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| ID | Type | Description | Link |
|---|---|---|---|
| A011-13 | Other Identifier | Acceleronpharma | |
| MK-7962-005 | Other Identifier | MSD | |
| 2023-509139-16-00 | Registry Identifier | EU CT | |
| U1111-1309-6312 | Registry Identifier | UTN | |
| 2021-000199-12 | EudraCT Number |
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Study was stopped early due to loss of clinical equipoise based on robust evidence of clinical benefit of sotatercept demonstrated in previous studies.
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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.
This is a phase 3, randomized, double-blind, placebo-controlled study to evaluate sotatercept when added to background PAH therapy in newly diagnosed intermediate- or high risk PAH participants.
Participants enrolled in the study will have a diagnosis within 12 months of study screening of symptomatic PAH (World Health Organization [WHO] Group 1, classified as functional class [FC] II or III) and presentation of idiopathic or heritable PAH, PAH associated with connective tissue diseases (CTD), drug- or toxin- induced PAH, post shunt correction PAH, or PAH presenting at least 1 year following the correction of congenital heart defects.
As of Amendment 11, this study will be closed so that all eligible participants can receive sotatercept either on the MK-7962-004 extension study (SOTERIA, NCT04796337) or by commercial access, if available. All eligible participants will complete the end of treatment visit before enrollment in the extension study or initiation of commercial product. Participants not enrolling into the extension study or initiating commercial product will complete the end of study visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sotatercept plus background PAH therapy | Experimental | Participants received sotatercept at a starting dose of 0.3 mg/kg, with a target dose of 0.7 mg/kg, subcutaneously (SC) every 21 days plus background PAH therapy. |
|
| Placebo plus background therapy | Placebo Comparator | Participants received placebo SC every 21 days plus background PAH therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sotatercept | Drug | SC injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Median Time to Clinical Worsening | Time to clinical worsening (TTCW) is defined as time from randomization to the first confirmed morbidity event or death. Clinical worsening events are defined as all-cause death, non-planned PAH-related hospitalization of ≥ 24 hours in duration, atrial septostomy, lung transplant, and/or deterioration in performance in 6-minute walk test from baseline combined with one of the following conditions: worsening of WHO FC from baseline, signs/symptoms of increased right heart failure, addition of a background PAH therapy or change in the background PAH therapy delivery route to parenteral. All events were adjudicated by a blinded, independent committee of clinical experts. The median TTCW is presented. | Up to ~35 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving the Multicomponent Improvement Endpoint of 6-Minute Walk Distance (6MWD), N-terminal Prohormone B-type Natriuretic Peptide (NT-ProBNP) WHO FC | The multicomponent improvement outcome measure is determined by the percentage of participants achieving all of the following at Week 24 relative to baseline:
|
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Inclusion Criteria:
Inclusion criteria include but are not limited to:
Documented diagnostic right heart catheterization (RHC) within 12 months of screening documenting a minimum pulmonary vascular resistance (PVR) of ≥ 4 Wood units and pulmonary capillary wedge pressure (PCWP) or left ventricular end-diastolic pressure (LVEDP) of ≤ 15 mmHg, with the diagnosis of WHO PAH Group 1 in any of the following subtypes:
Symptomatic PAH classified as World Health Organization (WHO) Functional Class (FC) II or III
Either Registry to Evaluate Early and Long-term PAH Disease Management (REVEAL) Lite 2 Risk Score ≥ 6 or Comparative, Prospective Registry of Newly Initiated Therapies for Pulmonary Hypertension (COMPERA) 2.0 risk score ≥2 (intermediate to-low-risk or above)
Diagnosis of PAH within 12 months of screening and on stable doses of a double or triple combination of background PAH therapies and diuretics (if any) for at least 90 days prior to screening
Six-minute walk distance ≥ 150 m repeated twice at screening at least 4 hours apart, but no longer than 1 week apart, and both values are within 15% of each other (calculated from the highest value)
Females of childbearing potential must meet the following criteria:
Male participants must meet the following criteria:
Exclusion Criteria:
Exclusion Criteria include but are not limited to:
Diagnosis of pulmonary hypertension (PH) WHO Groups 2, 3, 4, or 5
Diagnosis of the following PAH Group 1 subtypes: human immunodeficiency virus (HIV)-associated PAH and PAH associated with portal hypertension, schistosomiasis-associated PAH, pulmonary veno occlusive disease, and pulmonary capillary hemangiomatosis
Hemoglobin at screening above gender-specific upper limit of normal (ULN), per local laboratory test
Uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure (BP) > 180 mmHg or sitting diastolic BP > 110 mmHg during the Screening Visit after a period of rest
Baseline systolic BP < 90 mmHg at screening
Pregnant or breastfeeding women
Any of the following clinical laboratory values at the Screening Visit:
Currently enrolled in or have completed any other investigational product study within 30 days for small molecule drugs or within 5 half-lives for investigational biologics prior to the date of documented informed consent
Known allergic reaction to sotatercept (ACE-011), its excipients, or luspatercept
History of pneumonectomy
Pulmonary function test values of forced vital capacity < 60% predicted within 1 year prior to the Screening Visit
Stopped receiving any PH chronic general supportive therapy (e.g., diuretics, oxygen, anticoagulants, and digoxin) within 60 days prior to the Screening Visit
Initiation of an exercise program for cardiopulmonary rehabilitation within 90 days prior to the Screening Visit or planned initiation during the study (participants who are stable in the maintenance phase of a program and who will continue for the duration of the study are eligible)
