Clinical trials: Ulcerative Colitis, Active Severe
Ulcerative Colitis (UC)
A Study of MB-001 in Moderately to Severely Active Ulcerative Colitis
The goal of this clinical trial is to learn if MB-001, an oral biologic, is able to treat patients with ulcerative colitis. Participants will be asked to take MB-001 or a matching placebo once-daily for a period of 12 weeks.
- Trial name
- NCT07374471
- Testing
- MB-001
- Where
- 7 sites in Georgia, Moldova and 2 more
- Volunteers
- 100 people
- Sponsor
- Mage Biologics
Moderately to Severely Active Ulcerative Colitis
A Study to Assess the Efficacy and Safety of Induction Therapy With Afimkibart (Also Known as RO7790121) in Participants With Moderately to Severely Active Ulcerative Colitis
This Phase III, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of induction therapy with Afimkibart (RO7790121) compared with placebo in participants with moderately to severely active…
- Trial name
- Ametrine-2 (NCT06588855)
- Testing
- Afimkibart
- Where
- 168 sites in United States, Argentina and 27 more
- Volunteers
- 350 people
- Sponsor
- Hoffmann-La Roche
Ulcerative Colitis
A Study of Mirikizumab (LY3074828) in Children and Teenagers With Ulcerative Colitis (UC)
This study was designed to evaluate how the body processes and removes mirikizumab. The study also evaluated safety and disease response in pediatric participants with UC taking mirikizumab.
- Trial name
- SHINE-1 (NCT04004611)
- Testing
- Mirikizumab
- Where
- 37 sites in United States, Canada and 3 more
- Volunteers
- 26 people
- Sponsor
- Eli Lilly and Company
Ulcerative Colitis
The Efficacy of Cobitolimod in Patients With Moderate to Severe Active Ulcerative Colitis
The purpose of this study was to evaluate efficacy of cobitolimod treatment at different dose levels and frequencies compared to placebo in patients with moderate to severe left-sided ulcerative colitis.
- Trial name
- CONDUCT (NCT03178669)
- Testing
- cobitolimod
- Where
- 64 sites in Czechia, France and 8 more
- Volunteers
- 213 people
- Sponsor
- InDex Pharmaceuticals
Colitis, Ulcerative
Efficacy and Safety of Vedolizumab Subcutaneously (SC) as Maintenance Therapy in Ulcerative Colitis
The purpose of this study is to assess the effect of vedolizumab subcutaneous (vedolizumab SC) maintenance treatment on clinical remission at Week 52 in participants with moderately to severely active ulcerative colitis (UC) who…
- Trial name
- NCT02611830
- Testing
- Vedolizumab 300 mg IV, Vedolizumab 108 mg SC
- Where
- 174 sites in United States, Argentina and 29 more
- Volunteers
- 383 people
- Sponsor
- Takeda
Ulcerative Colitis (UC)
The Purpose of This Study is to Evaluate the Efficacy and Safety of 627 in the Treatment of UC
This study will evaluate the efficacy and safety of 627 in patients with UC.
- Trial name
- NCT07507513
- Testing
- 627
- Where
- China
- Volunteers
- 288 people
- Sponsor
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Colitis, Ulcerative
A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis
The purpose of this study is to evaluate the efficacy and safety of JNJ-78934804 as compared to guselkumab and golimumab in participants with moderately to severely active ulcerative colitis who have had an inadequate initial…
- Trial name
- DUET-UC (NCT05242484)
- Testing
- Guselkumab, Golimumab, JNJ-78934804
- Where
- 403 sites in United States, Argentina and 35 more
- Volunteers
- 577 people
- Sponsor
- Janssen Research & Development, LLC
Ulcerative Colitis
Study Evaluating the Long-term Safety and Efficacy of ABX464 in Active Ulcerative Colitis
This study is an open-label study aiming at evaluating the long-term safety and the efficacy profile of ABX464 given once a day (o.d) at 50 mg in subjects who have been previously enrolled in the ABX464-101 clinical study…
- Trial name
- NCT03368118
- Testing
- ABX464
- Where
- Belgium
- Volunteers
- 22 people
- Sponsor
- Abivax S.A.
Ulcerative Colitis
Study to Assess Adverse Events, Change in Disease Activity, and How Oral Upadacitinib Moves Through the Body of Pediatric Participants With Moderately to Severely Active Ulcerative Colitis.
Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine).
- Trial name
- U-ASTOUND (NCT05782907)
- Testing
- Upadacitinib
- Where
- 89 sites in United States, Australia and 21 more
- Volunteers
- 122 people
- Sponsor
- AbbVie
Ulcerative Colitis
Oral Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis in Adult Japanese Participants (ELEVATE UC 40 JAPAN)
The purpose of this study is to determine whether oral etrasimod is a safe and effective treatment in adult Japanese participants with moderately to severely active ulcerative colitis (UC).
- Trial name
- NCT04706793
- Testing
- Etrasimod
- Where
- 38 sites in Japan
- Volunteers
- 42 people
- Sponsor
- Pfizer
Ulcerative Colitis, Crohn's Disease
Vedolizumab Subcutaneous (SC) Versus Intravenous (IV) in Ulcerative Colitis or Crohn's Disease
The purpose of this study is to assess the bioavailability and pharmacokinetics (PK) of multiple doses of vedolizumab subcutaneous (SC) compared to vedolizumab intravenous (IV).
