A Study of Mosliciguat in PH-ILD

About

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).

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 2

Eligibility

Gender

All

Healthy Volunteers

No

Minimum Age

18 Years

Maximum Age

80 Years

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:
- 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.