NCT06663332

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

A Phase 3, Multicenter, Open-label, Basket, LTE Study to Evaluate the Safety of Guselkumab in Pediatric Participants With Crohn's Disease, Ulcerative Colitis, or Juvenile Psoriatic Arthritis

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 196 (estimated)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 3 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Guselkumab	Guselkumab will be administered as subcutaneous injection.

Timeline

• Start date: 2024-10-29
• Primary completion: 2031-12-12
• Completion: 2031-12-12
• First posted: 2024-10-29
• Last updated: 2026-04-13

Locations

38 sites across 14 countries: United States, Argentina, Australia, China, France, Germany, Italy, Japan, Poland, Portugal, South Korea, Spain, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study