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

NCT05272150 | Completed Phase 3 FDA Drug

• 2 other identifiers: CR109163CNTO1959PSO3018
• Study Type: interventional
• Target: 213
• Locations: 2 countries
• Sites: 94

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.

Conditions

Plaque Psoriasis; Scalp Psoriasis

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (17)

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

  Week 16

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

  Week 16

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

  Baseline and Week 16

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

  Baseline and Week 16

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

  Up to Week 16

Study Arms (2)

Cohort A: Moderate-to-severe Plaque Psoriasis

EXPERIMENTAL

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

Drug: Guselkumab; Drug: Placebo

Cohort B: Moderate-to-severe Scalp Psoriasis

EXPERIMENTAL

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

Drug: Guselkumab; Drug: Placebo

Interventions

Guselkumab DRUG

Participants will receive guselkumab as subcutaneous injection.

Also known as: CNTO1959, Tremfya

Cohort A: Moderate-to-severe Plaque Psoriasis; Cohort B: Moderate-to-severe Scalp Psoriasis

Placebo DRUG

Participants will receive placebo as subcutaneous injection.

Cohort A: Moderate-to-severe Plaque Psoriasis; Cohort B: Moderate-to-severe Scalp Psoriasis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (94)

Total Skin and Beauty Dermatology Center

Birmingham, Alabama, 35203, United States

Location

Cahaba Research Inc

Birmingham, Alabama, 35244, United States

Location

Stoll Dermatology

Beverly Hills, California, 90212, United States

Location

California Dermatology & Clinical Research Institute

Encinitas, California, 92024, United States

Location

First OC Dermatology

Fountain Valley, California, 92708, United States

Location

Center for Dermatology Clinical Research

Fremont, California, 94538, United States

Location

Community Regional Medical Center

Fresno, California, 93701, United States

Location

Paul Wallace MD

Ladera Heights, California, 90056, United States

Location

The Grimes Center for Medical and Aesthetic Dermatology

Los Angeles, California, 90036, United States

Location

Care Access Research

Newport Beach, California, 92660, United States

Location

MedDerm Associates

San Diego, California, 92103, United States

Location

Synergy Clinical Research

San Francisco, California, 94132, United States

Location

Southern California Dermatology

Santa Ana, California, 92701, United States

Location

Clinical Science Institute

Santa Monica, California, 90404, United States

Location

University of Connecticut Health Center

Farmington, Connecticut, 06030, United States

Location

Center for Dermatology and Dermatologic Surgery

Washington D.C., District of Columbia, 20037, United States

Location

Skin Care Research

Boca Raton, Florida, 33486, United States

Location

Driven Research LLC

Coral Gables, Florida, 33134, United States

Location

Florida Academic Dermatology Centers

Coral Gables, Florida, 33134, United States

Location

Hollywood Dermatology and Cosmetic Surgery

Hollywood, Florida, 33021, United States

Location

International Dermatology Research, Inc.

