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Phase 3Recruiting

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

Sponsored by Sanofi

About this study

This is a multinational, multicenter, randomized, double-blind, placebo-controlled, Phase 3 induction study, comprised of 3 sub-studies, to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active CD. Study details include: The study duration may be up to 35 weeks with: * Up to 5-week Screening Period. * 12-week Sub-Study 1 (Single Arm Open-Label Feeder Induction) or Sub-Study 2 (Pivotal Induction). * 12-week Sub-Study 3 (Extended Induction for non-responders). * 6 weeks (45 days) follow-up period for participants who do not enroll into the Pivotal Maintenance Study (EFC18327). The treatment duration will be up to 12 weeks in each sub-study. The number of scheduled study visits for participants who continue to the Pivotal Maintenance Study (EFC18327) will be up to 8 (Sub-Study 1 and Sub-Study 2) and up to 15 for participants who enroll in Sub-Study 3.

Where this study is enrolling (5)

  • Del Sol Research Management, LLC-Site Number: 8400012

    Tucson, Arizona

    Call (520) 257-3881

    This research site can be reached directly by phone. Call to ask about this study.

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  • One of a Kind Clinical Research Center LLC-Site Number: 8400061

    Scottsdale, Arizona

    Call 602-820-6906

    This research site can be reached directly by phone. Call to ask about this study.

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  • Atlanta Gastroenterology Associates-Site Number: 8400109

    Atlanta, Georgia

    I'm interested

  • M3 Wake Research - Atlanta: 8400028

    Sandy Springs, Georgia

    I'm interested

  • University of Pennsylvania School of Medicine- Site Number: 8400072

    Philadelphia, Pennsylvania

    I'm interested
Who can participate

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.

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Trial data sourced from ClinicalTrials.gov.