EUCTR2013-001090-24-BE进行中（未招募）1 期
A randomized, double-blind, placebo-controlled phase III multicenter study of secukinumab to demonstrate the efficacy at 16 weeks and to assess the long-term safety, tolerability and efficacy up to 3 years in subjects with active Ankylosing Spondylitis
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 222
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
- •- Moderate to severe AS
- •- Prior radiographic evidence according to the Modified NY Criteria (1984)
- •- Inadequate response to NSDAIDs
- •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 220
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
排除标准
- •- Pregnancy or lactation
- •- Ongoing infectious or malignant process on a chest X-ray or MRI
- •- Previous exposure to IL-17 or IL-17R targeting therapies
- •- Previous exposure to any biological immunomodulating agent excluding TNF antagonists
- •- Previous cell depleting therapy
- •Other protocol-defined exclusion critera may apply
研究者
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