drugset / Trial / NCT05837897
A Study of Vedolizumab in Adult Participants With Moderate to Severe Crohn's Disease
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Vedolizumab | Monoclonal antibody | 300 mg | Intravenous |