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ACTIVE NOT RECRUITING
NCT03451851
PHASE3

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

Sponsor: Janssen Research & Development, LLC

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

6 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2018-07-11

Completion Date

2026-12-18

Last Updated

2026-03-12

Healthy Volunteers

No

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.

Locations (39)

Stanford University

Palo Alto, California, United States

University of California, San Diego

San Diego, California, United States

Dermatologic Surgery Specialists

Macon, Georgia, United States

Northwestern University Feinberg School of Medicine Ann & Robert H Lurie Children's Hospital

Chicago, Illinois, United States

Arlington Dermatology

Rolling Meadows, Illinois, United States

Windsor Dermatology

East Windsor, New Jersey, United States

Mt. Sinai School of Medicine

New York, New York, United States

Wright State Physicians Health Center

Dayton, Ohio, United States

Arlington Center for Dermatology

Arlington, Texas, United States

Dell Children's Medical Center of Central Texas

Austin, Texas, United States

Eastern Health Research

Box Hill, Australia

Royal North Shore Hospital

St Leonards, Australia

Veracity Clinical Research

Woolloongabba, Australia

Cliniques Universitaires Saint Luc

Brussels, Belgium

Universitair Ziekenhuis Gent

Ghent, Belgium

Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman

Liège, Belgium

Kirk Barber Reseach Inc.

Calgary, Alberta, Canada

Dermatology Research Institute Inc

Calgary, Alberta, Canada

Skin Care Centre

Vancouver, British Columbia, Canada

Universitatsklinikum Bonn

Bonn, Germany

Universitatsklinikum Carl Gustav Carcus Dresden

Dresden, Germany

Universitatsklinikum Frankfurt

Frankfurt, Germany

Universitatsklinikum Schleswig Holstein Kiel

Kiel, Germany

Praxis Dr. med. Beate Schwarz - Germany

Langenau, Germany

Company for Medical Study & Service Selters

Selters, Germany

Hautarztpraxis Dr. Leitz & Kollegen

Stuttgart, Germany

Obudai Egeszsegugyi Centrum Kft

Budapest, Hungary

Debreceni Egyetem

Debrecen, Hungary

Borsod Abauj Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktato Korhaz

Miskolc, Hungary

Szegedi Tudomanyegyetem

Szeged, Hungary

Ospedali Riuniti Di Ancona

Ancona, Italy

Azienda Ospedaliera Policlinico S. Orsola-Malpighi

Bologna, Italy

AOU di Cagliari

Cagliari, Italy

Azienda Ospedaliera di Padova

Padova, Italy

Arcispedale Santa Maria Nuova - IRCCS

Reggio Emilia, Italy

Radboud University Medical Center

Nijmegen, Netherlands

Dermed Centrum Medyczne Sp z o o

Lodz, Poland

Szpital Dzieciecy im. prof. dr. med. Jana Bogdanowicza w Warszawie

Warsaw, Poland

Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu

Wroclaw, Poland