Study of Guselkumab Versus Placebo for the Treatment of Low Body Surface Area Moderate Plaque Psoriasis

NCT06039189 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: CR109328CNTO1959PSO3017
• Study Type: interventional
• Target: 338
• Locations: 2 countries
• Sites: 64

Brief Summary

The purpose of this study is to evaluate the efficacy of guselkumab compared to an inactive drug in participants with low body surface area moderate plaque psoriasis and special site involvement.

Conditions

Moderate Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16

  The IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 point scale. Induration: 0 = no evidence of plaque elevation, 1 = minimal plaque elevation, = 0.25 millimeters (mm); 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, greater than (\>) 1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over less than 5% of the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates. Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). Higher score indicated more severe disease.

  Week 16

Secondary Outcomes (14)

• Percent Change From Baseline in Body Surface Area (BSA) at Week 16

  Baseline (Week 0), Week 16

• Percent Change From Baseline in Psoriasis Area Severity Index (PASI) Total Score at Week 16

  Baseline (Week 0), Week 16

• Percentage of Participants Who Achieved IGA Score of Cleared (0) at Week 16

  Week 16

• Percentage of Participants Who Achieved PASI 90 Response at Week 16

  Week 16

• Percentage of Participants Who Achieved PASI 100 Response at Week 16

  Week 16

Study Arms (2)

Group 1: Guselkumab

EXPERIMENTAL

Participants will receive guselkumab by subcutaneous injection with placebo as needed to maintain the blind.

Drug: Guselkumab; Drug: Placebo

Group 2: Placebo

PLACEBO COMPARATOR

Participants will receive placebo by subcutaneous injection then receive guselkumab by subcutaneous injection.

Drug: Guselkumab; Drug: Placebo

Interventions

Guselkumab DRUG

Guselkumab will be administered as subcutaneous injection.

Also known as: CNTO1959, Tremfya

Group 1: Guselkumab; Group 2: Placebo

Placebo DRUG

Placebo will be administered as subcutaneous injection.

Group 1: Guselkumab; Group 2: Placebo

Eligibility Criteria

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

You may qualify if:

• All participants must have a diagnosis of plaque psoriasis (with or without psoriatic arthritis) for at least 6 months before first administration of study intervention
• All participants must meet the following disease severity criteria at screening and at baseline: (a) Overall Investigator's Global Assessment (IGA) 3 (moderate) plaque psoriasis; (b) Body Surface Area (BSA) 2-15 percent (%) with at least 1 plaque outside of special sites; (c) Involvement of at least 1 special site with at least moderate severity. Qualifying sites include scalp with scalp-specific IGA greater than or equal to (\>=) 3, face with facial psoriasis IGA \>=3, intertriginous with intertriginous psoriasis IGA \>=3, or genital with static physician global assessment of genitalia (sPGA-G) \>=3
• All participants be inadequately controlled with or intolerant of at least 1 prior topical therapy (including, but not limited to, corticosteroids, retinoids, vitamin D, or vitamin D/steroid and retinoid/steroid combinations, tacrolimus, pimecrolimus, anthralin/dithranol, coal tar preparations, tapinarof, roflumilast, etcetera) for the treatment of psoriasis at both screening
• All participants be a candidate for phototherapy or systemic treatment for psoriasis

You may not qualify if:

• Has a nonplaque form of psoriasis (example, erythrodermic, guttate, or pustular) at screening or randomization
• Has current drug-induced psoriasis (for example, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
• For participants with palmoplantar involvement, confounding diagnoses, including, but not limited, to palmoplantar pustulosis, eczematous dermatitis, contact/irritant dermatitis, acquired keratoderma, etcetera, should be confirmed and excluded
• Participants will not be eligible if they have ever received prior biologic (or biosimilars of) for the treatment of psoriasis, psoriatic arthritis (PsA), or any other indications that could impact the assessment of psoriasis. Prior biologics (or biosimilars of) may include, but not limited to, tumor necrosis factor (TNF)-inhibitors (for example: adalimumab, etanercept, infliximab, or certolizumab or biosimilars), interleukin (IL)-17 inhibitors (for example: secukinumab, ixekizumab, brodalumab, or bimekizumab), and IL-12/23 inhibitors (for example: ustekinumab), or IL-23 inhibitor (for example: guselkumab, risankizumab or tildrakizumab)
• Has a history of chronic or recurrent infectious disease, including, but not limited to, chronic renal infection, chronic chest infection (for example, bronchiectasis), recurrent urinary tract infection (recurrent pyelonephritis or chronic non-remitting cystitis), fungal infection (mucocutaneous candidiasis), or open, draining, or infected skin wounds or ulcers

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (64)

