A Phase 2A, Open-Label Study to Evaluate Oral ROC-101 in Adults With Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension Associated With Interstitial Lung Disease (ILD-PH)

What this Trial Is About

Researchers are evaluating the effects of 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 study aims to assess the safety, tolerability, and efficacy of oral ROC-101 in combination with standard of care (SOC) therapy. The study focuses on patients classified under World Health Organization (WHO) Group I PAH or Group III ILD-PH, monitoring clinical and hemodynamic parameters. Participants will receive ROC-101 orally once daily, starting at 10 mg with a planned increase to 40 mg daily during a 24-week treatment period alongside their SOC therapy. Following this main phase, participants may continue in a long-term extension phase until the study program ends or regulatory approval is obtained. Evaluations include detailed hemodynamic measurements taken during right heart catheterization (RHC) and monitoring of adverse events. Throughout the study, participants will undergo various assessments including pulmonary function tests, 6-minute walk distance evaluations, and multiple heart catheterization measurements to track changes in pulmonary vascular resistance and other cardiac functions. Safety will be closely monitored by recording adverse events. Participants are expected to comply with study procedures and contraceptive guidelines as applicable, with total participation lasting beyond 24 weeks if they join the extension phase.

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