A Phase 3, Multicenter, Randomized, Platform Study of p19 Inhibition of the IL-23 Pathway to Establish Efficacy in Pediatric Crohn's Disease
Janssen Research & Development, LLC
Summary
The purpose of this study is to evaluate the clinical and endoscopic efficacy of guselkumab in pediatric participants with Crohn's Disease (CD) at the end of maintenance therapy (Week 52) among participants who were in clinical response to guselkumab at Week 12.
Eligibility
- Age range
- 2–17 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participants must have a diagnosis of Crohn's Disease (CD) or fistulizing CD, with active colitis, ileitis, or ileocolitis, confirmed at any time in the past by clinical, endoscopic, and histologic criteria. * Participants must have moderately to severely active CD (as defined by a baseline Pediatric Crohn's Disease Activity Index \[PCDAI\] score greater than or equal to \[\>=\] 30) * Participants must have endoscopy with evidence of active CD defined as Simple Endoscopic Score for Crohn's Disease (SES-CD) score greater than or equal to (\>=) 6 (or \>=4 for participants…
Interventions
- DrugGuselkumab
Guselkumab will be administered subcutaneously.
- DrugGuselkumab
Guselkumab will be administered intravenously.
Locations (85)
- Cedars Sinai Medical CenterLos Angeles, California
- Connecticut Children's Medical CenterHartford, Connecticut
- Emory UniversityAtlanta, Georgia
- Children's Center for Digestive Health CareAtlanta, Georgia
- Riley Hospital for ChildrenIndianapolis, Indiana
- Boston Childrens HospitalBoston, Massachusetts