Psoriasis Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

120

Study ID:

NCT03451851

Recruitment Status:

Active, not recruiting

Sponsor:

Janssen Research & Development, LLC

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 39 Locations for this study

See Locations Near You

Stanford University
Palo Alto California, 94306, United States
University of California, San Diego
San Diego California, 92123, United States
Dermatologic Surgery Specialists
Macon Georgia, 31217, United States
Northwestern University Feinberg School of Medicine Ann & Robert H Lurie Children's Hospital
Chicago Illinois, 60611, United States
Arlington Dermatology
Rolling Meadows Illinois, 60008, United States
Windsor Dermatology
East Windsor New Jersey, 08520, United States
Mt. Sinai School of Medicine
New York New York, 10003, United States
Wright State Physicians Health Center
Dayton Ohio, 45324, United States
Arlington Center for Dermatology
Arlington Texas, 76011, United States
Dell Children's Medical Center of Central Texas
Austin Texas, 78723, United States
Eastern Health Research
Box Hill , 3128, Australia
Royal North Shore Hospital
St Leonards , 2065, Australia
Veracity Clinical Research
Woolloongabba , 4102, Australia
Cliniques Universitaires Saint Luc
Brussels , 1200, Belgium
Universitair Ziekenhuis Gent
Gent , 9000, Belgium
Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman
Liege , 4000, Belgium
Kirk Barber Reseach Inc.
Calgary Alberta, T2G 1, Canada
Dermatology Research Institute Inc.
Calgary Alberta, T2J 7, Canada
Skin Care Centre
Vancouver British Columbia, V5Z 4, Canada
Universitatsklinikum Bonn
Bonn , 53127, Germany
Universitatsklinikum Carl Gustav Carcus Dresden
Dresden , 01307, Germany
Universitatsklinikum Frankfurt
Frankfurt , 60590, Germany
Universitatsklinikum Schleswig Holstein Kiel
Kiel , 24105, Germany
Praxis Dr. med. Beate Schwarz - Germany
Langenau , 89129, Germany
Company for Medical Study & Service Selters
Selters , 56242, Germany
Hautarztpraxis Dr. Leitz & Kollegen
Stuttgart , 70178, Germany
Obudai Egeszsegugyi Centrum Kft
Budapest , 1036, Hungary
Debreceni Egyetem
Debrecen , 4032, Hungary
Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktato Korhaz
Miskolc , 3526, Hungary
Szegedi Tudomanyegyetem
Szeged , 6720, Hungary
Ospedali Riuniti Di Ancona
Ancona , 60026, Italy
Azienda Ospedaliera Policlinico S. Orsola-Malpighi
Bologna , 40138, Italy
AOU di Cagliari
Cagliari , 09124, Italy
Azienda Ospedaliera di Padova
Padova , 35128, Italy
Arcispedale Santa Maria Nuova - IRCCS
Reggio Emilia , 42123, Italy
Radboud University Medical Center
Nijmegen , 6525 , Netherlands
Dermed Centrum Medyczne Sp z o o
Lodz , 90 26, Poland
Szpital Dzieciecy im. prof. dr. med. Jana Bogdanowicza w Warszawie
Warszawa , 03-92, Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
Wroclaw , 50-36, Poland

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

120

Study ID:

NCT03451851

Recruitment Status:

Active, not recruiting

Sponsor:


Janssen Research & Development, LLC

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.