Pulmonary Arterial Hypertension Clinical Trial
— SOTERIAOfficial title:
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
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.
| Status | Recruiting |
| Enrollment | 700 |
| Est. completion date | November 30, 2027 |
| Est. primary completion date | September 30, 2027 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 Exclusion Criteria: - Did not participate in a sotatercept PAH parent trial - 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 |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Hospital Universitario Austral ( Site 1901) | Buenos Aires | |
| Argentina | Cardiologia Palermo ( Site 1911) | Ciudad Autonoma de Buenos Aires | Buenos Aires |
| Argentina | Centro Medico Dra De Salvo ( Site 1904) | Ciudad Autonoma de Buenos Aires | Caba |
| Argentina | Sanatorio Allende ( Site 1908) | Cordoba | |
| Argentina | Instituto Médico DAMIC ( Site 1909) | Córdoba | Cordoba |
| Argentina | Instituto de Investigaciones Clinicas Quilmes ( Site 1903) | Quilmes | Buenos Aires |
| Argentina | Instituto Medico Rio Cuarto ( Site 1907) | Rio Cuarto | Cordoba |
| Argentina | Centro Oncologico de Rosario ( Site 1905) | Rosario | Santa Fe |
| Argentina | Hospital Provincial del Centenario ( Site 1912) | Rosario | Santa Fe |
| Argentina | Instituto Cardiovascular de Rosario ( Site 1906) | Rosario | Santa Fe |
| Argentina | Hospital Dr. Jose Maria Cullen ( Site 1902) | Santa Fe | |
| Australia | Royal Adelaide Hospital ( Site 1109) | Adelaide | South Australia |
| Australia | The Prince Charles Hospital ( Site 1104) | Brisbane | Queensland |
| Australia | Royal Prince Alfred Hospital ( Site 1106) | Camperdown | New South Wales |
| Australia | Saint Vincents Hospital Sydney ( Site 1102) | Darlinghurst | New South Wales |
| Australia | Royal Hobart Hospital ( Site 1107) | Hobart | Tasmania |
| Australia | John Hunter Hospital ( Site 1101) | New Lambton | New South Wales |
| Australia | Fiona Stanley Hospital ( Site 1103) | Perth | Western Australia |
| Australia | Princess Alexandra Hospital ( Site 1108) | Woolloongabba | Queensland |
| Austria | Medizinische Universität Graz ( Site 2003) | Graz | Steiermark |
| Austria | Medizinische Universitat Innsbruck ( Site 2004) | Innsbruck | Tirol |
| Austria | Ordensklinikum Linz GmbH Elisabethinen ( Site 2002) | Linz | Oberosterreich |
| Austria | Medizinische Universitat Wien ( Site 2001) | Wien | |
| Belgium | Erasme Hospital ( Site 1402) | Bruxelles | Bruxelles-Capitale, Region De |
| Belgium | UZ Leuven - Campus Gasthuisberg ( Site 1401) | Leuven | Vlaams-Brabant |
| Brazil | Hospital Madre Teresa ( Site 1804) | Belo Horizonte | Minas Gerais |
| Brazil | Hospital Dia do Pulmao ( Site 1802) | Blumenau | Santa Catarina |
| Brazil | Hospital São Lucas da PUCRS ( Site 1801) | Porto Alegre | Rio Grande Do Sul |
| Brazil | Irmandade da Santa Casa de Misericórdia de Porto Alegre ( Site 1805) | Porto Alegre | Rio Grande Do Sul |
| Brazil | Instituto do Coracao - HCFMUSP ( Site 1803) | Sao Paulo | |
| Brazil | Hospital Sao Paulo ( Site 1806) | São Paulo | Sao Paulo |
| Canada | University of Alberta Hospital ( Site 2101) | Edmonton | Alberta |
| Canada | St. Joseph's Healthcare Hamilton ( Site 2105) | Hamilton | Ontario |
| Canada | Sir Mortimer B Davis Jewish General Hospital ( Site 2103) | Montreal | Quebec |
| Canada | St Boniface General Hospital ( Site 2106) | Winnepeg | Manitoba |
| Colombia | Fundacion Neumologica Colombiana ( Site 3403) | Bogota | Cundinamarca |
| Colombia | Fundacion Valle del Lili ( Site 3401) | Cali | Valle Del Cauca |
