Centre Hospitalier Universitaire de Saint Etienne | Ministry of Health, France | Recruiting | 18 Years | N/A | All | 120 | Phase 3 | France |
| 236 | NCT04469062 (ClinicalTrials.gov) | April 20, 2021 | 10/7/2020 | A Study of Mirikizumab (LY3074828) in Participants With Ulcerative Colitis | A Phase 3b, Randomized, Double-Blind, Parallel-Arm, Placebo- and Active- Controlled Treat-Through Study of Mirikizumab and Vedolizumab in Participants With Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Drug: Mirikizumab IV;Drug: Mirikizumab SC;Drug: Vedolizumab IV;Drug: Placebo IV;Drug: Placebo SC | Eli Lilly and Company | NULL | Withdrawn | 18 Years | 80 Years | All | 0 | Phase 3 | NULL |
| 237 | EUCTR2020-003556-33-PL (EUCTR) | 19/04/2021 | 17/02/2021 | A Placebo-controlled Study of BBT-401-1S in Subjects with Moderate to Severe Ulcerative Colitis | A Randomised, Double-blind, Placebo-controlled Study of Orally Administered BBT-401-1S in Subjects with Moderate to Severe Ulcerative Colitis, Incorporating a Response-Adaptive, Double-blind Extension Phase | Moderate to severe 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: BBT-401-1S Product Code: BBT-401-1S INN or Proposed INN: None Other descriptive name: Sodium (S)-3-(4-hydroxyphenyl)-2-(2-((S)-1-((S)-1-palmitoylpyrrolidine-2-carbonyl)pyrrolidine-2-carboxamido)acetamido)propanoate | Bridge Biotherapeutics, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 36 | Phase 2 | United States;Poland;Ukraine;New Zealand;Korea, Republic of | ||
| 238 | NCT04607837 (ClinicalTrials.gov) | April 19, 2021 | 23/10/2020 | Etrasimod Versus Placebo for the Treatment of Moderately Active Ulcerative Colitis | A Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects With Moderately Active Ulcerative Colitis | Ulcerative Colitis | Drug: Etrasimod;Drug: Placebo | Pfizer | Arena is a wholly owned subsidiary of Pfizer | Recruiting | 18 Years | 80 Years | All | 225 | Phase 2 | United States;Australia;Belarus;Belgium;Bulgaria;Canada;Czechia;France;Georgia;Germany;Hungary;Israel;Italy;Korea, Republic of;Poland;Portugal;Russian Federation;Spain;Ukraine |
| 239 | EUCTR2020-003017-35-BE (EUCTR) | 15/04/2021 | 05/02/2021 | A study of LY3471851 in adult participants with moderately to severely active ulcerative colitis (UC) | An Adaptive Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of LY3471851 (NKTR-358) in Patients with Moderately to Severely Active Ulcerative Colitis - INSTRUCT-UC | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: LY3471851 Product Code: LY3471851 INN or Proposed INN: LY3471851 | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | United States;Czechia;Slovakia;Ukraine;Israel;Russian Federation;United Kingdom;India;France;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Georgia;Latvia;Germany;China;Japan;Korea, Republic of | ||
| 240 | JPRN-jRCTs011200009 | 08/04/2021 | 06/11/2020 | vedolizumab-4026 | A study to evaluate the relationship between the pharmacokinetics of vedolizumab in the colon tissue and in the serum concentrations, alpha4beta7 integrin receptor occupancy and the efficacy in subjects with moderately to severely active ulcerative colitis and treated by vedolizumab IV - vedolizumab-4026 | Subjects with UC | Vedolizumab 300 mg is administered at Week 0, 2, 6 and every 8 weeks thereafter. Treatment duration is 46 weeks. | Fujiya Mikihiro | Takeda Pharmaceutical Company Limited (Takeda) | Not Recruiting | >= 20age old | <= 80age old | Both | 30 | Phase 4 | Japan |
| 241 | EUCTR2020-003507-34-BG (EUCTR) | 02/04/2021 | 10/02/2021 | Etrasimod Versus Placebo for the Treatment of Moderately Active Ulcerative Colitis | A Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately Active Ulcerative Colitis - GLADIATOR | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 162 | Phase 2 | Portugal;United States;Czechia;Spain;Israel;Russian Federation;Italy;France;Hungary;Canada;Belgium;Poland;Australia;Bulgaria;Germany;Korea, Republic of | ||
| 242 | NCT04818788 (ClinicalTrials.gov) | April 1, 2021 | 20/3/2021 | Hematological Indices and Fecal Calprotectin Predict Histological Remission in Ulcerative Colitis | Hematological Indices and Fecal Calprotectin as Predictors of Histological Remission in Ulcerative Colitis Patients Receiving Biological Therapy | Ulcerative Colitis | Drug: Biological Drug | Assiut University | NULL | Not yet recruiting | 18 Years | 55 Years | All | 24 | NULL | |
| 243 | NCT04630028 (ClinicalTrials.gov) | March 17, 2021 | 13/11/2020 | A Study of Ustekinumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis (UC) | A Phase 3 Study of the Efficacy, Safety and Pharmacokinetics of Ustekinumab as Open-label Intravenous Induction Treatment Followed by Randomized Double-blind Subcutaneous Ustekinumab Maintenance in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis | Colitis, Ulcerative | Drug: Ustekinumab Dose Based on BSA and Body Weight;Drug: Matching Placebo | Janssen Research & Development, LLC | NULL | Recruiting | 2 Years | 17 Years | All | 100 | Phase 3 | United States;Belgium;Germany;Hungary;Israel;Japan;Poland;Russian Federation;United Kingdom |
| 244 | NCT04613518 (ClinicalTrials.gov) | March 15, 2021 | 28/10/2020 | A Study of the Safety, Efficacy, and Biomarker Response of BMS-986165 in Participants With Moderate to Severe Ulcerative Colitis | A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Efficacy, and Biomarker Response of BMS-986165 in Subjects With Moderate to Severe Ulcerative Colitis | Colitis, Ulcerative | Drug: BMS-986165;Other: Placebo Comparator | Bristol-Myers Squibb | NULL | Active, not recruiting | 18 Years | 65 Years | All | 50 | Phase 2 | United States;Australia;Canada;Germany;Netherlands;Poland;Puerto Rico;United Kingdom |
| 245 | EUCTR2020-000047-31-PL (EUCTR) | 13/03/2021 | 15/07/2021 | A study of AMT-101 in patients with Ulcerative Colitis. | A Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter, Phase 2a Study of the Efficacy and Safety of Oral AMT-101 in Subjects with Moderate to Severe Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: AMT-101 INN or Proposed INN: Not yet assigned Other descriptive name: AMT-101 | Applied Molecular Transport Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 102 | Phase 2 | Belarus;Serbia;United States;Ukraine;Russian Federation;United Kingdom;Switzerland;Italy;India;France;Hungary;Canada;Poland;Romania;Kazakhstan;Georgia;Bulgaria;Germany;Moldova, Republic of | ||
| 246 | EUCTR2019-002942-19-DK (EUCTR) | 12/03/2021 | 05/11/2020 | Nordic study of treatment strategy in inflammatory bowel disease | NORDTREATThe Nordic IBD treatment strategy trial – a randomized controlled trial of access to a protein profile | Crohn's disease and Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remicade INN or Proposed INN: INFLIXIMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Imurel INN or Proposed INN: Azathioprine Trade Name: Puri-nethol INN or Proposed INN: MERCAPTOPURINE | Region Örebro län | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 4 | Denmark | ||
| 247 | EUCTR2019-003334-16-BG (EUCTR) | 11/03/2021 | 02/12/2020 | Novel budenosid suppository in addition to basic therapy with oral mesalazine compared to basic therapy alone for treatment of ulcerative colitis | Randomised, double-blind, placebo-controlled, multicentre study to compare the efficacy and safety of novel 4 mg budesonide suppository in combination with oral mesalazine versus oral mesalazine monotherapy in patients with acute ulcerative colitis | acute ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Budenofalk® suppositories INN or Proposed INN: BUDESONIDE Other descriptive name: Budenofalk® suppositories (BUS) Trade Name: Salofalk 3g gastro-resistant prolonged-release granules Product Name: Salofalk 3g gastro-resistant prolonged-release granules INN or Proposed INN: MESALAZINE | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 3 | Belarus;Poland;Ukraine;Russian Federation;Bulgaria;Germany;Latvia | ||
| 248 | EUCTR2016-004676-22-FR (EUCTR) | 09/03/2021 | 26/01/2021 | A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-006 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 942 | Phase 3 | Portugal;Serbia;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Malaysia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Czechia;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;New Zealand;Sweden | ||
| 249 | EUCTR2020-003017-35-CZ (EUCTR) | 04/03/2021 | 29/12/2020 | A study of LY3471851 in adult participants with moderately to severely active ulcerative colitis (UC) | An Adaptive Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of LY3471851 (NKTR-358) in Patients with Moderately to Severely Active Ulcerative Colitis - INSTRUCT-UC | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: LY3471851 Product Code: LY3471851 INN or Proposed INN: LY3471851 | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | United States;Czechia;Slovakia;Ukraine;Russian Federation;Israel;United Kingdom;India;France;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Georgia;Latvia;Germany;Japan;China;Korea, Republic of | ||
| 250 | EUCTR2020-003507-34-PT (EUCTR) | 26/02/2021 | 04/01/2021 | Etrasimod Versus Placebo for the Treatment of Moderately Active Ulcerative Colitis | A Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately Active Ulcerative Colitis - GLADIATOR | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 162 | Phase 2 | United States;Portugal;Czechia;Spain;Israel;Russian Federation;Italy;France;Hungary;Canada;Belgium;Poland;Australia;Bulgaria;Germany;Korea, Republic of | ||
| 251 | EUCTR2019-001653-99-BE (EUCTR) | 26/02/2021 | 26/02/2021 | A placebo-controlled study of mirikizumab and vedolizumab in participants withmoderately to severely active ulcerative colitis | A Phase 3b, Randomized, Double-Blind, Parallel-Arm, Placebo- and Active-Controlled Treat-Through Study of Mirikizumab and Vedolizumab in Participants withModerately to Severely Active Ulcerative Colitis - LUCENT-ACT | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Trade Name: Entyvio Product Name: vedolizumab INN or Proposed INN: vedolizumab Other descriptive name: VEDOLIZUMAB | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | Spain;Ukraine;Russian Federation;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;South Africa;Latvia;Netherlands;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan;Portugal;Serbia;United States;Slovakia | ||
| 252 | EUCTR2019-004224-38-DE (EUCTR) | 25/02/2021 | 20/10/2020 | A Clinical Study of the Efficacy, Safety and Pharmacokinetics of Ustekinumab as Intravenous Induction Treatment Followed by Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 3 Study of the Efficacy, Safety and Pharmacokinetics of Ustekinumab as Open-label Intravenous Induction Treatment Followed by Randomized Double-blind Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis - UNIFI-Jr | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 3 | United States;Hungary;Poland;Belgium;Russian Federation;Germany;United Kingdom;Japan | ||
| 253 | EUCTR2020-002833-13-PL (EUCTR) | 24/02/2021 | 19/11/2020 | A study of AMT-101 in combination with Adalimumab in patients with Ulcerative Colitis. | A Randomized, Placebo-controlled, Double-blind, Parallel-group, Exploratory, Phase 2 Study of the Efficacy and Safety of Oral AMT-101 in Combination with Adalimumab in Subjects with Moderate to Severe Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: AMT-101 INN or Proposed INN: Not yet assigned Other descriptive name: AMT-101 Trade Name: Humira INN or Proposed INN: ADALIMUMAB Other descriptive name: HUMIRA | Applied Molecular Transport Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 2 | Poland;Ukraine;Georgia;Netherlands | ||
| 254 | EUCTR2016-004677-40-FR (EUCTR) | 23/02/2021 | 24/12/2020 | A Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1547 | Phase 2;Phase 3 | Portugal;Serbia;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Malaysia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Czechia;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;New Zealand;Sweden | ||
| 255 | NCT04691232 (ClinicalTrials.gov) | February 22, 2021 | 7/12/2020 | Autologous Ex Vivo Expanded Regulatory T Cells in Ulcerative Colitis | Phase I, Open-label, Fast-track Dose-escalation Clinical Trial Exploring the Safety and the Tolerability of Autologous ex Vivo Expanded Regulatory T Cells in Adults With Ulcerative Colitis | Ulcerative Colitis;Autoimmune Diseases | Biological: Regulatory T cells | University of Erlangen-Nürnberg Medical School | NULL | Recruiting | 18 Years | 18 Years | All | 10 | Phase 1 | Germany |
| 256 | EUCTR2020-003017-35-HU (EUCTR) | 17/02/2021 | 29/12/2020 | A study of LY3471851 in adult participants with moderately to severely active ulcerative colitis (UC) | An Adaptive Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of LY3471851 (NKTR-358) in Patients with Moderately to Severely Active Ulcerative Colitis - INSTRUCT-UC | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: LY3471851 Product Code: LY3471851 INN or Proposed INN: LY3471851 | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | United States;Czechia;Slovakia;Ukraine;Russian Federation;Israel;United Kingdom;India;France;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Brazil;Romania;Australia;Georgia;Germany;Latvia;China;Japan;Korea, Republic of | ||
| 257 | EUCTR2020-003507-34-HU (EUCTR) | 11/02/2021 | 29/12/2020 | Etrasimod Versus Placebo for the Treatment of Moderately Active Ulcerative Colitis | A Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately Active Ulcerative Colitis - GLADIATOR | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 162 | Phase 2 | Portugal;United States;Czechia;Spain;Israel;Russian Federation;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Bulgaria;Germany;Korea, Republic of | ||
| 258 | EUCTR2020-000047-31-DE (EUCTR) | 11/02/2021 | 17/08/2020 | A study of AMT-101 in patients with Ulcerative Colitis. | A Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter, Phase 2a Study of the Efficacy and Safety of Oral AMT-101 in Subjects with Moderate to Severe Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: AMT-101 INN or Proposed INN: Not yet assigned Other descriptive name: AMT-101 | Applied Molecular Transport Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 102 | Phase 2 | Serbia;United States;Belarus;Ukraine;Russian Federation;United Kingdom;Italy;Switzerland;India;France;Hungary;Canada;Poland;Belgium;Romania;Kazakhstan;Georgia;Bulgaria;Germany;Netherlands;Moldova, Republic of | ||
| 259 | EUCTR2019-004878-26-NL (EUCTR) | 10/02/2021 | 20/10/2020 | A Study of the Safety, Efficacy, and Biomarker Response of BMS-986165 in Participants with Moderate to Severe Ulcerative Colitis | A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Efficacy, and Biomarker Response of BMS-986165 in Subjects with Moderate to Severe Ulcerative Colitis. | Moderate to Severe Ulcerative Colitis. MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BMS-986165 Product Code: BMS-986165 INN or Proposed INN: TYK2 Inhibitor Other descriptive name: BMS-986165 Product Name: BMS-986165 Product Code: BMS-986165 INN or Proposed INN: TYK2 Inhibitor Other descriptive name: BMS986165 | Bristol-Myers Squibb International Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 2 | United States;Canada;Australia;Germany;Netherlands;United Kingdom | ||
| 260 | EUCTR2020-003507-34-IT (EUCTR) | 09/02/2021 | 30/08/2021 | Etrasimod Versus Placebo for the Treatment of Moderately Active Ulcerative Colitis | A Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately Active Ulcerative Colitis - GLADIATOR | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: [APD334] INN or Proposed INN: etrasimod L-arginine | ARENA PHARMACEUTICALS, INC. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 162 | Phase 2 | Portugal;United States;Czechia;Spain;Israel;Russian Federation;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;South Africa;Bulgaria;Netherlands;Germany;Moldova, Republic of;Korea, Republic of | ||
| 261 | EUCTR2020-003006-31-IT (EUCTR) | 08/02/2021 | 02/08/2021 | Predictive value of colonic mucosal and synovial tissues profiles for response to JAKs inhibitor in patients affected by ulcerative colitis and concomitant peripheral arthritis | Predictive value of colonic mucosal and synovial tissues profiles for response to JAKs inhibitor in patients affected by ulcerative colitis and concomitant peripheral arthritis - ASPIRE | Ulcerative colitis and concomitant peripheral arthritis MedDRA version: 20.0;Level: LLT;Classification code 10045282;Term: UC;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TOFACINITIB Product Code: [TOFACINITIB] INN or Proposed INN: TOFACINITIB | FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 4 | Italy | ||
| 262 | NCT04750135 (ClinicalTrials.gov) | February 7, 2021 | 7/2/2021 | Assessment of Metformin as Adjuvant Therapy in Patients With Ulcerative Colitis | Assessment of Metformin as Adjuvant Therapy in Patients With Ulcerative Colitis | Ulcerative Colitis;Inflammatory Bowel Diseases | Drug: metformin 500 mg TID Oral Tablet;Drug: Placebo | National Hepatology & Tropical Medicine Research Institute | NULL | Not yet recruiting | 18 Years | 65 Years | All | 40 | Phase 2 | Egypt |
| 263 | EUCTR2020-002833-13-NL (EUCTR) | 05/02/2021 | 29/10/2020 | A study of AMT-101 in combination with Adalimumab in patients with Ulcerative Colitis. | A Randomized, Placebo-controlled, Double-blind, Parallel-group, Exploratory, Phase 2 Study of the Efficacy and Safety of Oral AMT-101 in Combination with Adalimumab in Subjects with Moderate to Severe Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: AMT-101 INN or Proposed INN: Not yet assigned Other descriptive name: AMT-101 Trade Name: Humira INN or Proposed INN: ADALIMUMAB Other descriptive name: HUMIRA | Applied Molecular Transport Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 50 | Phase 2 | Poland;Ukraine;Georgia;Netherlands | ||
| 264 | NCT05372939 (ClinicalTrials.gov) | February 5, 2021 | 22/9/2021 | Study of the Efficacy and Safety of AMT-101 in Combination With Adalimumab in Subjects With Ulcerative Colitis (MARKET) | A Randomized, Placebo-controlled, Double-blind, Parallel-group, Exploratory, Phase 2 Study of the Efficacy and Safety of Oral AMT-101 in Combination With Adalimumab in Subjects With Moderate to Severe Ulcerative Colitis | Ulcerative Colitis | Drug: AMT-101 (oral);Other: Placebo (oral);Combination Product: Humira (adalimumab) | Applied Molecular Transport | NULL | Completed | 18 Years | 75 Years | All | 51 | Phase 2 | Georgia;Netherlands;Poland;Ukraine |
| 265 | EUCTR2020-003507-34-FR (EUCTR) | 02/02/2021 | 16/12/2020 | Etrasimod Versus Placebo for the Treatment of Moderately Active Ulcerative Colitis | A Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately Active Ulcerative Colitis - GLADIATOR | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 162 | Phase 2 | United States;Portugal;Czechia;Spain;Russian Federation;Israel;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;South Africa;Bulgaria;Netherlands;Germany;Moldova, Republic of;Korea, Republic of | ||
| 266 | EUCTR2019-001653-99-LT (EUCTR) | 01/02/2021 | 23/09/2020 | A placebo-controlled study of mirikizumab and vedolizumab in participants withmoderately to severely active ulcerative colitis | A Phase 3b, Randomized, Double-Blind, Parallel-Arm, Placebo- and Active-Controlled Treat-Through Study of Mirikizumab and Vedolizumab in Participants withModerately to Severely Active Ulcerative Colitis - LUCENT-ACT | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Trade Name: Entyvio Product Name: vedolizumab INN or Proposed INN: vedolizumab Other descriptive name: VEDOLIZUMAB | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | Italy;India;France;Malaysia;Denmark;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan;United States;Serbia;Portugal;Slovakia;Spain;Ukraine;Russian Federation;Switzerland | ||
