NCT04840485已完成2 期
A Randomized, Double-blind, Multicenter, Placebo-controlled, Phase II/III Adaptive Study of SHR-1314 to Assess Efficacy and Safety in Patients With Active Ankylosing Spondylitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 548
- 试验地点
- 1
- 主要终点
- Percentage of Participants Responded for Assessment of SpondyloArthritis international Society 20 Criteria (ASAS20) at 16 Weeks
研究概览
简要总结
The purpose of this study is to assess efficacy, safety, pharmacokinetics and immunogenicity of subcutaneous SHR-1314 in patients with active ankylosing spondylitis
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Active Ankylosing Spondylitis, prior radiographic evidence according to the Modified NY Criteria (1984), inadequate response, contraindications or intolerance to NSAIDs
排除标准
- •pregnancy or lactation, serious infectious, malignancy, previous exposure to any biological agent excluding TNF antagonists
研究组 & 干预措施
Treatment group A
Experimental
干预措施: SHR-1314 (Drug)
Treatment group B
Experimental
干预措施: SHR-1314 (Drug)
Treatment group C
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants Responded for Assessment of SpondyloArthritis international Society 20 Criteria (ASAS20) at 16 Weeks
时间窗: 16 Weeks
次要结局
- Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at 16 and 32 Weeks(16 and 32 Weeks)
- Change From Baseline in Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL) at 16 and 32 Weeks(16 and 32 Weeks)
- Percentage of Participants Responded for ASAS 20 Response at 32 Weeks(32 Weeks)
- Percentage of Participants Responded for ASAS 40 Response at 16 and 32 Weeks(16 and 32 Weeks)
- Percentage of Participants Responded for ASAS 5/6 Response at 16 and 32 Weeks(16 and 32 Weeks)
研究者
研究点 (1)
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