An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis
Investigational Study on the Efficacy and Safety of an Investigational Medication for 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 study is to investigate the efficacy and safety of an investigational medication in participants with moderately to severely active Ulcerative Colitis (UC). This study includes different arms to evaluate the investigational medication in various scenarios.
Participants will undergo procedures such as screening and treatment over several weeks. The study includes a single-arm open-label feeder induction, a pivotal induction, and an extended induction for non-responders. Participants will be randomly assigned to receive either the investigational medication or a placebo, which is an inactive substance that looks like the investigational medicine but does not contain any medicine.
- Who can participate: Participants aged 18 to 80 years, and those 16 to under 18 who meet specific development criteria, can join. They must have a confirmed diagnosis of moderately to severely active UC for at least 3 months and have shown inadequate response to conventional or advanced therapies.
- Study details: The study involves different arms to assess the medication's efficacy and safety.
- Study timelines and visits: The study will last up to 35 weeks. The study requires up to 8 visits for Sub-Study 1 and Sub-Study 2, or up to 15 visits for participants in the extended induction.
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