Psoriasis Clinical Trial

Study of Guselkumab in Skin of Color Participants With Moderate-to-severe Plaque and/or Scalp Psoriasis

Summary

The purpose of this study is to evaluate the efficacy of guselkumab treatment versus placebo in skin of color participants with predominant moderate-to-severe body psoriasis or predominant moderate-to-severe scalp psoriasis by assessing improvements in the signs and symptoms of psoriasis.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Have a diagnosis of plaque psoriasis (with or without psoriatic arthritis [PsA]) for at least 6 months before the first administration of study drug
Self-identify as non-white or non-caucasian
Be a candidate for phototherapy or systemic treatment for psoriasis
Have an involved body surface area (BSA) greater than or equal to (>=) 10 percent (%), psoriasis area and severity index (PASI) >=12, investigator global assessment (IGA) >=3 at screening and at baseline (Cohort A), or have a scalp surface area >=30%, psoriasis scalp severity index (PSSI) >=12, scalp specific investigator global assessment (ss-IGA) >=3, and one plaque outside of the scalp at screening and at baseline (Cohort B)
Agree not to receive a live virus or live bacterial vaccination during the study, or within 12 weeks after the last administration of study intervention
Agree not to receive a Bacillus Calmette-Guérin (BCG) vaccination during the study, and within 12 weeks after the last administration of study intervention

Exclusion Criteria:

Has a nonplaque form of psoriasis (example: erythrodermic, guttate, or pustular)
Has received ustekinumab, ixekizumab, secukinumab, or brodalumab within 12 weeks of first dose of study drug
Has a history or current signs or symptoms of severe, progressive, or uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
Participant has known allergies, hypersensitivity, or intolerance to guselkumab or its excipients
Has or has had a serious infection (example: sepsis, pneumonia or pyelonephritis), or has been hospitalized or received intravenous antibiotics for an infection during the 2 months before screening

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

213

Study ID:

NCT05272150

Recruitment Status:

Active, not recruiting

Sponsor:

Janssen Research & Development, LLC

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There are 91 Locations for this study

