At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 292 enrolled
Drug / intervention
Vedolizumab +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase III, Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Intravenous MLN0002 (300 mg) Infusion in Induction and Maintenance Therapy in Japanese Subjects With Moderate or Severe Ulcerative Colitis
In Brief
A Phase 3 clinical trial evaluating Vedolizumab and Vedolizumab placebo for Ulcerative Colitis. Completed, enrolled 292 participants across 59 sites.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUlcerative Colitis
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJan 2014
Enrollment StartFeb 2014
Primary CompletionFeb 2018
Study CompletionJun 2018
TodayJul 2026
First PostedJan 17, 2014
Enrollment StartFeb 4, 2014
Primary CompletionFeb 27, 2018
Study CompletionJun 28, 2018
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 12.5 years ago
Interventions
Vedolizumabdrug
Vedolizumab intravenous infusion
Vedolizumab placebodrug
Vedolizumab placebo