Untreated more than mild obstructive sleep apnea
History of known pericardial constriction
History of restrictive or congestive cardiomyopathy
History of atrial septostomy within 180 days prior to the Screening Visit
Electrocardiogram with Fridericia's corrected QT interval > 500 ms during the Screening Period
Personal or family history of long QT syndrome or sudden cardiac death
Left ventricular ejection fraction < 50% on historical echocardiogram (ECHO) within 1 year prior to the Screening Visit
Any current or prior history of symptomatic coronary disease (prior myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft surgery, or cardiac anginal chest pain) in the past 6 months prior to the Screening Visit
Cerebrovascular accident within 3 months prior to the Screening Visit
Acutely decompensated heart failure within 30 days prior to the Screening Visit, as per investigator assessment
Significant (≥ 2+ regurgitation) mitral regurgitation or aortic regurgitation valvular disease
Received intravenous inotropes (e.g., dobutamine, dopamine, norepinephrine, and vasopressin) within 30 days prior to the Screening Visit
Has an active malignancy with the exception of fully excised or treated basal cell carcinoma, cervical carcinoma in-situ, or prostate cancer that is not currently or expected, during the study, to be treated with radiation therapy, chemotherapy, and/or surgical intervention, or hormonal treatment
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Pulmonary Specialists ( Site 1010) | Scottsdale | Arizona | 85258 | United States | ||
| University of Arizona ( Site 1006) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41025556 | Derived | McLaughlin VV, Hoeper MM, Badesch DB, Ghofrani HA, Gibbs JSR, Gomberg-Maitland M, Preston IR, Souza R, Waxman AB, Kopec G, Meyer G, Olsson KM, Fu W, Shi Y, Miller B, Kim SS, Mackenzie HS, Brambatti M, Patel MJ, Koglin J, Cornell AG, Humbert M; HYPERION Trial Investigators. Sotatercept for Pulmonary Arterial Hypertension within the First Year after Diagnosis. N Engl J Med. 2025 Oct 23;393(16):1599-1611. doi: 10.1056/NEJMoa2508170. Epub 2025 Sep 30. |
| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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Of the 321 participants who were randomized, one participant was randomized but withdrew from study before receiving study intervention. This participant, who was randomized to the sotatercept group, had no data collected for study specific baseline characteristics or outcome measures and was excluded from all analysis populations.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sotatercept Plus Background Pulmonary Arterial Hypertension (PAH) Therapy | Participants received sotatercept at a starting dose of 0.3 mg/kg, with a target dose of 0.7 mg/kg, subcutaneously (SC) every 21 days plus background PAH therapy. |
| FG001 | Placebo Plus Background PAH Therapy |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 17, 2024 |
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Double-blind
| Placebo | Other | Placebo-matched SC injection |
|
| Baseline and Week 24 |
| Percentage of Participants Who Maintained or Achieved a Low Registry to Evaluate Early and Long Term PAH Disease Management (REVEAL) Lite 2 Risk Score | REVEAL Lite 2.0 risk scoring is used to guide PAH treatment decisions. Total score uses 6 variables with each assessed based on contribution to mortality risk. Variables and sub-score ranges: estimated glomerular filtration rate [eGFR] (0, +1), WHO FC (-1, 0, +1, +2), SBP (0, +1), heart rate (0, +1), 6MWD (-2, -1, 0, +1), and NT-proBNP (-2, 0, +2). Sub-scores are added to a base score of +6 and a total score of 1 to 14 is obtained (≤5=low risk; 6,7=intermediate risk; ≥8=high risk). A higher score = higher risk. Per SAP, participants who did not have a REVEAL risk score at Week 24 were considered as non-responders and multiple imputation was not conducted for this endpoint. Comparisons between this analysis reporting non-imputed data should not be made to other REVEAL analyses which included imputation of missing Week 24 data. The percentage of participants who maintained or achieved a low REVEAL Lite 2.0 score at Week 24 is reported. | Baseline and Week 24 |
| Percentage of Participants Who Maintained or Achieved a Low Simplified French Risk Score | The simplified French Risk Score uses WHO FC, 6MWD, and NT-proBNP to determine the total risk score. A low risk score can be defined as attaining or maintaining all three low-risk criteria: WHO FC I or II, 6MWD > 440m, and NT-proBNP < 300 ng/L. The percentage of participants who maintained or achieved a low risk score at Week 24 versus baseline using the simplified French Risk score calculator is presented. | Baseline and Week 24 |
| Median Change From Baseline in NT-proBNP Levels at Week 24 | NT-proBNP is a circulating biomarker that reflects myocardial stretch and is an established biomarker used to determine the ventricular dysfunction in participants with PAH. NT-proBNP was measured at Day 1 (baseline) and at Week 24. The median change from baseline in NT-proBNP at Week 24 is presented. | Baseline and Week 24 |
| Percentage of Participants Who Improved in WHO FC or Maintained WHO FC II at 24 Weeks From Baseline | The severity of an individual's PAH symptoms was graded using the WHO FC system. WHO functional classification for PAH range 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). The change from baseline in WHO FC is classified into "Improved", "No change" and "Worsened". Improvement = reduction in FC, worsened = increase in FC and no change = no change in FC. The percentage of participants who improved in WHO FC or maintained WHO FC II at 24 Weeks from Baseline is presented. | Baseline and Week 24 |
| Median Change From Baseline in Six-Minute Walk Distance (6MWD) | The 6-minute walk distance (6MWD) was measured using the 6-Minute Walk Test (6MWT). The 6MWT measures the distance covered in 6 minutes and is intended to measure changes in functional exercise capacity. Each participant's 6MWD was measured at baseline and at 24 weeks. An increase in the distance walked during the 6MWT indicated improvement in functional exercise capacity. Median change from baseline in 6MWD at Week 24 is reported. | Baseline and Week 24 |
| Overall Survival (OS) | Overall survival is defined as the time from randomization to date of death due to any cause. OS is presented. | Up to ~35 Months |
