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

Recruitment Status
COMPLETED
(See Contacts and Locations)Verified August 2025 by Janssen Research & Development, LLC
Sponsor
Janssen Research & Development, LLC
Information Provided by (Responsible Party)
Janssen Research & Development, LLC
Clinicaltrials.gov Identifier
NCT05272150
Other Study ID Numbers:
CR109163
First Submitted
February 28, 2022
First Posted
March 8, 2022
Last Update Posted
September 11, 2025
Last Verified
August 2025

ClinicalTrials.gov processed this data on September 2025Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Plaque PsoriasisScalp Psoriasis
Drug: GuselkumabDrug: Guselkumab

Study Design

Study TypeInterventional
Actual Enrollment213 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingDouble
Primary PurposeTreatment
Official TitleA Phase 3b, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety and Efficacy of Guselkumab for the Treatment of Participants With Skin of Color Who Have Moderate-to-Severe Plaque Psoriasis and/or Moderate-to-Severe Scalp Psoriasis
Study Start DateJuly 12, 2022
Actual Primary Completion DateMay 29, 2025
Actual Study Completion DateMay 29, 2025

Groups and Cohorts

Group/CohortIntervention/Treatment
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.
Drug: Guselkumab
Participants will receive guselkumab 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.
Drug: Guselkumab
Participants will receive guselkumab as subcutaneous injection.

