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

• ClinicalTrials.gov Identifier: NCT05272150
• Recruitment Status: Recruiting
• First Posted: March 9, 2022
• Last Update Posted: May 3, 2023
• Sponsor: Janssen Research & Development, LLC
• Information provided by (Responsible Party): Janssen Research & Development, LLC

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.

Condition or disease	Intervention/treatment	Phase
Plaque Psoriasis; Scalp Psoriasis	Drug: Guselkumab; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: July 13, 2022
• Estimated Primary Completion Date: September 29, 2023
• Estimated Study Completion Date: July 10, 2025

Arms and Interventions

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: CNTO1959; Tremfya; 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: CNTO1959; Tremfya; Drug: Placebo; Participants will receive placebo as subcutaneous injection.

Outcome Measures

Primary Outcome Measures :

1. Cohort A: Percentage of Participants who Achieve Psoriasis Area and Severity Index (PASI) 90 Response at Week 16 [ Time Frame: Week 16 ]
   A PASI 90 response is defined as greater than or equal to (>=) 90 percent (%) improvement in PASI score from baseline. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: head, trunk, upper, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease.
2. Cohort A: Percentage of Participants who Achieve an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16 [ Time Frame: Week 16 ]
   Percentage of participants with IGA score of 0 (cleared) or 1 (minimal) will be reported. The IGA documents the investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
3. Cohort B: Percentage of Participants who Achieve Psoriasis Scalp Severity Index (PSSI) 90 Response at Week 16 [ Time Frame: Week 16 ]
   A PSSI 90 response is defined as >=90% reduction in PSSI score from baseline. The PSSI measures the extent of psoriasis involvement and the severity of erythema, infiltration, and desquamation of the scalp. Involved scalp area is measured on a scale from 0 (0% of scalp involved) to 6 (90-100% of scalp involved), clinical symptoms are each rated from 0 (absent) to 4 (severest possible). Involvement and severity of psoriasis for the PSSI is scored by physicians using a scale from 0 to 72, where 0=no psoriasis, and higher scores indicating more severe disease.
4. Cohort B: Percentage of Participants who Achieve Scalp-specific Investigator Global Assessment (ss-IGA) Score of Absence of Disease (0) or Very Mild Disease (1) at Week 16 [ Time Frame: Week 16 ]
   Percentage of participants with ss-IGA score 0 (absence of disease) or 1 (very mild disease) will be reported. The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis. The lesions are assessed in terms of the clinical signs of redness, thickness, and scaliness which are scored as: absence of disease (0), very mild disease (1), mild disease (2), moderate disease (3), and severe disease (4).

Secondary Outcome Measures :

