A Multicenter, Multinational, Randomized, Double-blind, Placebo-Controlled Phase 3 Maintenance Study to Evaluate the Efficacy and Safety of Duvakitug in Moderately to Severely Active Ulcerative Colitis

What this Trial Is About

Researchers are evaluating the efficacy and safety of duvakitug in people with moderately to severely active Ulcerative Colitis UC in a multicenter, randomized, double-blind, placebo-controlled Phase 3 maintenance study. The study is sponsored by Sanofi and aims to assess how well duvakitug maintains clinical remission and improves symptoms in participants who have responded to prior treatment. This investigation includes a long-term follow-up to understand the treatments effects over several years. Participants receive subcutaneous injections of duvakitug or placebo according to protocol. The study includes a 40-week pivotal maintenance phase followed by a 240-week open-label extension OLE phase for those who continue treatment. Participants not entering the extension phase will have a 45-day follow-up after the maintenance period. The total treatment duration may be up to 280 weeks, with up to 32 on-site visits during the entire study. During the study, participants will undergo regular assessments including clinical remission measured by the modified Mayo Score, endoscopic and histologic evaluations, symptom tracking like bowel urgency and abdominal pain, and quality of life questionnaires. Safety will be monitored through adverse event reporting and serum drug concentration measurements. The primary outcome is the proportion of participants achieving clinical remission at week 40, and the study will also track long-term safety and efficacy outcomes through the extension phase.

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