Miami, Florida, 33144, United States

Location

Tory P Sullivan M D PA

North Miami Beach, Florida, 33162, United States

Location

Park Avenue Dermatology

Orange Park, Florida, 32073, United States

Location

Riverchase Dermatology and Cosmetic Surgery

Pembroke Pines, Florida, 33028, United States

Location

GCP Research

St. Petersburg, Florida, 33705, United States

Location

Forcare Clinical Research Inc

Tampa, Florida, 33613, United States

Location

Hamilton Dermatology Atlanta Dermatology, Vein & Research Center, LLC

Alpharetta, Georgia, 30022-1160, United States

Location

Advanced Medical Research

Atlanta, Georgia, 30328, United States

Location

Skin Care Physicians of Georgia

Macon, Georgia, 31217, United States

Location

University Dermatology and Vein Clinic

Darien, Illinois, 60561, United States

Location

Northshore University Healthsystem

Skokie, Illinois, 60077, United States

Location

Dundee Dermatology

West Dundee, Illinois, 60118, United States

Location

Dawes Fretzin Clinical Research Group

Indianapolis, Indiana, 46256, United States

Location

Indiana Clinical Trial Center

Plainfield, Indiana, 46168, United States

Location

Epiphany Dermatology of Kansas, LLC

Overland Park, Kansas, 66210, United States

Location

Ds Research

Louisville, Kentucky, 40241, United States

Location

Callender Center for Clinical Research

Glenn Dale, Maryland, 20769, United States

Location

Care Access Research

Marriottsville, Maryland, 21104, United States

Location

DermAssociates, PC

Rockville, Maryland, 20850, United States

Location

Lawrence J Green MD LLC

Rockville, Maryland, 20850, United States

Location

Allcutis Research

Beverly, Massachusetts, 01915, United States

Location

Metro Boston Clinical Partners

Brighton, Massachusetts, 02135, United States

Location

David Fivenson MD, Dermatology

Ann Arbor, Michigan, 48103, United States

Location

St Joseph Dermatology and Vein Clinic

Saint Joseph, Michigan, 49085, United States

Location

Somerset Skin Centre

Troy, Michigan, 48084, United States

Location

Henry Ford Medical Center

West Bloomfield, Michigan, 48322, United States

Location

Twin Cities Dermatology Center

Minneapolis, Minnesota, 55416, United States

Location

Skin Specialists

Omaha, Nebraska, 68144, United States

Location

Psoriasis Treatment Center of Central New Jersey

East Windsor, New Jersey, 08520, United States

Location

Hudson Dermatology & Skin Cancer Center

Hoboken, New Jersey, 07030, United States

Location

Schweiger Dermatology Group

Verona, New Jersey, 07044, United States

Location

Forest Hills Dermatology Group PLLC

Forest Hills, New York, 11375, United States

Location

MDCS Dermatology

New York, New York, 10065, United States

Location

Sadick Research Group

New York, New York, 10075, United States

Location

Markowitz Medical OptiSkin

New York, New York, 10128, United States

Location

Accellacare Research of Cary

Cary, North Carolina, 27511, United States

Location

Darst Dermatology

Charlotte, North Carolina, 28277, United States

Location

Dermatology Specialists

Charlotte, North Carolina, 28277, United States

Location

Accellacare of Raleigh

Raleigh, North Carolina, 27612, United States

Location

PMG Research of Rocky Mount, LLC

Rocky Mount, North Carolina, 27804, United States

Location

PMG Research of Wilmington, LLC

Wilmington, North Carolina, 28401, United States

Location

Wake Forest Health Sciences

Winston-Salem, North Carolina, 27104, United States

Location

Advanced Dermatology and Skin Cancer Center

Boardman, Ohio, 44512, United States

Location

Wright State Physicians Health Center

Dayton, Ohio, 45324, United States

Location

Apex Dermatology Mayfield Heights

Mayfield Heights, Ohio, 44124, United States

Location

Central Sooner Research

Norman, Oklahoma, 73071, United States

Location

Schweiger Dermatology Group

Exton, Pennsylvania, 19341, United States

Location

Temple University School of Medicine

Philadelphia, Pennsylvania, 19140, United States

Location

University of Pittsburgh Medical Center (UPMC)

