Study of Guselkumab in Skin of Color Participants With Moderate-to-severe Plaque and/or Scalp Psoriasis
Study Purpose
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.
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 18 Years and Over |
Gender | All |
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.
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT05272150 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 3 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Janssen Research & Development, LLC |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Janssen Research & Development, LLC Clinical Trial |
Principal Investigator Affiliation | Janssen Research & Development, LLC |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
Overall Status | Recruiting |
Countries | Canada, United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Plaque Psoriasis, Scalp Psoriasis |
Arms
Experimental: 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.
Experimental: 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.
Interventions
Drug: - Guselkumab
Participants will receive guselkumab as subcutaneous injection.
Drug: - Placebo
Participants will receive placebo as subcutaneous injection.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Recruiting
Address
Total Skin & Beauty Dermatology Center
Birmingham, Alabama, 35205
Status
Recruiting
Address
Cahaba Research Inc
Birmingham, Alabama, 35244
Status
Recruiting
Address
Stoll Dermatology
Beverly Hills, California, 90212
Status
Recruiting
Address
California Dermatology & Clinical Research Institute
Encinitas, California, 92024
Status
Recruiting
Address
First OC Dermatology
Fountain Valley, California, 92708
Status
Recruiting
Address
Center for Dermatology Clinical Research
Fremont, California, 94538
Status
Recruiting
Address
Community Regional Medical Center
Fresno, California, 93701
Status
Recruiting
Address
Paul Wallace MD
Ladera Heights, California, 90056
Status
Recruiting
Address
The Grimes Center for Medical and Aesthetic Dermatology
Los Angeles, California, 90036
Status
Recruiting
Address
Care Access Research
Newport Beach, California, 92660
Status
Recruiting
Address
MedDerm Associates
San Diego, California, 92103
Status
Recruiting
Address
Synergy Clinical Research
San Francisco, California, 94132
Status
Recruiting
Address
Southern California Dermatology
Santa Ana, California, 92701
Status
Recruiting
Address
Clinical Science Institute
Santa Monica, California, 90404
Status
Recruiting
Address
University of Connecticut Health Center
Farmington, Connecticut, 06030
Status
Recruiting
Address
Center for Dermatology and Dermatologic Surgery
Washington, District of Columbia, 20037
Status
Recruiting
Address
Skin Care Research
Boca Raton, Florida, 33486
Status
Recruiting
Address
Driven Research LLC
Coral Gables, Florida, 33134
Status
Recruiting
Address
Florida Academic Dermatology Centers
Coral Gables, Florida, 33134
Status
Recruiting
Address
Hollywood Dermatology and Cosmetic Surgery
Hollywood, Florida, 33021
Status
Recruiting
Address
International Dermatology Research, Inc.
Miami, Florida, 33144
Status
Recruiting
Address
Tory P. Sullivan, M.D., PA
North Miami Beach, Florida, 33162
Status
Completed
Address
Park Avenue Dermatology
Orange Park, Florida, 32073
Status
Completed
Address
Riverchase Dermatology and Cosmetic Surgery
Pembroke Pines, Florida, 33028
Status
Recruiting
Address
GCP Research
Saint Petersburg, Florida, 33705
Status
Recruiting
Address
Forcare Clinical Research, Inc.
Tampa, Florida, 33613
Status
Recruiting
Address
Hamilton Dermatology Atlanta Dermatology, Vein & Research Center, LLC
Alpharetta, Georgia, 30022-1160
Status
Recruiting
Address
Advanced Medical Research
Atlanta, Georgia, 30328
Status
Recruiting
Address
Skin Care Physicians of Georgia
Macon, Georgia, 31217
Status
Recruiting
Address
University Dermatology and Vein Clinic
Darien, Illinois, 60561
Status
Recruiting
Address
Northshore Universite Healthsystem
Skokie, Illinois, 60077
Status
Recruiting
Address
Dundee Dermatology
West Dundee, Illinois, 60118
Status
Recruiting
Address
Dawes Fretzin Clinical Research Group
Indianapolis, Indiana, 46256
Status
Recruiting
Address
Indiana Clinical Trial Center
Plainfield, Indiana, 46168
Status
Recruiting
Address
Epiphany Dermatology of Kansas, LLC
Overland Park, Kansas, 66210
Status
Recruiting
Address
Ds Research
Louisville, Kentucky, 40241
Status
Recruiting
Address
Kindred Hair and Skin Center