| 267 | JPRN-UMIN000043165 | 2021/02/01 | 31/01/2021 | Safety and efficacy of non-medical switching from originator infliximab to infliximab biosimilar CT-P13 in patients with inflammatory bowel disease | Safety and efficacy of non-medical switching from originator infliximab to infliximab biosimilar CT-P13 in patients with inflammatory bowel disease - Safety and efficacy of non-medical switching from originator infliximab to infliximab biosimilar CT-P13 in patients with inflammatory bowel disease | Crohn's disease, Ulcerative colitis, IBDU | witching from originator infliximab to infliximab biosimilar CT-P13 | Fukuoka University Chikushi Hospital | NULL | Pending | Not applicable | Not applicable | Male and Female | 220 | Not selected | Japan |
| 268 | EUCTR2020-003420-16-IT (EUCTR) | 29/01/2021 | 02/08/2021 | A study comparing two different therapeutic approaches in the treatment of moderate to severe ulcerative colitis. | SPRINT_”AN OPEN-LABEL, MULTICENTER STUDY TO EVALUATE STEP-UP VS TOP-DOWN TREATMENT ALGORITHMS IN MODERATE TO SEVERE ULCERATIVE COLITIS.” - SPRINT | Moderate to severe ulcerative colitis. MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Amgevita Product Name: Adalimumab Product Code: [n.d.] INN or Proposed INN: ADALIMUMAB Product Name: Azatioprina Product Code: [n.d.] INN or Proposed INN: AZATIOPRINA Product Name: Prednisone Product Code: [n.d.] INN or Proposed INN: PREDNISONE INN or Proposed INN: PREDNISONE | IRCCS ISTITUTO CLINICO HUMANITAS | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 350 | Phase 4 | Portugal;France;Spain;Belgium;Austria;Germany;United Kingdom;Switzerland;Italy;Sweden | ||
| 269 | JPRN-jRCT1031200329 | 28/01/2021 | 28/01/2021 | UC Bio Study | Open-ravel randomized control trial to evaluate the efficacy of biologics for ulcerative colitis with treatment-refractoriness | Ulcerative colitis Biologics;D003093 | Infliximab:Infliximab (5 mg / kg / body weight) is infused intravenously at 0, 2, 6, 14, and 22 weeks. Vedolizumab:Intravenous infusion of vedolizumab 300 mg at 0, 2, 6, 14, and 22 weeks Ustekinumab: a single intravenous infusion of the dose shown below is given at the first induction therapy. Body weight dose 55kg or less 260mg 55-85kg 390mg 85kg or more 520mg After 8_weeks of intravenous drip infusion, 90 mg of ustekinumab is usually subcutaneously administered to adults, and 90 mg is subcutaneously administered at 12-week intervals thereafter. If the effect is diminished, the dosing interval can be shortened to 8 weeks. | Naganuma Makoto | NULL | Recruiting | >= 16age old | Not applicable | Both | 231 | N/A | Japan |
| 270 | EUCTR2019-001653-99-LV (EUCTR) | 18/01/2021 | 26/10/2020 | A placebo-controlled study of mirikizumab and vedolizumab in participants withmoderately to severely active ulcerative colitis | A Phase 3b, Randomized, Double-Blind, Parallel-Arm, Placebo- and Active-Controlled Treat-Through Study of Mirikizumab and Vedolizumab in Participants withModerately to Severely Active Ulcerative Colitis - LUCENT-ACT | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Trade Name: Entyvio Product Name: vedolizumab INN or Proposed INN: vedolizumab Other descriptive name: VEDOLIZUMAB | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | United States;Serbia;Portugal;Slovakia;Spain;Ukraine;Russian Federation;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan | ||
| 271 | JPRN-jRCT2071200081 | 12/01/2021 | 13/01/2021 | ELEVATE UC OLE: An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis | An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative colitis | Etrasimod 2 mg tablet by mouth, once daily up to approximately 5 years or until marketing authorization is obtained in the participant s country, whichever comes first | IQVIA Services Japan K.K. ICCC: | NULL | Not Recruiting | >= 16age old | <= 80age old | Both | 35 | Phase 3 | Croatia;Czech Republic;Denmark;Argentina;Australia;Austria;Belgium;Bulgaria;Canada;Chile;Egypt;Estonia;France;Germany;Hungary;India;Israel;Italy;Korea;Lebanon;Mexico;Moldova;Netherlands;Poland;Portugal;Romania;Russian Federation;Serbia;Slovakia;South Africa;Japan |
| 272 | EUCTR2020-002306-12-PL (EUCTR) | 12/01/2021 | 08/09/2020 | GB004 in adult subjects with active ulcerative colitis | A Phase 2, randomized, double-blind, placebo-controlled, multi-center study to evaluate GB004 in adult subjects with mild-to-moderate active ulcerative colitis | Mild-to-moderate active 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 Code: GB004 INN or Proposed INN: Not applicable Other descriptive name: GB004-HCl Product Code: GB004 INN or Proposed INN: Not applicable Other descriptive name: GB004-HCl | GB004, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 195 | Phase 2 | United States;Serbia;Belarus;Poland;Ukraine;Romania;Australia;Russian Federation;Georgia;Italy;Moldova, Republic of;Korea, Republic of | ||
| 273 | EUCTR2019-001653-99-AT (EUCTR) | 12/01/2021 | 24/11/2020 | A placebo-controlled study of mirikizumab and vedolizumab in participants withmoderately to severely active ulcerative colitis | A Phase 3b, Randomized, Double-Blind, Parallel-Arm, Placebo- and Active-Controlled Treat-Through Study of Mirikizumab and Vedolizumab in Participants withModerately to Severely Active Ulcerative Colitis - LUCENT-ACT | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Trade Name: Entyvio Product Name: vedolizumab INN or Proposed INN: vedolizumab Other descriptive name: VEDOLIZUMAB | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | United States;Serbia;Portugal;Slovakia;Spain;Ukraine;Russian Federation;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan | ||
| 274 | EUCTR2019-001653-99-DE (EUCTR) | 08/01/2021 | 05/10/2020 | A placebo-controlled study of mirikizumab and vedolizumab in participants withmoderately to severely active ulcerative colitis | A Phase 3b, Randomized, Double-Blind, Parallel-Arm, Placebo- and Active-Controlled Treat-Through Study of Mirikizumab and Vedolizumab in Participants withModerately to Severely Active Ulcerative Colitis - LUCENT-ACT | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Trade Name: Entyvio INN or Proposed INN: vedolizumab Other descriptive name: VEDOLIZUMAB | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | Portugal;Serbia;United States;Slovakia;Spain;Ukraine;Russian Federation;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan | ||
| 275 | EUCTR2019-004878-26-DE (EUCTR) | 05/01/2021 | 24/08/2020 | A Study of the Safety, Efficacy, and Biomarker Response of BMS-986165 in Participants with Moderate to Severe Ulcerative Colitis | A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Efficacy, and Biomarker Response of BMS-986165 in Subjects with Moderate to Severe Ulcerative Colitis. | Moderate to Severe Ulcerative Colitis. MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BMS-986165 Product Code: BMS-986165 INN or Proposed INN: TYK2 Inhibitor Other descriptive name: BMS-986165 Product Name: BMS-986165 Product Code: BMS-986165 INN or Proposed INN: TYK2 Inhibitor Other descriptive name: BMS986165 | Bristol-Myers Squibb International Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 2 | United States;Canada;Australia;Netherlands;Germany;United Kingdom | ||
| 276 | EUCTR2019-004224-38-HU (EUCTR) | 30/12/2020 | 22/10/2020 | A Clinical Study of the Efficacy, Safety and Pharmacokinetics of Ustekinumab as Intravenous Induction Treatment Followed by Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 3 Study of the Efficacy, Safety and Pharmacokinetics of Ustekinumab as Open-label Intravenous Induction Treatment Followed by Randomized Double-blind Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis - UNIFI-Jr | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 3 | United States;Hungary;Poland;Belgium;Russian Federation;Germany;United Kingdom;Japan | ||
| 277 | JPRN-jRCT2071200080 | 25/12/2020 | 13/01/2021 | ELEVATE UC 40 JAPAN: Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis in Japanese Subjects | A Phase 3, Double-Blind, Placebo-Controlled, 40-Week Extension Study to Assess the Efficacy and Safety of Etrasimod in Japanese Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative colitis | The investigational drug and the placebo are an oral tablet. The investigational drug is APD334 (etrasimod). | IQVIA Services Japan K.K. ICCC: | NULL | Not Recruiting | >= 16age old | <= 80age old | Both | 35 | Phase 3 | Japan |
| 278 | NCT04721873 (ClinicalTrials.gov) | December 18, 2020 | 19/1/2021 | Pharmacologic Weight Loss as Adjunct Therapy for Ulcerative Colitis in Obese Patients | Pharmacologic Weight Loss as Adjunct Therapy for Ulcerative Colitis in Obese Patients: A Phase 2A, Randomized, Placebo-Controlled Trial | Colitis, Ulcerative;Obesity | Drug: Phentermine-Topiramate;Drug: Placebo | University of California, San Diego | NULL | Recruiting | 18 Years | 80 Years | All | 40 | Phase 2 | United States |
| 279 | EUCTR2020-001398-59-BE (EUCTR) | 15/12/2020 | 13/10/2020 | Clinical trial to evaluate the efficacy and the safety of OSE-127 versus placebo in subjects with ulcerative colitis who have failed or are intolerant to previous treatment(s) | Randomized, double-blind, Phase 2 study to evaluate the efficacy and the safety of OSE-127 versus placebo in subjects with moderate to severe active ulcerative colitis who have failed or are intolerant to previous treatment(s) | Moderate to severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: OSE-127 Product Code: OSE-127 INN or Proposed INN: Lusvertikimab Other descriptive name: humanized recombinant IgG4 monoclonal antibody against CD-127 | OSE Immunotherapeutics | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 140 | Phase 2 | Serbia;Belarus;Hungary;Poland;Belgium;Ukraine;Lithuania;Croatia;Russian Federation;Georgia;Bulgaria;Latvia | ||
| 280 | NCT04749576 (ClinicalTrials.gov) | December 15, 2020 | 9/12/2020 | Saffron as Anti Inflammatory Agent In Patients With Inflammatory Bowel Disease | Efficacy of Nutritional Saffron Supplement As An Anti Inflammatory Agent In Patients With Inflammatory Bowel Disease | Ulcerative Colitis | Dietary Supplement: saffron supplement for IBD | Howard University | NULL | Recruiting | 18 Years | 80 Years | All | 100 | N/A | United States |
| 281 | NCT03414788 (ClinicalTrials.gov) | December 7, 2020 | 8/1/2018 | Distribution of a Single IV Dose Of [124I]-Pf 06687234 and Pf 06687234 Assessed With PET-CT Imaging In Moderate To Severe Ulcerative Colitis and Crohn's Disease | PHASE 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 AND CROHN'S COLITIS SUBJECTS | Inflammatory Bowel Disease | Biological: PF 06687234;Biological: [124I]IB PF 06687234 | Pfizer | NULL | Withdrawn | 18 Years | 75 Years | All | 0 | Phase 1 | United States |
| 282 | NCT04424303 (ClinicalTrials.gov) | December 4, 2020 | 8/6/2020 | Tofacitinib in Adult Patients With Moderate to Severe Ulcerative Colitis | Evaluation of the Clinical Benefit of ToFAcitinib Treatment in Patients With Moderate to Severe Ulcerative Colitis Under Real-life Conditions of Use: TOFAst Study | Ulcerative Colitis | Drug: Tofacitinib | Pfizer | NULL | Recruiting | 18 Years | N/A | All | 280 | France | |
| 283 | EUCTR2020-001398-59-HR (EUCTR) | 02/12/2020 | 07/12/2020 | Clinical trial to evaluate the efficacy and the safety of OSE-127 versus placebo in subjects with ulcerative colitis who have failed or are intolerant to previous treatment(s) | Randomized, double-blind, Phase 2 study to evaluate the efficacy and the safety of OSE-127 versus placebo in subjects with moderate to severe active ulcerative colitis who have failed or are intolerant to previous treatment(s) | Moderate to severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: OSE-127 Product Code: OSE-127 INN or Proposed INN: Lusvertikimab Other descriptive name: humanized recombinant IgG4 monoclonal antibody against CD-127 | OSE Immunotherapeutics | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 140 | Phase 2 | Belarus;Serbia;Spain;Ukraine;Russian Federation;Hungary;Belgium;Poland;Croatia;Georgia;South Africa;Bulgaria;Latvia | ||
| 284 | EUCTR2019-001653-99-FR (EUCTR) | 26/11/2020 | 12/10/2020 | A placebo-controlled study of mirikizumab and vedolizumab in participants withmoderately to severely active ulcerative colitis | A Phase 3b, Randomized, Double-Blind, Parallel-Arm, Placebo- and Active-Controlled Treat-Through Study of Mirikizumab and Vedolizumab in Participants withModerately to Severely Active Ulcerative Colitis - LUCENT-ACT | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Trade Name: Entyvio Product Name: vedolizumab INN or Proposed INN: vedolizumab Other descriptive name: VEDOLIZUMAB | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | Malaysia;Denmark;United States;Serbia;Portugal;Slovakia;Spain;Ukraine;Russian Federation;Switzerland;Italy;India;France;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan | ||
| 285 | EUCTR2020-000047-31-BG (EUCTR) | 25/11/2020 | 08/10/2020 | A study of AMT-101 in patients with Ulcerative Colitis. | A Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter, Phase 2a Study of the Efficacy and Safety of Oral AMT-101 in Subjects with Moderate to Severe Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: AMT-101 INN or Proposed INN: Not yet assigned Other descriptive name: AMT-101 | Applied Molecular Transport Inc. | NULL | Not Recruiting | Female: yes Male: yes | 102 | Phase 2 | Serbia;United States;Belarus;Ukraine;Russian Federation;United Kingdom;Switzerland;Italy;India;France;Hungary;Canada;Poland;Belgium;Romania;Kazakhstan;Georgia;Bulgaria;Netherlands;Germany;Moldova, Republic of | ||
| 286 | EUCTR2018-002135-19-RO (EUCTR) | 19/11/2020 | 01/04/2022 | A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Ulcerative Colitis (UC) | A 3-Year, Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects with Ulcerative Colitis (UC) - TD-1473 LTS UC Study | Moderately-to-severely active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 | Theravance Biopharma Ireland Limited | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;South Africa;Korea, Republic of;United Kingdom;Hungary;Canada;Poland;Romania;Croatia;Georgia;Bulgaria;Germany;Japan | ||
| 287 | NCT04505410 (ClinicalTrials.gov) | November 18, 2020 | 5/8/2020 | Second Line Induction Therapy and Healthy Diet for Patients With Ulcerative Colitis | A Randomized Control Study to Examine the Influence of a Healthy Diet on Moderate to Severe Ulcerative Colitis Patients Undergoing Second Line Induction With Biological Medications Tofacitinib, Ustekinumab or Vedolizumab | Ulcerative Colitis | Drug: Tofacitinib;Other: Fast Mimicking Diet;Drug: Ustekinumab induction;Drug: Infliximab induction | University of Miami | Pfizer | Recruiting | 18 Years | N/A | All | 76 | Phase 3 | United States |
| 288 | EUCTR2019-002698-74-GB (EUCTR) | 17/11/2020 | 30/03/2020 | A study to evaluate the efficacy and safety of PF 06480605 in adult participants with moderate to severe ulcerative colitis | A PHASE 2B, MULTICENTER, RANDOMIZED, DOUBLEBLIND,PLACEBO CONTROLLED DOSE-RANGINGSTUDY TO EVALUATE THE EFFICACY, SAFETY, ANDPHARMACOKINETICS OF PF-06480605 IN ADULTPARTICIPANTS WITH MODERATE TO SEVEREULCERATIVE COLITIS - Tuscany 2 | A phase 2b randomised, double-blind, placebo controlled dose-ranging study in Adults with Moderate to Severe Ulcerative Colitis MedDRA version: 20.0;Level: HLT;Classification code 10009888;Term: Colitis (excl infective);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PF-06480605 Product Code: PF-06480605 INN or Proposed INN: PF-06480605 Other descriptive name: Anti-TL1A | Pfizer Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 2 | United States;Serbia;Slovakia;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;India;France;Hungary;Mexico;Canada;Poland;Belgium;Romania;Australia;South Africa;Bulgaria;Germany;China;Japan | ||
| 289 | NCT04312113 (ClinicalTrials.gov) | November 16, 2020 | 14/3/2020 | Angiographic Delivery of AD-MSC for Ulcerative Colitis | A Phase I Single Site Open Label Study of Intra-arterial Delivery of Mesenchymal Stem Cells for Luminal Ulcerative Colitis | Ulcerative Colitis | Drug: Adipose derived, autologous mesenchymal stem cells | Mayo Clinic | NULL | Recruiting | 18 Years | 65 Years | All | 20 | Phase 1 | United States |
| 290 | NCT04543994 (ClinicalTrials.gov) | November 10, 2020 | 3/9/2020 | Study of Mesenchymal Stem Cells for the Treatment of Medically Refractory Ulcerative Colitis (UC) | A Phase IB/IIA Study of Remestemcel-L, an ex Vivo Culture-expanded Adult Allogeneic Bone Marrow Derived Mesenchymal Stem Cell Product, for the Treatment of Medically Refractory Ulcerative Colitis | Ulcerative Colitis | Drug: Remestemcel-L;Other: Placebo | The Cleveland Clinic | Mesoblast, Inc. | Recruiting | 18 Years | 75 Years | All | 24 | Phase 1/Phase 2 | United States |
| 291 | ChiCTR2000039161 | 2020-10-30 | 2020-10-20 | Effect of Kangfuxin Liquid enema combined with mesalazine on gestational outcomes and quality of life in child-bearing female with active ulcerative colitis: a randomized, double-blind, controlled trial | A systematic study on the criteria of syndrome differentiation of kidney Yang deficiency in infertility | Ulcerative colitis | control group:Mesalazine enteric-coated tablets + placebo enema;experimental group:Mesalazine enteric-coated tablets +Kangfuxin Liquid enema; | Chengdu University of Traditional Chinese Medicine | NULL | Recruiting | 20 | 45 | Female | control group:118;experimental group:118; | China | |
| 292 | EUCTR2020-004391-18-FR (EUCTR) | 28/10/2020 | 14/09/2020 | IMPACT OF ANTI-TNF, VEDOLIZUMAB AND TOFACITINIB ON AORTIC STIFFNESS, CAROTID INTIMA-MEDIA THICKNESS AND CARDIOVASCULAR RISK OF PATIENTS WITH ULCERATIVE COLITIS | IMPACT OF ANTI-TNF, VEDOLIZUMAB AND TOFACITINIB ON AORTIC STIFFNESS, CAROTID INTIMA-MEDIA THICKNESS AND CARDIOVASCULAR RISK OF PATIENTS WITH ULCERATIVE COLITIS - VASC-UC | ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Inflectra 100 mg Product Name: Inflectra 100 mg Trade Name: AMGEVITA Product Name: AMGEVITA Trade Name: Simponi Product Name: Simponi Trade Name: Entyvio 300 mg Product Name: Entyvio 300 mg Trade Name: XELJANZ Product Name: XELJANZ | CHU Amiens-Picardie | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 4 | France | ||
| 293 | EUCTR2018-005086-39-BG (EUCTR) | 27/10/2020 | 25/06/2020 | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacyand Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacyand Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis | Mild to Moderate Ulcerative Colitis Inflammatory bowel disease (IBD) is an autoimmune disease of the gastrointestinal (GI) tract with unknown etiology that encompasses 2 primary clinical manifestations: ulcerative colitis (UC) and Crohn’s disease (CD). UC manifests through complex interactions between the gut microbiome, dysregulated immune responses, genetic mutations, diet, and other environmental factors. MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: BT-11 500 mg Product Code: BT-11 INN or Proposed INN: to be requested Other descriptive name: BT-11 Product Name: BT-11 1000mg Product Code: BT-11 INN or Proposed INN: to be requested Other descriptive name: BT-11 | Landos Biopharma Inc. | NULL | Not Recruiting | Female: yes Male: yes | 195 | Phase 2 | United States;Serbia;Belarus;Hungary;Poland;Ukraine;Croatia;Russian Federation;Georgia;Bulgaria;Moldova, Republic of;Bosnia and Herzegovina | ||
