Study of Guselkumab in Skin of Color Participants With Moderate-to-severe Plaque and/or Scalp Psoriasis

Completed · Phase 3 · Has a placebo group

Conditions studied: Plaque Psoriasis, Scalp Psoriasis

In brief

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.

Key facts

Study ID

NCT05272150

Run by

Janssen Research & Development, LLC

People needed

211

Starts

2022-07-13

Expected to finish

2025-05-30

Last updated by the study team

2026-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Total Skin and Beauty Dermatology Center — Birmingham, Alabama, United States
• Cahaba Research Inc — Birmingham, Alabama, United States
• Stoll Dermatology — Beverly Hills, California, United States
• California Dermatology & Clinical Research Institute — Encinitas, California, United States
• First OC Dermatology — Fountain Valley, California, United States
• Center for Dermatology Clinical Research — Fremont, California, United States
• Community Regional Medical Center — Fresno, California, United States
• Paul Wallace MD — Ladera Heights, California, United States
• The Grimes Center for Medical and Aesthetic Dermatology — Los Angeles, California, United States
• Care Access Research 1 — Newport Beach, California, United States
• MedDerm Associates — San Diego, California, United States
• Synergy Clinical Research — San Francisco, California, United States
• Southern California Dermatology — Santa Ana, California, United States
• Clinical Science Institute — Santa Monica, California, United States
• University of Connecticut Health Center — Farmington, Connecticut, United States
• Center for Dermatology and Dermatologic Surgery — Washington D.C., District of Columbia, United States
• Skin Care Research — Boca Raton, Florida, United States
• Driven Research LLC — Coral Gables, Florida, United States
• Florida Academic Dermatology Centers — Coral Gables, Florida, United States
• Hollywood Dermatology and Cosmetic Surgery — Hollywood, Florida, United States
• International Dermatology Research, Inc. — Miami, Florida, United States
• Tory P Sullivan M D PA — North Miami Beach, Florida, United States
• Park Avenue Dermatology — Orange Park, Florida, United States
• Riverchase Dermatology and Cosmetic Surgery — Pembroke Pines, Florida, United States
• North York Research Inc — North York, Ontario, Canada

Full record on ClinicalTrials.gov

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