Status:
RECRUITING
A Long-Term Extension Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis (UC) or Crohn's Disease (CD)
Lead Sponsor:
Takeda
Conditions:
Ulcerative Colitis
Crohn's Disease
Eligibility:
All Genders
2-17 years
Phase:
PHASE3
Brief Summary
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 under...
Detailed Description
The drug being tested in this study is Vedolizumab SC. Vedolizumab SC is being tested to treat pediatric participants with moderate to severe active UC or CD. This study will look at the long-term saf...
Eligibility Criteria
Inclusion Criteria for Treatment Cohort 1. Has completed Week 34 of Study VedolizumabSC-3003 (NCT06100289) and achieved clinical response at Week 34 and was corticosteroid-free for at least the last 4 weeks (Week 30 to Week 34). Clinical response for participants with UC is defined as a reduction of partial Mayo score of >=2 points and >= 25 percentage (%) from baseline (from VedolizumabSC-3003 [NCT06100289]), including a >=1-point decrease in the Mayo stool frequency subscore and a >=1-point reduction in the rectal bleeding subscore or absolute rectal bleeding subscore of less than or equal to (<=) 1 point. Clinical response for participants with CD is defined as a pediatric Crohn's disease activity index (PCDAI) <=30 with a reduction in the PCDAI of >=15 points from baseline (from VedolizumabSC-3003 [NCT06100289]).
Inclusion Criteria for Observational Cohort
1. Has received at least 1 dose of vedolizumab during Study VedolizumabSC-3003 (NCT06100289) and early terminated OR completed the Week 34 clinic visit of Study VedolizumabSC-3003 (NCT06100289) but was not eligible to enroll in the treatment cohort of this study.
Exclusion Criteria for Treatment Cohort
- Has hypersensitivity or allergies to vedolizumab or any of its excipients.
- The participant currently requires major surgical intervention for UC or CD (example, bowel resection), or is anticipated to require major surgical intervention for UC or CD during the study.
Key Trial Info
Start Date :
October 27 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 26 2032
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06405087
Start Date
October 27 2025
End Date
January 26 2032
Last Update
December 2 2025
Active Locations (1)
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1
Juntendo University Hospital
Bunkyo-ku, Tokyo, Japan, 113-8431