At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 89 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 2, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety and Tolerability 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 89 participants across 88 sites in 11 countries.
Detailed Summary
The purpose of this study is to evaluate vedolizumab pharmacokinetics (PK), safety and tolerability in pediatric participants with moderately to severely active UC or CD.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUlcerative Colitis, Crohn's Disease
CountriesBelgium, Canada, France, Germany, Hungary, Israel, Netherlands, Poland, Ukraine, United Kingdom, United States
CollaboratorsTakeda Development Center Americas, Inc.
Timeline
Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedMay 2017
Enrollment StartNov 2017
Primary CompletionMar 2020
Study CompletionMay 2020
TodayJul 2026
First PostedMay 3, 2017
Enrollment StartNov 8, 2017
Primary CompletionMar 31, 2020
Study CompletionMay 26, 2020
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 9.2 years ago
Interventions
Vedolizumabdrug
Vedolizumab IV infusion.