- Trial name
- NCT02913508
- Testing
- Vedolizumab intravenous injection, Vedolizumab subcutaneous injection
- Sponsor
- Takeda
Crohn Disease, Ulcerative Colitis
Evaluation of the Safety, Tolerability, and Efficacy of MDGN-002 in Adults With Moderate to Severe Active Crohn's Disease or Ulcerative Colitis
This is a Phase 1b, open-label, dose-escalation, signal-finding, multi-center study. The study will evaluate the safety, tolerability, pharmacokinetics and short-term efficacy of MDGN-002 in adults with moderate to severe, active…
- Trial name
- NCT03169894
- Testing
- MDGN-002
- Where
- 13 sites in United States
- Volunteers
- 8 people
- Sponsor
- Avalo Therapeutics, Inc.
Ulcerative Colitis
Long-term Safety and Efficacy of Efavaleukin Alfa in Participants With Moderately to Severely Active Ulcerative Colitis
The primary objective of this study is to evaluate the long-term safety and tolerability of efavaleukin alfa in participants with moderate to severe ulcerative colitis (UC).
- Trial name
- NCT05672199
- Testing
- Efavaleukin alfa
- Where
- 25 sites in United States, Argentina and 11 more
- Volunteers
- 25 people
- Sponsor
- Amgen
Ulcerative Colitis
Extension Study of APD334-003 in Patients With Moderately to Severely Active Ulcerative Colitis
The purpose of this study is to determine whether etrasimod (APD334) is a safe and effective treatment for ulcerative colitis after 52 weeks of treatment.
- Trial name
- NCT02536404
- Testing
- Etrasimod
- Where
- 127 sites in United States, Australia and 19 more
- Volunteers
- 118 people
- Sponsor
- Arena Pharmaceuticals
Ulcerative Colitis
A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis
The purpose of this study is to determine the safety, efficacy, and pharmacokinetics (PK) of etrasimod for the treatment of moderately to severely active ulcerative colitis in adolescents (≥ 12 years up to < 18 years of age).
- Trial name
- NCT05287126
- Testing
- Etrasimod
- Where
- 47 sites in United States, Japan and 3 more
- Volunteers
- 36 people
- Sponsor
- Pfizer
Ulcerative Colitis
Efficacy, Safety and Immunogenicity of the Proposed Biosimilar Vedolizumab PB016 in Comparison With Entyvio®
This is a multi-center, randomized, parallel arm, double-blind study with approximately 750 participants with moderately to severely active Colitis Ulcerosa randomized to receive either PB016 or Entyvio®
- Trial name
- UCESIVE (NCT05771155)
- Testing
- Intravenous (IV) infusions
- Where
- Georgia
- Volunteers
- 750 people
- Sponsor
- Polpharma Biologics S.A.
Ulcerative Colitis
A Study of Filgotinib 200 mg in Korean Participants With Moderately to Severely Active Ulcerative Colitis Under Routine Clinical Practice
The primary purpose of this study is to evaluate the efficacy of filgotinib in establishing clinical remission at Week 10 or 22.
- Trial name
- NCT06964113
- Testing
- Filgotinib Maleate
- Where
- 19 sites in South Korea
- Volunteers
- 94 people
- Sponsor
- Eisai Korea Inc.
Ulcerative Colitis, Crohn's Disease
A Study of Vedolizumab in Adults With Ulcerative Colitis (UC) or Crohn's Disease (CD) in the Community Setting
Ulcerative Colitis (UC) and Crohn's Disease (CD) are long-term conditions in the gut that can cause diarrhea, swelling (inflammation), bleeding from the anus, and belly pain.
- Trial name
- PANORAMA (NCT06581328)
- Testing
- Vedolizumab IV, Vedolizumab SC
- Where
- 101 sites in United States
- Volunteers
- 200 people
- Sponsor
- Takeda
Moderately to Severely Active Ulcerative Colitis
A Phase 3 Study of Etrasimod in Subjects With Moderately to Severely Active Ulcerative Colitis
The purpose of this study is to determine whether etrasimod is a safe and effective treatment for moderately to severely active ulcerative colitis.
- Trial name
- NCT04176588
- Testing
- Etrasimod
- Where
- China
- Volunteers
- 341 people
- Sponsor
- Everstar Therapeutics Limited
Ulcerative Colitis
A Phase 2 Safety and Efficacy Study of Tulisokibart (MK-7240/PRA023) in Subjects With Moderately to Severely Active Ulcerative Colitis (MK-7240-005)
The purpose of this study is to assess the safety and efficacy of tulisokibart in participants with moderately to severely active Ulcerative Colitis (UC).
- Trial name
- ARTEMIS-UC (NCT04996797)
- Testing
- Tulisokibart, Companion Diagnostic (CDx) Testing
- Where
- 88 sites in United States, Australia and 10 more
- Volunteers
- 178 people
- Sponsor
- Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)