1. Cohort A: Percentage of Participants who Achieve IGA Score of Cleared (0) at Week 16 [ Time Frame: Week 16 ]
   Percentage of participants with IGA score 0 (cleared) will be reported. The IGA documents the investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
2. Cohort A: Percentage of Participants who Achieve PASI 100 Response at Week 16 [ Time Frame: Week 16 ]
   A PASI 100 response is defined as 100% improvement in PASI score from baseline. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: head, trunk, upper, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease.
3. Cohort A: Change from Baseline in PASI Score at Week 16 [ Time Frame: Baseline and Week 16 ]
   Change from baseline in PASI score at Week 16 will be reported. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: head, trunk, upper, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The individual scores are multiplied by a weighted factor for each body region; the sum of these scores gives the total PASI score. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease.
4. Cohort A: Change from Baseline in Body Surface Area (BSA) at Week 16 [ Time Frame: Baseline and Week 16 ]
   Change from baseline in BSA at Week 16 will be reported. The BSA is a measurement of involved skin over the whole body. The overall BSA affected by psoriasis is estimated based on the participant's handprint (defined as the entire palmar surface of the hand including fingers).
5. Cohort A: Time to >=90% Reduction in PASI Score [ Time Frame: Up to Week 16 ]
   Time to >=90% reduction in PASI score will be reported which is defined as time to achieve >=90% improvement in PASI. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: head, trunk, upper, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease.
6. Cohorts A and B: Change from Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16 [ Time Frame: Baseline and Week 16 ]
   Change from baseline in DLQI score at Week 16 will be reported. The DLQI is a dermatology specific quality of life instrument designed to assess the impact of dermatologic disease on a participant's quality of life (QoL). It is a 10 item patient-reported outcome(s) (PRO) questionnaire that, in addition to evaluating overall QoL, can be used to assess 6 different aspects that may affect QoL: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. The DLQI produces a numeric score that can range from 0 to 30. A higher score indicates more severe disease.
7. Cohort A: Percentage of Participants who Achieve >= 4-point Reduction (Improvement) from Baseline in the Psoriasis Symptom and Sign Diary (PSSD) Itch Score at Week 16, Among Participants with Baseline PSSD Itch >= 4 at Baseline [ Time Frame: Week 16 ]
   Percentage of participants who achieve >=4-point reduction (improvement) from baseline in PSSD itch score at Week 16 among participants with baseline PSSD itch >=4 at baseline will be reported. The PSSD includes PRO questionnaires designed to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefits. The participants are asked to answer the questions thinking about either the last 24 hours (24-hour recall version) or the last 7 days (7 days recall version). Both versions include 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Two subscores will be derived, each ranging from 0-100: the psoriasis symptom score and the psoriasis sign score. A higher score indicates more severe disease.
8. Cohorts A and B: Percentage of Participants who Achieve a PSSD Symptom Score of 0 at Week 16, Among Randomized Participants with Baseline PSSD Symptom Score >=1 [ Time Frame: Week 16 ]
   Percentage of participants who achieve a PSSD symptom score of 0 at Week 16 among randomized participants with baseline PSSD symptom score >=1 will be reported. The PSSD includes PRO questionnaires designed to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefits. The participants are asked to answer the questions thinking about either the last 24 hours (24-hour recall version) or the last 7 days (7 days recall version). Both versions include 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Two subscores will be derived, each ranging from 0-100: the psoriasis symptom score and the psoriasis sign score. A higher score indicates more severe disease.
9. Cohorts A and B: Change from Baseline in PSSD Symptom Score at Week 16 [ Time Frame: Baseline and Week 16 ]
