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NCT06039189

PHASE3

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

Sponsor: Janssen Research & Development, LLC

View on ClinicalTrials.gov

Summary

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.

Official title: A Phase 3b, Multicenter, Randomized, Double-blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Guselkumab Versus Placebo for the Treatment of Low Body Surface Area (BSA) Moderate Plaque Psoriasis With Special Site Involvement

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

338

Start Date

2023-08-24

Completion Date

2025-04-14

Last Updated

2026-05-01

Healthy Volunteers

Conditions

Moderate Plaque Psoriasis

Interventions

DRUG

Guselkumab

Guselkumab will be administered as subcutaneous injection.

DRUG

Placebo

Placebo will be administered as subcutaneous injection.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Locations (64)

Total Dermatology

Birmingham, Alabama, United States

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

Darst Dermatology

Charlotte, North Carolina, United States

Piedmont Plastic Surgery and Dermatology

Huntersville, North Carolina, United States

Bexley dermatology research

Bexley, Ohio, United States

Remington Davis Inc

Columbus, Ohio, United States

Apex Dermatology Mayfield Heights

Mayfield Heights, Ohio, United States

Dermatology and Laser Center of Charleston

Charleston, South Carolina, United States

Palmetto Clinical Trial Services, LLC

Fountain Inn, South Carolina, United States

Nashville Skin: Comprehensive Dermatology Center

Nashville, Tennessee, United States

Tennessee Clinical Research Center

Nashville, Tennessee, United States

Arlington Center for Dermatology

Arlington, Texas, United States

Bellair Dermatology

Bellaire, Texas, United States

Modern Research Associates PLLC

Dallas, Texas, United States

Bare Dermatology

Dallas, Texas, United States

Menter Dermatology Research Institute

Dallas, Texas, United States

Center for Clinical Studies

Houston, Texas, United States

Suzanne Bruce and Associates - The Center for Skin Research

Houston, Texas, United States

Texas Dermatology and Laser Specialists

San Antonio, Texas, United States

Progressive Clinical Research

San Antonio, Texas, United States

Acclaim Dermatology

Sugar Land, Texas, United States

Frontier Derm Partners CRO, LLC

Mill Creek, Washington, United States

Beacon Dermatology

Calgary, Alberta, Canada

Rejuvenation Dermatology Clinic Edmonton Downtown

Edmonton, Alberta, Canada

Dr. Chih ho Hong Medical

Surrey, British Columbia, Canada

Enverus Medical

Surrey, British Columbia, Canada

Winnipeg Clinic

Winnipeg, Manitoba, Canada

Wiseman Dermatology Research Inc.

Winnipeg, Manitoba, Canada

Brunswick Dermatology Center

Fredericton, New Brunswick, Canada

CCA Medical Research Corporation

Ajax, Ontario, Canada

SimcoDerm Medical and Surgical Dermatology Centre

Barrie, Ontario, Canada

Dermatrials Research

Hamilton, Ontario, Canada

Dr Wei Jing Loo Medicine Professional Corporation

London, Ontario, Canada

North York Research Inc

North York, Ontario, Canada

JRB Research Inc

Ottawa, Ontario, Canada

Canadian Dermatology Center

Toronto, Ontario, Canada

Toronto Research Centre

Toronto, Ontario, Canada

FACET Dermatology

Toronto, Ontario, Canada

Research Toronto

Toronto, Ontario, Canada

K. Papp Clinical Research Inc.

Waterloo, Ontario, Canada

The Centre de recherche Saint-Louis

Québec, Quebec, Canada

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (64)