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A Long-term Extension (LTE) Study of Guselkumab in Pediatric Participants

NCT06663332 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 196

Last updated 2026-05-08

No results posted yet for this study

Summary

The purpose of this study is to evaluate long-term safety of subcutaneous guselkumab in pediatric participants with moderately to severely active ulcerative colitis, or moderately to severely active Crohn's disease, or juvenile psoriatic arthritis (jPsA).

Conditions

  • Crohns Disease
  • Colitis, Ulcerative
  • Arthritis, Psoriatic
  • Arthritis, Juvenile

Interventions

DRUG

Guselkumab

Guselkumab will be administered as subcutaneous injection.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-29
Primary Completion
2031-12-12
Completion
2031-12-12
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • China
  • France
  • Germany
  • Italy
  • Japan
  • Poland
  • Portugal
  • South Korea
  • Spain
  • Turkey (Türkiye)
  • United Kingdom

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 NCT06663332 on ClinicalTrials.gov