164
Participants
Start Date
December 29, 2021
Primary Completion Date
September 5, 2025
Study Completion Date
January 30, 2026
Sotatercept 0.3 mg/kg
Administered by subcutaneous injection. Sotatercept (ACE-011) is a recombinant fusion protein consisting of the extracellular domain of the human activin receptor type IIA linked to the Fc piece of human IgG1.
Placebo
Administered by subcutaneous injection
Sotatercept 0.3 mg/kg escalating to 0.7 mg/kg
Administered by subcutaneous injection. Sotatercept (ACE-011) is a recombinant fusion protein consisting of the extracellular domain of the human activin receptor type IIA linked to the Fc piece of human IgG1.
Hôpital Erasme ( Site 1402), Anderlecht
UZ Leuven - Campus Gasthuisberg ( Site 1401), Leuven
Pulmonary Health Physicians ( Site 1080), Liverpool
ZIV Medical Center ( Site 1704), Safed
DRK Kliniken Berlin Westend ( Site 1507), Berlin
University of Rochester Medical Center - PPDS ( Site 1039), Rochester
Lankenau Institute for Medical Research ( Site 1089), Wynnewood
Fondazione IRCCS San Gerardo dei Tintori - ASST di Monza - A. O. San Gerardo ( Site 2406), Monza
Inova Heart and Vascular Institute ( Site 1078), Falls Church
Bon Secours St. Mary's Hospital ( Site 1069), Richmond
ASST Papa Giovanni XXIII ( Site 2410), Bergamo
Centre Hospitalier Universitaire du Besancon ( Site 1324), Besançon
West Virginia University ( Site 1081), Morgantown
Fondazione IRCCS-Policlinico San Matteo ( Site 2401), Pavia
Hospital Universitario 12 de Octubre ( Site 1603), Madrid
Hospital Universitario Puerta de Hierro (Majadahonda) ( Site 1604), Majadahonda
Hospital Costa del Sol ( Site 1613), Marbella
Medizinische Hochschule Hannover ( Site 1505), Hanover
Hopital de Rangueil du Toulouse ( Site 1322), Toulouse
Mayo Clinic Jacksonville - PPDS ( Site 1045), Jacksonville
AdventHealth Orlando ( Site 1058), Orlando
Bay Area Cardiology ( Site 1071), Brandon
Tampa General Hospital ( Site 1043), Tampa
CHU Montpellier Hôpital Arnaud de VIlleneuve ( Site 1301), Montpellier
Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) ( Site 2405), Trieste
Hôpital Pontchaillou ( Site 1319), Rennes
Universitätsklinikum Gießen und Marburg GmbH ( Site 1512), Giessen
Statcare Pulmonary Consultants - Knoxville ( Site 1031), Knoxville
Centre Hospitalier Universitaire de Grenoble ( Site 1303), Grenoble
AOU di Bologna Policlinico S Orsola Malpighi ( Site 2409), Bologna
Norton Pulmonary Specialists ( Site 1066), Louisville
University of Louisville ( Site 1099), Louisville
Hospital Universitario de Toledo ( Site 1607), Toledo
Hospital Universitario Virgen Macarena ( Site 1612), Seville
The Ohio State University Wexner Medical Center ( Site 1032), Columbus
University of Toledo Medical Center ( Site 1070), Toledo
CHU de Nantes - Hoptal Nord Laennec ( Site 1309), Nantes
University Hospitals Cleveland Medical Center ( Site 1005), Cleveland
Cleveland Clinic Foundation ( Site 1065), Cleveland
The Carl and Edyth Lindner Center for Research and Education at the Christ Hospital ( Site 1001), Cincinnati
Ascension Medical Group St. Vincent ( Site 1076), Indianapolis
University of Michigan ( Site 1011), Ann Arbor
CHU Angers ( Site 1313), Angers
Uniklinik Köln ( Site 1511), Cologne
University of Iowa Hospital and Clinics ( Site 1050), Iowa City
Aurora St Luke's Medical Center ( Site 1083), Milwaukee
Froedtert Hospital & the Medical College of Wisconsin ( Site 1051), Milwaukee
CHRU de Nancy Hopitaux de Brabois ( Site 1308), Vandœuvre-lès-Nancy
Universitaetsmedizin Johannes Gutenberg Universitaet Mainz ( Site 1515), Mainz
University of Minnesota Hospitals ( Site 1062), Minneapolis
CHRU Lille ( Site 1306), Lille
University of Illinois Hospital ( Site 1095), Chicago
Kerckhoff-Klinik-Forschungs-GmbH ( Site 1514), Bad Nauheim
Washington University School of Medicine [Saint Louis, MO] ( Site 1022), St Louis
