Study of Guselkumab in Skin of Color Participants With Moderate-to-severe Plaque and/or Scalp Psoriasis
NCT ID: NCT05272150
Last Updated: 2025-09-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
213 participants
INTERVENTIONAL
2022-07-13
2025-05-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Cohort A: Moderate-to-severe Plaque Psoriasis
Participants will receive either guselkumab subcutaneously (SC) or placebo SC. Placebo participants will then crossover to receive guselkumab SC.
Guselkumab
Participants will receive guselkumab as subcutaneous injection.
Placebo
Participants will receive placebo as subcutaneous injection.
Cohort B: Moderate-to-severe Scalp Psoriasis
Participants will receive either guselkumab SC or placebo SC. Placebo participants will then crossover to receive guselkumab SC.
Guselkumab
Participants will receive guselkumab as subcutaneous injection.
Placebo
Participants will receive placebo as subcutaneous injection.
Interventions
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Guselkumab
Participants will receive guselkumab as subcutaneous injection.
Placebo
Participants will receive placebo as subcutaneous injection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Total Skin and Beauty Dermatology Center
Birmingham, Alabama, United States
Cahaba Research Inc
Birmingham, Alabama, United States
Stoll Dermatology
Beverly Hills, California, United States
California Dermatology & Clinical Research Institute
Encinitas, California, United States
First OC Dermatology
Fountain Valley, California, United States
Center for Dermatology Clinical Research
Fremont, California, United States
Community Regional Medical Center
Fresno, California, United States
Paul Wallace MD
Ladera Heights, California, United States
The Grimes Center for Medical and Aesthetic Dermatology
Los Angeles, California, United States
Care Access Research
Newport Beach, California, United States
MedDerm Associates
San Diego, California, United States
Synergy Clinical Research
San Francisco, California, United States
Southern California Dermatology
Santa Ana, California, United States
Clinical Science Institute
Santa Monica, California, United States
University of Connecticut Health Center
Farmington, Connecticut, United States
Center for Dermatology and Dermatologic Surgery
Washington D.C., District of Columbia, United States
Skin Care Research
Boca Raton, Florida, United States
Driven Research LLC
Coral Gables, Florida, United States
Florida Academic Dermatology Centers
Coral Gables, Florida, United States
Hollywood Dermatology and Cosmetic Surgery
Hollywood, Florida, United States
International Dermatology Research, Inc.
Miami, Florida, United States
Tory P Sullivan M D PA
North Miami Beach, Florida, United States
Park Avenue Dermatology
Orange Park, Florida, United States
Riverchase Dermatology and Cosmetic Surgery
Pembroke Pines, Florida, United States
GCP Research
St. Petersburg, Florida, United States
Forcare Clinical Research Inc
Tampa, Florida, United States
Hamilton Dermatology Atlanta Dermatology, Vein & Research Center, LLC
Alpharetta, Georgia, United States
Advanced Medical Research
Atlanta, Georgia, United States
Skin Care Physicians of Georgia
Macon, Georgia, United States
University Dermatology and Vein Clinic
Darien, Illinois, United States
Northshore University Healthsystem
Skokie, Illinois, United States
Dundee Dermatology
West Dundee, Illinois, United States
Dawes Fretzin Clinical Research Group
Indianapolis, Indiana, United States
Indiana Clinical Trial Center
Plainfield, Indiana, United States
Epiphany Dermatology of Kansas, LLC
Overland Park, Kansas, United States
Ds Research
Louisville, Kentucky, United States
Callender Center for Clinical Research
Glenn Dale, Maryland, United States
Care Access Research
Marriottsville, Maryland, United States
DermAssociates, PC
Rockville, Maryland, United States
Lawrence J Green MD LLC
Rockville, Maryland, United States
Allcutis Research
Beverly, Massachusetts, United States
Metro Boston Clinical Partners
Brighton, Massachusetts, United States
David Fivenson MD, Dermatology
Ann Arbor, Michigan, United States
St Joseph Dermatology and Vein Clinic
Saint Joseph, Michigan, United States
Somerset Skin Centre
Troy, Michigan, United States
Henry Ford Medical Center
West Bloomfield, Michigan, United States
Twin Cities Dermatology Center
Minneapolis, Minnesota, United States
Skin Specialists
Omaha, Nebraska, United States
Psoriasis Treatment Center of Central New Jersey
East Windsor, New Jersey, United States
Hudson Dermatology & Skin Cancer Center
