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Active Not Recruiting
NCT06635850
A Study of Mosliciguat in PH-ILD
Conditions: Pulmonary Hypertension, Interstitial Lung Disease, Lung Diseases, Vascular Diseases, Cardiovascular Diseases, Fibrosis
Sex: All
Ages: 18 Years – 85 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 135
Sponsor: Pulmovant, Inc.
Location: Clinical Research Site Phoenix Arizona
Summary
This is a Phase 2, randomized, double-blind, placebo-controlled, multi-center clinical study to evaluate the safety and efficacy of inhaled mosliciguat in participants with pulmonary hypertension associated with interstitial lung disease (PH-ILD).
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 one of the following:
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 6MWT ≥100 meters.
Exclusion Criteria:
* Diagnosis of WHO 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 requiring augmentation of therapy or emergent hospitalization 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.
Source: ClinicalTrials.gov (NCT06635850). StuddyBuddy aggregates publicly available trial information.