Study of Guselkumab Versus Placebo for the Treatment of Low Body Surface Area Moderate Plaque Psoriasis
Moderate Plaque PsoriasisThe 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.
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Participation Requirements
-
Sex:
ALL -
Eligible Ages:
18 and up
Participation Criteria
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
Study Location
Dr. Chih ho Hong Medical
Dr. Chih ho Hong MedicalSurrey, British Columbia
Canada
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Brunswick Dermatology Center
Brunswick Dermatology CenterFredericton, New Brunswick
Canada
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FACET Dermatology
FACET DermatologyToronto, Ontario
Canada
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North York Research Inc
North York Research IncNorth York, Ontario
Canada
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Rejuvenation Dermatology Clinic Edmonton Downtown
Rejuvenation Dermatology Clinic Edmonton DowntownEdmonton, Alberta
Canada
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Wiseman Dermatology Research Inc.
Wiseman Dermatology Research Inc.Winnipeg, Manitoba
Canada
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Toronto Research Centre
Toronto Research CentreToronto, Ontario
Canada
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Dr Wei Jing Loo Medicine Professional Corporation
Dr Wei Jing Loo Medicine Professional CorporationLondon, Ontario
Canada
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Enverus Medical
Enverus MedicalSurrey, British Columbia
Canada
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CCA Medical Research Corporation
CCA Medical Research CorporationAjax, Ontario
Canada
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JRB Research Inc
JRB Research IncOttawa, Ontario
Canada
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Research Toronto
Research TorontoToronto, Ontario
Canada
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Beacon Dermatology
Beacon DermatologyCalgary, Alberta
Canada
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Winnipeg Clinic
Winnipeg ClinicWinnipeg, Manitoba
Canada
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Dermatrials Research
Dermatrials ResearchHamilton, Ontario
Canada
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K. Papp Clinical Research Inc.
K. Papp Clinical Research Inc.Waterloo, Ontario
Canada
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Canadian Dermatology Center
Canadian Dermatology CenterToronto, Ontario
Canada
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- Study Sponsored By
- Janssen Research & Development, LLC
- Participants Required
- More Information
- Study ID:
NCT06039189