Overview

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

Status:
Recruiting
Trial end date:
2028-04-27
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Janssen Research & Development, LLC
Criteria
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 [>] 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

Exclusion Criteria:

- 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