Ireland
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Active, not recruiting Phase 3

A Study of JNJ-77242113 for the Treatment of Participants With Plaque Psoriasis Involving Special Areas (Scalp, Genital, and/or Palms of the Hands and the Soles of the Feet)

NCT06095102 · tracked via the Priya Life Science South Korea tracker
Phase
Phase 3
Started
2023-10-12
Last updated
2026-09-25

Condition(s) studied

Plaque Psoriasis

Investigational drug(s) / intervention(s)

JNJ-77242113 →Placebo

JNJ-77242113: JNJ-77242113 will be administered orally.

Placebo: Placebo will be administered orally.

Study summary

The purpose of the study is to see how effective JNJ-77242113 is in participants with plaque psoriasis affecting special areas (scalp, genital, and/or palms of the hands and the soles of the feet).

Eligibility

Sex
ALL
Min age
12 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Diagnosis of plaque psoriasis, with or without psoriatic arthritis (PsA), for at least 26 weeks prior to the first administration of study intervention * Candidate for phototherapy or systemic treatment for plaque psoriasis * Need to meet criteria: Total body surface area (BSA) greater than or equal to (\>=)1 percent (%) at screening and baseline, and investigator global assessment (IGA) (overall) \>=2 at screening and baseline and at least one of the following: scalp-specific investigator global assessment (ss-IGA) score \>=3 at screening and baseline, and/or static physician's global assessment of genitalia (sPGA-G) \>=3 at screening and baseline, and/or physician's global assessment of hands and feet (hf-PGA) score \>=3 at screening and baseline * Failed to respond to at least 1 topical therapy (example, corticosteroids, calcineurin inhibitors, and/or vitamin D analogs) used for treatment of psoriasis * Confirmation of plaque psoriasis in a non-special area (example, areas excluding scalp, genital, palmoplantar) at screening and baseline Exclusion Criteria: * Nonplaque form of psoriasis (example, erythrodermic, guttate, or pustular) * Dermatoses other than plaque psoriasis (such as contact dermatitis) or palmoplantar pustulosis of the palmoplantar area (if hf-PGA \>=3 at baseline) * Current drug-induced psoriasis (example, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium) * A current diagnosis or signs or symptoms of severe, progressive, or uncontrolled renal, liver, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances * Known allergies, hypersensitivity, or intolerance to JNJ-77242113 or its excipients

Primary outcome measure(s)

  • Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Greater Than or Equal to (>=) 2-Grade Improvement From Baseline at Week 16 — Week 16
    IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema, scaling, each using 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,\>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 lesion, 2=mild; fine scale dominates, 3=moderate; coarse scale predominates, 4=severe; thick, scale predominates. Final IGA score was based upon average of induration, erythema and scaling scores assessed on 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe(4). Higher score=more severe disease. Baseline=closest measurement taken prior to or at time of first study drug administration date.

Trial sites (90)

FacilityCityRegionStatus
Center for Dermatology and Plastic Surgery Scottsdale Arizona
Johnson Dermatology Fort Smith Arkansas
California Dermatology & Clinical Research Institute Encinitas California
Forcare Clinical Research Inc Tampa Florida
Hamilton Research LLC Alpharetta Georgia
Arlington Dermatology Rolling Meadows Illinois
Dundee Dermatology West Dundee Illinois
Dawes Fretzin Clinical Research Group LLC Indianapolis Indiana
Indiana Clinical Trial Center Plainfield Indiana
Dermatology and Advanced Aesthetics Lake Charles Louisiana
Allcutis Research 1 Beverly Massachusetts
Hamzavi Dermatology Fort Gratiot Michigan
Minnesota Clinical Study Center New Brighton Minnesota
MediSearch Clinical Trials Saint Joseph Missouri
Skin Specialists Omaha Nebraska
Schweiger Dermatology Group East Windsor New Jersey
Optima Research Boardman Ohio
Oregon Dermatology and Research Center Portland Oregon
Paddington Testing Co, Inc. Philadelphia Pennsylvania
University of Pittsburgh Medical Center Pittsburgh Pennsylvania
Arlington Research Center, Inc. Arlington Texas
Center for Clinical Studies 1 Houston Texas
Austin Institute for Clinical Research Pflugerville Texas
Progressive Clinical Research San Antonio Texas
Dermatology Clinical Research Center of San Antonio San Antonio Texas
Center for Clinical Studies Webster Texas
Cope Family Medicine - Ogden Clinic Bountiful Utah
Frontier Derm Partners CRO, LLC Mill Creek Washington
CIPREC Buenos Aires Argentina
Centro Privado de Medicina Familiar Buenos Aires Argentina
Conexa Investigacion Clinica S.A. CABA Argentina
CEDIC Centro de Investigacion clinica Caba Argentina
Alberta DermaSurgery Centre Edmonton Alberta
Lynderm Research Inc. Markham Ontario
Skin Centre for Dermatology Peterborough Ontario
York Dermatology Clinic and Research Centre Richmond Hill Ontario
Innovaderm Research Inc. Montreal Quebec
Centre Dermatologique Québec Quebec
Skinsense Medical Research Saskatoon Saskatchewan
ISA - Interdisciplinary Study Association GmbH Berlin Germany

+ 50 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06095102 on ClinicalTrials.gov ↗ ← All trials in South Korea