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Study of Sotatercept in Newly Diagnosed Intermediate- and High-Risk PAH Participants (MK-7962-005/A011-13)
Sponsor: Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
Summary
The objective of this study is to evaluate the effects of sotatercept (MK-7962, formerly called ACE-011) treatment (plus background pulmonary arterial hypertension \[PAH\] therapy) versus placebo (plus background PAH therapy) on time to clinical worsening (TTCW) in participants who are newly diagnosed with PAH and are at intermediate or high-risk of disease progression.
Official title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy in Newly Diagnosed Intermediate- and High-risk PAH Patients
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
321
Start Date
2022-03-18
Completion Date
2025-04-03
Last Updated
2026-04-27
Healthy Volunteers
No
Conditions
Interventions
Sotatercept
SC injection
Placebo
Placebo-matched SC injection
Locations (152)
Arizona Pulmonary Specialists ( Site 1010)
Scottsdale, Arizona, United States
University of Arizona ( Site 1006)
Tucson, Arizona, United States
University of California San Diego ( Site 1002)
La Jolla, California, United States
UCLA Medical Center ( Site 1068)
Los Angeles, California, United States
University of California Irvine ( Site 1086)
Orange, California, United States
Santa Barbara Pulmonary Associates ( Site 1060)
Santa Barbara, California, United States
University of California Davis Medical Center ( Site 1064)
Sherman Oaks, California, United States
University of Colorado Hospital ( Site 1013)
Aurora, Colorado, United States
AdventHealth Medical Group Advanced Lung Disease ( Site 1058)
Orlando, Florida, United States
University of Iowa Hospital and Clinics ( Site 1050)
Iowa City, Iowa, United States
Johns Hopkins Hospital ( Site 1036)
Baltimore, Maryland, United States
Tufts Medical Center - PPDS ( Site 1014)
Boston, Massachusetts, United States
Boston Medical Center ( Site 1012)
Boston, Massachusetts, United States
University of Michigan ( Site 1011)
Ann Arbor, Michigan, United States
University of Kansas Medical Center ( Site 1020)
Kansas City, Missouri, United States
Washington University School of Medicine ( Site 1022)
St Louis, Missouri, United States
University of New Mexico, Health Sciences Center ( Site 1048)
Albuquerque, New Mexico, United States
NYU Langone Health ( Site 1052)
New York, New York, United States
University of North Carolina at Chapel Hill ( Site 1042)
Chapel Hill, North Carolina, United States
The Carl and Edyth Lindner Center for Research and Education at the Christ Hospital ( Site 1001)
Cincinnati, Ohio, United States
University of Cincinnati ( Site 1035)
Cincinnati, Ohio, United States
The Cleveland Clinic Foundation Taussig Cancer Center ( Site 1065)
Cleveland, Ohio, United States
Nazih Zuhdi Transplantation Institute ( Site 1084)
Oklahoma City, Oklahoma, United States
Oregon Health & Science University ( Site 1054)
Portland, Oregon, United States
Medical University of South Carolina ( Site 1003)
Charleston, South Carolina, United States
Vanderbilt University Medical Center ( Site 1027)
Nashville, Tennessee, United States
