EUCTR2012-005413-40-BE进行中（未招募）1 期
A randomized, double-blind, placebo-controlled, multicenter,study to demonstrate the efficacy at 16 weeks of secukinumab150 and 300 mg s.c. and to assess safety, tolerability and longtermefficacy up to 132 weeks in subjects with moderate tosevere nail psoriasis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 195
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Men and women at least age 18 at the time of screening
- •Subjects who have chronic moderate to severe plaque type psoriasis for at least 6 months prior to randomization, including significant nail involvement defined by a Nail Psoriasis Severity Index (NAPSI) score = 16 and number of fingernails involved = 4 AND a Psoriasis Area and Severity Index (PASI) score = 12 AND a Body Surface Area (BSA) score = 10%. Subject is a candidate for systemic therapy, defined as having psoriasis considered inadequately controlled by topical treatment and/or phototherapy and/or previous systemic therapy.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 185
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •Subjects who have forms of psoriasis other than chronic plaque type psoriasis (e.g.,pustular psoriasis, palmoplantar pustulosis, acrodermatitis of Hallopeau, erythrodermic and guttate psoriasis). Subjects who have drug-induced psoriasis (e.g. new onset or current exacerbation from ß-blockers, calcium channel inhibitors or lithium). Subjects who have active ongoing inflammatory skin diseases other than psoriasis, and any other disease affecting the fingernails that might confound the evaluation of the benefit of secukinumab treatment. Subjects who have ongoing use of prohibited treatments (e.g. topical or systemic corticosteroids (CS), UV therapy). Subjects who have been exposed to secukinumab or any other biologic drug directly targeting IL-17 or IL-17 Receptor. Subjects who have received any investigational drugs within 4 weeks of study drug initiation or within a period of 5 half-lives of the investigational treatment, whichever is longer. Subjects who have a history of hypersensitivity to constituents of the study treatment.
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究者
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