🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the USA / NCT03451851
Active, not recruiting Phase 3

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

NCT03451851 · tracked via the Priya Life Science USA tracker
Sponsor
Janssen Research & Development, LLC
Phase
Phase 3
Started
2018-07-11
Last updated
2026-08-31

Condition(s) studied

Psoriasis

Investigational drug(s) / intervention(s)

GuselkumabPlacebo for guselkumabEtanercept

Guselkumab: Participants will receive a weight-based dose of guselkumab subcutaneously.

Placebo for guselkumab: Participants will receive a weight-based dose of placebo for guselkumab subcutaneously.

Etanercept: Participants will receive a weight-based dose of etanercept (up to 50 mg) subcutaneously.

Study 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.

Eligibility

Sex
ALL
Min age
6 Years
Max age
17 Years
Healthy volunteers
No
Inclusion Criteria: * Have a diagnosis of chronic plaque-type psoriasis for at least 6 months (with or without psoriatic arthritis \[PsA\]), prior to first administration of study intervention, defined as having at screening and baseline, Investigator Global Assessment (IGA) greater than or equal to (\>=) 3, Psoriasis Area and Severity Index (PASI) \>=12, \>=10% body surface area (BSA) involvement and at least one of the following: very thick lesions, clinically relevant facial, genital, or hand/ foot involvement, PASI\>=20, \>20% BSA involvement, or IGA=4 * Be a candidate for phototherapy or systemic treatment of plaque psoriasis (either naive or history of previous treatment) * Have plaque psoriasis considered by the investigator as inadequately controlled with phototherapy and/or topical therapy after an adequate dose and duration of therapy * Be considered, in the opinion of the investigator, a suitable candidate for etanercept therapy, according to their country's approved Enbrel product labeling * Be otherwise healthy on the basis of physical examination, medical history, and vital signs performed at screening. Any abnormalities, must be consistent with the underlying illness in the study population and this determination must be recorded in the participant's source documents and initialed by the investigator * Must have acceptable evidence of immunity to varicella and measles, mumps, and rubella (MMR), which includes any one of the following: documentation of age-appropriate vaccination that includes both doses of each vaccine (unless local guidelines specify otherwise) or documentation of past infection by a healthcare provider or in the absence of previous 2 criteria, participants must have positive protective antibody titers to these infection prior to the first administration of study intervention. For participants who have not completed the recommended vaccination schedule for varicella and MMR, and the subsequent vaccination falls within the next 4 years, an accelerated vaccination schedule must be completed prior to study enrollment if available and required or strongly recommended for the location. If varicella or MMR vaccines are utilized, it is necessary for 2 weeks to elapse between the vaccination and receipt of study intervention Exclusion Criteria: * Currently has nonplaque forms of psoriasis (example, erythrodermic, guttate, or pustular) * Has current drug-induced psoriasis (example, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium) * Has previously received guselkumab or etanercept * Has a history of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infection (example, bronchiectasis), recurrent urinary tract infection (recurrent pyelonephritis or chronic non-remitting cystitis), fungal infection (mucocutaneous candidiasis), or open, draining, or infected skin wounds or ulcers * Has a known history of lymphoproliferative disease, including lymphoma; a history of monoclonal gammopathy of undetermined significance (MGUS); or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy or splenomegaly

Primary outcome measure(s)

Trial sites (39)

FacilityCityRegionStatus
Stanford University Palo Alto California
University of California, San Diego San Diego California
Dermatologic Surgery Specialists Macon Georgia
Northwestern University Feinberg School of Medicine Ann & Robert H Lurie Children's Hospital Chicago Illinois
Arlington Dermatology Rolling Meadows Illinois
Windsor Dermatology East Windsor New Jersey
Mt. Sinai School of Medicine New York New York
Wright State Physicians Health Center Dayton Ohio
Arlington Center for Dermatology Arlington Texas
Dell Children's Medical Center of Central Texas Austin Texas
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
Dermatology Research Institute Inc Calgary Alberta
Skin Care Centre Vancouver British Columbia
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

On this site

📄 Tremfya (guselkumab) drug profile → 📄 Enbrel (etanercept) drug profile →

More Janssen Research & Development, LLC trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03451851 on ClinicalTrials.gov ↗ ← All trials in the USA