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

NCT03451851 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-05-08

Study results available
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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

Interventions

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.

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
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-07-11
Primary Completion
2023-07-19
Completion
2026-12-18
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • Germany
  • Hungary
  • Italy
  • Netherlands
  • Poland

Study Locations

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Entities

Diseases

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 NCT03451851 on ClinicalTrials.gov