Back to search results

A Study of Guselkumab for Pediatric Crohn's Disease

This study is looking at guselkumab, a medication given either as a shot under the skin or through a vein, for children and teenagers (ages 2 to 17) with moderately to severely active Crohn's disease. Crohn's disease is a type of inflammatory bowel disease that causes inflammation of the digestive tract. The main goals are to see how many participants achieve clinical remission (meaning their symptoms improve significantly) and endoscopic response (meaning their digestive tract looks better during an endoscopy) at Week 52. You could be eligible if you have a confirmed diagnosis of Crohn's disease and your disease is moderately to severely active. The current status of this study is unclear, and it plans to enroll 120 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 120 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary goals are measured at Week 52, which suggests follow-up for at least this duration.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05923073

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

Recruiting
PHASE3Ages 2–17InterventionalTreatment
Janssen Research & Development, LLC
~120 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:Guselkumab

At a glance

Recruiting sites
84 of 85 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of Participants with Clinical Remission at Week 52
Measured over Week 52
+1 more outcome measured

Conditions

Crohn's Disease

Explore related trials

Crohn Disease

Where it's being run

85 sites across 28 states
Japan12
Brazil7
Israel6
Italy6
United Kingdom6
South Korea5
Belgium4
France4

Study leadership

  • Clinical Trial · STUDY_DIRECTOR · Janssen Research & Development, LLC

Who to contact

Study Contact
[email protected]
844-434-4210
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

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 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

What this trial measures

  • Percentage of Participants with Clinical Remission at Week 52Week 52

    Percentage of participants with clinical remission at Week 52 will be assessed. Clinical remission is defined as pediatric Crohn's Disease activity index (PCDAI) less than or equal to (\<=) 10.

  • Percentage of Participants Who Achieve Endoscopic Response at Week 52Week 52

    Percentage of participants who achieve endoscopic response at Week 52 will be assessed. Endoscopic response is defined as greater than or equal to (\>=) 50 percent (%) reduction (global) and greater than (\>) 50% reduction (U.S specific) from simplified endoscopic score-Crohn's Disease (SES-CD) score at baseline.