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Duvakitug for Moderately to Severely Active Crohn's Disease

This study is testing an investigational medicine called duvakitug to see if it is safe and effective for people with moderately to severely active Crohn's disease. Participants will receive either duvakitug or a placebo (an inactive substance) as an injection. The study is looking to see if duvakitug can help people achieve clinical remission (a significant reduction in symptoms) and endoscopic response (healing of the gut lining) by Week 12. You may be able to join if you are between 16 and 80 years old, have a confirmed diagnosis of Crohn's disease, and haven't responded well to previous treatments. The study aims to enroll 980 participants.

Study design
This is a Phase 3, randomized, double-blind, placebo-controlled study involving approximately 980 participants across multiple centers. It includes three sub-studies.
What's involved
The study duration can be up to 35 weeks, including a screening period, a 12-week treatment period in one of the sub-studies, and a follow-up period.
Compensation
Not stated in the trial record.
Follow-up
Participants who do not enroll in a maintenance study will have a 6-week (45-day) follow-up period after treatment.

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NCT07184931

An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease

Recruiting
PHASE3Ages 16–80InterventionalTreatment
Sanofi
~980 participants
Updated 2026-07-01 on ClinicalTrials.gov
What's tested:DuvakitugPlacebo

At a glance

Recruiting sites
301 of 301 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Sub-Study 2: Co-primary endpoints US/FDA: Proportion of participants achieving clinical remission per Crohn's Disease Activity Index (CDAI) at Week 12
Measured over Week 12
+3 more outcomes measured

Conditions

Crohn's Disease

Explore related trials

Crohn Disease

Where it's being run

301 sites across 76 states
Japan39
Poland31
California13
Florida13
Ukraine11
Georgia10
Texas9
South Korea9

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 Crohn's Disease (CD) for at least 3 months prior to baseline
Demonstrated inadequate response, have shown loss of response or intolerance to conventional therapies or advanced therapies (ATs)

Exclusion

Participants with Ulcerative Colitis (UC) or indeterminate colitis
Participants with two entire missing segments of the: terminal ileum, right colon transverse colon, sigmoid and left colon, and rectum
Prior or current high-grade gastrointestinal (GI) dysplasia
Participants on treatment with but not on stable doses of conventional therapy prior to baseline
Participants receiving prohibited medications or therapies
Participants with previous exposure to anti-TL1A investigational therapy

What this trial measures

  • Sub-Study 2: Co-primary endpoints US/FDA: Proportion of participants achieving clinical remission per Crohn's Disease Activity Index (CDAI) at Week 12Week 12

    Clinical Remission by CDAI: CDAI score \<150. The CDAI is a measure of disease activity based on symptoms, signs, and a laboratory test. Scores on the CDAI scale range from 0 to 600, with scores below 150 indicating relative disease quiescence (remission), 150 to 219 indicating mild disease activity, 220 to 450 indicating moderate activity, and scores exceeding 450 indicating severe disease.

  • Sub-Study 2: Co-primary endpoints US/FDA: Proportion of participants achieving endoscopic response (Simple Endoscopic Score for Crohn&#x0027;s Disease [SES-CD]) at Week 12Week 12

    Endoscopic Response is defined as decrease in SES-CD ≥50% from baseline (or a decrease of at least 2 points for participants with a baseline score of 4 or more, and isolated ileal disease) based on central reading. The SES-CD is a standardized method for evaluating disease activity. The total score is the sum of the 4 endoscopic variable scores and ranges from 0 to 56, where higher scores represent more severe disease.

  • Sub-Study 2: Co-primary endpoints EU/EMA: Proportion of participants achieving clinical remission per 2-item patient-reported outcome (PRO-2) at Week 12Week 12

    Clinical Remission per PRO-2: average daily stool frequency (SF) ≤3 and not worse than the Baseline, and average daily abdominal pain (AP) ≤1 and not worse than the Baseline.

  • Sub-Study 2: Co-primary endpoints EU/EMA: Proportion of participants achieving endoscopic response (SES-CD) at Week 12Week 12

    Endoscopic Response is defined as decrease in SES-CD ≥50% from baseline (or a decrease of at least 2 points for participants with a baseline score of 4 or more, and isolated ileal disease) based on central reading. The SES-CD is a standardized method for evaluating disease activity. The total score is the sum of the 4 endoscopic variable scores and ranges from 0 to 56, where higher scores represent more severe disease.