Clinical trials: Moderately to Severely Active Ulcerative Colitis
Ulcerative Colitis
Open-label Extension Study of Brazikumab in Ulcerative Colitis
The purpose of this OLE Study D5272C00002 (Legacy #3151-202-008) is to permit participants who previously enrolled in the double-blind Study D5272C00001 (Legacy #3151-201-008) to receive brazikumab, allowing for long-term…
- Trial name
- Expedition (NCT04277546)
- Testing
- Brazikumab Maintenance Dose, Brazikumab Induction Dose
- Where
- 36 sites in United States, Czechia and 9 more
- Volunteers
- 57 people
- Sponsor
- AstraZeneca
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
Efficacy and Safety of Adalimumab for the Induction of Clinical Response in Ulcerative Colitis
The purpose of this study is to assess the clinical benefit and tolerability of adalimumab, a fully human monoclonal antibody to tumor necrosis factor α (TNF- α), in patients with ulcerative colitis (UC) naive to treatment with…
- Trial name
- NCT01494857
- Testing
- Adalimumab
- Where
- 3 sites in Israel
- Volunteers
- 200 people
- Sponsor
- Clalit Health Services
Ulcerative Colitis
A Phase 3 Study to Investigate the Efficacy and Safety of SHR0302 With Moderately to Severely Active Ulcerative Colitis
This is a randomized, double-blind, placebo-controlled, multicenter Phase 3 study that will enroll approximately 368 subjects aged 18 to 75 years old with Moderately to Severely Active Ulcerative Colitis.
- Trial name
- NCT05181137
- Testing
- SHR0302
- Where
- 113 sites in United States, China and 3 more
- Volunteers
- 368 people
- Sponsor
- Reistone Biopharma Company Limited
Colitis, Ulcerative
A Study to Assess the Efficacy and Safety of Golimumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis
The purpose of this study is to evaluate efficacy of golimumab in inducing clinical remission as assessed by the Mayo score, in pediatric participants with moderately to severely active ulcerative colitis (UC).
- Trial name
- PURSUIT 2 (NCT03596645)
- Testing
- Golimumab, Infliximab
- Where
- 58 sites in United States, Belgium and 9 more
- Volunteers
- 84 people
- Sponsor
- Janssen Research & Development, LLC
Ulcerative Colitis
Corticosteroids+5-aminosalicylic Acid Compared to Corticosteroids in the Treatment of Moderate-severe Ulcerative Colitis
The role of steroids in the treatment of ulcerative Colitis (UC) is well established, and recommended by professional societies.
- Trial name
- NCT01941589
- Testing
- oral 5-ASA+/-topical 5-ASA+IV corticosteroids / PO Methylprednisolone, corticosteroids only
- Where
- 10 sites in China, France and 5 more
- Volunteers
- 149 people
- Sponsor
- Sheba Medical Center
Ulcerative Colitis
ABTECT - Maintenance
This is a multicenter, randomized, placebo-controlled study to evaluate the long-term efficacy and safety of ABX464 50mg and 25mg administered once daily (QD) as maintenance therapy in subjects with moderately to severely active…
- Trial name
- NCT05535946
- Testing
- ABX464
- Where
- 413 sites in United States, Argentina and 32 more
- Volunteers
- 1,116 people
- Sponsor
- Abivax S.A.
Ulcerative Colitis
Etrasimod Dose-Ranging Versus Placebo as Induction Therapy Study in Adult Japanese Subjects With Moderately to Severely Active Ulcerative Colitis
The purpose of this Japan-only study is to assess the safety and efficacy of etrasimod at 2 doses in Japanese subjects with moderately to severely active ulcerative colitis (UC) when administered for 12 weeks.
- Trial name
- NCT05061446
- Testing
- Etrasimod
- Where
- 80 sites in Japan
- Volunteers
- 54 people
- Sponsor
- Pfizer
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.
Moderate to Severe Ulcerative Colitis
Phase II Study of Hemay005 in Patients With Active Ulcerative Colitis
This study is a multicenter, randomized, double-blind study. There are three dosage groups: Hemay005 45 mg BID group, 60 mg BID group or placebo group, with 36 patients in each dosage group.
