A randomized, double-blind, double-dummy, placebo controlled, multicenter study of subcutaneous secukinumab to demonstrate efficacy after twelve weeks of treatment, compared to placebo and etanercept, and to assess the safety, tolerability and long-term efficacy up to one year in subjects with moderate to severe chronic plaque-type psoriasis. - FIXTURE

ovartis Pharma Services AG0 个研究点目标入组 1,264 人开始时间: 2011年8月22日最近更新: 2013年9月23日

试验速览

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•Subjects with chronic, plaque-type psoriasis for at least 6 months
•Must have moderate to severe psoriasis based on PASI greater than 12, IGA greater than 3, and greater than 10% body surface area
•Must be inadequately controlled by prior treatments (topicals, phototherapy, and/or systemic therapies)
•Other protocol-defined inclusion criteria may apply.
•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 1201
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 63

•Forms of psoriasis other than chronic, plaque-type (such as pustular, erythrodermic and guttate psoriasis)
•Drug induced psoriasis
•Use of other psoriasis treatments during the study
•Prior use of etanercept
•Prior use of secukinumab or any other drug that target IL-17 or the IL-17 receptor
•Pregnant or lactating women; women who do not agree to use contraception during the study and for 16 weeks after stopping treatment
•Significant medical problems such as uncontrolled high blood pressure, congestive heart failure, etc.
•History of an ongoing, chronic or recurrent infection or evidence of tuberculosis
•Allergy to rubber or latex
•Other protocol-defined exclusion criteria may apply.

发起方