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Phase 3Recruiting

A Maintenance 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 multicenter, randomized, double-blind, placebo-controlled, maintenance, Phase 3 study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Crohn's Disease (CD). Study details include: The study duration may be up to 286 weeks including: * 40-week Pivotal Maintenance Sub-Study * 240-week Open-Label Extension (OLE) Sub-Study * 45-day Follow-Up visit Note: For the participants who do not enroll into OLE Sub-Study, the duration will be up to 46 weeks, including the 40-week maintenance period and a 45-day follow-up visit. The treatment duration may be up to 280 weeks including: * 40 weeks in the Pivotal Maintenance Sub-Study * 240 weeks in OLE Sub-Study The total number of on-site visits will be up to 43: - 21 visits in the Pivotal Maintenance Sub-Study - 22 visits in the OLE Sub-Study

Where this study is enrolling

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

    Philadelphia, Pennsylvania

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Who can participate

Inclusion criteria

  • ✓Participants aged ≥18 and ≤80 years of age at Baseline. (Where locally permissible, participants 16 to \<18 years of age who meet the definition of Tanner stage 5 for development)
  • ✓Pivotal Maintenance Sub-Study: Participants who achieved clinical response and completed endoscopy at the end of STARSCAPE-1
  • ✓OLE Sub-Study: Participants who complete the Pivotal Maintenance Sub-Study or participation in the TV48574-IMM-20038 Study

Exclusion criteria

  • ✕Participants with medical or compliance conditions that are deemed unsuitable for the study by the investigator
  • ✕Participants with a known hypersensitivity to duvakitug that makes the participant unsuitable for the study by the investigator
  • ✕The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial

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Trial data sourced from ClinicalTrials.gov.