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

RecruitingPhase 3Ages 16 Years - 80 YearsAllSanofi
NCT07185009 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 Phase 3 maintenance 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 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 Pivotal Maintenance Sub-Study * 240 weeks in OLE Sub-Study The total number of on-site visit will be up to 32: * 21 visits in the Pivotal Maintenance Sub-Study. * 11 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 SUNSCAPE-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 participant's potential participation in a clinical trial.
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What it tests

  • Duvakitug
  • Placebo
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Where

171 sites
Del Sol Research Management, LLC - Site Number: 8400012
Tucson, United States
Southern California GI & Liver Centers - Site Number: 8400062
Coronado, United States
United Medical Doctors CA - Site Number: 8400044
Murrieta, United States
Om Research, LLC - Victorville - Site Number: 8400022
Victorville, United States
Peak Gastroenterology Associates - Colorado Springs - Site Number: 8400039
Colorado Springs, United States
Clinical Research of Osceola - Site Number: 8400013
Kissimmee, United States
Bioresearch Partner-Kendale Lakes - Site Number: 8400053
Miami, United States
NMC Research LLC - Site Number: 8400033
Tampa, United States

…and 163 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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