Total Dermatology

Birmingham, Alabama, 35203, United States

Location

Cahaba Research Inc

Birmingham, Alabama, 35244, United States

Location

California Dermatology & Clinical Research Institute

Encinitas, California, 92024, United States

Location

First OC Dermatology

Fountain Valley, California, 92708, United States

Location

Practice Wang

Riverside, California, 92505, United States

Location

Therapeutics Clinical Research

San Diego, California, 92123, United States

Location

Rehlen, Bartlow, Goodman and Baron Dermatology Group

Santa Ana, California, 92701, United States

Location

Clinical Science Institute

Santa Monica, California, 90404, United States

Location

University of Conn Health Center

Farmington, Connecticut, 06030, United States

Location

TrueBlue Clinical Research

Brandon, Florida, 33511, United States

Location

Florida Academic Dermatology Centers

Coral Gables, Florida, 33134, United States

Location

Revival Research

Doral, Florida, 33122, United States

Location

Glick Research Institute

Margate, Florida, 33063, United States

Location

Miami VA Healthcare System

Miami, Florida, 33124, United States

Location

Tory P Sullivan M D PA

North Miami Beach, Florida, 33162, United States

Location

Atlanta Biomedical Clinical Research

Atlanta, Georgia, 303331, United States

Location

Kindred Hair and Skin Center

Columbia, Maryland, 21045, United States

Location

DermAssociates, PC

Rockville, Maryland, 20850, United States

Location

Lawrence J Green MD LLC

Rockville, Maryland, 20850, United States

Location

Metro Boston Clinical Partners

Brighton, Massachusetts, 02135, United States

Location

DermCare, LLC

Quincy, Massachusetts, 02169, United States

Location

Henry Ford Medical Center

West Bloomfield, Michigan, 48322, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10003, 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

Piedmont Plastic Surgery and Dermatology

Huntersville, North Carolina, 28078, United States

Location

Bexley dermatology research

Bexley, Ohio, 43209, United States

Location

Remington Davis Inc

Columbus, Ohio, 43215, United States

Location

Apex Dermatology Mayfield Heights

Mayfield Heights, Ohio, 44124, United States

Location

Dermatology and Laser Center of Charleston

Charleston, South Carolina, 29414, United States

Location

Palmetto Clinical Trial Services, LLC

Fountain Inn, South Carolina, 29644, United States

Location

Nashville Skin: Comprehensive Dermatology Center

Nashville, Tennessee, 37212, United States

Location

Tennessee Clinical Research Center

Nashville, Tennessee, 37215, United States

Location

Arlington Center for Dermatology

Arlington, Texas, 76011, United States

Location

Bellair Dermatology

Bellaire, Texas, 77401, United States

Location

Modern Research Associates PLLC

Dallas, Texas, 75231, United States

Location

Bare Dermatology

Dallas, Texas, 75235, United States

Location

Menter Dermatology Research Institute

Dallas, Texas, 75246, 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

Texas Dermatology and Laser Specialists

San Antonio, Texas, 78218, United States

Location

Progressive Clinical Research

San Antonio, Texas, 78229, United States

Location

Acclaim Dermatology

Sugar Land, Texas, 77479, United States

Location

Frontier Derm Partners CRO, LLC

Mill Creek, Washington, 98102, United States

Location

Beacon Dermatology

Calgary, Alberta, T3E 0B2, Canada

Location

Rejuvenation Dermatology Clinic Edmonton Downtown

Edmonton, Alberta, T5J 3S9, Canada

Location

Dr. Chih ho Hong Medical

Surrey, British Columbia, V3R 6A7, Canada

Location

Enverus Medical

Surrey, British Columbia, V3V 0C6, Canada

Location

Winnipeg Clinic

Winnipeg, Manitoba, R3C 0N2, Canada

Location

Wiseman Dermatology Research Inc.

Winnipeg, Manitoba, R3M 3Z4, Canada

Location

Brunswick Dermatology Center

Fredericton, New Brunswick, E3B 1G9, Canada

Location

CCA Medical Research Corporation

Ajax, Ontario, L1S7K8, Canada

Location

SimcoDerm Medical and Surgical Dermatology Centre

Barrie, Ontario, L4M 7G1, Canada

Location

Dermatrials Research

Hamilton, Ontario, L8N 1Y2, Canada

Location

Dr Wei Jing Loo Medicine Professional Corporation

London, Ontario, N6H 5L5, Canada

Location

North York Research Inc

North York, Ontario, M2M 4J5, Canada

Location

JRB Research Inc

Ottawa, Ontario, K1H 7X3, 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 2N2, Canada

Location

K. Papp Clinical Research Inc.

Waterloo, Ontario, N2J 1C4, Canada

Location

The Centre de recherche Saint-Louis

Québec, Quebec, G1W 4R4, Canada

Location

MeSH Terms

Interventions

guselkumab

Results Point of Contact

• Title: Medical Director in Dermatology Therapeutic Area
• Organization: Janssen Research and Development, LLC

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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: September 9, 2023
• First Posted: September 15, 2023
• Study Start: August 24, 2023
• Primary Completion: April 14, 2025
• Study Completion: April 14, 2025
• Last Updated: May 1, 2026
• Results First Posted: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

CA (19); US (45)