NCT07318597招募中2 期
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamic Effects of REGN13335, an Anti-PDGF-B Monoclonal Antibody, in Adults With Pulmonary Arterial Hypertension
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 99
- 试验地点
- 30
- 主要终点
- Change from baseline in Pulmonary Vascular Resistance (PVR)
研究概览
简要总结
This study is researching an experimental drug called REGN13335. The study is focused on participants with Pulmonary Arterial Hypertension (PAH). The aim of the study is to see how safe and effective REGN13335 is in participants with PAH who are taking other PAH medicines.
The study is looking at several other research questions, including:
- What side effects may happen from taking REGN13335
- How much REGN13335 is in the blood at different times
- Whether the body makes antibodies against REGN13335 (which could make REGN13335 less effective or could lead to side effects)
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
- •Documented clinical diagnosis of PAH (Group 1 PH according to the 7th World Symposium on Pulmonary Hypertension (WSPH))
- •WHO functional class II or III (slight to marked limitation of functional status due to PAH)
- •Receiving background Standard Of Care (SOC) therapy for PAH on a stable dose and regimen, as determined by the investigator, as described in the protocol
- •PVR ≥400 dynes∙sec/cm^5 (5 Wood units) based on Right Heart Catheterization (RHC) during the screening period
- •Has 6MWD ≥150 and ≤550 meters repeated twice during screening as described in the protocol
排除标准
- •Has Group 2 (PH associated with left heart disease), Group 3 (PH associated with lung diseases and/or hypoxia), Group 4 (PH associated with pulmonary artery obstructions), or Group 5 (PH with unclear and/or multifactorial mechanisms) PH according to the 7th WSPH
- •Pulmonary Arterial Wedge Pressure (PAWP) >15 mm Hg by RHC during the screening period
- •History of left-sided heart disease and/or clinically significant cardiac disease, as described in the protocol
- •Obstructive lung disease defined as Forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity <0.7 and FEV1 <70% of the predicted value as described in the protocol
- •Evidence of interstitial lung disease as defined in the protocol
- •Evidence of chronic thromboembolic pulmonary disease or acute pulmonary embolism as described in the protocol
- •Participants requiring anticoagulation and/or antiplatelet therapy for an underlying medical condition as described in the protocol
- •Has any history of intracranial bleeding or any history of elevated intracranial pressure
- •Has any history of bleeding meeting criteria as described in the protocol
- •Note: Other protocol-defined Inclusion/ Exclusion criteria apply
研究组 & 干预措施
DBTP-Arm1
Experimental
干预措施: REGN13335 (Drug)
OLE-Arm1
Experimental
干预措施: REGN13335 (Drug)
DBTP-Arm2
Experimental
干预措施: REGN13335 (Drug)
DBTP-Arm3
Placebo Comparator
干预措施: Placebo (Drug)
OLE-Arm2
Experimental
干预措施: REGN13335 (Drug)
结局指标
主要结局
Change from baseline in Pulmonary Vascular Resistance (PVR)
时间窗: At week 24
次要结局
- Occurrence of Treatment-Emergent Adverse Events (TEAEs)(Through end of study, up to approximately 2.5 years)
- Severity of TEAEs(Through end of study, up to approximately 2.5 years)
- Change from baseline in circulating N-Terminal pro-B-type Natriuretic Peptide (NT-proBNP) concentrations(At week 24)
- Change from baseline in cardiac index(At week 24)
- Concentrations of functional REGN13335 in plasma(Through end of study, up to approximately 2.5 years)
- Change from baseline in mean pulmonary artery pressure(At week 24)
- Change from baseline in cardiac output(At week 24)
- Change from baseline in right atrial pressure(At week 24)
- Change from baseline in 6-Minute Walk Distance (6MWD)(At week 24)
- Concentrations of total soluble Platelet-Derived Growth Factor-B (PDGF-B) ligands in plasma(Through end of study, up to approximately 2.5 years)
研究者
研究点 (30)
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