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

Last updated: April 2, 2025
Sponsor: Janssen Research & Development, LLC
Overall Status: Active - Not Recruiting

Phase

3

Condition

Warts

Scalp Disorders

Skin Wounds

Treatment

Placebo

Guselkumab

Clinical Study ID

NCT06039189
CR109328
CNTO1959PSO3017
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • All participants must have a diagnosis of plaque psoriasis (with or withoutpsoriatic arthritis) for at least 6 months before first administration of studyintervention

  • All participants must meet the following disease severity criteria at screening andat baseline: (a) Overall Investigator's Global Assessment (IGA) 3 (moderate) plaquepsoriasis; (b) Body Surface Area (BSA) 2-15 percent (%) with at least 1 plaqueoutside of special sites; (c) Involvement of at least 1 special site with at leastmoderate severity. Qualifying sites include scalp with scalp-specific IGA greaterthan or equal to (>=) 3, face with facial psoriasis IGA >=3, intertriginous withintertriginous psoriasis IGA >=3, or genital with static physician global assessmentof genitalia (sPGA-G) >=3

  • All participants be inadequately controlled with or intolerant of at least 1 priortopical therapy (including, but not limited to, corticosteroids, retinoids, vitaminD, or vitamin D/steroid and retinoid/steroid combinations, tacrolimus, pimecrolimus,anthralin/dithranol, coal tar preparations, tapinarof, roflumilast, etcetera) forthe treatment of psoriasis at both screening

  • All participants be a candidate for phototherapy or systemic treatment for psoriasis

Exclusion

Exclusion Criteria:

  • Has a nonplaque form of psoriasis (example, erythrodermic, guttate, or pustular) atscreening or randomization

  • Has current drug-induced psoriasis (for example, a new onset of psoriasis or anexacerbation 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/irritantdermatitis, acquired keratoderma, etcetera, should be confirmed and excluded

  • Participants will not be eligible if they have ever received prior biologic (orbiosimilars of) for the treatment of psoriasis, psoriatic arthritis (PsA), or anyother indications that could impact the assessment of psoriasis. Prior biologics (orbiosimilars of) may include, but not limited to, tumor necrosis factor (TNF)-inhibitors (for example: adalimumab, etanercept, infliximab, or certolizumabor 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 ortildrakizumab)

  • Has a history of chronic or recurrent infectious disease, including, but not limitedto, chronic renal infection, chronic chest infection (for example, bronchiectasis),recurrent urinary tract infection (recurrent pyelonephritis or chronic non-remittingcystitis), fungal infection (mucocutaneous candidiasis), or open, draining, orinfected skin wounds or ulcers

Study Design

Total Participants: 338
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
August 24, 2023
Estimated Completion Date:
April 09, 2025

Connect with a study center

  • Beacon Dermatology

    Calgary, Alberta T3E 0B2
    Canada

    Site Not Available

  • Rejuvenation Dermatology Clinic Edmonton Downtown

    Edmonton, Alberta T5J 3S9
    Canada

    Site Not Available

  • Dr. Chih ho Hong Medical

    Surrey, British Columbia V3R 6A7
    Canada

    Site Not Available

  • Dr. Chih-ho Hong Medical

    Surrey, British Columbia V3R 6A7
    Canada

    Site Not Available

  • Enverus Medical

    Surrey, British Columbia V3V 0C6
    Canada

    Site Not Available

  • Winnipeg Clinic

    Winnipeg, Manitoba R3C 0N2
    Canada

    Site Not Available

  • Wiseman Dermatology Research Inc.

    Winnipeg, Manitoba R3M 3Z4
    Canada

    Site Not Available

  • Brunswick Dermatology Center

    Fredericton, New Brunswick E3B 1G9
    Canada

    Site Not Available

  • CCA Medical Research Corporation

    Ajax, Ontario L1S7K8
    Canada

    Site Not Available

  • Dermatrials Research

    Hamilton, Ontario L8N 1Y2
    Canada

    Site Not Available

  • Dr Wei Jing Loo Medicine Professional Corporation

    London, Ontario N6H 5L5
    Canada

    Site Not Available

  • North York Research Inc

    North York, Ontario M2M 4J5
    Canada

    Site Not Available

  • JRB Research Inc

    Ottawa, Ontario K1H 7X3
    Canada

    Site Not Available

  • Canadian Dermatology Center

    Toronto, Ontario M3B 0A7
    Canada

    Site Not Available

  • FACET Dermatology

    Toronto, Ontario M4E 2Y9
    Canada

    Site Not Available

  • Manna Research

    Toronto, Ontario M4C 1L1
    Canada

    Active - Recruiting

  • Research Toronto

    Toronto, Ontario M4W 2N2
    Canada

    Site Not Available

  • Toronto Research Centre

    Toronto, Ontario M3H 5Y8
    Canada

    Site Not Available

  • K. Papp Clinical Research Inc.

