Pulmovant, Inc.
A Phase 3, Multicenter, Randomized, Double-Blind Placebo-Controlled Trial to Evaluate the Safety and Efficacy of Inhaled Mosliciguat in Participants with Pulmonary Hypertension Associated with Interstitial Lung Disease
This study is a randomized double-blind placebo control study with an extension. The study consists of 2 periods: a blinded placebo-controlled period (24 weeks) and an extension (beyond 24 weeks). Participants will be randomized to receive mosliciguat or placebo in the 24-week double-blind treatment period. All participants who complete the 24-week double-blind period may continue to participate in the extension period where all participants receive mosliciguat.
Inclusion Criteria: * Participants willing and able to provide informed consent. * Participants with diagnosis of pulmonary hypertension (PH) associated with interstitial lung disease (ILD). Diagnosis will be confirmed by a high-resolution computerized tomography (HR-CT) scan showing diffuse parenchymal disease. Eligible diagnosed disease include: 1. Idiopathic interstitial pneumonia (IIP) 2. Chronic Hypersensitivity pneumonitis 3. ILD associated connective tissue disease (CTD) * Confirmed pulmonary hypertension by right heart catheterization (RHC). * Ability to perform 6-minute walk d…
Dose level 1, 2, or 3 for inhalation
Matching Placebo for inhalation
Administration via dry powder inhaler
Arctuva estimate
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