NCT05861128招募中3 期
An Open-Label, Multicenter, Extension Study to Assess the Long-Term Safety and Efficacy of Jaktinib in Patients With Active Ankylosing Spondylitis(AS)
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
- 258
- 试验地点
- 1
- 主要终点
- Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Related Discontinuations at 32 Weeks
研究概览
简要总结
The purpose of this study is to determine if Jaktinib is safe and effective in participants with active ankylosing spondylitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •The investigators concluded that the participants continued to benefit from treatment with Jaktinib.
- •The participants have been fully informed and voluntarily signed informed consent.
- •The participants completed the ZGJAK029 study for 16 weeks of treatment and visitation and had good compliance.
- •The interval between the participants' first dose and the last dose of ZGJAK029 ≤ 4 weeks.
排除标准
- •There were any grade ≥3 adverse events within 4 weeks prior to enrollment and no return to grade 1 or normal.
- •Within 4 weeks prior to enrollment, participants had the following infectious diseases: tuberculosis infection requiring treatment; HIV-positive, syphilis, HBV infection, HCV infection.
- •The investigators considered participants unsuitable for this study.
研究组 & 干预措施
Jaktinib 100mg BID (twice daily)
Experimental
干预措施: Jaktinib (Drug)
结局指标
主要结局
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Related Discontinuations at 32 Weeks
时间窗: Baseline up to Week 32
Treatment-emergent AEs were events that occurred between first dose of study drug and up to 32 weeks that were absent before treatment or that worsened relative to pretreatment state.
次要结局
- Change From Baseline in Patient's Assessment of Spinal Pain: Total Back Pain at Week 4, 8, 12, 16，20，24，28 and 32(Baseline, Week 4, 8, 12, 16，20，24，28 and 32)
- Percentage of Participants Achieving ASAS40 Response at Week 4, 8, 12, 16，20，24，28 and 32(Baseline, Week 4, 8, 12, 16，20，24，28 and 32)
- Percentage of Participants Achieving ASAS 5/6 Response at Week 4, 8, 12, 16，20，24，28 and 32(Baseline, Week 4, 8, 12, 16，20，24，28 and 32)
- Percentage of Participants Achieving ASAS20 Response at Week 4, 8, 12, 16，20，24，28 and 32(Baseline, Week 4, 8, 12, 16，20，24，28 and 32)
研究者
研究点 (1)
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