University of Texas Southwestern Medical Center ( Site 1038)
Dallas, Texas, United States
University of Utah ( Site 1049)
Salt Lake City, Utah, United States
Cardiologia Palermo ( Site 1911)
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Centro Medico Dra De Salvo ( Site 1904)
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Hospital Universitario Austral ( Site 1901)
Pilar, Buenos Aires, Argentina
Instituto de Investigaciones Clinicas Quilmes ( Site 1903)
Quilmes, Buenos Aires, Argentina
Instituto De Enfermedades Respiratorias E Investigacion Medica ( Site 1910)
Villa Vatteone, Buenos Aires, Argentina
Instituto Médico DAMIC ( Site 1909)
Córdoba, Córdoba Province, Argentina
Instituto Medico Rio Cuarto ( Site 1907)
Río Cuarto, Córdoba Province, Argentina
Hospital Provincial del Centenario ( Site 1912)
Rosario, Santa Fe Province, Argentina
Instituto Cardiovascular de Rosario ( Site 1906)
Rosario, Santa Fe Province, Argentina
Sanatorio Parque ( Site 1905)
Rosario, Santa Fe Province, Argentina
Sanatorio Allende ( Site 1908)
Córdoba, Argentina
Hospital Provincial Dr. Jose M. Cullen ( Site 1902)
Santa Fe, Argentina
Royal Prince Alfred Hospital ( Site 1106)
Camperdown, New South Wales, Australia
John Hunter Hospital ( Site 1101)
Newcastle, New South Wales, Australia
Prince Charles Hospital ( Site 1104)
Chermside, Queensland, Australia
Princess Alexandra Hospital ( Site 1108)
Woolloongabba, Queensland, Australia
Royal Adelaide Hospital ( Site 1109)
Adelaide, South Australia, Australia
Royal Hobart Hospital ( Site 1107)
Hobart, Tasmania, Australia
Fiona Stanley Hospital ( Site 1103)
Murdoch, Western Australia, Australia
Medizinische Universitat Wien ( Site 2001)
Vienna, State of Vienna, Austria
Medizinische Universität Graz ( Site 2003)
Graz, Styria, Austria
Medizinische Universitat Innsbruck ( Site 2004)
Innsbruck, Tyrol, Austria
Ordensklinikum Linz GmbH Elisabethinen ( Site 2002)
Linz, Upper Austria, Austria
Hopital Erasme ( Site 1402)
Anderlecht, Bruxelles-Capitale, Region de, Belgium
UZ Gasthuisberg ( Site 1401)
Leuven, Vlaams-Brabant, Belgium
Hospital Madre Teresa ( Site 1804)
Belo Horizonte, Minas Gerais, Brazil
Irmandade da Santa Casa de Misericordia de Porto Alegre ( Site 1805)
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Sao Paulo ( Site 1806)
São Paulo, São Paulo, Brazil
Instituto do Coracao - HCFMUSP ( Site 1803)
São Paulo, Brazil
University of Alberta Hospital ( Site 2101)
Edmonton, Alberta, Canada
St Boniface General Hospital ( Site 2106)
Winnepeg, Manitoba, Canada
McMaster University - HSC ( Site 2105)
Hamilton, Ontario, Canada
Sir Mortimer B Davis Jewish General Hospital ( Site 2103)
Montreal, Quebec, Canada
Centro Cardiovascular Colombiano Clínica Santa María Clínica Cardio VID ( Site 3402)
Medellín, Antioquia, Colombia
Fundacion Neumologica Colombiana ( Site 3403)
Bogota, Cundinamarca, Colombia
Fundacion Valle Del Lili ( Site 3401)
Cali, Valle del Cauca Department, Colombia
Centro Medico Imbanaco de Cali S.A ( Site 3404)
Cali, Valle del Cauca Department, Colombia
University Hospital Centre Split city ( Site 3901)
Split, Split-Dalmatia County, Croatia
Klinicki Bolnicki Centar Zagreb ( Site 3902)
Zagreb, Zagreb County, Croatia
