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Recruiting Phase 2 NCT07333183

NCT07333183 A Study of Mosliciguat in Combination With Inhaled Treprostinil in PH-ILD

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Clinical Trial Summary
NCT ID NCT07333183
Status Recruiting
Phase Phase 2
Sponsor Pulmovant, Inc.
Condition Pulmonary Hypertension
Study Type INTERVENTIONAL
Enrollment 20 participants
Start Date 2025-12-23
Primary Completion 2026-12

Trial Parameters

Condition Pulmonary Hypertension
Sponsor Pulmovant, Inc.
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 20
Sex ALL
Min Age 18 Years
Max Age 85 Years
Start Date 2025-12-23
Completion 2026-12
Interventions
inhaled mosliciguatDry Powder Inhaler

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Brief Summary

This is a Phase 2, open-label, multi-center clinical study to evaluate the safety and tolerability of inhaled mosliciguat in participants with pulmonary hypertension associated with interstitial lung disease (PH-ILD) on a background inhaled treprostinil.

Eligibility 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 w

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