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A Study of Duvakitug for Moderately to Severely Active Ulcerative Colitis

This study is testing an investigational medicine called duvakitug to see if it is safe and effective for people with moderately to severely active ulcerative colitis (UC). You may be able to join if you are between 16 and 80 years old, have had UC for at least 3 months, and your current treatments haven't worked well. The study will compare duvakitug to a placebo (an inactive substance) to see if duvakitug can help you achieve clinical remission (a significant reduction in your UC symptoms). The study aims to enroll about 980 participants. The current recruitment status is unclear.

Study design
This is a multinational, multicenter, randomized, double-blind, placebo-controlled Phase 3 study. It will compare duvakitug to a placebo in approximately 980 participants.
What's involved
The study may last up to 35 weeks, including a screening period, up to 12 weeks of treatment in different sub-studies, and a follow-up visit.
Compensation
Not stated in the trial record.
Follow-up
Participants who do not enroll in a maintenance study will have a follow-up visit 45 days after their last treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07184996

An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis

Recruiting
PHASE3Ages 16–80InterventionalTreatment
Sanofi
~980 participants
Updated 2026-08-20 on ClinicalTrials.gov
What's tested:DuvakitugPlacebo

At a glance

Recruiting sites
218 of 219 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of participants achieving clinical remission.
Measured over Week 12

Conditions

Ulcerative Colitis

Explore related trials

Ulcerative Colitis

Where it's being run

219 sites across 51 states
Japan32
California16
Florida15
Poland15
Georgia11
Ukraine11
Texas10
Louisiana7

Who to contact

Trial Transparency email recommended (Toll free for US & Canada)
[email protected]
800-633-1610 · ext. option 6
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

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 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.

What this trial measures

  • Proportion of participants achieving clinical remission.Week 12

    Clinical remission is defined as modified Mayo Score (mMS) score of 0 to 2, including SFS of 0 or 1, RBS of 0, and modified Mayo Endoscopic Score (MES) of 0 or 1 (score of 1 modified to exclude friability). mMS is a composite index designed to measure UC disease activity. The score ranges from 0 to 9 with higher scores indicating greater disease severity.