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

CNTO1959PSO3018: A 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

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.

Study Overview

• Status: Completed
• Conditions: Plaque Psoriasis; Scalp Psoriasis
• Intervention / Treatment: Drug: Guselkumab; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 211
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T3E 0B2
      • Beacon Dermatology
    • Calgary, Alberta, Canada, T2J 7E1
      • Dermatology Research Institute Inc
    • Edmonton, Alberta, Canada, T6G 2C1
      • Alberta Dermasurgery Centre
  • British Columbia
    • Surrey, British Columbia, Canada, V3V 0C6
      • Dr. Lorne E. Albrecht
    • Surrey, British Columbia, Canada, V3R 6A7
      • Dr. Chih ho Hong Medical
  • Ontario
    • Ajax, Ontario, Canada, L1S7K8
      • CCA Medical Research Corporation
    • Guelph, Ontario, Canada, N1L 0B7
      • Dr Dusan Sajic Medicine Professional Corporation
    • Markham, Ontario, Canada, L3P 1X2
      • Lynderm Research Inc.
    • North York, Ontario, Canada, M2M 4J5
      • North York Research Inc
    • Ottawa, Ontario, Canada, K1K 4L2
      • JRB Research Inc
    • Richmond Hill, Ontario, Canada, L4B 1A5
      • Nectar Research Group Inc
    • Toronto, Ontario, Canada, M4W 2N4
      • Research Toronto
    • Toronto, Ontario, Canada, M3H 5Y8
      • Toronto Research Centre
    • Toronto, Ontario, Canada, M3B 0A7
      • Canadian Dermatology Center
    • Toronto, Ontario, Canada, M4E 2Y9
      • FACET Dermatology
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35244
      • Cahaba Research Inc
    • Birmingham, Alabama, United States, 35203
      • Total Skin and Beauty Dermatology Center
  • California
    • Beverly Hills, California, United States, 90212
      • Stoll Dermatology
    • Encinitas, California, United States, 92024
      • California Dermatology & Clinical Research Institute
    • Fountain Valley, California, United States, 92708
      • First OC Dermatology
    • Fremont, California, United States, 94538
      • Center for Dermatology Clinical Research
    • Fresno, California, United States, 93701
      • Community Regional Medical Center
    • Ladera Heights, California, United States, 90056
      • Paul Wallace MD
    • Los Angeles, California, United States, 90036
      • The Grimes Center for Medical and Aesthetic Dermatology
    • Newport Beach, California, United States, 92660
      • Care Access Research 1
    • San Diego, California, United States, 92103
      • MedDerm Associates
    • San Francisco, California, United States, 94132
      • Synergy Clinical Research
    • Santa Ana, California, United States, 92701
      • Southern California Dermatology
    • Santa Monica, California, United States, 90404
      • Clinical Science Institute
  • Connecticut
    • Farmington, Connecticut, United States, 06030
      • University of Connecticut Health Center
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20037
      • Center for Dermatology and Dermatologic Surgery
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Skin Care Research
    • Coral Gables, Florida, United States, 33134
      • Florida Academic Dermatology Centers
    • Coral Gables, Florida, United States, 33134
      • Driven Research LLC
    • Hollywood, Florida, United States, 33021
      • Hollywood Dermatology and Cosmetic Surgery
    • Miami, Florida, United States, 33144
      • International Dermatology Research, Inc.
    • North Miami Beach, Florida, United States, 33162
      • Tory P Sullivan M D PA
    • Orange Park, Florida, United States, 32073
      • Park Avenue Dermatology
    • Pembroke Pines, Florida, United States, 33028
      • Riverchase Dermatology and Cosmetic Surgery
    • St. Petersburg, Florida, United States, 33705
      • GCP Research
    • Tampa, Florida, United States, 33613
      • Forcare Clinical Research Inc
  • Georgia
    • Alpharetta, Georgia, United States, 30022-1160
      • Hamilton Dermatology Atlanta Dermatology, Vein & Research Center, LLC
    • Atlanta, Georgia, United States, 30328
      • Advanced Medical Research
    • Macon, Georgia, United States, 31217
      • Skin Care Physicians of Georgia
  • Illinois
    • Darien, Illinois, United States, 60561
      • University Dermatology and Vein Clinic
    • Skokie, Illinois, United States, 60077
      • NorthShore University HealthSystem
    • West Dundee, Illinois, United States, 60118
      • Dundee Dermatology
  • Indiana
    • Indianapolis, Indiana, United States, 46256
      • Dawes Fretzin Clinical Research Group
    • Plainfield, Indiana, United States, 46168
      • Indiana Clinical Trial Center
  • Kansas
    • Overland Park, Kansas, United States, 66210
      • Epiphany Dermatology of Kansas, LLC
  • Kentucky
    • Louisville, Kentucky, United States, 40241
      • DS Research
  • Maryland
    • Glenn Dale, Maryland, United States, 20769
      • Callender Center for Clinical Research
    • Marriottsville, Maryland, United States, 21104
      • Care Access Research
    • Rockville, Maryland, United States, 20850
      • DermAssociates, PC
    • Rockville, Maryland, United States, 20850
      • Lawrence J Green MD LLC
  • Massachusetts
    • Beverly, Massachusetts, United States, 01915
      • Allcutis Research
    • Brighton, Massachusetts, United States, 02135
      • Metro Boston Clinical Partners
  • Michigan
    • Ann Arbor, Michigan, United States, 48103
      • David Fivenson MD, Dermatology
    • Saint Joseph, Michigan, United States, 49085
      • St Joseph Dermatology and Vein Clinic
    • Troy, Michigan, United States, 48084
      • Somerset Skin Centre
    • West Bloomfield, Michigan, United States, 48322
      • Henry Ford Medical Center
  • Minnesota
    • Minneapolis, Minnesota, United States, 55416
      • Twin Cities Dermatology Center
  • Nebraska
    • Omaha, Nebraska, United States, 68144
      • Skin Specialists
  • New Jersey
    • East Windsor, New Jersey, United States, 08520
      • Psoriasis Treatment Center of Central New Jersey
    • Hoboken, New Jersey, United States, 07030
      • Hudson Dermatology & Skin Cancer Center
    • Verona, New Jersey, United States, 07044
      • Schweiger Dermatology Group
  • New York
    • Forest Hills, New York, United States, 11375
      • Forest Hills Dermatology Group PLLC
    • New York, New York, United States, 10075
      • Sadick Research Group
    • New York, New York, United States, 10065
      • MDCS Dermatology
    • New York, New York, United States, 10128
      • Markowitz Medical OptiSkin
  • North Carolina
    • Cary, North Carolina, United States, 27511
      • Accellacare Research of Cary
    • Charlotte, North Carolina, United States, 28277
      • Darst Dermatology
    • Charlotte, North Carolina, United States, 28277
      • Dermatology Specialists
    • Raleigh, North Carolina, United States, 27612
      • Accellacare of Raleigh
    • Rocky Mount, North Carolina, United States, 27804
      • PMG Research of Rocky Mount, LLC
    • Wilmington, North Carolina, United States, 28401
      • PMG Research of Wilmington, LLC
    • Winston-Salem, North Carolina, United States, 27104
      • Wake Forest Health Sciences
  • Ohio
    • Boardman, Ohio, United States, 44512
      • Advanced Dermatology and Skin Cancer Center
    • Dayton, Ohio, United States, 45324
      • Wright State Physicians Health Center
    • Mayfield Heights, Ohio, United States, 44124
      • Apex Dermatology Mayfield Heights
  • Oklahoma
    • Norman, Oklahoma, United States, 73071
      • Central Sooner Research
  • Pennsylvania
    • Exton, Pennsylvania, United States, 19341
      • Schweiger Dermatology Group 1
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple University School of Medicine
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center (UPMC)
  • South Carolina
    • Charleston, South Carolina, United States, 29407
      • Dermatology and Laser Center of Charleston
    • Fountain Inn, South Carolina, United States, 29644
      • Palmetto Clinical Trial Services, LLC
  • Texas
    • Arlington, Texas, United States, 76011
      • Arlington Center for Dermatology
    • Dallas, Texas, United States, 75231
      • Modern Research Associates PLLC
    • Dallas, Texas, United States, 75230
      • Dermatology Treatment & Research Center, PA
    • Houston, Texas, United States, 77004
      • Center for Clinical Studies
    • Houston, Texas, United States, 77056-4132
      • Suzanne Bruce and Associates - The Center for Skin Research
    • Pflugerville, Texas, United States, 78660
      • Austin Institute for Clinical Research
    • San Antonio, Texas, United States, 78218
      • Texas Dermatology and Laser Specialists
    • San Antonio, Texas, United States, 78213
      • Progressive Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Guselkumab; Participants will receive guselkumab as subcutaneous injection.; Other Names: Tremfya; CNTO1959; Drug: Placebo; Participants will receive placebo as subcutaneous injection.
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.	Drug: Guselkumab; Participants will receive guselkumab as subcutaneous injection.; Other Names: Tremfya; CNTO1959; Drug: Placebo; Participants will receive placebo as subcutaneous injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cohort A: Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16	The IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 point scale. Induration: 0 = no evidence of plaque elevation; 1 = minimal plaque elevation, = 0.25 millimeters (mm); 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, greater than (>) 1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over less than 5% of the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates. Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). Higher score indicated more severe disease.	Week 16
Cohort A: Percentage of Participants Who Achieved Psoriasis Area Severity Index (PASI) 90 Response at Week 16	Percentage of participants who achieved PASI 90 response (greater than or equal to [>=] 90 percent [%] improvement from baseline in PASI) at Week 16 was reported. PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1=slight, 2=moderate, 3=severe and 4=very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date unless otherwise specified.	Week 16
Cohort B: Percentage of Participants Who Achieved Scalp Specific (ss)-IGA Score of Absence of Disease (0) or Very Mild Disease (1) at Week 16	The ss-IGA instrument was used to evaluate the disease severity of scalp psoriasis. The lesions were assessed in terms of the clinical signs of redness, thickness, and scaliness which was scored as: absence of disease = 0, very mild disease = 1, mild disease = 2, moderate disease = 3, and severe disease = 4. A higher score indicated more severe disease.	Week 16
Cohort B: Percentage of Participants Who Achieved Psoriasis Scalp Severity Index (PSSI) 90 Response at Week 16	PSSI 90 response is defined as a percentage of participants who achieved at least 90% improvement from baseline in the PSSI score. PSSI is a physician assessment of severity of erythema, infiltration, and desquamation and extent of psoriasis involvement. Severity of erythema, infiltration, and desquamation each scored on a scale of 0 (none) to 4 (very severe) and the extent of psoriasis involvement scored on a scale from 1 (<10% of scalp involved) to 6 (90 to 100% of scalp involved). The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the psoriasis involvement. The PSSI score ranged from 0 (less severity) to 72 (more severity). Higher scores indicated more severe symptoms. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date unless otherwise specified.	Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cohort A: Percentage of Participants Who Achieved IGA Score of Cleared (0) at Week 16	The IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 point scale. Induration: 0 = no evidence of plaque elevation; 1 = minimal plaque elevation, = 0.25 millimeters (mm); 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, greater than (>) 1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over less than 5% of the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates. Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). Higher score indicated more severe disease.	Week 16
Cohort A: Percentage of Participants Who Achieved PASI 100 Response at Week 16	Percentage of participants who achieved PASI-100 response (100% improvement from baseline in PASI) at Week 16 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date unless otherwise specified.	Week 16
Cohort A: Percent Change From Baseline in PASI Total Score at Week 16	Percent change from baseline in PASI total score at Week 16 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date unless otherwise specified.	Baseline (Week 0), Week 16
Cohort A: Percent Change From Baseline in Body Surface Area (BSA) at Week 16	A BSA was commonly used measure of severity of skin disease. It was defined as the percentage of surface area of the body involved with the condition being assessed, (that is, plaque psoriasis). BSA was assessed using hand print method where the surface area of the participant's hand including the palm and all 5 digits was used as a guide to estimate 1% BSA. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date unless otherwise specified.	Baseline (Week 0), Week 16
Cohort A: Time to Greater Than or Equal to (>=) 90 Percent (%) Reduction in PASI Score	Time to >=90% reduction was defined as the time at which >=90% improvement in PASI from baseline was achieved. PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1=slight, 2=moderate, 3=severe and 4=very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date unless otherwise specified.	From baseline (Week 0) up to Week 16
Cohorts A and B: Change From Baseline in Total Dermatology Life Quality Index (DLQI) Score at Week 16	Change from baseline in total DLQI score at Week 16 was reported. The DLQI was a dermatology specific health related quality of life (HRQoL) instrument designed to assess the impact of the disease on a participant's HRQoL. It was a 10-item questionnaire that assesses HRQoL over the past week and in addition to evaluating overall HRQoL, could be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. Each question was scored on a 4-point scale of 0 to 3 (0 = not at all, 1 = a little; 2 = a lot; or 3 = very much), where higher score indicated more impact on QoL. The total score was sum of scores from all 10 questions and it ranged from 0 (not at all) to 30 (very much), with a higher score indicating greater impact on HRQoL. Baseline = closest measurement taken prior to or at the time of the first study drug administration date unless otherwise specified.	Baseline (Week 0), Week 16
Cohort A: Percentage of Participants Who Achieved >= 4-point Reduction From Baseline in the Psoriasis Symptom and Sign Diary (PSSD) Itch Score at Week 16 Among Participants With Baseline PSSD Itch Score >=4	PSSD was a patient reported outcomes (PRO) questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. 7 day recall version was used. PSSD was a self-administered PRO instrument that included 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. PSSD itch item score over seven days was averaged into a weekly itch score, ranging from 0 to 10 with higher scores indicating severe disease. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date unless otherwise specified.	Week 16
Cohorts A and B: Change From Baseline in PSSD Symptom Score at Week 16	Change from baseline in PSSD symptoms scores at Week 16 was reported. PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. 7-day recall version was used. PSSD was self-administered PRO instrument that included 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. Items were averaged on the weekly symptom score when at least 3 items (>=50 percentage of 5 items) on these scales are answered. The average value was converted into 0-100 scoring, such that symptom score = average value*10, where, 0= least severe and 100= most severe. Higher score indicated more severe disease. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date unless otherwise specified.	Baseline (Week 0), Week 16
Cohorts A and B: Percentage of Participants Who Achieved PSSD Symptom Score of 0 at Week 16 Among Participants With Baseline PSSD Symptom Score >=1	PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. 7-day recall version was used. PSSD was self-administered PRO instrument that included 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. Items were averaged on the weekly symptom score when at least 3 items (>=50 percentage of 5 items) on these scales are answered. The average value was converted into 0-100 scoring, such that symptom score = average value*10, where, 0= least severe and 100= most severe. Higher score indicated more severe disease. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date unless otherwise specified.	Week 16
Cohort B: Percent Change From Baseline in Psoriasis Scalp Severity Index (PSSI) Score at Week 16	PSSI is a physician assessment of severity of erythema, infiltration, and desquamation and extent of psoriasis involvement. Severity of erythema, infiltration, and desquamation each scored on a scale of 0 (none) to 4 (very severe) and the extent of psoriasis involvement scored on a scale from 1 (<10% of scalp involved) to 6 (90 to 100% of scalp involved). The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the psoriasis involvement. The PSSI score ranged from 0 (less severity) to 72 (more severity). Higher scores indicated more severe symptoms. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date unless otherwise specified.	Baseline (Week 0), Week 16
Cohort B: Percent Change From Baseline in Scalp Surface Area (SSA) at Week 16	Scalp Surface Area (SSA) is defined as the extent of scalp skin affected by psoriasis, expressed as a percentage of the total scalp surface area. The adult SSA was 520-705 centimeter^2 (cm^2), which mean 1% SSA is 5.2 - 7.1 cm^2. The thumbprint has an average surface area of 5.5 cm^2 +/- 1.3 cm^2. The thumb (in particular, the thumb projection) was used as a tool for accurate measurement of 1% SSA. The overall SSA affected by psoriasis was thus be estimated based on the participant's thumb. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date unless otherwise specified.	Baseline (Week 0), Week 16
Cohort B: Percentage of Participants Who Achieved Scalp Specific (ss)-IGA Score of Absence of Disease (0) at Week 16	The ss-IGA instrument was used to evaluate the disease severity of scalp psoriasis. The lesions were assessed in terms of the clinical signs of redness, thickness, and scaliness which was scored as: absence of disease = 0, very mild disease = 1, mild disease = 2, moderate disease = 3, and severe disease = 4. A higher score indicated more severe disease.	Week 16