| Mean Change From Baseline in the Physical Impacts Domain Score of Pulmonary Arterial Hypertension Symptoms and Impact (PAH-SYMPACT)® | The PAH SYMPACT is a 23-item questionnaire to measure pulmonary arterial hypertension (PAH)-related symptoms and impact of PAH on daily life. The physical impact domain consists of walking slowly on a flat surface, walking quickly on a flat surface, walking uphill, carrying things, doing light indoor household chores, washing, or dressing oneself, and needing help from others. Participants were asked to recall and report on each item experienced in past 7 days. Score for each item ranges from 0 (not difficult at all) to 4 (extremely difficult). A domain score was calculated by summing the individual responses for each item and dividing by the number of impact items (range: 0=no physical impact to 4=severe physical impact). A higher score indicated more severe physical impact. Mean change from baseline in responses in physical symptoms of the PAH-SYMPACT questionnaire at Week 24 is reported. | Baseline and Week 24 |
| Mean Change From Baseline in the Cardiopulmonary Symptoms Domain Score of PAH-SYMPACT® | The PAH SYMPACT is a 23-item questionnaire to measure PAH-related symptoms and impact of PAH on daily life. The cardiopulmonary symptoms consist of shortness of breath, fatigue, lack of energy, swelling in the ankles or legs, swelling in the stomach area, and cough. Participants were asked to recall and report on each item experienced in past 7 days. Score for each item ranges from 0 (no symptom at all) to 4 (very severe symptoms). The mean individual symptom item score was determined for each of the 6 items and a domain score was calculated by summing the mean individual symptom item scores and dividing by the number of items (range: 0=no cardiopulmonary symptoms to 4=severe cardiopulmonary symptoms). A higher score indicated more severe symptoms experienced. Mean change from baseline in cardiopulmonary symptoms of the PAH-SYMPACT questionnaire at Week 24 is reported. | Baseline and Week 24 |
| Mean Change From Baseline in the Cognitive/Emotional Impacts Domain Score of PAH-SYMPACT® | The PAH SYMPACT is a 23-item questionnaire to measure PAH-related symptoms and impact of PAH on daily life. The Cognitive/Emotional Impact domain consists of thinking clearly, feeling sad, feeling worried, and feeling frustrated. Participants were asked to recall and report on each item experienced in past 7 days. Score for each item ranges from 0 (not difficult at all) to 4 (extremely difficult). A domain score was calculated by summing the individual responses for each item and dividing by the number of impact items (range: 0=no cognitive/emotional impact to 4=severe cognitive/emotional impact). A higher score indicated more severe cognitive/emotional impact. Mean change from baseline in responses in the Cognitive/Emotional Impacts Domain Score of the PAH-SYMPACT questionnaire at Week 24 is reported. | Baseline and Week 24 |
| Percentage of Participants Who Experience an Adverse Event (AE) | An 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug whether or not it is considered related to the study drug. The percentage of participants who experienced an AE are presented. | Up to ~35 Months |
| Percentage of Participants Who Discontinued Study Treatment Due to AEs | An 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug whether or not it is considered related to the study drug. The percentage of participants who discontinued study treatment due to an AE are presented. | Up to ~35 months |
| Number of Participants Who Had Anti-drug Antibodies (ADAs) to Sotatercept | Blood samples collected at designated timepoints were used to determine the ADA response to sotatercept. The number of participants who had ADAs to sotatercept over time is presented. | Up to ~35 Months |
| Tucson |
| Arizona |
| 85724 |
| United States |
| University of California San Diego ( Site 1002) | La Jolla | California | 92037 | United States |
| UCLA Medical Center ( Site 1068) | Los Angeles | California | 90095 | United States |
| University of California Irvine ( Site 1086) | Orange | California | 92868 | United States |
| Santa Barbara Pulmonary Associates ( Site 1060) | Santa Barbara | California | 93105-5316 | United States |
| University of California Davis Medical Center ( Site 1064) | Sherman Oaks | California | 95817 | United States |
| University of Colorado Hospital ( Site 1013) | Aurora | Colorado | 80045 | United States |
| AdventHealth Medical Group Advanced Lung Disease ( Site 1058) | Orlando | Florida | 32804 | United States |
| University of Iowa Hospital and Clinics ( Site 1050) | Iowa City | Iowa | 52242 | United States |
| Johns Hopkins Hospital ( Site 1036) | Baltimore | Maryland | 21287-0005 | United States |
| Tufts Medical Center - PPDS ( Site 1014) | Boston | Massachusetts | 02111-1526 | United States |
| Boston Medical Center ( Site 1012) | Boston | Massachusetts | 02118 | United States |
| University of Michigan ( Site 1011) | Ann Arbor | Michigan | 48109 | United States |
| University of Kansas Medical Center ( Site 1020) | Kansas City | Missouri | 66160 | United States |
| Washington University School of Medicine ( Site 1022) | St Louis | Missouri | 63110 | United States |
| University of New Mexico, Health Sciences Center ( Site 1048) | Albuquerque | New Mexico | 87131 | United States |
| NYU Langone Health ( Site 1052) | New York | New York | 10016-9196 | United States |
| University of North Carolina at Chapel Hill ( Site 1042) | Chapel Hill | North Carolina | 27514 | United States |
| The Carl and Edyth Lindner Center for Research and Education at the Christ Hospital ( Site 1001) | Cincinnati | Ohio | 45219 | United States |
| University of Cincinnati ( Site 1035) | Cincinnati | Ohio | 45219 | United States |
| The Cleveland Clinic Foundation Taussig Cancer Center ( Site 1065) | Cleveland | Ohio | 44195 | United States |
| Nazih Zuhdi Transplantation Institute ( Site 1084) | Oklahoma City | Oklahoma | 73112-4421 | United States |
| Oregon Health & Science University ( Site 1054) | Portland | Oregon | 97239 | United States |
| Medical University of South Carolina ( Site 1003) | Charleston | South Carolina | 29425-8900 | United States |
| Vanderbilt University Medical Center ( Site 1027) | Nashville | Tennessee | 37232 | United States |