Institut Klinicke a Experimentalni Mediciny ( Site 2202)
Prague, Praha 4, Czechia
Vseobecna fakultni nemocnice v Praze ( Site 2201)
Prague, Czechia
Rigshospitalet ( Site 3802)
København Ø, Capital Region, Denmark
Aarhus Universitetshospital, Skejby ( Site 3801)
Aarhus, Central Jutland, Denmark
Hopital Louis Pasteur ( Site 1311)
Nice, Alpes-Maritimes, France
Hopital Louis Pradel ( Site 1317)
Lyon, Auvergne, France
Hopitaux Universitaires de Strasbourg ( Site 1307)
Strasbourg, Bas-Rhin, France
Hopital Cavale Blanche ( Site 1314)
Brest, Brittany Region, France
CHU Caen Normandie ( Site 1325)
Caen, Calvados, France
CHU de Besancon ( Site 1303)
Besançon, Doubs, France
Hopital Haut Leveque ( Site 1312)
Bordeaux, Gironde, France
CHU de Toulouse - Hopital Larrey ( Site 1315)
Toulouse, Haute-Garonne, France
C.H.U. de Tours - Hopital Bretonneau ( Site 1310)
Tours, Indre-et-Loire, France
Hopital Nord Laennec ( Site 1309)
Nantes, Loire-Atlantique, France
CHU Angers ( Site 1313)
Angers, Maine-et-Loire, France
C.H.U. de Nancy. Hopital de Brabois Adultes ( Site 1308)
Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France
Centre Hospitalier Universitaire de Saint-Etienne ( Site 1302)
Saint-Priest-en-Jarez, Pays de la Loire Region, France
CHU - Hopital de Bicetre ( Site 1304)
Le Kremlin-Bicêtre, Val-de-Marne, France
CHU de Poitiers ( Site 1316)
Poitiers, Vienne, France
Universitaetsklinikum Heidelberg ( Site 1509)
Heidelberg, Baden-Wurttemberg, Germany
Krankenhaus Neuwittelsbach ( Site 1510)
Munich, Bavaria, Germany
Universitaetsklinik Regensburg ( Site 1503)
Regensburg, Bavaria, Germany
Medizinische Hochschule Hannover ( Site 1505)
Hanover, Lower Saxony, Germany
Universitaetsklinikum Giessen und Marburg GmbH ( Site 1512)
Bad Oeynhausen, North Rhine-Westphalia, Germany
Uniklinik Köln ( Site 1511)
Cologne, North Rhine-Westphalia, Germany
Universitatsklinikum des Saarlandes ( Site 1513)
Homburg, Saarland, Germany
Universitaetsklinikum Carl Gustav Carus ( Site 1501)
Dresden, Saxony, Germany
Universitatsklinikum Leipzig ( Site 1508)
Leipzig, Saxony, Germany
Universitaetsklinik und Poliklinik Halle/Saale ( Site 1502)
Halle, Saxony-Anhalt, Germany
DRK Kliniken Berlin Westend ( Site 1507)
Berlin, Germany
Evangelismos General Hospital of Athens ( Site 3605)
Athens, Attica, Greece
Onassis Cardiac Surgery Center ( Site 3602)
Athens, Attica, Greece
Attikon University General Hospital of Athens ( Site 3604)
Haidari, Attica, Greece
AHEPA University General Hospital of Thessaloniki ( Site 3601)
Thessaloniki, Greece
Assuta Ashdod Medical Center ( Site 1710)
Ashdod, Israel
Lady Davis Carmel Medical Center ( Site 1705)
Haifa, Israel
Hadassah Medical Center ( Site 1711)
Jerusalem, Israel
Sheba Medical Center ( Site 1701)
Tel Litwinsky, Israel
Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) ( Site 2405)
Trieste, Friuli Venezia Giulia, Italy
Ospedale S. Giuseppe Multimedica ( Site 2403)
Milan, Lombardy, Italy
Azienda Ospedaliera San Gerardo di Monza ( Site 2406)
Monza, Monza E Brianza, Italy
Azienda Ospedaliera R. N. V. Monaldi ( Site 2407)
Naples, Italy
La Sapienza-Università di Roma-Policlinico Umberto I ( Site 2402)
Roma, Italy
Radboud University Nijmegen Medical Centre ( Site 2605)
