At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 157 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 Crohn's Disease
In Brief
A Phase 3 clinical trial evaluating Vedolizumab and Vedolizumab placebo for Crohn's Disease. Completed, enrolled 157 participants across 56 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCrohn's Disease
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJan 2014
Enrollment StartJan 2014
Primary CompletionJan 2019
Study CompletionMay 2019
TodayJul 2026
First PostedJan 17, 2014
Enrollment StartJan 28, 2014
Primary CompletionJan 25, 2019
Study CompletionMay 21, 2019
TodayJul 2, 2026
Enrollment to primary: 5.0 yearsPosted 12.5 years ago
Interventions
Vedolizumabdrug
Vedolizumab IV injection
Vedolizumab placebodrug
Vedolizumab placebo-matching IV infusion