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Efficacy and Safety of Vedolizumab IV in Chinese Participants With Ulcerative Colitis

NCT03221036 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 392

Last updated 2026-05-22

No results posted yet for this study

Summary

The purpose of this study is to assess the effect of vedolizumab intravenous IV as induction and maintenance treatment in Chinese participants with moderately to severely active ulcerative colitis (UC).

Conditions

  • Moderately to Severely Active Ulcerative Colitis

Interventions

DRUG

Vedolizumab IV

Vedolizumab IV infusion

DRUG

Placebo

Matching-placebo IV infusion

Sponsors & Collaborators

Principal Investigators

  • Medical 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
2027-09-24
Completion
2028-01-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
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 NCT03221036 on ClinicalTrials.gov