Tel Aviv Sourasky Medical Center ( Site 1714), Tel Aviv
Unidad de Investigacion Clinica En Medicina SC ( Site 2505), Monterrey
University of Kansas Medical Center ( Site 1020), Kansas City
University of Nebraska Medical Center ( Site 1053), Omaha
Thoraxklinik-Heidelberg gGmbH ( Site 1509), Heidelberg
University Medical Center New Orleans ( Site 1057), New Orleans
Shamir Medical Center Assaf Harofeh ( Site 1713), Be’er Ya‘aqov
Baylor University Medical Center ( Site 1096), Dallas
University of Texas Southwestern Medical Center ( Site 4002), Dallas
CHU de Rouen ( Site 1323), Rouen
University Of Colorado ( Site 1013), Aurora
South Denver Cardiology Associates ( Site 1091), Littleton
Krankenhaus Neuwittelsbach ( Site 1510), München
Intermountain Medical Center ( Site 1079), Murray
PULMONARY ASSOCIATES, P.A. ( Site 1008), Phoenix
Cedars Sinai Medical Center ( Site 1082), Los Angeles
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center ( Site 1028), Torrance
Shaare Zedek Medical Center ( Site 1715), Jerusalem
Hadassah Ein Kerem Medical Center ( Site 1711), Jerusalem
University of California Irvine ( Site 1086), Orange
University Hospital Regensburg ( Site 1503), Regensburg
Centre Hospitalier Universitaire de Bicetre ( Site 1304), Le Kremlin-Bicêtre
Stanford University ( Site 1024), Stanford
Oregon Health Science University ( Site 1054), Portland
Rambam Health Corp. ( Site 1716), Haifa
Lady Davis Carmel Medical Center ( Site 1705), Haifa
Meir Medical Center. ( Site 1707), Kfar Saba
Rabin Medical Center ( Site 1703), Petah Tikva
Edith Wolfson Medical Center ( Site 1717), Holon
Kaplan Medical Center ( Site 1712), Rehovot
Assuta Ashdod Medical Center ( Site 1710), Ashdod
University of Arizona ( Site 1006), Tucson
Scripps Clinic ( Site 4001), La Jolla
Jeffrey S.Sager MD Medical Corporation ( Site 1060), Santa Barbara
Winchester Chest Clinic ( Site 1093), New Haven
The George Washington University Medical Faculty Associates ( Site 1025), Washington D.C.
Piedmont Atlanta Hospital ( Site 1085), Atlanta
Emory University ( Site 1030), Atlanta
Saint Alphonsus Regional Medical Center ( Site 1097), Boise
IU Health Advanced Heart and Lung Care ( Site 1092), Indianapolis
Tufts Medical Center - PPDS ( Site 1012), Boston
Brigham and Women's Hospital [Boston, MA] ( Site 1014), Boston
Weill Cornell Medical College ( Site 1046), New York
Duke University Medical Center ( Site 1026), Durham
Allegheny General Hospital ( Site 1088), Pittsburgh
Rhode Island Hospital ( Site 1033), Providence
Medical University of South Carolina - PPDS ( Site 1003), Charleston
University Of Alberta ( Site 2101), Edmonton
Hamilton General Hospital-Special Immunology Services Clinic ( Site 2110), Hamilton
University Health Network ( Site 2109), Toronto
Institut Universitaire de Cardiologie et de Pneumologie ( Site 2107), Sainte-Foy
Hôpital Pasteur - CHU Nice ( Site 1311), Nice
Universitätsklinikum Carl Gustav Carus an der TU Dresden. ( Site 1501), Dresden
Ospedale SS Annunziata ( Site 2408), Sassari
Azienda Policlinico Umberto I ( Site 2402), Roma
Krakowski Szpital Specjalistyczny im Jana Pawla II ( Site 2801), Krakow
Wojewodzki Szpital Specjalistyczny im Stefana Kardynala Wyszynskiego ( Site 2806), Lubin
Europejskie Centrum Zdrowia Otwock Szpital im Fryderyka Chopina ( Site 2802), Otwock
Państwowy Instytut Medyczny MSWiA ( Site 2805), Warsaw
Uniwersytecki Szpital Kliniczny w Bialymstoku - Marii Sklodowskiej-Curie 24A ( Site 2803), Bialystok
Samodzielny Publiczny Szpital Kliniczny Nr 2 PUM w Szczecinie ( Site 2804), Szczecin
Wojewodzki Specjalistyczny Szpital im dr WI Bieganskiego w Lodzi ( Site 2807), Lodz
Hospital Clinic de Barcelona ( Site 1602), Barcelona
Sahlgrenska Universitetssjukhuset ( Site 3201), Gothenburg
Imperial College Healthcare NHS Trust ( Site 1203), London
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
INDUSTRY