Specifying the anti-inflammatory effects of ziltivekimab with diverse imaging modalities and in-depth cellular phenotyping (SPIDER)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Mean percentage change in coronary arteries target to background ratio (TBRmax) and monocyte activation marker protein expression between the treatment and placebo group, at the primary analysis time point of 20 weeks, compared to baseline.
研究概览
简要总结
The objective of this study is to research whether ziltivekimab therapy for 20 weeks reduces arterial wall inflammation, as assessed by state-of-the-art imaging modalities, and reduces systemic inflammatory tone, as assessed by in depth phenotyping of circulating monocytes, inflammatory biomarkers and proteomics.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Age 50 years and older
- •Multi-vessel coronary artery disease (defined as CAD-RADS ≥2 and/or PAV/NCPV stage ≥2)
- •Serum hsCRP level ≥2 mg/L
排除标准
- •Coronary stents in situ
- •Chronic or recent (<1 month) (serious) infections and/or clinical signs of acute (serious) infection
- •History of severe auto-immune diseases, or other (severe) (recurrent or chronic) inflammatory disorders
- •Untreated latent tuberculosis, active hepatitis B (positive HBsAg and/or positive anti-HBc with detectable HBV DNA) or C, human immunodeficiency virus (HIV) not on stable antiretroviral regimen
结局指标
主要结局
Mean percentage change in coronary arteries target to background ratio (TBRmax) and monocyte activation marker protein expression between the treatment and placebo group, at the primary analysis time point of 20 weeks, compared to baseline.
Mean percentage change in coronary arteries target to background ratio (TBRmax) and monocyte activation marker protein expression between the treatment and placebo group, at the primary analysis time point of 20 weeks, compared to baseline.
次要结局
- The impact of ziltivekimab on inflammation in plasma cytokine and chemokine levels.
- Difference in PCAT (CCTA derived) after ziltivekimab treatment
- Correlation between changes in coronary 68Ga-DOTATATE uptake and anatomical plaque changes on CCTA.
- Difference in 68Ga-DOTATATE SUVmax of bone marrow and spleen after treatment.
- Difference in 68Ga-DOTATATE TBRmax of ascending aorta after treatment.
- The impact of ziltivekimab on monocyte phenotype in transendothelial migration (TEM) capacity and transcriptome profile.
- The mean percentage change in plasmatic proteins before and after ziltivekimab treatment.
研究者
Prof. Dr. E.S.G. Stroes
Scientific
Stichting Amsterdam UMC