A Long-term Follow-up Study of Sotatercept for PAH
An Open-Label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH
Acceleron Pharma Inc.
This is a clinical trial of a new treatment called sotatercept with background Pulmonary Arterial Hypertension (PAH) therapy for the treatment of PAH. This study is following up participants with PAH previously treated with sotatercept or placebo previously on other studies to understand the long-term safety, tolerability and efficacy of the treatment. PAH is a disease causing a progressive increase in pulmonary vascular resistance (PVR), resulting in right ventricular dysfunction and ultimately failure, as well as premature death. PAH is a progressive, fatal disease that causes marked limitations in physical activity and quality of life, even when treated with approved therapies. This study is supported by data from the primary phase of the PULSAR study (Phase 2, NCT03496207), in which participants taking any approved single or combination therapy for PAH were randomised to receive additional sotatercept or placebo for 24 weeks. The PULSAR study demonstrated a statistically significant improvement in its primary endpoint, PVR. The study duration for a given participant will be approximately 4 years with a Screening Period, Treatment Period and a Follow Up Period.
The size of this study will be defined by the number of participants rolling over to this study from parent sotatercept studies. Approximately 700 participants are expected to enrol in the study.
Participants rolling over to the A011-12 study from a blinded parent study will begin sotatercept treatment at a dose of 0.3 mg/kg (administered subcutaneously). Participants rolling over to the A011-12 study from an unblinded parent study will continue sotatercept treatment at their current dose.
The study involves procedures including physical examinations, vital signs, ECG, assessment of heart pumping rate and measurement of pressure in heart and lungs via a Right Heart Catheterisation process, Six Minute Walk Test (6MWT) and an echocardiogram. This study is sponsored by Acceleron Pharma Inc.
Wales REC 2
Date of REC Opinion
31 Aug 2021
Further Information Favourable Opinion