A Study of Mosliciguat in Combination With Inhaled Treprostinil in PH-ILD
Purpose
This is a Phase 2, open-label, 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) on a background inhaled treprostinil.
Conditions
- Pulmonary Hypertension
- Interstitial Lung Disease (ILD)
- Lung Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Fibrosis
Eligibility
- Eligible Ages
- Between 18 Years and 85 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Participants willing and able to provide informed consent - Participants on inhaled treprostinil - 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 exclusion criteria may apply.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Active Comparator: inhaled mosliciguat |
Participants will receive inhaled mosliciguat daily for 16 weeks |
|
|
Experimental Extension: inhaled mosliciguat |
After Week 16, all participants will continue to receive inhaled mosliciguat through an Extension period |
|
Recruiting Locations
Florida Lung, Asthma & Sleep Specialists/Clinical Research Specialists, LLC
Kissimmee 4160983, Florida 4155751 34746
Kissimmee 4160983, Florida 4155751 34746
More Details
- NCT ID
- NCT07333183
- Status
- Recruiting
- Sponsor
- Pulmovant, Inc.
Detailed Description
This study is an open-label study with an extension. The study consists of 2 periods: an open label treatment period (16 weeks) and an extension (beyond 16 weeks). Participants will receive mosliciguat in the 16-week treatment period. All participants who complete the 16-week treatment period may continue to participate in the extension period where all participants will receive mosliciguat.