Psoriasis Clinical Trial
Study of Guselkumab in Skin of Color Participants With Moderate-to-severe Plaque and/or Scalp Psoriasis
Summary
The purpose of this study is to evaluate the efficacy of guselkumab treatment versus placebo in skin of color participants with predominant moderate-to-severe body psoriasis or predominant moderate-to-severe scalp psoriasis by assessing improvements in the signs and symptoms of psoriasis.
Eligibility Criteria
Inclusion Criteria:
Have a diagnosis of plaque psoriasis (with or without psoriatic arthritis [PsA]) for at least 6 months before the first administration of study drug
Self-identify as non-white or non-caucasian
Be a candidate for phototherapy or systemic treatment for psoriasis
Have an involved body surface area (BSA) greater than or equal to (>=) 10 percent (%), psoriasis area and severity index (PASI) >=12, investigator global assessment (IGA) >=3 at screening and at baseline (Cohort A), or have a scalp surface area >=30%, psoriasis scalp severity index (PSSI) >=12, scalp specific investigator global assessment (ss-IGA) >=3, and one plaque outside of the scalp at screening and at baseline (Cohort B)
Agree not to receive a live virus or live bacterial vaccination during the study, or within 12 weeks after the last administration of study intervention
Agree not to receive a Bacillus Calmette-Guérin (BCG) vaccination during the study, and within 12 weeks after the last administration of study intervention
Exclusion Criteria:
Has a nonplaque form of psoriasis (example: erythrodermic, guttate, or pustular)
Has received ustekinumab, ixekizumab, secukinumab, or brodalumab within 12 weeks of first dose of study drug
Has a history or current signs or symptoms of severe, progressive, or uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
Participant has known allergies, hypersensitivity, or intolerance to guselkumab or its excipients
Has or has had a serious infection (example: sepsis, pneumonia or pyelonephritis), or has been hospitalized or received intravenous antibiotics for an infection during the 2 months before screening
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There are 87 Locations for this study
Birmingham Alabama, 35205, United States
Birmingham Alabama, 35244, United States
Beverly Hills California, 90212, United States
Encinitas California, 92024, United States
Fountain Valley California, 92708, United States
Fremont California, 94538, United States
Fresno California, 93701, United States
Ladera Heights California, 90056, United States
Los Angeles California, 90036, United States
Newport Beach California, 92660, United States
San Diego California, 92103, United States
San Francisco California, 94132, United States
Santa Ana California, 92701, United States
Santa Monica California, 90404, United States
Farmington Connecticut, 06030, United States
Washington District of Columbia, 20037, United States
Boca Raton Florida, 33486, United States
Coral Gables Florida, 33134, United States
Coral Gables Florida, 33134, United States
Hollywood Florida, 33021, United States
Miami Florida, 33144, United States
North Miami Beach Florida, 33162, United States
Orange Park Florida, 32073, United States
Pembroke Pines Florida, 33028, United States
Saint Petersburg Florida, 33705, United States
Tampa Florida, 33613, United States
Alpharetta Georgia, 30022, United States
Atlanta Georgia, 30328, United States
Macon Georgia, 31217, United States
Darien Illinois, 60561, United States
Skokie Illinois, 60077, United States
West Dundee Illinois, 60118, United States
Indianapolis Indiana, 46256, United States
Plainfield Indiana, 46168, United States
Overland Park Kansas, 66210, United States
Louisville Kentucky, 40241, United States
Columbia Maryland, 21045, United States
Glenn Dale Maryland, 20769, United States
Rockville Maryland, 20850, United States
Rockville Maryland, 20850, United States
Beverly Massachusetts, 01915, United States
Brighton Massachusetts, 02135, United States
Ann Arbor Michigan, 48103, United States
Saint Joseph Michigan, 49085, United States
Troy Michigan, 48084, United States
West Bloomfield Michigan, 48322, United States
Minneapolis Minnesota, 55416, United States
Omaha Nebraska, 68144, United States
East Windsor New Jersey, 08520, United States
Hoboken New Jersey, 07030, United States
Verona New Jersey, 07044, United States
New York New York, 10065, United States
New York New York, 10128, United States
Cary North Carolina, 27511, United States
Charlotte North Carolina, 28277, United States
Charlotte North Carolina, 28277, United States
Raleigh North Carolina, 27612, United States
Rocky Mount North Carolina, 27804, United States
Wilmington North Carolina, 28401, United States
Winston-Salem North Carolina, 27104, United States
Boardman Ohio, 44512, United States
Dayton Ohio, 45324, United States
Mayfield Heights Ohio, 44124, United States
Norman Oklahoma, 73071, United States
Exton Pennsylvania, 19341, United States
Pittsburgh Pennsylvania, 15213, United States
Fountain Inn South Carolina, 29644, United States
Arlington Texas, 76011, United States
Austin Texas, 78705, United States
Dallas Texas, 75230, United States
Dallas Texas, 75231, United States
Houston Texas, 77004, United States
Houston Texas, 77056, United States
San Antonio Texas, 78213, United States
San Antonio Texas, 78218, United States
Calgary Alberta, T2J 7, Canada
Calgary Alberta, T3E 0, Canada
Edmonton Alberta, T6G 2, Canada
Surrey British Columbia, V3R 6, Canada
Surrey British Columbia, V3V 0, Canada
Ajax Ontario, L1S7K, Canada
Guelph Ontario, N1L 0, Canada
Markham Ontario, L3P 1, Canada
North York Ontario, M2M 4, Canada
Ottawa Ontario, K1H 7, Canada
Richmond Hill Ontario, L4B 1, Canada
Toronto Ontario, M3B 0, Canada
Toronto Ontario, M3H5Y, Canada
Toronto Ontario, M4C 1, Canada
Toronto Ontario, M4W 2, Canada
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