A Phase 2b3 Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Icotrokinra in Moderately to Severely Active Crohns Disease

What this Trial Is About

Researchers are evaluating how well icotrokinra works and how safe it is for people with moderately to severely active Crohns disease, a condition that causes long-term inflammation in the intestines. This study is a Phase 2b3 trial that aims to understand both the effectiveness and safety of icotrokinra in treating this condition. Participants will receive icotrokinra or a matching placebo orally every day during the induction period lasting up to 12 weeks. Those who respond to the treatment at Week 12 may continue with different dosing options of icotrokinra or placebo during a maintenance phase up to Week 40. Following this, eligible participants can join a long-term extension study to further monitor treatment effects. During the study, participants will undergo evaluations of their clinical response, remission, and endoscopic response at Weeks 12 and 40 using established disease activity scores. Researchers will monitor safety by tracking adverse events up to 4 weeks after the last dose. The study includes regular assessments through endoscopy, patient-reported outcomes, and laboratory tests to measure how the disease and treatment effects progress.

A Study of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease