Phase 3 Crohn's Disease and Colitis Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
Treatment Group:
- People who completed Week 34 of the related study (NCT06100289), showed a meaningful improvement in their condition by that point, and had not used corticosteroids for at least the 4 weeks before that visit
- For those with ulcerative colitis (UC): improvement is measured using a scoring system that tracks stool frequency and rectal bleeding, with specific reductions required from the starting score (confirm with trial site for exact score details)
- For those with Crohn's disease (CD): improvement is measured using a children's Crohn's disease activity score, with the score needing to be at or below a certain level and showing a meaningful drop from the starting score (confirm with trial site for exact score details)
Observation-Only Group:
- People who received at least one dose of the study medication during the related study (NCT06100289) and either left that study early, or completed the Week 34 visit but were not eligible to join the Treatment Group of this trial
Who may not be able to join:
(Applies to the Treatment Group)
- People who have a known allergy or sensitivity to vedolizumab or any of its ingredients
- People who currently need, or are expected to need, major bowel surgery (such as bowel removal) during the course of this trial
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Study Director, Takeda
Phone: +1-877-825-3327
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Treatment Cohort: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs); Treatment Cohort: Number of Participants With Adverse Events of Special Interests (AESIs); Observational Cohort: Number of Participants With Prespecified Safety Events
Can't join this trial?
Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.