Psoriasis Clinical Trial
Study of Guselkumab Versus Placebo for the Treatment of Low Body Surface Area Moderate Plaque Psoriasis
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 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
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There are 48 Locations for this study
Birmingham Alabama, 35205, United States
Encinitas California, 92024, United States
Fountain Valley California, 92708, United States
Riverside California, 92505, United States
Santa Ana California, 92701, United States
Coral Gables Florida, 33134, United States
Margate Florida, 33063, United States
Miami Florida, 33124, United States
North Miami Beach Florida, 33162, United States
Chicago Illinois, 60612, United States
Rockville Maryland, 20850, United States
Rockville Maryland, 20850, United States
Brighton Massachusetts, 02135, United States
Quincy Massachusetts, 02169, United States
New York New York, 10128, United States
Cary North Carolina, 27511, United States
Charlotte North Carolina, 28277, United States
Huntersville North Carolina, 28078, United States
Bexley Ohio, 43209, United States
Columbus Ohio, 43215, United States
Mayfield Heights Ohio, 44124, United States
Charleston South Carolina, 29414, United States
Nashville Tennessee, 37212, United States
Nashville Tennessee, 37215, United States
Arlington Texas, 76011, United States
Bellaire Texas, 77401, United States
Dallas Texas, 75231, United States
Dallas Texas, 75235, United States
Dallas Texas, 75246, United States
Houston Texas, 77004, United States
Houston Texas, 77056, United States
San Antonio Texas, 78218, United States
San Antonio Texas, 78229, United States
Mill Creek Washington, 98102, United States
Surrey British Columbia, V3R 6, Canada
Surrey British Columbia, V3V 0, Canada
Winnipeg Manitoba, R3M 3, Canada
Ajax Ontario, L1S7K, Canada
Hamilton Ontario, L8N 1, Canada
London Ontario, N6H 5, Canada
North York Ontario, M2M 4, Canada
Ottawa Ontario, K1H 7, Canada
Toronto Ontario, M3B 0, Canada
Toronto Ontario, M3H 5, Canada
Toronto Ontario, M4C 1, Canada
Toronto Ontario, M4W 2, Canada
Waterloo Ontario, N2J 1, Canada
Ontario , L4M 7, Canada
Quebec , G1W 4, Canada
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