Actively Recruiting
A Long-Term Extension Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis (UC) or Crohn's Disease (CD)
Led by Takeda · Updated on 2025-12-02
70
Participants Needed
1
Research Sites
326 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The main aim of this study is to learn about medical problems (adverse events) if vedolizumab subcutaneously (SC) is given to a child or teenager with UC or CD for a long time. Other aims are to understand if the long time use of vedolizumab SC has an impact on the time period until hospital visits because of bowel swelling (inflammation) are needed and has an impact on the quality of life of children and teenagers who received vedolizumab SC. In this study, participants who responded well to the treatment with vedolizumab SC in the parent study (VedolizumabSC-3003 \[NCT06100289\]) will continue to be treated with vedolizumab SC. Participants who did not respond well to the treatment with vedolizumab SC in the parent study or who received corticosteroids in the last 4 weeks of the parent study will not receive vedolizumab SC in this study but will be followed for up to 2 years after the last treatment with vedolizumab SC in the parent study. During the study, participants will visit their study clinic several times.
CONDITIONS
Official Title
A Long-Term Extension Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis (UC) or Crohn's Disease (CD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Completed Week 34 of Study VedolizumabSC-3003 with clinical response and corticosteroid-free for at least last 4 weeks
- Clinical response for UC: reduction of partial Mayo score by ≥2 points and ≥25% from baseline, including improvements in stool frequency and rectal bleeding scores
- Clinical response for CD: pediatric Crohn's disease activity index (PCDAI) ≤30 with a reduction of ≥15 points from baseline
- For observational cohort: received at least 1 dose of vedolizumab in the parent study and either ended early or were not eligible for treatment cohort
You will not qualify if you...
- Known hypersensitivity or allergies to vedolizumab or its excipients
- Currently requires or is expected to require major surgical intervention for UC or CD during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Juntendo University Hospital
Bunkyo-ku, Tokyo, Japan, 113-8431
Actively Recruiting
Research Team
T
Takeda Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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