Outcome Measures

Primary Outcome Measures
  1. Cohort A: Percentage of Participants who Achieve Psoriasis Area and Severity Index (PASI) 90 Response at Week 16
    A PASI 90 response is defined as greater than or equal to (\>=) 90 percent (%) improvement in PASI score from baseline. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: head, trunk, upper, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease.
  2. Cohort A: Percentage of Participants who Achieve an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16
    Percentage of participants with IGA score of 0 (cleared) or 1 (minimal) will be reported. The IGA documents the investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
  3. Cohort B: Percentage of Participants who Achieve Psoriasis Scalp Severity Index (PSSI) 90 Response at Week 16
    A PSSI 90 response is defined as \>=90% reduction in PSSI score from baseline. The PSSI measures the extent of psoriasis involvement and the severity of erythema, infiltration, and desquamation of the scalp. Involved scalp area is measured on a scale from 0 (0% of scalp involved) to 6 (90-100% of scalp involved), clinical symptoms are each rated from 0 (absent) to 4 (severest possible). Involvement and severity of psoriasis for the PSSI is scored by physicians using a scale from 0 to 72, where 0=no psoriasis, and higher scores indicating more severe disease.
  4. Cohort B: Percentage of Participants who Achieve Scalp-specific Investigator Global Assessment (ss-IGA) Score of Absence of Disease (0) or Very Mild Disease (1) at Week 16
    Percentage of participants with ss-IGA score 0 (absence of disease) or 1 (very mild disease) will be reported. The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis. The lesions are assessed in terms of the clinical signs of redness, thickness, and scaliness which are scored as: absence of disease (0), very mild disease (1), mild disease (2), moderate disease (3), and severe disease (4).
Secondary Outcome Measures
  1. Cohort A: Percentage of Participants who Achieve IGA Score of Cleared (0) at Week 16
    Percentage of participants with IGA score 0 (cleared) will be reported. The IGA documents the investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
  2. Cohort A: Percentage of Participants who Achieve PASI 100 Response at Week 16
    A PASI 100 response is defined as 100% improvement in PASI score from baseline. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: head, trunk, upper, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease.
  3. Cohort A: Change from Baseline in PASI Score at Week 16
    Change from baseline in PASI score at Week 16 will be reported. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: head, trunk, upper, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The individual scores are multiplied by a weighted factor for each body region; the sum of these scores gives the total PASI score. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease.
  4. Cohort A: Change from Baseline in Body Surface Area (BSA) at Week 16
    Change from baseline in BSA at Week 16 will be reported. The BSA is a measurement of involved skin over the whole body. The overall BSA affected by psoriasis is estimated based on the participant's handprint (defined as the entire palmar surface of the hand including fingers).
  5. Cohort A: Time to >=90% Reduction in PASI Score
    Time to \>=90% reduction in PASI score will be reported which is defined as time to achieve \>=90% improvement in PASI. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: head, trunk, upper, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease.
  6. Cohorts A and B: Change from Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16
    Change from baseline in DLQI score at Week 16 will be reported. The DLQI is a dermatology specific quality of life instrument designed to assess the impact of dermatologic disease on a participant's quality of life (QoL). It is a 10 item patient-reported outcome(s) (PRO) questionnaire that, in addition to evaluating overall QoL, can be used to assess 6 different aspects that may affect QoL: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. The DLQI produces a numeric score that can range from 0 to 30. A higher score indicates more severe disease.
  7. Cohort A: Percentage of Participants who Achieve >= 4-point Reduction (Improvement) from Baseline in the Psoriasis Symptom and Sign Diary (PSSD) Itch Score at Week 16, Among Participants with Baseline PSSD Itch >= 4 at Baseline
    Percentage of participants who achieve \>=4-point reduction (improvement) from baseline in PSSD itch score at Week 16 among participants with baseline PSSD itch \>=4 at baseline will be reported. The PSSD includes PRO questionnaires designed to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefits. The participants are asked to answer the questions thinking about either the last 24 hours (24-hour recall version) or the last 7 days (7 days recall version). Both versions include 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Two subscores will be derived, each ranging from 0-100: the psoriasis symptom score and the psoriasis sign score. A higher score indicates more severe disease.
