Clinical Trial

A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease

Study acronym: MACARONI-23
Recruiting Phase 3
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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.
Protocol Amendment History 1 change
notable Trial sites expanded: 79 -> 83 locations 2026-04-01
Trial Details
NCT Number NCT05923073
Lead Sponsor Janssen Research & Development, LLC
Conditions Crohn's Disease
Enrollment 120 participants
Start Date 2024-03-13
Primary Completion 2027-10-27 (estimated)
Study Completion 2028-07-12 (estimated)
Updated on ClinicalTrials.gov 2026-07-06