Status:
ACTIVE_NOT_RECRUITING
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)
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Plaque Psoriasis
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief 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 Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 12 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 10 2027
Estimated Enrollment :
311 Patients enrolled
Trial Details
Trial ID
NCT06095102
Start Date
October 12 2023
End Date
June 10 2027
Last Update
December 8 2025
Active Locations (90)
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1
Center for Dermatology and Plastic Surgery
Scottsdale, Arizona, United States, 85260
2
Johnson Dermatology
Fort Smith, Arkansas, United States, 72916
3
California Dermatology & Clinical Research Institute
Encinitas, California, United States, 92024
4
Forcare Clinical Research Inc
Tampa, Florida, United States, 33613