A Study of Mosliciguat in Combination With Inhaled Treprostinil in PH-ILD
Recruiting · NCT07333183 · Interventional (participants receive a specific treatment) · Lead sponsor: Pulmovant, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
Dry Powder Inhalerinhaled mosliciguat
What this trial is about
This is a Phase 2, open-label, multi-center clinical study to evaluate the safety and tolerability of inhaled mosliciguat in participants with pulmonary hypertension associated with interstitial lung disease (PH-ILD) on a background inhaled treprostinil.
Who can take part
Age range
18 Years to 85 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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:
- 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 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.
Where it is running
13 locations listed across 11 US states.
- Clinical Research Site - Santa Barbara, California, United States
- Clinical Research Site - Torrance, California, United States
- Clinical Research Site - Kissimmee, Florida, United States
- Clinical Research Site - Chicago, Illinois, United States
- Clinical Research Site - Kansas City, Kansas, United States
- Clinical Research Site - Boston, Massachusetts, United States
- Clinical Research Site - Ann Arbor, Michigan, United States
- Clinical Research Site - Detroit, Michigan, United States
- Clinical Research Site - Albuquerque, New Mexico, United States
- Clinical Research Site - Greensboro, North Carolina, United States
- Clinical Research Site - Providence, Rhode Island, United States
- Clinical Research Site - Charleston, South Carolina, United States
- Clinical Research Site - Houston, Texas, United States