A Phase 2, Randomized, Placebo-Controlled Trial to Assess the Efficacy and Safety of Mosliciguat in Participants with Pulmonary Hypertension Associated with Interstitial Lung Disease

Pulmovant, Inc.0 个研究点目标入组 12 人开始时间: 待定最近更新: 2025年3月31日

试验速览

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•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: a.Idiopathic interstitial pneumonia (IIP). b.Chronic hypersensitivity pneumonitis. c.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.
•Note: Other inclusion criteria may apply.

•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 exclusion criteria may apply.

Percent change from baseline in PVR

时间窗: Week 16

Assessed at estimated peak exposure at Week 16 by right heart catheterization (RHC)

发起方

Pulmovant, Inc.