Phase 3 Study of Vedolizumab IV Treatment for Moderate to Severe Crohns Disease in Adults in China

What this Trial Is About

Researchers are evaluating vedolizumab, given as an intravenous infusion, as a treatment for adults in China with moderate to severe Crohns Disease. This Phase 3 study aims to assess the safety and effectiveness of vedolizumab compared to a placebo. Approximately 408 participants will take part, and the study is sponsored by Takeda. Participants will be randomly assigned to receive either vedolizumab 300 mg or a placebo intravenously at Weeks 0, 2, and 6 during the 14-week Induction Period. After Week 14, all participants continue in an open-label extension phase where they receive vedolizumab 300 mg every 8 weeks until Week 54 or 58. Those who do not respond or whose disease worsens after Week 18 may receive vedolizumab every 4 weeks. This treatment schedule includes up to 20 study visits over about 58 weeks. During the study, participants will undergo various assessments including clinical response evaluations at Week 14, endoscopic exams, and monitoring for adverse events up to 18 weeks after the last dose. Safety follow-up visits and a long-term safety survey by telephone will occur up to 6 months post-treatment. The main outcome measured is the percentage of participants achieving a clinical response at Week 14, with other measures including remission rates and safety lab results over the study period.

A Study of Vedolizumab in Adult Participants With Moderate to Severe Crohn's Disease