A randomized, double-blind, placebo controlled,multicenter study of subcutaneous secukinumab, todemonstrate efficacy after twelve weeks of treatment andto assess safety, tolerability and long-term efficacy up toone year in subjects with moderate to severe chronicplaque-type psoriasis with or without psoriatic arthritiscomorbidity

ovartis Pharma Services AG0 个研究点目标入组 536 人开始时间: 2016年11月30日最近更新: 2018年12月10日

适应症

试验速览

暂无简介。

•* Men or women at least 18 years of age at time of screening.
•* Moderate to severe plaque psoriasis Chronic plaque-type psoriasis present for at least 6 months and diagnosed before Baseline.
•* Candidate for systemic therapy.
•Additional inclusion criteria may apply , please refer to the protocol.
•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 482
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 54

•* Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic, guttate, light sensitive, drug induced)
•* Ongoing use of prohibited treatments
•* Previous exposure to secukinumab (AIN457) or any other biologic drug directly targeting IL-17 or the IL-17 receptor.
•* Pregnant or nursing (lactating) women
•* Women of child-bearing potential not willing to use contraception
•*Active ongoing inflammatory diseases other than psoriasis or psoriatic arthritis that might confound the evaluation of the benefit of secukinumab therapy
•*Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 30 days until the expected pharmacodynamic effect has returned to baseline, whichever is longer; or longer if required by local regulations.
•Additional exclusion criteria may apply , please refer to the protocol.

发起方