Study of Guselkumab Versus Placebo for the Treatment of Low Body Surface Area Moderate Plaque Psoriasis
NCT ID: NCT06039189
Last Updated: 2025-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
338 participants
INTERVENTIONAL
2023-08-24
2025-04-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Group 1: Guselkumab
Participants will receive guselkumab by subcutaneous injection with placebo as needed to maintain the blind.
Guselkumab
Guselkumab will be administered as subcutaneous injection.
Placebo
Placebo will be administered as subcutaneous injection.
Group 2: Placebo
Participants will receive placebo by subcutaneous injection then receive guselkumab by subcutaneous injection.
Guselkumab
Guselkumab will be administered as subcutaneous injection.
Placebo
Placebo will be administered as subcutaneous injection.
Interventions
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Guselkumab
Guselkumab will be administered as subcutaneous injection.
Placebo
Placebo will be administered as subcutaneous injection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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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
Countries
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References
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Stein Gold L, Gottlieb AB, Armstrong AW, Alkousakis T, Bissonnette R, Langley RG, Krueger J, Papp K, Choi O, Rowland K, Chan D, Jeyarajah J, Park-Wyllie L, Gao LL, Gordon KB, Merola JF, Lebwohl MG, Strober B. SPECTREM Phase 3b Clinical Trial Results Through Week 16: Guselkumab Efficacy and Safety for the Treatment of Low Body Surface Area, Moderate Psoriasis With High-Impact Site Involvement. Br J Dermatol. 2025 Aug 28:ljaf327. doi: 10.1093/bjd/ljaf327. Online ahead of print.
Other Identifiers
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CNTO1959PSO3017
Identifier Type: OTHER
Identifier Source: secondary_id
CR109328
Identifier Type: -
Identifier Source: org_study_id
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