Pulmonary Hypertension Associated with Interstitial Lung Disease
Conditions
Interventions
Investigational medical product: mosliciguat 1, 2 and 4mg
Administration route: inhalation
Part 1:All participants will be assessed for pre-dose 6MWD on Day 1 (6MWD baseline) and will initiate treatm
Sponsors
Martin Ubaldo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participants willing and able to provide informed consent. 2. 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: a.Idiopathic interstitial pneumonia (IIP). b.Chronic hypersensitivity pneumonitis. c.ILD associated with connective tissue disease (CTD) with a forced vital capacity (FVC) -= 100 meters. Note: Other inclusion criteria may apply.
Exclusion criteria
Exclusion criteria: 1. 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). 2. Exacerbation of underlying lung disease within 28 days prior to randomization. 3. Initiation of pulmonary rehabilitation within 28 days prior to randomization. 4. Receiving ->10 L/min of oxygen supplementation by any mode of delivery at rest at Baseline. 5. History or intolerance to or lack of efficacy with mosliciguat or sGC stimulators or activators. 6. Receipt of investigational, or experimental therapy within 42 days OR 5 half-lives prior to randomization. Note: Other exclusion criteria may apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change from baseline in PVR assessed at estimated peak exposure at Week 16 by right heart catheterization (RHC) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Change in 6MWD from baseline measured at estimated peak exposure at Week 16 using the 6-Minute Walk Test (6MWT) 2.Change from baseline in NT-proBNP at Week 16 | — |
Countries
Argentina, Australia, Belgium, Brazil, Canada, Czech Republic, France, Germany, Italy, Japan, Latvia, Mexico, Netherlands, New Zealand, Poland, South Korea, Spain, Turkey, United Kingdom, United States
Contacts
Public Contactcontact Clinical trial
ICON Clinical Research GK
Outcome results
None listed