A Study of Mosliciguat in PH-ILD

Launched by PULMOVANT, INC. · Oct 8, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called mosliciguat, which is inhaled, to see how safe and effective it is for people with pulmonary hypertension associated with interstitial lung disease (PH-ILD). This condition affects the lungs and can make it hard to breathe. The trial is currently recruiting participants aged between 65 and 74, and it is open to people of all genders. To qualify, participants must have a confirmed diagnosis of interstitial lung disease and pulmonary hypertension, which will be verified through specific medical tests.

Participants in this study will be randomly assigned to receive either the medication or a placebo (a treatment that looks like the actual medication but has no active ingredients) without knowing which one they are receiving. This helps researchers determine the real effects of mosliciguat. Those who join the trial will undergo regular check-ups and tests throughout the process. It's important to note that some individuals may not be eligible due to specific health conditions or treatments they have recently received. If you or someone you know is interested in participating, it's best to discuss it with a healthcare provider to see if it’s a good fit.

Gender

ALL

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.