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临床试验/NCT06237309
NCT06237309终止2 期

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of a Single Dose of REGN5381, an NPR1 Monoclonal Antibody Agonist, in Patients With Chronic Heart Failure With Reduced Ejection Fraction

Regeneron Pharmaceuticals44 个研究点 分布在 12 个国家目标入组 89 人开始时间: 2024年4月11日最近更新:
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适应症
干预措施

试验速览

阶段
2 期
状态
终止
入组人数
89
试验地点
44
主要终点
Change from baseline in circulating N-Terminal pro-Brain Natriuretic Peptide (NTproBNP)
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study is researching an experimental drug called REGN5381 (called "study drug"). The study is focused on patients with heart failure with reduced ejection fraction (ie, the heart is not functioning as well as it should).

The aim of the study is to see how safe, tolerable, and effective the study drug is.

The study is looking at several other research questions, including:

  • What side effects may happen from taking the study drug
  • How much study drug is in the blood at different times
  • Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects)

详细描述

Enrollment for the Part A2 low eGFR cohort has been closed

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 —（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Body mass index (BMI) between 18 and 45 kg/m^2, inclusive, at initial screening visit
  • •Diagnosis of chronic heart failure
  • •Left ventricular ejection fraction 20-49% by echocardiogram performed within 3 months of screening
  • •Plasma NT-proBNP ≥800 pg/mL (or ≥1000 pg/mL if in atrial fibrillation) at screening (visit 1) and NT-proBNP ≥600 pg/mL (or ≥800 pg/mL if in atrial fibrillation) approximately 30 days prior to randomization (visit 5)
  • •Receiving optimized standard of care therapy for heart failure as described in the protocol
  • •Sacubitril-valsartan treatment:
  • •a. Treatment with sacubitril-valsartan at screening and at baseline permitted in Part A2 sacubitril-valsartan cohort and in Part B if supported by safety data from the Part A2 sacubitril-valsartan cohort as described in the protocol
  • •Estimated Glomerular Filtration Rate (eGFR) levels:
  • •eGFR of ≥30 mL/min/1.73 m2 according to locally used formula (Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] preferred), at screening (visit 1) or approximately 30 days prior to randomization (visit 5) as described in the protocol

排除标准

  • •Hospital discharge within 180 days of anticipated randomization
  • •Resting SBP that remains out of range after two repeated measurements prior to randomization as described in the protocol
  • •Current or recent diagnosis of acute coronary syndrome or myocardial infarction as described in the protocol
  • •History of symptomatic autonomic dysfunction as evidenced by orthostatic hypotension and/or syncope
  • •Unexplained syncope <12 months prior to initial screening or during the Run-in period
  • •History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, or neurological disease, as assessed by the investigator that may confer unreasonable risk to the participant's participation in the study
  • •Uncorrected congenital heart disease
  • •Cardiac surgery within 6 months prior to screening or any planned surgery during the study
  • •Implantation of a cardiac resynchronization therapy device in the prior 90 days, or planned during the study, or planned device optimization 30 days prior to randomization or during the study
  • •Current chronic lung disease requiring long-term oxygen therapy
  • •Note: Other protocol-defined inclusion/ exclusion criteria apply

研究组 & 干预措施

Part B Low Dose

Experimental

干预措施: REGN5381 (Drug)

Part A1 and Part B Placebo Only

Placebo Comparator

干预措施: Placebo (Drug)

Part A2 High Dose, sacubitril-valsartan group

Experimental

Single ascending dose cohort

干预措施: REGN5381 (Drug)

Part A2 Low Dose, sacubitril-valsartan group

Experimental

Single ascending dose cohort

干预措施: REGN5381 (Drug)

Placebo for Part A2, sacubitril-valsartan group

Placebo Comparator

干预措施: Placebo (Drug)

Part A2 High Dose, Low estimated glomerular filtration rate (eGFR) group

Experimental

Single ascending dose cohort. Note: This group has been closed

干预措施: REGN5381 (Drug)

Part A2 Low Dose, Low eGFR group

Experimental

Single ascending dose cohort. Note: This group has been closed

干预措施: REGN5381 (Drug)

Placebo for Part A2, Low eGFR group

Placebo Comparator

Note: This group has been closed

干预措施: Placebo (Drug)

Part B High Dose

Experimental

干预措施: REGN5381 (Drug)

Part A1 High Dose

Experimental

Single ascending dose cohort

干预措施: REGN5381 (Drug)

Part A1 Low Dose

Experimental

Single ascending dose cohort

干预措施: REGN5381 (Drug)

Part A1 Optional

Experimental

Single ascending dose cohort

干预措施: REGN5381 (Drug)

结局指标

主要结局

Change from baseline in circulating N-Terminal pro-Brain Natriuretic Peptide (NTproBNP)

时间窗: Day 8

次要结局

  • Occurrence of Treatment Emergent Adverse Events (TEAEs)(Through week 16)
  • Severity of TEAEs(Through week 16)
  • Change from baseline in circulating NT-proBNP(Up to week 16)
  • Change from baseline in Systolic Blood Pressure (SBP)(Each visit through week 16)
  • Change from baseline in Diastolic Blood Pressure (DBP)(Each visit through week 16)
  • Change from baseline in Mean Arterial Pressure (MAP)(Each visit through week 16)
  • Change from baseline in Heart Rate (HR)(Each visit through week 16)
  • Concentrations of REGN5381 in serum(Through week 16)
  • Incidence of Anti-Drug Antibodies (ADAs) to REGN5381(Through week 16)
  • Magnitude of ADAs to REGN5381(Through week 16)
  • Change from baseline in circulating NT-proBNP(Week 2)
  • Change from baseline in circulating NT-proBNP(Week 3)
  • Change from baseline in circulating NT-proBNP(Week 4)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (44)

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