At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 644 enrolled
Drug / intervention
Vedolizumab SC 108 mg +2 moredrug
Likely dose
Vedolizumab SC 108 mgfrom 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 Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Crohn's Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy
In Brief
A Phase 3 clinical trial evaluating Vedolizumab SC 108 mg, Placebo, and 1 other intervention for Crohn's Disease. Completed, enrolled 644 participants across 194 sites in 30 countries.
Detailed Summary
The purpose of this study is to assess the effect of vedolizumab subcutaneous (vedolizumab SC) as maintenance treatment in participants with moderately to severely active CD who achieved clinical response following administration of vedolizumab intravenous (vedolizumab IV) induction therapy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCrohn's Disease
CountriesAustralia, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Czechia, Denmark, Estonia, Germany, Hungary, Israel, Italy, Japan, Lithuania, Mexico, Netherlands, Poland, Romania, Russia, Serbia, Slovakia, South Africa, South Korea, Sweden, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedNov 2015
Enrollment StartJan 2016
Primary CompletionMay 2019
Study CompletionAug 2019
TodayJul 2026
First PostedNov 23, 2015
Enrollment StartJan 4, 2016
Primary CompletionMay 6, 2019
Study CompletionAug 6, 2019
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 10.6 years ago
Interventions
Vedolizumab SC 108 mgdrug
Vedolizumab SC Injection.
Placebodrug
Vedolizumab placebo-matching SC injection.
Vedolizumab IV 300 mgdrug
Vedolizumab IV Injection.