| Colombia | Centro Cardiovascular Colombiano Clínica Santa María Clínica Cardio VID ( Site 3402) | Medellin | Antioquia |
| Colombia | Centro Medico Imbanaco de Cali S.A ( Site 3404) | Santiago de Cali | Valle Del Cauca |
| Croatia | Klinicki Bolnicki Centar Split ( Site 3901) | Split | Splitsko-dalmatinska Zupanija |
| Croatia | Klinicki Bolnicki Centar Zagreb ( Site 3902) | Zagreb | Zagrebacka Zupanija |
| Czechia | Vseobecna fakultni nemocnice v Praze-Centrum srdecního selhání ( Site 2201) | Praha 2 | |
| Czechia | Institut klinicke a experimentalni mediciny (IKEM) ( Site 2202) | Praha 4 | |
| Denmark | Aarhus Universitetshospital, Skejby ( Site 3801) | Aarhus | Midtjylland |
| Denmark | Rigshospitalet ( Site 3802) | København Ø | Hovedstaden |
| France | CHU Angers ( Site 1313) | Angers | Maine-et-Loire |
| France | Hopital Cavale Blanche ( Site 1314) | Brest | Finistere |
| France | Hôpital Louis Pradel - Service Endocrino, Diabeto, Nutrition ( Site 1317) | Bron | Rhone-Alpes |
| France | Hopital cote de Nacre ( Site 1325) | Caen | Calvados |
| France | C.H.U de Grenoble - Hopital Albert Michallon ( Site 1303) | La Tronche | Isere |
| France | CHU - Hopital de Bicetre ( Site 1304) | Le Kremlin Bicetre | Val-de-Marne |
| France | CHRU Lille ( Site 1306) | Lille | Nord |
| France | Hôpital Arnaud de Villeneuve - CHU Montpellier ( Site 1301) | Montpellier | Herault |
| France | Hopital Nord Laennec ( Site 1309) | Nantes | Loire-Atlantique |
| France | Centre Hospitalier Universitaire de Nice - Hopital Pasteur ( Site 1311) | Nice | Alpes-Maritimes |
| France | Groupe Hospitalier Sud ( Site 1312) | Pessac | Gironde |
| France | CHU de la Miletrie Poitiers ( Site 1316) | Poitiers | Vienne |
| France | Centre Hospitalier Universitaire de Saint-Etienne ( Site 1302) | Saint-Priest-en-Jarez | Loire |
| France | Hopital Civil - CHU Strasbourg ( Site 1307) | Strasbourg | Bas-Rhin |
| 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 | C.H.U. de Nancy. Hopital de Brabois Adultes ( Site 1308) | Vandoeuvre Les Nancy | Meurthe-et-Moselle |
| Germany | DRK Kliniken Berlin Westend ( Site 1507) | Berlin | |
| Germany | Universitätsklinik Köln ( Site 1511) | Cologne | Nordrhein-Westfalen |
| Germany | Universitaetsklinikum Carl Gustav Carus der TU Dresden ( Site 1501) | Dresden | Sachsen |
| Germany | Universitätsklinikum Gießen und Marburg GmbH ( Site 1512) | Gießen | Hessen |
| Germany | Universitätsklinikum Halle ( Site 1502) | Halle | Sachsen-Anhalt |
| Germany | Medizinische Hochschule Hannover ( Site 1505) | Hannover | Niedersachsen |
| Germany | Thoraxklinik-Heidelberg gGmbH ( Site 1509) | Heidelberg | Baden-Wurttemberg |
| Germany | Universataet des Saarlandes ( Site 1513) | Homburg | Saarland |
| Germany | Universitatsklinikum Leipzig ( Site 1508) | Leipzig | Sachsen |
| Germany | Krankenhaus Neuwittelsbach ( Site 1510) | München | Bayern |
| Germany | Universitaetsklinik Regensburg ( Site 1503) | Regensburg | Bayern |
| Greece | Attikon University General Hospital of Athens ( Site 3604) | Athens | Attiki |
| Greece | Onassis Cardiac Surgery Center ( Site 3602) | Athens | Attiki |
| Greece | Evangelismos General Hospital of Athens ( Site 3605) | Athina | Attiki |
| Greece | AHEPA University General Hospital of Thessaloniki ( Site 3601) | Thessaloniki | |
| Israel | Assuta Ashdod Medical Center ( Site 1710) | Ashdod | |
| Israel | Barzilai Medical Center ( Site 1708) | Ashkelon | |
| Israel | Lady Davis Carmel Medical Center ( Site 1705) | Haifa | |
| Israel | Hadassah Medical Center ( Site 1711) | Jerusalem | |
