← Back to all trials
Recruiting
NCT07333183
A Study of Mosliciguat in Combination With Inhaled Treprostinil in PH-ILD
Conditions: Pulmonary Hypertension, Interstitial Lung Disease (ILD), Lung Diseases, Vascular Diseases, Cardiovascular Diseases, Fibrosis
Sex: All
Ages: 18 Years – 85 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 20
Sponsor: Pulmovant, Inc.
Location: Clinical Research Site Santa Barbara California
Summary
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07333183). StuddyBuddy aggregates publicly available trial information.