Study of Guselkumab Versus Placebo for the Treatment of Low Body Surface Area Moderate Plaque Psoriasis

Completed · Phase 3 · Has a placebo group

Conditions studied: Moderate Plaque Psoriasis

In brief

The purpose of this study is to evaluate the efficacy of guselkumab compared to an inactive drug in participants with low body surface area moderate plaque psoriasis and special site involvement.

Key facts

Study ID

NCT06039189

Run by

Janssen Research & Development, LLC

People needed

338

Starts

2023-08-24

Expected to finish

2025-04-14

Last updated by the study team

2026-05-01

Who can join

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

You may qualify if…

• All participants must have a diagnosis of plaque psoriasis (with or without psoriatic arthritis) for at least 6 months before first administration of study intervention
• All participants must meet the following disease severity criteria at screening and at baseline: (a) Overall Investigator's Global Assessment (IGA) 3 (moderate) plaque psoriasis; (b) Body Surface Area (BSA) 2-15 percent (%) with at least 1 plaque outside of special sites; (c) Involvement of at least 1 special site with at least moderate severity. Qualifying sites include scalp with scalp-specific IGA greater than or equal to (>=) 3, face with facial psoriasis IGA >=3, intertriginous with intertriginous psoriasis IGA >=3, or genital with static physician global assessment of genitalia (sPGA-G) >=3
• All participants be inadequately controlled with or intolerant of at least 1 prior topical therapy (including, but not limited to, corticosteroids, retinoids, vitamin D, or vitamin D/steroid and retinoid/steroid combinations, tacrolimus, pimecrolimus, anthralin/dithranol, coal tar preparations, tapinarof, roflumilast, etcetera) for the treatment of psoriasis at both screening
• All participants be a candidate for phototherapy or systemic treatment for psoriasis

You may not qualify if…

• Has a nonplaque form of psoriasis (example, erythrodermic, guttate, or pustular) at screening or randomization
• Has current drug-induced psoriasis (for example, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
• For participants with palmoplantar involvement, confounding diagnoses, including, but not limited, to palmoplantar pustulosis, eczematous dermatitis, contact/irritant dermatitis, acquired keratoderma, etcetera, should be confirmed and excluded
• Participants will not be eligible if they have ever received prior biologic (or biosimilars of) for the treatment of psoriasis, psoriatic arthritis (PsA), or any other indications that could impact the assessment of psoriasis. Prior biologics (or biosimilars of) may include, but not limited to, tumor necrosis factor (TNF)-inhibitors (for example: adalimumab, etanercept, infliximab, or certolizumab or biosimilars), interleukin (IL)-17 inhibitors (for example: secukinumab, ixekizumab, brodalumab, or bimekizumab), and IL-12/23 inhibitors (for example: ustekinumab), or IL-23 inhibitor (for example: guselkumab, risankizumab or tildrakizumab)
• Has a history of chronic or recurrent infectious disease, including, but not limited to, chronic renal infection, chronic chest infection (for example, bronchiectasis), recurrent urinary tract infection (recurrent pyelonephritis or chronic non-remitting cystitis), fungal infection (mucocutaneous candidiasis), or open, draining, or infected skin wounds or ulcers

Where it is running

• Cahaba Research Inc — Birmingham, Alabama, United States
• California Dermatology & Clinical Research Institute — Encinitas, California, United States
• First OC Dermatology — Fountain Valley, California, United States
• Practice Wang — Riverside, California, United States
• Therapeutics Clinical Research — San Diego, California, United States
• Rehlen, Bartlow, Goodman and Baron Dermatology Group — Santa Ana, California, United States
• Clinical Science Institute — Santa Monica, California, United States
• University of Conn Health Center — Farmington, Connecticut, United States
• TrueBlue Clinical Research — Brandon, Florida, United States
• Florida Academic Dermatology Centers — Coral Gables, Florida, United States
• Revival Research — Doral, Florida, United States
• Glick Research Institute — Margate, Florida, United States
• Miami VA Healthcare System — Miami, Florida, United States
• Tory P Sullivan M D PA — North Miami Beach, Florida, United States
• Atlanta Biomedical Clinical Research — Atlanta, Georgia, United States
• Kindred Hair and Skin Center — Columbia, Maryland, United States
• DermAssociates, PC — Rockville, Maryland, United States
• Lawrence J Green MD LLC — Rockville, Maryland, United States
• Metro Boston Clinical Partners — Brighton, Massachusetts, United States
• DermCare, LLC — Quincy, Massachusetts, United States
• Henry Ford Medical Center — West Bloomfield, Michigan, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• Markowitz Medical OptiSkin — New York, New York, United States
• Accellacare Research of Cary — Cary, North Carolina, United States
• Total Dermatology — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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