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

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

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: Active, not recruiting
• Conditions: Plaque Psoriasis; Scalp Psoriasis
• Intervention / Treatment: Drug: Guselkumab; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 213
• 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, V3R 6A7
      • Dr. Chih-ho Hong Medical
    • Surrey, British Columbia, Canada, V3V 0C6
      • Dr. Lorne E. Albrecht
  • 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, K1H 7X3
      • 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 & 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
    • 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, 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
    • Saint 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
    • 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 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.	Week 16
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).	Week 16
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.	Week 16
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).	Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Week 16
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.	Week 16
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.	Baseline and Week 16
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).	Baseline and Week 16
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.	Up to Week 16
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.	Baseline and Week 16
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.	Week 16
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.	Week 16
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.	Baseline and Week 16
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).	Week 16
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.	Baseline and Week 16
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.	Week 16
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.	Baseline and Week 16
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.	Up to Week 16
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.	Week 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.	Up to Week 116
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.	Up to Week 116

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2022
• Primary Completion (Estimated): July 9, 2025
• Study Completion (Estimated): July 10, 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): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• 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