Vedolizumab Treatment for Children and Teens With Moderate to Severe Crohns Disease Phase 3 Study to Evaluate Safety and Effectiveness of IV Vedolizumab as Maintenance Therapy For Pediatric Patients Responding to Initial Vedolizumab Infusions

What this Trial Is About

Researchers are studying vedolizumab, a medicine designed to reduce inflammation and pain in the digestive system, for children and teenagers with moderate to severe Crohns disease who have not responded well or were intolerant to standard treatments. The main goal is to see if participants can achieve remission, meaning their symptoms improve or disappear and endoscopy shows no inflammation. This phase 3, randomized, double-blind study involves about 120 pediatric participants worldwide. Participants will receive three intravenous infusions of vedolizumab over six weeks during the Induction Period, with doses based on their weight. Those who show a clinical response at Week 14 will be randomly assigned to receive either a high or low dose of vedolizumab every eight weeks up to Week 46 during the Maintenance Period. Dose adjustments may be made if disease worsens, and corticosteroid rescue therapy is allowed once during maintenance. After Week 54, eligible participants may continue treatment in an extension study or enter long-term follow-up. Throughout the study, participants will undergo assessments including clinical evaluations, endoscopies, and laboratory tests to measure disease activity and remission using tools like the Pediatric Crohns Disease Activity Index and Simple Endoscopic Score for Crohns Disease. Safety will be monitored through reports of adverse events and antibody levels against vedolizumab. The total participation can include additional safety visits and up to two years of long-term follow-up after the last dose.

A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Crohn's Disease (CD)