Phase 3 Study of Duvakitug Injection for Treating Moderate to Severe Ulcerative Colitis in Adults and Older Teens

What this Trial Is About

Researchers are evaluating the efficacy and safety of duvakitug, a drug given by subcutaneous injection, in people with moderately to severely active Ulcerative Colitis UC. This Phase 3 randomized, double-blind, placebo-controlled study includes participants aged 16 to 80 years and aims to assess clinical remission and other health improvements over a series of treatment periods. The study lasts up to 35 weeks and includes a screening period followed by three possible sub-studies a 12-week open-label induction, a 12-week pivotal induction, and a 12-week extended induction for those who do not respond initially. Participants receive injections of either duvakitug at one of two doses or placebo according to the study protocol, with up to 15 visits scheduled for those in extended induction. During the study, participants will undergo assessments including clinical remission rates at week 12, endoscopic and histological improvements, symptom tracking, quality of life questionnaires, and safety monitoring for adverse events. Follow-up visits occur up to 45 days after the last dose for those not continuing in the maintenance study. Researchers will also measure drug levels and immune responses over the study period to better understand treatment effects.

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