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.
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)
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
Parallel
Guselkumab
DrugGuselkumab will be administered subcutaneously.
Guselkumab
DrugGuselkumab will be administered intravenously.
Percentage of Participants with Clinical Remission at Week 52
Percentage of participants with clinical remission at Week 52 will be assessed. Clinical remission is defined as pediatric Crohn's Disease activity index (PCDAI) less than or equal to (\<=) 10.
Percentage of Participants Who Achieve Endoscopic Response at Week 52
Percentage of participants who achieve endoscopic response at Week 52 will be assessed. Endoscopic response is defined as greater than or equal to (\>=) 50 percent (%) reduction (global) and greater than (\>) 50% reduction (U.S specific) from simplified endoscopic score-Crohn's Disease (SES-CD) score at baseline.
Percentage of Participants with Clinical Response at Week 12
Percentage of participants with clinical response at Week 12 will be assessed. Clinical responder is defined as a decrease from baseline in the PCDAI score of \>=12.5 points with a total PCDAI score \<30.
Percentage of Participants with Clinical Response at Week 52
Percentage of participants with clinical response at Week 52 will be assessed. Clinical responder is defined as a decrease from baseline in the PCDAI score of \>=12.5 points with a total PCDAI score \<30.
Percentage of Participants with Clinical Remission at Week 12
Percentage of participants with clinical remission at Week 12 will be assessed. Clinical remission is defined as PCDAI score \<=10.
Percentage of Participants with Endoscopic Remission at Week 52
Percentage of participants with endoscopic remission at Week 52 will be assessed. Endoscopic remission is defined as SES-CD total score \<=4 and at least a 2-point reduction from baseline and no subscore \>1.
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