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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Onyx Clinical Research - Site Number:8400021
  Peoria, Arizona, United States Recruiting
• One of a Kind Clinical Research Center AZ, LLC-Site Number: 8400061
  Scottsdale, Arizona, United States Recruiting
• Scottsdale Clinical Trials-Site Number: 8400145
  Scottsdale, Arizona, United States Recruiting
• Del Sol Research Management, LLC-Site Number: 8400012
  Tucson, Arizona, United States Recruiting
• Preferred Research Partners-Site Number: 8400018
  Little Rock, Arkansas, United States Recruiting
• Alliance Research Institute-Site Number: 8400008
  Canoga Park, California, United States Recruiting

+411 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Trial Transparency email recommended (Toll free for US & Canada)
• Email: Contact-US@sanofi.com
• Phone: 800-633-1610

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.