An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis
Study of an Investigational Study Drug for Moderate to Severe Ulcerative Colitis
Study Overview
This is a multinational, multicenter, randomized, double-blind, placebo-controlled, Phase 3 induction study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Ulcerative Colitis (UC). Study details include:
The study duration may be up to 35 weeks with:
- Screening period
- 12-week Sub-Study 1 (Single-Arm Open-Label Feeder Induction) or Sub-Study 2 (Pivotal Induction)
- 12-week Sub-Study 3 (Extended Induction for non-responders)
- 45 days follow-up visit for participants who do not enroll into the maintenance study (EFC18359)
The treatment duration will be up to 12 weeks in each sub-study. The number of scheduled on-site visits will be up to 8 for the Sub-Study 1 and Sub Study 2 or a maximum of 15 visits for participants completing extended induction.
Eligibility Criteria
You may be eligible for this study if you meet the following criteria:
- Conditions: Ulcerative Colitis
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Age: 16 years - 80 years
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Gender: All
Inclusion Criteria:
- Participants aged ≥18 and ≤80 years of age at Screening. Where permitted locally, participants 16 to <18 years of age who meet the definition of Tanner Stage 5 for development
- Confirmed diagnosis of moderately to severely active UC for at least 3 months prior to Baseline
- Demonstrated inadequate response, have shown loss of response or intolerance to conventional therapies or advanced therapies
Exclusion Criteria:
- Participants with Crohn's Disease (CD), indeterminate colitis
- Current diagnosis of Ulcerative Proctitis
- Participants with surgical bowel resection within the past 3 months prior to Baseline, or a history of >3 bowel resections
- Prior or current high-grade gastrointestinal (GI) dysplasia
- Participants on treatment with but not on stable doses of conventional therapies prior to baseline
- Participants with prohibited medications or therapies prior to baseline
- Participants with previous exposure to anti-TL1A investigational therapy The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
The purpose of this research study is to learn about the effects and safety of an investigational study drug in people with moderately to severely active ulcerative colitis.
Participants will receive either the investigational study drug or a placebo. A placebo looks like the investigational study drug but does not contain active medication. Some participants may be able to continue on the investigational study drug for a longer induction period if they do not respond at first.
Who can participate:
Adults with moderately to severely active ulcerative colitis may be able to participate if they:
- Are 18 to 80 years old
- Have had a confirmed diagnosis of moderately to severely active ulcerative colitis for at least three months
- Have tried other ulcerative colitis treatments (conventional or advanced therapies) that did not work well enough, stopped working, or caused difficult side effects
Study timeline and visits:
Participation may last up to 35 weeks. There will be up to 8 scheduled in-person visits for some participants, and up to 15 visits for participants who continue in the extended induction period.
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