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Clinical Trials List

Protocol Number77242113PSO3003
NCT Number(ClinicalTrials.gov Identfier)NCT06095102
Active

2023-10-01 - 2027-12-31

Phase III

Recruiting4

ICD-10L40.50

Arthropathic psoriasis, unspecified

ICD-10L40.51

Distal interphalangeal psoriatic arthropathy

ICD-10L40.52

Psoriatic arthritis mutilans

ICD-10L40.53

Psoriatic spondylitis

ICD-10L40.54

Psoriatic juvenile arthropathy

ICD-10L40.59

Other psoriatic arthropathy

ICD-9696.0

Psoriatic arthropathy

A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Participants with Plaque Psoriasis involving Special Areas

  • Trial Applicant

    Johnson & Johnson

  • Sponsor

    JOHNSON & JOHNSON TAIWAN LTD.

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator TSEN-FANG TSAI

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 邱顯鎰

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 何宜承

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Plaque Psoriasis

Objectives

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).

Test Drug

JNJ-77242113

Active Ingredient

JNJ-77242113

Dosage Form

tablets

Dosage

200mg

Endpoints

IGA (overall) score of 0 or 1 and a ≥2-grade improvement from baseline at Week 16.

Inclution Criteria

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

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

The Estimated Number of Participants

  • Taiwan

    23 participants

  • Global

    300 participants