ISRCTN54453452进行中（未招募）3 期
A Phase III 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
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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