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

NCT05837897 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 408

Last updated 2025-11-05

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Vedolizumab IV

Vedolizumab IV infusion

DRUG

Placebo

Vedolizumab placebo-matching IV infusion

Sponsors & Collaborators

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-16
Primary Completion
2030-03-08
Completion
2031-05-30
FDA Drug
Yes

Countries

  • China

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05837897 on ClinicalTrials.gov