The objectives of this study are to evaluate the efficacy and safety of sotatercept treatment
(plus background PAH therapy) versus placebo (plus background PAH therapy) at 24 weeks in
adults with PAH.
This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, parallel-group
study in subjects with symptomatic Pulmonary Arterial Hypertension (PAH) who present with
idiopathic or heritable PAH, PAH associated with connective tissue diseases (CTD), drug or
toxin induced, post shunt correction PAH, or PAH presenting at least 1 year following the
correction of congenital heart defects (CHDs), and currently on background PAH therapy.
The primary efficacy endpoint of the study is exercise capacity, as measured by the 6-minute
walk distance (6MWD) measured at 24 week following initiation of treatment.
Approximately 284 participants will be enrolled and randomized 1:1 to receive either
sotatercept or placebo on the background of stable standard-of-care PAH mediation. Study
duration will be approximately 2 years A stratified Wilcoxon test will be used for analysis
of the primary endpoint, with appropriate imputation for missing data, as detailed in the
Statistical Analysis Plan. An unblinded, external, independent Data Monitoring Committee
(DMC) will monitor participant safety throughout the course of the study. Participants
completing this study will be eligible to receive sotatercept in a separate, open-label
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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