Pittsburgh, Pennsylvania, 15213, United States

Location

Dermatology and Laser Center of Charleston

Charleston, South Carolina, 29407, United States

Location

Palmetto Clinical Trial Services, LLC

Fountain Inn, South Carolina, 29644, United States

Location

Arlington Center for Dermatology

Arlington, Texas, 76011, United States

Location

Dermatology Treatment & Research Center, PA

Dallas, Texas, 75230, United States

Location

Modern Research Associates PLLC

Dallas, Texas, 75231, United States

Location

Center for Clinical Studies

Houston, Texas, 77004, United States

Location

Suzanne Bruce and Associates - The Center for Skin Research

Houston, Texas, 77056-4132, United States

Location

Austin Institute for Clinical Research

Pflugerville, Texas, 78660, United States

Location

Progressive Clinical Research

San Antonio, Texas, 78213, United States

Location

Texas Dermatology and Laser Specialists

San Antonio, Texas, 78218, United States

Location

Dermatology Research Institute Inc

Calgary, Alberta, T2J 7E1, Canada

Location

Beacon Dermatology

Calgary, Alberta, T3E 0B2, Canada

Location

Alberta DermaSurgery Centre

Edmonton, Alberta, T6G 2C1, Canada

Location

Dr. Chih ho Hong Medical

Surrey, British Columbia, V3R 6A7, Canada

Location

Dr. Lorne E. Albrecht

Surrey, British Columbia, V3V 0C6, Canada

Location

CCA Medical Research Corporation

Ajax, Ontario, L1S7K8, Canada

Location

Dr Dusan Sajic Medicine Professional Corporation

Guelph, Ontario, N1L 0B7, Canada

Location

Lynderm Research Inc.

Markham, Ontario, L3P 1X2, Canada

Location

North York Research Inc

North York, Ontario, M2M 4J5, Canada

Location

JRB Research Inc

Ottawa, Ontario, K1K 4L2, Canada

Location

Nectar Research Group Inc

Richmond Hill, Ontario, L4B 1A5, Canada

Location

Canadian Dermatology Center

Toronto, Ontario, M3B 0A7, Canada

Location

Toronto Research Centre

Toronto, Ontario, M3H 5Y8, Canada

Location

FACET Dermatology

Toronto, Ontario, M4E 2Y9, Canada

Location

Research Toronto

Toronto, Ontario, M4W 2N4, Canada

Location

Related Publications (3)

• Alexis A, McMichael A, Soung J, Choi O, Alkousakis T, Alonso-Llamazares J, Shahriari M, Rodriguez AO, Bhutani T, Chan D, Rowland K, Sauder M, Hong HC, Yadav G, Yeung J, Jeyarajah J, Ma T, Gao LL, Park-Wyllie L, Green L, Lee M, Vashi N, Kindred C, Grimes P, Taylor SC, Desai SR; VISIBLE Trial Investigators. Guselkumab for Moderate to Severe Psoriasis Across All Skin Tones: Cohort A of the VISIBLE Randomized Clinical Trial. JAMA Dermatol. 2025 Sep 1;161(9):901-911. doi: 10.1001/jamadermatol.2025.1836.

  PMID: 40560559 DERIVED

• McMichael A, Shahriari M, Stein Gold L, Alkousakis T, Choi O, Bhutani T, Rodriguez AO, Tyring SK, Chan D, Rowland K, Albrecht L, Lynde C, Yadav G, Yeung J, Park-Wyllie L, Ma T, Jeyarajah J, Gao LL, Smith S, Moore AY, Vashi N, Kindred C, Grimes P, Desai SR, Taylor SC, Alexis A; VISIBLE Trial Investigators. Guselkumab for Moderate to Severe Scalp Psoriasis Across All Skin Tones: Cohort B of the VISIBLE Randomized Clinical Trial. JAMA Dermatol. 2025 Sep 1;161(9):912-922. doi: 10.1001/jamadermatol.2025.1849.

  PMID: 40560554 DERIVED

• Alexis A, McMichael A, Vashi N, Bhutani T, Rodriguez AO, Yeung J, Choi O, Chan D, Alkousakis T, Bronner DN, Park-Wyllie L, Gao LL, Grimes P, Shahriari M, Yadav G, Kindred C, Taylor SC, Desai SR. Improving Diversity in a Novel Psoriasis Study: VISIBLE as a Framework for Clinical Trial Quality Improvement. JAMA Dermatol. 2025 Mar 1;161(3):256-264. doi: 10.1001/jamadermatol.2024.5103.

  PMID: 39661358 DERIVED

MeSH Terms

Interventions

guselkumab

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2022
• First Posted: March 9, 2022
• Study Start: July 13, 2022
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

US (79); CA (15)