NCT02980705终止2 期
A Randomized, Double-blind, Placebo-controlled Phase 2a Study to Evaluate the Efficacy and Safety of Tildrakizumab in Subjects With Active Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 180
- 试验地点
- 3
- 主要终点
- Assessment of SpondyloArthritis International Society 20 Response Rates
研究概览
简要总结
This is a randomized, double-Blind, placebo-controlled Phase 2a study to evaluate the efficacy and safety of SUNPG1622.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Subject has provided informed written consent
- •Subject is ≥ 18 years of age at time of Screening
- •Subject must be on a stable dose of NSAID for ≥ 2 weeks prior to initiation of investigational product
- •Subject has a negative test for TB within 4 weeks before initiating IMP
排除标准
- •Subjects with known diagnosis of fibromyalgia or complex regional pain syndromes
- •Active uveitis or symptomatic inflammatory bowel disease requiring therapy at screening
- •Radiographic evidence of total ankylosis of the spine
- •Subject has a planned surgical intervention between Baseline and the Week 24 evaluation for a pre-treatment condition
研究组 & 干预措施
SUNPG1622 I
Experimental
SUNPG1622 I dose
干预措施: SUNPG1622 I dose (Drug)
Placebo
Placebo Comparator
Placebo dose
干预措施: Placebo dose (Drug)
结局指标
主要结局
Assessment of SpondyloArthritis International Society 20 Response Rates
时间窗: Week 24
Percentage of subjects who achieve improvement of ≥ 40% and absolute improvement of ≥ 20 units from baseline in a visual analog scale (0 \[no disease activity\]-100 \[high disease activity\]). The results for this endpoint is as per the Cochran-Mantel-Haenszel Analysis of ASAS20 Response Rates (Full Analysis Set).
次要结局
- Assessment of SpondyloArthritis International Society 20 Response Rates(Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24)
研究者
研究点 (3)
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