drugset / Trial / NCT05837897

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

NCT05837897

Phase 3 Recruiting 408 enrolled Takeda
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a study to evaluate vedolizumab for injection (300 mg) as a safe and active treatment for Crohn's Disease in adults in China. Participants will receive an injection of Vedolizumab 300 mg at scheduled weeks 0, 2, and 6, and starting at week 14, every 8 weeks over 58 weeks or starting at week 18, every 4 weeks over 54 weeks. There will be up to 20 study visits over 58 weeks to complete assessments.

Timeline

Start
2023-06-16
Primary completion
2030-03-08
Completion
2031-05-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Vedolizumab Monoclonal antibody 300 mg Intravenous

Indications