| Israel | Meir Medical Center ( Site 1707) | Kfar Saba | |
| Israel | Rabin Medical Center ( Site 1703) | Petach Tikvah | |
| Israel | Sheba MC ( Site 1701) | Ramat Gan | |
| Italy | Ospedale S. Giuseppe Multimedica ( Site 2403) | Milano | Lombardia |
| Italy | Fondazione IRCCS San Gerardo dei Tintori - ASST di Monza - A. O. San Gerardo ( Site 2406) | Monza | Lombardia |
| Italy | Azienda Ospedaliera dei Colli V. Monaldi ( Site 2407) | Napoli | |
| Italy | Universita "La Sapienza" Policlinico Umberto I ( Site 2402) | Roma | |
| Italy | Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) ( Site 2405) | Trieste | Friuli-Venezia Giulia |
| Korea, Republic of | Chonnam National University Hospital ( Site 3105) | Gwangju | Kyonggi-do |
| Korea, Republic of | Gachon University Gil Medical Center ( Site 3103) | Incheon | |
| Korea, Republic of | Samsung Medical Center ( Site 3106) | Seoul | |
| Korea, Republic of | Seoul National University Hospital ( Site 3102) | Seoul | |
| Korea, Republic of | The Catholic University Seoul St. Mary's Hospital ( Site 3104) | Seoul | |
| Mexico | Instituto Nacional de Cardiologia Ignacio Chavez ( Site 2503) | Ciudad de Mexico | Distrito Federal |
| Mexico | Hospital Angeles Lomas ( Site 2501) | Huixquilucan | |
| Mexico | Hospital Universitario ""Dr. Jose Eleuterio Gonzalez"" ( Site 2504) | Monterrey | Nuevo Leon |
| Mexico | Unidad de Investigación Clínica en Medicina, S.C ( Site 2505) | Sertoma | Nuevo Leon |
| Netherlands | VU Medisch Centrum ( Site 2601) | Amsterdam | Noord-Holland |
| Netherlands | Maastricht University Medical Center ( Site 2603) | Maastricht | Limburg |
| Netherlands | Radboud University Nijmegen Medical Centre ( Site 2605) | Nijmegen | Gelderland |
| Netherlands | Erasmus MC ( Site 2604) | Rotterdam | Zuid-Holland |
| New Zealand | Greenlane Clinical Centre ( Site 2703) | Auckland | |
| New Zealand | Waikato District Health Board ( Site 2702) | Hamilton | Waikato |
| Poland | Krakowski Szpital Specjalistyczny im. Jana Pawla II ( Site 2801) | Krakow | Malopolskie |
| Poland | Europejskie Centrum Zdrowia Otwock Szpital im Fryderyka Chopina ( Site 2802) | Otwock | Mazowieckie |
| Portugal | Hospital Garcia de Orta ( Site 3501) | Almada | Setubal |
| Portugal | Centro Hospitalar E Universitário De Coimbra ( Site 3502) | Coimbra | |
| Portugal | Centro Hospitalar Lisboa Norte E.P.E. - Hospital Pulido Valente ( Site 3503) | Lisboa | |
| Serbia | Clinical Center of Serbia ( Site 2901) | Beograd | |
| Serbia | Institute of Cardiovascular Diseases Dedinje ( Site 2903) | Beograd | |
| Serbia | Clinical Center Kragujevac ( Site 2905) | Kragujevac | Sumadijski Okrug |
| Serbia | University Clinical Center Nis ( Site 2904) | Nis | Nisavski Okrug |
| Serbia | Institute for pulmonary diseases of Vojvodina ( Site 2906) | Sremska kamenica | Juznobacki Okrug |
| Spain | Hospital Clinic de Barcelona ( Site 1602) | Barcelona | |
| Spain | Hospital Universitari Vall d'Hebron ( Site 1605) | Barcelona | |
| Spain | Hospital Universitario 12 de Octubre ( Site 1603) | Madrid | |
| Spain | Hospital Universitario La Paz ( Site 1610) | Madrid | |
| Spain | Hospital Universitario Ramon y Cajal ( Site 1609) | Madrid | |
| Spain | Hospital Universitario Puerta de Hierro-Majadahonda ( Site 1604) | Majadahonda | Madrid |
| Spain | Hospital Universitario de Son Espases ( Site 1611) | Palma de Mallorca | Islas Baleares |
| Spain | Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca ( Site 1608) | Salamanca | |
| Spain | Hospital Universitario Marques de Valdecilla ( Site 1601) | Santander | Cantabria |
| Spain | Hospital Universitario de Toledo ( Site 1607) | Toledo | |
| Sweden | Sahlgrenska Universitetssjukhuset ( Site 3201) | Goteburg | Vastra Gotalands Lan |
| Sweden | Skanes Universitetssjukhus Lund ( Site 3203) | Lund | Skane Lan |
| Sweden | Norrlands Universitetssjukhus ( Site 3205) | Umea | Vasterbottens Lan |
| Sweden | Akademiska Sjukhuset [Uppsala, Sweden] ( Site 3204) | Uppsala | Uppsala Lan |
| Switzerland | Universitaetsspital Zurich ( Site 3301) | Zurich | |
| Taiwan | Kaohsiung Veterans General Hospital ( Site 3702) | Kaohsiung | |
| Taiwan | China Medical University Hospital ( Site 3701) | Taichung | |
| Taiwan | National Cheng Kung University Hospital ( Site 3703) | Tainan | |
| United Kingdom | Royal Papworth Hospital ( Site 1208) | Cambridge | Cambridgeshire |
| United Kingdom | Golden Jubilee National Hospital ( Site 1204) | Glasgow | Glasgow City |
| United Kingdom | Imperial College Healthcare NHS Trust ( Site 1203) | London | London, City Of |
| United Kingdom | Royal Brompton Hospital ( Site 1206) | London | England |
| United Kingdom | Royal Free London NHS Foundation Trust ( Site 1202) | London | London, City Of |
| United Kingdom | The Newcastle Upon Tyne NHS Foundation Trust ( Site 1205) | Newcastle Upon Tyne | |
| United Kingdom | Royal Hallamshire Hospital ( Site 1207) | Sheffield | North Yorkshire |
| United States | University of New Mexico Health Sciences Center ( Site 1048) | Albuquerque | New Mexico |
| United States | University of Michigan ( Site 1011) | Ann Arbor | Michigan |
| United States | Emory University ( Site 1030) | Atlanta | Georgia |
| United States | University of Colorado Hospital ( Site 1013) | Aurora | Colorado |
| United States | Johns Hopkins Pulmonary and Critical Care Medicine ( Site 1036) | Baltimore | Maryland |
| United States | Brigham & Women's Hospital ( Site 1014) | Boston | Massachusetts |
| United States | Tufts Medical Center - PPDS ( Site 1012) | Boston | Massachusetts |
| United States | The University of North Carolina at Chapel Hill ( Site 1042) | Chapel Hill | North Carolina |
| United States | The Lindner Center for Research and Education at The Christ Hospital ( Site 1001) | Cincinnati | Ohio |
| United States | University of Cincinnati Medical Center ( Site 1035) | Cincinnati | Ohio |
| United States | The Ohio State University Wexner Medical Center ( Site 1032) | Columbus | Ohio |
| United States | University of Texas Southwestern Medical Center ( Site 1038) | Dallas | Texas |
| United States | Duke University Medical Center ( Site 1026) | Durham | North Carolina |
| United States | CHI St. Luke's Health Baylor College of Medicine Medical Center ( Site 1044) | Houston | Texas |
| United States | Houston Methodist Hospital ( Site 1009) | Houston | Texas |
| United States | University of Iowa Hospital and Clinics ( Site 1050) | Iowa City | Iowa |
| United States | Mayo Clinic Jacksonville - PPDS ( Site 1045) | Jacksonville | Florida |
| United States | University of Kansas Medical Center ( Site 1020) | Kansas City | Missouri |
| United States | Statcare Pulmonary Consultants - Knoxville ( Site 1031) | Knoxville | Tennessee |
| United States | University of California San Diego ( Site 1002) | La Jolla | California |
| United States | David Geffen School of Medicine at UCLA ( Site 1068) | Los Angeles | California |
| United States | Norton Pulmonary Specialists ( Site 1066) | Louisville | Kentucky |
| United States | Froedtert Hospital & the Medical College of Wisconsin ( Site 1051) | Milwaukee | Wisconsin |
