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Evaluating Guselkumab for Children with Active Crohn's Disease

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

PHASE3 · Janssen Research & Development, LLC · NCT05923073

This study is testing if a new medication called guselkumab can help children with active Crohn's Disease feel better and improve their symptoms over a year.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment120 (estimated)
Ages2 Years to 17 Years
SexAll
SponsorJanssen Research & Development, LLC (industry)
Drugs / interventionsguselkumab
Locations85 sites (Los Angeles, California and 84 other locations)
Trial IDNCT05923073 on ClinicalTrials.gov

What this trial studies

This study aims to assess the effectiveness of guselkumab in treating pediatric patients with moderately to severely active Crohn's Disease. Participants who have shown a clinical response to the medication at Week 12 will be evaluated for clinical and endoscopic efficacy at Week 52. The study focuses on children diagnosed with Crohn's Disease, ensuring they meet specific criteria related to disease activity and prior treatment history. The intervention involves administering guselkumab to monitor its impact on disease symptoms and endoscopic findings.

Who should consider this trial

Good fit: Ideal candidates are children diagnosed with moderately to severely active Crohn's Disease who have not responded adequately to previous treatments.

Not a fit: Patients with mild Crohn's Disease or those who have not previously been treated for the condition may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the management of Crohn's Disease in pediatric patients, leading to better health outcomes.

How similar studies have performed: Other studies have shown promising results with similar biologic therapies for Crohn's Disease, indicating potential for success with this approach.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Los Angeles, California and 84 other locations

+35 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Crohn's Disease, Pediatric, Inflammatory bowel disease

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.