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Induction treatment with duvakitug for moderate to severe Crohn's disease

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 Crohn's Disease

PHASE3 · Sanofi · NCT07184931

This trial will test whether duvakitug helps adults with moderate to severe Crohn's disease improve symptoms over a 12-week induction period compared with placebo.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment980 (estimated)
Ages16 Years to 80 Years
SexAll
SponsorSanofi (industry)
Locations196 sites (Peoria, Arizona and 195 other locations)
Trial IDNCT07184931 on ClinicalTrials.gov

What this trial studies

This multinational, multicenter, randomized, double-blind, placebo-controlled Phase 3 induction program tests duvakitug in participants with moderately to severely active Crohn's disease across three sub-studies: a single-arm open-label feeder induction, a pivotal randomized induction, and an extended induction for non-responders. Each sub-study involves up to 12 weeks of treatment within an overall study duration up to 35 weeks that includes screening and follow-up, and participants may continue into a separate maintenance study. Eligible participants are generally adults aged 18–80 (some sites may permit 16–17 year-olds with mature development) with at least 3 months of active disease and prior inadequate response, loss of response, or intolerance to conventional or advanced therapies. Participants are randomized to receive duvakitug or placebo and are monitored for clinical response and safety, with key exclusions such as prior anti-TL1A investigational therapy and certain gastrointestinal conditions.

Who should consider this trial

Good fit: Adults (typically 18–80 years; some sites may enroll 16–17 year-olds with Tanner Stage 5) with confirmed moderately to severely active Crohn's disease for at least 3 months who have had inadequate response, loss of response, or intolerance to conventional or advanced therapies are ideal candidates.

Not a fit: Patients with ulcerative colitis or indeterminate colitis, prior exposure to anti-TL1A investigational therapy, certain missing bowel segments, prior high-grade GI dysplasia, unstable conventional therapy, or those taking prohibited medications are unlikely to be eligible or receive benefit from participation.

Why it matters

Potential benefit: If successful, duvakitug could offer a new induction option that brings symptom relief or remission for patients with moderate to severe Crohn's disease who have not benefited from other treatments.

How similar studies have performed: Early-phase studies of anti-TL1A approaches and other biologic agents have shown promising signals of symptom improvement in Crohn's disease, though large Phase 3 confirmation is still needed.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 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 Criteria:

* 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

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Where this trial is running

Peoria, Arizona and 195 other locations

+146 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Crohn's Disease

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.