Duvakitug to induce remission in moderate to severe ulcerative colitis

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 is a multicenter, randomized, double-blind, placebo-controlled Phase 3 induction program testing duvakitug in people with moderately to severely active ulcerative colitis. Participants may enter a 12-week pivotal induction (duvakitug or placebo), a single-arm open-label feeder induction, and a 12-week extended induction for non-responders, with total participation lasting up to 35 weeks including screening and follow-up. Efficacy and safety will be measured by clinical response and adverse event monitoring across multiple international sites, with Sanofi as the lead sponsor and Teva as a collaborator. Participants who respond may be eligible to continue into a maintenance study, while others will complete a 45-day follow-up.

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 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 Criteria:

* 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.

Where it's running

• Onyx Clinical Research - Site Number: 8400021
  Peoria, Arizona, United States Recruiting
• One of a Kind Clinical Research Center 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
• FOMAT - Unio Specialty Care Arcadia - Site Number: 8400027
  Arcadia, California, United States Recruiting

+190 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.