Study of Guselkumab in Skin of Color Participants With Moderate-to-severe Plaque and/or Scalp Psoriasis
Launched by JANSSEN RESEARCH & DEVELOPMENT, LLC · Mar 1, 2022
Trial Information
Current as of May 28, 2025
Active, not recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a medication called guselkumab to see how well it works for people with moderate-to-severe plaque psoriasis or scalp psoriasis who identify as non-white or non-Caucasian. The main goal is to measure improvements in the signs and symptoms of psoriasis in these participants compared to those receiving a placebo, which is an inactive treatment.
To be eligible for this trial, participants should have been diagnosed with plaque psoriasis for at least six months and should have a significant amount of skin affected by the condition. Specifically, they need to have at least 10% of their body covered in psoriasis or significant involvement of the scalp. Participants must also agree not to receive certain vaccines during the study and should not have received specific psoriasis treatments in the recent past. If someone joins the trial, they will receive either the guselkumab treatment or a placebo and will be monitored for improvements in their psoriasis over the course of the study.
Gender
ALL
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
About Janssen Research & Development, Llc
Janssen Research & Development, LLC, a subsidiary of Johnson & Johnson, is a leading pharmaceutical company dedicated to advancing innovative therapies in multiple therapeutic areas, including oncology, immunology, neuroscience, infectious diseases, and cardiovascular health. With a strong commitment to scientific excellence and patient-centered research, Janssen leverages cutting-edge technology and collaborative partnerships to drive the development of transformative treatments. The company is focused on addressing unmet medical needs through rigorous clinical trials and a robust pipeline, aiming to improve health outcomes and enhance the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Providence, Rhode Island, United States
Jackson, Mississippi, United States
Durham, North Carolina, United States
Farmington, Connecticut, United States
Philadelphia, Pennsylvania, United States
Columbus, Ohio, United States
New York, New York, United States
Fridley, Minnesota, United States
Orange Park, Florida, United States
Troy, Michigan, United States
Nashville, Tennessee, United States
Pittsburgh, Pennsylvania, United States
Portland, Oregon, United States
West Bloomfield, Michigan, United States
Arlington, Texas, United States
Portland, Oregon, United States
Verona, New Jersey, United States
Stony Brook, New York, United States
Fountain Inn, South Carolina, United States
Birmingham, Alabama, United States
San Diego, California, United States
Coral Gables, Florida, United States
Hollywood, Florida, United States
West Dundee, Illinois, United States
Ann Arbor, Michigan, United States
Hoboken, New Jersey, United States
Dallas, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
Markham, Ontario, Canada
Ottawa, Ontario, Canada
Wilmington, North Carolina, United States
Indianapolis, Indiana, United States
Miami, Florida, United States
Santa Monica, California, United States
Cleveland, Ohio, United States
Fremont, California, United States
Skokie, Illinois, United States
Norman, Oklahoma, United States
Washington, District Of Columbia, United States
New York, New York, United States
Wenatchee, Washington, United States
Austin, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
Fresno, California, United States
Glenn Dale, Maryland, United States
Rocky Mount, North Carolina, United States
Charlotte, North Carolina, United States
Plainfield, Indiana, United States
Rockville, Maryland, United States
Boca Raton, Florida, United States
Encinitas, California, United States
San Antonio, Texas, United States
Pflugerville, Texas, United States
East Windsor, New Jersey, United States
Toronto, Ontario, Canada
Ocala, Florida, United States
Santa Ana, California, United States
Charleston, South Carolina, United States
Louisville, Kentucky, United States
Brighton, Massachusetts, United States
San Antonio, Texas, United States
Surrey, British Columbia, Canada
Los Angeles, California, United States
Atlanta, Georgia, United States
Marietta, Georgia, United States
Skokie, Illinois, United States
High Point, North Carolina, United States
Houston, Texas, United States
Toronto, Ontario, Canada
Fountain Valley, California, United States
Charlotte, North Carolina, United States
Calgary, Alberta, Canada
Toronto, Ontario, Canada
Pembroke Pines, Florida, United States
Bexley, Ohio, United States
Dayton, Ohio, United States
Calgary, Alberta, Canada
Newport Beach, California, United States
Macon, Georgia, United States
Sherman Oaks, California, United States
Saint Joseph, Michigan, United States
Overland Park, Kansas, United States
Markham, Ontario, Canada
Tampa, Florida, United States
Verona, New Jersey, United States
Saint Petersburg, Florida, United States
Miramar, Florida, United States
Plano, Texas, United States
Beverly, Massachusetts, United States
Coral Gables, Florida, United States
Birmingham, Alabama, United States
San Francisco, California, United States
Fort Lauderdale, Florida, United States
Miami, Florida, United States
Palm Beach Gardens, Florida, United States
Boston, Massachusetts, United States
Beverly Hills, California, United States
Rockville, Maryland, United States
Birmingham, Alabama, United States
Birmingham, Alabama, United States
Ladera Heights, California, United States
Los Angeles, California, United States
Newport Beach, California, United States
Fort Myers, Florida, United States
Darien, Illinois, United States
Columbia, Maryland, United States
Minneapolis, Minnesota, United States
Omaha, Nebraska, United States
Cary, North Carolina, United States
Charlotte, North Carolina, United States
Raleigh, North Carolina, United States
Boardman, Ohio, United States
Cincinnati, Ohio, United States
Mayfield Heights, Ohio, United States
Exton, Pennsylvania, United States
Lynchburg, Virginia, United States
Edmonton, Alberta, Canada
Surrey, British Columbia, Canada
Ajax, Ontario, Canada
Etobicoke, Ontario, Canada
Guelph, Ontario, Canada
North York, Ontario, Canada
Richmond Hill, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Encinitas, California, United States
San Diego, California, United States
San Francisco, California, United States
North Miami Beach, Florida, United States
Alpharetta, Georgia, United States
New York, New York, United States
Winston Salem, North Carolina, United States
Newport News, Virginia, United States
Forest Hills, New York, United States
New York, New York, United States
Nashville, Tennessee, United States
Marriottsville, Maryland, United States
Birmingham, Alabama, United States
Birmingham, Alabama, United States
Tampa, Florida, United States
Toronto, Ontario, Canada
Ottawa, Ontario, Canada
Surrey, British Columbia, Canada
North Miami Beach, Florida, United States
Calgary, Alberta, Canada
Ottawa, Ontario, Canada
Patients applied
Trial Officials
Janssen Research & Development, LLC Clinical Trial
Study Director
Janssen Research & Development, LLC
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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