Tests guselkumab in children with active Crohn's disease
Tests guselkumab in children aged 2 to 17 with moderate to severe Crohn's disease.
Plain-language title generated from the registry record
Registry title: A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease
Key facts
- Where
- Atlanta, Boston, Colchester, Dayton, Fort Worth, Hartford, Indianapolis, Los Angeles, Morristown, New York, and Philadelphia, United StatesSee the 14 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 2 and 17 years old?
Source: NCT05923073, who can take part
Where in United States
- Children's Center for Digestive Health CareAtlanta, United StatesTaking people
- Emory UniversityAtlanta, United StatesTaking people
- Boston Childrens HospitalBoston, United StatesTaking people
- University of Vermont Medical CenterColchester, United StatesTaking people
- The Children's Medical Center of DaytonDayton, United StatesTaking people
- Cook Childrens Medical CenterFort Worth, United StatesTaking people
- Connecticut Children's Medical CenterHartford, United StatesTaking people
- Riley Hospital for ChildrenIndianapolis, United StatesTaking people
- Cedars-Sinai Medical CenterLos Angeles, United StatesTaking people
- Goryeb Children's HospitalMorristown, United StatesTaking people
- Columbia University Medical CenterNew York, United StatesTaking people
- Icahn School of Medicine at Mount SinaiNew York, United StatesTaking people
- Weill Cornell Medical College - Judith Jaffe Multiple Sclerosis CenterNew York, United StatesTaking people
- Children's Hospital of PhiladelphiaPhiladelphia, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Janssen Research & Development, LLC
- Trial code
- NCT05923073EU 2023-504735-41-00
- Record updated
- 3 November 2026
- Original description
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.Read full original descriptionShow less
A Phase 3, Multicenter, Randomized, Platform Study of p19 Inhibition of the IL-23 Pathway to Establish Efficacy in Pediatric Crohn's Disease
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.
Inclusion: 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: Participants must not have any kind of bowel resection within 26 weeks or any other intra-abdominal surgery within 12 weeks of baseline; 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.