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A Maintenance 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
NCT07184944 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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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What it tests

  • Duvakitug
  • Placebo
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Where

109 sites
Peak Gastroenterology Associates - Colorado Springs-Site Number: 8400039
Colorado Springs, United States
Clinical Research of Osceola-Site Number: 8400013
Kissimmee, United States
Columbus Clinical Services LLc-Site Number: 8400038
Miami, United States
Bioresearch Partner-Kendale Lakes-Site Number: 8400053
Miami, United States
Orlando Health, Inc., Digestive Health Institute-Site Number: 8400084
Orlando, United States
NMC Research LLC-Site Number: 8400033
Tampa, United States
Illinois Gastroenterology Group d/b/a GI Alliance - Gurnee-Site Number: 8400049
Gurnee, United States
Gastroenterology Health Partners, PLLC - New Albany-Site Number: 8400100
New Albany, United States

…and 101 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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