NCT04481139已完成2 期
A Multicenter, Randomized, Double-blind, Placebo-controlled Adaptive Seamless Phase 2/3 Clinical Study to Evaluate the Efficacy and Safety of SHR0302 in Active Ankylosing Spondylitis Subjects
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
- 504
- 试验地点
- 1
- 主要终点
- Percentage of Participants with Assessment in Ankylosing Spondylitis (ASAS) 20 response at Week 12.
研究概览
简要总结
This study is to evaluate the efficacy and safety of different doses of JAK1 inhibitor SHR0302 in subjects 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provide signed informed consent.
- •AS diagnosis consistent with the Modified New York Criteria for AS (1984);
- •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.
- •BMI ≥18 kg/m2
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 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.
- •Previous treatment with JAK inhibitor or cytotoxic drugs; bDMARDs within 6 months of randomization; other strong immunosuppressants within 6 months of randomization.
研究组 & 干预措施
SHR0302 dose1
Experimental
SHR0302 dose1 for 24 weeks
干预措施: SHR0302 (Drug)
SHR0302 dose2
Experimental
SHR0302 dose2 for 24 weeks
干预措施: SHR0302 (Drug)
SHR0302 dose3
Experimental
SHR0302 dose3 for 24 weeks
干预措施: SHR0302 (Drug)
Placebo
Placebo Comparator
Placebo for 12 weeks
干预措施: SHR0302 placebo (Drug)
结局指标
主要结局
Percentage of Participants with Assessment in Ankylosing Spondylitis (ASAS) 20 response at Week 12.
时间窗: Week 12
ASAS20 is defined as a \>= 20% improvement and an absolute improvement of \>= 1 units (on a scale of 0 to 10) from Baseline in at least 3 of the 4 domains (patient's global assessment, back pain, function and inflammation) with no deterioration in the remaining domain (where deterioration is defined as a worsening of \>= 20% and a net worsening of \>= 1 unit \[on a scale of 0 to 10\])
次要结局
- Percentage of Participants with Assessment in Ankylosing Spondylitis (ASAS) 20 response at Week 24.(Week 24)
- Change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)(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)
- Percentage of Participants with Assessment in Ankylosing Spondylitis (ASAS) 5/6 response at Week 12 and Week 24.(Week 12 and Week 24)
- Percentage of Participants with Assessment in Ankylosing Spondylitis (ASAS) 40 response 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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