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A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis

NCT06260163 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2026-05-08

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy of guselkumab in pediatric participants with moderately to severely active ulcerative colitis at the end of maintenance therapy among participants who were induction responders.

Conditions

  • Colitis, Ulcerative

Interventions

DRUG

Guselkumab Subcutaneous

Guselkumab will be administered subcutaneously.

DRUG

Guselkumab Intravenous

Guselkumab will be administered intravenously.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-01-19
Primary Completion
2028-05-22
Completion
2028-08-14
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • China
  • Denmark
  • France
  • Italy
  • Japan
  • Norway
  • Poland
  • Portugal
  • Spain
  • Turkey (Türkiye)

Study Locations

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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 NCT06260163 on ClinicalTrials.gov