Nijmegen, Gelderland, Netherlands
Maastricht University Medical Center ( Site 2603)
Maastricht, Limburg, Netherlands
VU Medisch Centrum ( Site 2601)
Amsterdam, North Holland, Netherlands
Erasmus MC ( Site 2604)
Rotterdam, South Holland, Netherlands
Waikato District Health Board ( Site 2702)
Hamilton, Waikato Region, New Zealand
Krakowski Szpital Specjalistyczny im. Jana Pawla II ( Site 2801)
Krakow, Lesser Poland Voivodeship, Poland
Instytut Gruzlicy i Chorob Pluc w Warszawie ( Site 2802)
Warsaw, Masovian Voivodeship, Poland
Hospital Garcia de Orta ( Site 3501)
Almada, Setúbal District, Portugal
Centro Hospitalar E Universitário De Coimbra ( Site 3502)
Coimbra, Portugal
Hospital Pulido Valente ( Site 3503)
Lisbon, Portugal
Institute for pulmonary diseases of Vojvodina ( Site 2906)
Kamenitz, Juznobacki Okrug, Serbia
University Clinical Center Nis ( Site 2904)
Niš, Nisavski Okrug, Serbia
Clinical Center Kragujevac ( Site 2905)
Kragujevac, Sumadijski Okrug, Serbia
Clinical Center of Serbia ( Site 2901)
Belgrade, Serbia
Gachon University Gil Medical Center ( Site 3103)
Namdong-Gu, Incheon, South Korea
Chonnam National University Hospital ( Site 3105)
Gwangju, Kyonggi-do, South Korea
Samsung Medical Center ( Site 3106)
Seuol, Seoul, South Korea
Seoul National University Hospital ( Site 3102)
Seoul, South Korea
Severance Hospital Yonsei University Health System - PPDS ( Site 3101)
Seoul, South Korea
The Catholic University of Korea St. Mary s Hospital ( Site 3104)
Seoul, South Korea
Hospital Universitario de Son Espases ( Site 1611)
Palma de Mallorca, Balearic Islands, Spain
Hospital Universitario Marques de Valdecilla ( Site 1601)
Santander, Cantabria, Spain
Hospital Universitario Puerta de Hierro (Majadahonda) ( Site 1604)
Majadahonda, Madrid, Spain
Hospital Universitari Vall de Hebron ( Site 1605)
Barcelona, Spain
Hospital Universitario 12 de Octubre ( Site 1603)
Madrid, Spain
Hospital Universitario La Paz ( Site 1610)
Madrid, Spain
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca ( Site 1608)
Salamanca, Spain
Hospital Virgen de la Salud ( Site 1607)
Toledo, Spain
Skanes Universitetssjukhus Lund ( Site 3203)
Lund, Skåne County, Sweden
Hjart-lungmedicin och klinisk fysiologi ( Site 3204)
Uppsala, Uppsala County, Sweden
Norrlands Universitetssjukhus ( Site 3205)
Umeå, Västerbotten County, Sweden
UniversitätsSpital Zürich ( Site 3301)
Zurich, Switzerland
Kaohsiung Veterans General Hospital ( Site 3702)
Kaohsiung City, Taiwan
China Medical University Hospital ( Site 3701)
Taichung, Taiwan
National Cheng Kung University Hospital ( Site 3703)
Tainan, Taiwan
Papworth Hospital NHS Foundation Trust ( Site 1208)
Cambrigge, Cambridgeshire, United Kingdom
Sheffield Teaching Hospital NHS Foundation Trust ( Site 1207)
Sheffield, Derbyshire, United Kingdom
Golden Jubilee National Hospital ( Site 1204)
Glasgow, Glasgow City, United Kingdom
Royal Free London NHS Foundation Trust ( Site 1202)
London, London, City of, United Kingdom
Royal Brompton Hospital ( Site 1206)
London, London, City of, United Kingdom
Imperial College Healthcare NHS Trust ( Site 1203)
London, London, City of, United Kingdom
Freeman Hospital ( Site 1205)
Newcastle upon Tyne, United Kingdom