NCT07448038招募中2 期
A Phase IIa, Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Efficacy, Safety, Pharmacodynamics, and Pharmacokinetics of Selnoflast in Reducing Vascular Inflammation in Patients With Atherosclerosis at Risk for Major Adverse Cardiac Events
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 162
- 试验地点
- 25
- 主要终点
- Change in mdsTBR (Most-diseased Segment TBR [Target-to-background Ratio]) of Index Vessel From Baseline to Week 12 in Participants With Baseline Elevated hsCRP (≥ 2 milligrams per liter [mg/L])
研究概览
简要总结
The main purpose of the study is to evaluate the efficacy of selnoflast compared with placebo in participants with atherosclerosis, at high-risk for major adverse cardiovascular event (MACE), who are currently on standard-of-care (SOC) therapy.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed evidence of atherosclerosis
- •Left or right carotid TBR ≥ 1.8 or aorta TBR ≥ 2.0 on centrally-assessed 18F-fluorodeoxyglucose-Positron Emission Tomography (18F-FDG-PET) scan
- •Stable treatment of atherosclerosis through the use of SOC medications or revascularization
- •QT interval corrected through use of Fridericia's formula (QTcF) of ≤ 450 milliseconds (ms) in men and ≤ 470 ms in women by a single 12-lead electrocardiogram (ECG) recording
排除标准
- •Individuals with Class III and IV heart failure
- •Uncontrolled cardiac arrhythmia
- •Uncontrolled hypertension
- •Suspected or known immunocompromised state
- •Planned procedure or surgery during the study and any major surgery within 90 days prior to screening Visit 1
- •History of malignancy within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or Stage I uterine cancer
- •Positive test results for hepatitis B (HBV) infection at screening
- •Positive hepatitis C virus (HCV) antibody test at screening
- •Positive human immunodeficiency virus (HIV) test at screening
- •Estimated glomerular filtration rate <50 mL/min/1.73 m² as calculated through use of the Chronic Kidney Disease Epidemiology Collaboration equation, at the time of screening.
- •Treatment with any live vaccine within 28 days prior to the first dose of study drug until the end of the study
- •Treatment with other non-live vaccines within 14 days prior to the first dose of study drug until the end of the study
研究组 & 干预措施
Selnoflast
Experimental
Participants will receive selnoflast, orally (PO), twice a day (BID) for 12 weeks.
干预措施: Selnoflast (Drug)
Placebo
Placebo Comparator
Participants will receive placebo, PO, BID for 12 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in mdsTBR (Most-diseased Segment TBR [Target-to-background Ratio]) of Index Vessel From Baseline to Week 12 in Participants With Baseline Elevated hsCRP (≥ 2 milligrams per liter [mg/L])
时间窗: Baseline up to Week 12
hsCRP=high-sensitivity C-reactive protein.
次要结局
- Number of Participants With Adverse Events (AEs) and Severity of AEs Determined According to the NCI CTCAE v5.0 Grading Scale(Up to approximately 22 weeks)
- Change From Baseline in mdsTBR of Carotids at Week 12 in all Participants (hsCRP < 2 mg/L and ≥ 2 mg/L)(Baseline and Week 12)
- Change From Baseline in mdsTBR of Index Vessel at Week 12 in all Participants (hsCRP < 2 mg/L and ≥ 2mg/L)(Baseline and Week 12)
- Change From Baseline in mdsTBR of Carotids at Week 12 in Participants With Baseline Elevated hsCRP (≥ 2 mg/L)(Baseline and Week 12)
- Change From Baseline in Active Segments TBR and the Whole Vessel TBR of the Index Vessel at Week 12 in all Participants (hsCRP < 2 mg/L and ≥ 2 mg/L)(Baseline and Week 12)
- Change From Baseline in Active Segments TBR and the Whole Vessel TBR of the Index Vessel at Week 12 in Participants With Baseline Elevated hsCRP (≥ 2 mg/L)(Baseline and Week 12)
- Number of Participants With Adverse Events (AEs) and Severity of AEs Determined According to the NCI CTCAE v5.0 Grading Scale(Up to approximately 20 weeks)
- Plasma Concentration of Selnoflast at Specified Timepoints(Up to 12 weeks)
研究者
研究点 (25)
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