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

Last updated: April 2, 2025
Sponsor: Janssen Research & Development, LLC
Overall Status: Active - Not Recruiting

Phase

3

Condition

Warts

Skin Wounds

Rash

Treatment

Placebo for guselkumab

Etanercept

Guselkumab

Clinical Study ID

NCT03451851
CR108452
CNTO1959PSO3011
2023-503378-19-00
2017-003053-42
  • Ages 6-17
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  • Have a diagnosis of chronic plaque-type psoriasis for at least 6 months (with orwithout psoriatic arthritis [PsA]), prior to first administration of studyintervention, defined as having at screening and baseline, Investigator GlobalAssessment (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 thefollowing: very thick lesions, clinically relevant facial, genital, or hand/ footinvolvement, PASI>=20, >20% BSA involvement, or IGA=4

  • Be a candidate for phototherapy or systemic treatment of plaque psoriasis (eithernaive or history of previous treatment)

  • Have plaque psoriasis considered by the investigator as inadequately controlled withphototherapy and/or topical therapy after an adequate dose and duration of therapy

  • Be considered, in the opinion of the investigator, a suitable candidate foretanercept therapy, according to their country's approved Enbrel product labeling

  • Be otherwise healthy on the basis of physical examination, medical history, andvital signs performed at screening. Any abnormalities, must be consistent with theunderlying illness in the study population and this determination must be recordedin the participant's source documents and initialed by the investigator

  • Must have acceptable evidence of immunity to varicella and measles, mumps, andrubella (MMR), which includes any one of the following: documentation ofage-appropriate vaccination that includes both doses of each vaccine (unless localguidelines specify otherwise) or documentation of past infection by a healthcareprovider or in the absence of previous 2 criteria, participants must have positiveprotective antibody titers to these infection prior to the first administration ofstudy intervention. For participants who have not completed the recommendedvaccination schedule for varicella and MMR, and the subsequent vaccination fallswithin the next 4 years, an accelerated vaccination schedule must be completed priorto study enrollment if available and required or strongly recommended for thelocation. If varicella or MMR vaccines are utilized, it is necessary for 2 weeks toelapse between the vaccination and receipt of study intervention

Exclusion

Exclusion Criteria:

  • Currently has nonplaque forms of psoriasis (example, erythrodermic, guttate, orpustular)

  • Has current drug-induced psoriasis (example, a new onset of psoriasis or anexacerbation 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 limitedto chronic renal infection, chronic chest infection (example, bronchiectasis),recurrent urinary tract infection (recurrent pyelonephritis or chronic non-remittingcystitis), fungal infection (mucocutaneous candidiasis), or open, draining, orinfected skin wounds or ulcers

  • Has a known history of lymphoproliferative disease, including lymphoma; a history ofmonoclonal gammopathy of undetermined significance (MGUS); or signs and symptomssuggestive of possible lymphoproliferative disease, such as lymphadenopathy orsplenomegaly

Study Design

Total Participants: 120
Treatment Group(s): 3
Primary Treatment: Placebo for guselkumab
Phase: 3
Study Start date:
July 11, 2018
Estimated Completion Date:
December 18, 2026

Connect with a study center

  • Eastern Health Research

    Box Hill, 3128
    Australia

    Site Not Available

  • Royal North Shore Hospital

    St Leonards, 2065
    Australia

    Site Not Available

  • Veracity Clinical Research

    Woolloongabba, 4102
    Australia

    Site Not Available

  • Cliniques Universitaires Saint Luc

    Brussels, 1200
    Belgium

    Site Not Available

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200
    Belgium

    Site Not Available

  • Universitair Ziekenhuis Gent

    Gent, 9000
    Belgium

    Site Not Available

  • Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman

    Liege, 4000
    Belgium

    Site Not Available

  • Faculdade de Ciências Médicas - Universidade Estadual de Campinas - FCM/Unicamp

    Campinas, 13083-887
    Brazil

    Site Not Available

  • Hospital de Clínicas de Porto Alegre/ HCPA / UFRGS

    Porto Alegre, 90035-903
    Brazil

    Site Not Available

  • Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto - USP

    Ribeirão Preto, 14048-900
    Brazil

    Site Not Available

  • Instituto de Dermatologia E Estetica Do Brasil

    Rio De Janeiro, 224702
    Brazil

    Site Not Available

  • Centro de Estudos Multidisciplinar CEPES da Faculdade de Medicina do ABC

    Santo André, 09060-650
    Brazil

    Site Not Available

  • Hospital Das Clinicas Da Faculdade De Medicina Da Universidade De Sao Paulo

    São Paulo, 05403-000
    Brazil

    Site Not Available

  • Dermatology Research Institute Inc

    Calgary, Alberta T2J 7E1
    Canada

    Site Not Available

  • Dermatology Research Institute Inc.

    Calgary, Alberta T2J 7E1
    Canada

    Site Not Available

  • Kirk Barber Reseach Inc.