   Change from baseline in PSSD symptom score at Week 16 will be reported. The PSSD includes PRO questionnaires designed to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefits. The participants are asked to answer the questions thinking about either the last 24 hours (24-hour recall version) or the last 7 days (7 days recall version). Both versions include 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Two subscores will be derived, each ranging from 0-100: the psoriasis symptom score and the psoriasis sign score. A higher score indicates more severe disease.
10. Cohort B: Percentage of Participants who Achieve ss-IGA Score of Absence of Disease (0) at Week 16 [ Time Frame: Week 16 ]
    Percentage of participants with ss-IGA score 0 (absence of disease) will be reported. The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis. The lesions are assessed in terms of the clinical signs of redness, thickness, and scaliness which are scored as: absence of disease (0), very mild disease (1), mild disease (2), moderate disease (3), and severe disease (4).
11. Cohort B: Change from Baseline in Scalp Surface Area (SSA) at Week 16 [ Time Frame: Baseline and Week 16 ]
    Change from baseline in SSA at Week 16 will be reported. The SSA is a measurement of involved skin on the scalp. The overall SSA affected by psoriasis will be estimated based on the participant's thumb.
12. Cohort B: Percentage of Participants who Achieve PSSI 100 Response at Week 16 [ Time Frame: Week 16 ]
    A PSSI 100 response is defined as 100% reduction in PSSI score from baseline. The PSSI measures the extent of psoriasis involvement and the severity of erythema, infiltration, and desquamation of the scalp. Involved scalp area is measured on a scale from 0 (0% of scalp involved) to 6 (90-100% of scalp involved), clinical symptoms are each rated from 0 (absent) to 4 (severest possible). Involvement and severity of psoriasis for the PSSI is scored by physicians using a scale from 0 to 72, where 0=no psoriasis, and higher scores indicating more severe disease.
13. Cohort B: Change from Baseline in PSSI Score at Week 16 [ Time Frame: Baseline and Week 16 ]
    Change from baseline in PSSI score at Week 16 will be reported. The PSSI measures the extent of psoriasis involvement and the severity of erythema, infiltration, and desquamation of the scalp. Involved scalp area is measured on a scale from 0 (0% of scalp involved) to 6 (90-100% of scalp involved), clinical symptoms are each rated from 0 (absent) to 4 (severest possible).The PSSI total score is a composite score derived from the sum of the scores for erythema, induration and desquamation multiplied by the score for the extent of scalp area involved (percent of scalp involved). Involvement and severity of psoriasis for the PSSI is scored by physicians using a scale from 0 to 72, where 0=no psoriasis, and higher scores indicating more severe disease.
14. Cohort B: Time to >=90% Reduction in PSSI Score [ Time Frame: Up to Week 16 ]
    Time to >=90% reduction in PSSI score will be reported which is defined as time to achieve >=90% improvement in PSSI. The PSSI measures the extent of psoriasis involvement and the severity of erythema, infiltration, and desquamation of the scalp. Involvement and severity of psoriasis for the PSSI is scored by physicians using a scale from 0 to 72, where 0=no psoriasis, and higher scores indicating more severe disease.
15. Cohort B: Percentage of Participants with >= 4 Point Reduction (Improvement) from Baseline in the Scalp Itch NRS Score at Week 16, Among Participants with Baseline Scalp Itch >=4 at Baseline [ Time Frame: Week 16 ]
    Percentage of participants with >=4 point reduction (improvement) from baseline in scalp itch NRS score, among participants with scalp itch >=4 at baseline will be reported. The scalp itch NRS is a single-item scale that asks participants to rate the severity of their scalp itching due to psoriasis by considering their worst level of itching over the past 24 hours. The participants will be asked to assess scalp itch and select a number on a scale of 0-10, where "0" represents no scalp itch, and "10" represents the worst imaginable scalp itch.
16. Cohorts A and B: Number of Participants with Adverse Events (AEs) [ Time Frame: Up to Week 116 ]
    An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
17. Cohorts A and B: Number of Participants with Serious Adverse Events (SAEs) [ Time Frame: Up to Week 116 ]
    SAE is an adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.

