Clinical trials: Moderate Active Ulcerative Colitis
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)
LIV001 in Patients with Mild-to-Moderate Active Ulcerative Colitis (UC)
A Phase 1b study to evaluate the safety and tolerability of LIV001 in Patients with Mild-to- Moderate Active Ulcerative Colitis
- Trial name
- NCT06749795
- Testing
- LIV001
- Where
- Poland
- Volunteers
- 15 people
- Sponsor
- Liveome Inc.
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
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.
Ulcerative Colitis
Oligofructose-enriched Inulin for the Treatment of Mild to Moderate Active Ulcerative Colitis
Based on the efficacy of inulin and oligofructose in treating experimental colitis and emerging evidence suggesting probiotics are efficacious in maintaining and inducing remission in human ulcerative colitis (UC), the…
- Trial name
- NCT02093767
- Testing
- Synergy1
- Where
- Canada
- Volunteers
- 24 people
- Sponsor
- University of Alberta
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
Ulcerative Colitis Chronic Mild, Ulcerative Colitis Chronic Moderate
Fecal Microbiota Therapy Vs 5-aminosalicylates for Induction of Remission in Newly Diagnosed Mild-moderately Active UC
Ulcerative colitis is a chronic idiopathic inflammatory disease of the colon that is characterized by abdominal pain and bloody diarrhea.
- Trial name
- NCT03716388
- Testing
- Fecal Microbiota Transplantation, Mesalamine Granules
- Where
- India
- Volunteers
- 20 people
- Sponsor
- Dayanand Medical College and Hospital
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