EUCTR2012-005412-25-ES进行中（未招募）1 期
A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Demonstrate the Efficacy at 16 Weeks of Secukinumab 150 and 300 mg s.c. and to Assess Safety, Tolerability and Long-term Efficacy up to 80 Weeks in Subjects With Moderate to Severe Palmoplantar Psoriasis
ovartis Farmacéutica, S.A.0 个研究点目标入组 201 人开始时间: 2013年3月6日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 201
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 or women at least 18 years at the time of screening
- •?Subjects should have chronic moderate to severe plaque type psoriasis for at least 6 months prior to entering the study, including significant involvement of plaque type psoriasis on the palms and soles defined by a palmplantar Investiator Global Assessment (ppIGA) score of > 3 (on a 5-point scale) and at least one extra palmoplantar plaque on the skin
- •?Subjects should be candidates for systemic therapy, which means having psoriasis considered inadequately controlled by topical treatment (including super potent topical corticosteroid) 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 191
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •?Forms of psoriasis other than chronic plaque type psoriasis (e.g., pustular psoriasis, palmoplantar pustulosis, acrodermatitis of Hallopeau, erythrodermic and guttate psoriasis)
- •?Drug-induced psoriasis (e.g. new onset or current exacerbation from ?-blockers, calcium channel inhibitors or lithium)
- •?Ongoing use of prohibited treatments (e.g. topical or systemic corticosteroids (CS), UV therapy). Washout periods have to be adhered to.
- •?Prior exposure to secukinumab (AIN457) or any other biologic drug directly targeting IL-17 or IL-17 Receptor
- •?Receipt of 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
- •?Active ongoing inflammatory diseases other than psoriasis that might confound the evaluation of the benefit of secukinumab therapy
- •?History of hypersensitivity to constituents of the study treatment. Other protocol-defined inclusion/exclusion criteria may apply
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