This study is a randomized double-blind placebo control study with an extension.
The study consists of 2 periods: a blinded placebo-controlled period (24 weeks) and an extension (beyond 24 weeks).
Participants will be randomized to receive mosliciguat or placebo in the 24-week double-blind treatment period.
All participants who complete the 24-week double-blind period may continue to participate in the extension period where all participants receive mosliciguat.
Age
18–85
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Participants willing and able to provide informed consent.
Participants with diagnosis of pulmonary hypertension (PH) associated with interstitial lung disease (ILD). Diagnosis will be confirmed by a high-resolution computerized tomography (HR-CT) scan showing diffuse parenchymal disease. Eligible diagnosed disease include:
1. Idiopathic interstitial pneumonia (IIP)
2. Chronic Hypersensitivity pneumonitis
3. ILD associated connective tissue disease (CTD)
Confirmed pulmonary hypertension by right heart catheterization (RHC).
Ability to perform 6-minute walk distance ≥100 meters.
You may not be if
Diagnosis of PH Group 1 (eg, pulmonary arterial hypertension), Group 2 (related to left heart disease), Group 4 (eg, chronic thromboembolic pulmonary hypertension), or Group 5 (eg, unclassified).
Exacerbation of underlying lung disease requiring change in therapy or hospitalization within 28 days prior to randomization
Receiving \>10 L/min oxygen supplementation by any mode of delivery at rest
History of intolerance to mosliciguat, or sGC stimulators or activators.
Initiation of pulmonary rehabilitation or ongoing acute phase of rehabilitation within 28 days prior to randomization.
Receipt of investigational or interventional therapy within 42 days OR 5 half-lives (whichever is longer) prior to randomization.