Vedolizumab-3040
Recruiting
A Study of Vedolizumab in Adult Participants With Moderate to Severe Crohn's Disease
Clinicaltrials.gov
#NCT05837897About this clinical trial
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.
CN
Interventional Phase 3 clinical trial.
At a glance
What medical conditions are being studied?
Crohn's Disease
What is the clinical trial testing?
Placebo, Vedolizumab IV
How many participants are being enrolled?
408
Are placebos part of the clinical trial?
No
When is the clinical trial being conducted?
Jun 2023 - May 2031
How long is participation in the clinical trial?
Each participant will be in the study for about 58 weeks.
Key requirements
Sex
All
Age
18-80 years
Healthy volunteers?
No
Entry criteria
Must be an adult with moderate to severe Crohn’s disease in China.
Have not had subtotal or total colectomy.
Cannot have previous exposure to vedolizumab.
Cannot have more than 3 small bowel resections or diagnosis of short bowel syndrome.
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