Phase
Condition
Warts
Skin Wounds
Rash
Treatment
Placebo for guselkumab
Etanercept
Guselkumab
Clinical Study ID
Ages 6-17 All Genders
Study Summary
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
Connect with a study center
Eastern Health Research
Box Hill, 3128
AustraliaSite Not Available
Royal North Shore Hospital
St Leonards, 2065
AustraliaSite Not Available
Veracity Clinical Research
Woolloongabba, 4102
AustraliaSite Not Available
Cliniques Universitaires Saint Luc
Brussels, 1200
BelgiumSite Not Available
Cliniques Universitaires Saint-Luc
Brussels, 1200
BelgiumSite Not Available
Universitair Ziekenhuis Gent
Gent, 9000
BelgiumSite Not Available
Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman
Liege, 4000
BelgiumSite Not Available
Faculdade de Ciências Médicas - Universidade Estadual de Campinas - FCM/Unicamp
Campinas, 13083-887
BrazilSite Not Available
Hospital de Clínicas de Porto Alegre/ HCPA / UFRGS
Porto Alegre, 90035-903
BrazilSite Not Available
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto - USP
Ribeirão Preto, 14048-900
BrazilSite Not Available
Instituto de Dermatologia E Estetica Do Brasil
Rio De Janeiro, 224702
BrazilSite Not Available
Centro de Estudos Multidisciplinar CEPES da Faculdade de Medicina do ABC
Santo André, 09060-650
BrazilSite Not Available
Hospital Das Clinicas Da Faculdade De Medicina Da Universidade De Sao Paulo
São Paulo, 05403-000
BrazilSite Not Available
Dermatology Research Institute Inc
Calgary, Alberta T2J 7E1
CanadaSite Not Available
Dermatology Research Institute Inc.
Calgary, Alberta T2J 7E1
CanadaSite Not Available
Kirk Barber Reseach Inc.
Calgary, Alberta T2G 1B1
CanadaSite Not Available
Skin Care Centre
Vancouver, British Columbia V5Z 4E8
CanadaSite Not Available
Eastern Canada Research Associates
Halifax, Nova Scotia B3H 1Z2
CanadaSite Not Available
Charite - Universitatsmedizin Berlin (CCM)
Berlin, 10117
GermanySite Not Available
Universitatsklinikum Bonn
Bonn, 53127
GermanySite Not Available
Universitatsklinikum Carl Gustav Carcus Dresden
Dresden, 01307
GermanySite Not Available
Universitatsklinikum Frankfurt
Frankfurt, 60590
GermanySite Not Available
Universitatsklinikum Schleswig Holstein Kiel
Kiel, 24105
GermanySite Not Available
Universitatsklinikum Schleswig-Holstein - Kiel
Kiel, 24105
GermanyCompleted
Praxis Dr. med. Beate Schwarz - Germany
Langenau, 89129
GermanySite Not Available
Universitaetsklinikum Muenster
Muenster, 48149
GermanySite Not Available
Company for Medical Study & Service Selters
Selters, 56242
GermanySite Not Available
Hautarztpraxis Dr. Leitz & Kollegen
Stuttgart, 70178
GermanySite Not Available
Obudai Egeszsegugyi Centrum Kft
Budapest, 1036
HungarySite Not Available
Obudai Egeszsegugyi Centrum Kft.
Budapest, 1036
HungarySite Not Available
Debreceni Egyetem
Debrecen, 4032
HungarySite Not Available
Borsod Abauj Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktato Korhaz
Miskolc, 3526
HungarySite Not Available
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
Miskolc, 3526
HungarySite Not Available
Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktato Korhaz
Miskolc, 3526
HungarySite Not Available
Szegedi Tudomanyegyetem
Szeged, 6720
HungarySite Not Available
Medmare Egeszsegugyi Es Szolgaltato Bt.
Veszprem, 8200
HungarySite Not Available
Ospedali Riuniti Di Ancona
Ancona, 60026
ItalySite Not Available
Azienda Ospedaliera Policlinico S. Orsola-Malpighi
Bologna, 40138
ItalySite Not Available
AOU di Cagliari
Cagliari, 09124
ItalySite Not Available
Ospedale San Raffaele
Milano, 20132
ItalySite Not Available
Azienda Ospedaliera di Padova
Padova, 35128
ItalySite Not Available
Arcispedale Santa Maria Nuova - IRCCS
Reggio Emilia, 42123
ItalySite Not Available
Istituto Clinico Humanitas
Rozzano, 20089
ItalySite Not Available
Radboud University Medical Center
Nijmegen, 6525 GA
NetherlandsSite Not Available
Dermed Centrum Medyczne Sp z o o
Lodz, 90 265
PolandSite Not Available
Dermed Centrum Medyczne Sp. z o.o
Lodz, 90-265
PolandSite Not Available
Szpital Dzieciecy im. prof. dr. med. Jana Bogdanowicza w Warszawie
Warszawa, 03-924
PolandSite Not Available
Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu
Wroclaw, 50 556
PolandSite Not Available
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
Wroclaw, 50-368
PolandSite Not Available
Clinical Dermatological Dispensary
Krasnodar, 350020
Russian FederationSite Not Available
Moscow Center of Scientific and Practical Dermatology and Cosmetology
Moscow, 119071
Russian FederationSite Not Available
University of Arizona
Tucson, Arizona 85719
United StatesSite Not Available
Stanford University
Palo Alto, California 94306
United StatesSite Not Available
University of California, San Diego
San Diego, California 92123
United StatesSite Not Available
University of California, San Francisco
San Francisco, California 94115
United StatesSite Not Available
Dermatologic Surgery Specialists
Macon, Georgia 31217
United StatesSite Not Available
Northwestern University Feinberg School of Medicine Ann & Robert H Lurie Children's Hospital
Chicago, Illinois 60611
United StatesSite Not Available
Arlington Dermatology
Rolling Meadows, Illinois 60008
United StatesSite Not Available
Windsor Dermatology
East Windsor, New Jersey 08520-2505
United StatesSite Not Available
Mt. Sinai School of Medicine
New York, New York 10003
United StatesSite Not Available
Wright State Physicians Health Center
Dayton, Ohio 45324
United StatesSite Not Available
Arlington Center for Dermatology
Arlington, Texas 76011-3800
United StatesSite Not Available
Dell Children's Medical Center of Central Texas
Austin, Texas 78723
United StatesSite Not Available
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