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

In plain English

What this trial is testing

This study is testing Guselkumab (a drug) and Guselkumab (a drug) as a possible treatment. Condition(s) listed: Crohn's Disease.

Participants are assigned to groups by chance (randomized).

It is blinded: participants and the study team do not know who receives what.

Phase 3 studies are large studies comparing a treatment with placebo or standard care. They are often the last step before a company asks regulators for approval.

Who can join

• Ages 2 to 17
• Any sex

Some of the main requirements, copied from the record:

• 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…
• 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…

There are also 3 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.

What's involved

• About 120 participants are expected to take part.
• The study has 5 groups.
• Start date: 2024-03-13.
• Main results expected around 2027-10-27 (estimate from the record).
• 85 study sites listed (55 marked recruiting) in Australia, Austria, Belgium, Brazil and Canada and 12 more countries.

Groups in this study

• Open-label induction phase: Guselkumab Intravenously (IV) (listed as: experimental group)
• Open-label induction phase: Guselkumab Subcutaneously (SC) (listed as: experimental group)
• Double-blind maintenance phase: Guselkumab SC Dose Regimen 1 (listed as: experimental group)
• Double-blind Maintenance Phase: Guselkumab SC Dose Regimen 2 (listed as: experimental group)
• Open-label maintenance phase: Guselkumab SC (listed as: experimental group)

Main thing being measured

• Percentage of Participants with Clinical Remission at Week 52 (Week 52)
• Percentage of Participants Who Achieve Endoscopic Response at Week 52 (Week 52)

In the researchers’ words

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.

This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.