A Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability and Effects on Arterial Structure and Function of ACZ885 in Patients With Intermittent Claudication.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Mean Vessel Wall Area Ratio of 12 Months to Baseline
研究概览
简要总结
This study was designed to assess the safety, tolerability and efficacy of ACZ885 on the leg artery structure and physical activity in patients with atherosclerotic peripheral artery disease and leg pain from walking.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have a signed informed consent form.
- •Must be between the ages of 18 and 85
- •Must experience leg pain associated with walking and have an ankle brachial index between 0.40 and 0.9
- •Must be on stable aspirin and statin doses for at least 6 weeks
- •Blood pressure within ranges specified in the protocol
- •Able to communicate well with the Investigator and understand and comply with the study procedures
排除标准
- •Recent use of any other experimental drugs
- •Pregnant or nursing women
- •Women of child bearing potential unless willing to use contraception as detailed in the protocol
- •Cannot walk 15 meters (50 feet)
- •People on restricted medications as listed in the protocol
- •Any open or non-healing wounds with 3 months of study start or infection within 2 weeks or study start
- •Significant heart disease
- •Uncontrolled diabetes
- •Significant kidney or liver disease
- •Live vaccinations within 3 months of study start
- •History of untreated tuberculosis or active tuberculosis (TB)
- •Patients with metal in their body (excluded due to MRI scan) as detailed in the protocol.
研究组 & 干预措施
Canakinumab (ACZ885)
Monthly subcutaneous doses of Canakinumab 150 mg/1 mL for 12 months
干预措施: Canakinumab (ACZ885) (Drug)
Placebo
Monthly subcutaneous doses of placebo of Canakinumab 150 mg/1 mL for 12 months
干预措施: Placebo (Drug)
结局指标
主要结局
Mean Vessel Wall Area Ratio of 12 Months to Baseline
时间窗: Baseline, 12 months post-dose
Peripheral artery wall area (superficial femoral artery) measured using Magnetic Resonance Imaging (MRI) cross-section slices. Mean vessel wall area (mm\^2) was derived by converting total plaque volume (TPV) (mL) of the vessel to mm\^3 by multiplying by 1000, dividing by the number of slices used for the volume calculation, and dividing by the thickness of a slice (3 mm). Least squares mean for ratio of 12 months to baseline was measured from repeated measures mixed effect model with visit, treatment, the treatment-by-visit interaction, baseline and the visit-by-baseline interaction as fixed effects.
次要结局
- High Sensitivity C-reactive Protein (hsCRP) Ratio of 12 Months to Baseline(Baseline, 12 months post-dose)
- Serum Amyloid A (SAA) Level Ratio of 12 Months to Baseline(Baseline, 12 months post-dose)
- Number of Patients With Adverse Events in 12 Months(Baseline to 12 months post-dose)