Researchers are looking for other ways to treat people with PAH. In PAH, the blood vessels in the lungs become thick and narrow, which makes it harder for blood to flow to the lungs. The goal of the study is to learn: * What happens to different doses of sotatercept in a person's body over time when it is given using weight-banded doses compared to weight-based doses. There may be differences in how the medicine works with the new dosing method (weight-banded dosing) being studied in this trial. * About the safety of sotatercept and if people tolerate it
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
164
SC administered every 3 weeks.
Background PAH therapy may consist of the following drug classes: single, double, or triple combination of therapy with endothelin-receptor antagonists, phosphodiesterase inhibitors, soluble guanylate cyclase stimulators, and/or prostacyclin analogs or receptor antagonists
Pulmonary Associates, PA ( Site 1903)
Phoenix, Arizona, United States
University of Colorado Anschutz Medical Campus-University of Colorado Hospital Cardiac and Vascular ( Site 1930)
Aurora, Colorado, United States
Indiana University Health Methodist Hospital ( Site 1905)
Indianapolis, Indiana, United States
University of Kansas Medical Center ( Site 1928)
Kansas City, Kansas, United States
Norton Pulmonary Specialists ( Site 1935)
Louisville, Kentucky, United States
Steady-State Average Serum Concentrations of Sotatercept (Cavg)
Steady-state Cavg of sotatercept will be reported.
Time frame: Predose and at designated time points post-dose (up to 24 weeks)
Number of Participants Who Experience One or More Adverse Events (AEs)
An AE is a health problem that happens or worsens during a study. Number of participants who experience an AE will be reported.
Time frame: Up to 37 weeks
Number of Participants who Discontinue Study Treatment due to an Adverse Event
An AE is a health problem that happens or worsens during a study. Number of participants who discontinue study treatment will be reported.
Time frame: Up to 21 weeks
Initial Dose Average Serum Concentrations of Sotatercept (Cavg)
Initial dose Cavg of sotatercept will be reported.
Time frame: Predose and at designated time points post-dose (up to 3 weeks)
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University of New Mexico Health Sciences Center - Department of Internal Medicine ( Site 1916)
Albuquerque, New Mexico, United States
University of Cincinnati Medical Center ( Site 1927)
Cincinnati, Ohio, United States
Ascension Seton Heart Specialty Care and Transplant Center ( Site 1918)
Austin, Texas, United States
Froedtert Hospital & the Medical College of Wisconsin ( Site 1934)
Milwaukee, Wisconsin, United States
Centro Medico Capital ( Site 0002)
La Plata, Buenos Aires, Argentina
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