2026-525974-21-00招募中2 期
A Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-finding study of YMI024 to assess efficacy in reducing inflammatory markers, safety, and tolerability in adults with stable coronary artery disease and elevated hsCRP
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 43
- 试验地点
- 14
- 主要终点
- Change from baseline in log-transformed IL-6
研究概览
简要总结
To evaluate the dose-response relationship of YMI024 compared with placebo in reducing inflammatory markers in adults with stable CAD and elevated hsCRP ≥2 mg/L
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent must be obtained prior to any study specific procedures, and participant able to understand and comply with study requirements.
- •Male and female participants aged between 18-80 years (inclusive) at Screening.
- •Confirmed diagnosis of CAD
- •Participants have CRP levels more than ≥2 mg/L, which is a sign of increased inflammation
- •Participant may be receiving standard treatment for high blood pressure, high cholesterol, diabetes, kidney and heart problems
- •Participant may have ongoing kidney disease or heart failure
排除标准
- •Participants who have undergone open heart surgery in the past 6 months
- •Participants who have certain heart problems, like a heart attack within 30 days before entering the trial
- •Participants who have an autoimmune disease like rheumatoid arthritis or Crohn’s disease or ulcerative colitis and are taking certain therapies to treat, or if they have certain chronic infections such as hepatitis B or C
结局指标
主要结局
Change from baseline in log-transformed IL-6
Change from baseline in log-transformed IL-6
次要结局
- Change from baseline in log-transformed IL-6
- Change from baseline in log-transformed hsCRP
- Responder status (yes/no), defined as hsCRP <2 mg/L
- Responder status (yes/no), defined as hsCRP <1 mg/L
- Adverse events, and parameters from safety assessments, including vital signs, ECGs, and laboratory assessments (urine and blood) through the end of treatment / study (EOT/EOS)
研究者
Novartis Pharma Arzneimittel GmbH
Scientific
Novartis Pharma AG
研究点 (14)
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