NCT06860750招募中3 期
A Randomized, Double-blind, Multicenter, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of SHR-1314 Injection in Adult Patients With Active Non-radiographic Axial Spondyloarthritis
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
- 380
- 试验地点
- 1
- 主要终点
- Proportion of participants achieving ASAS 40 (ankylosing spondylitis disease activity score).
研究概览
简要总结
The study is being conducted to evaluate the efficacy and safety of SHR-1314 injection in adult patients 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
- 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
- •Age ≥ 18 years at the time of signing the informed consent form, regardless of gender.
- •BMI (Body Mass Index) ≥ 18 kg/m² at the time of screening.
- •Presence of objective signs of inflammation at the time of screening.
- •The subject voluntarily signs the ICF (informed consent form) before the start of any study-related procedures.
- •The subject is able to communicate effectively with the investigator, understands and is willing to strictly adhere to the requirements of the clinical study protocol to complete the study.
排除标准
- •Subjects with active systemic infection or severe infection.
- •Subjects with active tuberculosis or latent tuberculosis infection.
- •Subjects with lymphoma or lymphoproliferative disease.
- •Subjects with uncontrolled hypertension.
- •Subjects with history of malignancy within the past 5 years or current malignancy.
- •Subjects with moderate to severe congestive heart failure.
- •Subjects with history of organ transplantation, or severe, progressive, or uncontrolled diseases of any organ system.
- •Presence of protocol-defined abnormalities in laboratory tests and/or 12-lead ECG at the time of screening.
- •Pregnant or breastfeeding women.
- •known allergy to the study drug or any of its components.
- •Subjects with history of alcohol abuse or illegal drug use within the past year.
- •Receipt of a live vaccine within 12 weeks before randomization, or plans to receive a live vaccine during the study period.
- •Blood donation of approximately 500 mL within 8 weeks before randomization, or plans to donate blood during the study period.
研究组 & 干预措施
SHR-1314 Injection
Experimental
Subjects will receive SHR-1314 injection in the core treatment period and the extended treatment period.
干预措施: SHR-1314 Injection (Drug)
SHR-1314 Placebo Injection
Placebo Comparator
Subjects will receive SHR-1314 placebo injection in the core treatment period and receive SHR-1314 injection in the extended treatment period.
干预措施: SHR-1314 Injection (Drug)
SHR-1314 Placebo Injection
Placebo Comparator
Subjects will receive SHR-1314 placebo injection in the core treatment period and receive SHR-1314 injection in the extended treatment period.
干预措施: SHR-1314 Placebo Injection (Drug)
结局指标
主要结局
Proportion of participants achieving ASAS 40 (ankylosing spondylitis disease activity score).
时间窗: At the 16th week after administration.
次要结局
- Proportion of participants achieving ASAS 20 (ankylosing spondylitis disease activity score).(At the 16th week after administration.)
- Change in CRP (C-reactive protein) value from baseline.(At the 16th week after administration.)
- AEs (adverse events).(Up to 60 weeks after administration.)
研究者
研究点 (1)
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