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

Summary

Participation Requirements

Description

The drug being tested in this study is called vedolizumab. Vedolizumab is being tested to treat pediatric participants who have moderately to severely active CD. The study will enroll approximately 120 patients. Participants will receive 3 doses of vedolizumab IV infusion at Day 1, Week 2, and Week ...

The drug being tested in this study is called vedolizumab. Vedolizumab is being tested to treat pediatric participants who have moderately to severely active CD. The study will enroll approximately 120 patients. Participants will receive 3 doses of vedolizumab IV infusion at Day 1, Week 2, and Week 6 based on their baseline weight in the Induction Period: Participants ?30 kg, Vedolizumab 300 mg Participants >15 to <30 kg, Vedolizumab 200 mg Participants 10 to 15 kg, Vedolizumab 150 mg At Week 14, participants who achieve clinical response will be randomized in the 1:1 ratio to 2 double-blind dose groups (high dose and low dose) within each of the 3 weight groups and will receive respective treatment up to Week 46 in the Maintenance Period as: Participants ?30 kg, Vedolizumab 300 mg Participants ?30 kg, Vedolizumab 150 mg Participants >15 to <30 kg, Vedolizumab 200 mg Participants >15 to <30 kg, Vedolizumab 100 mg Participants 10 to 15 kg, Vedolizumab 150 mg Participants 10 to 15 kg, Vedolizumab 100 mg At the discretion of the investigator, participants receiving the low dose (150 or 100 mg) of vedolizumab IV may be escalated to the high dose (300, 200 or 150 mg) or receive rescue therapy with corticosteroids, if the participants demonstrate disease worsening. This multi-center trial will be conducted worldwide. The overall time to participate in this study is 54 weeks and 2 years of long term follow-up (up to 104 weeks). After the Week 54, participants may be eligible to participate in extension Study. Participants will make multiple visits to the clinic, and will be contacted by telephone after receiving their last dose of drug for a follow-up assessment.

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