Study to Evaluate Safety and Efficacy of Mirivadelgat in PH-ILD (Windward)

The study is a phase 2, multinational, double-blind, 3-arm study to evaluate the safety and efficacy of mirivadelgat, an aldehyde dehydrogenase 2 activator, in adult subjects (aged 18 to 85 years) with PH-ILD. Participants must have a confirmed diagnosis of ILD as defined by the American Thoracic Society (ATS), European Respiratory Society (ERS), Japanese Respiratory Society (JRS), and/or Latin American Thoracic Society (ALAT) guidelines (Raghu, 2018). The diagnosis is based on a HRCT either performed at screening or within 180 days prior to screening or a historical surgical biopsy (or other appropriate tissue sampling (e.g., cryobiopsy)) and an RHC performed at screening. To be eligible for the study, a participant must be willing to undergo a Right Heart Catheterization (RHC) during screening and at the Week 12 Visit (at the end of study treatment). Participants on chronic treatment for underlying pulmonary diseases must be on a stable/optimized dose for ≥30 days prior to screening and have been receiving treatment for ≥90 days prior to screening. The study will enroll approximately 126 participants, assuming a drop-out rate of 20%, to obtain 99 evaluable participants (33 evaluable subjects in each cohort). Study visits will include a Screening Visit; Visit 2 (Study Day 1); Weeks 2, 3, 4, 6, 8,10, and 12 Visits (+/ 3 days); and a safety Follow-up Visit (+/ 3 days) after the Week 12 Visit. Visits on Weeks 2, 3, 6, and 10 will be conducted by phone calls.