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)
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)
Facility
City
Region
Status
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.
More Janssen Research & Development, LLC trials in the UK
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.
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