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Phase III Study of MLN0002 (300 mg) in Treatment of Crohn's Disease

NCT02038920 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 157

Last updated 2019-12-09

Study results available
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Summary

This study is a phase 3, multicenter, randomized, double-blinded, placebo-controlled, parallel-group study to examine the efficacy, safety, and pharmacokinetics of vedolizumab (MLN0002) in induction and maintenance therapy in Japanese participants with moderately or severely active Crohn's disease.

Conditions

Interventions

DRUG

Vedolizumab

Vedolizumab IV injection

DRUG

Vedolizumab placebo

Vedolizumab placebo-matching IV infusion

Sponsors & Collaborators

Principal Investigators

  • Study Director Clinical Science · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-01-28
Primary Completion
2019-01-25
Completion
2019-05-21
FDA Drug
Yes

Countries

  • Japan

Study Locations

More Related Trials

Entities

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 NCT02038920 on ClinicalTrials.gov