NCT01258907已完成2 期
A Multicenter, Randomized, Double Blind, Placebo-Controlled Phase II Study to Evaluate the Safety, Tolerability, and Activity of Intravenous MLDL1278A in Patients on Standard-of-Care Therapy for Stable Atherosclerotic Cardiovascular Disease (GLACIER - Goal of Oxidized Ldl and Activated Macrophage Inhibition by Exposure to a Recombinant Antibody)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 147
- 主要终点
- Change in TBR as measured by FDG-PET/CT
研究概览
简要总结
This is a Phase II (proof-of-activity), double-blind, placebo-controlled, randomized, multicenter study of MLDL1278A (also known as BI-204) involving patients on standard-of-care therapy for atherosclerotic cardiovascular disease with evidence of vascular inflammation, as quantified by FDG-PET/CT.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Evidence of qualifying vessel (carotid or aortic) plaque inflammation
- •Documented atherosclerotic vascular disease clinically stable for at least 3 months prior to screening or type 2 diabetes mellitus with elevated cardiovascular risk
- •Use of a stable dose of statin therapy for at least 6 weeks prior to screening. Patients must be capable of maintaining statin therapy at a current dose level from screening until the last follow-up visit.
- •For patients taking angiotensin-converting enzyme (ACE) inhibitors (ACE-I) or angiotensin-receptor blockers (ARBs), non-statin lipid-modifying therapy, thiazolidinediones, inhaled steroids, or leukotriene modifying agents, use of a stable dose for at least 6 weeks prior to screening and capable of continuing with that dose for the duration of the study
排除标准
- •Occurrence of a cardiovascular event < 6 months prior to screening
- •Pregnant, planning to become pregnant during the study, or breastfeeding
- •Clinically significant abnormal laboratory values or abnormal ECG or vital signs
- •History of anaphylactic reactions
- •Newly discovered Type 2 diabetes mellitus (T2DM) (prior to study entry) or medical treatment for T2DM started < 3 months prior to study entry
- •Use of insulin, corticosteroids (oral, rectal, or injectable), or other immunosuppressive medications
- •Current or recent (within 4 weeks prior to screening) infection, including signs, symptoms or serology of any infection, including HIV, hepatitis B or C
- •Impaired renal function
- •History of malignancy within 2 years prior to screening
- •Current life-threatening condition other than vascular disease that may prevent a patient from completing the study
- •Use of an investigational drug or biologic within 30 days or 5 half-lives (whichever is longer) prior to the first dose of study medication
- •Exposure to substantial radiation within 12 months prior to screening
研究组 & 干预措施
C
Placebo Comparator
干预措施: placebo (Drug)
C
Placebo Comparator
干预措施: statin, stable dose (Drug)
A
Experimental
干预措施: MLDL1278A (Drug)
A
Experimental
干预措施: statin, stable dose (Drug)
B
Experimental
干预措施: MLDL1278A (Drug)
B
Experimental
干预措施: statin, stable dose (Drug)
结局指标
主要结局
Change in TBR as measured by FDG-PET/CT
时间窗: Baseline to Week 12
次要结局
- Incidence and severity of adverse events and clinical laboratory abnormalities as a measure of safety and tolerability of MLDL1278A(Throughout study or until early discontinuation)
- Effects of MLDL1278A on inflammatory and metabolic biomarkers(Throughout study or until early discontinuation)
研究者
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