| University of Texas Southwestern Medical Center ( Site 1038) | Dallas | Texas | 78701 | United States |
| University of Utah ( Site 1049) | Salt Lake City | Utah | 84132-0001 | United States |
| Cardiologia Palermo ( Site 1911) | Ciudad Autonoma de Buenos Aires | Buenos Aires | C1425BNG | Argentina |
| Centro Medico Dra De Salvo ( Site 1904) | Ciudad Autonoma de Buenos Aires | Buenos Aires | C1426ABP | Argentina |
| Hospital Universitario Austral ( Site 1901) | Pilar | Buenos Aires | B1629ODT | Argentina |
| Instituto de Investigaciones Clinicas Quilmes ( Site 1903) | Quilmes | Buenos Aires | 1878 | Argentina |
| Instituto De Enfermedades Respiratorias E Investigacion Medica ( Site 1910) | Villa Vatteone | Buenos Aires | B1853AIK | Argentina |
| Instituto Médico DAMIC ( Site 1909) | Córdoba | Córdoba Province | 5003DCE | Argentina |
| Instituto Medico Rio Cuarto ( Site 1907) | Río Cuarto | Córdoba Province | X5800AEV | Argentina |
| Hospital Provincial del Centenario ( Site 1912) | Rosario | Santa Fe Province | 2002 | Argentina |
| Instituto Cardiovascular de Rosario ( Site 1906) | Rosario | Santa Fe Province | S2000DSR | Argentina |
| Sanatorio Parque ( Site 1905) | Rosario | Santa Fe Province | S2000DSV | Argentina |
| Sanatorio Allende ( Site 1908) | Córdoba | X5021FPQ | Argentina |
| Hospital Provincial Dr. Jose M. Cullen ( Site 1902) | Santa Fe | S3000EOZ | Argentina |
| Royal Prince Alfred Hospital ( Site 1106) | Camperdown | New South Wales | 2050 | Australia |
| John Hunter Hospital ( Site 1101) | Newcastle | New South Wales | 2308 | Australia |
| Prince Charles Hospital ( Site 1104) | Chermside | Queensland | 4032 | Australia |
| Princess Alexandra Hospital ( Site 1108) | Woolloongabba | Queensland | 4102 | Australia |
| Royal Adelaide Hospital ( Site 1109) | Adelaide | South Australia | 5000 | Australia |
| Royal Hobart Hospital ( Site 1107) | Hobart | Tasmania | 7000 | Australia |
| Fiona Stanley Hospital ( Site 1103) | Murdoch | Western Australia | 6150 | Australia |
| Medizinische Universitat Wien ( Site 2001) | Vienna | State of Vienna | 1090 | Austria |
| Medizinische Universität Graz ( Site 2003) | Graz | Styria | 8036 | Austria |
| Medizinische Universitat Innsbruck ( Site 2004) | Innsbruck | Tyrol | 6020 | Austria |
| Ordensklinikum Linz GmbH Elisabethinen ( Site 2002) | Linz | Upper Austria | 4020 | Austria |
| Hopital Erasme ( Site 1402) | Anderlecht | Bruxelles-Capitale, Region de | 1070 | Belgium |
| UZ Gasthuisberg ( Site 1401) | Leuven | Vlaams-Brabant | 3000 | Belgium |
| Hospital Madre Teresa ( Site 1804) | Belo Horizonte | Minas Gerais | 30430-142 | Brazil |
| Irmandade da Santa Casa de Misericordia de Porto Alegre ( Site 1805) | Porto Alegre | Rio Grande do Sul | 90020-090 | Brazil |
| Hospital Sao Paulo ( Site 1806) | São Paulo | São Paulo | 04038-031 | Brazil |
| Instituto do Coracao - HCFMUSP ( Site 1803) | São Paulo | 05403-000 | Brazil |
| University of Alberta Hospital ( Site 2101) | Edmonton | Alberta | T6G 2B7 | Canada |
| St Boniface General Hospital ( Site 2106) | Winnepeg | Manitoba | R2H 2A6 | Canada |
| McMaster University - HSC ( Site 2105) | Hamilton | Ontario | L8N 4A6 | Canada |
| Sir Mortimer B Davis Jewish General Hospital ( Site 2103) | Montreal | Quebec | H3T 1E2 | Canada |
| Centro Cardiovascular Colombiano Clínica Santa María Clínica Cardio VID ( Site 3402) | Medellín | Antioquia | 50034 | Colombia |
| Fundacion Neumologica Colombiana ( Site 3403) | Bogota | Cundinamarca | 110131 | Colombia |
| Fundacion Valle Del Lili ( Site 3401) | Cali | Valle del Cauca Department | 760032 | Colombia |
| Centro Medico Imbanaco de Cali S.A ( Site 3404) | Cali | Valle del Cauca Department | 760042 | Colombia |
| University Hospital Centre Split city ( Site 3901) | Split | Split-Dalmatia County | 21000 | Croatia |
| Klinicki Bolnicki Centar Zagreb ( Site 3902) | Zagreb | Zagreb County | 10000 | Croatia |
| Institut Klinicke a Experimentalni Mediciny ( Site 2202) | Prague | Praha 4 | 140 21 | Czechia |
| Vseobecna fakultni nemocnice v Praze ( Site 2201) | Prague | 128 08 | Czechia |
| Rigshospitalet ( Site 3802) | København Ø | Capital Region | 2100 | Denmark |
| Aarhus Universitetshospital, Skejby ( Site 3801) | Aarhus | Central Jutland | 8200 | Denmark |
| Hopital Louis Pasteur ( Site 1311) | Nice | Alpes-Maritimes | 06001 | France |
| Hopital Louis Pradel ( Site 1317) | Lyon | Auvergne | 69003 | France |
| Hopitaux Universitaires de Strasbourg ( Site 1307) | Strasbourg | Bas-Rhin | 67000 | France |
| Hopital Cavale Blanche ( Site 1314) | Brest | Brittany Region | 29200 | France |
| CHU Caen Normandie ( Site 1325) | Caen | Calvados | 14033 | France |
| CHU de Besancon ( Site 1303) | Besançon | Doubs | 25000 | France |
| Hopital Haut Leveque ( Site 1312) | Bordeaux | Gironde | 33604 | France |
| CHU de Toulouse - Hopital Larrey ( Site 1315) | Toulouse | Haute-Garonne | 31059 | France |
| C.H.U. de Tours - Hopital Bretonneau ( Site 1310) | Tours | Indre-et-Loire | 37000 | France |
| Hopital Nord Laennec ( Site 1309) | Nantes | Loire-Atlantique | 44000 | France |
| CHU Angers ( Site 1313) | Angers | Maine-et-Loire | 49933 | France |
| C.H.U. de Nancy. Hopital de Brabois Adultes ( Site 1308) | Vandœuvre-lès-Nancy | Meurthe-et-Moselle | 54500 | France |
| Centre Hospitalier Universitaire de Saint-Etienne ( Site 1302) | Saint-Priest-en-Jarez | Pays de la Loire Region | 42270 | France |
| CHU - Hopital de Bicetre ( Site 1304) | Le Kremlin-Bicêtre | Val-de-Marne | 94270 | France |
| CHU de Poitiers ( Site 1316) | Poitiers | Vienne | 86000 | France |
| Universitaetsklinikum Heidelberg ( Site 1509) | Heidelberg | Baden-Wurttemberg | 69120 | Germany |
| Krankenhaus Neuwittelsbach ( Site 1510) | Munich | Bavaria | 80639 | Germany |
| Universitaetsklinik Regensburg ( Site 1503) | Regensburg | Bavaria | 93053 | Germany |
| Medizinische Hochschule Hannover ( Site 1505) | Hanover | Lower Saxony | 30625 | Germany |
| Universitaetsklinikum Giessen und Marburg GmbH ( Site 1512) | Bad Oeynhausen | North Rhine-Westphalia | 35392 | Germany |
| Uniklinik Köln ( Site 1511) | Cologne | North Rhine-Westphalia | 50937 | Germany |
| Universitatsklinikum des Saarlandes ( Site 1513) | Homburg | Saarland | 66421 | Germany |
| Universitaetsklinikum Carl Gustav Carus ( Site 1501) | Dresden | Saxony | 01307 | Germany |
| Universitatsklinikum Leipzig ( Site 1508) | Leipzig | Saxony | 04103 | Germany |
