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Recruiting Phase 2 NCT07333183

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

Phase 2 – studying effectiveness and dosage
Conditions: Pulmonary Hypertension Interstitial Lung Disease (ILD) Lung Diseases Vascular Diseases Cardiovascular Diseases Fibrosis

Sponsor: Pulmovant, Inc.

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Overview
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.
Description
This study is an open-label study with an extension. The study consists of 2 periods: an open label treatment period (16 weeks) and an extension (beyond 16 weeks). Participants will receive mosliciguat in the 16-week treatment period. All participants who complete the 16-week treatment period may continue to participate in the extension period where all participants will receive mosliciguat.
Who can participate
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.
Interventions
inhaled mosliciguat
DRUG
Dry Powder Inhaler
DEVICE
Locations 1
United States (1)
Florida Lung, Asthma & Sleep Specialists/Clinical Research Specialists, LLC
Kissimmee , Florida
Technical details
Status
Recruiting
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
85 Years
Healthy volunteers
No
Start date
23.12.2025
Completion date
01.01.2028
Registry ID
NCT07333183
Source
clinicaltrials.gov
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