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Vedolizumab-3040
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A Study of Vedolizumab in Adult Participants With Moderate to Severe Crohn's Disease

Clinicaltrials.gov
#NCT05837897

About 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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