Phase
Condition
Warts
Scalp Disorders
Rash
Treatment
Guselkumab
Placebo
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
A woman of childbearing potential must have a negative urine pregnancy test (beta-human chorionic gonadotropin) at screening and at Week 0
Before randomization, a woman must be either: a) Not of childbearing potential:premenarchal; postmenopausal (greater than [>] 45 years of age with amenorrhea forat least 12 months or any age with amenorrhea for at least 6 months and a serumfollicle-stimulating hormone level (FSH) >40 International Units Per Liter [IU/L]);permanently sterile (example, tubal occlusion, hysterectomy, bilateralsalpingectomy); or otherwise be incapable of pregnancy, b) Of childbearing potentialand practicing a highly effective method of birth control, consistent with localregulations regarding the use of birth control methods for subjects participating inclinical studies: example, established use of oral, injected or implanted hormonalmethods of contraception; placement of an intrauterine device (IUD) or intrauterinesystem (IUS); barrier methods: condom or occlusive cap (diaphragm or cervical/vaultcaps) plus spermicidal foam/gel/ film/cream/suppository (if available in theirlocale); male partner sterilization (the vasectomized partner should be the solepartner for that participant); true abstinence (when this is in line with thepreferred and usual lifestyle of the participant)
Agree not to receive a Bacillus Calmette Guerin (BCG) vaccination during the study,or within 12 months after the last administration of study drug
Have a Psoriasis Area and Severity Index (PASI) greater than or equal to [>=] 12 atscreening and at baseline
Have an involved body surface area (BSA) >= 10 percent (%) at screening and atbaseline
Exclusion
Exclusion Criteria:
Has unstable cardiovascular disease, defined as a recent clinical deterioration (eg,unstable angina, rapid atrial fibrillation) in the last 3 months or a cardiachospitalization within the last 3 months
Has a 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
Has a transplanted organ (with exception of a corneal transplant >3 months beforethe first administration of study drug)
Has a nonplaque form of psoriasis (example, erythrodermic, guttate, or pustular)
Has received any anti-tumor necrosis factor alpha (TNF-alpha) biologic therapywithin 3 months before the first administration of study drug
Study Design
Connect with a study center
Dr. Chih ho Hong Medical
Surrey, British Columbia V3R 6A7
CanadaSite Not Available
Dr. Chih-ho Hong Medical
Surrey, British Columbia V3R 6A7
CanadaSite Not Available
Eastern Canada Research Associates
Halifax, Nova Scotia B3H 1Z4
CanadaSite Not Available
Dermatrials Research
Hamilton, Ontario L8N 1Y2
CanadaSite Not Available
DermEdge Research
Mississauga, Ontario L4Y 4C5
CanadaSite Not Available
Niepubliczny Zaklad Opieki Zdrowotnej Osteo-Medic s.c. Artur Racewicz i Jerzy Supronik
Bialystok, 15 351
PolandSite Not Available
Szpital Uniwersytecki nr 1 im Dr A Jurasza
Bydgoszcz, 85 094
PolandSite Not Available
Szpital Uniwersytecki nr 1 im. Dr A. Jurasza
Bydgoszcz, 85-094
PolandSite Not Available
Centrum Medyczne WroMedica
Wroclaw, 51-685
PolandSite Not Available
Wromedica Irena Bielicka, Janusz Szczepanik S.C.
Wroclaw, 51-685
PolandSite Not Available
Renstar Medical Research
Ocala, Florida 34470
United StatesSite Not Available
Arlington Dermatology
Arlington Heights, Illinois 60005
United StatesSite Not Available
Arlington Dermatology
Arlington Hts., Illinois 60005
United StatesSite Not Available
Arlington Dermatology
Rolling Meadows, Illinois 60008
United StatesSite Not Available
Indiana Clinical Trial Center
Plainfield, Indiana 46168
United StatesSite Not Available
Dermatology Specialists
Louisville, Kentucky 40241
United StatesSite Not Available
Hamzavi Dermatology
Fort Gratiot, Michigan 48059
United StatesSite Not Available
Hamzavi Dermatology
Fort Gratiot Township, Michigan 48059
United StatesSite Not Available
Oregon Dermatology and Research Center
Portland, Oregon 97210
United StatesSite Not Available
University of Pittsburgh Department of Dermatology
Pittsburgh, Pennsylvania 15213
United StatesSite Not Available
Clinical Partners
Johnston, Rhode Island 02919
United StatesSite Not Available
Menter Dermatology Research Institute
Dallas, Texas 75246
United StatesSite Not Available
Virginia Clinical Research
Norfolk, Virginia 23502
United StatesSite Not Available
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