  8. Cohorts A and B: Percentage of Participants who Achieve a PSSD Symptom Score of 0 at Week 16, Among Randomized Participants with Baseline PSSD Symptom Score >=1
    Percentage of participants who achieve a PSSD symptom score of 0 at Week 16 among randomized participants with baseline PSSD symptom score \>=1 will be reported. The PSSD includes PRO questionnaires designed to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefits. The participants are asked to answer the questions thinking about either the last 24 hours (24-hour recall version) or the last 7 days (7 days recall version). Both versions include 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Two subscores will be derived, each ranging from 0-100: the psoriasis symptom score and the psoriasis sign score. A higher score indicates more severe disease.
  9. Cohorts A and B: Change from Baseline in PSSD Symptom Score at Week 16
    Change from baseline in PSSD symptom score at Week 16 will be reported. The PSSD includes PRO questionnaires designed to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefits. The participants are asked to answer the questions thinking about either the last 24 hours (24-hour recall version) or the last 7 days (7 days recall version). Both versions include 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Two subscores will be derived, each ranging from 0-100: the psoriasis symptom score and the psoriasis sign score. A higher score indicates more severe disease.
  10. Cohort B: Percentage of Participants who Achieve ss-IGA Score of Absence of Disease (0) at Week 16
    Percentage of participants with ss-IGA score 0 (absence of disease) will be reported. The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis. The lesions are assessed in terms of the clinical signs of redness, thickness, and scaliness which are scored as: absence of disease (0), very mild disease (1), mild disease (2), moderate disease (3), and severe disease (4).
  11. Cohort B: Change from Baseline in Scalp Surface Area (SSA) at Week 16
    Change from baseline in SSA at Week 16 will be reported. The SSA is a measurement of involved skin on the scalp. The overall SSA affected by psoriasis will be estimated based on the participant's thumb.
  12. Cohort B: Percentage of Participants who Achieve PSSI 100 Response at Week 16
    A PSSI 100 response is defined as 100% reduction in PSSI score from baseline. The PSSI measures the extent of psoriasis involvement and the severity of erythema, infiltration, and desquamation of the scalp. Involved scalp area is measured on a scale from 0 (0% of scalp involved) to 6 (90-100% of scalp involved), clinical symptoms are each rated from 0 (absent) to 4 (severest possible). Involvement and severity of psoriasis for the PSSI is scored by physicians using a scale from 0 to 72, where 0=no psoriasis, and higher scores indicating more severe disease.
  13. Cohort B: Change from Baseline in PSSI Score at Week 16
    Change from baseline in PSSI score at Week 16 will be reported. The PSSI measures the extent of psoriasis involvement and the severity of erythema, infiltration, and desquamation of the scalp. Involved scalp area is measured on a scale from 0 (0% of scalp involved) to 6 (90-100% of scalp involved), clinical symptoms are each rated from 0 (absent) to 4 (severest possible).The PSSI total score is a composite score derived from the sum of the scores for erythema, induration and desquamation multiplied by the score for the extent of scalp area involved (percent of scalp involved). Involvement and severity of psoriasis for the PSSI is scored by physicians using a scale from 0 to 72, where 0=no psoriasis, and higher scores indicating more severe disease.
  14. Cohort B: Time to >=90% Reduction in PSSI Score
    Time to \>=90% reduction in PSSI score will be reported which is defined as time to achieve \>=90% improvement in PSSI. The PSSI measures the extent of psoriasis involvement and the severity of erythema, infiltration, and desquamation of the scalp. Involvement and severity of psoriasis for the PSSI is scored by physicians using a scale from 0 to 72, where 0=no psoriasis, and higher scores indicating more severe disease.
  15. Cohort B: Percentage of Participants with >= 4 Point Reduction (Improvement) from Baseline in the Scalp Itch NRS Score at Week 16, Among Participants with Baseline Scalp Itch >=4 at Baseline
    Percentage of participants with \>=4 point reduction (improvement) from baseline in scalp itch NRS score, among participants with scalp itch \>=4 at baseline will be reported. The scalp itch NRS is a single-item scale that asks participants to rate the severity of their scalp itching due to psoriasis by considering their worst level of itching over the past 24 hours. The participants will be asked to assess scalp itch and select a number on a scale of 0-10, where "0" represents no scalp itch, and "10" represents the worst imaginable scalp itch.
  16. Cohorts A and B: Number of Participants with Adverse Events (AEs)
    An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
  17. Cohorts A and B: Number of Participants with Serious Adverse Events (SAEs)
    SAE is an adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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