| 294 | NCT04883840 (ClinicalTrials.gov) | October 22, 2020 | 6/5/2021 | Drug Repurposing - Statins as Microbiota Modulating Agents in Ulcerative Colitis | Drug Repurposing - Statins as Microbiota Modulating Agents in Ulcerative Colitis | Ulcerative Colitis | Drug: Rosuvastatin 10mg | Universitaire Ziekenhuizen KU Leuven | Vlaams Instituut Biotechnologie (VIB) | Recruiting | 18 Years | 70 Years | All | 220 | Phase 2/Phase 3 | Belgium |
| 295 | ChiCTR2000038888 | 2020-10-19 | 2020-10-09 | Effect of Kangfuxin Liquid enema combined with mesalazine on gestational outcomes and quality of life in child -bearing female with active ulcerative colitis: a randomized, double-blind, controlled trial | A systematic study on the criteria of syndrome differentiation of kidney yang deficiency in infertility | Ulcerative colitis | control group:Mesalazine enteric-coated tablets + placebo enema;experimental group:Mesalazine enteric-coated tablets +Kangfuxin Liquid enema; | Chengdu University of Traditional Chinese Medicine | NULL | Recruiting | 20 | 45 | Female | control group:118;experimental group:118; | China | |
| 296 | EUCTR2020-002695-12-NL (EUCTR) | 14/10/2020 | 02/09/2020 | Treatment of refractory pouchitis with tofacitinib | Tofacitinib in the treatment of chronic, recurrent and/or antibiotic refractory pouchitis: a multi-omics approach - TOFA-Pouchitis | Chronic, recurrent and/or antibiotic refractory pouchitis in patients with ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Xeljanz 5mg film-coated tablets | Amsterdam UMC, location AMC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 12 | Phase 2 | Netherlands | ||
| 297 | EUCTR2020-001398-59-BG (EUCTR) | 13/10/2020 | 18/09/2020 | Clinical trial to evaluate the efficacy and the safety of OSE-127 versus placebo in subjects with ulcerative colitis who have failed or are intolerant to previous treatment(s) | Randomized, double-blind, Phase 2 study to evaluate the efficacy and the safety of OSE-127 versus placebo in subjects with moderate to severe active ulcerative colitis who have failed or are intolerant to previous treatment(s) | Moderate to severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: OSE-127 Product Code: OSE-127 INN or Proposed INN: Lusvertikimab Other descriptive name: humanized recombinant IgG4 monoclonal antibody against CD-127 | OSE Immunotherapeutics | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 140 | Phase 2 | Belarus;Serbia;Spain;Ukraine;Russian Federation;Hungary;Poland;Belgium;Croatia;Bulgaria;South Africa;Georgia;Latvia | ||
| 298 | JPRN-UMIN000046650 | 2020/10/08 | 18/01/2022 | exploratory study of optimizing ustekinumab dosing interval in ulcerative colitis | exploratory study of optimizing ustekinumab dosing interval in ulcerative colitis - exploratory study of optimizing ustekinumab dosing interval in ulcerative colitis | ulcerative colitis | Endoscopy was performed 28 to 32 weeks after the administration of ustekinumab | JUNTENDO UNIVERSITY NERIMA HOSPITAL | NULL | Recruiting | 20years-old | 100years-old | Male and Female | 30 | Not selected | Japan |
| 299 | EUCTR2020-000047-31-FR (EUCTR) | 07/10/2020 | 13/05/2020 | A study of AMT-101 in patients with Ulcerative Colitis. | A Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter, Phase 2a Study of the Efficacy and Safety of Oral AMT-101 in Subjects with Moderate to Severe Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: AMT-101 INN or Proposed INN: Not yet assigned Other descriptive name: AMT-101 | Applied Molecular Transport Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 102 | Phase 2 | United States;Serbia;Belarus;Spain;Ukraine;Russian Federation;United Kingdom;Switzerland;Italy;India;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Kazakhstan;Bulgaria;Georgia;Netherlands;Germany;Moldova, Republic of | ||
| 300 | NCT04577794 (ClinicalTrials.gov) | October 5, 2020 | 30/9/2020 | A Study Evaluating the Effects of GLPG3970 Given as an Oral Treatment for 6 Weeks in Adults With Ulcerative Colitis | A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of GLPG3970, Administered Orally for 6 Weeks in Adult Subjects With Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Drug: GLPG3970;Drug: Placebo | Galapagos NV | NULL | Completed | 18 Years | 64 Years | All | 31 | Phase 2 | Georgia;Moldova, Republic of;Poland;Ukraine |
| 301 | NCT04882007 (ClinicalTrials.gov) | October 2, 2020 | 13/4/2021 | Study of OSE-127 vs Placebo in Patients With Moderate to Severe Active Ulcerative Colitis | Randomized, Double-blind, Phase 2 Study to Evaluate the Efficacy and the Safety of OSE-127 Versus Placebo in Subjects With Moderate to Severe Active Ulcerative Colitis Who Have Failed or Are Intolerant to Previous Treatment(s) | Ulcerative Colitis | Drug: OSE-127;Drug: Placebo | OSE Immunotherapeutics | NULL | Recruiting | 18 Years | 75 Years | All | 150 | Phase 2 | Belarus;Belgium;Bulgaria;Croatia;Georgia;Hungary;Latvia;Poland;Russian Federation;South Africa;Ukraine |
| 302 | ChiCTR2000035497 | 2020-10-01 | 2020-08-13 | A multicenter, randomized, controlled trial of Qingyu Powder in the treatment of mild to moderate active ulcerative colitis | A multicenter, randomized, controlled trial of Qingyu Powder in the treatment of mild to moderate active ulcerative colitis | ulcerative colitis | Experimental group:Qingyusan;Control group:Mesalazine; | Shuguang Hospital affiliated to Shanghai University of traditional Chinese Medicine | NULL | Pending | Both | Experimental group:40;Control group:40; | China | |||
| 303 | ITMCTR2000003772 | 2020-10-01 | 2020-08-27 | A randomized controlled clinical trial of Qingdai(indigo naturalis) in the treatment of mild to moderate active ulcerative colitis | A randomized controlled clinical trial of Qingdai(indigo naturalis) in the treatment of mild to moderate active ulcerative colitis | ulcerative colitis | Traditional Chinese medicine group:Qingdai (indigo naturalis);Western medicine group:Mesalazine granules; | Shuguang Hospital affiliated to Shanghai University of traditional Chinese Medicine | NULL | Recruiting | Both | Traditional Chinese medicine group:40;Western medicine group:40; | China | |||
| 304 | ITMCTR2000003714 | 2020-10-01 | 2020-08-25 | Study of Jianpi Huashi Decoction and Mesalazine on Ulcerative Colitis Patients with Spleen Deficiency and Damp-Heat Type | Study of Jianpi Huashi Decoction and Mesalazine on Ulcerative Colitis Patients with Spleen Deficiency and Damp-Heat Type | Uicerative colitis | Mesalazine Group:Mesalazine;Jianpi Huashi Decoction Group:Jianpi Huashi Decoction; | Yueyang Hospital of Integrated Traditional Chinese and Western Medicine,Shanghai University of TCM | NULL | Recruiting | Both | Mesalazine Group:45;Jianpi Huashi Decoction Group:45; | China | |||
| 305 | NCT04225819 (ClinicalTrials.gov) | October 1, 2020 | 3/1/2020 | Adjunctive Treatment With Vitamin D3 in Patients With Active IBD | Adjunctive Treatment With Vitamin D3 in Patients With Active IBD (ACTIVATED): A Randomized, Double-blind, Placebo-controlled Trial | IBD;Inflammatory Bowel Diseases;Crohn Disease;Ulcerative Colitis;Vitamin D3 Deficiency | Dietary Supplement: Vitamin D3;Other: Placebo | Massachusetts General Hospital | NULL | Recruiting | 18 Years | N/A | All | 100 | N/A | United States |
| 306 | ChiCTR2000036950 | 2020-10-01 | 2020-08-25 | Study of Jianpi Huashi Decoction and Mesalazine on Ulcerative Colitis Patients with Spleen Deficiency and Damp-Heat Type | Study of Jianpi Huashi Decoction and Mesalazine on Ulcerative Colitis Patients with Spleen Deficiency and Damp-Heat Type | Uicerative colitis | Jianpi Huashi Decoction Group:Jianpi Huashi Decoction;Mesalazine Group:Mesalazine; | Yueyang Hospital of Integrated Traditional Chinese and Western Medicine,Shanghai University of TCM | NULL | Recruiting | Both | Jianpi Huashi Decoction Group:45;Mesalazine Group:45; | China | |||
| 307 | ITMCTR2000003558 | 2020-10-01 | 2020-08-13 | A multicenter, randomized, controlled trial of Qingyu Powder in the treatment of mild to moderate active ulcerative colitis | A multicenter, randomized, controlled trial of Qingyu Powder in the treatment of mild to moderate active ulcerative colitis | ulcerative colitis | Experimental group:Qingyusan;Control group:Mesalazine; | Shuguang Hospital affiliated to Shanghai University of traditional Chinese Medicine | NULL | Pending | Both | Experimental group:40;Control group:40; | China | |||
| 308 | ChiCTR2000037261 | 2020-10-01 | 2020-08-27 | Study on the clinic of stasis removing and renewal therapy for ulcerative colitis based on serum exosome miRNA to regulate the immune microenvironment | Study on the clinic of stasis removing and renewal therapy for ulcerative colitis based on serum exosome miRNA to regulate the immune microenvironment | Ulcerative Colitis | experimental group:stasis removing and immunoregulation therapy;control group:mesalamine; | Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai | NULL | Recruiting | 18 | 65 | Both | experimental group:30;control group:30; | China | |
| 309 | JPRN-UMIN000041972 | 2020/10/01 | 01/10/2020 | Clinical trial on the effects of dietary intake of sulforaphane-rich broccoli sprouts on severity of ulcerative colitis. | Clinical trial on the effects of dietary intake of sulforaphane-rich broccoli sprouts on severity of ulcerative colitis. - BS-UC-2020 | ulcerative colitis | Broccoli Sprouts (20 g/day, 8 weeks) Alfalfa Sprouts (20 g/day, 8 weeks) | University of Tsukuba | NULL | Recruiting | 20years-old | Not applicable | Male and Female | 50 | Not selected | Japan |
| 310 | ChiCTR2000037220 | 2020-10-01 | 2020-08-27 | A randomized controlled clinical trial of Qingdai(indigo naturalis) in the treatment of mild to moderate active ulcerative colitis | A randomized controlled clinical trial of Qingdai(indigo naturalis) in the treatment of mild to moderate active ulcerative colitis | ulcerative colitis | Traditional Chinese medicine group:Qingdai (indigo naturalis);Western medicine group:Mesalazine granules; | Shuguang Hospital affiliated to Shanghai University of traditional Chinese Medicine | NULL | Recruiting | Both | Traditional Chinese medicine group:40;Western medicine group:40; | China | |||
| 311 | EUCTR2020-001811-26-NL (EUCTR) | 30/09/2020 | 08/07/2020 | IBD under control with less medication | De-escalation of anti-TNF therapy in adolescents and young adults with IBD with tight faecal calprotectin and trough level monitoring - FREE-study | Crohn's disease, ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remicade INN or Proposed INN: INFLIXIMAB Trade Name: Flixabi INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra INN or Proposed INN: INFLIXIMAB Trade Name: Remsima INN or Proposed INN: INFLIXIMAB Trade Name: Zessly INN or Proposed INN: INFLIXIMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Amgevita INN or Proposed INN: ADALIMUMAB Trade Name: Hulio INN or Proposed INN: ADALIMUMAB | University Medical Center Groningen | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 4 | Netherlands | ||
| 312 | EUCTR2020-001398-59-LV (EUCTR) | 21/09/2020 | 28/07/2020 | Clinical trial to evaluate the efficacy and the safety of OSE-127 versus placebo in subjects with ulcerative colitis who have failed or are intolerant to previous treatment(s) | Randomized, double-blind, Phase 2 study to evaluate the efficacy and the safety of OSE-127 versus placebo in subjects with moderate to severe active ulcerative colitis who have failed or are intolerant to previous treatment(s) | Moderate to severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: OSE-127 Product Code: OSE-127 Other descriptive name: humanized recombinant IgG4 monoclonal antibody against CD-127 | OSE Immunotherapeutics | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 2 | Belarus;Serbia;Ukraine;Lithuania;Russian Federation;France;Hungary;Belgium;Poland;Croatia;Bulgaria;Georgia;Latvia | ||
| 313 | NCT04259138 (ClinicalTrials.gov) | September 17, 2020 | 4/2/2020 | Determination of the Optimal Treatment Target in Ulcerative Colitis | VERDICT: In actiVE Ulcerative Colitis, a RanDomIzed Controlled Trial for Determination of the Optimal Treatment Target | Colitis, Ulcerative | Biological: Treatment Algorithm A;Biological: Treatment Algorithm B;Biological: Treatment Algorithm C | Alimentiv Inc. | Takeda Development Center Americas, Inc. | Recruiting | 18 Years | N/A | All | 660 | Phase 4 | United States;Belgium;Canada;France;Netherlands;Poland;Ukraine;United Kingdom |
| 314 | NCT04353791 (ClinicalTrials.gov) | September 16, 2020 | 24/3/2020 | Study of OST-122 in Patients With Moderate to Severe Ulcerative Colitis | A Phase Ib/IIa, Randomized, Double Blind, Placebo Controlled, Multicenter Clinical Trial to Evaluate the Safety, Pharmacokinetics and Efficacy of Oral Treatment With OST-122 in Patients With Moderate to Severe Ulcerative Colitis | Ulcerative Colitis Chronic Moderate;Ulcerative Colitis Chronic Severe | Drug: OST-122;Drug: Placebo | Oncostellae S.L | NULL | Completed | 18 Years | 75 Years | All | 32 | Phase 1/Phase 2 | Spain;Ukraine |
| 315 | NCT03996369 (ClinicalTrials.gov) | September 15, 2020 | 21/6/2019 | Etrasimod Versus Placebo as Induction Therapy in Moderately to Severely Active Ulcerative Colitis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 12-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects With Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Drug: Etrasimod;Drug: Placebo | Arena Pharmaceuticals | NULL | Completed | 16 Years | 80 Years | All | 354 | Phase 3 | United States;Argentina;Australia;Austria;Belarus;Belgium;Bulgaria;Canada;Chile;Colombia;Croatia;Czechia;Denmark;Estonia;France;Georgia;Germany;Hungary;India;Israel;Italy;Japan;Korea, Republic of;Lebanon;Lithuania;Mexico;Moldova, Republic of;Netherlands;Poland;Portugal;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Switzerland;Thailand;Turkey;Ukraine;United Kingdom |
| 316 | NCT04338204 (ClinicalTrials.gov) | September 14, 2020 | 4/4/2020 | Observational Study To Assess The Effectiveness and Treatment Adherence Of Tofacitinib of Ulcerative Colitis In Clinical Practice In Sweden | Observational Study of Tofacitinib in Ulcerative Colitis in Sweden (ODEN) | Ulcerative Colitis | Drug: tofacitinib | Pfizer | NULL | Recruiting | 18 Years | 99 Years | All | 120 | Sweden | |
| 317 | NCT04373473 (ClinicalTrials.gov) | September 14, 2020 | 28/4/2020 | Evaluation the Safety and Efficacy of Lyophilized Fecal Microbiota Transplantation Administered Orally for Prevention of Relapse or Intestinal Inflammation in Adults With Ulcerative Colitis | A Phase 2a, Randomized, Double-blinded, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Lyophilized Fecal Microbiota Transplantation (PRIM-DJ2727) Administered Orally in Combination With Standard of Care Therapy for Prevention of Relapse or Intestinal Inflammation in Adults With Ulcerative Colitis | Adults With Ulcerative Colitis | Drug: PRIM-DJ2727;Drug: Placebos | The University of Texas Health Science Center, Houston | NULL | Recruiting | 18 Years | N/A | All | 58 | Phase 2 | United States |
| 318 | EUCTR2020-000659-11-PL (EUCTR) | 10/09/2020 | 23/07/2020 | A study evaluating the effects of GLPG3970 given as an oral treatment for 6 weeks in adults with ulcerative colitis | A randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety, tolerability, efficacy, and pharmacokinetics of GLPG3970, administered orally for 6 weeks in adult subjects with moderately to severely active ulcerative colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GLPG3970 Product Code: G1567970 INN or Proposed INN: Not applicable Other descriptive name: GLPG3970 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 2 | Poland;Ukraine;Georgia;Moldova, Republic of | ||
| 319 | EUCTR2020-000047-31-HU (EUCTR) | 09/09/2020 | 07/07/2020 | A study of AMT-101 in patients with Ulcerative Colitis. | A Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter, Phase 2a Study of the Efficacy and Safety of Oral AMT-101 in Subjects with Moderate to Severe Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: AMT-101 INN or Proposed INN: Not yet assigned Other descriptive name: AMT-101 | Applied Molecular Transport Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 102 | Phase 2 | Belarus;Serbia;United States;Spain;Ukraine;Russian Federation;United Kingdom;Switzerland;Italy;India;France;Hungary;Canada;Poland;Belgium;Romania;Kazakhstan;Georgia;Bulgaria;Netherlands;Germany;Moldova, Republic of | ||
| 320 | EUCTR2019-002698-74-DE (EUCTR) | 08/09/2020 | 21/02/2020 | A study to evaluate the efficacy and safety of PF 06480605 in adult participants with moderate to severe ulcerative colitis | A PHASE 2B, MULTICENTER, RANDOMIZED, DOUBLEBLIND,PLACEBO CONTROLLED DOSE-RANGINGSTUDY TO EVALUATE THE EFFICACY, SAFETY, ANDPHARMACOKINETICS OF PF-06480605 IN ADULTPARTICIPANTS WITH MODERATE TO SEVEREULCERATIVE COLITIS - Tuscany 2 | A phase 2b randomised, double-blind, placebo controlled dose-ranging study in Adults with Moderate to Severe Ulcerative Colitis MedDRA version: 20.0;Level: HLT;Classification code 10009888;Term: Colitis (excl infective);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PF-06480605 Product Code: PF-06480605 INN or Proposed INN: PF-06480605 Other descriptive name: Anti-TL1A | Pfizer Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 2 | United States;Serbia;Slovakia;Thailand;Spain;Ukraine;Russian Federation;Colombia;Italy;India;France;Australia;South Africa;China;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Poland;Belgium;Romania;Bulgaria;Germany;Japan | ||
| 321 | NCT04205643 (ClinicalTrials.gov) | September 2, 2020 | 18/12/2019 | CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Ulcerative Colitis (LIBERTY-UC) | A Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Biological: CT-P13 SC (Infliximab);Other: Placebo SC | Celltrion | NULL | Active, not recruiting | 18 Years | 75 Years | All | 548 | Phase 3 | Poland |
| 322 | NCT04109300 (ClinicalTrials.gov) | September 1, 2020 | 27/9/2019 | Preemptive HLA Genotyping for the Safe Use of Infliximab-combination Therapy in Inflammatory Bowel Disease | Pharmacogenomic Strategies in Inflammatory Bowel Disease: Evaluating the Role of Pre-emptive HLADQA1 Genotyping for the Application of Targeted Infliximab-based Combination Therapy (INHERIT) | Inflammatory Bowel Diseases;Ulcerative Colitis;Crohn Disease | Genetic: HLADQA1*05A>G screening;Other: Standard of Care | Western University, Canada | NULL | Not yet recruiting | 18 Years | 85 Years | All | 162 | N/A | Canada |
| 323 | ChiCTR2000032498 | 2020-09-01 | 2020-04-30 | Human experimental study on the effect of probiotics combined with prebiotics on ulcerative colitis: a randomized double-blind controlled trial | Human experimental study on the effect of probiotics combined with prebiotics on ulcerative colitis | Ulcerative colitis | Experimental group:Probiotics and prebiotics;placebo group:maltodextrin; | Capital Medical University | NULL | Pending | Both | Experimental group:15;placebo group:15; | China | |||
