Actively Recruiting
Phase 2 Study of Inhaled Mosliciguat with Inhaled Treprostinil for Pulmonary Hypertension in Interstitial Lung Disease
Led by Pulmovant, Inc. · Updated on 2026-04-22
20
Participants Needed
1
Research Sites
56 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of inhaled mosliciguat combined with inhaled treprostinil in adults with pulmonary hypertension associated with interstitial lung disease PH-ILD. This Phase 2, open-label, multi-center study focuses on participants who already use inhaled treprostinil to manage their condition. The trial aims to gather important safety information about this combination treatment in this specific lung disease population. Participants will receive daily inhaled mosliciguat during a 16-week open-label treatment period. After this period, those who complete the initial phase may continue to receive mosliciguat in an extension phase lasting beyond 16 weeks. Mosliciguat will be delivered using a dry powder inhaler device, and doses may vary among three different levels. All participants will continue treatment with inhaled mosliciguat during the extension. Throughout the study, researchers will monitor participants for treatment-emergent adverse events, serious adverse events, and any side effects leading to discontinuation, with assessments at baseline and at week 16. Participants must be able to perform a six-minute walk of at least 100 meters. The study includes imaging confirmation of interstitial lung disease and right heart catheterization to confirm pulmonary hypertension. The total participation duration may extend beyond 16 weeks depending on continuation in the extension phase.
CONDITIONS
Brief Title
A Study of Mosliciguat in Combination With Inhaled Treprostinil in PH-ILD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants willing and able to provide informed consent
- Participants on inhaled treprostinil
- Participants diagnosed with Interstitial Lung Disease confirmed by high-resolution CT scan
- Diagnosed conditions including idiopathic interstitial pneumonia, chronic hypersensitivity pneumonitis, or ILD associated with connective tissue disease with forced vital capacity less than 70% of predicted
- Confirmed pulmonary hypertension by right heart catheterization
- Ability to perform a six-minute walk distance of at least 100 meters
You will not qualify if you...
- Diagnosis of pulmonary hypertension Groups 1, 2, 4, or 5 (such as pulmonary arterial hypertension, left-heart dysfunction-related PH, chronic thromboembolic PH, or unclassified PH)
- Exacerbation of underlying lung disease within 28 days before randomization
- Starting pulmonary rehabilitation within 28 days before randomization
- Receiving more than 10 liters per minute of oxygen at rest at baseline
- History of intolerance or lack of response to mosliciguat or sGC stimulators or activators
- Receipt of investigational or experimental therapy within 42 days or 5 half-lives before randomization
- Other inclusion and exclusion criteria may apply
Research Team
P
Pulmovant
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