At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 771 enrolled
Drug / intervention
Vedolizumab +3 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.
A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis
In Brief
A Phase 3 clinical trial evaluating Vedolizumab, Adalimumab placebo, and 2 other interventions for Colitis, Ulcerative. Completed, enrolled 771 participants across 330 sites in 34 countries.
Detailed Summary
The purpose of this study is to evaluate the efficacy and safety of vedolizumab intravenous (IV) treatment compared to adalimumab subcutaneous (SC) treatment over a 52-week treatment period.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColitis, Ulcerative
CountriesArgentina, Australia, Belgium, Bosnia and Herzegovina, Bulgaria, Canada, Colombia, Croatia, Czechia, Denmark, Estonia, France, Germany, Hong Kong, Hungary, Israel, Italy, Latvia, Lithuania, Mexico, Netherlands, Poland, Portugal, Romania, Russia, Serbia, Slovakia, South Korea, Spain, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartJun 2015
First PostedJul 2015
Primary CompletionSep 2018
Study CompletionJan 2019
TodayJul 2026
First PostedJul 14, 2015
Enrollment StartJun 29, 2015
Primary CompletionSep 26, 2018
Study CompletionJan 18, 2019
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 11.0 years ago
Interventions
Vedolizumabdrug
Vedolizumab infusion
Adalimumab placebodrug
Adalimumab placebo-matching injection
Adalimumabdrug
Adalimumab injection
Vedolizumab placebodrug
Vedolizumab placebo-matching infusion