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Vedolizumab Intravenous (IV) Compared to Placebo in Chinese Participants With Crohn's Disease.

NCT03234907 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 215

Last updated 2023-03-01

Study results available
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Summary

The purpose of this study is to assess the safety and efficacy of vedolizumab intravenous (IV) infusion as induction treatment in Chinese participants with moderately to severely active Crohn's disease (CD) at Week 10.

Conditions

Interventions

DRUG

Vedolizumab IV

Vedolizumab IV infusion

DRUG

Placebo

Vedolizumab placebo-matching

Sponsors & Collaborators

Principal Investigators

  • Study Director Clinical Science · 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
2017-08-03
Primary Completion
2020-08-14
Completion
2020-08-14
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

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 NCT03234907 on ClinicalTrials.gov