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.

View Eligibility Criteria

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

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

300

Study ID:

NCT06039189

Recruitment Status:

Recruiting

Sponsor:

Janssen Research & Development, LLC

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There are 63 Locations for this study

See Locations Near You

Total Dermatology
Birmingham Alabama, 35203, United States
Cahaba Research Inc
Birmingham Alabama, 35244, United States
California Dermatology & Clinical Research Institute
Encinitas California, 92024, United States
First OC Dermatology
Fountain Valley California, 92708, United States
Practice Wang
Riverside California, 92505, United States
Therapeutics Clinical Research
San Diego California, 92123, United States
Rehlen, Bartlow, Goodman and Baron Dermatology Group
Santa Ana California, 92701, United States
Clinical Science Institute
Santa Monica California, 90404, United States
University of Conn Health Center
Farmington Connecticut, 06030, United States
TrueBlue Clinical Research
Brandon Florida, 33511, United States
Florida Academic Dermatology Centers
Coral Gables Florida, 33134, United States
Revival Research
Doral Florida, 33122, United States
Glick Research Institute
Margate Florida, 33063, United States
Miami VA Healthcare System
Miami Florida, 33124, United States
Tory P. Sullivan, M.D., PA
North Miami Beach Florida, 33162, United States
Atlanta Biomedical Clinical Research
Atlanta Georgia, 30333, United States
Kindred Hair and Skin Center
Columbia Maryland, 21045, United States
DermAssociates, PC
Rockville Maryland, 20850, United States
Lawrence J Green MD LLC
Rockville Maryland, 20850, United States
Metro Boston Clinical Partners
Brighton Massachusetts, 02135, United States
DermCare, LLC
Quincy Massachusetts, 02169, United States
Henry Ford Medical Center
West Bloomfield Michigan, 48322, United States
Icahn School of Medicine at Mount Sinai
New York New York, 10003, United States
Markowitz Medical OptiSkin
New York New York, 10128, United States
Accellacare Research of Cary
Cary North Carolina, 27511, United States
Darst Dermatology
Charlotte North Carolina, 28277, United States
Piedmont Plastic Surgery and Dermatology
Huntersville North Carolina, 28078, United States
Bexley dermatology research
Bexley Ohio, 43209, United States
Remington Davis Inc
Columbus Ohio, 43215, United States
Apex Dermatology Mayfield Heights
Mayfield Heights Ohio, 44124, United States
Dermatology and Laser Center of Charleston
Charleston South Carolina, 29414, United States
Palmetto Clinical Trial Services, LLC
Fountain Inn South Carolina, 29644, United States
Nashville Skin: Comprehensive Dermatology Center
Nashville Tennessee, 37212, United States
Tennessee Clinical Research Center
Nashville Tennessee, 37215, United States
Arlington Center for Dermatology
Arlington Texas, 76011, United States
Bellair Dermatology
Bellaire Texas, 77401, United States
Modern Research Associates PLLC
Dallas Texas, 75231, United States
Bare Dermatology
Dallas Texas, 75235, United States
Menter Dermatology Research Institute
Dallas Texas, 75246, United States
Center for Clinical Studies
Houston Texas, 77004, United States
Suzanne Bruce and Associates - The Center for Skin Research
Houston Texas, 77056, United States
Texas Dermatology and Laser Specialists
San Antonio Texas, 78218, United States
Progressive Clinical Research
San Antonio Texas, 78229, United States
Acclaim Dermatology
Sugar Land Texas, 77479, United States
Frontier Derm Partners CRO, LLC
Mill Creek Washington, 98102, United States
Beacon Dermatology
Calgary Alberta, T3E 0, Canada
Rejuvenation Dermatology Clinic Edmonton Downtown
Edmonton Alberta, T5J 3, Canada
Dr. Chih-ho Hong Medical
Surrey British Columbia, V3R 6, Canada
Enverus Medical
Surrey British Columbia, V3V 0, Canada
Winnipeg Clinic
Winnipeg Manitoba, R3C 0, Canada
Wiseman Dermatology Research Inc.
Winnipeg Manitoba, R3M 3, Canada
Brunswick Dermatology Center
Fredericton New Brunswick, E3B 1, Canada
CCA Medical Research Corporation
Ajax Ontario, L1S7K, Canada
Dermatrials Research
Hamilton Ontario, L8N 1, Canada
Dr Wei Jing Loo Medicine Professional Corporation
London Ontario, N6H 5, Canada
North York Research Inc
North York Ontario, M2M 4, Canada
JRB Research Inc
Ottawa Ontario, K1H 7, Canada
Canadian Dermatology Center
Toronto Ontario, M3B 0, Canada
Toronto Research Centre
Toronto Ontario, M3H 5, Canada
FACET Dermatology
Toronto Ontario, M4E 2, Canada
Research Toronto
Toronto Ontario, M4W 2, Canada
K. Papp Clinical Research Inc.
Waterloo Ontario, N2J 1, Canada
SimcoDerm Medical and Surgical Dermatology Centre
Ontario , L4M 7, Canada
The Centre de recherche Saint-Louis
Quebec , G1W 4, Canada

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

300

Study ID:

NCT06039189

Recruitment Status:

Recruiting

Sponsor:


Janssen Research & Development, LLC

How clear is this clinincal trial information?

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