NCT03451851

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Guselkumab for the Treatment of Chronic Plaque Psoriasis in Pediatric Participants

A Phase 3, Multicenter, Randomized, Placebo- and Active Comparator-Controlled Study Evaluating the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Guselkumab for the Treatment of Chronic Plaque Psoriasis in Pediatric Subjects (>=6 To <18 Years of Age)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of guselkumab in pediatric participants aged greater than or equal to 6 through less than 18 years with chronic plaque psoriasis.

Conditions

• Psoriasis

Interventions

Type	Name	Description
DRUG	Guselkumab	Participants will receive a weight-based dose of guselkumab subcutaneously.
DRUG	Placebo for guselkumab	Participants will receive a weight-based dose of placebo for guselkumab subcutaneously.
DRUG	Etanercept	Participants will receive a weight-based dose of etanercept (up to 50 mg) subcutaneously.

Timeline

• Start date: 2018-07-11
• Primary completion: 2023-07-19
• Completion: 2026-12-18
• First posted: 2018-03-02
• Last updated: 2026-04-13
• Results posted: 2025-03-28

Locations

39 sites across 9 countries: United States, Australia, Belgium, Canada, Germany, Hungary, Italy, Netherlands, Poland

Regulatory

• FDA-regulated drug study