| Universitaetsklinik und Poliklinik Halle/Saale ( Site 1502) | Halle | Saxony-Anhalt | 06120 | Germany |
| DRK Kliniken Berlin Westend ( Site 1507) | Berlin | 14050 | Germany |
| Evangelismos General Hospital of Athens ( Site 3605) | Athens | Attica | 106 76 | Greece |
| Onassis Cardiac Surgery Center ( Site 3602) | Athens | Attica | 176 74 | Greece |
| Attikon University General Hospital of Athens ( Site 3604) | Haidari | Attica | 124 62 | Greece |
| AHEPA University General Hospital of Thessaloniki ( Site 3601) | Thessaloniki | 546 36 | Greece |
| Assuta Ashdod Medical Center ( Site 1710) | Ashdod | 7747629 | Israel |
| Lady Davis Carmel Medical Center ( Site 1705) | Haifa | 3436212 | Israel |
| Hadassah Medical Center ( Site 1711) | Jerusalem | 9112001 | Israel |
| Sheba Medical Center ( Site 1701) | Tel Litwinsky | 52621 | Israel |
| Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) ( Site 2405) | Trieste | Friuli Venezia Giulia | 34149 | Italy |
| Ospedale S. Giuseppe Multimedica ( Site 2403) | Milan | Lombardy | 20123 | Italy |
| Azienda Ospedaliera San Gerardo di Monza ( Site 2406) | Monza | Monza E Brianza | 20900 | Italy |
| Azienda Ospedaliera R. N. V. Monaldi ( Site 2407) | Naples | 80131 | Italy |
| La Sapienza-Università di Roma-Policlinico Umberto I ( Site 2402) | Roma | 161 | Italy |
| Radboud University Nijmegen Medical Centre ( Site 2605) | Nijmegen | Gelderland | 6500 HB | Netherlands |
| Maastricht University Medical Center ( Site 2603) | Maastricht | Limburg | 6229 HX | Netherlands |
| VU Medisch Centrum ( Site 2601) | Amsterdam | North Holland | 1081 HV | Netherlands |
| Erasmus MC ( Site 2604) | Rotterdam | South Holland | 3015 GD | Netherlands |
| Waikato District Health Board ( Site 2702) | Hamilton | Waikato Region | 3204 | New Zealand |
| Krakowski Szpital Specjalistyczny im. Jana Pawla II ( Site 2801) | Krakow | Lesser Poland Voivodeship | 31-202 | Poland |
| Instytut Gruzlicy i Chorob Pluc w Warszawie ( Site 2802) | Warsaw | Masovian Voivodeship | 01-138 | Poland |
| Hospital Garcia de Orta ( Site 3501) | Almada | Setúbal District | 2801-951 | Portugal |
| Centro Hospitalar E Universitário De Coimbra ( Site 3502) | Coimbra | 3000-075 | Portugal |
| Hospital Pulido Valente ( Site 3503) | Lisbon | 1769-001 | Portugal |
| Institute for pulmonary diseases of Vojvodina ( Site 2906) | Kamenitz | Juznobacki Okrug | 21204 | Serbia |
| University Clinical Center Nis ( Site 2904) | Niš | Nisavski Okrug | 18000 | Serbia |
| Clinical Center Kragujevac ( Site 2905) | Kragujevac | Sumadijski Okrug | 34000 | Serbia |
| Clinical Center of Serbia ( Site 2901) | Belgrade | 11000 | Serbia |
| Gachon University Gil Medical Center ( Site 3103) | Namdong-Gu | Incheon | 21565 | South Korea |
| Chonnam National University Hospital ( Site 3105) | Gwangju | Kyonggi-do | 61469 | South Korea |
| Samsung Medical Center ( Site 3106) | Seuol | Seoul | 06351 | South Korea |
| Seoul National University Hospital ( Site 3102) | Seoul | 03080 | South Korea |
| Severance Hospital Yonsei University Health System - PPDS ( Site 3101) | Seoul | 03722 | South Korea |
| The Catholic University of Korea St. Mary s Hospital ( Site 3104) | Seoul | 06591 | South Korea |
| Hospital Universitario de Son Espases ( Site 1611) | Palma de Mallorca | Balearic Islands | 07120 | Spain |
| Hospital Universitario Marques de Valdecilla ( Site 1601) | Santander | Cantabria | 39008 | Spain |
| Hospital Universitario Puerta de Hierro (Majadahonda) ( Site 1604) | Majadahonda | Madrid | 28222 | Spain |
| Hospital Universitari Vall de Hebron ( Site 1605) | Barcelona | 08035 | Spain |
| Hospital Universitario 12 de Octubre ( Site 1603) | Madrid | 28041 | Spain |
| Hospital Universitario La Paz ( Site 1610) | Madrid | 28046 | Spain |
| Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca ( Site 1608) | Salamanca | 37007 | Spain |
| Hospital Virgen de la Salud ( Site 1607) | Toledo | 45004 | Spain |
| Skanes Universitetssjukhus Lund ( Site 3203) | Lund | Skåne County | 22185 | Sweden |
| Hjart-lungmedicin och klinisk fysiologi ( Site 3204) | Uppsala | Uppsala County | 751 85 | Sweden |
| Norrlands Universitetssjukhus ( Site 3205) | Umeå | Västerbotten County | 90185 | Sweden |
| UniversitätsSpital Zürich ( Site 3301) | Zurich | 8091 | Switzerland |
| Kaohsiung Veterans General Hospital ( Site 3702) | Kaohsiung City | 81362 | Taiwan |
| China Medical University Hospital ( Site 3701) | Taichung | 40447 | Taiwan |
| National Cheng Kung University Hospital ( Site 3703) | Tainan | 704 | Taiwan |
| Papworth Hospital NHS Foundation Trust ( Site 1208) | Cambrigge | Cambridgeshire | CB23 0AY | United Kingdom |
| Sheffield Teaching Hospital NHS Foundation Trust ( Site 1207) | Sheffield | Derbyshire | S10 2JF | United Kingdom |
| Golden Jubilee National Hospital ( Site 1204) | Glasgow | Glasgow City | G81 4DY | United Kingdom |
| Royal Free London NHS Foundation Trust ( Site 1202) | London | London, City of | NW3 2QG | United Kingdom |
| Royal Brompton Hospital ( Site 1206) | London | London, City of | SW3 6HP | United Kingdom |
| Imperial College Healthcare NHS Trust ( Site 1203) | London | London, City of | W12 OHS | United Kingdom |
| Freeman Hospital ( Site 1205) | Newcastle upon Tyne | NE7 7DN | United Kingdom |
| Plain Language Summary | View source |
Participants received placebo subcutaneously (SC) every 21 days plus background PAH therapy. |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Sotatercept Plus Background Pulmonary Arterial Hypertension (PAH) Therapy | Participants received sotatercept at a starting dose of 0.3 mg/kg, with a target dose of 0.7 mg/kg, subcutaneously (SC) every 21 days plus background PAH therapy. |
| BG001 | Placebo Plus Background PAH Therapy | Participants received placebo subcutaneously (SC) every 21 days plus background PAH therapy. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| PAH World Health Organization Functional Class (WHO FC) (Class II or III) | Participants were stratified by PAH World Health Organization Functional Class [WHO FC] (II or III), determined at the evaluation taken at Visit one prior to the first dose of intervention. 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). | The analysis population only included participants who started study intervention. | Number | Count of Participants |
| ||||||||||||||
