Mosliciguat added to inhaled treprostinil for pulmonary hypertension from ILD
An Open-Label, Phase 2 Study Evaluating the Safety of Mosliciguat in Combination With Inhaled Treprostinil in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease
This trial tests whether adding inhaled mosliciguat to your inhaled treprostinil is safe and tolerable for people with pulmonary hypertension caused by interstitial lung disease.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Pulmovant, Inc. Industry-sponsored |
| Locations | 1 site (Kissimmee, Florida) |
| Trial ID | NCT07333183 on ClinicalTrials.gov |
What this trial studies
This is a Phase 2, open-label, multi-center study where participants with right-heart-catheterization–confirmed pulmonary hypertension associated with interstitial lung disease receive inhaled mosliciguat while continuing background inhaled treprostinil. The core treatment period lasts 16 weeks, after which participants who complete it may continue in an open extension period. Key entry requirements include a confirming HRCT for ILD, being on inhaled treprostinil, and a 6-minute walk distance of at least 100 meters. The study focuses on safety and tolerability of the inhaled mosliciguat delivered via a dry powder inhaler in this population.
Who should consider this trial
Good fit: Adults with pulmonary hypertension confirmed by right heart catheterization, ILD shown on high-resolution CT who are already receiving inhaled treprostinil and can walk at least 100 meters on the 6-minute walk test are the intended participants.
Not a fit: Patients with other types of pulmonary hypertension (Groups 1, 2, 4, or 5), recent ILD exacerbation, those not on inhaled treprostinil, or those unable to perform the 6-minute walk may not be eligible or likely to benefit.
Why it matters
Potential benefit: If successful, the combination could offer a new inhaled treatment option that helps breathing and exercise capacity for people with PH-ILD.
How similar studies have performed: Inhaled treprostinil has demonstrated benefit in PH-ILD, but inhaled mosliciguat is a relatively novel approach and its combination with treprostinil in this population is largely untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants willing and able to provide informed consent * Participants on inhaled treprostinil * 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.
Where this trial is running
Kissimmee, Florida
- Florida Lung, Asthma & Sleep Specialists/Clinical Research Specialists, LLC — Kissimmee, Florida, United States (Recruiting)
Study contacts
- Study coordinator: Pulmovant
- Email: clinicaltrials@pulmovant.com
- Phone: +1-919-462-1310
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.