Evaluating inhaled mosliciguat for pulmonary hypertension linked to interstitial lung disease

A Phase 2, Randomized, Placebo-Controlled Trial to Assess the Efficacy and Safety of Mosliciguat in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease

This study is testing if inhaled mosliciguat can help people with pulmonary hypertension caused by interstitial lung disease feel better and improve their walking ability.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Pulmovant, Inc. (industry)
• Locations: 2 sites (Greensboro, North Carolina and 1 other locations)
• Trial ID: NCT06635850 on ClinicalTrials.gov

What this trial studies

This Phase 2 clinical study investigates the safety and efficacy of inhaled mosliciguat in patients suffering from pulmonary hypertension associated with interstitial lung disease (PH-ILD). The study is designed as a randomized, double-blind, placebo-controlled trial consisting of a 24-week treatment period followed by an extension phase where all participants receive mosliciguat. Participants will be monitored for improvements in their condition, including their ability to perform a 6-minute walk test. The study aims to provide insights into the potential benefits of this treatment for affected individuals.

Who should consider this trial

Good fit: Ideal candidates include individuals diagnosed with interstitial lung disease and confirmed pulmonary hypertension who can perform a 6-minute walk test of at least 100 meters.

Not a fit: Patients with pulmonary hypertension classified as Group 1, Group 2, Group 4, or Group 5, or those experiencing recent exacerbations of lung disease, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve exercise capacity and overall quality of life for patients with PH-ILD.

How similar studies have performed: Other studies have shown promise in treating pulmonary hypertension with novel therapies, but this specific approach with mosliciguat is relatively novel.

Eligibility criteria

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.

Where this trial is running

Greensboro, North Carolina and 1 other locations

• PulmonIx — Greensboro, North Carolina, United States (RECRUITING)
• Summit Health — Bend, Oregon, United States (RECRUITING)

Study contacts

• Study coordinator: Pulmovant

Conditions: Pulmonary Hypertension, Interstitial Lung Disease, Lung Diseases, Vascular Diseases, Cardiovascular Diseases, Fibrosis, PH, ILD