| Background PAH therapy (double or triple therapy) | Participants were stratified by background PAH therapy (double or triple therapy), which may have included the following: endothelin-receptor antagonists, phosphodiesterase inhibitors, soluble guanylate cyclase stimulators and/or prostacyclin analogs or receptor agonists, but does not include diuretics. | The analysis population only includes those participants who started study intervention. | Number | Count of Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Percentage of Participants Achieving the Multicomponent Improvement Endpoint of 6-Minute Walk Distance (6MWD), N-terminal Prohormone B-type Natriuretic Peptide (NT-ProBNP) WHO FC | The multicomponent improvement outcome measure is determined by the percentage of participants achieving all of the following at Week 24 relative to baseline:
| All participants who received at least one dose of study intervention and had baseline and Week 24 data for 6MWD, NT-ProBNP and WHO FC | Posted | Number | Percentage of participants | Baseline and Week 24 |
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| Primary | Median Time to Clinical Worsening | Time to clinical worsening (TTCW) is defined as time from randomization to the first confirmed morbidity event or death. Clinical worsening events are defined as all-cause death, non-planned PAH-related hospitalization of ≥ 24 hours in duration, atrial septostomy, lung transplant, and/or deterioration in performance in 6-minute walk test from baseline combined with one of the following conditions: worsening of WHO FC from baseline, signs/symptoms of increased right heart failure, addition of a background PAH therapy or change in the background PAH therapy delivery route to parenteral. All events were adjudicated by a blinded, independent committee of clinical experts. The median TTCW is presented. | All participants who received at least one dose of study intervention | Posted | Median | 95% Confidence Interval | Months | Up to ~35 months |
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| Secondary | Percentage of Participants Who Maintained or Achieved a Low Registry to Evaluate Early and Long Term PAH Disease Management (REVEAL) Lite 2 Risk Score | REVEAL Lite 2.0 risk scoring is used to guide PAH treatment decisions. Total score uses 6 variables with each assessed based on contribution to mortality risk. Variables and sub-score ranges: estimated glomerular filtration rate [eGFR] (0, +1), WHO FC (-1, 0, +1, +2), SBP (0, +1), heart rate (0, +1), 6MWD (-2, -1, 0, +1), and NT-proBNP (-2, 0, +2). Sub-scores are added to a base score of +6 and a total score of 1 to 14 is obtained (≤5=low risk; 6,7=intermediate risk; ≥8=high risk). A higher score = higher risk. Per SAP, participants who did not have a REVEAL risk score at Week 24 were considered as non-responders and multiple imputation was not conducted for this endpoint. Comparisons between this analysis reporting non-imputed data should not be made to other REVEAL analyses which included imputation of missing Week 24 data. The percentage of participants who maintained or achieved a low REVEAL Lite 2.0 score at Week 24 is reported. | All participants who received at least one dose of study intervention and had data used to calculate the REVEAL Lite 2 risk score for baseline and Week 24 | Posted | Number | Percentage of Participants | Baseline and Week 24 |
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| Secondary | Percentage of Participants Who Maintained or Achieved a Low Simplified French Risk Score | The simplified French Risk Score uses WHO FC, 6MWD, and NT-proBNP to determine the total risk score. A low risk score can be defined as attaining or maintaining all three low-risk criteria: WHO FC I or II, 6MWD > 440m, and NT-proBNP < 300 ng/L. The percentage of participants who maintained or achieved a low risk score at Week 24 versus baseline using the simplified French Risk score calculator is presented. | All participants who received at least one dose of study intervention and had data used to determine the simplified French Risk Score at baseline and Week 24 | Posted | Number | Percentage of Participants | Baseline and Week 24 |
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| Secondary | Median Change From Baseline in NT-proBNP Levels at Week 24 | NT-proBNP is a circulating biomarker that reflects myocardial stretch and is an established biomarker used to determine the ventricular dysfunction in participants with PAH. NT-proBNP was measured at Day 1 (baseline) and at Week 24. The median change from baseline in NT-proBNP at Week 24 is presented. | All participants who received at least one dose of study intervention and had data for NT-proBNP at baseline and Week 24 | Posted | Median | Full Range | pg/mL | Baseline and Week 24 |
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| Secondary | Percentage of Participants Who Improved in WHO FC or Maintained WHO FC II at 24 Weeks From Baseline | The severity of an individual's PAH symptoms was graded using the WHO FC system. WHO functional classification for PAH range 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). The change from baseline in WHO FC is classified into "Improved", "No change" and "Worsened". Improvement = reduction in FC, worsened = increase in FC and no change = no change in FC. The percentage of participants who improved in WHO FC or maintained WHO FC II at 24 Weeks from Baseline is presented. | All participants who received at least one dose of study intervention and have data for WHO FC at baseline and Week 24 | Posted | Number | Percentage of Participants | Baseline and Week 24 |
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| Secondary | Median Change From Baseline in Six-Minute Walk Distance (6MWD) | The 6-minute walk distance (6MWD) was measured using the 6-Minute Walk Test (6MWT). The 6MWT measures the distance covered in 6 minutes and is intended to measure changes in functional exercise capacity. Each participant's 6MWD was measured at baseline and at 24 weeks. An increase in the distance walked during the 6MWT indicated improvement in functional exercise capacity. Median change from baseline in 6MWD at Week 24 is reported. | All participants who received at least one dose of study intervention and had data for 6MWD at baseline and Week 24 | Posted | Median | Full Range | Meters | Baseline and Week 24 |
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| Secondary | Overall Survival (OS) | Overall survival is defined as the time from randomization to date of death due to any cause. OS is presented. | All participants who received at least one dose of study intervention | Posted | Median | 95% Confidence Interval | Months | Up to ~35 Months |
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| Secondary | Mean Change From Baseline in the Physical Impacts Domain Score of Pulmonary Arterial Hypertension Symptoms and Impact (PAH-SYMPACT)® | The PAH SYMPACT is a 23-item questionnaire to measure pulmonary arterial hypertension (PAH)-related symptoms and impact of PAH on daily life. The physical impact domain consists of walking slowly on a flat surface, walking quickly on a flat surface, walking uphill, carrying things, doing light indoor household chores, washing, or dressing oneself, and needing help from others. Participants were asked to recall and report on each item experienced in past 7 days. Score for each item ranges from 0 (not difficult at all) to 4 (extremely difficult). A domain score was calculated by summing the individual responses for each item and dividing by the number of impact items (range: 0=no physical impact to 4=severe physical impact). A higher score indicated more severe physical impact. Mean change from baseline in responses in physical symptoms of the PAH-SYMPACT questionnaire at Week 24 is reported. | All randomized participants who received at least one dose of study treatment and who had data for physical impact domain score at baseline and Week 24 | Posted | Mean | Standard Deviation | Scores on a scale | Baseline and Week 24 |
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| Secondary | Mean Change From Baseline in the Cardiopulmonary Symptoms Domain Score of PAH-SYMPACT® | The PAH SYMPACT is a 23-item questionnaire to measure PAH-related symptoms and impact of PAH on daily life. The cardiopulmonary symptoms consist of shortness of breath, fatigue, lack of energy, swelling in the ankles or legs, swelling in the stomach area, and cough. Participants were asked to recall and report on each item experienced in past 7 days. Score for each item ranges from 0 (no symptom at all) to 4 (very severe symptoms). The mean individual symptom item score was determined for each of the 6 items and a domain score was calculated by summing the mean individual symptom item scores and dividing by the number of items (range: 0=no cardiopulmonary symptoms to 4=severe cardiopulmonary symptoms). A higher score indicated more severe symptoms experienced. Mean change from baseline in cardiopulmonary symptoms of the PAH-SYMPACT questionnaire at Week 24 is reported. | All randomized participants who received at least one dose of study treatment and who had data for cardiopulmonary domain score at baseline and Week 24 | Posted | Mean | Standard Deviation | Scores on a scale | Baseline and Week 24 |
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| Secondary | Mean Change From Baseline in the Cognitive/Emotional Impacts Domain Score of PAH-SYMPACT® | The PAH SYMPACT is a 23-item questionnaire to measure PAH-related symptoms and impact of PAH on daily life. The Cognitive/Emotional Impact domain consists of thinking clearly, feeling sad, feeling worried, and feeling frustrated. Participants were asked to recall and report on each item experienced in past 7 days. Score for each item ranges from 0 (not difficult at all) to 4 (extremely difficult). A domain score was calculated by summing the individual responses for each item and dividing by the number of impact items (range: 0=no cognitive/emotional impact to 4=severe cognitive/emotional impact). A higher score indicated more severe cognitive/emotional impact. Mean change from baseline in responses in the Cognitive/Emotional Impacts Domain Score of the PAH-SYMPACT questionnaire at Week 24 is reported. | All randomized participants who received at least one dose of study treatment and who had data for cognitive/emotional impacts domain score at baseline and Week 24 | Posted | Mean | Standard Deviation | Scores on a scale | Baseline and Week 24 |
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| Secondary | Percentage of Participants Who Experience an Adverse Event (AE) | An 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug whether or not it is considered related to the study drug. The percentage of participants who experienced an AE are presented. | All participants who received at least one dose of study intervention | Posted | Number | Percentage of participants | Up to ~35 Months |
|
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| Secondary | Percentage of Participants Who Discontinued Study Treatment Due to AEs | An 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug whether or not it is considered related to the study drug. The percentage of participants who discontinued study treatment due to an AE are presented. | All participants who received at least one dose of study intervention | Posted | Number | Percentage of participants | Up to ~35 months |
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| Secondary | Number of Participants Who Had Anti-drug Antibodies (ADAs) to Sotatercept | Blood samples collected at designated timepoints were used to determine the ADA response to sotatercept. The number of participants who had ADAs to sotatercept over time is presented. | Participants who had at least one dose of sotatercept and had at least one ADA assay result | Posted | Count of Participants | Participants | Up to ~35 Months |
|
|
Death and adverse events up to approximately 35 months.
Participants were only counted a single time within each applicable system organ class or preferred term.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sotatercept | Participants received sotatercept at a starting dose of 0.3 mg/kg, with a target dose of 0.7 mg/kg, subcutaneously (SC) every 21 days plus background PAH therapy. | 10 | 161 | 39 | 160 | 127 | 160 |
| EG001 | Placebo | Participants received placebo subcutaneously (SC) every 21 days plus background PAH therapy. | 13 | 160 | 45 | 160 | 128 | 160 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Microcytic anaemia | Blood and lymphatic system disorders | MedDRA 28.0 | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 28.0 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA 28.0 | Systematic Assessment |
