A Study of ROC-101 in Patients With Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension Associated With Interstitial Lung Disease (ILD-PH) (ROCSTAR STUDY)

This is a Phase 2a, open-label, single-arm, multicenter, exploratory study to evaluate the safety, tolerability, and efficacy of oral doses of ROC-101 for the treatment of participants with either World Health Organization (WHO) Group I PAH or WHO Group III ILD-PH. All eligible PAH/ILD-PH participants will receive SOC therapy plus ROC-101 at a starting dose level of 10 mg orally (PO) daily (QD) and escalating to 40 mg PO QD for the remainder of the main study period of 24 weeks. Evaluations include hemodynamic measures collected during right heart catheterization (RHC) and adverse events.