EUCTR2011-002510-36-BG进行中（未招募）不适用
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
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 140
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
- •-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
排除标准
- •-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
研究者
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