At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 59 enrolled
Drug / intervention
Vedolizumabdrug
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 Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn's Disease
In Brief
A Phase 2 clinical trial evaluating Vedolizumab for Ulcerative Colitis and Crohn's Disease. Completed, enrolled 59 participants across 23 sites in 7 countries.
Detailed Summary
The purpose of this study is to determine the safety profile of long-term vedolizumab IV treatment in pediatric participants with UC or CD.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUlcerative Colitis, Crohn's Disease
CountriesFrance, Hungary, Israel, Poland, Ukraine, United Kingdom, United States
CollaboratorsTakeda Development Center Americas, Inc.
Timeline
Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedJun 2017
Enrollment StartJul 2018
Primary CompletionApr 2025
Study CompletionJul 2025
TodayJul 2026
First PostedJun 22, 2017
Enrollment StartJul 30, 2018
Primary CompletionApr 3, 2025
Study CompletionJul 17, 2025
TodayJul 2, 2026
Enrollment to primary: 6.7 yearsPosted 9.0 years ago
Interventions
Vedolizumabdrug
Vedolizumab intravenous infusion