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Phase III Study of MLN0002 (300 mg) in the Treatment of Ulcerative Colitis

NCT02039505 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 292

Last updated 2019-04-25

Study results available
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Summary

The purpose of this study is to evaluate efficacy, safety and pharmacokinetics of the vedolizumab (MLN0002) induction and maintenance therapy in Japanese participants with moderate or severe ulcerative colitis (UC).

Conditions

Interventions

DRUG

Vedolizumab

Vedolizumab intravenous infusion

DRUG

Vedolizumab placebo

Vedolizumab placebo

Sponsors & Collaborators

Principal Investigators

  • Study Director · 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
2014-02-04
Primary Completion
2018-02-27
Completion
2018-06-28
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 NCT02039505 on ClinicalTrials.gov