A Multi-center, Randomized, Double-blind, Placebo, Parallel-controlled Phase Ⅱ Clinical Trial of Jaktinib Hydrochloride Tablets in the Treatment of Patients With Active Ankylosing Spondylitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Percentage of Participants Achieving 20 Percent (%) Improvement in Assessment of SpondyloArthritis International Society (ASAS) Score (ASAS 20) at Week 16
研究概览
简要总结
This trial uses a multi-center, randomized, double-blind, placebo, parallel-controlled design, and it is expected that about 105 cases will be enrolled in about 10 sites.
详细描述
The study is divided into two stages, the first stage (1-16 weeks) is the main study; the second stage (17-32 weeks) is the extended study. This study set up 3 groups:Jaktinib Hydrochloride Tablets 75mg Bid group, 100mg Bid group and a placebo control group. The subjects were randomly enrolled in the group 1:1:1.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65, both gender;
- •Active Ankylosing Spondylitis;
- •Participants who have been treated with non-steroidal anti-inflammatory drugs(NSAIDs) and still have active disease, or Participants who are intolerant to NSAIDs and stop the drug;
- •Participants receiving low-dose oral glucocorticoid therapy (≤10mg/d prednisone) should maintain a stable medication regimen for at least 4 weeks before the first dose of this study. Do not adjust the dose during the entire study period except in emergency situations.
- •Participants receiving other non-prohibited co-drugs should maintain a stable medication regimen for at least 7 days before the first dose of this study;
- •Understand and voluntarily signed informed consent.
排除标准
- •A history of known or suspected complete spinal rigidity, or clinical and imaging confirmed complete spinal rigidity;
- •A history of any other autoimmune rheumatic disease;
- •Any history of joint prosthesis infection, and the prosthesis is still in place;
- •Participants who are using strong opioid analgesics (such as methadone, hydromorphone, morphine, etc.);
- •Participants who have been treated with any JAK inhibitors (such as Tofacitinib, Baricitinib, Ruxolitinib, Filgotinib, Upadacitinib, etc.);
- •Participants who have drug abuse or alcohol dependence;
- •Participants who have had herpes virus infection in the past month;
- •Participants who have a history of venous thrombosis (regardless of current treatment);
- •Any significant clinical and laboratory abnormalities that the investigator believes will affect the safety evaluator；
- •Participants who cannot be treated and followed up according to the trial protocol;
- •Any Participant considered by the investigator to be unsuitable to participate in this clinical study
研究组 & 干预措施
Jaktinib 100mg
100 mg bid.po
干预措施: Jaktinib Hydrochloride Tablets (Drug)
Jaktinib 75mg
75 mg bid.po
干预措施: Jaktinib Hydrochloride Tablets (Drug)
Placebo
Placebo bid.po
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants Achieving 20 Percent (%) Improvement in Assessment of SpondyloArthritis International Society (ASAS) Score (ASAS 20) at Week 16
时间窗: Week 16
ASAS20 responder had improvement of greater than or equal to (≥) 20% and ≥1 unit in at least 3 domains (on a scale of 0 \[least\] to 10 \[worst\]) and no worsening of ≥20% and less than or equal to (≤)1 unit in the remaining domain. The domains are: Patient's Global Assessment of Disease Activity, spinal pain, function and inflammation (from Bath Ankylosing Spondylitis Disease Activity Index \[BASDAI\]). Missing data were handled by nonresponsive (NRI)/ last observation carried forward (LOCF). Missing values due to a subject dropping out from the study were handled by setting the ASAS20 value to NRI. The LOCF approach was applied to missing components, if just some of the components of the ASAS20 were missing.
次要结局
- Percentage of Participants Achieving ASAS 20 at Week 2, 4, 8, 12, 20, 24, and 32(Week 2,4,8,12,16,20,24,32)
- Percentage of Participants Achieving ASAS 5/6 Response at Weeks 2, 4, 8, 12, 16, 20, 24, and 32(Week 2,4,8,12,16,20,24,32)
- Percentage of Participants Achieving ASAS 70 at Week 2, 4, 8, 12, 16, 20, 24, and 32(Week 2,4,8,12,16,20,24,32)
- Percentage of Participants Achieving ASAS 40 at Week 2, 4, 8, 12, 16, 20, 24, and 32(Week 2,4,8,12,16,20,24,32)