| 324 | JPRN-jRCTs031200103 | 01/09/2020 | 01/09/2020 | Alginate combined fecal microbiota transplantation for ulcerative colitis | Single center randomized study: Alginate combined fecal microbiota transplantation for ulcerative colitis | Ulcerative colitis Ulcerative colitis | A-FMT plus algin acid therapy arm Patients are performed Colonoscopy before participating in this clinical research and make sure the patients is eligible. Patient undergoes FMT two days after AFM therapy. Approximately 150 g to 200 g of fresh stool provided in advance from a donor is dissolved in 500 ml of physiological saline, and the treated stool that has been processed to remove excess residues and the like through a filter is stored frozen at minus 80 degree celsius. The diluted and filtered fecal suspension with dextrin added is transferred into the patients colon from cecum to rectum during total colonoscopy. As usual examinations, the patient undergoes biopsy of inflammatory site. For the next 8weeks, patients take algin acid two times a day every single day. A-FMT plus placebo arm Patients are performed Colonoscopy before participating in this clinical research and make sure the patients is eligible. Patient undergoes FMT two days after AFM therapy. Approximately 150 g to 200 g of fresh stool provided in advance from a donor is dissolved in 500 ml of physiological saline, and the treated stool that has been processed to remove excess residues and the like through a filter is stored frozen at minus 80 degree celsius. The diluted and filtered fecal suspension with dextrin added is transferred into the patients colon from cecum to rectum during total colonoscopy. As usual examinations, the patient undergoes biopsy of inflammatory site. For the next 8weeks, patients take Placebo two times a day every single day. | Ishikawa Dai | NULL | Recruiting | >= 20age old | Not applicable | Both | 60 | N/A | Japan |
| 325 | NCT04348890 (ClinicalTrials.gov) | September 1, 2020 | 13/4/2020 | Proof of Concept Trial of Vamorolone in Pediatric Ulcerative Colitis | A Phase I/II Open-Label, Proof-of-Concept Study of Vamorolone in Children and Adolescents With Mild-Moderately Active Ulcerative Colitis | Pediatric Ulcerative Colitis | Drug: Vamorolone 4% suspension for oral dosing | ReveraGen BioPharma, Inc. | NULL | Withdrawn | 4 Years | 17 Years | All | 0 | Phase 1/Phase 2 | NULL |
| 326 | NCT05538026 (ClinicalTrials.gov) | September 1, 2020 | 9/9/2022 | Effectiveness of Fecal Microbiota Transplantation as add-on Therapy in Mild-to-moderate Ulcerative Colitis | Efficacy and Safety of Fecal Microbiota Transplantation as add-on Therapy in Patients With Mild-To-Moderate Ulcerative Colitis: A Randomized, Clinical Trial | Ulcerative Colitis Chronic Mild;Inflammatory Bowel Diseases | Drug: Mesalazine;Biological: Fecal transplantation | Bogomolets National Medical University | Ukrainian Research and Practical Centre of Endocrine Surgery, Transplantation of Endocrine Organs and Tissues of the Ministry of Health of Ukraine | Completed | 18 Years | 60 Years | All | 53 | N/A | Ukraine |
| 327 | NCT04521205 (ClinicalTrials.gov) | September 2020 | 18/8/2020 | A Multicenter Clinical Trial: Efficacy, Safety of Fecal Microbiota Transplantation for Inflammatory Bowel Disease | A Multicenter Clinical Trial: Efficacy, Safety of Fecal Microbiota Transplantation for Inflammatory Bowel Disease | Inflammatory Bowel Disease, Ulcerative Colitis Type | Drug: fecal microbiota capsule | Zhongshan Hospital Xiamen University | NULL | Recruiting | 18 Years | 65 Years | All | 200 | Phase 1 | China |
| 328 | EUCTR2019-004652-11-SI (EUCTR) | 28/08/2020 | 31/08/2020 | A Study of Etrolizumab-Based Induction Therapy Combinations Followed by Etrolizumab Maintenance Therapy in Patients with Moderate-To-Severe Ulcerative Colitis | RANDOMIZED, OPEN-LABEL PHASE 3B STUDY OF ETROLIZUMAB BASED INDUCTION THERAPY COMBINATIONS FOLLOWED BY ETROLIZUMAB MAINTENANCE THERAPY IN PATIENTS WITH MODERATE-TO-SEVERE ULCERATIVE COLITIS - Lantana | Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: RO5490261/F04-02 INN or Proposed INN: Etrolizumab Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223 Trade Name: Remicade INN or Proposed INN: INFLIXIMAB Other descriptive name: INFLIXIMAB Trade Name: Xeljanz INN or Proposed INN: TOFACITINIB Other descriptive name: TOFACITINIB Trade Name: Xeljanz INN or Proposed INN: TOFACITINIB Other descriptive name: TOFACITINIB Trade Name: Stelara INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB Trade Name: Stelara INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 372 | Phase 3 | Serbia;United States;Slovakia;Spain;Ukraine;Ireland;Israel;Russian Federation;Italy;Switzerland;France;Latvia;Netherlands;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Brazil;Belgium;Poland;Germany | ||
| 329 | NCT04583358 (ClinicalTrials.gov) | August 26, 2020 | 16/9/2020 | Study of the Efficacy and Safety of AMT-101 in Subjects With Ulcerative Colitis (LOMBARD) | A Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter, Phase 2a Study of the Efficacy and Safety of Oral AMT-101 in Subjects With Moderate to Severe Ulcerative Colitis (LOMBARD) | Ulcerative Colitis | Drug: AMT-101 (oral);Other: Placebo (oral) | Applied Molecular Transport | NULL | Active, not recruiting | 18 Years | 80 Years | All | 105 | Phase 2 | United States;Belarus;Bulgaria;Canada;France;Georgia;Germany;Hungary;Moldova, Republic of;Poland;Russian Federation;Switzerland;Ukraine;United Kingdom |
| 330 | NCT04576000 (ClinicalTrials.gov) | August 25, 2020 | 17/9/2020 | Identification of Biomarkers of Janus Kinase Inhibitor Therapy in Patients With Ulcerative Colitis | PhaRmacOkinetics and PHarmacodynamic BiomarkErs of Janus Kinase Inhibitor Therapy in PatIents With Ulcerative Colitis (PROPHETIC) | Ulcerative Colitis | Drug: Janus Kinase Inhibitor | Alimentiv Inc. | Alimentiv Translational Research Consortium | Recruiting | 18 Years | N/A | All | 40 | United States;Belgium;Canada;Italy;Netherlands;Spain | |
| 331 | EUCTR2019-003999-39-NO (EUCTR) | 17/08/2020 | 29/04/2020 | A placebo-controlled study followed by an open label treatment to evaluate the safety and efficacy of PF-06826647 in participants with moderate to severe ulcerative colitis | A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP, PLACEBO-CONTROLLED STUDY WITH AN OPEN LABEL EXTENSION TO EVALUATE THE SAFETY AND EFFICACY OF PF-06826647 IN PARTICIPANTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | moderate to severe ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PF-06826647 Product Code: PF-06826647 INN or Proposed INN: PF-06826647 | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 202 | Phase 2 | United States;United Arab Emirates;Qatar;Saudi Arabia;Hong Kong;Slovakia;Morocco;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Italy;India;France;Macedonia, the former Yugoslav Republic of;Puerto Rico;Jordan;Malaysia;Australia;Tunisia;China;Bosnia and Herzegovina;Oman;Turkey;United Kingdom;Czech Republic;Armenia;Mexico;Brazil;Belgium;Poland;Romania;Croatia;Georgia;Germany;Norway | ||
| 332 | EUCTR2018-000930-37-HU (EUCTR) | 17/08/2020 | 24/06/2020 | A Study to Investigate safety and how well Ravagalimab (ABBV-323) works and how safe it is in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy | A Multicenter, Single-Arm, Open-Label Study to Investigate the Efficacy and Safety of Ravagalimab (ABBV-323) in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Ravagalimab Product Code: ABBV-323 Other descriptive name: ABBV-323 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | United States;France;Hungary;Canada;Spain;Netherlands;Germany;United Kingdom;Italy;Korea, Republic of | ||
| 333 | JPRN-UMIN000042017 | 2020/08/13 | 05/10/2020 | Hydrogen gas inhalation randomized double blinded trial for ulcerative colitis | Hydrogen gas inhalation randomized double blinded trial for ulcerative colitis - Hydrogen gas inhalation randomized double blinded trial for ulcerative colitis | Ulcerative colitis | hydrogen gas 8 weeks inhalation the inhalation for 4 hours per day 12 weeks observation after the inhalation placebo gas 8 weeks inhalation the inhalation for 4 hours per day 12 weeks observation after the inhalation | Juntendo University Hospital | NULL | Suspended | 20years-old | Not applicable | Male and Female | 20 | Not selected | Japan |
| 334 | EUCTR2019-004469-41-DE (EUCTR) | 11/08/2020 | 26/03/2020 | A trial to investigate the safety and efficacy of PN-943 in patients with moderate or severe Ulcerative Colitis (a long-term condition where the colon and rectum become inflamed) | A Phase 2 Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center Study to Evaluate the Safety and Efficacy of Oral PN-943 in Subjects with Moderate to Severe Active Ulcerative Colitis | Ulcerative colitis (US) is a chronic relapsing inflammatory bowel disease of the large intestine characterized by bloody diarrhoea, abdominal cramps and fatigue. UC is characterized by inflammation and ulceration of mainly the mucosal and occasionally submucosal intestinal layers. MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: PN-943 Other descriptive name: PN-943 Product Code: PN-943 Other descriptive name: PN-943 | Protagonist Therapeutics, Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 169 | Phase 2 | Serbia;United States;Ukraine;Austria;Russian Federation;Italy;Hungary;Canada;Poland;Bulgaria;Georgia;Germany;Korea, Republic of | ||
| 335 | EUCTR2019-004469-41-BG (EUCTR) | 11/08/2020 | 27/04/2020 | A trial to investigate the safety and efficacy of PN-943 in patients with moderate or severe Ulcerative Colitis (a long-term condition where the colon and rectum become inflamed) | A Phase 2 Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center Study to Evaluate the Safety and Efficacy of Oral PN-943 in Subjects with Moderate to Severe Active Ulcerative Colitis | Ulcerative colitis (US) is a chronic relapsing inflammatory bowel disease of the large intestine characterized by bloody diarrhoea, abdominal cramps and fatigue. UC is characterized by inflammation and ulceration of mainly the mucosal and occasionally submucosal intestinal layers. MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: PN-943 Other descriptive name: PN-943 Product Code: PN-943 Other descriptive name: PN-943 | Protagonist Therapeutics, Inc | NULL | Not Recruiting | Female: yes Male: yes | 169 | Phase 2 | Serbia;United States;Ukraine;Austria;Russian Federation;Italy;Hungary;Canada;Poland;Bulgaria;Georgia;Germany;Korea, Republic of | ||
| 336 | NCT04504383 (ClinicalTrials.gov) | August 5, 2020 | 5/8/2020 | PN-943 in Adults With Moderate to Severe Active Ulcerative Colitis (UC) | A Phase 2 Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center Study to Evaluate the Safety and Efficacy of Oral PN-943 in Subjects With Moderate to Severe Active Ulcerative Colitis | Ulcerative Colitis Chronic Moderate;Ulcerative Colitis Chronic Severe | Drug: PN-943;Drug: Placebo | Protagonist Therapeutics, Inc. | NULL | Active, not recruiting | 18 Years | 75 Years | All | 150 | Phase 2 | United States;Austria;Bulgaria;Canada;Georgia;Germany;Hungary;Italy;Korea, Republic of;Poland;Russian Federation;Serbia;Ukraine |
| 337 | EUCTR2019-004208-37-BE (EUCTR) | 03/08/2020 | 04/03/2020 | Statins for treating ulcerative colitis through GI microbiome | Drug repurposing - Statins as microbiota modulating agents in ulcerative colitis - ReMiDy | There are two population groups, 20 healthy volunteers and at least 150 individuals diagnosed with mild/moderate active ulcerative colitis or are in remission.;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Rosuvastatine EG Product Name: rosuvastatin INN or Proposed INN: rosuvastatin Other descriptive name: ROSUVASTATIN CALCIUM | UZ Leuven | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 400 | Phase 3 | Belgium | ||
| 338 | EUCTR2020-000047-31-GB (EUCTR) | 03/08/2020 | 20/04/2020 | A study of AMT-101 in patients with Ulcerative Colitis. | A Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter, Phase 2a Study of the Efficacy and Safety of Oral AMT-101 in Subjects with Moderate to Severe Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: AMT-101 INN or Proposed INN: Not yet assigned Other descriptive name: AMT-101 | Applied Molecular Transport Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 102 | Phase 2 | Serbia;United States;Belarus;Spain;Ukraine;Russian Federation;Italy;United Kingdom;Switzerland;India;France;Hungary;Canada;Poland;Romania;Kazakhstan;Bulgaria;Georgia;Germany;Moldova, Republic of | ||
| 339 | ITMCTR2000003530 | 2020-08-01 | 2020-07-31 | Study on TCM accurate syndrome differentiation and treatment scheme of ulcerative colitis based on intestinal microecology and multi-omics technology | Study on TCM accurate syndrome differentiation and treatment scheme of ulcerative colitis based on intestinal microecology and multi-omics technology | Uicerative colitis | qi deficiency syndrome control group:Mesalazine;damp-heat syndrome control group:Mesalazine;healthy control group:nil;qi deficiency syndrome treatment group:Modified Shenling Baizhu Powder and Mesalazine;ulcerative colitis damp-heat syndrome group:nil;damp-heat syndrome treatment group:Modified Gegenqinlian Decoction and Mesalazine;ulcerative colitis qi deficiency syndrome group:nil; | Jiangsu Province Hospital of Chinese Medicine | NULL | Recruiting | 18 | 65 | Both | qi deficiency syndrome control group:30;damp-heat syndrome control group:30;healthy control group:30;qi deficiency syndrome treatment group:60;ulcerative colitis damp-heat syndrome group:30;damp-heat syndrome treatment group:60;ulcerative colitis qi defi | China | |
| 340 | ChiCTR2000035099 | 2020-08-01 | 2020-07-31 | Study on TCM accurate syndrome differentiation and treatment scheme of ulcerative colitis based on intestinal microecology and multi-omics technology | Study on TCM accurate syndrome differentiation and treatment scheme of ulcerative colitis based on intestinal microecology and multi-omics technology | Uicerative colitis | ulcerative colitis damp-heat syndrome group:nil;ulcerative colitis qi deficiency syndrome group:nil;healthy control group:nil;damp-heat syndrome treatment group:Modified Gegenqinlian Decoction and Mesalazine;damp-heat syndrome control group:Mesalazine;qi deficiency syndrome treatment group:Modified Shenling Baizhu Powder and Mesalazine;qi deficiency syndrome control group:Mesalazine; | Jiangsu Province Hospital of Chinese Medicine | NULL | Recruiting | 18 | 65 | Both | ulcerative colitis damp-heat syndrome group:30;ulcerative colitis qi deficiency syndrome group:30;healthy control group:30;damp-heat syndrome treatment group:60;damp-heat syndrome control group:30;qi deficiency syndrome treatment group:60;qi deficiency s | China | |
| 341 | EUCTR2019-003596-19-DE (EUCTR) | 29/07/2020 | 29/07/2020 | A Three-Arm, Randomized, Placebo-Controlled, Double-Blind Phase 3 Study to Evaluate the Safety and Efficacy of Once-Daily and Twice-Daily Dosing of a Novel Hydrocortisone Acetate 90 mg Suppository Formulation Administered with the Sephure® Suppository Applicator in Subjects with Ulcerative Colitis of the Rectum. | A Three-Arm, Randomized, Placebo-Controlled, Double-Blind Phase 3 Study to Evaluate the Safety and Efficacy of Once-Daily and Twice-Daily Dosing of a Novel Hydrocortisone Acetate 90 mg Suppository Formulation Administered with the Sephure® Suppository Applicator in Subjects with Ulcerative Colitis of the Rectum. - cessa | Ulcerative Colitis of the Rectum MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;Level: HLT;Classification code 10027682;Term: Immune and associated conditions NEC;System Organ Class: 10021428 - Immune system disorders MedDRA version: 20.0;Level: SOC;Classification code 10021428;Term: Immune system disorders;Level: HLGT;Classification code 10027665;Term: Immune disorders NEC;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 90 mg hydrocortisone acetate suppository with Sephure suppository applicator INN or Proposed INN: HYDROCORTISONE ACETATE | Cristcot HCA LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 618 | Phase 3 | United States;Philippines;Hong Kong;Spain;Poland;Ukraine;Romania;Russian Federation;Germany;Italy;India | ||
| 342 | EUCTR2019-004469-41-AT (EUCTR) | 27/07/2020 | 26/03/2020 | A trial to investigate the safety and efficacy of PN-943 in patients with moderate or severe Ulcerative Colitis (a long-term condition where the colon and rectum become inflamed) | A Phase 2 Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center Study to Evaluate the Safety and Efficacy of Oral PN-943 in Subjects with Moderate to Severe Active Ulcerative Colitis | Ulcerative colitis (US) is a chronic relapsing inflammatory bowel disease of the large intestine characterized by bloody diarrhoea, abdominal cramps and fatigue. UC is characterized by inflammation and ulceration of mainly the mucosal and occasionally submucosal intestinal layers. MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: PN-943 Other descriptive name: PN-943 Product Code: PN-943 Other descriptive name: PN-943 | Protagonist Therapeutics, Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 169 | Phase 2 | Serbia;United States;Ukraine;Austria;Russian Federation;Italy;Hungary;Canada;Poland;Georgia;Bulgaria;Germany;Korea, Republic of | ||
| 343 | NCT03920254 (ClinicalTrials.gov) | July 23, 2020 | 28/3/2019 | TD-1473 Long-Term Safety (LTS) Ulcerative Colitis (UC) Study | 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) | Ulcerative Colitis (UC) | Drug: TD-1473 Dose A;Drug: TD-1473 Dose B;Drug: TD-1473 Dose C | Theravance Biopharma | NULL | Terminated | 18 Years | N/A | All | 46 | Phase 2/Phase 3 | United States;Australia;Bulgaria;Canada;France;Georgia;Germany;Greece;Hungary;Israel;Italy;Japan;Korea, Republic of;Poland;Portugal;Romania;Serbia;Slovakia;South Africa;Spain;Taiwan;Ukraine |
| 344 | EUCTR2019-002485-12-GB (EUCTR) | 14/07/2020 | 30/03/2020 | Determination of the Optimal Treatment Target in Ulcerative Colitis | VERDICT: In actiVE ulcerative colitis, a RanDomIzed Controlled Trial for determination of the optimal treatment target - VERDICT | Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entyvio INN or Proposed INN: vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio INN or Proposed INN: vedolizumab Other descriptive name: VEDOLIZUMAB | Alimentiv Inc. (formerly Robarts Clinical Trials) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 660 | Phase 4 | France;Belarus;United States;Canada;Poland;Belgium;Ukraine;Russian Federation;Netherlands;Italy;United Kingdom | ||
| 345 | EUCTR2018-002136-24-RO (EUCTR) | 13/07/2020 | 30/03/2022 | A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Ulcerative Colitis | A Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with TD-1473 in Subjects with Moderately-to-Severely Active Ulcerative Colitis - Rhea: Efficacy and Safety of TD-1473 in Ulcerative Colitis | Moderately-to-Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 | Theravance Biopharma Ireland Limited | NULL | Not Recruiting | Female: yes Male: yes | 880 | Phase 2;Phase 3 | United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;South Africa;Korea, Republic of;United Kingdom;Hungary;Canada;Poland;Romania;Croatia;Georgia;Bulgaria;Germany;Japan | ||
| 346 | NCT04458805 (ClinicalTrials.gov) | July 10, 2020 | 16/6/2020 | Safety, Tolerability and Pharmacokinetics of Oral NX-13 in Healthy Adults Male and Female Volunteers | A Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral NX-13 in Healthy Adult Male and Female Volunteers | Ulcerative Colitis | Drug: NX-13 250 mg;Drug: Placebo | Landos Biopharma Inc. | NULL | Completed | 18 Years | 64 Years | All | 56 | Phase 1 | Australia |
| 347 | NCT05386290 (ClinicalTrials.gov) | July 9, 2020 | 17/5/2022 | A Multicentered Prospective Cohort Study of Chinese IBD Patients | A Multicentered Prospective Cohort Study of Chinese IBD Patients Concerning Cost-effectiveness Analysis, Therapeutic Effect Predictor Exploration and Gut Microbiota Analysis | Ulcerative Colitis;Crohn Disease | Drug: Infliximab;Drug: Vedolizumab;Drug: Ustekinumab;Drug: conventional treatment (glucocoticoid, immunosupressive drugs and/or mesalazine) | Peking Union Medical College Hospital | NULL | Enrolling by invitation | 14 Years | 80 Years | All | 200 | China | |
