A Multicenter, Multinational, Randomized, Double-blind, Placebo-controlled Phase 3 Maintenance Study to Evaluate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease

What this Trial Is About

Researchers are studying the drug duvakitug in a large, Phase 3 clinical trial to assess its effectiveness and safety for people with moderately to severely active Crohn's Disease. This randomized, double-blind, placebo-controlled study aims to evaluate whether duvakitug can help maintain remission and improve symptoms, with important outcome measures including clinical remission and endoscopic response at 40 weeks. Participants receive subcutaneous injections of duvakitug or a placebo according to the study protocol. The trial includes a 40-week pivotal maintenance phase followed by a 240-week open-label extension phase, allowing some participants to continue treatment. Those not entering the extension will have a 45-day follow-up visit. In total, participants may be involved for up to 286 weeks, with up to 43 on-site visits across both phases. During the study, participants undergo clinical evaluations, endoscopic assessments, and symptom monitoring at regular intervals. Researchers will measure clinical remission using CDAI and PRO-2 scores, endoscopic response using SES-CD, and other outcomes such as fatigue, quality of life, bowel urgency, and hospitalization rates. Safety is closely monitored through adverse event tracking and serum drug concentration measurements throughout treatment and follow-up periods.

A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease