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

Primary Purpose

Plaque Psoriasis, Scalp Psoriasis

Status

Active

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Guselkumab

Placebo

About this trial

This is an interventional treatment trial for Plaque Psoriasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Total Skin & Beauty Dermatology Center
Cahaba Research Inc
Stoll Dermatology
California Dermatology & Clinical Research Institute
First OC Dermatology
Center for Dermatology Clinical Research
Community Regional Medical Center
Paul Wallace MD
The Grimes Center for Medical and Aesthetic Dermatology
Care Access Research
MedDerm Associates
Synergy Clinical Research
Southern California Dermatology
Clinical Science Institute
University of Connecticut Health Center
Center for Dermatology and Dermatologic Surgery
Skin Care Research
Driven Research LLC
Florida Academic Dermatology Centers
Hollywood Dermatology and Cosmetic Surgery
International Dermatology Research, Inc.
Tory P. Sullivan, M.D., PA
Park Avenue Dermatology
Riverchase Dermatology and Cosmetic Surgery
GCP Research
Forcare Clinical Research, Inc.
Hamilton Dermatology Atlanta Dermatology, Vein & Research Center, LLC
Advanced Medical Research
Skin Care Physicians of Georgia
University Dermatology and Vein Clinic
Northshore Universite Healthsystem
Dundee Dermatology
Dawes Fretzin Clinical Research Group
Indiana Clinical Trial Center
Epiphany Dermatology of Kansas, LLC
Ds Research
Callender Center for Clinical Research
Care Access Research
DermAssociates, PC
Lawrence J Green MD LLC
Allcutis Research
Metro Boston Clinical Partners
David Fivenson MD, Dermatology
St Joseph Dermatology and Vein Clinic
Somerset Skin Centre
Henry Ford Medical Center
Twin Cities Dermatology Center
Skin Specialists
Psoriasis Treatment Center of Central New Jersey
Hudson Dermatology & Skin Cancer Center
Schweiger Dermatology Group
Forest Hills Dermatology Group PLLC
MDCS Dermatology
Sadick Research Group
Markowitz Medical OptiSkin
Accellacare Research of Cary
Darst Dermatology
Dermatology Specialists
Accellacare of Raleigh
PMG Research of Rocky Mount, LLC
PMG Research of Wilmington, LLC
Wake Forest Health Sciences
Advanced Dermatology and Skin Cancer Center
Wright State Physicians Health Center
Apex Dermatology Mayfield Heights
Central Sooner Research
Schweiger Dermatology Group
Temple University School of Medicine
University of Pittsburgh Medical Center (UPMC)
Dermatology and Laser Center of Charleston
Palmetto Clinical Trial Services, LLC
Arlington Center for Dermatology
Austin Dermatology Associates
Dermatology Treatment & Research Center, PA
Modern Research Associates PLLC
Center for Clinical Studies
Suzanne Bruce and Associates - The Center for Skin Research
Progressive Clinical Research
Texas Dermatology and Laser Specialists
Dermatology Research Institute Inc.
Beacon Dermatology
Alberta DermaSurgery Centre
Dr. Chih-ho Hong Medical
Dr. Lorne E. Albrecht
CCA Medical Research Corporation
Dr Dusan Sajic Medicine Professional Corporation
Lynderm Research Inc.
North York Research Inc
JRB Research Inc
Nectar Research Group Inc
Canadian Dermatology Center
Toronto Research Centre
Manna Research
Research Toronto

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Cohort A: Moderate-to-severe Plaque Psoriasis

Cohort B: Moderate-to-severe Scalp Psoriasis

Arm Description

Participants will receive either guselkumab subcutaneously (SC) or placebo SC. Placebo participants will then crossover to receive guselkumab SC.

Participants will receive either guselkumab SC or placebo SC. Placebo participants will then crossover to receive guselkumab SC.

Outcomes

Primary Outcome Measures

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.

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).

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.

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

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).

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.

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.

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).

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.

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.

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.

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.

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.

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).

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.

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.

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT05272150

First Posted

March 1, 2022

Last Updated

September 12, 2023

Sponsor

Janssen Research & Development, LLC

1. Study Identification

Unique Protocol Identification Number

NCT05272150

Brief Title

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

Acronym

VISIBLE

Official Title

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-to-Severe Scalp Psoriasis

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

July 13, 2022 (Actual)

Primary Completion Date

September 29, 2023 (Anticipated)

Study Completion Date

July 10, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Janssen Research & Development, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Plaque Psoriasis, Scalp Psoriasis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

213 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cohort A: Moderate-to-severe Plaque Psoriasis

Arm Type

Experimental

Arm Description

Participants will receive either guselkumab subcutaneously (SC) or placebo SC. Placebo participants will then crossover to receive guselkumab SC.

Arm Title

Cohort B: Moderate-to-severe Scalp Psoriasis

Arm Type

Experimental

Arm Description

Participants will receive either guselkumab SC or placebo SC. Placebo participants will then crossover to receive guselkumab SC.

Intervention Type

Drug

Intervention Name(s)

Guselkumab

Other Intervention Name(s)

CNTO1959, Tremfya

Intervention Description

Participants will receive guselkumab as subcutaneous injection.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Participants will receive placebo as subcutaneous injection.

Primary Outcome Measure Information:

Title

Cohort A: Percentage of Participants who Achieve Psoriasis Area and Severity Index (PASI) 90 Response at Week 16

Description

Time Frame

Week 16

Title

Cohort A: Percentage of Participants who Achieve an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16

Description

Time Frame

Week 16

Title

Cohort B: Percentage of Participants who Achieve Psoriasis Scalp Severity Index (PSSI) 90 Response at Week 16

Description

Time Frame

Week 16

Title

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

Description

Time Frame

Week 16

Secondary Outcome Measure Information:

Title

Cohort A: Percentage of Participants who Achieve IGA Score of Cleared (0) at Week 16

Description

Time Frame

Week 16

Title

Cohort A: Percentage of Participants who Achieve PASI 100 Response at Week 16

Description

Time Frame

Week 16

Title

Cohort A: Change from Baseline in PASI Score at Week 16

Description

Time Frame

Baseline and Week 16

Title

Cohort A: Change from Baseline in Body Surface Area (BSA) at Week 16

Description

Time Frame

Baseline and Week 16

Title

Cohort A: Time to >=90% Reduction in PASI Score

Description

Time Frame

Up to Week 16

Title

Cohorts A and B: Change from Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16

Description

Time Frame

Baseline and Week 16

Title

Description

Time Frame

Week 16

Title

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

Description

Time Frame

Week 16

Title

Cohorts A and B: Change from Baseline in PSSD Symptom Score at Week 16

Description

Time Frame

Baseline and Week 16

Title

Cohort B: Percentage of Participants who Achieve ss-IGA Score of Absence of Disease (0) at Week 16

Description

Time Frame

Week 16

Title

Cohort B: Change from Baseline in Scalp Surface Area (SSA) at Week 16

Description

Time Frame

Baseline and Week 16

Title

Cohort B: Percentage of Participants who Achieve PSSI 100 Response at Week 16

Description

Time Frame

Week 16

Title

Cohort B: Change from Baseline in PSSI Score at Week 16

Description

Time Frame

Baseline and Week 16

Title

Cohort B: Time to >=90% Reduction in PSSI Score

Description

Time Frame

Up to Week 16

Title

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

Description

Time Frame

Week 16

Title

Cohorts A and B: Number of Participants with Adverse Events (AEs)

Description

Time Frame

Up to Week 116

Title

Cohorts A and B: Number of Participants with Serious Adverse Events (SAEs)

Description

Time Frame

Up to Week 116

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Janssen Research & Development, LLC Clinical Trial

Organizational Affiliation

Janssen Research & Development, LLC

Official's Role

Study Director

Facility Information:

Facility Name

Total Skin & Beauty Dermatology Center

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35205

Country

United States

Facility Name

Cahaba Research Inc

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35244

Country

United States

Facility Name

Stoll Dermatology

City

Beverly Hills

State/Province

California

ZIP/Postal Code

90212

Country

United States

Facility Name

California Dermatology & Clinical Research Institute

City

Encinitas

State/Province

California

ZIP/Postal Code

92024

Country

United States

Facility Name

First OC Dermatology

City

Fountain Valley

State/Province

California

ZIP/Postal Code

92708

Country

United States

Facility Name

Center for Dermatology Clinical Research

City

Fremont

State/Province

California

ZIP/Postal Code

94538

Country

United States

Facility Name

Community Regional Medical Center

City

Fresno

State/Province

California

ZIP/Postal Code

93701

Country

United States

Facility Name

Paul Wallace MD

City

Ladera Heights

State/Province

California

ZIP/Postal Code

90056

Country

United States

Facility Name

The Grimes Center for Medical and Aesthetic Dermatology

City

Los Angeles

State/Province

California

ZIP/Postal Code

90036

Country

United States

Facility Name

Care Access Research

City

Newport Beach

State/Province

California

ZIP/Postal Code

92660

Country

United States

Facility Name

MedDerm Associates

City

San Diego

State/Province

California

ZIP/Postal Code

92103

Country

United States

Facility Name

Synergy Clinical Research

City

San Francisco

State/Province

California

ZIP/Postal Code

94132

Country

United States

Facility Name

Southern California Dermatology

City

Santa Ana

State/Province

California

ZIP/Postal Code

92701

Country

United States

Facility Name

Clinical Science Institute

City

Santa Monica

State/Province

California

ZIP/Postal Code

90404

Country

United States

Facility Name

University of Connecticut Health Center

City

Farmington

State/Province

Connecticut

ZIP/Postal Code

06030

Country

United States

Facility Name

Center for Dermatology and Dermatologic Surgery

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20037

Country

United States

Facility Name

Skin Care Research

City

Boca Raton

State/Province

Florida

ZIP/Postal Code

33486

Country

United States

Facility Name

Driven Research LLC

City

Coral Gables

State/Province

Florida

ZIP/Postal Code

33134

Country

United States

Facility Name

Florida Academic Dermatology Centers

City

Coral Gables

State/Province

Florida

ZIP/Postal Code

33134

Country

United States

Facility Name

Hollywood Dermatology and Cosmetic Surgery

City

Hollywood

State/Province

Florida

ZIP/Postal Code

33021

Country

United States

Facility Name

International Dermatology Research, Inc.

City

Miami

State/Province

Florida

ZIP/Postal Code

33144

Country

United States

Facility Name

Tory P. Sullivan, M.D., PA

City

North Miami Beach

State/Province

Florida

ZIP/Postal Code

33162

Country

United States

Facility Name

Park Avenue Dermatology

City

Orange Park

State/Province

Florida

ZIP/Postal Code

32073

Country

United States

Facility Name

Riverchase Dermatology and Cosmetic Surgery

City

Pembroke Pines

State/Province

Florida

ZIP/Postal Code

33028

Country

United States

Facility Name

GCP Research

City

Saint Petersburg

State/Province

Florida

ZIP/Postal Code

33705

Country

United States

Facility Name

Forcare Clinical Research, Inc.

City

Tampa

State/Province

Florida

ZIP/Postal Code

33613

Country

United States

Facility Name

Hamilton Dermatology Atlanta Dermatology, Vein & Research Center, LLC

City

Alpharetta

State/Province

Georgia

ZIP/Postal Code

30022-1160

Country

United States

Facility Name

Advanced Medical Research

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30328

Country

United States

Facility Name

Skin Care Physicians of Georgia

City

Macon

State/Province

Georgia

ZIP/Postal Code

31217

Country

United States

Facility Name

University Dermatology and Vein Clinic

City

Darien

State/Province

Illinois

ZIP/Postal Code

60561

Country

United States

Facility Name

Northshore Universite Healthsystem

City

Skokie

State/Province

Illinois

ZIP/Postal Code

60077

Country

United States

Facility Name

Dundee Dermatology

City

West Dundee

State/Province

Illinois

ZIP/Postal Code

60118

Country

United States

Facility Name

Dawes Fretzin Clinical Research Group

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46256

Country

United States

Facility Name

Indiana Clinical Trial Center

City

Plainfield

State/Province

Indiana

ZIP/Postal Code

46168

Country

United States

Facility Name

Epiphany Dermatology of Kansas, LLC

City

Overland Park

State/Province

Kansas

ZIP/Postal Code

66210

Country

United States

Facility Name

Ds Research

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40241

Country

United States

Facility Name

Callender Center for Clinical Research

City

Glenn Dale

State/Province

Maryland

ZIP/Postal Code

20769

Country

United States

Facility Name

Care Access Research

City

Marriottsville

State/Province

Maryland

ZIP/Postal Code

21104

Country

United States

Facility Name

DermAssociates, PC

City

Rockville

State/Province

Maryland

ZIP/Postal Code

20850

Country

United States

Facility Name

Lawrence J Green MD LLC

City

Rockville

State/Province

Maryland

ZIP/Postal Code

20850

Country

United States

Facility Name

Allcutis Research

City

Beverly

State/Province

Massachusetts

ZIP/Postal Code

01915

Country

United States

Facility Name

Metro Boston Clinical Partners

City

Brighton

State/Province

Massachusetts

ZIP/Postal Code

02135

Country

United States

Facility Name

David Fivenson MD, Dermatology

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48103

Country

United States

Facility Name

St Joseph Dermatology and Vein Clinic

City

Saint Joseph

State/Province

Michigan

ZIP/Postal Code

49085

Country

United States

Facility Name

Somerset Skin Centre

City

Troy

State/Province

Michigan

ZIP/Postal Code

48084

Country

United States

Facility Name

Henry Ford Medical Center

City

West Bloomfield

State/Province

Michigan

ZIP/Postal Code

48322

Country

United States

Facility Name

Twin Cities Dermatology Center

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55416

Country

United States

Facility Name

Skin Specialists

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68144

Country

United States

Facility Name

Psoriasis Treatment Center of Central New Jersey

City

East Windsor

State/Province

New Jersey

ZIP/Postal Code

08520

Country

United States

Facility Name

Hudson Dermatology & Skin Cancer Center

City

Hoboken

State/Province

New Jersey

ZIP/Postal Code

07030

Country

United States

Facility Name

Schweiger Dermatology Group

City

Verona

State/Province

New Jersey

ZIP/Postal Code

07044

Country

United States

Facility Name

Forest Hills Dermatology Group PLLC

City

Forest Hills

State/Province

New York

ZIP/Postal Code

11375

Country

United States

Facility Name

MDCS Dermatology

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Facility Name

Sadick Research Group

City

New York

State/Province

New York

ZIP/Postal Code

10075

Country

United States

Facility Name

Markowitz Medical OptiSkin

City

New York

State/Province

New York

ZIP/Postal Code

10128

Country

United States

Facility Name

Accellacare Research of Cary

City

Cary

State/Province

North Carolina

ZIP/Postal Code

27511

Country

United States

Facility Name

Darst Dermatology

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28277

Country

United States

Facility Name

Dermatology Specialists

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28277

Country

United States

Facility Name

Accellacare of Raleigh

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27612

Country

United States

Facility Name

PMG Research of Rocky Mount, LLC

City

Rocky Mount

State/Province

North Carolina

ZIP/Postal Code

27804

Country

United States

Facility Name

PMG Research of Wilmington, LLC

City

Wilmington

State/Province

North Carolina

ZIP/Postal Code

28401

Country

United States

Facility Name

Wake Forest Health Sciences

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27104

Country

United States

Facility Name

Advanced Dermatology and Skin Cancer Center

City

Boardman

State/Province

Ohio

ZIP/Postal Code

44512

Country

United States

Facility Name

Wright State Physicians Health Center

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45324

Country

United States

Facility Name

Apex Dermatology Mayfield Heights

City

Mayfield Heights

State/Province

Ohio

ZIP/Postal Code

44124

Country

United States

Facility Name

Central Sooner Research

City

Norman

State/Province

Oklahoma

ZIP/Postal Code

73071

Country

United States

Facility Name

Schweiger Dermatology Group

City

Exton

State/Province

Pennsylvania

ZIP/Postal Code

19341

Country

United States

Facility Name

Temple University School of Medicine

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19140

Country

United States

Facility Name

University of Pittsburgh Medical Center (UPMC)

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

Facility Name

Dermatology and Laser Center of Charleston

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29407

Country

United States

Facility Name

Palmetto Clinical Trial Services, LLC

City

Fountain Inn

State/Province

South Carolina

ZIP/Postal Code

29644

Country

United States

Facility Name

Arlington Center for Dermatology

City

Arlington

State/Province

Texas

ZIP/Postal Code

76011

Country

United States

Facility Name

Austin Dermatology Associates

City

Austin

State/Province

Texas

ZIP/Postal Code

78705

Country

United States

Facility Name

Dermatology Treatment & Research Center, PA

City

Dallas

State/Province

Texas

ZIP/Postal Code

75230

Country

United States

Facility Name

Modern Research Associates PLLC

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

Center for Clinical Studies

City

Houston

State/Province

Texas

ZIP/Postal Code

77004

Country

United States

Facility Name

Suzanne Bruce and Associates - The Center for Skin Research

City

Houston

State/Province

Texas

ZIP/Postal Code

77056-4132

Country

United States

Facility Name

Progressive Clinical Research

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78213

Country

United States

Facility Name

Texas Dermatology and Laser Specialists

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78218

Country

United States

Facility Name

Dermatology Research Institute Inc.

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2J 7E1

Country

Canada

Facility Name

Beacon Dermatology

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T3E 0B2

Country

Canada

Facility Name

Alberta DermaSurgery Centre

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 2C1

Country

Canada

Facility Name

Dr. Chih-ho Hong Medical

City

Surrey

State/Province

British Columbia

ZIP/Postal Code

V3R 6A7

Country

Canada

Facility Name

Dr. Lorne E. Albrecht

City

Surrey

State/Province

British Columbia

ZIP/Postal Code

V3V 0C6

Country

Canada

Facility Name

CCA Medical Research Corporation

City

Ajax

State/Province

Ontario

ZIP/Postal Code

L1S7K8

Country

Canada

Facility Name

Dr Dusan Sajic Medicine Professional Corporation

City

Guelph

State/Province

Ontario

ZIP/Postal Code

N1L 0B7

Country

Canada

Facility Name

Lynderm Research Inc.

City

Markham

State/Province

Ontario

ZIP/Postal Code

L3P 1X2

Country

Canada

Facility Name

North York Research Inc

City

North York

State/Province

Ontario

ZIP/Postal Code

M2M 4J5

Country

Canada

Facility Name

JRB Research Inc

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1H 7X3

Country

Canada

Facility Name

Nectar Research Group Inc

City

Richmond Hill

State/Province

Ontario

ZIP/Postal Code

L4B 1A5

Country

Canada

Facility Name

Canadian Dermatology Center

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M3B 0A7

Country

Canada

Facility Name

Toronto Research Centre

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M3H5Y8

Country

Canada

Facility Name

Manna Research

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4C 1L1

Country

Canada

Facility Name

Research Toronto

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4W 2N4

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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

IPD Sharing URL

https://www.janssen.com/clinical-trials/transparency

Learn more about this trial

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

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