A Phase 2, Randomized, Placebo-Controlled Trial to Assess the Efficacy and Safety of Mosliciguat in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 135
- 试验地点
- 103
- 主要终点
- Change from Baseline to Week 16 in Pulmonary Vascular Resistance (PVR)
研究概览
简要总结
This is a Phase 2, randomized, double-blind, placebo-controlled, multi-center clinical study to evaluate the safety and efficacy of inhaled mosliciguat in participants with pulmonary hypertension associated with interstitial lung disease (PH-ILD).
详细描述
This study is a randomized, double-blind, placebo-controlled study with an extension.
The study consists of 2 periods: a blinded placebo-controlled period (24 weeks) and an extension (beyond 24 weeks).
Participants will be randomized to receive mosliciguat or placebo in the 24-week double-blind treatment period.
All participants who complete the 24-week double-blind period may continue to participate in the extension period where all participants will receive mosliciguat.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants willing and able to provide informed consent
- •Participants with diagnosis of Interstitial Lung Disease (ILD). Diagnosis will be confirmed by a high-resolution computerized tomography (HR-CT) scan showing diffuse parenchymal disease. Eligible diagnosed diseases include one of the following:
- •Idiopathic interstitial pneumonia (IIP)
- •Chronic hypersensitivity pneumonitis
- •ILD associated with connective tissue disease (CTD) with a forced vital capacity (FVC) < 70% of predicted
- •Confirmed pulmonary hypertension (PH) by right heart catheterization (RHC).
- •Ability to perform 6MWT ≥100 meters.
排除标准
- •Diagnosis of WHO PH Group 1 (eg. pulmonary arterial hypertension), Group 2 (related to left-heart dysfunction), Group 4 (eg, chronic thromboembolic pulmonary hypertension), or Group 5 (eg, unclassified).
- •Exacerbation of underlying lung disease requiring augmentation of therapy or emergent hospitalization within 28 days prior to randomization.
- •Initiation of pulmonary rehabilitation within 28 days prior to randomization.
- •Receiving >10 L/min of oxygen supplementation by any mode of delivery at rest at Baseline.
- •History or intolerance to or lack of efficacy with mosliciguat or sGC stimulators or activators.
- •Receipt of investigational, or experimental therapy within 42 days OR 5 half-lives prior to randomization.
- •Note: Other inclusion and exclusion criteria may apply.
研究组 & 干预措施
Matched Placebo
Participants will be randomized to receive inhaled mosliciguat or placebo daily for 24 weeks
干预措施: Placebo (Drug)
Mosliciguat
Participants will be randomized to receive inhaled mosliciguat or placebo daily for 24 weeks
干预措施: Mosliciguat (Drug)
Mosliciguat
Participants will be randomized to receive inhaled mosliciguat or placebo daily for 24 weeks
干预措施: Dry Powder Inhaler (Device)
Extension
After Week 24, all participants may receive mosliciguat through an Extension period
干预措施: Dry Powder Inhaler (Device)
Extension
After Week 24, all participants may receive mosliciguat through an Extension period
干预措施: Mosliciguat (Drug)
Matched Placebo
Participants will be randomized to receive inhaled mosliciguat or placebo daily for 24 weeks
干预措施: Dry Powder Inhaler (Device)
结局指标
主要结局
Change from Baseline to Week 16 in Pulmonary Vascular Resistance (PVR)
时间窗: Baseline, Week 16
PVR evaluated using right heart catheterization (RHC).
次要结局
- Change from Baseline to Week 16 in Distance Achieved on the Six-Minute Walk Test (6MWT)(Baseline, Week 16)
- Change from Baseline to Week 16 in N-terminal pro-brain natriuretic peptide (NT-proBNP)(Baseline, Week 16)