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

Janssen (J&J Innovative Medicine)

Status and phase: Active, not recruiting; Phase 3

Conditions: Scalp Psoriasis; Plaque Psoriasis

Treatments: Drug: Placebo; Drug: Guselkumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05272150

CNTO1959PSO3018 (Other Identifier)

CR109163

Details and patient eligibility

About

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.

Enrollment: 213 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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213 participants in 2 patient groups

Cohort A: Moderate-to-severe Plaque Psoriasis

Experimental group

Description:

Participants will receive either guselkumab subcutaneously (SC) or placebo SC. Placebo participants will then crossover to receive guselkumab SC.

Treatment:

Drug: Guselkumab

Drug: Placebo

Cohort B: Moderate-to-severe Scalp Psoriasis

Experimental group

Description:

Participants will receive either guselkumab SC or placebo SC. Placebo participants will then crossover to receive guselkumab SC.

Treatment:

Drug: Guselkumab

Drug: Placebo