| 348 | EUCTR2018-004694-27-FR (EUCTR) | 06/07/2020 | 10/04/2020 | Safety and Efficacy of BMS-986165 Compared with Placebo in Subjects with Ulcerative Colitis | A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BMS-986165 Product Code: BMS-986165 INN or Proposed INN: BMS-986165 Other descriptive name: BMS986165 | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | Poland;Australia;Germany;Japan;Korea, Republic of;United States;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Belgium | ||
| 349 | EUCTR2018-003986-33-PT (EUCTR) | 06/07/2020 | 28/10/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 330 | Phase 3 | United States;Serbia;Belarus;Portugal;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan | ||
| 350 | EUCTR2018-004002-25-NL (EUCTR) | 06/07/2020 | 17/09/2019 | A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis - QUASAR | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 2;Phase 3 | Portugal;Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;France;Jordan;Malaysia;Australia;Latvia;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Hungary;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand;Japan;Sweden | ||
| 351 | EUCTR2017-004092-31-AT (EUCTR) | 02/07/2020 | 20/09/2019 | A study of the efficacy and safety of Mirikizumab in Ulcerative Colitis | I6T-MC-AMAPA Phase 3, Multicenter, Open-Label Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients with Moderately toSeverely Active Ulcerative Colitis (LUCENT 3) - LUCENT 3 | moderately to severely active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: mirikizumab Other descriptive name: MIRIKIZUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 960 | Phase 3 | Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Russian Federation;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Germany;Japan | ||
| 352 | EUCTR2019-004469-41-IT (EUCTR) | 02/07/2020 | 15/06/2021 | A trial to investigate the safety and efficacy of PN-943 in patients withmoderate or severe Ulcerative Colitis (a long-term condition where thecolon and rectum become inflamed) | A Phase 2 Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center Study to Evaluate the Safety and Efficacy of Oral PN-943 in Subjects with Moderate to Severe Active Ulcerative Colitis - PN-943-03 | Ulcerative colitis (US) is a chronic relapsing inflammatory bowel disease of the large intestine characterized by bloody diarrhoea, abdominal cramps and fatigue. UC is characterized by inflammation and ulceration of mainly the mucosal and occasionally submucosal intestinal layers. MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PN-943 Product Code: [PN-943] INN or Proposed INN: ACETATO DI AMMONIO Other descriptive name: PN-943 Product Name: PN-943 Product Code: [PN-943] INN or Proposed INN: ACETATO DI AMMONIO | Protagonist Therapeutics, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 2 | Serbia;United States;Ukraine;Austria;Russian Federation;Italy;Hungary;Canada;Poland;Bulgaria;Georgia;Germany;Netherlands;Korea, Republic of | ||
| 353 | NCT04457960 (ClinicalTrials.gov) | July 1, 2020 | 1/7/2020 | A Study of JNJ-66525433 in Healthy Participants and Participants With Ulcerative Colitis | A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study in Healthy Participants and Multiple Dose Study in Participants With Ulcerative Colitis to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-66525433 | Healthy;Colitis, Ulcerative | Drug: JNJ-66525433;Drug: Placebo | Janssen Research & Development, LLC | NULL | Recruiting | 18 Years | 60 Years | All | 140 | Phase 1 | Georgia;Germany;Moldova, Republic of |
| 354 | ChiCTR2000033953 | 2020-07-01 | 2020-06-18 | Effect of the probiotic on symptoms in patients with ulcerative colitis (UC) | Effect of the probiotic on symptoms in patients with ulcerative colitis (UC) | Ulcerative colitis | Placebo group:Maltodextrin;experimental group 1:Lactobacillus plantarum CCFM8610;experimental group 2:Lactobacillus plantarum N13;experimental group 3:Lactobacillus casei CCFM1059; | Jiangnan University | NULL | Pending | Both | Placebo group:20;experimental group 1:20;experimental group 2:20;experimental group 3:20; | China | |||
| 355 | NCT04360343 (ClinicalTrials.gov) | July 1, 2020 | 6/4/2020 | Compare the Pharmacokinetics, Pharmacodynamics and Safety/Tolerability of LC51-0255 Film-coated Tablet (SG85) With LC51-0255 Uncoated Tablet (SG82) in Healthy Subjects | A Randomized, Open-label, Single Dose, 2-period, 2-sequence, 2-treatment, Crossover Study to Compare the Pharmacokinetics, Pharmacodynamics and Safety/Tolerability of LC51-0255 Film-coated Tablet (SG85) With LC51-0255 Uncoated Tablet (SG82) in Healthy Subjects | Ulcerative Colitis | Drug: Film-coated tablet | LG Chem | NULL | Completed | 19 Years | 45 Years | All | 18 | Phase 1 | Korea, Republic of |
| 356 | NCT04209556 (ClinicalTrials.gov) | June 30, 2020 | 1/12/2019 | A Study To Evaluate The Safety And Efficacy Of PF-06826647 In Participants With Moderate To Severe Ulcerative Colitis | A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP, PLACEBO-CONTROLLED STUDY WITH AN OPEN LABEL EXTENSION TO EVALUATE THE SAFETY AND EFFICACY OF PF-06826647 IN PARTICIPANTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative Colitis | Drug: PF-06826647 100 mg QD;Drug: PF-06826647 300 mg QD;Drug: PF-06826647 600 mg QD;Drug: Placebo;Drug: PF-6826647 400 mg QD | Pfizer | NULL | Recruiting | 18 Years | 75 Years | All | 202 | Phase 2 | United States |
| 357 | EUCTR2019-003596-19-IT (EUCTR) | 26/06/2020 | 17/06/2021 | A Three-Arm, Randomized, Placebo-Controlled, Double-Blind Phase 3 Study to Evaluate the Safety and Efficacy of Once-Daily and Twice-Daily Dosing of a Novel Hydrocortisone Acetate 90 mg Suppository Formulation Administered with the Sephure® Suppository Applicator in Subjects withUlcerative Colitis of the Rectum. | A Three-Arm, Randomized, Placebo-Controlled, Double-Blind Phase 3 Study to Evaluate the Safety and Efficacy of Once-Daily and Twice-Daily Dosing of a Novel Hydrocortisone Acetate 90 mg Suppository Formulation Administered with the Sephure® Suppository Applicator in Subjects withUlcerative Colitis of the Rectum. - CESSA | Ulcerative Colitis of the Rectum MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;Level: HLT;Classification code 10027682;Term: Immune and associated conditions NEC;System Organ Class: 10021428 - Immune system disorders MedDRA version: 20.0;Level: SOC;Classification code 10021428;Term: Immune system disorders;Level: HLGT;Classification code 10027665;Term: Immune disorders NEC;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 90 mg idrocortisone acetato in supposta con applicatore per supposte Sephure Product Code: [90 mg idrocortisone acetato in supposta con appli INN or Proposed INN: IDROCORTISONE ACETATO | Cristcot HCA LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 618 | Phase 3 | United States;Philippines;Hong Kong;Spain;Poland;Ukraine;Russian Federation;Germany;Italy;India | ||
| 358 | EUCTR2019-003334-16-DE (EUCTR) | 26/06/2020 | 05/05/2020 | Novel budenosid suppository in addition to basic therapy with oral mesalazine compared to basic therapy alone for treatment of ulcerative colitis | Randomised, double-blind, placebo-controlled, multicentre study to compare the efficacy and safety of novel 4 mg budesonide suppository in combination with oral mesalazine versus oral mesalazine monotherapy in patients with acute ulcerative colitis | acute ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Budenofalk® suppositories INN or Proposed INN: BUDESONIDE Other descriptive name: Budenofalk® suppositories (BUS) Trade Name: Salofalk 3g gastro-resistant prolonged-release granules Product Name: Salofalk 3g gastro-resistant prolonged-release granules INN or Proposed INN: MESALAZINE | Dr. Falk Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 360 | Phase 3 | Belarus;Poland;Ukraine;Russian Federation;Bulgaria;Latvia;Germany | ||
| 359 | EUCTR2019-001430-33-DE (EUCTR) | 18/06/2020 | 25/02/2020 | A clinical trial to see if GS-4875 is effective and safe in treating people with moderate to severe ulcerative colitis | A Phase 2, Blinded, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of GS-4875 in Subjects with Moderately to Severely Active Ulcerative Colitis | ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: GS-4875 Product Code: GS-4875 | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | United States;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Belgium;Poland;Australia;Germany | ||
| 360 | NCT04188990 (ClinicalTrials.gov) | June 15, 2020 | 2/12/2019 | Cost Effectiveness of an Intervention in Hospitalized Patients With Disease-related Malnutrition | Evaluation of the Effectiveness and Cost Effectiveness of an Intervention in Hospitalized Patients With Disease-related Malnutrition | Pancreatitis, Acute;Crohn Disease;Ulcerative Colitis;Inflammatory Bowel Diseases;Pancreatic Cancer;Esophagus Cancer;Gastric Cancer;Colorectal Cancer | Dietary Supplement: Nutritional dietary intervention;Dietary Supplement: By demand;Dietary Supplement: Usual current care | Hospital Galdakao-Usansolo | NULL | Active, not recruiting | 18 Years | N/A | All | 900 | N/A | Spain |
| 361 | EUCTR2018-003987-29-FR (EUCTR) | 11/06/2020 | 12/09/2019 | An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis | An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 702 | Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan | ||
| 362 | EUCTR2019-003849-15-HR (EUCTR) | 05/06/2020 | 20/11/2020 | Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) asmaintenance therapy in patients with Ulcerative Colitis | A Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients with Moderately to Severely Active Ulcerative Colitis | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remsima Product Code: Remsima (CT-P13) INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB | Celltrion, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 615 | Phase 3 | United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Italy;France;Peru;South Africa;Latvia;Moldova, Republic of;Czechia;Turkey;Austria;Hungary;Mexico;Brazil;Poland;Croatia;Bulgaria;Germany | ||
| 363 | EUCTR2019-002698-74-BE (EUCTR) | 03/06/2020 | 02/04/2020 | A study to evaluate the efficacy and safety of PF 06480605 in adult participants with moderate to severe ulcerative colitis | A PHASE 2B, MULTICENTER, RANDOMIZED, DOUBLEBLIND,PLACEBO CONTROLLED DOSE-RANGINGSTUDY TO EVALUATE THE EFFICACY, SAFETY, ANDPHARMACOKINETICS OF PF-06480605 IN ADULTPARTICIPANTS WITH MODERATE TO SEVEREULCERATIVE COLITIS - Tuscany 2 | A phase 2b randomised, double-blind, placebo controlled dose-ranging study in Adults with Moderate to Severe Ulcerative Colitis MedDRA version: 20.0;Level: HLT;Classification code 10009888;Term: Colitis (excl infective);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PF-06480605 Product Code: PF-06480605 INN or Proposed INN: PF-06480605 Other descriptive name: Anti-TL1A | Pfizer Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 2 | Japan;Serbia;United States;Slovakia;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;India;France;Hungary;Mexico;Canada;Poland;Belgium;Romania;Australia;Bulgaria;South Africa;Germany;China | ||
| 364 | NCT03802214 (ClinicalTrials.gov) | June 1, 2020 | 10/12/2018 | Ulcerative Colitis - Vedolizumab- With/Without Prior Exposure to Anti-TNF(Tumor Necrosis Factor)Therapy | A Case-control Study to Evaluate the Immunoinflammatory Effect of Prior Exposure to Anti-TNF Therapy in Patients With Ulcerative Colitis Starting Vedolizumab Therapy | Ulcerative Colitis | Drug: Vedolizumab | Stanford University | Takeda;University of Western Ontario, Canada;University of California, San Diego | Recruiting | 18 Years | N/A | All | 20 | United States;Canada | |
| 365 | NCT04259060 (ClinicalTrials.gov) | June 2020 | 27/1/2020 | Hydroxocobalamin Approach to Reduction of Calprotectin With Butyrate for Ulcerative Colitis Research | Hydroxocobalamin Approach to Reduction of Nitrite With Butyrate for Ulcerative Colitis | Ulcerative Colitis | Drug: Hydroxocobalamin with Butyrate;Drug: Placebo with Butyrate | Joshua Korzenik | NULL | Not yet recruiting | 18 Years | 75 Years | All | 42 | Phase 2 | United States |
| 366 | EUCTR2019-003849-15-CZ (EUCTR) | 28/05/2020 | 16/03/2020 | Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) asmaintenance therapy in patients with Ulcerative Colitis | A Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients with Moderately to Severely Active Ulcerative Colitis | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remsima Product Code: Remsima (CT-P13) INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB | Celltrion, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 615 | Phase 3 | Belarus;Serbia;Czechia;Greece;Spain;Ukraine;Turkey;Austria;Israel;Russian Federation;Italy;France;Czech Republic;Mexico;Poland;Croatia;Peru;South Africa;Bulgaria;Latvia;Moldova, Republic of | ||
| 367 | NCT04254783 (ClinicalTrials.gov) | May 27, 2020 | 3/2/2020 | A Study to Evaluate the Effect of Intravenous (IV) Infusions of Risankizumab on Pharmacokinetics of Cytochome P450 Substrates in Adult Participants With Moderately to Severely Active Ulcerative Colitis or Crohn's Disease | A Phase 1 Study to Evaluate the Effect of Multiple IV Infusions of Risankizumab on the Pharmacokinetics of Cytochrome P450 Substrates Administered Orally in Subjects With Moderately to Severely Active Ulcerative Colitis or Crohn's Disease | Ulcerative Colitis (UC);Crohn's Disease | Drug: Risankizumab;Drug: Cytochrome P450 (CYP) Substrates | AbbVie | NULL | Completed | 18 Years | 80 Years | All | 20 | Phase 1 | United States;Germany;Israel |
| 368 | JPRN-JapicCTI-194980 | 22/5/2020 | 30/09/2019 | A Study of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Intervention 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. | NULL | recruiting | 18 | BOTH | 1000 | Phase 2-3 | Japan, Asia except Japan, North America, Europe | |
| 369 | EUCTR2019-001430-33-PL (EUCTR) | 20/05/2020 | 28/02/2020 | A clinical trial to see if GS-4875 is effective and safe in treating people with moderate to severe ulcerative colitis | A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of GS-4875 in Subjects with Moderately to Severely Active Ulcerative Colitis | ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: GS-4875 Product Code: GS-4875 | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | United States;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Australia;Germany | ||
| 370 | EUCTR2019-002698-74-IT (EUCTR) | 20/05/2020 | 15/06/2021 | A study to evaluate the efficacy and safety of PF-06480605 in adult participants with moderate to severe ulcerative colitis. | A PHASE 2B, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED DOSE-RANGING STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF PF-06480605 IN ADULT PARTICIPANTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS. - TUSCANY 2 | A PHASE 2B, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED DOSE-RANGING STUDY IN ADULT WITH MODERATE TO SEVERE ULCERATIVE COLITIS. MedDRA version: 20.0;Level: HLT;Classification code 10009888;Term: Colitis (excl infective);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PF-06480605 Product Code: [PF-06480605] INN or Proposed INN: PF-06480605 | PFIZER INC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 2 | Serbia;United States;Czechia;Slovakia;Spain;Ukraine;Turkey;Israel;Russian Federation;United Kingdom;Italy;India;France;Hungary;Mexico;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Germany;China;Japan | ||
| 371 | EUCTR2018-001605-93-DE (EUCTR) | 20/05/2020 | 04/06/2019 | Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis | A 54-Week, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis (Expedition Lead-in) - Phase 2 Dose-finding UC Study | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Brazikumab Product Code: MEDI2070 INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as MEDI2070 Product Name: Brazikumab Product Code: MEDI2070 INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as MEDI2070 | AstraZeneca AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 255 | Phase 2 | United States;Czechia;Taiwan;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;South Africa;Germany;Japan;Korea, Republic of | ||
| 372 | EUCTR2019-002698-74-FR (EUCTR) | 20/05/2020 | 24/01/2020 | A study to evaluate the efficacy and safety of PF 06480605 in adult participants with moderate to severe ulcerative colitis | A PHASE 2B, MULTICENTER, RANDOMIZED, DOUBLEBLIND,PLACEBO CONTROLLED DOSE-RANGINGSTUDY TO EVALUATE THE EFFICACY, SAFETY, ANDPHARMACOKINETICS OF PF-06480605 IN ADULTPARTICIPANTS WITH MODERATE TO SEVEREULCERATIVE COLITIS - Tuscany 2 | A phase 2b randomised, double-blind, placebo controlled dose-ranging study in Adults with Moderate to Severe Ulcerative Colitis MedDRA version: 20.0;Level: HLT;Classification code 10009888;Term: Colitis (excl infective);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PF-06480605 Product Code: PF-06480605 INN or Proposed INN: PF-06480605 Other descriptive name: Anti-TL1A | Pfizer Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 2 | United States;Serbia;Slovakia;Spain;Ukraine;Turkey;Austria;Russian Federation;Israel;Italy;India;France;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Germany;Japan;China | ||
| 373 | EUCTR2019-001430-33-AT (EUCTR) | 15/05/2020 | 31/01/2020 | A clinical trial to see if GS-4875 is effective and safe in treating people with moderate to severe ulcerative colitis | A Phase 2, Blinded, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of GS-4875 in Subjects with Moderately to Severely Active Ulcerative Colitis | Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: GS-4875 Product Code: GS-4875 | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | United States;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Belgium;Poland;Australia;Germany | ||
| 374 | EUCTR2019-000733-39-FR (EUCTR) | 14/05/2020 | 20/02/2020 | Open-label maintenance therapy in moderate to severe Ulcerative Colitis patients | A phase 2b, open-label, efficacy and safety study of ABX464 as maintenance therapy in patients with moderate to severe Ulcerative Colitis. | Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | ABIVAX | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 232 | Phase 2 | Belarus;Serbia;Slovenia;Slovakia;Spain;Ukraine;Ireland;Austria;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Netherlands | ||
| 375 | NCT04272307 (ClinicalTrials.gov) | May 14, 2020 | 14/2/2020 | MIcroorganisms as Triggers in Acute Severe Ulcerative Colitis and Their Influence on Medical Therapy Efficacy: a Multi-omics Pilot Approach. | MIcroorganisms as Triggers in Acute Severe Ulcerative Colitis and Their Influence on Medical Therapy Efficacy: a Multi-omics Pilot Approach. | Inflammatory Bowel Diseases;Colitis;Ulcerative | Biological: Blood samples;Procedure: Stool samples;Procedure: Colorectal biopsies | University Hospital, Bordeaux | McGill University Health Centre/Research Institute of the McGill University Health Centre | Recruiting | 18 Years | N/A | All | 40 | France | |
| 376 | EUCTR2018-004002-25-BG (EUCTR) | 13/05/2020 | 24/02/2020 | A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis - QUASAR | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: GUSELKUMAB Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 2;Phase 3 | United States;Portugal;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Italy;France;Malaysia;Australia;Latvia;Netherlands;China;Korea, Republic of;Czechia;Turkey;United Kingdom;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 377 | EUCTR2019-003849-15-ES (EUCTR) | 12/05/2020 | 28/02/2020 | Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) asmaintenance therapy in patients with Ulcerative Colitis | A Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients with Moderately to Severely Active Ulcerative Colitis | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remsima Product Code: Remsima (CT-P13) INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB | Celltrion, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 615 | Phase 3 | United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Italy;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Hungary;Czech Republic;Mexico;Brazil;Poland;Croatia;Bulgaria;Germany | ||