| United States | University of Minnesota ( Site 1062) | Minneapolis | Minnesota |
| United States | Medical University of South Carolina - PPDS ( Site 1003) | Mount Pleasant | South Carolina |
| United States | Vanderbilt University Medical Center ( Site 1027) | Nashville | Tennessee |
| United States | New York Presbyterian Hospital - Weill Cornell Medical Center ( Site 1046) | New York | New York |
| United States | Integris Health, Inc. ( Site 1084) | Oklahoma City | Oklahoma |
| United States | University of Nebraska Medical Center ( Site 1053) | Omaha | Nebraska |
| United States | University of California Irvine ( Site 1086) | Orange | California |
| United States | AdventHealth Orlando ( Site 1058) | Orlando | Florida |
| United States | Arizona Pulmonary Specialists ( Site 1010) | Phoenix | Arizona |
| United States | Pulmonary Associates, PA ( Site 1008) | Phoenix | Arizona |
| United States | UPMC Presbyterian. UPMC Presbyterian Hospital ( Site 1059) | Pittsburgh | Pennsylvania |
| United States | The Oregon Clinic Pulmonary, Critical Care and Sleep Medicine - West ( Site 1054) | Portland | Oregon |
| United States | Rhode Island Hospital ( Site 1033) | Providence | Rhode Island |
| United States | Renown Regional Medical Center ( Site 1055) | Reno | Nevada |
| United States | University of Rochester Medical Center - PPDS ( Site 1039) | Rochester | New York |
| United States | UC Davis - Medial Center ( Site 1064) | Sacramento | California |
| United States | Barnes-Jewish Hospital Center for Outpatient Health ( Site 1022) | Saint Louis | Missouri |
| United States | University of Utah - PPDS ( Site 1049) | Salt Lake City | Utah |
| United States | University of California San Francisco ( Site 1019) | San Francisco | California |
| United States | Jeffrey S.Sager MD Medical Corporation ( Site 1060) | Santa Barbara | California |
| United States | University of Washington Medical Center ( Site 1067) | Seattle | Washington |
| United States | University of South Florida ( Site 1043) | Tampa | Florida |
| United States | Harbor UCLA Medical Center ( Site 1028) | Torrance | California |
| United States | University of Arizona ( Site 1006) | Tucson | Arizona |
| United States | Cleveland Clinic Foundation ( Site 1065) | Twinsburg | Ohio |
| United States | The George Washington University Medical Faculty Associates ( Site 1025) | Washington | District of Columbia |
| Lead Sponsor | Collaborator |
|---|---|
| Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA |
United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Colombia, Croatia, Czechia, Denmark, France, Germany, Greece, Israel, Italy, Korea, Republic of, Mexico, Netherlands, New Zealand, Poland, Portugal, Serbia, Spain, Sweden, Switzerland, Taiwan, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Participants Who Experience an Adverse Event (AE) | 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 | |
| Primary | Number of Participants Who Discontinue Study Treatment Due to an AE | 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 | |
| Primary | Number of Participants with Detectable Anti-Drug Antibodies (ADAs) | ADAs will be detected in serum. The number of participants with detectable ADAs will be presented. | Up to approximately 50 months | |
| Primary | Laboratory parameters (Hematology): Concentration of Red Blood Cell Count, White Blood Cell Count, Platelet Count, Hemoglobin and Hematocrit | 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 | |
