Pulmonary Hypertension, Interstitial Lung Disease, Lung Diseases, Vascular Diseases, Cardiovascular Diseases, Fibrosis
Conditions
Keywords
PH, ILD, 6 Minute Walk Test, mosliciguat
Brief summary
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).
Detailed description
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.
Interventions
DRUGMosliciguat
Dose level 1, 2, or 3 for inhalation
DEVICEDry Powder Inhaler
Dry powder inhaler for mosliciguat or placebo delivery
DRUGPlacebo
Matching placebo for inhalation
Sponsors
Pulmovant, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* 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: 1. Idiopathic interstitial pneumonia (IIP) 2. Chronic hypersensitivity pneumonitis 3. 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 6MWD ≥100 meters.
Exclusion criteria
* Diagnosis of 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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline to Week 16 in Pulmonary Vascular Resistance (PVR) | Baseline, Week 16 | PVR evaluated using right heart catheterization (RHC). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline to Week 16 in Distance Achieved on the Six-Minute Walk Test (6MWT) | Baseline, Week 16 | The 6MWT measures the distance a participant is able to walk quickly on a flat, hard surface in a period of 6 minutes. |
| Change from Baseline to Week 16 in N-terminal pro-brain natriuretic peptide (NT-proBNP) | Baseline, Week 16 | The NT-proBNP serum concentration is a useful biomarker associated with changes in right heart morphology and function. NT-proBNP serum concentration will be assessed to compare the severity of heart failure at Baseline and Week 16. |
Countries
United States
Contacts
STUDY_DIRECTORUbaldo Martin, MD
Pulmovant, Inc.
Outcome results
None listed