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

RecruitingPhase 3

A Phase 3, Multicenter, Randomized, Platform Study of p19 Inhibition of the IL-23 Pathway to Establish Efficacy in Pediatric Crohn's Disease

Who can join

Ages 2 to 17 · All sexes

Full eligibility 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 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 with isolated ileal disease) within 1 month of receiving study intervention at Week 0
* Participants must have a history of inadequate response, loss of response, or intolerance to immunomodulators (6-MP, AZA, or MTX), oral or IV corticosteroids, or biologic therapy/JAK inhibitor therapy; OR have a history of corticosteroid dependence; OR have a history of inadequate response to exclusive enteral nutrition (EEN)

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

About the study

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.

What is being tested

Sponsor: Janssen Research & Development, LLC · Participants: 120 · Started: Mar 13, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT05923073

Locations in the U.S.

CaliforniaCedars Sinai Medical Center, Los Angeles
GeorgiaChildren's Center for Digestive Health Care, Atlanta
Emory University, Atlanta
MassachusettsBoston Childrens Hospital, Boston
New JerseyGoryeb Children's Hospital, Morristown
New YorkIcahn School of Medicine at Mount Sinai, New York
Weill Cornell Medical College - Judith Jaffe Multiple Sclerosis Center, New York
PennsylvaniaChildren's Hospital of Philadelphia, Philadelphia
TexasCook Childrens Medical Center, Fort Worth

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.