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RecruitingPhase 3

A Study of Guselkumab in Pediatric Participants With Moderately to Severely 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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
2 Years to 17 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests guselkumab in children with moderate to severe Crohn's disease. It checks symptoms and bowel health at Week 52 in children who improved with guselkumab by Week 12.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have confirmed Crohn's disease with swelling in the small bowel, large bowel, or both. Crohn's with fistulas (abnormal tunnels between body parts) is also allowed.
  • Have moderate to severe Crohn's disease, with a score of at least 30 on a children's Crohn's symptom scale.
  • Have a bowel exam with a camera within 1 month before starting treatment. The Crohn's exam score must be at least 6, or at least 4 if only the last part of the small bowel is affected.
  • Have tried immune-system medicines, steroids, biologic medicines, or JAK inhibitors that did not work, stopped working, or caused side effects; need ongoing steroids; or have not improved enough with a liquid-only nutrition treatment.

Who can't join

  • Have Crohn's problems such as narrowed bowel that causes symptoms, short gut syndrome (not enough working small bowel), or another problem likely to need surgery.
  • Have an abscess (a pocket of pus).
  • Have had part of the bowel removed within 26 weeks, or other surgery inside the belly within 12 weeks, before the study starts.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (14)

CA

CT

GA

IN

MA

NJ

NY

OH

PA

TX

VT