Eligibility Criteria

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

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

Contacts and Locations

Contacts

Contact: Study Contact; 844-434-4210; Participate-In-This-Study@its.jnj.com

Locations

United States, Alabama

Total Skin & Beauty Dermatology Center; Recruiting

Birmingham, Alabama, United States, 35205

Cahaba Research Inc; Recruiting

Birmingham, Alabama, United States, 35244

United States, California

Stoll Dermatology; Recruiting

Beverly Hills, California, United States, 90212

California Dermatology & Clinical Research Institute; Recruiting

Encinitas, California, United States, 92024

First OC Dermatology; Recruiting

Fountain Valley, California, United States, 92708

Center for Dermatology Clinical Research; Recruiting

Fremont, California, United States, 94538

Community Regional Medical Center; Recruiting

Fresno, California, United States, 93701

Paul Wallace MD; Recruiting

Ladera Heights, California, United States, 90056

The Grimes Center for Medical and Aesthetic Dermatology; Recruiting

Los Angeles, California, United States, 90036

Care Access Research; Recruiting

Newport Beach, California, United States, 92660

MedDerm Associates; Recruiting

San Diego, California, United States, 92103

Synergy Clinical Research; Recruiting

San Francisco, California, United States, 94132

Southern California Dermatology; Recruiting

Santa Ana, California, United States, 92701

Clinical Science Institute; Recruiting

Santa Monica, California, United States, 90404

United States, Connecticut

University of Connecticut Health Center; Recruiting

Farmington, Connecticut, United States, 06030

United States, District of Columbia

Center for Dermatology and Dermatologic Surgery; Recruiting

Washington, District of Columbia, United States, 20037

United States, Florida

Skin Care Research; Recruiting

Boca Raton, Florida, United States, 33486

Driven Research LLC; Recruiting

Coral Gables, Florida, United States, 33134

Florida Academic Dermatology Centers; Recruiting

Coral Gables, Florida, United States, 33134

Hollywood Dermatology and Cosmetic Surgery; Recruiting

Hollywood, Florida, United States, 33021

International Dermatology Research, Inc.; Recruiting

Miami, Florida, United States, 33144

Tory P. Sullivan, M.D., PA; Recruiting

North Miami Beach, Florida, United States, 33162

Park Avenue Dermatology; Completed

Orange Park, Florida, United States, 32073

Riverchase Dermatology and Cosmetic Surgery; Completed

Pembroke Pines, Florida, United States, 33028

GCP Research; Recruiting

Saint Petersburg, Florida, United States, 33705

Forcare Clinical Research, Inc.; Recruiting

Tampa, Florida, United States, 33613

United States, Georgia

Hamilton Dermatology Atlanta Dermatology, Vein & Research Center, LLC; Recruiting

