NCT06593600已完成2 期
A Phase 2 Double-Blind Placebo-Controlled Single-Dose Study of Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of REGN7544, an NPR1 Antagonist Monoclonal Antibody, in Patients With Postural Orthostatic Tachycardia Syndrome
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
- 82
- 试验地点
- 33
- 主要终点
- Change in Heart Rate (HR) from supine to standing (DeltaHR)
研究概览
简要总结
This study is researching an experimental drug called REGN7544 (called "study drug"). The study is focused on participants with POTS.
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:
- How the study drug changes heart rate and blood pressure in participants with POTS
- 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)
- How the study drug affects symptoms associated with POTS
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is diagnosed with POTS and demonstrates consensus criteria (a), (b), (c) and (d) below during screening:
- •Increase in HR ≥30 Beats Per Minute (BPM) within 10 minutes of changing from supine to a standing position, as described in the protocol
- •Absence of orthostatic hypotension, defined as a decrease in Systolic Blood Pressure (SBP) >20 mm Hg within 3 minutes of standing
- •Absence of other conditions explaining orthostatic tachycardia in the judgment of the investigator, as defined in the protocol
- •Ongoing episodic symptoms consistent with POTS (for example, lightheadedness, palpitations, tremulousness, generalized weakness, blurred vision, and fatigue) that are worse with standing and are relieved by lying down and which have been present for ≥3 months
- •During screening, a participant must score ≥3 on the Patient Global Impressions of Severity (PGIS)
- •Has a body mass index between 18 and 35 kg/m2, inclusive
排除标准
- •History of hypertension or a seated SBP during screening that is >140 mm Hg
- •SBP during Active Stand (AS) test during screening, either supine or standing, that is >140 mm Hg systolic on ≥2 measurements
- •Increase in HR <20 BPM within 10 minutes of changing from supine to a standing position, as defined in protocol
- •Is judged by the investigator to have significant heart failure, cardiovascular disease, liver disease, or renal disease (ie, estimated Glomerular Filtration Rate (eGFR) <60 ml/min/1.73m2) based on medical history, physical exam, laboratory studies, and/or electrocardiogram (ECG) performed during screening period
- •Is confined to bed more than 50% of waking hours
- •Within 5 days of screening visit has used medications with direct effects on blood volume, BP, or HR (eg, midodrine, droxidopa, octreotide, clonidine, methyldopa, ivabradine, beta-blockers, calcium channel blockers, pyridostigmine, fludrocortisone, desmopressin, stimulants or intravenous (IV) saline)
- •NOTE: Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
High Dose
Experimental
Randomized 1:1:1
干预措施: REGN7544 (Drug)
Low Dose
Experimental
Randomized 1:1:1
干预措施: REGN7544 (Drug)
Matching Placebo
Placebo Comparator
Randomized 1:1:1
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Heart Rate (HR) from supine to standing (DeltaHR)
时间窗: At Day 8
次要结局
- Occurrence of Treatment-Emergent Adverse Events (TEAEs)(Through 90 Days)
- Severity of TEAEs(Through 90 Days)
- DeltaHR(At Day 15 and 29)
- Supine HR(At Day 8, 15, and 29)
- Standing HR(At Day 8, 15, and 29)
- Supine blood pressure (BP)(At Day 8, 15, and 29)
- Standing BP(At Day 8, 15, and 29)
- Concentrations of REGN7544 in serum(Through 90 Days)
- Incidence of anti-drug antibodies (ADAs) to REGN7544(Through 90 Days)
- Titer of ADAs to REGN7544(Through 90 Days)
研究者
研究点 (33)
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