Contacts and Locations

Sponsors and CollaboratorsJanssen Research & Development, LLC
Locations
Total Skin and Beauty Dermatology Center | Birmingham Alabama, United States, 35203Cahaba Research Inc | Birmingham Alabama, United States, 35244Stoll Dermatology | Beverly Hills California, United States, 90212California Dermatology & Clinical Research Institute | Encinitas California, United States, 92024First OC Dermatology | Fountain Valley California, United States, 92708Center for Dermatology Clinical Research | Fremont California, United States, 94538Community Regional Medical Center | Fresno California, United States, 93701Paul Wallace MD | Ladera Heights California, United States, 90056The Grimes Center for Medical and Aesthetic Dermatology | Los Angeles California, United States, 90036Care Access Research | Newport Beach California, United States, 92660MedDerm Associates | San Diego California, United States, 92103Synergy Clinical Research | San Francisco California, United States, 94132Southern California Dermatology | Santa Ana California, United States, 92701Clinical Science Institute | Santa Monica California, United States, 90404University of Connecticut Health Center | Farmington Connecticut, United States, 06030Center for Dermatology and Dermatologic Surgery | Washington D.C. District of Columbia, United States, 20037Skin Care Research | Boca Raton Florida, United States, 33486Driven Research LLC | Coral Gables Florida, United States, 33134Florida Academic Dermatology Centers | Coral Gables Florida, United States, 33134Hollywood Dermatology and Cosmetic Surgery | Hollywood Florida, United States, 33021International Dermatology Research, Inc. | Miami Florida, United States, 33144Tory P Sullivan M D PA | North Miami Beach Florida, United States, 33162Park Avenue Dermatology | Orange Park Florida, United States, 32073Riverchase Dermatology and Cosmetic Surgery | Pembroke Pines Florida, United States, 33028GCP Research | St. Petersburg Florida, United States, 33705Forcare Clinical Research Inc | Tampa Florida, United States, 33613Hamilton Dermatology Atlanta Dermatology, Vein & Research Center, LLC | Alpharetta Georgia, United States, 30022-1160Advanced Medical Research | Atlanta Georgia, United States, 30328Skin Care Physicians of Georgia | Macon Georgia, United States, 31217University Dermatology and Vein Clinic | Darien Illinois, United States, 60561Northshore University Healthsystem | Skokie Illinois, United States, 60077Dundee Dermatology | West Dundee Illinois, United States, 60118Dawes Fretzin Clinical Research Group | Indianapolis Indiana, United States, 46256Indiana Clinical Trial Center | Plainfield Indiana, United States, 46168Epiphany Dermatology of Kansas, LLC | Overland Park Kansas, United States, 66210Ds Research | Louisville Kentucky, United States, 40241Callender Center for Clinical Research | Glenn Dale Maryland, United States, 20769Care Access Research | Marriottsville Maryland, United States, 21104DermAssociates, PC | Rockville Maryland, United States, 20850Lawrence J Green MD LLC | Rockville Maryland, United States, 20850Allcutis Research | Beverly Massachusetts, United States, 01915Metro Boston Clinical Partners | Brighton Massachusetts, United States, 02135David Fivenson MD, Dermatology | Ann Arbor Michigan, United States, 48103St Joseph Dermatology and Vein Clinic | Saint Joseph Michigan, United States, 49085Somerset Skin Centre | Troy Michigan, United States, 48084Henry Ford Medical Center | West Bloomfield Michigan, United States, 48322Twin Cities Dermatology Center | Minneapolis Minnesota, United States, 55416Skin Specialists | Omaha Nebraska, United States, 68144Psoriasis Treatment Center of Central New Jersey | East Windsor New Jersey, United States, 08520Hudson Dermatology & Skin Cancer Center | Hoboken New Jersey, United States, 07030Schweiger Dermatology Group | Verona New Jersey, United States, 07044Forest Hills Dermatology Group PLLC | Forest Hills New York, United States, 11375MDCS Dermatology | New York New York, United States, 10065Sadick Research Group | New York New York, United States, 10075Markowitz Medical OptiSkin | New York New York, United States, 10128Accellacare Research of Cary | Cary North Carolina, United States, 27511Darst Dermatology | Charlotte North Carolina, United States, 28277Dermatology Specialists | Charlotte North Carolina, United States, 28277Accellacare of Raleigh | Raleigh North Carolina, United States, 27612PMG Research of Rocky Mount, LLC | Rocky Mount North Carolina, United States, 27804PMG Research of Wilmington, LLC | Wilmington North Carolina, United States, 28401Wake Forest Health Sciences | Winston-Salem North Carolina, United States, 27104Advanced Dermatology and Skin Cancer Center | Boardman Ohio, United States, 44512Wright State Physicians Health Center | Dayton Ohio, United States, 45324Apex Dermatology Mayfield Heights | Mayfield Heights Ohio, United States, 44124Central Sooner Research | Norman Oklahoma, United States, 73071Schweiger Dermatology Group | Exton Pennsylvania, United States, 19341Temple University School of Medicine | Philadelphia Pennsylvania, United States, 19140University of Pittsburgh Medical Center (UPMC) | Pittsburgh Pennsylvania, United States, 15213Dermatology and Laser Center of Charleston | Charleston South Carolina, United States, 29407Palmetto Clinical Trial Services, LLC | Fountain Inn South Carolina, United States, 29644Arlington Center for Dermatology | Arlington Texas, United States, 76011Dermatology Treatment & Research Center, PA | Dallas Texas, United States, 75230Modern Research Associates PLLC | Dallas Texas, United States, 75231Center for Clinical Studies | Houston Texas, United States, 77004Suzanne Bruce and Associates - The Center for Skin Research | Houston Texas, United States, 77056-4132Austin Institute for Clinical Research | Pflugerville Texas, United States, 78660Progressive Clinical Research | San Antonio Texas, United States, 78213Texas Dermatology and Laser Specialists | San Antonio Texas, United States, 78218Dermatology Research Institute Inc | Calgary Alberta, Canada, T2J 7E1Beacon Dermatology | Calgary Alberta, Canada, T3E 0B2Alberta DermaSurgery Centre | Edmonton Alberta, Canada, T6G 2C1Dr. Chih ho Hong Medical | Surrey British Columbia, Canada, V3R 6A7Dr. Lorne E. Albrecht | Surrey British Columbia, Canada, V3V 0C6CCA Medical Research Corporation | Ajax Ontario, Canada, L1S7K8Dr Dusan Sajic Medicine Professional Corporation | Guelph Ontario, Canada, N1L 0B7Lynderm Research Inc. | Markham Ontario, Canada, L3P 1X2North York Research Inc | North York Ontario, Canada, M2M 4J5JRB Research Inc | Ottawa Ontario, Canada, K1K 4L2Nectar Research Group Inc | Richmond Hill Ontario, Canada, L4B 1A5Canadian Dermatology Center | Toronto Ontario, Canada, M3B 0A7Toronto Research Centre | Toronto Ontario, Canada, M3H 5Y8FACET Dermatology | Toronto Ontario, Canada, M4E 2Y9Research Toronto | Toronto Ontario, Canada, M4W 2N4
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC