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

NCT05923073

RecruitingPhase 3

Sponsor: Janssen Research & Development, LLC

Conditions: Crohn's Disease

Interventions: Guselkumab, Guselkumab

Countries: United States, Australia, Austria, Belgium, Brazil, Canada, France, Israel

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.

Eligibility overview

Sex: ALL

Age: 2 Years to 17 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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
Locations (85)
  • Los Angeles, California, United States
  • Hartford, Connecticut, United States
  • Atlanta, Georgia, United States
  • Atlanta, Georgia, United States
  • Indianapolis, Indiana, United States
  • Boston, Massachusetts, United States
  • Morristown, New Jersey, United States
  • New York, New York, United States
  • New York, New York, United States
  • New York, New York, United States
  • Dayton, Ohio, United States
  • Philadelphia, Pennsylvania, United States
  • Fort Worth, Texas, United States
  • Colchester, Vermont, United States
  • Nedlands, Australia
  • South Brisbane, Australia
  • Westmead, Australia
  • Vienna, Austria
  • Brussels, Belgium
  • Brussels, Belgium
  • Ghent, Belgium
  • Leuven, Belgium
  • Campinas, Brazil
  • Curitiba, Brazil
  • Goiânia, Brazil
  • Porto Alegre, Brazil
  • Porto Alegre, Brazil
  • Vitória, Brazil
  • Votuporanga, Brazil
  • Halifax, Nova Scotia, Canada
  • + 55 more on CT.gov