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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Psoriasis

In brief

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.

Key facts

Study ID: NCT03451851
Run by: Janssen Research & Development, LLC
People needed: 120
Starts: 2018-07-11
Expected to finish: 2026-12-18
Last updated by the study team: 2026-07-06

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

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

Full record on ClinicalTrials.gov

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