| 378 | EUCTR2019-001430-33-IT (EUCTR) | 05/05/2020 | 27/01/2021 | A clinical trial to see if GS-4875 is effective and safe in treating people with moderate to severe ulcerative colitis | A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of GS-4875 in Subjects with Moderately to Severely Active Ulcerative Colitis - FALCON | ulcerative colitis 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: GS-4875 Product Code: [GS-4875] Product Name: GS-4875 Product Code: [GS-4875] | GILEAD SCIENCES INCORPORATED | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | United States;Czechia;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Poland;Australia;Germany | ||
| 379 | EUCTR2019-001430-33-GB (EUCTR) | 05/05/2020 | 21/02/2020 | A clinical trial to see if GS-4875 is effective and safe in treating people with moderate to severe ulcerative colitis | A Phase 2, Blinded, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of GS-4875 in Subjects with Moderately to Severely Active Ulcerative Colitis | ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: GS-4875 INN or Proposed INN: to be confirmed Product Code: GS-4875 INN or Proposed INN: to be confirmed | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 2 | United States;Czechia;Austria;Russian Federation;United Kingdom;Italy;Switzerland;France;Canada;Belgium;Poland;Australia;Germany | ||
| 380 | EUCTR2019-003780-21-NL (EUCTR) | 04/05/2020 | 21/02/2020 | Pharmacokinetics and Pharmacodynamic Biomarkers of Janus Kinase Inhibitor Therapy in Patients With Ulcerative Colitis (PROPHETIC Study) | Pharmacokinetics and Pharmacodynamic Biomarkers of Janus Kinase Inhibitor Therapy in Patients With Ulcerative Colitis (PROPHETIC Study) | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: XELJANZ Product Name: Janus kinase Inhibitor INN or Proposed INN: Janus kinase Inhibitor | Alimentiv Inc. | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 4 | United States;Canada;Spain;Belgium;Netherlands;Italy | ||
| 381 | EUCTR2019-003113-34-NO (EUCTR) | 04/05/2020 | 21/01/2020 | Ulcerative colitis | A randomized, multi-center, subject and investigator blinded, placebo controlled, parallel group study to assess the efficacy, safety and tolerability of LYS006 in patients with mild to moderate ulcerative colitis - NA | Mild to moderate ulcerative colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: LYS006 Product Code: LYS006 INN or Proposed INN: not yet defined Other descriptive name: LYS006 | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 45 | Phase 2 | United States;Czechia;Hungary;Slovakia;Poland;Russian Federation;Bulgaria;Germany;Norway | ||
| 382 | NCT04156984 (ClinicalTrials.gov) | May 2020 | 24/10/2019 | Comparison of Two Different Golimumab Dosing Regimens for Ulcerative Colitis | Exposure-response of Golimumab During Maintenance in Ulcerative Colitis: An Exploratory Pharmacokinetics/Pharmacodynamics Comparison of Different Dose Regimens | Ulcerative Colitis | Drug: Golimumab Prefilled Syringe | David Drobne | NULL | Not yet recruiting | 18 Years | 65 Years | All | 30 | Phase 4 | Slovenia |
| 383 | ChiCTR2000028767 | 2020-04-27 | 2020-01-03 | A randomized, controlled trial for evaluating the efficacy and safety of oseltamivir in the treatment of ulcerative colitis | A randomized, controlled trial for evaluating the efficacy and safety of oseltamivir in the treatment of ulcerative colitis | ulcerative colitis | Experimental group:Oseltamivir and mesalazine;Control group:mesalazine; | Xiangya Hospital of Central South University | NULL | Recruiting | 18 | 75 | Both | Experimental group:53;Control group:53; | N/A | China |
| 384 | EUCTR2018-003278-28-BG (EUCTR) | 22/04/2020 | 23/05/2019 | Safety, tolerability, efficacy and dose-response of GSK2831781 in ulcerative colitis. | A multicentre randomized, double-blind, placebo-controlled Phase 2 study to evaluate the safety, tolerability, efficacy, dose-response, pharmacokinetics and pharmacodynamics of repeat dosing of an anti-LAG3 cell depleting monoclonal antibody (GSK2831781) in patients with active ulcerative colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: GSK2831781 INN or Proposed INN: Not Assigned Other descriptive name: GSK2831781 | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 320 | Phase 2 | United States;Serbia;Czechia;Estonia;Slovakia;Ukraine;Russian Federation;United Kingdom;India;France;Czech Republic;Hungary;Mexico;Canada;Poland;South Africa;Bulgaria;Netherlands;Japan;Korea, Republic of | ||
| 385 | EUCTR2019-000733-39-GB (EUCTR) | 16/04/2020 | 31/01/2020 | Open-label maintenance therapy in moderate to severe Ulcerative Colitis patients | A phase 2b, open-label, efficacy and safety study of ABX464 as maintenance therapy in patients with moderate to severe Ulcerative Colitis. | Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | ABIVAX | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 244 | Phase 2 | Belarus;Serbia;Slovakia;Slovenia;Spain;Ukraine;Austria;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany | ||
| 386 | EUCTR2019-003849-15-IT (EUCTR) | 15/04/2020 | 17/06/2021 | Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Ulcerative Colitis | A Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients with Moderately to Severely Active Ulcerative Colitis - NA | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remsima Product Name: Remsima (CT-P13) Product Code: [Remsima (CT-P13)] INN or Proposed INN: INFLIXIMAB Product Name: CT-P13 Product Code: [CT-p13] INN or Proposed INN: INFLIXIMAB | CELLTRION INC. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 615 | Phase 3 | Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Chile;Italy;France;Peru;South Africa;Latvia;Moldova, Republic of;Czechia;Turkey;Austria;Hungary;Mexico;Brazil;Poland;Croatia;Bulgaria;Germany | ||
| 387 | EUCTR2019-002698-74-HU (EUCTR) | 15/04/2020 | 20/04/2020 | A study to evaluate the efficacy and safety of PF 06480605 in adult participants with moderate to severe ulcerative colitis | A PHASE 2B, MULTICENTER, RANDOMIZED, DOUBLEBLIND,PLACEBO CONTROLLED DOSE-RANGINGSTUDY TO EVALUATE THE EFFICACY, SAFETY, ANDPHARMACOKINETICS OF PF-06480605 IN ADULTPARTICIPANTS WITH MODERATE TO SEVEREULCERATIVE COLITIS - Tuscany 2 | A phase 2b randomised, double-blind, placebo controlled dose-ranging study in Adults with Moderate to Severe Ulcerative Colitis MedDRA version: 20.0;Level: HLT;Classification code 10009888;Term: Colitis (excl infective);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PF-06480605 Product Code: PF-06480605 INN or Proposed INN: PF-06480605 Other descriptive name: Anti-TL1A | Pfizer Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 2 | United States;Serbia;Slovakia;Spain;Ukraine;Turkey;Austria;Russian Federation;Israel;Italy;India;France;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Germany;Japan;China | ||
| 388 | EUCTR2018-003987-29-AT (EUCTR) | 15/04/2020 | 09/10/2019 | An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis | An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 912 | Phase 3 | Portugal;Belarus;Serbia;United States;Estonia;Taiwan;Slovakia;Spain;Thailand;Ukraine;Lebanon;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;China;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan | ||
| 389 | EUCTR2018-003986-33-AT (EUCTR) | 07/04/2020 | 20/09/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 330 | Phase 3 | Portugal;Belarus;Serbia;United States;Estonia;Slovakia;Spain;Thailand;Ukraine;Lebanon;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Georgia;Bulgaria;Germany;Japan | ||
| 390 | EUCTR2018-004002-25-DE (EUCTR) | 07/04/2020 | 23/08/2019 | A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis - QUASAR | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: GUSELKUMAB Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 2;Phase 3 | United States;Portugal;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Russian Federation;Israel;Italy;France;Malaysia;Australia;Latvia;Netherlands;China;Korea, Republic of;Czechia;Turkey;United Kingdom;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 391 | EUCTR2017-003703-22-BG (EUCTR) | 07/04/2020 | 06/02/2020 | Phase 2 Dose-finding IMU-838 for Ulcerative Colitis (CALDOSE-1) | A phase 2, multicenter, randomized, double-blind, placebo controlled, dose-finding study to evaluate the efficacy and safety of IMU 838 for induction and maintenance therapy in moderate-to-severe ulcerative colitis CALDOSE-1 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 | Immunic AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 2 | United States;Serbia;Belarus;Portugal;Czechia;Spain;Ukraine;Russian Federation;North Macedonia;United Kingdom;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Netherlands;Bosnia and Herzegovina | ||
| 392 | EUCTR2019-003849-15-BG (EUCTR) | 03/04/2020 | 07/02/2020 | Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) asmaintenance therapy in patients with Ulcerative Colitis | A Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients with Moderately to Severely Active Ulcerative Colitis | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remsima Product Code: Remsima (CT-P13) INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB | Celltrion, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 615 | Phase 3 | Serbia;Belarus;Czechia;Greece;Spain;Ukraine;Turkey;Austria;Israel;Russian Federation;Italy;France;Czech Republic;Mexico;Poland;Croatia;Peru;South Africa;Bulgaria;Latvia;Moldova, Republic of | ||
| 393 | EUCTR2019-003849-15-FR (EUCTR) | 03/04/2020 | 03/02/2020 | Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) asmaintenance therapy in patients with Ulcerative Colitis | A Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients with Moderately to Severely Active Ulcerative Colitis | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remsima Product Code: Remsima (CT-P13) INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB | Celltrion, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 615 | Phase 3 | United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Italy;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Hungary;Czech Republic;Mexico;Brazil;Poland;Croatia;Bulgaria;Germany | ||
| 394 | EUCTR2019-003849-15-GR (EUCTR) | 03/04/2020 | 02/04/2020 | Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) asmaintenance therapy in patients with Ulcerative Colitis | A Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients with Moderately to Severely Active Ulcerative Colitis | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remsima Product Code: Remsima (CT-P13) INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB | Celltrion, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 615 | Phase 3 | United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Italy;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Hungary;Czech Republic;Mexico;Brazil;Poland;Croatia;Bulgaria;Germany | ||
| 395 | EUCTR2019-001430-33-FR (EUCTR) | 02/04/2020 | 20/02/2020 | A clinical trial to see if GS-4875 is effective and safe in treating people with moderate to severe ulcerative colitis | A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of GS-4875 in Subjects with Moderately to Severely Active Ulcerative Colitis | ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: GS-4875 Product Code: GS-4875 | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | United States;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Belgium;Poland;Australia;Germany | ||
| 396 | NCT03980405 (ClinicalTrials.gov) | April 1, 2020 | 5/6/2019 | Combination of Diet and 5ASA ( 5-aminosalicylic Acid) for Ulcerative Colitis | Combination Therapy With Drug and Diet for Induction of Remission in Mild to Moderate Active Pediatric Ulcerative Colitis: A Single Blinded, International Randomized Controlled Trial | Ulcerative Colitis | Dietary Supplement: Group 1- Control Diet;Dietary Supplement: Group 2- UCD Diet | Prof. Arie Levine | NULL | Terminated | 10 Years | 19 Years | All | 12 | N/A | Israel |
| 397 | NCT04332328 (ClinicalTrials.gov) | April 1, 2020 | 31/3/2020 | Study of Demographic and Dietary Profile in Patients With Ulcerative Colitis in Upper Egypt | Study of Demographic and Dietary Profile in Patients With Ulcerative Colitis in Upper Egypt | Diet in Ulcerative Colitis Patients | Dietary Supplement: Diet | Assiut University | NULL | Not yet recruiting | N/A | N/A | All | 50 | NULL | |
| 398 | EUCTR2019-002698-74-ES (EUCTR) | 01/04/2020 | 23/01/2020 | A study to evaluate the efficacy and safety of PF 06480605 in adult participants with moderate to severe ulcerative colitis | A PHASE 2B, MULTICENTER, RANDOMIZED, DOUBLEBLIND,PLACEBO CONTROLLED DOSE-RANGINGSTUDY TO EVALUATE THE EFFICACY, SAFETY, ANDPHARMACOKINETICS OF PF-06480605 IN ADULTPARTICIPANTS WITH MODERATE TO SEVEREULCERATIVE COLITIS - Tuscany 2 | A phase 2b randomised, double-blind, placebo controlled dose-ranging study in Adults with Moderate to Severe Ulcerative Colitis MedDRA version: 20.0;Level: HLT;Classification code 10009888;Term: Colitis (excl infective);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PF-06480605 Product Code: PF-06480605 INN or Proposed INN: PF-06480605 Other descriptive name: Anti-TL1A | Pfizer Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 2 | United States;Serbia;Slovakia;Spain;Ukraine;Turkey;Austria;Russian Federation;Israel;Italy;India;France;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Germany;Japan;China | ||
| 399 | NCT04096573 (ClinicalTrials.gov) | April 2020 | 18/9/2019 | Efficacy and Safety of LC51-0255 in Subjects With Ulcerative Colitis | A 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 Colitis | Ulcerative Colitis | Drug: LC51-0255;Drug: Placebo | LG Chem | NULL | Withdrawn | 18 Years | 80 Years | All | 0 | Phase 2 | NULL |
| 400 | EUCTR2019-002698-74-BG (EUCTR) | 27/03/2020 | 31/01/2020 | A study to evaluate the efficacy and safety of PF 06480605 in adult participants with moderate to severe ulcerative colitis | A PHASE 2B, MULTICENTER, RANDOMIZED, DOUBLEBLIND,PLACEBO CONTROLLED DOSE-RANGINGSTUDY TO EVALUATE THE EFFICACY, SAFETY, ANDPHARMACOKINETICS OF PF-06480605 IN ADULTPARTICIPANTS WITH MODERATE TO SEVEREULCERATIVE COLITIS - Tuscany 2 | A phase 2b randomised, double-blind, placebo controlled dose-ranging study in Adults with Moderate to Severe Ulcerative Colitis MedDRA version: 20.0;Level: HLT;Classification code 10009888;Term: Colitis (excl infective);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PF-06480605 Product Code: PF-06480605 INN or Proposed INN: PF-06480605 Other descriptive name: Anti-TL1A | Pfizer Inc | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United States;Serbia;Slovakia;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;India;France;Hungary;Mexico;Canada;Poland;Belgium;Romania;Australia;South Africa;Bulgaria;Germany;China;Japan | ||
| 401 | EUCTR2019-002698-74-SK (EUCTR) | 26/03/2020 | 31/01/2020 | A study to evaluate the efficacy and safety of PF 06480605 in adult participants with moderate to severe ulcerative colitis | A PHASE 2B, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED DOSE-RANGING STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF PF-06480605 IN ADULT PARTICIPANTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS - Tuscany 2 | A phase 2b randomised, double-blind, placebo controlled dose-ranging study in Adults with Moderate to Severe Ulcerative Colitis MedDRA version: 20.0;Level: HLT;Classification code 10009888;Term: Colitis (excl infective);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PF-06480605 100 mg/ml Product Code: PF-06480605 INN or Proposed INN: PF-06480605 Other descriptive name: Anti-TL1A | Pfizer Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 2 | United States;Serbia;Slovakia;Thailand;Spain;Ukraine;Russian Federation;Colombia;Italy;India;France;Australia;South Africa;China;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Poland;Belgium;Romania;Bulgaria;Germany;Japan | ||
| 402 | EUCTR2018-003524-36-IE (EUCTR) | 25/03/2020 | 05/11/2019 | Randomized, mulitcenter study to investigate how infliximab dosing calculated by a computer compares to the standard dosing during the induction of infliximab in patients with severe colitis ulcerosa. | Randomized, Multicenter Study to Investigate the Efficacy of Dashboard Driven Individualized Dosing of Infliximab Compared To Standard Dosing During the Induction in Patients with Acute Severe Ulcerative Colitis - TITRATE | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remicade Product Name: NA Product Code: NA INN or Proposed INN: INFLIXIMAB Trade Name: Metoject INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE DISODIUM Trade Name: Puri-Nethol INN or Proposed INN: MERCAPTOPURINE Trade Name: Remsima INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra INN or Proposed INN: INFLIXIMAB Trade Name: Flixabi INN or Proposed INN: INFLIXIMAB | UMC Amsterdam location AMC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 124 | Phase 4 | Ireland;Netherlands | ||
| 403 | EUCTR2019-002698-74-PL (EUCTR) | 24/03/2020 | 11/02/2020 | A study to evaluate the efficacy and safety of PF 06480605 in adult participants with moderate to severe ulcerative colitis | A PHASE 2B, MULTICENTER, RANDOMIZED, DOUBLEBLIND,PLACEBO CONTROLLED DOSE-RANGINGSTUDY TO EVALUATE THE EFFICACY, SAFETY, ANDPHARMACOKINETICS OF PF-06480605 IN ADULTPARTICIPANTS WITH MODERATE TO SEVEREULCERATIVE COLITIS - Tuscany 2 | A phase 2b randomised, double-blind, placebo controlled dose-ranging study in Adults with Moderate to Severe Ulcerative Colitis MedDRA version: 20.0;Level: HLT;Classification code 10009888;Term: Colitis (excl infective);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PF-06480605 Product Code: PF-06480605 INN or Proposed INN: PF-06480605 Other descriptive name: Anti-TL1A | Pfizer Inc | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United States;Serbia;Slovakia;Thailand;Spain;Ukraine;Russian Federation;Colombia;Italy;India;France;Australia;South Africa;China;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Poland;Belgium;Romania;Bulgaria;Germany;Japan | ||
| 404 | EUCTR2019-003849-15-AT (EUCTR) | 20/03/2020 | 06/02/2020 | Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) asmaintenance therapy in patients with Ulcerative Colitis | A Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients with Moderately to Severely Active Ulcerative Colitis | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remsima Product Code: Remsima (CT-P13) INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB | Celltrion, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 615 | Phase 3 | United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Italy;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Hungary;Czech Republic;Mexico;Brazil;Poland;Croatia;Bulgaria;Germany | ||
| 405 | EUCTR2019-000733-39-DE (EUCTR) | 20/03/2020 | 13/03/2020 | Open-label maintenance therapy in moderate to severe Ulcerative Colitis patients | A phase 2b, open-label, efficacy and safety study of ABX464 as maintenance therapy in patients with moderate to severe Ulcerative Colitis. | Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | ABIVAX | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 217 | Phase 2 | Belarus;Serbia;Czechia;Slovakia;Slovenia;Spain;Ukraine;Austria;Italy;United Kingdom;France;Hungary;Canada;Belgium;Poland;Germany | ||
