324
Participants
Start Date
January 25, 2021
Primary Completion Date
August 26, 2022
Study Completion Date
December 6, 2022
Sotatercept
Sotatercept at a starting dose of 0.3 mg/kg with a target dose of 0.7 mg/kg administered subcutaneously (SC) every 21 days plus background PAH therapy.
Placebo
Placebo administered subcutaneously (SC) every 21 days plus background PAH therapy.
Background PAH Therapy
Background PAH therapy may consist of the following drug classes: an endothelin-receptor antagonist (ERA), a phosphodiesterase 5 (PDE5) inhibitor, a soluble guanylate cyclase stimulator, and/or a prostacyclin analogue or receptor agonist.
Greenlane Clinical Centre (Site 2703), Auckland
Hopital Erasme ( Site 1402), Brussels
Hopitaux Universitaires de Geneve HUG (Site 3302), Thônex
University Clinical Center Nis (Site 2904), Niš
Sanatorio Parque ( Site 1905), Rosario
Saint Vincents Hospital Sydney ( Site 1102), Darlinghurst
Royal Prince Alfred Hospital ( Site 1106), Camperdown
Westmead Hospital ( Site 1105), Westmead
John Hunter Hospital ( Site 1101), New Lambton
U.Z.-Gasthuisberg ( Site 1401), Leuven
The Alfred Hospital ( Site 1110), Melbourne
Waikato District Health Board (Site 2702), Hamilton
Prince Charles Hospital ( Site 1104), Chermside
University of Otago, Wellington (Site 2701), Christchurch
Universitaetsspital Zuerich (Site 3301), Zurich
New York Presbyterian Hospital (Site 1046), New York
Clinical Center of Serbia (Site 2901), Belgrade
DRK Kliniken Berlin Westend ( Site 1507), Berlin
UPMC Presbyterian. UPMC Presbyterian Hospital (Site 1059), Pittsburgh
University of Pennsylvania (Site 1047), Philadelphia
The George Washington University Medical Faculty Associates (Site 1025), Washington D.C.
Gachon University Gil Medical Center (Site 3103), Incheon
CIMAB SA de CV (Site 2502), Torreón
Duke University Medical Center (Site 1026), Durham
Hospital Universitario Ramon y Cajal (Site 1609), Madrid
Hospital Universitario Marques de Valdecilla (Site 1603), Madrid
Hospital Universitario Puerta de Hierro-Majadahonda (Site 1604), Majadahonda
CHRU Brest - Hopital Cavale Blanche (Site 1314), Brest
The Emory Clinic (Site 1030), Atlanta
Medizinische Hochschule Hannover (Site 1505), Hanover
CHU de Toulouse - Hopital Larrey ( Site 1315), Toulouse
Mayo Clinic Jacksonville (Site 1045), Jacksonville
Groupe Hospitalier Sud ( Site 1312), Pessac
University of South Florida (Site 1043), Tampa
Hopital Arnaud de Villeneuve ( Site 1301), Montpellier
Lady Davis Carmel Medical Center (Site 1705), Haifa
Universitaetsklinikum Giessen und Marburg GmbH ( Site 1512), Giessen
Hospital Clinico Universitario de Salamanca (Site 1608), Salamanca
Vanderbilt University Medical Center (Site 1027), Nashville
Statcare Pulmonary Consultants - Knoxville (Site 1031), Knoxville
CHU de Grenoble - Hopital Michallon ( Site 1303), Grenoble
Hospital Universitario Marques de Valdecilla (Site 1601), Santander
Norton Pulmonary Specialists (Site 1066), Louisville
Centre Hospitalier Universitaire de Saint-Etienne ( Site 1302), Saint-Priest-en-Jarez
The Ohio State University Wexner Medical Center (Site 1032), Columbus
CHU Nantes - Hopital Laennec (Site 1309), Nantes
University Hospitals Cleveland Medical Center (Site 1005), Cleveland
The Carl and Edyth Lindner Center for Research and Education at the Christ Hospital (Site 1001), Cincinnati
CHU Angers (Site 1313), Angers
Uniklinik Köln, Institut für Kliniche Chemie ( Site 1511), Cologne
Operadora de Hospitales Angeles. S.A. de C.V. -Sucursal Lomas (Site 2501), Huixquilucan
C.H.U. de Nancy. Hopital de Brabois Adultes ( Site 1308), Vandœuvre-lès-Nancy
University of Minnesota (Site 1062), Minneapolis
Mayo Clinic (Site 1023), Rochester
CHRU Lille ( Site 1306), Lille
Washington University School of Medicine (Site 1022), St Louis
