Clinical Trial

A Study of Vedolizumab in Children With Ulcerative Colitis (UC) or Crohn's Disease (CD)

Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
The study is an extension of two parent studies (MLN0002-3024 \[NCT04779307\] and MLN0002-3025 \[NCT04779320\]). Participants must have participated in one of the previous studies. The purpose of this study is to collect the long-term safety of vedolizumab in children with UC or CD.
Protocol Amendment History 3 changes
notable Primary completion pushed: 2031-08-15 -> 2033-02-07 2026-05-08
minor Completion pushed: 2031-08-15 -> 2033-02-07 2026-05-08
notable Trial sites expanded: 68 -> 98 locations 2026-04-29
Trial Details
NCT Number NCT05442567
Lead Sponsor Takeda
Conditions Ulcerative Colitis, Crohn's Disease
Enrollment 240 participants
Start Date 2023-05-16
Primary Completion 2033-02-07 (estimated)
Study Completion 2033-02-07 (estimated)
Updated on ClinicalTrials.gov 2026-05-07