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

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, 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-St

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📋 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 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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What it tests

  • Duvakitug
  • Placebo
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Where

461 sites
Onyx Clinical Research - Site Number:8400021
Peoria, United States
One of a Kind Clinical Research Center AZ, 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
Alliance Research Institute-Site Number: 8400008
Canoga Park, United States
Southern California GI & Liver Centers-Site Number: 8400062
Coronado, United States
Gastroenterology and Liver Institute - Escondido-Site Number: 8400146
Escondido, United States

…and 453 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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