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

Phase 3 Active, not recruiting NCT03451851

Condition	Psoriasis
Phase	Phase 3
Sponsor	Janssen Research & Development, LLC
Status	Active, not recruiting
Enrollment	120 participants
Interventions	Guselkumab, Placebo for guselkumab, Etanercept
Start date	Jul 11, 2018
Completion date	Jul 19, 2023
Results posted	Mar 28, 2025

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.

Part 1: Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16

At Week 16 · Percentages of participants

Group 1 (Part 1): Placebo (Week 0-16)	16.0 Percentages of participants
Group 2 (Part 1): Guselkumab (Week 0-16)	65.9 Percentages of participants
Group 3 (Part 1): Etanercept (Week 0-16)	69.2 Percentages of participants

p-value	<0.001
Difference in percentage	49.9 (95% CI 25.9–69.4)

Part 1: Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 16

At Week 16 · Percentage of Participants

Group 1 (Part 1): Placebo (Week 0-16)	20.0 Percentage of Participants
Group 2 (Part 1): Guselkumab (Week 0-16)	75.6 Percentage of Participants
Group 3 (Part 1): Etanercept (Week 0-16)	69.2 Percentage of Participants

p-value	<0.001
Difference in percentage	55.6 (95% CI 32.1–74.0)

Open in BENITIONS View on ClinicalTrials.gov

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A Study to Assess the Pharmacokinetics, Safety, and Efficacy of Two Doses of Bimekizumab i — UCB Biopharma SRL
A Study of JNJ-77242113 for the Treatment of Participants With Generalized Pustular Psoria — Janssen Pharmaceutical K.K.
A Study of Guselkumab and Golimumab Combination Therapy in Participants With Active Psoria — Janssen Research & Development, LLC
A Study to Evaluate the Efficacy and Safety of Bimekizumab in the Treatment of Subjects Wi — UCB Biopharma SRL
A Study to Test the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With A — UCB Biopharma SRL
The Efficacy and Safety of TLL018 in Moderate-to-severe Plaque Psoriasis — Hangzhou Highlightll Pharmaceutical Co., Ltd

All trials

This page summarises publicly available data from ClinicalTrials.gov. It is not medical advice and not investment advice. Always consult a qualified healthcare professional.

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