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

Last Updated   March 27, 2024 - 21:00

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OVERVIEW

  • Gender
    all
  • Age
    18+ years
  • Phase
    phase 3
    The 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
    64 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

Locations in:
United States, Canada
Country (2) City or Province (64) Status
United States Arlington, TX Arlington Center for Dermatology
RECRUITING
United States Atlanta, GA Atlanta Biomedical Clinical Research
COMPLETED
United States Bellaire, TX Bellair Dermatology
RECRUITING
United States Bexley, OH Bexley dermatology research
COMPLETED
United States Birmingham, AL Cahaba Research Inc
RECRUITING
United States Birmingham, AL Total Dermatology
RECRUITING
United States Brandon, FL TrueBlue Clinical Research
RECRUITING
United States Brighton, MA Metro Boston Clinical Partners
RECRUITING
United States Cary, NC Accellacare Research of Cary
RECRUITING
United States Charleston, SC Dermatology and Laser Center of Charleston
COMPLETED
United States Charlotte, NC Darst Dermatology
COMPLETED
United States Columbia, MD Kindred Hair and Skin Center
RECRUITING
United States Columbus, OH Remington Davis Inc
RECRUITING
United States Coral Gables, FL Florida Academic Dermatology Centers
RECRUITING
United States Dallas, TX Bare Dermatology
RECRUITING
United States Dallas, TX Menter Dermatology Research Institute
RECRUITING
United States Dallas, TX Modern Research Associates PLLC
RECRUITING
United States Doral, FL Revival Research
RECRUITING
United States Encinitas, CA California Dermatology & Clinical Research Institute
RECRUITING
United States Farmington, CT University of Conn Health Center
RECRUITING
United States Fountain Inn, SC Palmetto Clinical Trial Services, LLC
RECRUITING
United States Fountain Valley, CA First OC Dermatology
RECRUITING
United States Houston, TX Center for Clinical Studies
RECRUITING
United States Houston, TX Suzanne Bruce and Associates - The Center for Skin Research
RECRUITING
United States Huntersville, NC Piedmont Plastic Surgery and Dermatology
RECRUITING
United States Margate, FL Glick Research Institute
RECRUITING
United States Mayfield Heights, OH Apex Dermatology Mayfield Heights
RECRUITING
United States Miami, FL Miami VA Healthcare System
RECRUITING
United States Mill Creek, WA Frontier Derm Partners CRO, LLC
RECRUITING
United States Nashville, TN Nashville Skin: Comprehensive Dermatology Center
RECRUITING
United States Nashville, TN Tennessee Clinical Research Center
RECRUITING
United States New York, NY Icahn School of Medicine at Mount Sinai
RECRUITING
United States New York, NY Markowitz Medical OptiSkin
RECRUITING
United States North Miami Beach, FL Tory P. Sullivan, M.D., PA
RECRUITING
United States Quincy, MA DermCare, LLC
RECRUITING
United States Riverside, CA Practice Wang
RECRUITING
United States Rockville, MD DermAssociates, PC
RECRUITING
United States Rockville, MD Lawrence J Green MD LLC
RECRUITING
United States San Antonio, TX Progressive Clinical Research
RECRUITING
United States San Antonio, TX Texas Dermatology and Laser Specialists
RECRUITING
United States San Diego, CA Therapeutics Clinical Research
RECRUITING
United States Santa Ana, CA Rehlen, Bartlow, Goodman and Baron Dermatology Group
RECRUITING
United States Santa Monica, CA Clinical Science Institute
RECRUITING
United States Sugar Land, TX Acclaim Dermatology
COMPLETED
United States West Bloomfield, MI Henry Ford Medical Center
RECRUITING
Canada Ajax, ON CCA Medical Research Corporation
RECRUITING
Canada Calgary, AB Beacon Dermatology
RECRUITING
Canada Edmonton, AB Rejuvenation Dermatology Clinic Edmonton Downtown
RECRUITING
Canada Fredericton, NB Brunswick Dermatology Center
RECRUITING
Canada Hamilton, ON Dermatrials Research
RECRUITING
Canada London, ON Dr Wei Jing Loo Medicine Professional Corporation
RECRUITING
Canada North York, ON North York Research Inc
RECRUITING
Canada Ontario, ON SimcoDerm Medical and Surgical Dermatology Centre
RECRUITING
Canada Ottawa, ON JRB Research Inc
RECRUITING
Canada Quebec, QC The Centre de recherche Saint-Louis
RECRUITING
Canada Surrey, BC Dr. Chih-ho Hong Medical
RECRUITING
Canada Surrey, BC Enverus Medical
RECRUITING
Canada Toronto, ON Canadian Dermatology Center
RECRUITING
Canada Toronto, ON FACET Dermatology
RECRUITING
Canada Toronto, ON Research Toronto
RECRUITING
Canada Toronto, ON Toronto Research Centre
RECRUITING
Canada Waterloo, ON K. Papp Clinical Research Inc.
RECRUITING
Canada Winnipeg, MB Winnipeg Clinic
RECRUITING
Canada Winnipeg, MB Wiseman Dermatology Research Inc.
RECRUITING
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