Alpharetta, Georgia, United States, 30022-1160

Advanced Medical Research; Recruiting

Atlanta, Georgia, United States, 30328

Skin Care Physicians of Georgia; Recruiting

Macon, Georgia, United States, 31217

United States, Illinois

University Dermatology and Vein Clinic; Recruiting

Darien, Illinois, United States, 60561

Northshore Universite Healthsystem; Recruiting

Skokie, Illinois, United States, 60077

Dundee Dermatology; Recruiting

West Dundee, Illinois, United States, 60118

United States, Indiana

Dawes Fretzin Clinical Research Group; Recruiting

Indianapolis, Indiana, United States, 46256

Indiana Clinical Trial Center; Recruiting

Plainfield, Indiana, United States, 46168

United States, Kansas

Epiphany Dermatology of Kansas, LLC; Recruiting

Overland Park, Kansas, United States, 66210

United States, Kentucky

Ds Research; Recruiting

Louisville, Kentucky, United States, 40241

United States, Maryland

Kindred Hair and Skin Center; Recruiting

Columbia, Maryland, United States, 21045

Callender Center for Clinical Research; Recruiting

Glenn Dale, Maryland, United States, 20769

DermAssociates, PC; Recruiting

Rockville, Maryland, United States, 20850

Lawrence J Green MD LLC; Recruiting

Rockville, Maryland, United States, 20850

United States, Massachusetts

Allcutis Research; Recruiting

Beverly, Massachusetts, United States, 01915

Metro Boston Clinical Partners; Recruiting

Brighton, Massachusetts, United States, 02135

United States, Michigan

David Fivenson MD, Dermatology; Recruiting

Ann Arbor, Michigan, United States, 48103

St Joseph Dermatology and Vein Clinic; Recruiting

Saint Joseph, Michigan, United States, 49085

Somerset Skin Centre; Recruiting

Troy, Michigan, United States, 48084

Henry Ford Medical Center; Recruiting

West Bloomfield, Michigan, United States, 48322

United States, Minnesota

Twin Cities Dermatology Center; Recruiting

Minneapolis, Minnesota, United States, 55416

United States, Nebraska

Skin Specialists; Recruiting

Omaha, Nebraska, United States, 68144

United States, New Jersey

Psoriasis Treatment Center of Central New Jersey; Recruiting

East Windsor, New Jersey, United States, 08520

Hudson Dermatology & Skin Cancer Center; Recruiting

Hoboken, New Jersey, United States, 07030

Schweiger Dermatology Group; Recruiting

Verona, New Jersey, United States, 07044

United States, New York

MDCS Dermatology; Recruiting

New York, New York, United States, 10065

Markowitz Medical OptiSkin; Recruiting

New York, New York, United States, 10128

United States, North Carolina

Accellacare Research of Cary; Recruiting

Cary, North Carolina, United States, 27511

Darst Dermatology; Recruiting

Charlotte, North Carolina, United States, 28277

Dermatology Specialists; Recruiting

Charlotte, North Carolina, United States, 28277

Accellacare of Raleigh; Recruiting

Raleigh, North Carolina, United States, 27612

PMG Research of Rocky Mount, LLC; Recruiting

Rocky Mount, North Carolina, United States, 27804

PMG Research of Wilmington, LLC; Recruiting

Wilmington, North Carolina, United States, 28401

Wake Forest Health Sciences; Recruiting

Winston-Salem, North Carolina, United States, 27104

United States, Ohio

Advanced Dermatology and Skin Cancer Center; Recruiting

Boardman, Ohio, United States, 44512

Wright State Physicians Health Center; Recruiting

Dayton, Ohio, United States, 45324

Apex Dermatology Mayfield Heights; Recruiting

Mayfield Heights, Ohio, United States, 44124

United States, Oklahoma

Central Sooner Research; Recruiting

Norman, Oklahoma, United States, 73071

United States, Pennsylvania

Schweiger Dermatology Group; Recruiting

Exton, Pennsylvania, United States, 19341

University of Pittsburgh Medical Center (UPMC); Recruiting

Pittsburgh, Pennsylvania, United States, 15213

United States, South Carolina

Palmetto Clinical Trial Services, LLC; Recruiting

Fountain Inn, South Carolina, United States, 29644

United States, Texas

Arlington Center for Dermatology; Recruiting

Arlington, Texas, United States, 76011

Austin Dermatology Associates; Recruiting

Austin, Texas, United States, 78705

Dermatology Treatment & Research Center, PA; Recruiting

Dallas, Texas, United States, 75230

Modern Research Associates PLLC; Recruiting

Dallas, Texas, United States, 75231

Center for Clinical Studies; Recruiting

Houston, Texas, United States, 77004

Suzanne Bruce and Associates - The Center for Skin Research; Recruiting

Houston, Texas, United States, 77056-4132

Progressive Clinical Research; Recruiting

San Antonio, Texas, United States, 78213

Texas Dermatology and Laser Specialists; Recruiting

San Antonio, Texas, United States, 78218

Canada, Alberta

Dermatology Research Institute Inc.; Recruiting

Calgary, Alberta, Canada, T2J 7E1

Beacon Dermatology; Recruiting

Calgary, Alberta, Canada, T3E 0B2

Alberta DermaSurgery Centre; Recruiting

Edmonton, Alberta, Canada, T6G 2C1

Canada, British Columbia

Dr. Chih-ho Hong Medical; Recruiting

Surrey, British Columbia, Canada, V3R 6A7

Dr. Lorne E. Albrecht; Recruiting

Surrey, British Columbia, Canada, V3V 0C6

Canada, Ontario

CCA Medical Research Corporation; Recruiting

Ajax, Ontario, Canada, L1S7K8

Dr Dusan Sajic Medicine Professional Corporation; Recruiting

Guelph, Ontario, Canada, N1L 0B7

Lynderm Research Inc.; Recruiting

Markham, Ontario, Canada, L3P 1X2

North York Research Inc; Recruiting

North York, Ontario, Canada, M2M 4J5

JRB Research Inc; Recruiting

Ottawa, Ontario, Canada, K1H 7X3

Nectar Research Group Inc; Recruiting

Richmond Hill, Ontario, Canada, L4B 1A5

Canadian Dermatology Center; Recruiting

Toronto, Ontario, Canada, M3B 0A7

Toronto Research Centre; Recruiting

Toronto, Ontario, Canada, M3H5Y8

Manna Research; Recruiting

Toronto, Ontario, Canada, M4C 1L1

Research Toronto; Recruiting

Toronto, Ontario, Canada, M4W 2N4

Sponsors and Collaborators

Janssen Research & Development, LLC

Investigators

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

More Information

• Responsible Party: Janssen Research & Development, LLC
• ClinicalTrials.gov Identifier: NCT05272150
• Other Study ID Numbers: CR109163; CNTO1959PSO3018 ( Other Identifier: Janssen Research & Development, LLC )
• First Posted: March 9, 2022
• Last Update Posted: May 3, 2023
• Last Verified: May 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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
• URL: https://www.janssen.com/clinical-trials/transparency

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases