A Long-term Follow-up Study of Sotatercept for PAH Treatment (MK-7962-004/A011-12) (SOTERIA)

July 8, 2025 updated by: Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA

An Open-label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH (MK-7962-004)

This study is being conducted to assess the long-term safety, tolerability, and efficacy of sotatercept (MK-7962, formerly called ACE-011) in participants with Pulmonary Arterial Hypertension (PAH). This open-label, long-term follow-up (LTFU) study is supported by data from the PULSAR study (Phase 2, NCT03496207) in which treatment with sotatercept resulted in hemodynamic and functional improvements in the study participants, including those receiving maximal PAH therapy with double/triple drug combinations and intravenous prostacyclin.

The primary objective of this open-label, LTFU study is to evaluate the long-term safety and tolerability of sotatercept when added to background PAH therapy in adult participants with PAH who have completed prior sotatercept studies. The secondary objective is to evaluate continued efficacy in adult participants with PAH who have completed prior sotatercept studies.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Participants eligible to enroll in this study will have participated in and completed the relevant study requirements of the parent PAH sotatercept clinical studies.

Participants enrolled in this study may be eligible to participate in MK-7962-038 (NCT number pending), an open-label LTFU study to evaluate the effects of sotatercept when added to background PAH therapy.

Study Type

Interventional

Enrollment (Estimated)

815

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, B1629AHJ
        • Hospital Universitario Austral ( Site 1901)
      • Cordoba, Argentina, X5000JHQ
        • Sanatorio Allende ( Site 1908)
      • Santa Fe, Argentina, S3000EOZ
        • Hospital Dr. Jose Maria Cullen ( Site 1902)
    • Buenos Aires
      • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1425BNG
        • Cardiologia Palermo ( Site 1911)
      • Quilmes, Buenos Aires, Argentina, 1878
        • Instituto de Investigaciones Clinicas Quilmes ( Site 1903)
    • Caba
      • Ciudad Autonoma de Buenos Aires, Caba, Argentina, C1426ABP
        • Centro Medico Dra De Salvo ( Site 1904)
    • Cordoba
      • Córdoba, Cordoba, Argentina, 5003DCE
        • Instituto Médico DAMIC ( Site 1909)
      • Rio Cuarto, Cordoba, Argentina, X5800AEV
        • Instituto Médico Río Cuarto ( Site 1907)
    • Santa Fe
      • Rosario, Santa Fe, Argentina, 2002
        • Hospital Provincial del Centenario ( Site 1912)
      • Rosario, Santa Fe, Argentina, S2000DSR
        • Instituto Cardiovascular de Rosario ( Site 1906)
      • Rosario, Santa Fe, Argentina, S2000DVC
        • Centro Oncologico de Rosario ( Site 1905)
  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Royal Prince Alfred Hospital ( Site 1106)
      • Darlinghurst, New South Wales, Australia, 2010
        • Saint Vincents Hospital Sydney ( Site 1102)
      • New Lambton, New South Wales, Australia, 2305
        • John Hunter Hospital ( Site 1101)
    • Queensland
      • Brisbane, Queensland, Australia, 4032
        • The Prince Charles Hospital ( Site 1104)
      • Woolloongabba, Queensland, Australia, 4102
        • Princess Alexandra Hospital ( Site 1108)
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital ( Site 1109)
    • Tasmania
      • Hobart, Tasmania, Australia, 7000
        • Royal Hobart Hospital ( Site 1107)
    • Western Australia
      • Perth, Western Australia, Australia, 6150
        • Fiona Stanley Hospital ( Site 1103)
  • Austria
      • Wien, Austria, 1090
        • Medizinische Universitat Wien ( Site 2001)
    • Oberosterreich
      • Linz, Oberosterreich, Austria, 4020
        • Ordensklinikum Linz GmbH Elisabethinen ( Site 2002)
    • Steiermark
      • Graz, Steiermark, Austria, 8036
        • Medizinische Universität Graz ( Site 2003)
    • Tirol
      • Innsbruck, Tirol, Austria, 6020
        • Medizinische Universitat Innsbruck ( Site 2004)
  • Belgium
    • Bruxelles-Capitale, Region De
      • Bruxelles, Bruxelles-Capitale, Region De, Belgium, 1070
        • Erasme Hospital ( Site 1402)
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • UZ Leuven - Campus Gasthuisberg ( Site 1401)
  • Brazil
      • Sao Paulo, Brazil, 05403-000
        • Instituto do Coracao - HCFMUSP ( Site 1803)
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30430-142
        • Hospital Madre Teresa ( Site 1804)
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-074
        • Irmandade da Santa Casa de Misericordia de Porto Alegre ( Site 1805)
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
        • Hospital São Lucas da PUCRS ( Site 1801)
    • Santa Catarina
      • Blumenau, Santa Catarina, Brazil, 89010-000
        • Hospital Dia do Pulmao ( Site 1802)
    • Sao Paulo
      • São Paulo, Sao Paulo, Brazil, 04038-031
        • Hospital Sao Paulo ( Site 1806)
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T1Y 6J4
        • Peter Lougheed Centre ( Site 2102)
      • Edmonton, Alberta, Canada, T6G 2B7
        • University of Alberta Hospital ( Site 2101)
    • Manitoba
      • Winnepeg, Manitoba, Canada, R2H 2A6
        • St Boniface General Hospital ( Site 2106)
    • Ontario
      • Hamilton, Ontario, Canada, L8N 1A6
        • St. Joseph's Healthcare Hamilton ( Site 2105)
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Sir Mortimer B Davis Jewish General Hospital ( Site 2103)
  • Colombia
    • Antioquia
      • Medellin, Antioquia, Colombia, 50034
        • Centro Cardiovascular Colombiano Clínica Santa María Clínica Cardio VID ( Site 3402)
    • Cundinamarca
      • Bogota, Cundinamarca, Colombia, 110131
        • Fundación Neumológica Colombiana ( Site 3403)
    • Valle Del Cauca
      • Cali, Valle Del Cauca, Colombia, 760032
        • Fundacion Valle Del Lili ( Site 3401)
      • Santiago de Cali, Valle Del Cauca, Colombia, 760042
        • Centro Medico Imbanaco de Cali S.A ( Site 3404)
  • Croatia
    • Splitsko-dalmatinska Zupanija
      • Split, Splitsko-dalmatinska Zupanija, Croatia, 21000
        • Klinicki Bolnicki Centar Split ( Site 3901)
    • Zagrebacka Zupanija
      • Zagreb, Zagrebacka Zupanija, Croatia, 10000
        • Klinicki Bolnicki Centar Zagreb ( Site 3902)
  • Czechia
      • Praha 2, Czechia, 128 08
        • Vseobecna fakultni nemocnice v Praze-Centrum srdečního selhání ( Site 2201)
      • Praha 4, Czechia, 140 21
        • Institut klinicke a experimentalni mediciny (IKEM) ( Site 2202)
  • Denmark
    • Hovedstaden
      • København Ø, Hovedstaden, Denmark, 2100
        • Rigshospitalet ( Site 3802)
    • Midtjylland
      • Aarhus, Midtjylland, Denmark, 8200
        • Aarhus Universitetshospital, Skejby ( Site 3801)
  • France
    • Alpes-Maritimes
      • Nice, Alpes-Maritimes, France, 06001
        • Centre Hospitalier Universitaire de Nice - Hopital Pasteur ( Site 1311)
    • Bas-Rhin
      • Strasbourg, Bas-Rhin, France, 67000
        • Hopital Civil - CHU Strasbourg ( Site 1307)
    • Calvados
      • Caen, Calvados, France, 14033
        • CHU Caen Normandie ( Site 1325)
    • Finistere
      • Brest, Finistere, France, 29200
        • Hopital Cavale Blanche ( Site 1314)
    • Gironde
      • Pessac, Gironde, France, 33600
        • Groupe Hospitalier Sud ( Site 1312)
    • Haute-Garonne
      • Toulouse, Haute-Garonne, France, 31059
        • CHU de Toulouse - Hopital Larrey ( Site 1315)
    • Herault
      • Montpellier, Herault, France, 34295
        • Hôpital Arnaud de Villeneuve - CHU Montpellier ( Site 1301)
    • Indre-et-Loire
      • Tours, Indre-et-Loire, France, 37000
        • C.H.U. de Tours - Hopital Bretonneau ( Site 1310)
    • Isere
      • La Tronche, Isere, France, 38700
        • C.H.U de Grenoble - Hopital Albert Michallon ( Site 1303)
    • Loire
      • Saint-Priest-en-Jarez, Loire, France, 42270
        • Centre Hospitalier Universitaire de Saint-Etienne ( Site 1302)
    • Loire-Atlantique
      • Nantes, Loire-Atlantique, France, 44000
        • Hopital Nord Laennec ( Site 1309)
    • Maine-et-Loire
      • Angers, Maine-et-Loire, France, 49933
        • CHU Angers ( Site 1313)
    • Meurthe-et-Moselle
      • Vandoeuvre Les Nancy, Meurthe-et-Moselle, France, 54500
        • C.H.U. de Nancy. Hopital de Brabois Adultes ( Site 1308)
    • Nord
      • Lille, Nord, France, 59037
        • CHRU Lille ( Site 1306)
    • Rhone-Alpes
      • Bron, Rhone-Alpes, France, 69677
        • Hôpital Louis Pradel - Service Endocrino, Diabeto, Nutrition ( Site 1317)
    • Val-de-Marne
      • Le Kremlin Bicetre, Val-de-Marne, France, 94270
        • CHU - Hopital de Bicetre ( Site 1304)
    • Vienne
      • Poitiers, Vienne, France, 86021
        • CHU de la Miletrie Poitiers ( Site 1316)
  • Germany
      • Berlin, Germany, 14050
        • DRK Kliniken Berlin Westend ( Site 1507)
    • Baden-Wurttemberg
      • Heidelberg, Baden-Wurttemberg, Germany, 69126
        • Thoraxklinik-Heidelberg gGmbH ( Site 1509)
    • Bayern
      • München, Bayern, Germany, 80639
        • Krankenhaus Neuwittelsbach ( Site 1510)
      • Regensburg, Bayern, Germany, 93053
        • Universitaetsklinik Regensburg ( Site 1503)
    • Hessen
      • Gießen, Hessen, Germany, 35392
        • Universitätsklinikum Gießen und Marburg GmbH ( Site 1512)
    • Niedersachsen
      • Hannover, Niedersachsen, Germany, 30625
        • Medizinische Hochschule Hannover ( Site 1505)
    • Nordrhein-Westfalen
      • Cologne, Nordrhein-Westfalen, Germany, 50931
        • Universitätsklinik Köln ( Site 1511)
    • Saarland
      • Homburg, Saarland, Germany, 66424
        • Universataet des Saarlandes ( Site 1513)
    • Sachsen
      • Dresden, Sachsen, Germany, 01307
        • Universitaetsklinikum Carl Gustav Carus der TU Dresden ( Site 1501)
      • Leipzig, Sachsen, Germany, 04103
        • Universitätsklinikum Leipzig ( Site 1508)
    • Sachsen-Anhalt
      • Halle, Sachsen-Anhalt, Germany, 06120
        • Universitätsklinikum Halle ( Site 1502)
  • Greece
      • Thessaloniki, Greece, 546 36
        • AHEPA University General Hospital of Thessaloniki ( Site 3601)
    • Attiki
      • Athens, Attiki, Greece, 176 74
        • Onassis Cardiac Surgery Center ( Site 3602)
      • Athens, Attiki, Greece, 124 62
        • Attikon University General Hospital of Athens ( Site 3604)
      • Athina, Attiki, Greece, 106 76
        • Evangelismos General Hospital of Athens ( Site 3605)
  • Israel
      • Ashdod, Israel, 7747629
        • Assuta Ashdod Medical Center ( Site 1710)
      • Ashkelon, Israel, 7830604
        • Barzilai Medical Center ( Site 1708)
      • Haifa, Israel, 3436212
        • Lady Davis Carmel Medical Center ( Site 1705)
      • Jerusalem, Israel, 9112001
        • Hadassah Medical Center ( Site 1711)
      • Kfar Saba, Israel, 4428164
        • Meir Medical Center. ( Site 1707)
      • Petach Tikvah, Israel, 49100
        • Rabin Medical Center ( Site 1703)
      • Ramat Gan, Israel, 5265601
        • Sheba MC ( Site 1701)
  • Italy
      • Napoli, Italy, 80131
        • Azienda Ospedaliera dei Colli V. Monaldi ( Site 2407)
      • Roma, Italy, 00161
        • Universita "La Sapienza" Policlinico Umberto I ( Site 2402)
    • Friuli-Venezia Giulia
      • Trieste, Friuli-Venezia Giulia, Italy, 34149
        • Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) ( Site 2405)
    • Lombardia
      • Milano, Lombardia, Italy, 20123
        • Ospedale S. Giuseppe Multimedica ( Site 2403)
      • Monza, Lombardia, Italy, 20900
        • Fondazione IRCCS San Gerardo dei Tintori - ASST di Monza - A. O. San Gerardo ( Site 2406)
  • Korea, Republic of
      • Incheon, Korea, Republic of, 21565
        • Gachon University Gil Medical Center ( Site 3103)
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital ( Site 3102)
      • Seoul, Korea, Republic of, 06351
        • Samsung Medical Center ( Site 3106)
      • Seoul, Korea, Republic of, 06591
        • The Catholic University Seoul St. Mary's Hospital ( Site 3104)
    • Kyonggi-do
      • Gwangju, Kyonggi-do, Korea, Republic of, 61469
        • Chonnam National University Hospital ( Site 3105)
  • Mexico
      • Huixquilucan, Mexico, 52763
        • Hospital Angeles Lomas ( Site 2501)
    • Distrito Federal
      • Ciudad de Mexico, Distrito Federal, Mexico, 14080
        • Instituto Nacional de Cardiologia Ignacio Chavez ( Site 2503)
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 64460
        • Hospital Universitario ""Dr. Jose Eleuterio Gonzalez"" ( Site 2504)
      • Sertoma, Nuevo Leon, Mexico, 64718
        • Unidad de Investigación Clínica en Medicina, S.C ( Site 2505)
  • Netherlands
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6500 HB
        • Radboud University Nijmegen Medical Centre ( Site 2605)
    • Limburg
      • Maastricht, Limburg, Netherlands, 6229 HX
        • Maastricht University Medical Center ( Site 2603)
    • Noord-Holland
      • Amsterdam, Noord-Holland, Netherlands, 1081 HV
        • VU Medisch Centrum ( Site 2601)
    • Zuid-Holland
      • Rotterdam, Zuid-Holland, Netherlands, 3015 GJ
        • Erasmus MC ( Site 2604)
  • New Zealand
      • Auckland, New Zealand, 1051
        • Greenlane Clinical Centre ( Site 2703)
    • Waikato
      • Hamilton, Waikato, New Zealand, 3240
        • Waikato District Health Board ( Site 2702)
  • Poland
    • Malopolskie
      • Krakow, Malopolskie, Poland, 31-202
        • Krakowski Szpital Specjalistyczny im. Jana Pawla II ( Site 2801)
    • Mazowieckie
      • Otwock, Mazowieckie, Poland, 05-400
        • Europejskie Centrum Zdrowia Otwock Szpital im Fryderyka Chopina ( Site 2802)
  • Portugal
      • Coimbra, Portugal, 3000-075
        • Centro Hospitalar E Universitário De Coimbra ( Site 3502)
      • Lisboa, Portugal, 1769-001
        • Centro Hospitalar Lisboa Norte E.P.E. - Hospital Pulido Valente ( Site 3503)
    • Setubal
      • Almada, Setubal, Portugal, 2801-951
        • Hospital Garcia de Orta ( Site 3501)
  • Serbia
      • Beograd, Serbia, 11000
        • Clinical Center of Serbia ( Site 2901)
      • Beograd, Serbia, 11040
        • Institute of Cardiovascular Diseases Dedinje ( Site 2903)
    • Juznobacki Okrug
      • Sremska kamenica, Juznobacki Okrug, Serbia, 21204
        • Institute for pulmonary diseases of Vojvodina ( Site 2906)
    • Nisavski Okrug
      • Nis, Nisavski Okrug, Serbia, 18000
        • University Clinical Center Nis ( Site 2904)
    • Sumadijski Okrug
      • Kragujevac, Sumadijski Okrug, Serbia, 34000
        • Clinical Center Kragujevac ( Site 2905)
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic de Barcelona ( Site 1602)
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron ( Site 1605)
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre ( Site 1603)
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz ( Site 1610)
      • Madrid, Spain, 28048
        • Hospital Universitario Ramon y Cajal ( Site 1609)
      • Salamanca, Spain, 37007
        • Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca ( Site 1608)
      • Toledo, Spain, 41007
        • Hospital Universitario de Toledo ( Site 1607)
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Hospital Universitario Marques de Valdecilla ( Site 1601)
    • Islas Baleares
      • Palma de Mallorca, Islas Baleares, Spain, 07120
        • Hospital Universitario de Son Espases ( Site 1611)
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Hospital Universitario Puerta de Hierro-Majadahonda ( Site 1604)
  • Sweden
    • Skane Lan
      • Lund, Skane Lan, Sweden, 22185
        • Skanes Universitetssjukhus Lund ( Site 3203)
    • Uppsala Lan
      • Uppsala, Uppsala Lan, Sweden, 751 85
        • Akademiska Sjukhuset [Uppsala, Sweden] ( Site 3204)
    • Vasterbottens Lan
      • Umea, Vasterbottens Lan, Sweden, 90185
        • Norrlands Universitetssjukhus ( Site 3205)
    • Vastra Gotalands Lan
      • Goteborg, Vastra Gotalands Lan, Sweden, 413 45
        • Sahlgrenska Universitetssjukhuset ( Site 3201)
  • Switzerland
      • Zurich, Switzerland, 8091
        • Universitaetsspital Zurich ( Site 3301)
  • Taiwan
      • Kaohsiung, Taiwan, 813
        • Kaohsiung Veterans General Hospital ( Site 3702)
      • Taichung, Taiwan, 40447
        • China Medical University Hospital ( Site 3701)
      • Tainan, Taiwan, 704
        • National Cheng Kung University Hospital ( Site 3703)
  • United Kingdom
      • Newcastle Upon Tyne, United Kingdom, NE7 7DN
        • The Newcastle Upon Tyne NHS Foundation Trust ( Site 1205)
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB23 3RE
        • Royal Papworth Hospital ( Site 1208)
    • England
      • London, England, United Kingdom, SW3 6HP
        • Royal Brompton Hospital ( Site 1206)
    • Glasgow City
      • Glasgow, Glasgow City, United Kingdom, G81 4HX
        • Golden Jubilee National Hospital ( Site 1204)
    • London, City Of
      • London, London, City Of, United Kingdom, W2 1NY
        • Imperial College Healthcare NHS Trust ( Site 1203)
      • London, London, City Of, United Kingdom, NW3 2QG
        • Royal Free London NHS Foundation Trust ( Site 1202)
    • North Yorkshire
      • Sheffield, North Yorkshire, United Kingdom, S10 2JF
        • Royal Hallamshire Hospital ( Site 1207)
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • Pulmonary Associates, PA ( Site 1008)
      • Scottsdale, Arizona, United States, 85258
        • Arizona Pulmonary Specialists ( Site 1010)
      • Tucson, Arizona, United States, 85724-0001
        • University of Arizona ( Site 1006)
    • California
      • La Jolla, California, United States, 92037
        • University of California San Diego ( Site 1002)
      • Los Angeles, California, United States, 90095
        • David Geffen School of Medicine at UCLA ( Site 1068)
      • Orange, California, United States, 92868
        • University of California Irvine ( Site 1086)
      • Sacramento, California, United States, 95817-2201
        • UC Davis - Medial Center ( Site 1064)
      • San Francisco, California, United States, 94143-2202
        • University of California San Francisco ( Site 1019)
      • Santa Barbara, California, United States, 93105-5311
        • Jeffrey S.Sager MD Medical Corporation ( Site 1060)
      • Torrance, California, United States, 90502-2006
        • Harbor UCLA Medical Center ( Site 1028)
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Hospital ( Site 1013)
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • The George Washington University Medical Faculty Associates ( Site 1025)
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic Jacksonville - PPDS ( Site 1045)
      • Orlando, Florida, United States, 32803
        • AdventHealth Orlando ( Site 1058)
      • Tampa, Florida, United States, 33612
        • University of South Florida ( Site 1043)
    • Georgia
      • Atlanta, Georgia, United States, 30322-1013
        • Emory University ( Site 1030)
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospital and Clinics ( Site 1050)
    • Kentucky
      • Louisville, Kentucky, United States, 40205
        • Norton Pulmonary Specialists ( Site 1066)
    • Maryland
      • Baltimore, Maryland, United States, 21206
        • Johns Hopkins Pulmonary and Critical Care Medicine ( Site 1036)
    • Massachusetts
      • Boston, Massachusetts, United States, 02111-1526
        • Tufts Medical Center - PPDS ( Site 1012)
      • Boston, Massachusetts, United States, 02115
        • Brigham & Women's Hospital ( Site 1014)
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan ( Site 1011)
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota ( Site 1062)
    • Missouri
      • Kansas City, Missouri, United States, 66160
        • University of Kansas Medical Center ( Site 1020)
      • Saint Louis, Missouri, United States, 63108-1495
        • Barnes-Jewish Hospital Center for Outpatient Health ( Site 1022)
    • Nebraska
      • Omaha, Nebraska, United States, 68118
        • University of Nebraska Medical Center ( Site 1053)
    • Nevada
      • Reno, Nevada, United States, 89502-1262
        • Renown Regional Medical Center ( Site 1055)
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • University of New Mexico Health Sciences Center ( Site 1048)
    • New York
      • New York, New York, United States, 10065
        • New York Presbyterian Hospital - Weill Cornell Medical Center ( Site 1046)
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center - PPDS ( Site 1039)
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • The University of North Carolina at Chapel Hill ( Site 1042)
      • Durham, North Carolina, United States, 27710-4000
        • Duke University Medical Center ( Site 1026)
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • The Lindner Center for Research and Education at The Christ Hospital ( Site 1001)
      • Cincinnati, Ohio, United States, 45219
        • University of Cincinnati Medical Center ( Site 1035)
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation ( Site 1065)
      • Columbus, Ohio, United States, 43221
        • The Ohio State University Wexner Medical Center ( Site 1032)
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112-4492
        • Integris Health, Inc. ( Site 1084)
    • Oregon
      • Portland, Oregon, United States, 97239
        • The Oregon Clinic Pulmonary, Critical Care and Sleep Medicine - West ( Site 1054)
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC Presbyterian. UPMC Presbyterian Hospital ( Site 1059)
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital ( Site 1033)
    • South Carolina
      • Mount Pleasant, South Carolina, United States, 29464-3771
        • Medical University of South Carolina - PPDS ( Site 1003)
    • Tennessee
      • Knoxville, Tennessee, United States, 37919
        • Statcare Pulmonary Consultants - Knoxville ( Site 1031)
      • Nashville, Tennessee, United States, 37232-0011
        • Vanderbilt University Medical Center ( Site 1027)
    • Texas
      • Dallas, Texas, United States, 78701
        • University Of Texas Southwestern Medical Center ( Site 1038)
      • Houston, Texas, United States, 77030
        • CHI St. Luke's Health Baylor College of Medicine Medical Center ( Site 1044)
      • Houston, Texas, United States, 77030
        • Houston Methodist Hospital ( Site 1009)
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah - PPDS ( Site 1049)
    • Washington
      • Seattle, Washington, United States, 98195-0001
        • University of Washington Medical Center ( Site 1067)
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Froedtert Hospital & the Medical College of Wisconsin ( Site 1051)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Have completed their current respective PAH sotatercept clinical study and its requirements, and must not have discontinued early
  • Must be willing to adhere to the study visit schedule and understand and comply with all protocol requirements
  • Must have the ability to understand and provide documented informed consent

  • Females of childbearing potential must:

    • Have a negative pregnancy test as verified by the investigator prior to starting study drug administration; she must agree to ongoing pregnancy testing during the course of the study and until 8 weeks after the last dose of the study drug
    • If sexually active, have used, and agree to continue to use highly effective contraception in combination with a barrier method without interruption, for at least 28 days prior to starting the investigational product, during the study (including dose interruptions), and for 16 weeks (112 days) after discontinuation of study drug
    • Refrain from breastfeeding a child or donating blood, eggs, or ovum for the duration of the study and for at least 16 weeks (112 days) after the last dose of study drug

  • Male participants must:

    • Agree to use a condom, defined as a male latex condom or non latex condom NOT made out of natural (animal) membrane (e.g., polyurethane), during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions, and for at least 16 weeks (112 days) following investigational product discontinuation, even if he has undergone a successful vasectomy
    • Refrain from donating blood or sperm for the duration of the study and for 16 weeks (112 days) after the last dose of study drug
  • Must agree not to participate in any other trials of investigational drugs/devices while they are enrolled in the MK-7962-004 study, except for the MK-7962-038 study

Exclusion Criteria:

  • Did not participate in a sotatercept PAH parent study
  • Missed more than the equivalent of 4 consecutive doses between the end of parent study and the start of this study.
  • Presence of an ongoing serious adverse event (SAE) that occurred during a PAH sotatercept clinical study that is assessed to be possibly or probably related to sotatercept
  • Pregnant or breastfeeding females

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sotatercept Treatment
Participants rolling over from a blinded parent study will begin sotatercept at a dose of 0.3 mg/kg subcutaneous (SC) injection for Visit 1. Dose will escalate to 0.7 mg/kg SC injection at Visit 2 through the remainder of the study. Participants rolling over from an unblinded parent study will continue sotatercept at their current dose and, if at a dose <0.7 mg/kg SC injection, can titrate up to 0.7 mg/kg SC injection for the remainder of the study.
Biological: Sotatercept
Sotatercept SC injection at a dose of 0.3 to 0.7 mg/kg.
Other Names:
  • ACE-011
  • MK-7962

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Experience an Adverse Event (AE)
Time Frame: Up to approximately 50 months
AE is any untoward medical occurrence in a clinical investigation participant administered a study drug, which does not necessarily have a causal relationship with this treatment. The number of participants who experience an AE will be reported.
Up to approximately 50 months
Number of Participants Who Discontinue Study Treatment Due to an AE
Time Frame: Up to approximately 50 months
AE is any untoward medical occurrence in a clinical investigation participant administered a study drug, which does not necessarily have a causal relationship with this treatment. The number of participants who discontinue study treatment due to an AE will be reported.
Up to approximately 50 months
Number of Participants with Detectable Anti-Drug Antibodies (ADAs)
Time Frame: Up to approximately 50 months
ADAs will be detected in serum. The number of participants with detectable ADAs will be presented.
Up to approximately 50 months
Laboratory parameters (Hematology): Concentration of Red Blood Cell Count, White Blood Cell Count, Platelet Count, Hemoglobin and Hematocrit
Time Frame: Up to approximately 50 months
Blood samples will be collected to determine concentration of red blood cell count, white blood cell count, platelet count, hemoglobin and hematocrit at designated timepoints up to approximately 50 months.
Up to approximately 50 months
Change From Baseline in Body Weight
Time Frame: Baseline and up to approximately 48 months
Change from baseline in body weight will be reported at designated time points up to approximately 48 months.
Baseline and up to approximately 48 months
Change From Baseline in Blood Pressure
Time Frame: Baseline and up to approximately 48 months
Change from baseline in systolic and diastolic blood pressure will be reported at designated time points up to approximately 48 months.
Baseline and up to approximately 48 months
Change From Baseline in Electrocardiogram (ECG)
Time Frame: Baseline and up to approximately 48 months
Change from baseline in ECG (12-lead) for the determination of QTcF interval will be reported at designated time points up to approximately 48 months.
Baseline and up to approximately 48 months
Laboratory parameters (Chemistry): Concentration of Blood Urea, Creatinine, Total Bilirubin, Direct Bilirubin, AST, ALT, ALP, Sodium, Potassium, Chloride, Calcium, Phosphorous, Glucose, Magnesium, Carbon Dioxide, and Albumin
Time Frame: Up to approximately 50 months
Blood samples will be collected to determine concentration of blood urea, creatinine, total bilirubin, direct bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), sodium, potassium, chloride, calcium, phosphorous, glucose, magnesium, carbon dioxide, and albumin at designated time points for up to approximately 50 months.
Up to approximately 50 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in 6-Minute Walk Distance (6MWD)
Time Frame: Baseline and up to approximately 48 months
The 6MWD was the distance walked in 6 minutes as a measure of functional capacity. This was assessed using the 6-minute walk test (6MWT). The change from baseline in 6MWD will be reported.
Baseline and up to approximately 48 months
Change From Baseline in N-Terminal Pro-Hormone B-type Natriuretic Peptide (NT-proBNP) Levels
Time Frame: Baseline and up to approximately 48 months
NT-proBNP is a circulating biomarker that reflects myocardial stretch. The change from baseline in NT-proBNP level will be reported.
Baseline and up to approximately 48 months
Change From Baseline in the Percentage of Participants Who Improve in modified New York Heart Association/World Health Organization Classification of Functional Status (WHO FC)
Time Frame: Baseline and up to approximately 48 months
The severity of participant's PAH symptoms will be graded using the WHO FC system. WHO functional classification for PAH ranges from Class I (no limitation in physical activity, no dyspnea with normal activity), Class II (slight limitation of physical activity), Class III (marked limitation of physical activity) and Class IV (cannot perform a physical activity without any symptoms, dyspnea at rest). Participants who improve in WHO FC were classified into "Improved", "No change" and "Worsened". Improvement = reduction in FC, worsened = increase in FC and no change = no change in FC. The change from baseline in the percentage of participants who improve in WHO FC will be reported.
Baseline and up to approximately 48 months
Change From Baseline in Pulmonary Vascular Resistance (PVR)
Time Frame: Baseline and up to approximately 48 months
PVR is a hemodynamic variable of pulmonary circulation and was measured by right heart catheterization. The change from baseline in PVR will be reported.
Baseline and up to approximately 48 months
Change From Baseline in Percentage of Participants Who Maintain or Achieve a Low Risk Score Using the Simplified French Risk Score Calculator
Time Frame: Baseline and up to approximately 48 months
The simplified French risk scoring system was based on the 2015 European Society of Cardiology/European Respiratory Society guidelines for the diagnosis and treatment of pulmonary hypertension. In this study, the noninvasive parameters were used to determine the score. 'Low risk' was defined as attaining or maintaining all 3 low-risk criteria: WHO FC I or II, 6MWD > 440 m, and NT-proBNP <300 ng/L. The change from baseline in percentage of participants who maintained or achieved a low risk score using the simplified French risk score calculator will be reported.
Baseline and up to approximately 48 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 12, 2021

Primary Completion (Estimated)

February 27, 2026

Study Completion (Estimated)

February 27, 2026

Study Registration Dates

First Submitted

February 22, 2021

First Submitted That Met QC Criteria

March 11, 2021

First Posted (Actual)

March 12, 2021

Study Record Updates

Last Update Posted (Actual)

July 11, 2025

Last Update Submitted That Met QC Criteria

July 8, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7962-004
  • A011-12 (Other Identifier: Acceleronpharma)
  • 2020-005061-13 (EudraCT Number)
  • MK-7962-004 (Other Identifier: MSD)
  • U1111-1309-6218 (Registry Identifier: UTN)
  • SOTERIA (Other Identifier: MSD)
  • 2023-509138-21-00 (Registry Identifier: EU CT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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