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

NCT05923073 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-05-08

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Guselkumab

Guselkumab will be administered subcutaneously.

DRUG

Guselkumab

Guselkumab will be administered intravenously.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-13
Primary Completion
2027-10-27
Completion
2028-07-12
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Canada
  • France
  • Israel
  • Italy
  • Japan
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • South Korea
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05923073 on ClinicalTrials.gov