    Calgary, Alberta T2G 1B1
    Canada

    Site Not Available

  • Skin Care Centre

    Vancouver, British Columbia V5Z 4E8
    Canada

    Site Not Available

  • Eastern Canada Research Associates

    Halifax, Nova Scotia B3H 1Z2
    Canada

    Site Not Available

  • Charite - Universitatsmedizin Berlin (CCM)

    Berlin, 10117
    Germany

    Site Not Available

  • Universitatsklinikum Bonn

    Bonn, 53127
    Germany

    Site Not Available

  • Universitatsklinikum Carl Gustav Carcus Dresden

    Dresden, 01307
    Germany

    Site Not Available

  • Universitatsklinikum Frankfurt

    Frankfurt, 60590
    Germany

    Site Not Available

  • Universitatsklinikum Schleswig Holstein Kiel

    Kiel, 24105
    Germany

    Site Not Available

  • Universitatsklinikum Schleswig-Holstein - Kiel

    Kiel, 24105
    Germany

    Completed

  • Praxis Dr. med. Beate Schwarz - Germany

    Langenau, 89129
    Germany

    Site Not Available

  • Universitaetsklinikum Muenster

    Muenster, 48149
    Germany

    Site Not Available

  • Company for Medical Study & Service Selters

    Selters, 56242
    Germany

    Site Not Available

  • Hautarztpraxis Dr. Leitz & Kollegen

    Stuttgart, 70178
    Germany

    Site Not Available

  • Obudai Egeszsegugyi Centrum Kft

    Budapest, 1036
    Hungary

    Site Not Available

  • Obudai Egeszsegugyi Centrum Kft.

    Budapest, 1036
    Hungary

    Site Not Available

  • Debreceni Egyetem

    Debrecen, 4032
    Hungary

    Site Not Available

  • Borsod Abauj Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktato Korhaz

    Miskolc, 3526
    Hungary

    Site Not Available

  • Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz

    Miskolc, 3526
    Hungary

    Site Not Available

  • Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktato Korhaz

    Miskolc, 3526
    Hungary

    Site Not Available

  • Szegedi Tudomanyegyetem

    Szeged, 6720
    Hungary

    Site Not Available

  • Medmare Egeszsegugyi Es Szolgaltato Bt.

    Veszprem, 8200
    Hungary

    Site Not Available

  • Ospedali Riuniti Di Ancona

    Ancona, 60026
    Italy

    Site Not Available

  • Azienda Ospedaliera Policlinico S. Orsola-Malpighi

    Bologna, 40138
    Italy

    Site Not Available

  • AOU di Cagliari

    Cagliari, 09124
    Italy

    Site Not Available

  • Ospedale San Raffaele

    Milano, 20132
    Italy

    Site Not Available

  • Azienda Ospedaliera di Padova

    Padova, 35128
    Italy

    Site Not Available

  • Arcispedale Santa Maria Nuova - IRCCS

    Reggio Emilia, 42123
    Italy

    Site Not Available

  • Istituto Clinico Humanitas

    Rozzano, 20089
    Italy

    Site Not Available

  • Radboud University Medical Center

    Nijmegen, 6525 GA
    Netherlands

    Site Not Available

  • Dermed Centrum Medyczne Sp z o o

    Lodz, 90 265
    Poland

    Site Not Available

  • Dermed Centrum Medyczne Sp. z o.o

    Lodz, 90-265
    Poland

    Site Not Available

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

    Warszawa, 03-924
    Poland

    Site Not Available

  • Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu

    Wroclaw, 50 556
    Poland

    Site Not Available

  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu

    Wroclaw, 50-368
    Poland

    Site Not Available

  • Clinical Dermatological Dispensary

    Krasnodar, 350020
    Russian Federation

    Site Not Available

  • Moscow Center of Scientific and Practical Dermatology and Cosmetology

    Moscow, 119071
    Russian Federation

    Site Not Available

  • University of Arizona

    Tucson, Arizona 85719
    United States

    Site Not Available

  • Stanford University

    Palo Alto, California 94306
    United States

    Site Not Available

  • University of California, San Diego

    San Diego, California 92123
    United States

    Site Not Available

  • University of California, San Francisco

    San Francisco, California 94115
    United States

    Site Not Available

  • Dermatologic Surgery Specialists

    Macon, Georgia 31217
    United States

    Site Not Available

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

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Arlington Dermatology

    Rolling Meadows, Illinois 60008
    United States

    Site Not Available

  • Windsor Dermatology

    East Windsor, New Jersey 08520-2505
    United States

    Site Not Available

  • Mt. Sinai School of Medicine

    New York, New York 10003
    United States

    Site Not Available

  • Wright State Physicians Health Center

    Dayton, Ohio 45324
    United States

    Site Not Available

  • Arlington Center for Dermatology

    Arlington, Texas 76011-3800
    United States

    Site Not Available

  • Dell Children's Medical Center of Central Texas

    Austin, Texas 78723
    United States

    Site Not Available

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