See Locations Near You

Total Skin & Beauty Dermatology Center
Birmingham Alabama, 35203, United States
Cahaba Research Inc
Birmingham Alabama, 35244, United States
Stoll Dermatology
Beverly Hills California, 90212, United States
California Dermatology & Clinical Research Institute
Encinitas California, 92024, United States
First OC Dermatology
Fountain Valley California, 92708, United States
Center for Dermatology Clinical Research
Fremont California, 94538, United States
Community Regional Medical Center
Fresno California, 93701, United States
Paul Wallace MD
Ladera Heights California, 90056, United States
The Grimes Center for Medical and Aesthetic Dermatology
Los Angeles California, 90036, United States
Care Access Research
Newport Beach California, 92660, United States
MedDerm Associates
San Diego California, 92103, United States
Synergy Clinical Research
San Francisco California, 94132, United States
Southern California Dermatology
Santa Ana California, 92701, United States
Clinical Science Institute
Santa Monica California, 90404, United States
University of Connecticut Health Center
Farmington Connecticut, 06030, United States
Center for Dermatology and Dermatologic Surgery
Washington District of Columbia, 20037, United States
Skin Care Research
Boca Raton Florida, 33486, United States
Driven Research LLC
Coral Gables Florida, 33134, United States
Florida Academic Dermatology Centers
Coral Gables Florida, 33134, United States
Hollywood Dermatology and Cosmetic Surgery
Hollywood Florida, 33021, United States
International Dermatology Research, Inc.
Miami Florida, 33144, United States
Tory P. Sullivan, M.D., PA
North Miami Beach Florida, 33162, United States
Park Avenue Dermatology
Orange Park Florida, 32073, United States
Riverchase Dermatology and Cosmetic Surgery
Pembroke Pines Florida, 33028, United States
GCP Research
Saint Petersburg Florida, 33705, United States
Forcare Clinical Research Inc
Tampa Florida, 33613, United States
Hamilton Dermatology Atlanta Dermatology, Vein & Research Center, LLC
Alpharetta Georgia, 30022, United States
Advanced Medical Research
Atlanta Georgia, 30328, United States
Skin Care Physicians of Georgia
Macon Georgia, 31217, United States
University Dermatology and Vein Clinic
Darien Illinois, 60561, United States
Northshore University Healthsystem
Skokie Illinois, 60077, United States
Dundee Dermatology
West Dundee Illinois, 60118, United States
Dawes Fretzin Clinical Research Group
Indianapolis Indiana, 46256, United States
Indiana Clinical Trial Center
Plainfield Indiana, 46168, United States
Epiphany Dermatology of Kansas, LLC
Overland Park Kansas, 66210, United States
Ds Research
Louisville Kentucky, 40241, United States
Callender Center for Clinical Research
Glenn Dale Maryland, 20769, United States
Care Access Research
Marriottsville Maryland, 21104, United States
DermAssociates, PC
Rockville Maryland, 20850, United States
Lawrence J Green MD LLC
Rockville Maryland, 20850, United States
Allcutis Research
Beverly Massachusetts, 01915, United States
Metro Boston Clinical Partners
Brighton Massachusetts, 02135, United States
David Fivenson MD, Dermatology
Ann Arbor Michigan, 48103, United States
St Joseph Dermatology and Vein Clinic
Saint Joseph Michigan, 49085, United States
Somerset Skin Centre
Troy Michigan, 48084, United States
Henry Ford Medical Center
West Bloomfield Michigan, 48322, United States
Twin Cities Dermatology Center
Minneapolis Minnesota, 55416, United States
Skin Specialists
Omaha Nebraska, 68144, United States
Psoriasis Treatment Center of Central New Jersey
East Windsor New Jersey, 08520, United States
Hudson Dermatology & Skin Cancer Center
Hoboken New Jersey, 07030, United States
Schweiger Dermatology Group
Verona New Jersey, 07044, United States
Forest Hills Dermatology Group PLLC
Forest Hills New York, 11375, United States
MDCS Dermatology
New York New York, 10065, United States
Sadick Research Group
New York New York, 10075, 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
Dermatology Specialists
Charlotte North Carolina, 28277, United States
Accellacare of Raleigh
Raleigh North Carolina, 27612, United States
PMG Research of Rocky Mount, LLC
Rocky Mount North Carolina, 27804, United States
PMG Research of Wilmington, LLC
Wilmington North Carolina, 28401, United States
Wake Forest Health Sciences
Winston-Salem North Carolina, 27104, United States
Advanced Dermatology and Skin Cancer Center
Boardman Ohio, 44512, United States
Wright State Physicians Health Center
Dayton Ohio, 45324, United States
Apex Dermatology Mayfield Heights
Mayfield Heights Ohio, 44124, United States
Central Sooner Research
Norman Oklahoma, 73071, United States
Schweiger Dermatology Group
Exton Pennsylvania, 19341, United States
Temple University School of Medicine
Philadelphia Pennsylvania, 19140, United States
University of Pittsburgh Medical Center (UPMC)
Pittsburgh Pennsylvania, 15213, United States
Dermatology and Laser Center of Charleston
Charleston South Carolina, 29407, United States
Palmetto Clinical Trial Services, LLC
Fountain Inn South Carolina, 29644, United States
Arlington Center for Dermatology
Arlington Texas, 76011, United States
Dermatology Treatment & Research Center, PA
Dallas Texas, 75230, United States
Modern Research Associates PLLC
Dallas Texas, 75231, 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
Austin Institute for Clinical Research
Pflugerville Texas, 78660, United States
Progressive Clinical Research
San Antonio Texas, 78213, United States
Texas Dermatology and Laser Specialists
San Antonio Texas, 78218, United States
Dermatology Research Institute Inc.
Calgary Alberta, T2J 7, Canada
Beacon Dermatology
Calgary Alberta, T3E 0, Canada
Alberta DermaSurgery Centre
Edmonton Alberta, T6G 2, Canada
Dr. Chih-ho Hong Medical
Surrey British Columbia, V3R 6, Canada
Dr. Lorne E. Albrecht
Surrey British Columbia, V3V 0, Canada
CCA Medical Research Corporation
Ajax Ontario, L1S7K, Canada
Dr Dusan Sajic Medicine Professional Corporation
Guelph Ontario, N1L 0, Canada
Lynderm Research Inc.
Markham Ontario, L3P 1, Canada
North York Research Inc
North York Ontario, M2M 4, Canada
JRB Research Inc
Ottawa Ontario, K1H 7, Canada
Nectar Research Group Inc
Richmond Hill Ontario, L4B 1, 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

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

213

Study ID:

NCT05272150

Recruitment Status:

Active, not recruiting

Sponsor:


Janssen Research & Development, LLC

How clear is this clinincal trial information?

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