A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Safety and Efficacy of L606 (Treprostinil Liposome Inhalation Suspension) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (WHO Group 3)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 344
- 试验地点
- 36
- 主要终点
- Change from baseline in 6-minute walk distance (6MWD) as evaluated by the 6-minute walk test (6MWT)
研究概览
简要总结
The purpose of this study is to find out if L606 is safe and if it helps people with high blood pressure in the lungs (pulmonary hypertension) caused by interstitial lung disease (PH-ILD, WHO Group 3). One of the main ways the study will check this is by seeing if people can walk further in six minutes (called the "six-minute walk test"). Another important (secondary) goal is to see how long it takes for PH-ILD to get worse while people are taking L606. One way the study will measure this is by looking at the distance people walk at different times in the study on different doses of L606. Throughout the study, doctors will also closely monitor for any side effects people have to make sure L606 is safe. People who decide to join this study will be randomly (like tossing a coin) placed into one of two groups: one group will get L606 and the other group will get a placebo, which will look like L606 but will not contain any active medicine. At the end of the initial blinded portion of the study, study participants may have the opportunity to enroll in an open-label extension portion of the study where all participants will receive L606.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant is between 18 years to 80 years old.
- •Has a confirmed diagnosis of ILD based on High Resolution Computed Tomography (HRCT) chest imaging.
- •Evidence of PH as demonstrated from Right Heart Catheterization (RHC) with the following hemodynamic parameters:
- •Pulmonary vascular resistance (PVR) ≥ 320 dynes.sec/cm5 (i.e. 4 Woods Units (WU)), and
- •Mean Pulmonary Artery Pressure (mPAP) of ≥ 25 mmHg, and
- •- Pulmonary capillary wedge pressure (PCWP) or Left-Ventricular End Diastolic Pressure (LVEDP) of ≤ 15 mmHg.
- •FEV1/FVC (ratio) > 0.
- •6-minute walk distance ≥ 150 meters
排除标准
- •PH in the updated WHO Classification Groups 1, 2, 4, or
- •Has evidence of clinically significant left-sided heart disease as defined by echocardiography.
- •Participants with history of persistent/permanent or uncontrolled atrial fibrillation.
- •Participants with severe obstructive sleep apnea.
- •Has experienced exacerbation of underlying lung disease or active respiratory infection requiring antibiotics.
- •Initiation of pulmonary rehabilitation.
- •Note: Other protocol defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
L606 (in combination with nebulizer)
干预措施: L606 (Drug)
Placebo (in combination with nebulizer)
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in 6-minute walk distance (6MWD) as evaluated by the 6-minute walk test (6MWT)
时间窗: 16 weeks
次要结局
- Time to first occurrence of: -Death -Hospitalization due to a cardio-pulmonary indication related to underlying disease -Lung transplant -Decrease in 6MWD > 15% from Baseline related to disease under study at 2 consecutive visits >1 week apart(24 weeks)
- Change from baseline in 6-minute walk distance (6MWD) as evaluated by the 6-minute walk test (6MWT)(24 weeks)