    Waterloo, Ontario N2J 1C4
    Canada

    Site Not Available

  • SimcoDerm Medical and Surgical Dermatology Centre

    Ontario, L4M 7G1
    Canada

    Site Not Available

  • The Centre de recherche Saint-Louis

    Quebec, G1W 4R4
    Canada

    Site Not Available

  • Cahaba Research Inc

    Birmingham, Alabama 35244
    United States

    Site Not Available

  • Total Dermatology

    Birmingham, Alabama 35203
    United States

    Site Not Available

  • Total Skin & Beauty Dermatology Center

    Birmingham, Alabama 35205
    United States

    Active - Recruiting

  • California Dermatology & Clinical Research Institute

    Encinitas, California 92024
    United States

    Site Not Available

  • First OC Dermatology

    Fountain Valley, California 92708
    United States

    Site Not Available

  • Practice Wang

    Riverside, California 92505
    United States

    Site Not Available

  • Therapeutics Clinical Research

    San Diego, California 92123
    United States

    Site Not Available

  • Rehlen, Bartlow, Goodman and Baron Dermatology Group

    Santa Ana, California 92701
    United States

    Site Not Available

  • Clinical Science Institute

    Santa Monica, California 90404
    United States

    Site Not Available

  • University of Conn Health Center

    Farmington, Connecticut 06030
    United States

    Site Not Available

  • TrueBlue Clinical Research

    Brandon, Florida 33511
    United States

    Site Not Available

  • Florida Academic Dermatology Centers

    Coral Gables, Florida 33134
    United States

    Site Not Available

  • Revival Research

    Doral, Florida 33122
    United States

    Site Not Available

  • Glick Research Institute

    Margate, Florida 33063
    United States

    Site Not Available

  • Miami VA Healthcare System

    Miami, Florida 33124
    United States

    Site Not Available

  • Tory P Sullivan M D PA

    North Miami Beach, Florida 33162
    United States

    Site Not Available

  • Tory P. Sullivan, M.D., PA

    North Miami Beach, Florida 33162
    United States

    Site Not Available

  • Atlanta Biomedical Clinical Research

    Atlanta, Georgia 303331
    United States

    Site Not Available

  • Rush University

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Kindred Hair and Skin Center

    Columbia, Maryland 21045
    United States

    Site Not Available

  • DermAssociates, PC

    Rockville, Maryland 20850
    United States

    Site Not Available

  • Lawrence J Green MD LLC

    Rockville, Maryland 20850
    United States

    Site Not Available

  • Metro Boston Clinical Partners

    Brighton, Massachusetts 02135
    United States

    Site Not Available

  • DermCare, LLC

    Quincy, Massachusetts 02169
    United States

    Site Not Available

  • Henry Ford Medical Center

    West Bloomfield, Michigan 48322
    United States

    Site Not Available

  • Icahn School of Medicine at Mount Sinai

    New York, New York 10003
    United States

    Site Not Available

  • Markowitz Medical OptiSkin

    New York, New York 10128
    United States

    Site Not Available

  • Accellacare Research of Cary

    Cary, North Carolina 27511
    United States

    Site Not Available

  • Darst Dermatology

    Charlotte, North Carolina 28277
    United States

    Site Not Available

  • Piedmont Plastic Surgery and Dermatology - Denver

    Denver, North Carolina 28037
    United States

    Site Not Available

  • Piedmont Plastic Surgery and Dermatology

    Huntersville, North Carolina 28078
    United States

    Site Not Available

  • Bexley dermatology research

    Bexley, Ohio 43209
    United States

    Site Not Available

  • Remington Davis Inc

    Columbus, Ohio 43215
    United States

    Site Not Available

  • Apex Dermatology Mayfield Heights

    Mayfield Heights, Ohio 44124
    United States

    Site Not Available

  • Dermatology and Laser Center of Charleston

    Charleston, South Carolina 29414
    United States

    Site Not Available

  • Palmetto Clinical Trial Services, LLC

    Fountain Inn, South Carolina 29644
    United States

    Site Not Available

  • Nashville Skin: Comprehensive Dermatology Center

    Nashville, Tennessee 37212
    United States

    Site Not Available

  • Tennessee Clinical Research Center

    Nashville, Tennessee 37215
    United States

    Site Not Available

  • Arlington Center for Dermatology

    Arlington, Texas 76011
    United States

    Site Not Available

  • Bellair Dermatology

    Bellaire, Texas 77401
    United States

    Site Not Available

  • Bare Dermatology

    Dallas, Texas 75235
    United States

    Site Not Available

  • Menter Dermatology Research Institute

    Dallas, Texas 75246
    United States

    Site Not Available

  • Modern Research Associates PLLC

    Dallas, Texas 75231
    United States

    Site Not Available

  • Center for Clinical Studies

    Houston, Texas 77004
    United States

    Site Not Available

  • Suzanne Bruce and Associates - The Center for Skin Research

    Houston, Texas 77056-4132
    United States

    Site Not Available

  • Progressive Clinical Research

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Texas Dermatology and Laser Specialists

    San Antonio, Texas 78218
    United States

    Site Not Available

  • Acclaim Dermatology

    Sugar Land, Texas 77479
    United States

    Site Not Available

  • Frontier Derm Partners CRO, LLC

    Mill Creek, Washington 98102
    United States

    Site Not Available

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