Long-Term Extension Study Evaluating Seralutinib Inhalation in Adults with Pulmonary Arterial Hypertension

What this Trial Is About

Researchers are evaluating the long-term safety, tolerability, and effectiveness of orally inhaled seralutinib in adults who have previously completed a seralutinib study for pulmonary arterial hypertension PAH. This open-label extension study continues until seralutinib receives market approval or the study ends, aiming to gather extended information on this treatment in a real-world setting. Participants will receive seralutinib capsules delivered via a generic dry powder inhaler twice daily. The treatment period lasts up to 48 months or until commercial availability of seralutinib. This single-group study allows all participants to receive the investigational drug, focusing on continued evaluation rather than comparison with a placebo or other treatments. During the study, participants will attend scheduled visits for assessments including monitoring of treatment-emergent adverse events, walking distance tests Six-Minute Walk Test, and blood tests measuring NT-proBNP levels at regular intervals up to 48 months. Women of childbearing potential and men with partners of childbearing potential will undergo pregnancy testing and follow contraception guidelines. The research team will closely monitor safety and treatment effects throughout the extended study period.

Open-label Extension Study of Seralutinib in Adult Subjects With PAH (PROSERA-EXT)