Evaluating Inhaled Mosliciguat Versus Placebo in Adults With Pulmonary Hypertension and Interstitial Lung Disease A Randomized, Double-Blind Phase 3 Trial With Extension

What This Trial Is About

Researchers are evaluating inhaled mosliciguat in adults with pulmonary hypertension associated with interstitial lung disease PH-ILD. This Phase 3, multicenter, randomized, double-blind, placebo-controlled trial aims to study the safety and efficacy of this treatment in improving exercise capacity measured by the 6-minute walk distance. Pulmovant, Inc. is sponsoring this study to better understand treatment options for this condition. Participants will be randomly assigned to receive either inhaled mosliciguat or a matching placebo daily for 24 weeks during the blinded treatment period. Those who complete this phase may continue into an extension period where all receive mosliciguat. The treatment is administered via a dry powder inhaler, with three dose levels of mosliciguat evaluated. Throughout the study, participants will undergo assessments including the 6-minute walk test, right heart catheterization to confirm pulmonary hypertension, and symptom questionnaires. Researchers will monitor changes in pulmonary vascular resistance, biomarker levels such as NT-proBNP, and clinical worsening events. The total study duration extends beyond 24 weeks with continued safety and efficacy monitoring through the extension phase.

A Phase 3 Trial of Inhaled Mosliciguat in PH-ILD (PHrontier)