Study of Guselkumab Versus Placebo for the Treatment of Low Body Surface Area Moderate Plaque Psoriasis (SPECTREM)
Last Updated   March 27, 2024 - 21:00
OVERVIEW
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Gender
all -
Age
years -
Phase
phase 3The drug or treatment is given to large groups of people to confirm its effectiveness, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely. -
Sites
sites -
Status
Recruiting
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.
CONDITIONS
- Moderate plaque psoriasis
ELIGIBILITY
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
DETAILS
LOCATIONS
Country (2) | City or Province (64) | Status |
United States | Arlington, TX Arlington Center for Dermatology |
RECRUITING
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United States | Atlanta, GA Atlanta Biomedical Clinical Research |
COMPLETED
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United States | Bellaire, TX Bellair Dermatology |
RECRUITING
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United States | Bexley, OH Bexley dermatology research |
COMPLETED
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United States | Birmingham, AL Cahaba Research Inc |
RECRUITING
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United States | Birmingham, AL Total Dermatology |
RECRUITING
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United States | Brandon, FL TrueBlue Clinical Research |
RECRUITING
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United States | Brighton, MA Metro Boston Clinical Partners |
RECRUITING
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United States | Cary, NC Accellacare Research of Cary |
RECRUITING
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United States | Charleston, SC Dermatology and Laser Center of Charleston |
COMPLETED
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United States | Charlotte, NC Darst Dermatology |
COMPLETED
|
United States | Columbia, MD Kindred Hair and Skin Center |
RECRUITING
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United States | Columbus, OH Remington Davis Inc |
RECRUITING
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United States | Coral Gables, FL Florida Academic Dermatology Centers |
RECRUITING
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United States | Dallas, TX Bare Dermatology |
RECRUITING
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United States | Dallas, TX Menter Dermatology Research Institute |
RECRUITING
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United States | Dallas, TX Modern Research Associates PLLC |
RECRUITING
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United States | Doral, FL Revival Research |
RECRUITING
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United States | Encinitas, CA California Dermatology & Clinical Research Institute |
RECRUITING
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United States | Farmington, CT University of Conn Health Center |
RECRUITING
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United States | Fountain Inn, SC Palmetto Clinical Trial Services, LLC |
RECRUITING
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United States | Fountain Valley, CA First OC Dermatology |
RECRUITING
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United States | Houston, TX Center for Clinical Studies |
RECRUITING
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United States | Houston, TX Suzanne Bruce and Associates - The Center for Skin Research |
RECRUITING
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United States | Huntersville, NC Piedmont Plastic Surgery and Dermatology |
RECRUITING
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United States | Margate, FL Glick Research Institute |
RECRUITING
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United States | Mayfield Heights, OH Apex Dermatology Mayfield Heights |
RECRUITING
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United States | Miami, FL Miami VA Healthcare System |
RECRUITING
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United States | Mill Creek, WA Frontier Derm Partners CRO, LLC |
RECRUITING
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United States | Nashville, TN Nashville Skin: Comprehensive Dermatology Center |
RECRUITING
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United States | Nashville, TN Tennessee Clinical Research Center |
RECRUITING
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United States | New York, NY Icahn School of Medicine at Mount Sinai |
RECRUITING
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United States | New York, NY Markowitz Medical OptiSkin |
RECRUITING
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United States | North Miami Beach, FL Tory P. Sullivan, M.D., PA |
RECRUITING
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United States | Quincy, MA DermCare, LLC |
RECRUITING
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United States | Riverside, CA Practice Wang |
RECRUITING
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United States | Rockville, MD DermAssociates, PC |
RECRUITING
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United States | Rockville, MD Lawrence J Green MD LLC |
RECRUITING
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United States | San Antonio, TX Progressive Clinical Research |
RECRUITING
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United States | San Antonio, TX Texas Dermatology and Laser Specialists |
RECRUITING
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United States | San Diego, CA Therapeutics Clinical Research |
RECRUITING
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United States | Santa Ana, CA Rehlen, Bartlow, Goodman and Baron Dermatology Group |
RECRUITING
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United States | Santa Monica, CA Clinical Science Institute |
RECRUITING
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United States | Sugar Land, TX Acclaim Dermatology |
COMPLETED
|
United States | West Bloomfield, MI Henry Ford Medical Center |
RECRUITING
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Canada | Ajax, ON CCA Medical Research Corporation |
RECRUITING
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Canada | Calgary, AB Beacon Dermatology |
RECRUITING
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Canada | Edmonton, AB Rejuvenation Dermatology Clinic Edmonton Downtown |
RECRUITING
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Canada | Fredericton, NB Brunswick Dermatology Center |
RECRUITING
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Canada | Hamilton, ON Dermatrials Research |
RECRUITING
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Canada | London, ON Dr Wei Jing Loo Medicine Professional Corporation |
RECRUITING
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Canada | North York, ON North York Research Inc |
RECRUITING
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Canada | Ontario, ON SimcoDerm Medical and Surgical Dermatology Centre |
RECRUITING
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Canada | Ottawa, ON JRB Research Inc |
RECRUITING
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Canada | Quebec, QC The Centre de recherche Saint-Louis |
RECRUITING
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Canada | Surrey, BC Dr. Chih-ho Hong Medical |
RECRUITING
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Canada | Surrey, BC Enverus Medical |
RECRUITING
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Canada | Toronto, ON Canadian Dermatology Center |
RECRUITING
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Canada | Toronto, ON FACET Dermatology |
RECRUITING
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Canada | Toronto, ON Research Toronto |
RECRUITING
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Canada | Toronto, ON Toronto Research Centre |
RECRUITING
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Canada | Waterloo, ON K. Papp Clinical Research Inc. |
RECRUITING
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Canada | Winnipeg, MB Winnipeg Clinic |
RECRUITING
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Canada | Winnipeg, MB Wiseman Dermatology Research Inc. |
RECRUITING
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