Tests duvakitug against placebo in ulcerative colitis
Tests duvakitug versus placebo in adults with moderately to severely active ulcerative colitis.
Plain-language title generated from the registry record
Registry title: An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis
Key facts
- Where
- Dorado and Vega Baja, Puerto RicoSee the 2 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 16 and 80 years old?
Source: NCT07184996, who can take part
Where in Puerto Rico
- Puerto Rico Health and Wellness Institute-Site Number: 8400104Dorado, Puerto RicoTaking people
- Wellness Clinical Research - Vega Baja-Site Number: 8400099Vega Baja, Puerto RicoTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Sanofi
- Trial code
- NCT07184996
- Record updated
- 23 October 2026
- Original description
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:Read full original descriptionShow less
A Multicenter, Multinational, 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.
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.
Inclusion: 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: 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; Participants with Crohn's Disease (CD), indeterminate colitis; Current diagnosis of Ulcerative Proctitis.