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Crohn's Disease (CD)Children's healthDrugPhase 3

What this study is

Vedolizumab is a medicine that helps to reduce inflammation and pain in the digestive system. In this study, children and teenagers with moderate to severe Crohn's disease will be treated with vedolizumab.

The main aim of the study is to check if participants achieve remission after treatment with the vedolizumab. Remission means symptoms improve or disappear and an endoscopy shows no signs of inflammation.

Participants will receive 3 infusions of vedolizumab over 6 weeks. Then, those who have a clinical response will receive either a high dose or low dose of vedolizumab once every 8 weeks. They will receive the same dose every time.

What's being tested

  • Vedolizumab IV

    Intervention · DRUG

    Vedolizumab IV

Study details

Official title
A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects With Moderately to Severely Active Crohn's Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy
Sponsor
Takeda
Conditions
Crohn's Disease (CD)
Enrolling
120 people
Starts
2022-02-10
Est. completion
2027-09-13
Design
Quadruple-blind, randomized, parallel groups, Phase 3
Record
View on ClinicalTrials.gov ↗