Study of Vedolizumab Given Under the Skin for Children and Teens With Moderate to Severe Ulcerative Colitis or Crohns Disease Who Improved After Vedolizumab IV Treatment

What this Trial Is About

This research is focused on children and teenagers aged 2 to 17 years who have moderately to severely active ulcerative colitis UC or Crohns disease CD. It aims to evaluate how their bodies process vedolizumab given under the skin, and to study the drugs safety and immune response effects. The study involves participants who have already shown improvement after receiving vedolizumab through intravenous infusion. Participants will first receive three doses of vedolizumab through intravenous infusion during an Induction Period at Day 1, Week 2, and Week 6, with the dosage based on their weight. Those who respond positively by Week 14 will enter a Maintenance Period where they receive vedolizumab under the skin every 2 or 4 weeks, depending on their weight, for up to 20 weeks. After the treatment period ends at Week 34, some participants may continue treatment in an extension study, while others will complete a follow-up safety visit 18 weeks after their last dose. During the study, participants will visit the clinic several times for treatment and assessments. Researchers will measure how vedolizumab levels stay in the blood over time and monitor immune responses. Safety visits will follow to observe any side effects or reactions after treatment ends. The total treatment duration is up to 34 weeks with an additional 18 weeks of follow-up for some participants.

A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease