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.
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
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
Sanofi
Lead sponsor
Teva Branded Pharmaceutical Products R&D LLC
Collaborator