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

Name: A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease — clinical trial record (NCT05923073)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

Study acronym: MACARONI-23

StatusRecruiting

PhasePhase 3

SponsorJanssen Research & Development, LLC

Started2024-03-13

View on ClinicalTrials.gov ↗

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.

Amendment history 2 changes detected by DataLookout

2026-08-29

Completion pushed: 2028-07-12 → 2028-08-14

2026-04-01

Trial sites expanded: 79 → 83 locations

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	2028-08-14 (estimated)
Updated on ClinicalTrials.gov	2026-08-28