| Primary | Laboratory parameters (Serum Chemistry): Concentration of Blood Urea, Creatinine, Total Bilirubin, Direct Bilirubin, AST, ALT, ALP, Sodium, Potassium, Chloride, Calcium, Phosphorous, Glucose, Magnesium, Carbon Dioxide, and Albumin | 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 | |
| Primary | Laboratory parameter: Concentration of Follicle Stimulating Hormone (FSH) | Blood samples will be collected to determine concentration of FSH level at designated time points up to approximately 50 months. | Up to approximately 50 months | |
| Primary | Change From Baseline in Body Weight | 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 | |
| Primary | Change From Baseline in Blood Pressure | 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 | |
| Primary | Change From Baseline in Electrocardiogram (ECG) | 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 | |
| Primary | Laboratory parameters (Urinalysis): pH, Specific Gravity, Protein, Glucose, Bilirubin, Ketones, Blood, Leukocyte Esterase, Urobilinogen, and Nitrite | Urine samples will be collected to determine pH, specific gravity, protein, glucose, bilirubin, ketones, blood, leukocyte esterase, urobilinogen, and nitrite at designated timepoints up to approximately 48 months. | Up to approximately 48 months | |
| Secondary | Change From Baseline in 6-Minute Walk Distance (6MWD) | 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 | |
| Secondary | Change From Baseline in N-Terminal Pro-Hormone B-type Natriuretic Peptide (NT-proBNP) Levels | 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 | |
| Secondary | Change From Baseline in the Percentage of Participants Who Improve in modified New York Heart Association (NYHA)/ World Health Organization classification of functional status (WHO FC) | The severity of participant's pulmonary arterial hypertension (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 | |
| Secondary | Change From Baseline in Pulmonary Vascular Resistance (PVR) | PVR is a hemodynamic variable of pulmonary circulation and was measured by right heart catheterization (RHC). The change from baseline in PVR will be reported. | Baseline and up to approximately 48 months | |
| Secondary | Overall Survival (OS) | Overall survival is defined as the time from the start of the first sotatercept treatment in the individual participant's parent study or in this study, if the participant was completely on placebo in the parent study, to the date of death in this study, regardless of the actual cause of the participant's death. | Up to approximately 78 months | |
| Secondary | Change From Baseline in Percentage of Participants Who Maintain or Achieve a Low Risk Score Using the Simplified French Risk Score Calculator | The simplified French risk scoring system was based on the 2015 European Society of Cardiology (ESC)/European Respiratory Society (ERS) guidelines for the diagnosis and treatment of pulmonary hypertension (PH). 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 | |
| Secondary | Change From Baseline in Borg Dyspnea Scale Category Ratio 10 (Borg CR 10) Score | The Borg CR 10 Scale assesses the severity of shortness of breath as perceived by the participant. Participants will be asked: How much difficulty is your breathing causing you right now?". The score of the item ranges from 0 (no difficulty in breathing) to10 (maximum difficulty in breathing). Higher score indicates more severe dyspnea. The change from baseline in Borg CR10 scale score will be reported. | Baseline and up to approximately 48 months |
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