Hoboken, New Jersey, United States
Schweiger Dermatology Group
Verona, New Jersey, United States
Forest Hills Dermatology Group PLLC
Forest Hills, New York, United States
MDCS Dermatology
New York, New York, United States
Sadick Research Group
New York, New York, United States
Markowitz Medical OptiSkin
New York, New York, United States
Accellacare Research of Cary
Cary, North Carolina, United States
Darst Dermatology
Charlotte, North Carolina, United States
Dermatology Specialists
Charlotte, North Carolina, United States
Accellacare of Raleigh
Raleigh, North Carolina, United States
PMG Research of Rocky Mount, LLC
Rocky Mount, North Carolina, United States
PMG Research of Wilmington, LLC
Wilmington, North Carolina, United States
Wake Forest Health Sciences
Winston-Salem, North Carolina, United States
Advanced Dermatology and Skin Cancer Center
Boardman, Ohio, United States
Wright State Physicians Health Center
Dayton, Ohio, United States
Apex Dermatology Mayfield Heights
Mayfield Heights, Ohio, United States
Central Sooner Research
Norman, Oklahoma, United States
Schweiger Dermatology Group
Exton, Pennsylvania, United States
Temple University School of Medicine
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center (UPMC)
Pittsburgh, Pennsylvania, United States
Dermatology and Laser Center of Charleston
Charleston, South Carolina, United States
Palmetto Clinical Trial Services, LLC
Fountain Inn, South Carolina, United States
Arlington Center for Dermatology
Arlington, Texas, United States
Dermatology Treatment & Research Center, PA
Dallas, Texas, United States
Modern Research Associates PLLC
Dallas, Texas, United States
Center for Clinical Studies
Houston, Texas, United States
Suzanne Bruce and Associates - The Center for Skin Research
Houston, Texas, United States
Austin Institute for Clinical Research
Pflugerville, Texas, United States
Progressive Clinical Research
San Antonio, Texas, United States
Texas Dermatology and Laser Specialists
San Antonio, Texas, United States
Dermatology Research Institute Inc
Calgary, Alberta, Canada
Beacon Dermatology
Calgary, Alberta, Canada
Alberta DermaSurgery Centre
Edmonton, Alberta, Canada
Dr. Chih ho Hong Medical
Surrey, British Columbia, Canada
Dr. Lorne E. Albrecht
Surrey, British Columbia, Canada
CCA Medical Research Corporation
Ajax, Ontario, Canada
Dr Dusan Sajic Medicine Professional Corporation
Guelph, Ontario, Canada
Lynderm Research Inc.
Markham, Ontario, Canada
North York Research Inc
North York, Ontario, Canada
JRB Research Inc
Ottawa, Ontario, Canada
Nectar Research Group Inc
Richmond Hill, Ontario, Canada
Canadian Dermatology Center
Toronto, Ontario, Canada
Toronto Research Centre
Toronto, Ontario, Canada
FACET Dermatology
Toronto, Ontario, Canada
Research Toronto
Toronto, Ontario, Canada
Countries
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References
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Alexis A, McMichael A, Soung J, Choi O, Alkousakis T, Alonso-Llamazares J, Shahriari M, Rodriguez AO, Bhutani T, Chan D, Rowland K, Sauder M, Hong HC, Yadav G, Yeung J, Jeyarajah J, Ma T, Gao LL, Park-Wyllie L, Green L, Lee M, Vashi N, Kindred C, Grimes P, Taylor SC, Desai SR; VISIBLE Trial Investigators. Guselkumab for Moderate to Severe Psoriasis Across All Skin Tones: Cohort A of the VISIBLE Randomized Clinical Trial. JAMA Dermatol. 2025 Sep 1;161(9):901-911. doi: 10.1001/jamadermatol.2025.1836.
McMichael A, Shahriari M, Stein Gold L, Alkousakis T, Choi O, Bhutani T, Rodriguez AO, Tyring SK, Chan D, Rowland K, Albrecht L, Lynde C, Yadav G, Yeung J, Park-Wyllie L, Ma T, Jeyarajah J, Gao LL, Smith S, Moore AY, Vashi N, Kindred C, Grimes P, Desai SR, Taylor SC, Alexis A; VISIBLE Trial Investigators. Guselkumab for Moderate to Severe Scalp Psoriasis Across All Skin Tones: Cohort B of the VISIBLE Randomized Clinical Trial. JAMA Dermatol. 2025 Sep 1;161(9):912-922. doi: 10.1001/jamadermatol.2025.1849.
Alexis A, McMichael A, Vashi N, Bhutani T, Rodriguez AO, Yeung J, Choi O, Chan D, Alkousakis T, Bronner DN, Park-Wyllie L, Gao LL, Grimes P, Shahriari M, Yadav G, Kindred C, Taylor SC, Desai SR. Improving Diversity in a Novel Psoriasis Study: VISIBLE as a Framework for Clinical Trial Quality Improvement. JAMA Dermatol. 2025 Mar 1;161(3):256-264. doi: 10.1001/jamadermatol.2024.5103.
Other Identifiers
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CNTO1959PSO3018
Identifier Type: OTHER
Identifier Source: secondary_id
CR109163
Identifier Type: -
Identifier Source: org_study_id
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