A Phase 2, Multicenter, Single-blinded, Randomized Study to Evaluate the Pharmacokinetics and Safety of Sotatercept (MK-7962) Administered Using Either a Weight-based or Weight-banded Approach in Participants With Pulmonary Arterial Hypertension (PAH) on Standard of Care
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 164
- 试验地点
- 98
- 主要终点
- Steady-State Average Serum Concentrations of Sotatercept (Cavg)
研究概览
简要总结
Researchers are looking for other ways to treat people with PAH. In PAH, the blood vessels in the lungs become thick and narrow, which makes it harder for blood to flow to the lungs.
The goal of the study is to learn:
- What happens to different doses of sotatercept in a person's body over time when it is given using weight-banded doses compared to weight-based doses. There may be differences in how the medicine works with the new dosing method (weight-banded dosing) being studied in this trial.
- About the safety of sotatercept and if people tolerate it
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
- Single (Participant)
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
- •Has documented diagnostic Right Heart Catheterization, with the diagnosis of World Health Organization (WHO) Pulmonary Atrial Hypertension (PAH) Group 1 in any of the following subtypes: Idiopathic PAH, Heritable PAH, Drug/toxin-induced PAH, PAH associated with connective tissue disease, PAH associated with simple, congenital systemic-to-pulmonary shunts at least 1 year following repair
- •Has symptomatic PAH classified as WHO Functional Class II or III
排除标准
- •Has a weight of <35 kg
- •Has a diagnosis of PH WHO Groups 2, 3, 4, or 5
- •Has a diagnosis of the following PAH Group 1 subtypes: HIV-associated PAH, PAH associated with portal hypertension, Exclusion in PAH Group 1 should also include schistosomiasis-associated PAH, pulmonary veno occlusive disease and pulmonary capillary hemangiomatosis
- •Has uncontrolled systemic hypertension
- •Has a history of pneumonectomy
- •Has a history of known pericardial constriction
- •Has a history of restrictive cardiomyopathy
- •Has history of atrial septostomy (within 180 days prior to study start)
- •Has personal or family history of long QT syndrome
- •Has history of coronary artery disease (myocardial infarction, percutaneous coronary intervention, coronary artery bypass, graft surgery, or cardiac anginal chest pain) (within 6 months prior to study start)
- •Has a cerebrovascular accident (within 3 months prior to study start)
- •Has significant (>2+ regurgitation) mitral regurgitation or aortic regurgitation valvular disease
- •Has untreated more than mild obstructive sleep apnea
- •Has known malignancy that is progressing or has required active treatment within the past 5 years
- •Has recently started (within 12 months prior to study start) or has plans to start weight loss medication or enter a weight loss program during the study period
- •Has a previous (within 3 years) or planned (during the study) obesity treatment with surgery or a weight-loss device
研究组 & 干预措施
Weight-based sotatercept dosing
Participants will receive sotatercept via subcutaneous (SC) injection every 3 weeks at an initial dose of 0.3 mg/kg and then at a maintenance dose of 0.7 mg/kg using a weight-based method during a 24-week treatment period. Participants will continue to take their background PAH therapy during the study.
干预措施: Sotatercept (Biological)
Weight-based sotatercept dosing
Participants will receive sotatercept via subcutaneous (SC) injection every 3 weeks at an initial dose of 0.3 mg/kg and then at a maintenance dose of 0.7 mg/kg using a weight-based method during a 24-week treatment period. Participants will continue to take their background PAH therapy during the study.
干预措施: Background PAH Therapy (Biological)
Weight-banded sotatercept dosing
Participants will receive sotatercept via SC injection every 3 weeks at an initial dose of up to 45 mg and then at a maintenance dose of up to 90 mg using a weight-banded method during a 24-week treatment period. Participants will continue to take their background PAH therapy during the study.
干预措施: Sotatercept (Biological)
Weight-banded sotatercept dosing
Participants will receive sotatercept via SC injection every 3 weeks at an initial dose of up to 45 mg and then at a maintenance dose of up to 90 mg using a weight-banded method during a 24-week treatment period. Participants will continue to take their background PAH therapy during the study.
干预措施: Background PAH Therapy (Biological)
结局指标
主要结局
Steady-State Average Serum Concentrations of Sotatercept (Cavg)
时间窗: Predose and at designated time points post-dose (up to 24 weeks)
Steady-state Cavg of sotatercept will be reported.
Number of Participants Who Experience One or More Adverse Events (AEs)
时间窗: Up to 37 weeks
An AE is a health problem that happens or worsens during a study. Number of participants who experience an AE will be reported.
Number of Participants who Discontinue Study Treatment due to an Adverse Event
时间窗: Up to 21 weeks
An AE is a health problem that happens or worsens during a study. Number of participants who discontinue study treatment will be reported.
次要结局
- Initial Dose Average Serum Concentrations of Sotatercept (Cavg)(Predose and at designated time points post-dose (up to 3 weeks))