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TERMINATED
NCT04811092
PHASE3

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

View on ClinicalTrials.gov

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

Interventions

DRUG

Sotatercept

SC injection

OTHER

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