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An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis

RecruitingPhase 3Ages 16 Years - 80 YearsAllSanofi
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In plain words

What the trial is, and whether it could suit you

This is a multinational, multicenter, randomized, double-blind, placebo-controlled, Phase 3 induction study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Ulcerative Colitis (UC). Study details include: The study duration may be up to 35 weeks with: * 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) * 45 days follow-up visit for participants who do not enroll into the maintenance study (EFC18359) The treatment duration will be up to 12 weeks in each sub-study. The number of scheduled on-site visits will be up to 8 for the Sub-Study 1 and Sub Study 2 or a maximum of 15 visits for participants completing extended induction.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • Duvakitug
  • Placebo
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Where

240 sites
Onyx Clinical Research - Site Number: 8400021
Peoria, United States
One of a Kind Clinical Research Center LLC - Site Number: 8400061
Scottsdale, United States
Scottsdale Clinical Trials - Site Number: 8400145
Scottsdale, United States
Del Sol Research Management, LLC - Site Number: 8400012
Tucson, United States
Preferred Research Partners - Site Number: 8400018
Little Rock, United States
FOMAT - Unio Specialty Care Arcadia - Site Number: 8400027
Arcadia, United States
Alliance Research Institute - Site Number: 8400008
Canoga Park, United States
Southern California GI & Liver Centers - Site Number: 8400062
Coronado, United States

…and 232 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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