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NCT07184996
An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis
Conditions: Ulcerative Colitis
Sex: All
Ages: 16 Years – 80 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 980
Sponsor: Sanofi
Location: Onyx Clinical Research - Site Number: 8400021 Peoria Arizona
Summary
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.
Eligibility Criteria
Inclusion Criteria:
* Participants aged ≥18 and ≤80 years of age at Screening. Where permitted locally, participants 16 to \
Source: ClinicalTrials.gov (NCT07184996). StuddyBuddy aggregates publicly available trial information.