| 406 | EUCTR2016-000642-62-SE (EUCTR) | 18/03/2020 | 25/10/2018 | A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis | M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 462 | Phase 3 | Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden;Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic | ||
| 407 | EUCTR2016-000642-62-FR (EUCTR) | 10/03/2020 | 30/07/2019 | A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis | M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 462 | Phase 3 | Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden | ||
| 408 | EUCTR2018-001605-93-AT (EUCTR) | 09/03/2020 | 07/11/2019 | Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis | A 54-Week, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis (Expedition Lead-in) - Phase 2 Dose-finding UC Study | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Brazikumab Product Code: MEDI2070 INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as MEDI2070 Product Name: Brazikumab Product Code: MEDI2070 INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as MEDI2070 | AstraZeneca AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 255 | Phase 2 | United States;Czechia;Taiwan;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;South Africa;Germany;Japan;Korea, Republic of | ||
| 409 | NCT04277546 (ClinicalTrials.gov) | March 3, 2020 | 18/2/2020 | Open-label Extension Study of Brazikumab in Ulcerative Colitis | A Phase 2 Open-label, Long-term Extension Safety Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis (EXPEDITION OLE) | Ulcerative Colitis | Drug: Brazikumab Maintenance Dose;Drug: Brazikumab Induction Dose | AstraZeneca | NULL | Enrolling by invitation | 18 Years | 80 Years | All | 165 | Phase 2 | India;Israel;Italy;Japan;Korea, Republic of;Poland;Puerto Rico;Slovakia;South Africa;Spain;Taiwan;Ukraine;United Kingdom;United States;Belgium;Bulgaria;Romania;Russian Federation;Austria;Canada;Czechia;France;Germany;Hungary |
| 410 | EUCTR2018-003987-29-PT (EUCTR) | 02/03/2020 | 28/10/2019 | An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis | An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 912 | Phase 3 | Serbia;Belarus;Portugal;United States;Taiwan;Estonia;Slovakia;Spain;Thailand;Ukraine;Lebanon;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Japan | ||
| 411 | EUCTR2017-003703-22-PT (EUCTR) | 02/03/2020 | 18/12/2019 | Phase 2 Dose-finding IMU-838 for Ulcerative Colitis (CALDOSE-1) | A phase 2, multicenter, randomized, double-blind, placebo controlled, dose-finding study to evaluate the efficacy and safety of IMU 838 for induction and maintenance therapy in moderate-to-severe ulcerative colitis CALDOSE-1 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium | Immunic AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 2 | Serbia;Portugal;United States;Belarus;Czechia;Spain;Ukraine;Russian Federation;North Macedonia;United Kingdom;Poland;Belgium;Romania;Croatia;Bulgaria;Netherlands;Germany;Bosnia and Herzegovina | ||
| 412 | NCT02277223 (ClinicalTrials.gov) | March 1, 2020 | 25/10/2014 | Curcumin in Pediatric Ulcerative Colitis | Curcumin for Induction and Maintenance Therapy in Pediatric Ulcerative Colitis | Ulcerative Colitis | Dietary Supplement: Curcumin;Drug: Placebo | Schneider Children's Medical Center, Israel | NULL | Withdrawn | 6 Years | 18 Years | All | 0 | Phase 3 | Israel |
| 413 | NCT04309058 (ClinicalTrials.gov) | March 2020 | 24/2/2020 | Observation of the Effect of Vitamin D Supplementation on Chronic Course of Patients With Ulcerative Colitis Based on Vitamin D Receptor Fok I Gene Polymorphism | Observation of the Effect of Vitamin D Supplementation on Chronic Course of Patients With Ulcerative Colitis Based on Vitamin D Receptor Fok I Gene Polymorphism,a Prospective Cohort Study | Ulcerative Colitis;Vitamin D Deficiency;Vitamin D Supplement | Drug: Vitamin D drops | Second Affiliated Hospital of Wenzhou Medical University | NULL | Not yet recruiting | N/A | N/A | All | 100 | Early Phase 1 | China |
| 414 | EUCTR2018-004002-25-ES (EUCTR) | 28/02/2020 | 04/09/2019 | A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis - QUASAR | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: GUSELKUMAB Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkum | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Taiwan;Hong Kong;Thailand;Spain;Ukraine;Russian Federation;Israel;Italy;France;Malaysia;Australia;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Bulgaria;Germany;Japan;Sweden | ||
| 415 | EUCTR2018-003986-33-DK (EUCTR) | 28/02/2020 | 02/10/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 330 | Phase 3 | Portugal;Belarus;Serbia;United States;Estonia;Slovakia;Spain;Thailand;Ukraine;Lebanon;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Georgia;Bulgaria;Germany;Japan | ||
| 416 | EUCTR2019-003220-21-GB (EUCTR) | 26/02/2020 | 12/12/2019 | Management of diarrhoea in ulcerative colitis: multi-arm multi stage trial of low FODMAP diet, amitriptyline, ondansetron, or loperamide: MODULATE. | Management of diarrhoea in ulcerative colitis: multi-arm multi-stage trial of low FODMAP diet, amitriptyline, ondansetron, or loperamide: MODULATE. - MODULATE | Diarrhoea in patients with stable ulcerative colitis. MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10066557;Term: Chronic diarrhoea;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Amitriptyline Product Name: Amitriptyline INN or Proposed INN: Amitriptyline hydrochloride Product Name: Ondansetron INN or Proposed INN: Ondansetron hydrochloride dihydrate Product Name: Loperamide INN or Proposed INN: loperamide hydrochloride | University of Leeds | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 491 | Phase 2;Phase 3 | United Kingdom | ||
| 417 | EUCTR2019-003987-37-SI (EUCTR) | 26/02/2020 | 27/11/2019 | Comparison of Two Different Golimumab Dosing Regimens for Ulcerative Colitis | Exposure-response of golimumab during maintenance in ulcerative colitis: An exploratory Pharmacokinetics/Pharmacodynamics comparison of different dose regimens | Ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Simponi Product Name: Simponi Product Code: CNTO-148 | University Medical Centre Ljubljana, Department of gastroenterology | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 4 | Slovenia | ||
| 418 | EUCTR2017-004092-31-RO (EUCTR) | 26/02/2020 | 17/03/2022 | A study of the efficacy and safety of Mirikizumab in Ulcerative Colitis | I6T-MC-AMAPA Phase 3, Multicenter, Open-Label Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients with Moderately toSeverely Active Ulcerative Colitis (LUCENT 3) - LUCENT 3 | moderately to severely active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: mirikizumab Other descriptive name: MIRIKIZUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 840 | Phase 3 | Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Russian Federation;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Netherlands;Latvia;China;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Germany;Japan | ||
| 419 | NCT04241029 (ClinicalTrials.gov) | February 25, 2020 | 17/1/2020 | Boosting Biologics in UC | Boosting Biologics in Ulcerative Colitis | Ulcerative Colitis;Inflammatory Bowel Diseases | Dietary Supplement: IDOFORM®Travel | Oslo University Hospital | Helse Sor-Ost | Recruiting | 18 Years | 75 Years | All | 20 | Phase 1 | Norway |
| 420 | EUCTR2019-003113-34-HU (EUCTR) | 25/02/2020 | 09/01/2020 | Study of efficacy, safety and tolerability of LYS006 in patients with mild to moderate ulcerative colitis | A randomized, multi-center, subject and investigator blinded, placebo controlled, parallel group study to assess the efficacy, safety and tolerability of LYS006 in patients with mild to moderate ulcerative colitis - NA | Mild to moderate ulcerative colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: LYS006 Product Code: LYS006 INN or Proposed INN: not yet defined Other descriptive name: LYS006 | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 45 | Phase 2 | Czech Republic;Russian Federation;Hungary;Norway;United States;Poland;Slovakia;Bulgaria;Germany | ||
| 421 | EUCTR2018-003986-33-GB (EUCTR) | 24/02/2020 | 17/09/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 330 | Phase 3 | Serbia;Portugal;United States;Belarus;Estonia;Taiwan;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Bulgaria;Germany;Japan | ||
| 422 | EUCTR2019-003113-34-DE (EUCTR) | 19/02/2020 | 08/11/2019 | Ulcerative colitis | A randomized, multi-center, subject and investigator blinded, placebo controlled, parallel group study to assess the efficacy, safety and tolerability of LYS006 in patients with mild to moderate ulcerative colitis - NA | Mild to moderate ulcerative colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: LYS006 Product Code: LYS006 INN or Proposed INN: not yet defined Other descriptive name: LYS006 | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 45 | Phase 2 | United States;Hungary;Czech Republic;Norway;Germany | ||
| 423 | EUCTR2018-003987-29-BG (EUCTR) | 17/02/2020 | 23/10/2019 | An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis | An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 912 | Phase 3 | Portugal;Belarus;Serbia;United States;Estonia;Taiwan;Slovakia;Spain;Thailand;Ukraine;Lebanon;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;China;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Georgia;Bulgaria;Germany;Japan | ||
| 424 | EUCTR2018-003986-33-ES (EUCTR) | 14/02/2020 | 24/02/2020 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 330 | Phase 3 | Russian Federation;United States;Egypt;Thailand;Portugal;Austria;Latvia;Netherlands;China;Brazil;Korea, Republic of;Poland;Slovakia;Bulgaria;Chile;France;Lithuania;Serbia;Croatia;Argentina;Romania;Hungary;Ukraine;United Kingdom;Belarus;Switzerland;Spain;India;Lebanon;Canada;Czech Republic;Turkey;Belgium;Moldova, Republic of;Taiwan;Denmark;Italy;Mexico;South Africa;Georgia;Israel;Australia;Germany;Estonia | ||
| 425 | EUCTR2019-000733-39-AT (EUCTR) | 13/02/2020 | 14/10/2019 | Open-label maintenance therapy in moderate to severe Ulcerative Colitis patients | A phase 2b, open-label, efficacy and safety study of ABX464 as maintenance therapy in patients with moderate to severe Ulcerative Colitis. | Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | ABIVAX | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 217 | Phase 2 | Belgium;Poland;Germany;Serbia;Belarus;Czechia;Slovakia;Slovenia;Spain;Ukraine;Austria;Italy;United Kingdom;France;Hungary;Canada | ||
| 426 | EUCTR2018-003986-33-BG (EUCTR) | 11/02/2020 | 23/10/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 330 | Phase 3 | Portugal;Belarus;Serbia;United States;Estonia;Taiwan;Slovakia;Spain;Thailand;Ukraine;Lebanon;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;China;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Bulgaria;Germany;Japan | ||
| 427 | EUCTR2018-003558-26-GB (EUCTR) | 11/02/2020 | 05/11/2019 | Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments. | A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-a] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment. - Investigate the safety and efficacy of study drug ABX464-103 | Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | ABIVAX | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 244 | Phase 2 | United States;Belarus;Serbia;Slovenia;Slovakia;Spain;Ukraine;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany | ||
| 428 | EUCTR2019-004090-50-ES (EUCTR) | 07/02/2020 | 11/11/2019 | Clinical Trial to evaluate the safety and efficacy of oral treatment with OST-122 in patients with moderate to severe ulcerative colitis | A Phase Ib/IIa, randomized, double blind, placebo controlled, multicenter clinical trial to evaluate the safety, pharmacokinetics and efficacy of oral treatment with OST-122 in patients with moderate to severe ulcerative colitis | Moderate to severe ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: OST-122 INN or Proposed INN: Not available yet Other descriptive name: OST-122 Product Name: OST-122 INN or Proposed INN: Not available yet Other descriptive name: OST-122 | ONCOSTELLAE S.L. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 32 | Phase 1;Phase 2 | Spain | ||
| 429 | EUCTR2018-004002-25-PT (EUCTR) | 03/02/2020 | 06/08/2019 | A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis - QUASAR | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: GUSELKUMAB Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 950 | Phase 2;Phase 3 | Portugal;United States;Taiwan;Hong Kong;Spain;Thailand;Ukraine;Russian Federation;Israel;Italy;France;Malaysia;Australia;Netherlands;China;Korea, Republic of;Czechia;Turkey;United Kingdom;Hungary;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Japan;Sweden | ||
| 430 | NCT04074590 (ClinicalTrials.gov) | February 3, 2020 | 29/8/2019 | Study of Efficacy, Safety, and Tolerability of LYS006, in Patients With Mild to Moderate Ulcerative Colitis | A Randomized, Multi-center, Subject and Investigator-blinded, Placebo-controlled, Parallel-group Study to Assess the Efficacy Safety and Tolerability of LYS006 in Patients With Mild to Moderate Ulcerative Colitis | Colitis, Ulcerative | Drug: LYS006;Drug: Placebo | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 75 Years | All | 23 | Phase 2 | Bulgaria;Czechia;Germany;Poland;Russian Federation;Slovakia;Hungary;Norway;United Kingdom;United States |
| 431 | NCT04202211 (ClinicalTrials.gov) | February 2020 | 13/12/2019 | FMT for Remission of Active Ulcerative Colitis in Adults | A Randomized Double-blind, Placebo-controlled Trial of Lyophilized Fecal Microbiota Transplantation for the Induction of Remission in Adults With Active Ulcerative Colitis | Ulcerative Colitis;Inflammatory Bowel Diseases | Biological: FMT oral;Biological: FMT enema;Other: Placebo oral;Other: Placebo enema | University of British Columbia | Crohn's and Colitis Canada;Vancouver Island Health Authority | Not yet recruiting | 18 Years | N/A | All | 145 | Phase 2 | Canada |
| 432 | NCT03998488 (ClinicalTrials.gov) | January 31, 2020 | 24/6/2019 | Examining the Efficacy of Fecal Microbiota Transplantation (FMT) and Dietary Fiber in Patients With Ulcerative Colitis | A Randomized, Placebo-controlled Clinical Trial Examining the Efficacy of Fecal Microbiota Transplantation (FMT) and Subsequent Dietary Fiber in Patients With Moderate Ulcerative Colitis | Ulcerative Colitis;Inflammatory Bowel Diseases | Drug: Fecal Microbiota Transplantation;Dietary Supplement: Psyllium Husk Powder | Weill Medical College of Cornell University | Crohn's and Colitis Foundation | Recruiting | 18 Years | 89 Years | All | 135 | Phase 2 | United States |
| 433 | EUCTR2018-004491-35-RO (EUCTR) | 30/01/2020 | 18/03/2022 | A study evaluating safety and efficacy of Itacitinib as treatment of moderate to severe ulcerative Colitis | A Phase 2, Double-Blind, Dose-Ranging, Placebo-Controlled Study With Open-Label Extension to Evaluate the Safety and Efficacy of Itacitinib in Moderate to Severe Ulcerative Colitis | Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Itacitinib Product Code: INCB039110 INN or Proposed INN: ITACITINIB ADIPATE Other descriptive name: ITACITINIB ADIPATE | Incyte Corporation | NULL | Not Recruiting | Female: yes Male: yes | 206 | Phase 2 | United States;Czechia;Poland;Romania;Germany | ||
| 434 | EUCTR2018-002135-19-IT (EUCTR) | 30/01/2020 | 17/06/2021 | A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Ulcerative Colitis (UC) | A 3-Year, Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects with Ulcerative Colitis (UC) - TD-1473 LTS UC Study | Moderately-to-severely active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TD-1473 Product Code: [TD-1473] Product Name: TD-1473 Product Code: [TD-1473] Product Name: TD-1473 Product Code: [TD-1473] | Theravance Biopharma Ireland Limited | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;South Africa;Korea, Republic of;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Japan | ||
| 435 | EUCTR2018-003986-33-LV (EUCTR) | 24/01/2020 | 01/11/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 330 | Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany | ||
| 436 | EUCTR2018-003987-29-DE (EUCTR) | 23/01/2020 | 30/09/2019 | An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis | An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 912 | Phase 3 | Portugal;Belarus;Serbia;United States;Estonia;Taiwan;Slovakia;Spain;Thailand;Ukraine;Lebanon;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;China;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan | ||
| 437 | EUCTR2018-003985-15-AT (EUCTR) | 21/01/2020 | 08/07/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 420 | Phase 3 | Portugal;Belarus;Serbia;United States;Estonia;Taiwan;Slovakia;Spain;Thailand;Ukraine;Lebanon;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Georgia;Bulgaria;Germany;Japan | ||
| 438 | EUCTR2018-003985-15-FR (EUCTR) | 20/01/2020 | 12/07/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 372 | Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan | ||
| 439 | NCT04223479 (ClinicalTrials.gov) | January 15, 2020 | 6/1/2020 | Effect of Probiotic Supplementation on the Immune System in Patients With Ulcerative Colitis in Amman, Jordan | Effect of Probiotic Supplementation on the Immune System in Patients With Ulcerative Colitis in Amman, Jordan | Ulcerative Colitis | Drug: Probiotic Formula Capsule;Drug: Placebos | University of Jordan | NULL | Completed | 35 Years | 65 Years | All | 30 | Phase 2/Phase 3 | Jordan |
| 440 | EUCTR2018-003986-33-FR (EUCTR) | 14/01/2020 | 20/09/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 330 | Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany | ||
| 441 | NCT04183608 (ClinicalTrials.gov) | January 14, 2020 | 28/10/2019 | A Trial COmparing staNdard of Care Versus Treat to Target With telemonitoRing and Patient Education in Patients With Ulcerative cOlitis Initiating Adalimumab | An Open-label Randomized Trial COmparing staNdard of Care Versus Treat to Target With telemonitoRing and Patient Education in Patients With Ulcerative cOlitis Initiating adaLimumab: The CONTROL Trial | Ulcerative Colitis | Drug: Adalimumab;Diagnostic Test: Calprotectin;Other: e-Monitoring;Other: Therapy Education | Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives | AbbVie | Recruiting | 18 Years | 75 Years | All | 238 | Phase 4 | France |
| 442 | NCT04023396 (ClinicalTrials.gov) | January 13, 2020 | 5/7/2019 | Efficacy and Safety Study of ABX464 as Maintenance Therapy in Patients With Moderate to Severe Ulcerative Colitis | A Phase 2b, Open-label, Efficacy and Safety Study of ABX464 as Maintenance Therapy in Patients With Moderate to Severe Ulcerative Colitis | Ulcerative Colitis | Drug: ABX464 | Abivax S.A. | NULL | Active, not recruiting | 18 Years | 75 Years | All | 217 | Phase 2 | Austria;Belarus;Belgium;Canada;Czechia;France;Germany;Hungary;Italy;Poland;Serbia;Slovakia;Slovenia;Spain;Ukraine;United Kingdom |
| 443 | EUCTR2018-002136-24-IT (EUCTR) | 10/01/2020 | 17/06/2021 | A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Ulcerative Colitis | A Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with TD-1473 in Subjects with Moderately-to-Severely Active Ulcerative Colitis - Rhea: Efficacy and Safety of TD-1473 in Ulcerative Colitis | Moderately-to-Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TD-1473 Product Code: [TD-1473] Product Name: TD-1473 Product Code: [TD-1473] Product Name: TD-1473 Product Code: [TD-1473] | Theravance Biopharma Ireland Limited | NULL | Not Recruiting | Female: yes Male: yes | 880 | Phase 2;Phase 3 | United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;South Africa;Korea, Republic of;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Japan | ||
