Efficacy and Safety of Xeligekimab in the Treatment of Non-Radiographic Axial Spondyloarthritis: A Single-Center, Single-Arm Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Proportion of participants achieving ASAS20 (ankylosing spondylitis disease activity score) at week 12
研究概览
简要总结
Subjects who have signed the informed consent form will undergo examinations and assessments according to the inclusion/exclusion criteria specified in the trial protocol. After screening and successful enrollment, they will enter the treatment period. Dosing time points are (W0, W2, W4, W8, W12), with a subcutaneous injection of Xeligekimab 100mg each time. Week 12 is the last dosing time. After week 12, the physician will comprehensively assess whether to continue using Xeligekimab based on the patient's condition. If continuation is required, the patient will need to purchase Xeligekimab at their own expense.
During the trial, the research physician and nurse will monitor safety, record the subject's vital signs and adverse events after dosing. Laboratory tests will be performed before and after the trial.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients aged 18 years or older;
- •Diagnosis of non-radiographic axial spondyloarthritis (nr-axSpA) according to the Assessment of SpondyloArthritis International Society (ASAS) criteria for axial spondyloarthritis;
- •Ineffective or intolerant to NSAID therapy;
- •Objective signs of inflammation (abnormal MRI or C-reactive protein);
- •Active axial spondyloarthritis with BASDAI score ≥4 and BASDAI question 2 ≥4;
- •Visual Analogue Scale (VAS) score ≥4;
排除标准
- •Patients with radiographic evidence of sacroiliitis, bilateral ≥grade 2 or unilateral ≥grade 3;
- •Presence of other active inflammations besides axial spondyloarthritis (e.g., active inflammatory bowel disease [IBD] or uveitis);
- •Chest X-ray suggesting active infection or malignant lesions;
- •Active systemic infection within 2 weeks prior to enrollment;
- •Known tuberculosis, HIV, hepatitis B, or hepatitis C infection at screening;
- •History of lymphoproliferative disease, any history of malignancy (within the past 5 years);
- •Subjects with unstable cardiovascular disease;
- •Patients taking potent opioid analgesics;
- •Pregnant or lactating women.
研究组 & 干预措施
Xeligekimab treatment
Through the subcutaneous administration of Xeligekimab, it is hoped to achieve the control of symptoms and inflammation in nr-axSpA, prevent or delay structural damage, and maximize patients' quality of life.
干预措施: Xeligekimab injection (Drug)
结局指标
主要结局
Proportion of participants achieving ASAS20 (ankylosing spondylitis disease activity score) at week 12
时间窗: at the 12th week after administration
ASAS20 response is defined as an improvement of 20% and an absolute improvement from baseline of 2 units on a 10-point scale in at least three of the four main domains and no worsening assessed at all in the remaining domain. Main ASAS domains: Patient's global assessment of disease activity measured on a VAS scale Patient's assessment of back pain, represented by either total or nocturnal pain scores, both measured on a VAS scale Function represented by BASFI average of 10 questions regarding ability to perform specific tasks as measured by VAS scale Inflammation represented by mean duration and severity of morning stiffness, represented by the average of the last 2 questions on the 6-question BASDAI as measured by VAS scale
次要结局
- The proportion of overall participants achieving an ASAS40 response at week 12.(week 12)
- The proportion of participants meeting the ASAS 5/6 response criteria.(week 12)
- The change from baseline in total Bath Ankylosing Spondylitis Disease Activity Index (BASDAI).(week 12)
- The change from baseline in total Bath Ankylosing Spondylitis Functional Index (BASFI).(week 12)
- The change from baseline in Ankylosing Spondylitis Quality of Life (ASQoL) scores.(week 12)
- Incidents of AE、TRAE、SAE(up to 12 weeks)
研究者
Lingli Dong
professor;professor of medicine
Tongji Hospital