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 safety profile in pediatric participants who take vedolizumab SC.
The study will enroll approximately 70 participants. This extension study consists of a treatment cohort and an observational cohort. Participants will continue receiving the same dose and frequency of vedolizumab SC that was received at the last dose of the parent study VedolizumabSC-3003 (NCT06100289).
For the Treatment cohort participants will be randomized (1:1) to receive vedolizumab in either a prefilled syringe (PFS) as part of an autoinjector pen (PFS+AI) or a PFS with a needle safety device (PFS+NSD):
* Treatment Cohort: Vedolizumab 108 milligram (mg) PFS+AI
* Treatment Cohort: Vedolizumab 108 mg PFS+NSD
This multi-center trial will be conducted globally. The overall time to participate in this study is up to 2 years from the first dose in the study. Participants in the treatment cohort will have a follow-up safety visit of 18 weeks after their last dose of study drug. Participants who will not be eligible for the treatment cohort will be enrolled in the observational cohort and will be followed for approximately 2 years after the last dose of vedolizumab SC received during Study VedolizumabSC-3003 (NCT06100289).
Age
2–17
Sex
ALL
Healthy volunteers
Not accepted
You may not be if
1. Has hypersensitivity or allergies to vedolizumab or any of its excipients.
2. 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.
Clareo Health | A Long-Term Extension Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis (UC) or Crohn's Disease (CD)
