Overview

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).

Eligibility

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 exclusion criteria may apply.