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Completed
NCT05272150
Study of Guselkumab in Skin of Color Participants With Moderate-to-severe Plaque and/or Scalp Psoriasis
Conditions: Plaque Psoriasis, Scalp Psoriasis
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 211
Sponsor: Janssen Research & Development, LLC
Location: Total Skin and Beauty Dermatology Center Birmingham Alabama
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
Source: ClinicalTrials.gov (NCT05272150). StuddyBuddy aggregates publicly available trial information.