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NCT06039189CompletedPhase 3

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

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

Source: ClinicalTrials.gov · Last updated 1 May 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
338 (actual)
First submitted
9 Sept 2023
Start date
24 Aug 2023
Primary completion date
14 Apr 2025
Lead sponsor
Janssen Research & Development, LLC
Diseases
Psoriasis
NCT number
NCT06039189

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 338
  • From 24 Aug 2023 to the primary completion date, 14 Apr 2025
  • 64 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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)

Other illness

  • 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

Lab values

  • 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)

Other

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

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (64)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CCA Medical Research Corporation
Coordinator of this site? Confirm its status
AjaxCanadaUnknown status
Simcoderm Medical and Surgical Dermatology Centre
Coordinator of this site? Confirm its status
BarrieCanadaUnknown status
Beacon Dermatology
Coordinator of this site? Confirm its status
CalgaryCanadaUnknown status
Rejuvenation Dermatology Clinic Edmonton Downtown
Coordinator of this site? Confirm its status
EdmontonCanadaUnknown status
Brunswick Dermatology Center
Coordinator of this site? Confirm its status
FrederictonCanadaUnknown status
Dermatrials Research
Coordinator of this site? Confirm its status
HamiltonCanadaUnknown status
Dr Wei Jing Loo Medicine Professional Corporation
Coordinator of this site? Confirm its status
LondonCanadaUnknown status
North York Research Inc
Coordinator of this site? Confirm its status
North YorkCanadaUnknown status
JRB Research Inc.
Coordinator of this site? Confirm its status
OttawaCanadaUnknown status
The Centre de recherche Saint-Louis
Coordinator of this site? Confirm its status
QuébecCanadaUnknown status
Dr. Chih ho Hong Medical
Coordinator of this site? Confirm its status
SurreyCanadaUnknown status
Enverus Medical
Coordinator of this site? Confirm its status
SurreyCanadaUnknown status
Research Toronto
Coordinator of this site? Confirm its status
TorontoCanadaUnknown status
Canadian Dermatology Center
Coordinator of this site? Confirm its status
TorontoCanadaUnknown status
FACET Dermatology
Coordinator of this site? Confirm its status
TorontoCanadaUnknown status
Toronto Research Centre
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TorontoCanadaUnknown status
K. Papp Clinical Research Inc.
Coordinator of this site? Confirm its status
WaterlooCanadaUnknown status
Winnipeg Clinic
Coordinator of this site? Confirm its status
WinnipegCanadaUnknown status
Wiseman Dermatology Research Inc.
Coordinator of this site? Confirm its status
WinnipegCanadaUnknown status
Arlington Center for Dermatology
Coordinator of this site? Confirm its status
ArlingtonUnited StatesUnknown status
Atlanta Biomedical Clinical Research
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AtlantaUnited StatesUnknown status
Bellair Dermatology
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BellaireUnited StatesUnknown status
Bexley Dermatology Research
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BexleyUnited StatesUnknown status
Total Dermatology
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BirminghamUnited StatesUnknown status
Cahaba Research Inc
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BirminghamUnited StatesUnknown status
TrueBlue Clinical Research
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BrandonUnited StatesUnknown status
Metro Boston Clinical Partners
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BrightonUnited StatesUnknown status
Accellacare Research of Cary
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CaryUnited StatesUnknown status
Dermatology and Laser Center of Charleston
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CharlestonUnited StatesUnknown status
Darst Dermatology
Coordinator of this site? Confirm its status
CharlotteUnited StatesUnknown status
Kindred Hair and Skin Center
Coordinator of this site? Confirm its status
ColumbiaUnited StatesUnknown status
Remington Davis, Inc.
Coordinator of this site? Confirm its status
ColumbusUnited StatesUnknown status
Florida Academic Dermatology Centers
Coordinator of this site? Confirm its status
Coral GablesUnited StatesUnknown status
Bare Dermatology
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DallasUnited StatesUnknown status
Modern Research Associates Pllc
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DallasUnited StatesUnknown status
Menter Dermatology Research Institute
Coordinator of this site? Confirm its status
DallasUnited StatesUnknown status
Revival Research
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DoralUnited StatesUnknown status
California Dermatology & Clinical Research Institute
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EncinitasUnited StatesUnknown status
University of Conn Health Center
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FarmingtonUnited StatesUnknown status
Palmetto Clinical Trial Services, LLC
Coordinator of this site? Confirm its status
Fountain InnUnited StatesUnknown status
First OC Dermatology
Coordinator of this site? Confirm its status
Fountain ValleyUnited StatesUnknown status
Suzanne Bruce and Associates - The Center for Skin Research
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HoustonUnited StatesUnknown status
Center for Clinical Studies
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HoustonUnited StatesUnknown status
Piedmont Plastic Surgery and Dermatology
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HuntersvilleUnited StatesUnknown status
Glick Research Institute
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MargateUnited StatesUnknown status
Apex Dermatology Mayfield Heights
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Mayfield HeightsUnited StatesUnknown status
Miami VA Healthcare System
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MiamiUnited StatesUnknown status
Frontier Derm Partners CRO LLC
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Mill CreekUnited StatesUnknown status
Nashville Skin: Comprehensive Dermatology Center
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NashvilleUnited StatesUnknown status
Tennessee Clinical Research Center
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NashvilleUnited StatesUnknown status
Markowitz Medical OptiSkin
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New YorkUnited StatesUnknown status
Icahn School of Medicine at Mount Sinai
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New YorkUnited StatesUnknown status
Tory P Sullivan M D PA
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North Miami BeachUnited StatesUnknown status
DermCare, LLC
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QuincyUnited StatesUnknown status
Practice Wang
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RiversideUnited StatesUnknown status
Lawrence J. Green, MD, LLC
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RockvilleUnited StatesUnknown status
DermAssociates, PC
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RockvilleUnited StatesUnknown status
Progressive Clinical Research
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San AntonioUnited StatesUnknown status
Texas Dermatology and Laser Specialists
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San AntonioUnited StatesUnknown status
Therapeutics Clinical Research
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San DiegoUnited StatesUnknown status
Rehlen, Bartlow, Goodman and Baron Dermatology Group
Coordinator of this site? Confirm its status
Santa AnaUnited StatesUnknown status
Clinical Science Institute
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Santa MonicaUnited StatesUnknown status
Acclaim Dermatology
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Sugar LandUnited StatesUnknown status
Henry Ford Medical Center
Coordinator of this site? Confirm its status
West BloomfieldUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.