Phase 2a Study of Oral ROC-101 with Standard Care in Adults Aged 18-80 with Pulmonary Arterial Hypertension or Pulmonary Hypertension from Interstitial Lung Disease

What this Trial Is About

Researchers are evaluating ROC-101 in adults with Pulmonary Arterial Hypertension PAH or Pulmonary Hypertension associated with Interstitial Lung Disease ILD-PH. This Phase 2a, open-label, single-arm, multicenter study aims to assess the safety, tolerability, and effectiveness of oral ROC-101 combined with standard care in these patients. The study focuses on adults aged 18 to 80 and uses measures such as pulmonary vascular resistance and heart catheterization data to evaluate outcomes. Participants will receive standard therapy plus ROC-101 starting at 10 mg orally once daily, increasing up to 40 mg daily over a 24-week treatment period. After this main period, eligible participants may continue in a long-term extension phase until the end of the program or until marketing approval. The study includes detailed heart and lung assessments and monitors for adverse events throughout treatment. During the study, participants will undergo evaluations including right heart catheterization to measure hemodynamic parameters, pulmonary function tests, walk distance tests, and safety assessments. Researchers will track changes from baseline at 24 weeks and monitor adverse events. The studys total duration includes the initial 24-week treatment followed by an extended period, with continuous monitoring of participant health and response to the study drug.

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