A study of JNJ-77242113 for the treatment of participants with plaque psoriasis involving special areas (scalp, genital, and/or palms of hands and the soles of the feet)
- Conditions
- Plaque psoriasisSkin and Connective Tissue Diseases
- Registration Number
- ISRCTN54453452
- Lead Sponsor
- Janssen-Cilag International NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 300
1. Aged 18 years or older
2. Diagnosis of plaque psoriasis, with or without psoriatic arthritis (PsA), for at least 26 weeks prior to the first administration of study intervention
3. Candidate for phototherapy or systemic treatment for plaque psoriasis
4. Need to meet criteria:
4.1. Total body surface area (BSA) greater than or equal to (>=)1 percent (%) at screening and baseline,
4.2. and investigator global assessment (IGA) (overall) >=2 at screening and baseline
4.3. and at least one of the following: scalp-specific investigator global assessment (ss-IGA) score >=3 at screening and baseline, and/or
4.4. 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
5. Failed to respond to at least 1 topical therapy (example, corticosteroids, calcineurin inhibitors, and/or vitamin D analogs) used for treatment of psoriasis
6. Confirmation of plaque psoriasis in a non-special area (example, areas excluding scalp, genital, palmoplantar) at screening and baseline
1. Nonplaque form of psoriasis (example, erythrodermic, guttate, or pustular)
2. Dermatoses other than plaque psoriasis (such as contact dermatitis) or palmoplantar pustulosis of the palmoplantar area (if hf-PGA >=3 at baseline)
3. Current drug-induced psoriasis (example, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
4. A current diagnosis or signs or symptoms of severe, progressive, or uncontrolled renal, liver, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, haematologic, rheumatologic, psychiatric, or metabolic disturbances
5. Known allergies, hypersensitivity, or intolerance to JNJ-77242113 or its excipients
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of participants achieving an Investigator's Global Assessment (IGA) Score of 0 or 1 and Greater Than or Equal to (>=) 2 Grade Improvement from Baseline at Week 16. 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).
- Secondary Outcome Measures
Name Time Method