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: 2016年8月8日

适应症

试验速览

暂无简介。

•?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

•?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

发起方

ovartis Farmacéutica, S.A.