| 444 | EUCTR2019-000733-39-IT (EUCTR) | 08/01/2020 | 22/01/2021 | Open-label maintenance therapy in moderate to severe Ulcerative Colitis patients | A phase 2b, open-label, efficacy and safety study of ABX464 as maintenance therapy in patients with moderate to severe Ulcerative Colitis. - na | 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 Name: ABX464 Product Code: [ABX464] INN or Proposed INN: ABX464 Other descriptive name: ABX464 | Abivax | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 232 | Phase 2 | Belarus;Serbia;Czechia;Slovenia;Slovakia;Spain;Ukraine;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Germany;Netherlands | ||
| 445 | ChiCTR2000028869 | 2020-01-03 | 2020-01-05 | phase IIa clinical trial of Colitis Suppositories | A multicenter, randomized, blinded management, positive-drug parallel-controlled, preliminary exploratory phase IIa clinical trial on the efficacy and safety of Colitis Suppositories in the treatment for mild-to-moderate active ulcerative colitis (Qi-Deficiency and Blood-Stasis Syndrome), compared with the Mesalazine Suppositories (Salofalk) | mild-to-moderate active ulcerative colitis (Qi-Deficiency and Blood-Stasis Syndrome) | Experimental group:Colitis Suppositories, one at a time, twice a day, in the early and late anal plug into the rectum.;The control group:Mesalazine Suppositories, one at a time, twice a day, in the early and late anal plug into the rectum.; | Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University | NULL | Recruiting | 18 | 65 | Both | Experimental group:30;The control group:30; | Phase 2 | China |
| 446 | ITMCTR2000002903 | 2020-01-03 | 2020-01-05 | phase IIa clinical trial of Colitis Suppositories | A multicenter, randomized, blinded management, positive-drug parallel-controlled, preliminary exploratory phase IIa clinical trial on the efficacy and safety of Colitis Suppositories in the treatment for mild-to-moderate active ulcerative colitis (Qi-Deficiency and Blood-Stasis Syndrome), compared with the Mesalazine Suppositories (Salofalk) | mild-to-moderate active ulcerative colitis (Qi-Deficiency and Blood-Stasis Syndrome) | The control group:Mesalazine Suppositories, one at a time, twice a day, in the early and late anal plug into the rectum.;Experimental group:Colitis Suppositories, one at a time, twice a day, in the early and late anal plug into the rectum.; | Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University | NULL | Recruiting | 18 | 65 | Both | The control group:30;Experimental group:30; | Phase 2 | China |
| 447 | NCT05542459 (ClinicalTrials.gov) | January 1, 2020 | 10/9/2022 | Multi-omics to Predict Responses to Biologics in IBD | Multi-omics to Predict Responses to Biologics in Inflammatory Bowel Disease | Crohn Disease;Ulcerative Colitis | Drug: Biologics | Sixth Affiliated Hospital, Sun Yat-sen University | NULL | Recruiting | 18 Years | 70 Years | All | 1050 | China | |
| 448 | EUCTR2018-003986-33-LT (EUCTR) | 31/12/2019 | 08/10/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 330 | Phase 3 | Portugal;Belarus;Serbia;United States;Estonia;Slovakia;Spain;Thailand;Ukraine;Lebanon;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Georgia;Bulgaria;Germany;Japan | ||
| 449 | EUCTR2018-003987-29-ES (EUCTR) | 20/12/2019 | 20/12/2019 | An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis | An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 702 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Belarus;Estonia;Taiwan;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Bulgaria;Germany;Japan | ||
| 450 | NCT04130919 (ClinicalTrials.gov) | December 20, 2019 | 16/10/2019 | Study to Evaluate the Efficacy and Safety of Tilpisertib in Adults With Moderately to Severely Active Ulcerative Colitis | A Phase 2, Blinded, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of GS-4875 in Subjects With Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Drug: Tilpisertib;Drug: Placebo | Gilead Sciences | NULL | Completed | 18 Years | N/A | All | 19 | Phase 2 | United States;Australia;Austria;Canada;France;Germany;Italy;Poland;Switzerland |
| 451 | NCT04090411 (ClinicalTrials.gov) | December 19, 2019 | 12/9/2019 | A Study to Evaluate the Efficacy and Safety of PF-06480605 in Adult Participants With Moderate to Severe Ulcerative Colitis | A PHASE 2B, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED DOSE-RANGING STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF PF-06480605 IN ADULT PARTICIPANTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Moderate to Severe Ulcerative Colitis | Drug: 50 mg Induction/Chronic;Drug: 450 mg Induction/Chronic;Drug: 150 mg Induction/Chronic;Other: 0 mg Induction ONLY | Pfizer | NULL | Completed | 18 Years | 75 Years | All | 246 | Phase 2 | United States;Australia;Belgium;Bulgaria;Colombia;France;Germany;Hungary;India;Italy;Japan;Mexico;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Thailand;Turkey;Ukraine;United Kingdom;Austria;Canada |
| 452 | EUCTR2019-003662-40-DE (EUCTR) | 18/12/2019 | 22/10/2019 | Prospective, open-label, single-arm, single-center phase IV clinical trial to evaluate efficacy and safety of the adalimumab biosimilar Amgevita in subjects with moderate to severe active chronic inflammatory bowel diesease (Crohn's disease and ulcerative colitis) | Prospective, open-label, single-arm, single-center phase IV clinical trial to evaluate efficacy and safety of the adalimumab biosimilar Amgevita in subjects with moderate to severe active chronic inflammatory bowel diesease (Crohn's disease and ulcerative colitis) - Amgevita de novo in CED | MedDRA version: 20.1;Level: PT;Classification code 10021972;Term: Inflammatory bowel disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Amgevita 40 mg Injektionslösung in einer Fertigspritze INN or Proposed INN: ADALIMUMAB Trade Name: Amgevita 40 mg Injektionslösung im Fertigpen INN or Proposed INN: ADALIMUMAB | Universitätsklinikum Erlangen | NULL | Not Recruiting | Female: yes Male: yes | 82 | Phase 4 | Germany | ||
| 453 | EUCTR2018-005086-39-HR (EUCTR) | 16/12/2019 | 17/01/2020 | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacyand Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis | Mild to Moderate Ulcerative Colitis Inflammatory bowel disease (IBD) is an autoimmune disease of the gastrointestinal (GI) tract with unknown etiology that encompasses 2 primary clinical manifestations: ulcerative colitis (UC) and Crohn’s disease (CD). UC manifests through complex interactions between the gut microbiome, dysregulated immune responses, genetic mutations, diet, and other environmental factors. MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: BT-11 500 mg Product Code: BT-11 INN or Proposed INN: to be requested Other descriptive name: BT-11 Product Name: BT-11 1000mg Product Code: BT-11 INN or Proposed INN: to be requested Other descriptive name: BT-11 | Landos Biopharma Inc. | NULL | Not Recruiting | Female: yes Male: yes | 195 | Phase 2 | Belarus;Serbia;United States;Ukraine;Russian Federation;Hungary;Canada;Poland;Croatia;Bulgaria;Georgia;Moldova, Republic of;Bosnia and Herzegovina | ||
| 454 | NCT05656391 (ClinicalTrials.gov) | December 16, 2019 | 1/12/2022 | Impact of Bread Diet on Intestinal Dysbiosis and Irritable Bowel Syndrome Symptoms in Quiescent Ulcerative Colitis | Impact of Bread Diet on Intestinal Dysbiosis and Irritable Bowel Syndrome Symptoms in Quiescent Ulcerative Colitis: A Pilot Study | Ulcerative Colitis in Remission | Dietary Supplement: Treatment vs control bread | Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta | NULL | Completed | 18 Years | N/A | All | 31 | N/A | Spain |
| 455 | EUCTR2018-003278-28-NL (EUCTR) | 13/12/2019 | 22/07/2019 | Safety, tolerability, efficacy and dose-response of GSK2831781 in ulcerative colitis. | A multicentre randomized, double-blind, placebo-controlled Phase 2 study to evaluate the safety, tolerability, efficacy, dose-response, pharmacokinetics and pharmacodynamics of repeat dosing of an anti-LAG3 cell depleting monoclonal antibody (GSK2831781) in patients with active ulcerative colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: GSK2831781 INN or Proposed INN: Not Assigned Other descriptive name: GSK2831781 | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 320 | Phase 2 | Serbia;United States;Czechia;Estonia;Slovenia;Slovakia;Ukraine;Russian Federation;United Kingdom;India;France;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;South Africa;Bulgaria;Netherlands;Korea, Republic of | ||
| 456 | EUCTR2019-000733-39-ES (EUCTR) | 11/12/2019 | 11/11/2019 | Open-label maintenance therapy in moderate to severe Ulcerative Colitis patients | A phase 2b, open-label, efficacy and safety study of ABX464 as maintenance therapy in patients with moderate to severe Ulcerative Colitis. | Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | ABIVAX | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 232 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;Belarus;Slovakia;Slovenia;Spain;Ukraine;Ireland;Austria;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Netherlands;Germany | ||
| 457 | EUCTR2018-003558-26-FR (EUCTR) | 10/12/2019 | 08/02/2019 | Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments. | A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-a] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment. | Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | ABIVAX | NULL | Not Recruiting | Female: yes Male: yes | 232 | Phase 2 | Belarus;Serbia;Slovenia;Slovakia;Spain;Ukraine;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Netherlands | ||
| 458 | JPRN-jRCTs031190156 | 09/12/2019 | 09/12/2019 | IN for practical use | Study on efficacy and safety of indigo naturalis in patients with intractable ulcerative colitis. | ulcertive colitis | administration of one indigo naturalis FC enteric-coated tablet (including 0.5g indigo naturalis per tablet)twice a day for 4 weeks | Kanai Takanori | NULL | Recruiting | >= 16age old | Not applicable | Both | 100 | Phase 3 | Japan |
| 459 | ITMCTR1900002594 | 2019-12-01 | 2019-09-13 | 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. | 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 colitis | Experimental group:Mesalazine+DHEP II;control group:Mesalazine+Compound Huangbai lotion; | Nanjing Hospital of Chinese Medicine | NULL | Pending | Both | Experimental group:200;control group:100; | Phase 3 | China | ||
| 460 | ChiCTR1900025900 | 2019-12-01 | 2019-09-13 | 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. | 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 colitis | Experimental group:Mesalazine+DHEP II;control group:Mesalazine+Compound Huangbai lotion; | Nanjing Hospital of Chinese Medicine | NULL | Pending | Both | Experimental group:200;control group:100; | Phase 3 | China | ||
| 461 | NCT04133194 (ClinicalTrials.gov) | November 28, 2019 | 10/10/2019 | Adherence of a 1.600 mg Single Tablet 5-ASA Treatment of Ulcerative Colitis | Adherence of a 1.600 mg Single Tablet 5-ASA Treatment of Ulcerative Colitis (EASI-trial) | Ulcerative Colitis | Drug: Mesalazine | Flemming Bendtsen | NULL | Recruiting | 18 Years | 60 Years | All | 200 | Phase 4 | Denmark |
| 462 | EUCTR2018-000334-35-NO (EUCTR) | 27/11/2019 | 12/06/2019 | BI 655130 long-term treatment in patients with moderate-to-severe ulcerative colitis | An open label, long term safety trial of BI 655130 treatment in patients with moderate to severely active ulcerative colitis who have completed previous BI 655130 trials | Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 INN or Proposed INN: spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 INN or Proposed INN: spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim Norway KS | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 2 | Russian Federation;Hungary;United States;Japan;United Kingdom;Spain;Canada;Austria;Netherlands;Belgium;Norway;Korea, Republic of;Poland;Italy;Germany | ||
| 463 | ChiCTR2000029648 | 2019-11-26 | 2020-02-09 | The dynamic alteration of gut microenvironment of moderate to severe UC patient under glucocorticoid induction of remission: an observational study | The dynamic alteration of gut microenvironment of moderate to severe UC patient under glucocorticoid induction of remission: an observational study | Ulcerative Colitis | GC treatment:1mg/kg prednison or other GC with same dose;Health Control:NO intervention; | Peking Union Medical College Hospital | NULL | Recruiting | 18 | 65 | Both | GC treatment:120;Health Control:30; | N/A | China |
| 464 | EUCTR2019-000733-39-SK (EUCTR) | 21/11/2019 | 06/09/2019 | Open-label maintenance therapy in moderate to severe Ulcerative Colitis patients | A phase 2b, open-label, efficacy and safety study of ABX464 as maintenance therapy in patients with moderate to severe Ulcerative Colitis. | Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | ABIVAX | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 217 | Phase 2 | Belarus;Serbia;Czechia;Slovakia;Slovenia;Spain;Ukraine;Austria;Italy;United Kingdom;France;Hungary;Canada;Belgium;Poland;Germany | ||
| 465 | EUCTR2018-001605-93-CZ (EUCTR) | 21/11/2019 | 05/08/2019 | Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis | A 54-Week, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis (Expedition Lead-in) - Phase 2 Dose-finding UC Study | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Brazikumab Product Code: MEDI2070 INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as MEDI2070 Product Name: Brazikumab Product Code: MEDI2070 INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as MEDI2070 | AstraZeneca AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 255 | Phase 2 | United States;Czechia;Taiwan;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;Italy;India;France;Hungary;Czech Republic;Canada;Belgium;Poland;Romania;Bulgaria;South Africa;Germany;Japan;Korea, Republic of | ||
| 466 | EUCTR2017-003703-22-HR (EUCTR) | 20/11/2019 | 13/01/2020 | Phase 2 Dose-finding IMU-838 for Ulcerative Colitis (CALDOSE-1) | A phase 2, multicenter, randomized, double-blind, placebo controlled, dose-finding study to evaluate the efficacy and safety of IMU 838 for induction and maintenance therapy in moderate-to-severe ulcerative colitis CALDOSE-1 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: Vidofludimus calcium | Immunic AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 2 | Serbia;Portugal;United States;Belarus;Czechia;Spain;Ukraine;Russian Federation;North Macedonia;United Kingdom;Poland;Belgium;Croatia;Romania;Bulgaria;Georgia;Netherlands;Germany;Bosnia and Herzegovina | ||
| 467 | EUCTR2018-003987-29-DK (EUCTR) | 20/11/2019 | 02/10/2019 | An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis | An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 912 | Phase 3 | Portugal;Belarus;Serbia;United States;Estonia;Taiwan;Slovakia;Spain;Thailand;Ukraine;Lebanon;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;China;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan | ||
| 468 | EUCTR2019-003068-39-NL (EUCTR) | 20/11/2019 | 04/11/2019 | In patients with inflammatory bowel disease (IBD) on infliximab (IFX) maintenance treatment, low trough levels of IFX suggest inefficacy of the drug and have consistently been shown to be protective of relapse following withdrawal of IFX. However, up to 30% of these patients will experience a relapse after IFX withdrawal. Pharmacokinetic parameters other than trough levels may predict relapse following drug withdrawal in IBD patients with undetectable IFX trough levels. | Withdrawal of Infliximab in patients with inflammatory bowel disease in remission guided by pharmacokinetics: WINK study - WINK study | Inflammatory Bowel Disease (IBD) Ulcerative colitis Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Infliximab Product Name: Infliximab INN or Proposed INN: INFLIXIMAB | UMC Utrecht | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 4 | Netherlands | ||
| 469 | EUCTR2018-003987-29-LT (EUCTR) | 14/11/2019 | 06/11/2019 | An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis | An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 912 | Phase 3 | Portugal;Belarus;Serbia;United States;Estonia;Taiwan;Slovakia;Spain;Thailand;Ukraine;Lebanon;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;China;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan | ||
| 470 | EUCTR2019-000733-39-SI (EUCTR) | 11/11/2019 | 16/10/2019 | Open-label maintenance therapy in moderate to severe Ulcerative Colitis patients | A phase 2b, open-label, efficacy and safety study of ABX464 as maintenance therapy in patients with moderate to severe Ulcerative Colitis. | Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | ABIVAX | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 244 | Phase 2 | Belarus;Serbia;Czechia;Slovenia;Slovakia;Spain;Ukraine;Austria;United Kingdom;France;Hungary;Canada;Belgium;Poland;Germany | ||
| 471 | EUCTR2019-000733-39-PL (EUCTR) | 09/11/2019 | 12/09/2019 | Open-label maintenance therapy in moderate to severe Ulcerative Colitis patients | A phase 2b, open-label, efficacy and safety study of ABX464 as maintenance therapy in patients with moderate to severe Ulcerative Colitis. | Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Obefazimod Product Code: ABX464 INN or Proposed INN: Obefazimod Other descriptive name: ABX464 | ABIVAX | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 217 | Phase 2 | Serbia;Czechia;Slovakia;Slovenia;Spain;Ukraine;Austria;Italy;United Kingdom;France;Hungary;Canada;Poland;Belgium;Germany | ||
| 472 | EUCTR2018-003986-33-HR (EUCTR) | 08/11/2019 | 17/01/2020 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 330 | Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany | ||
| 473 | EUCTR2018-003987-29-HU (EUCTR) | 07/11/2019 | 17/09/2019 | An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis | An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 912 | Phase 3 | Portugal;Belarus;Serbia;United States;Estonia;Taiwan;Slovakia;Spain;Thailand;Ukraine;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;China;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan | ||
| 474 | EUCTR2018-003987-29-LV (EUCTR) | 07/11/2019 | 16/09/2019 | An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis | An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 702 | Phase 3 | Serbia;Portugal;United States;Belarus;Estonia;Taiwan;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Bulgaria;Germany;Japan;Lithuania;Turkey;Austria;United Kingdom | ||
| 475 | EUCTR2018-003986-33-HU (EUCTR) | 07/11/2019 | 08/11/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 330 | Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany | ||
| 476 | EUCTR2016-000642-62-DE (EUCTR) | 04/11/2019 | 18/10/2018 | A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis | M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 522 | Phase 3 | Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Belarus;Serbia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden | ||
| 477 | NCT05225545 (ClinicalTrials.gov) | November 4, 2019 | 9/10/2020 | Sucrosomial Iron vs. Oral Iron Sulfate for the Treatment of Iron Deficiency Anemia in Patients With Ulcerative Colitis | Randomized Controlled Trial of Sucrosomial Iron vs. Oral Iron Sulfate for the Treatment of Iron Deficiency Anemia in Patients With Ulcerative Colitis | Anemia, Iron Deficiency;Ulcerative Colitis | Drug: Sucrosomial Iron;Drug: Oral Iron | American University of Beirut Medical Center | Pharma M | Recruiting | 18 Years | N/A | All | 30 | Phase 3 | Lebanon |
| 478 | EUCTR2018-000334-35-HU ( |