- Trial name
- NCT05486104
- Testing
- Hemay005 tablets
- Where
- 18 sites in China
- Volunteers
- 92 people
- Sponsor
- Ganzhou Hemay Pharmaceutical Co., Ltd
Ulcerative Colitis (UC)
Study of the Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of BCD-261 in Subjects With Moderate to Severe Active Ulcerative Colitis
The aim of the study is to evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics and immunogenicity of study drug (BCD-261) in comparison with placebo and to characterize the dose-response relationship in patients…
- Trial name
- ULTRAMARINE (NCT07080034)
- Testing
- anti-TL1A monoclonal antibody, low dose, anti-TL1A monoclonal antibody, medium dose, anti-TL1A monoclonal antibody, high dose
- Where
- 20 sites in Russia
- Volunteers
- 198 people
- Sponsor
- Biocad
Ulcerative Colitis (UC)
A Study for HSK47388 in Participants With Ulcerative Colitis
The purpose of this protocol is to evaluate the efficacy and safety of HSK47388 as therapy in participants with moderately to severely active ulcerative colitis .
- Trial name
- NCT07335055
- Testing
- HSK47388
- Where
- China
- Volunteers
- 150 people
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
Ulcerative Colitis (UC)
A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Ulcerative Colitis
The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo in inducing clinical remission (per Adapted Mayo score) in participants with moderately to severely active ulcerative colitis…
- Trial name
- U-Accomplish (NCT03653026)
- Testing
- Upadacitinib
- Where
- 379 sites in United States, Argentina and 42 more
- Volunteers
- 522 people
- Sponsor
- AbbVie
Ulcerative Colitis
ABTECT-1 - ABX464 Treatment Evaluation for Ulcerative Colitis Therapy -1
This is a multicenter, randomized, placebo controlled study to evaluate the efficacy and safety of ABX464 given at 25 or 50 mg QD in inducing clinical remission in subjects with moderately to severely active ulcerative colitis…
- Trial name
- NCT05507203
- Testing
- ABX464
- Where
- 264 sites in United States, Argentina and 22 more
- Volunteers
- 639 people
- Sponsor
- Abivax S.A.
Colitis, Ulcerative, Crohn Disease
Phase 4, Vedolizumab-4002 Post-marketing, Disease-Drug-Drug Interaction Study
The purpose of this study is to evaluate in a step-wise approach the disease drug-drug interaction (DDI) potential for vedolizumab to indirectly affect the exposure of cytochrome P-450 (CYP) substrate drugs by modulating…
- Trial name
- NCT02760615
- Testing
- Caffeine, Losartan, Omeprazole
- Where
- 2 sites in United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Takeda
Ulcerative Colitis
ABX464 in Subjects With Moderate to Severe Active Ulcerative Colitis
This Phase IIa study is an 8-week, double-blind, placebo-controlled, randomized study aiming at evaluating the safety and the efficacy of ABX464 given once a day (o.d) at 50 mg in subjects with moderate to severe Active…
- Trial name
- NCT03093259
- Testing
- ABX464
- Where
- 19 sites in Austria, Belgium and 6 more
- Volunteers
- 32 people
- Sponsor
- Abivax S.A.
Ulcerative Colitis
Efficacy and Safety of SAR339658 in Patients With Moderate to Severe Ulcerative Colitis
Primary Objective: To assess the efficacy of SAR339658 Secondary Objective: To assess the safety of SAR339658
- Trial name
- FUSCIA (NCT01659138)
- Testing
- SAR339658
- Where
- 41 sites in United States, Austria and 5 more
- Volunteers
- 28 people
- Sponsor
- Sanofi
Ulcerative Colitis (UC)
A Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of PTT-621 in Patients With Moderately to Severely Active Ulcerative Colitis
This Phase IIa, multicenter, single-arm trial evaluates the efficacy, safety, tolerability, and pharmacokinetics of PTT-621 tablets in adults (18-70 years) with moderate-to-severe active ulcerative colitis (UC) who have…
- Trial name
- NCT07747155
- Testing
- PTT-621 Tablets
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Pyrotech Therapeutics, Inc.
Colitis, Ulcerative
BI655130 (SPESOLIMAB) Induction Treatment in Patients With Moderate-to-severe Ulcerative Colitis
This trial has two sequentially enrolling parts with different objectives. The primary objectives of this trial are to prove the concept of clinical activity of BI655130 (SPESOLIMAB) in patients with moderate-to-severely active…
- Trial name
- NCT03482635
- Testing
- Spesolimab
- Where
- 54 sites in United States, Austria and 10 more
- Volunteers
- 98 people
- Sponsor
- Boehringer Ingelheim
Colitis, Ulcerative
To Evaluate Efficacy and Long-term Safety of Ozanimod in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis
Japanese patients with moderate or severe active ulcerative colitis as a subject when ozanimod 0.46 mg or 0.92 mg is orally administered is evaluated about dose response, efficacy and safety with placebo as a control.
- Trial name
- NCT03915769
- Testing
- Ozanimod
- Where
- 67 sites in Japan
- Volunteers
- 198 people
- Sponsor
- Celgene