Phase 2 Study of Inhaled Mosliciguat with Inhaled Treprostinil for Pulmonary Hypertension in Interstitial Lung Disease

What this Trial Is About

Researchers are evaluating the safety and tolerability of inhaled mosliciguat combined with inhaled treprostinil in adults with pulmonary hypertension associated with interstitial lung disease PH-ILD. This Phase 2, open-label, multi-center study focuses on participants who already use inhaled treprostinil to manage their condition. The trial aims to gather important safety information about this combination treatment in this specific lung disease population. Participants will receive daily inhaled mosliciguat during a 16-week open-label treatment period. After this period, those who complete the initial phase may continue to receive mosliciguat in an extension phase lasting beyond 16 weeks. Mosliciguat will be delivered using a dry powder inhaler device, and doses may vary among three different levels. All participants will continue treatment with inhaled mosliciguat during the extension. Throughout the study, researchers will monitor participants for treatment-emergent adverse events, serious adverse events, and any side effects leading to discontinuation, with assessments at baseline and at week 16. Participants must be able to perform a six-minute walk of at least 100 meters. The study includes imaging confirmation of interstitial lung disease and right heart catheterization to confirm pulmonary hypertension. The total participation duration may extend beyond 16 weeks depending on continuation in the extension phase.

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