Clinical trials: Ulcerative Colitis, Active Moderate
Moderately Active Ulcerative Colitis
A Phase 2a Study to Evaluate the Safety, Tolerability, Pharmacodynamics and Efficacy of AG011 in Ulcerative Colitis
The purpose of this study is to verify the safety and tolerability of AG011 (genetically modified L. lactis that has been engineered to secrete human Interleukin-10), and to determine whether AG011 can successfully treat the…
- Trial name
- NCT00729872
- Testing
- AG011
- Where
- 18 sites in Belgium, Canada and 2 more
- Volunteers
- 60 people
- Sponsor
- ActoGeniX N.V.
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
A Study to Investigate Efficacy and Safety of KBL697 in Patients With Mild to Moderate Active Ulcerative Colitis
The study is designed to investigate efficacy and safety of KBL697 in patients with mild to moderate active ulcerative colitis. KBL697 has been developed as a potential new treatment for ulcerative colitis.
- Trial name
- NCT04898348
- Testing
- KBL697
- Where
- Australia
- Sponsor
- KoBioLabs
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
Confirmatory Clinical Study in Active Ulcerative Colitis
The main goal of the study is to check if MH002 works and is safe to use. In a previous study in 45 patients with Ulcerative Colitis, MH002 was found to have favorable effects.
- Trial name
- StarFish-UC (NCT07296315)
- Testing
- Low-dose MH002, High-dose MH002
- Where
- 49 sites in United States, Czechia and 5 more
- Volunteers
- 204 people
- Sponsor
- MRM Health NV
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
Ulcerative Colitis
A Study of LIV001 in Healthy Subjects and Those with Mild-to-Moderate Active Ulcerative Colitis (UC)
This study is only for the first in human phase 1a study designed to investigate the safety and tolerability of LIV001 in healthy participants.
- Trial name
- NCT05975047
- Testing
- LIV001
- Where
- Australia
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Liveome Inc.
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
Colitis, Ulcerative
A Study of Ustekinumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis (UC)
The purpose of this study is to evaluate: a) the efficacy of ustekinumab dosing in inducing clinical remission, b) safety profile of ustekinumab, and c) ustekinumab exposure (pharmacokinetics [PK]) in pediatric participants with…
- Trial name
- UNIFI Jr (NCT04630028)
- Testing
- Ustekinumab Dose Based on BSA and Body Weight
- Where
- 58 sites in United States, Belgium and 7 more
- Volunteers
- 112 people
- Sponsor
- Janssen Research & Development, LLC
Ulcerative Colitis
A Study to Learn More About How Risankizumab Works in Young Participants With 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
- MIGHTY (NCT07071519)
- Testing
- Risankizumab
- Where
- 72 sites in United States, Belgium and 14 more
- Volunteers
- 120 people
- Sponsor
- AbbVie
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
Colitis, Ulcerative
A Phase 2a, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Trial of IBD98-M
IBD98-M-2002 is a phase 2a , Randomized, Double blind, Placebo-controlled of IBD98-M Delayed Release capsules in subjects with Mild to Moderately Ulcerative Colitis to investigate the clinical efficacy of IBD98-M delayed release…
- Trial name
- NCT02493712
- Testing
- High dose, Low dose
- Where
- Italy
- Volunteers
- 51 people
- Sponsor
- Holy Stone Healthcare Co., Ltd
Ulcerative Colitis
Etrasimod Versus Placebo as Induction Therapy in Moderately to Severely Active Ulcerative Colitis
The purpose of this study is to assess the efficacy of etrasimod on clinical remission in participants with moderately to severely active ulcerative colitis (UC).
- Trial name
- ELEVATE UC 12 (NCT03996369)
- Testing
- Etrasimod
- Where
- 407 sites in United States, Argentina and 39 more
- Volunteers
- 354 people
- Sponsor
- Arena Pharmaceuticals
Ulcerative Colitis
A Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 3)
This study is designed to evaluate the long-term efficacy and safety of mirikizumab in participants with moderately to severely active ulcerative colitis (UC). The study will last up to 3 years.
- Trial name
- NCT03519945
- Testing
- Mirikizumab
- Where
- 352 sites in United States, Argentina and 34 more
- Volunteers
- 1,058 people
- Sponsor
- Eli Lilly and Company
Ulcerative Colitis
A Study of the Efficacy and Safety of Etrolizumab in Participants With Ulcerative Colitis Who Have Been Previously Exposed to Tumor Necrosis Factor (TNF) Inhibitors
This Phase III, double-blind, placebo-controlled, multicenter study will investigate the efficacy and safety of etrolizumab during induction and maintenance of remission compared with placebo in the treatment of participants with…
- Trial name
- HICKORY (NCT02100696)
- Testing
- Etrozulimab
- Where
- 184 sites in United States, Argentina and 22 more
- Volunteers
- 609 people
- Sponsor
- Hoffmann-La Roche
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.
Proctitis, Proctosigmoiditis
Efficacy and Safety of Budesonide Foam for Participants With Active Mild to Moderate Ulcerative Proctitis or Proctosigmoiditis
The purpose of this study is to establish the efficacy profile of rectally administered budesonide foam, as compared to an equivalent volume of rectally administered placebo foam over the same dosing schedule, in participants who…
- Trial name
- NCT01008423
- Testing
- Budesonide
- Where
- 62 sites in United States
- Volunteers
- 281 people
- Sponsor
- Bausch Health Americas, Inc.