Unidad de Investigacion Clinica en Medicina, S.C. (Site 2505), Monterrey
Hopitaux Universitaires de Strasbourg ( Site 1307), Strasbourg
Nebraska Medical Center (Site 1053), Omaha
Thoraxklinik-Heidelberg gGmbH (Site 1509), Heidelberg
CHI St. Luke's Health Baylor College of Medicine Medical Center (Site 1044), Houston
Houston Methodist Hospital (Site 1009), Houston
University of Colorado Hospital (Site 1013), Aurora
Krankenhaus Neuwittelsbach (Site 1510), Munich
University of Utah - PPDS (Site 1049), Salt Lake City
Arizona Pulmonary Specialists (Site 1010), Phoenix
Pulmonary Associates, PA (Site 1008), Phoenix
University of Arizona (Site 1006), Tucson
Harbor UCLA Medical Center (Site 1028), Torrance
University of California San Diego Medical Center (Site 1002), San Diego
Universitaetsklinik Regensburg (Site 1503), Regensburg
Centre Hospitalier Universitaire de Bicetre ( Site 1304), Le Kremlin-Bicêtre
Stanford University Medical Center (Site 1024), Stanford
University of California - Davis Medical Center (Site 1064), Sherman Oaks
Oregon Health and Science University (Site 1054), Portland
Institute of Cardiovascular Diseases Dedinje (Site 2903), Belgrade
Meir Medical Center (Site 1707), Kfar Saba
Rabin Medical Center (Site 1703), Petah Tikva
Sheba Medical Center (Site 1701), Tel Litwinsky
Tufts Medical Center - PPDS (Site 1012), Boston
Brigham and Women's Hospital (Site 1014), Boston
University of Michigan (Site 1011), Ann Arbor
University of Kansas Medical Center (Site 1020), Kansas City
Renown Institute for Heart & Vascular Health (Site 1055), Reno
University of Cincinnati Medical Center (Site 1035), Cincinnati
Rhode Island Hospital (Site 1033), Providence
Medical University of South Carolina - PPDS (Site 1003), Charleston
University of Washington Medical Center - Montlake (Site 1067), Seattle
Hospital Universitario Austral ( Site 1901), Pilar
Instituto de Investigaciones Clinicas Quilmes ( Site 1903), Quilmes
Centro Medico Dra De Salvo ( Site 1904), Buenos Aires
Hospital Provincial Dr. Jose M. Cullen ( Site 1902), Santa Fe
Irmandade da Santa Casa de Misericordia de Porto Alegre ( Site 1805), Porto Alegre
Hospital Dia do Pulmao ( Site 1802), Blumenau
Instituto do Coracao - HC FMUSP ( Site 1803), São Paulo
University Of Alberta Hospital ( Site 2101), Edmonton
University of Ottawa Heart Institute ( Site 2104), Ottawa
Jewish General Hospital ( Site 2103), Montreal
Fakultni Nemocnice Olomouc ( Site 2203), Olomouc
Institut Klinicke a Experimentalni Mediciny ( Site 2202), Prague
Vseobecna fakultni nemocnice v Praze ( Site 2201_, Prague
Hopital Pasteur (Site 1311), Nice
Universitaetsklinikum Carl Gustav Carus der TU Dresden (Site 1501), Dresden
Universitätsklinikum Halle (Site 1502), Halle
"Universita La Sapienza Policlinico Umberto I (Site 2402)", Roma
Maastricht University Medical Center (Site 2603), Maastricht
VU Medisch Centrum (Site 2601), Amsterdam
Krakowski Szpital Specjalistyczny im. Jana Pawla II (Site 2801), Krakow
Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina (Site 2802), Otwock
Uniwersytecki Szpital Kliniczny w Bialymstoku (Site 2803), Bialystok
Seoul National University Hospital (Site 3102), Seoul
Severance Hospital Yonsei University Health System - PPDS (Site 3101), Seoul
Hospital Universitari Vall d'Hebron (Site 1605), Barcelona
Hospital Clinic de Barcelona (Site 1602), Barcelona
Akademiska Sjukhuset (Site 3204), Uppsala
Sahlgrenska Universitets Sjukhuset (Site 3201), Gothenburg
Golden Jubilee National Hospital (Site 1204), Glasgow
Royal Free London NHS Foundation Trust (Site 1202), London
Royal Brompton Hospital (Site 1206), London
Imperial College Healthcare NHS Trust (Site 1203), London
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
INDUSTRY