A Phase 3, Multicenter, Randomized, Double-Blind Placebo-Controlled Trial to Evaluate the Safety and Efficacy of Inhaled Mosliciguat in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 376
- 试验地点
- 3
- 主要终点
- Change from Baseline in 6-Minute Walk Distance (6MWD)
研究概览
简要总结
A Phase 3, Multicenter, Randomized, Double-Blind Placebo-Controlled Trial to Evaluate the Safety and Efficacy of Inhaled Mosliciguat in Participants with Pulmonary Hypertension Associated with Interstitial Lung Disease
详细描述
This study is a randomized double-blind placebo control 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 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 pulmonary hypertension (PH) associated with interstitial lung disease (ILD). Diagnosis will be confirmed by a high-resolution computerized tomography (HR-CT) scan showing diffuse parenchymal disease. Eligible diagnosed disease include:
- •Idiopathic interstitial pneumonia (IIP)
- •Chronic Hypersensitivity pneumonitis
- •ILD associated connective tissue disease (CTD)
- •Confirmed pulmonary hypertension by right heart catheterization (RHC).
- •Ability to perform 6-minute walk distance ≥100 meters.
排除标准
- •Diagnosis of PH Group 1 (eg, pulmonary arterial hypertension), Group 2 (related to left heart disease), Group 4 (eg, chronic thromboembolic pulmonary hypertension), or Group 5 (eg, unclassified).
- •Exacerbation of underlying lung disease requiring change in therapy or hospitalization within 28 days prior to randomization
- •Receiving >10 L/min oxygen supplementation by any mode of delivery at rest
- •History of intolerance to mosliciguat, or sGC stimulators or activators.
- •Initiation of pulmonary rehabilitation or ongoing acute phase of rehabilitation within 28 days prior to randomization.
- •Receipt of investigational or interventional therapy within 42 days OR 5 half-lives (whichever is longer) prior to randomization.
研究组 & 干预措施
Extension
After Week 24, all participants may receive mosliciguat through an Extension period
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)
Matched Placebo
Participants will be randomized to receive inhaled mosliciguat or placebo daily for 24 weeks
干预措施: Placebo (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)
Extension
After Week 24, all participants may receive mosliciguat through an Extension period
干预措施: Dry Powder Inhaler (Device)
Mosliciguat
Participants will be randomized to receive inhaled mosliciguat or placebo daily for 24 weeks
干预措施: Mosliciguat (Drug)
结局指标
主要结局
Change from Baseline in 6-Minute Walk Distance (6MWD)
时间窗: Baseline to Week 24
The 6MWD measures the distance a participant is able to walk quickly on a flat, hard surface in a period of 6 minutes
次要结局
- Time to Clinical Worsening (TTCW)(From randomization through Week 24)
- Percent Change from Baseline in Pulmonary Vascular Resistance (PVR)(Baseline to Week 24)
- Change from Baseline in N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP)(Baseline to Week 24)
- Change from Baseline in Living with Pulmonary Fibrosis (L-PF) Total Symptom Score(Baseline to Week 24)