Last updated 17 days ago
A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease
120 patients around the world
Available in Brazil
Participants screened in the MACARONI-23 platform study could be randomized to guselkumab
to participate in this intervention specific arm of the study.
Janssen Research & Development, LLC
1Research sites
120Patients around the world
This study is for people with
Crohn's disease
Moderate to severe crohn's disease
Requirements for the patient
To 17 Years
All Gender
Medical requirements
- 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 [>] 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 with isolated ileal disease) during screening into this study.Participants must have a prior or current CD medication history that includes either inadequate response, loss of response to or failure to tolerate current treatment immunomodulators or with oral or intravenously (IV) corticosteroids or have received biologic therapy/JAK inhibitor for the treatment of CD and have a documented history of inadequate response, loss of response (LOR), or intolerance to the biologic therapy/JAK inhibitor.
- Participants has complications of CD such as symptomatic strictures or stenosis, short gut syndrome, or any other manifestation that might be anticipated to require surgery.Participants must not have an abscess.Participants must not have any kind of bowel resection within 26 weeks or any other intra-abdominal surgery within 12 weeks of baseline.
Sites
Instituto de Proteção à Infância Dr. Raul Carneiro
Recruiting
StudyMACARONI-23
SponsorJanssen Research & Development, LLC
Conditions
Moderate to severe crohn's disease
Requirements
To 17 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05923073
