A randomized, double-blind, double dummy, multicenter study to assess the safety, tolerability and long-term efficacy of intravenous (10 mg/kg) and subcutaneous (300 mg) secukinumab in subjects with moderate to severe chronic plaque-type psoriasis who are partial responders to secukinumab - Efficacy and safety of i.v and s.c secukinumab in moderate to severe chronic plaque-type psoriasis

ovartis Pharma Services AG0 个研究点目标入组 140 人开始时间: 2011年9月12日最近更新: 2016年5月2日

适应症

试验速览

暂无简介。

•-Written Informed Consent must be obtained before any assessment is performed,
•-Subject must be able to understand and communicate with the investigator and comply with the requirements of the study.
•-Subjects must have participated in the study CAIN457A2304 and have achieved a partial response after twelve weeks of treatment with no major protocol deviations.
•A partial response is defined as having achieved = PASI 50 but < 75 response.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 132
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 8

•-Pregnant women or lactating women
•-Forms of psoriasis other than chronic plaque –type
•-Ongoing use of prohibited psoriasis treatments
•-Ongoing use of other non-psoriasis prohibited treatments
•-Previous exposure to any biologic drug directly targeting IL-17 or the IL-17 receptor, except secukinumab in study CAIN457A2304
•-Active ongoing inflammation diseases other than psoriasis that might confound the evaluation of the benefits of secukinumab therapy
•-UV therapy or excessive exposure to sunlight

发起方