Status:
COMPLETED
Study of Guselkumab in Skin of Color Participants With Moderate-to-severe Plaque and/or Scalp Psoriasis
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Plaque Psoriasis
Scalp Psoriasis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2025
Estimated Enrollment :
213 Patients enrolled
Trial Details
Trial ID
NCT05272150
Start Date
July 13 2022
End Date
May 30 2025
Last Update
September 12 2025
Active Locations (94)
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1
Total Skin and Beauty Dermatology Center
Birmingham, Alabama, United States, 35203
2
Cahaba Research Inc
Birmingham, Alabama, United States, 35244
3
Stoll Dermatology
Beverly Hills, California, United States, 90212
4
California Dermatology & Clinical Research Institute
Encinitas, California, United States, 92024