Columbia, Maryland, 21045
Status
Recruiting
Address
Callender Center for Clinical Research
Glenn Dale, Maryland, 20769
Status
Recruiting
Address
DermAssociates, PC
Rockville, Maryland, 20850
Status
Recruiting
Address
Lawrence J Green MD LLC
Rockville, Maryland, 20850
Status
Recruiting
Address
Allcutis Research
Beverly, Massachusetts, 01915
Status
Recruiting
Address
Metro Boston Clinical Partners
Brighton, Massachusetts, 02135
Status
Recruiting
Address
David Fivenson MD, Dermatology
Ann Arbor, Michigan, 48103
Status
Recruiting
Address
St Joseph Dermatology and Vein Clinic
Saint Joseph, Michigan, 49085
Status
Recruiting
Address
Somerset Skin Centre
Troy, Michigan, 48084
Status
Recruiting
Address
Henry Ford Medical Center
West Bloomfield, Michigan, 48322
Status
Recruiting
Address
Twin Cities Dermatology Center
Minneapolis, Minnesota, 55416
Status
Recruiting
Address
Skin Specialists
Omaha, Nebraska, 68144
Status
Recruiting
Address
Psoriasis Treatment Center of Central New Jersey
East Windsor, New Jersey, 08520
Status
Recruiting
Address
Hudson Dermatology & Skin Cancer Center
Hoboken, New Jersey, 07030
Status
Recruiting
Address
Schweiger Dermatology Group
Verona, New Jersey, 07044
Status
Recruiting
Address
MDCS Dermatology
New York, New York, 10065
Status
Recruiting
Address
Markowitz Medical OptiSkin
New York, New York, 10128
Status
Recruiting
Address
Accellacare Research of Cary
Cary, North Carolina, 27511
Status
Recruiting
Address
Darst Dermatology
Charlotte, North Carolina, 28277
Status
Recruiting
Address
Dermatology Specialists
Charlotte, North Carolina, 28277
Status
Recruiting
Address
Accellacare of Raleigh
Raleigh, North Carolina, 27612
Status
Recruiting
Address
PMG Research of Rocky Mount, LLC
Rocky Mount, North Carolina, 27804
Status
Recruiting
Address
PMG Research of Wilmington, LLC
Wilmington, North Carolina, 28401
Status
Recruiting
Address
Wake Forest Health Sciences
Winston-Salem, North Carolina, 27104
Status
Recruiting
Address
Advanced Dermatology and Skin Cancer Center
Boardman, Ohio, 44512
Status
Recruiting
Address
Wright State Physicians Health Center
Dayton, Ohio, 45324
Status
Recruiting
Address
Apex Dermatology Mayfield Heights
Mayfield Heights, Ohio, 44124
Status
Recruiting
Address
Central Sooner Research
Norman, Oklahoma, 73071
Status
Recruiting
Address
Schweiger Dermatology Group
Exton, Pennsylvania, 19341
Status
Recruiting
Address
University of Pittsburgh Medical Center (UPMC)
Pittsburgh, Pennsylvania, 15213
Status
Recruiting
Address
Palmetto Clinical Trial Services, LLC
Fountain Inn, South Carolina, 29644
Status
Recruiting
Address
Arlington Center for Dermatology
Arlington, Texas, 76011
Status
Recruiting
Address
Austin Dermatology Associates
Austin, Texas, 78705
Status
Recruiting
Address
Dermatology Treatment & Research Center, PA
Dallas, Texas, 75230
Status
Recruiting
Address
Modern Research Associates PLLC
Dallas, Texas, 75231
Status
Recruiting
Address
Center for Clinical Studies
Houston, Texas, 77004
Status
Recruiting
Address
Suzanne Bruce and Associates - The Center for Skin Research
Houston, Texas, 77056-4132
Status
Recruiting
Address
Progressive Clinical Research
San Antonio, Texas, 78213
Status
Recruiting
Address
Texas Dermatology and Laser Specialists
San Antonio, Texas, 78218
International Sites
Status
Recruiting
Address
Dermatology Research Institute Inc.
Calgary, Alberta, T2J 7E1
Status
Recruiting
Address
Beacon Dermatology
Calgary, Alberta, T3E 0B2
Status
Recruiting
Address
Alberta DermaSurgery Centre
Edmonton, Alberta, T6G 2C1
Status
Recruiting
Address
Dr. Chih-ho Hong Medical
Surrey, British Columbia, V3R 6A7
Status
Recruiting
Address
Dr. Lorne E. Albrecht
Surrey, British Columbia, V3V 0C6
Status
Recruiting
Address
CCA Medical Research Corporation
Ajax, Ontario, L1S7K8
Status
Recruiting
Address
Dr Dusan Sajic Medicine Professional Corporation
Guelph, Ontario, N1L 0B7
Status
Recruiting
Address
Lynderm Research Inc.
Markham, Ontario, L3P 1X2
Status
Recruiting
Address
North York Research Inc
North York, Ontario, M2M 4J5
Status
Recruiting
Address
JRB Research Inc
Ottawa, Ontario, K1H 7X3
Status
Recruiting
Address
Nectar Research Group Inc
Richmond Hill, Ontario, L4B 1A5
Status
Recruiting
Address
Canadian Dermatology Center
Toronto, Ontario, M3B 0A7
Status
Recruiting
Address
Toronto Research Centre
Toronto, Ontario, M3H5Y8
Status
Recruiting
Address
Manna Research
Toronto, Ontario, M4C 1L1
Status
Recruiting
Address
Research Toronto
Toronto, Ontario, M4W 2N4