A Phase 3b Extension Study to Evaluate the Long-term Safety of Vedolizumab Subcutaneous in Children and Teenagers With Ulcerative Colitis or Crohn's Disease

What this Trial Is About

Researchers are evaluating the long-term safety of vedolizumab given as a subcutaneous injection to children and teenagers with moderate to severe active ulcerative colitis (UC) or Crohn's disease (CD). This study aims to understand medical problems that may occur with extended use, how long it takes before hospital visits due to bowel inflammation are needed, and the impact on quality of life. It includes participants who responded well to vedolizumab in a previous study and those who did not respond or used corticosteroids recently will be observed without further treatment. The study has two groups: a treatment cohort and an observational cohort. Participants in the treatment group will continue receiving vedolizumab subcutaneously at doses of 108 mg either via a prefilled syringe with an autoinjector pen or with a needle safety device. The dosing frequency depends on body weight: every two weeks for those weighing 30 kg or more, and every four weeks for those between 10 and less than 30 kg. The study treatment can last up to about 2 years or until the drug becomes commercially available for their condition. Those not eligible for treatment will be followed in the observational group for up to 2 years without receiving the drug. Participants will visit the study clinic multiple times for evaluations including monitoring for adverse events, assessing quality of life with the IMPACT-III questionnaire, and tracking time to major disease-related events. Safety follow-up visits will occur 18 weeks after the last dose for those in the treatment group. The study includes up to 70 pediatric participants aged 2 to 17 years and involves regular assessments to measure safety and treatment effects over time.

A Long-Term Extension Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis (UC) or Crohn's Disease (CD)