NCT05324631招募中3 期
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Clinical Study to Evaluate the Efficacy and Safety of SHR0302 in Active Non-Radiographic Axial Spondyloarthritis Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Percentage of Participants Achieving Assessment of SpondyloArthritis International Society (ASAS) 40 Response at week 12
研究概览
简要总结
This study is to evaluate the efficacy and safety of SHR0302 in subjects with active non-radiographic axial spondyloarthritis.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provide signed informed consent.
- •BMI ≥18 kg/m
- •Participant has the clinical diagnosis of nr-axSpA fulfilling the 2009 ASAS classification criteria for axSpA but not meeting the radiologic criterion of the modified New York criteria for AS and have objective signs of active inflammation on magnetic resonance imaging (MRI) or based on high sensitivity C-reactive protein (CRP).
- •Participant must have baseline disease activity as defined by having a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score >= 4 and a Patient's Assessment of Total Back Pain score >= 4 based on a 0 - 10 Numeric Rating Scale (NRS) at the Screening and Baseline Visits.
- •Participant has had an inadequate response to at least two Nonsteroidal Anti-inflammatory Drugs (NSAIDs) over an at least 4-week period in total at maximum recommended or tolerated doses, or participant has an intolerance to or contraindication for NSAIDs as defined by the Investigator.
- •If subjects are taking permitted csDMARDs or low-dose corticosteroid orally at baseline, the stable doses should have lasted for more than 4 weeks already.
排除标准
- •Pregnant women or refuse to receive contraception during the study.
- •Lab abnormality within 4 weeks of randomization as follows: WBC count <3.0×10^9/L；neutrophil count<1.5×10^9/L;hemoglobin level<90.0 g/L ; platelet count <100×10^9/L; AST or ALT levels greater than the 1.5 times the upper limit of normal; HBsAg or HCV or HIV antibody positivity.
- •History of other autoimmune diseases ; history of cancer or infection including tuberculosis and hepatitis; history of important cardiovascular events or thrombotic diseases.
研究组 & 干预措施
Treatment group A
Experimental
SHR0302
干预措施: SHR0302 (Drug)
Treatment group B
Placebo Comparator
SHR0302 Placebo
干预措施: SHR0302 placebo (Drug)
结局指标
主要结局
Percentage of Participants Achieving Assessment of SpondyloArthritis International Society (ASAS) 40 Response at week 12
时间窗: Week 12
次要结局
- Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at week 12(Week 12)
- Percentage of Participants With ASAS 20 Response at week 12(Week 12)
- Change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at week 12(Week 12)
- Percentage of Participants with ASAS 5/6 response at Week 12 and Week 24(Week 12 and Week 24)
- Change from baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 12 and Week 24(Week 12 and Week 24)
- Change from baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 12 and Week 24(Week 12 and Week 24)
- Change from baseline in Short-Form-36-Health Survey (SF-36) at Week 12 and Week 24(Week 12 and Week 24)
- Change from baseline in Ankylosing Spondylitis Quality of Life (ASQoL) at Week 12 and Week 24(Week 12 and Week 24)
研究者
研究点 (1)
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