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

Recruiting now · Phase 3

Conditions studied: Crohn's Disease

In brief

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.

Key facts

Study ID

NCT05923073

Run by

Janssen Research & Development, LLC

People needed

120

Starts

2024-03-13

Expected to finish

2028-07-12

Last updated by the study team

2026-07-06

Who can join

Age: 2 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Hospital De Clinicas De Porto Alegre — Porto Alegre, Brazil (enrolling)
• Cedars Sinai Medical Center — Los Angeles, California, United States (enrolling)
• Children's Center for Digestive Health Care — Atlanta, Georgia, United States (enrolling)
• Connecticut Children's Medical Center — Hartford, Connecticut, United States (enrolling)
• Boston Childrens Hospital — Boston, Massachusetts, United States (enrolling)
• Goryeb Children's Hospital — Morristown, New Jersey, United States (enrolling)
• Weill Cornell Medical College - Judith Jaffe Multiple Sclerosis Center — New York, New York, United States (enrolling)
• Icahn School of Medicine at Mount Sinai — New York, New York, United States (enrolling)
• Columbia University Medical Center — New York, New York, United States (enrolling)
• Riley Hospital for Children — Indianapolis, Indiana, United States (enrolling)
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (enrolling)
• Cook Childrens Medical Center — Fort Worth, Texas, United States (enrolling)
• University of Vermont Medical Center — Colchester, Vermont, United States (enrolling)
• Perth Children's Hospital — Nedlands, Australia (enrolling)
• Mater Hospital Brisbane — South Brisbane, Australia (enrolling)
• The Children's Hospital at Westmead — Westmead, Australia (enrolling)
• AKH - Medizinische Universitat Wien — Vienna, Austria (enrolling)
• Universitair Ziekenhuis Brussel — Brussels, Belgium (enrolling)
• Cliniques Universitaires Saint Luc — Brussels, Belgium (enrolling)
• Universitair Ziekenhuis Gent — Ghent, Belgium (enrolling)
• UZ Leuven — Leuven, Belgium (enrolling)
• Sociedade Campineira de Educacao e Instrucao Hospital e Maternidade Celso Pierro — Campinas, Brazil (enrolling)
• Associacao Hospitalar de Protecao a Infancia Dr. Raul Carneiro — Curitiba, Brazil (enrolling)
• Universidade Federal de Goias - Hospital das Clinicas da UFG — Goiânia, Brazil (enrolling)
• Irmandade Santa Casa de Misericordia de Porto Alegre — Porto Alegre, Brazil (enrolling)

Full record on ClinicalTrials.gov

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