Cohort B: Percentage of Participants Who Achieved PSSI 100 Response at Week 16	PSSI 100 response is defined as a percentage of participants who achieved 100% improvement from baseline in the PSSI score. PSSI is a physician assessment of severity of erythema, infiltration, and desquamation and extent of psoriasis involvement. Severity of erythema, infiltration, and desquamation each scored on a scale of 0 (none) to 4 (very severe) and the extent of psoriasis involvement scored on a scale from 1 (<10% of scalp involved) to 6 (90 to 100% of scalp involved). The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the psoriasis involvement. The PSSI score ranged from 0 (less severity) to 72 (more severity). Higher scores indicated more severe symptoms. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date unless otherwise specified.	Week 16
Cohort B: Time to >=90% Reduction in PSSI Score	Time to >=90% reduction was defined as the time at which >=90% improvement in PSSI from baseline was achieved. PSSI is a physician assessment of severity of erythema, infiltration, and desquamation and extent of psoriasis involvement. Severity of erythema, infiltration, and desquamation each scored on a scale of 0 (none) to 4 (very severe) and the extent of psoriasis involvement scored on a scale from 1 (<10% of scalp involved) to 6 (90 to 100% of scalp involved). The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the psoriasis involvement. The PSSI score ranged from 0 (less severity) to 72 (more severity). Higher scores indicated more severe symptoms. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date unless otherwise specified.	From Baseline (Week 0) up to Week 16
Cohort B: Percentage of Participants Who Achieved >=4-point Reduction From Baseline in the Scalp Itch Numeric Rating Scale (NRS) Score at Week 16 Among Participants With Baseline Scalp Itch Score >=4	The scalp itch NRS was 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 11-point scalp itch NRS ranged from 0 (no scalp itch) to 10 (worst scalp itch imaginable). Higher scores indicated more severe scalp itch. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date unless otherwise specified.	Week 16
Cohorts A and B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAE was defined as any AE that occurred after the start of initial study agent administration and those AEs that were presented at baseline but worsened in severity after the start of initial study agent administration.	Cohorts A and B: Placebo: From Week 0 to Week 16; Cohorts A and B: Placebo Followed by Guselkumab 100 mg: From Week 16 to Week 112; Cohorts A and B: Guselkumab 100 mg: From Week 0 to Week 112
Cohorts A and B: Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs)	An AE was any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Serious adverse event (SAE) was any untoward medical occurrence at any dose that: resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or resulted in congenital anomaly/birth defect. TEAE was defined as any AE that occurred after the start of initial study agent administration and those AEs that were presented at baseline but worsened in severity after the start of initial study agent administration.	Cohorts A and B: Placebo: From Week 0 to Week 16; Cohorts A and B: Placebo Followed by Guselkumab 100 mg: From Week 16 to Week 112; Cohorts A and B: Guselkumab 100 mg: From Week 0 to Week 112

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Investigators: Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Publications and helpful links

General Publications

• 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.
• Alexis A, McMichael A, Vashi N, Bhutani T, Yeung J, Alkousakis T, Rowland K, Choi O, Ma T, Chan D, Lester J, Rodriguez AO, Yadav G, Kindred C, Grimes P, Taylor SC, Desai SR. The Impact of Post-inflammatory Pigment Alteration After Psoriasis: Novel Data from the VISIBLE Study. Dermatol Ther (Heidelb). 2026 Apr;16(4):2031-2045. doi: 10.1007/s13555-026-01688-z. Epub 2026 Mar 2.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2022
• Primary Completion (Actual): May 30, 2025
• Study Completion (Actual): May 30, 2025

Study Registration Dates

• First Submitted: March 1, 2022
• First Submitted That Met QC Criteria: March 1, 2022
• First Posted (Actual): March 9, 2022

Study Record Updates

• Last Update Posted (Actual): June 24, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases, Papulosquamous; Skin Diseases; Psoriasis; Substandard Drugs; Pharmaceutical Preparations; guselkumab
• Other Study ID Numbers: CR109163; CNTO1959PSO3018 (Other Identifier: Janssen Research & Development, LLC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No