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| Atrial flutter | Cardiac disorders | MedDRA 28.0 | Systematic Assessment |
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| Atrial tachycardia | Cardiac disorders | MedDRA 28.0 | Systematic Assessment |
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| Atrioventricular block complete | Cardiac disorders | MedDRA 28.0 | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA 28.0 | Systematic Assessment |
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| Pericardial effusion | Cardiac disorders | MedDRA 28.0 | Systematic Assessment |
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| Right ventricular dysfunction | Cardiac disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Right ventricular failure | Cardiac disorders | MedDRA 28.0 | Systematic Assessment |
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| Supraventricular tachycardia | Cardiac disorders | MedDRA 28.0 | Systematic Assessment |
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| Adrenal cortex necrosis | Endocrine disorders | MedDRA 28.0 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
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| Abdominal wall haematoma | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
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| Colonic angioectasia | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
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| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
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| Ileus | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
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| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
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| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
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| Small intestinal haemorrhage | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
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| Complication associated with device | General disorders | MedDRA 28.0 | Systematic Assessment |
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| Device related thrombosis | General disorders | MedDRA 28.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 28.0 | Systematic Assessment |
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| Multiple organ dysfunction syndrome | General disorders | MedDRA 28.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 28.0 | Systematic Assessment |
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| Cholangitis | Hepatobiliary disorders | MedDRA 28.0 | Systematic Assessment |
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| Cholecystitis | Hepatobiliary disorders | MedDRA 28.0 | Systematic Assessment |
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| Anti-neutrophil cytoplasmic antibody positive vasculitis | Immune system disorders | MedDRA 28.0 | Systematic Assessment |
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| Overlap syndrome | Immune system disorders | MedDRA 28.0 | Systematic Assessment |
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| Abscess limb | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
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| Anal abscess | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
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| Bacteraemia | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
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| Bacterial sepsis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
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| Bone abscess | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
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| Dermo-hypodermitis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
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| Device related infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
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| Diverticulitis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
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| Infective exacerbation of chronic obstructive airways disease | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
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| Parotitis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
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| Pneumococcal sepsis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
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| Pneumonia aspiration | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
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| Pneumonia bacterial | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Pneumonia haemophilus | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Pseudomonal sepsis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
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| Pyelonephritis acute | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Superinfection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Incision site haemorrhage | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Subarachnoid haematoma | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Liver function test increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hypervolaemia | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
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| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Lactic acidosis | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Intervertebral disc disorder | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Tenosynovitis | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Anal squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 28.0 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 28.0 | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 28.0 | Systematic Assessment |
| |
| Pituitary tumour benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 28.0 | Systematic Assessment |
| |
| Plasma cell myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 28.0 | Systematic Assessment |
| |
| Prostate cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 28.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Device dislocation | Product Issues | MedDRA 28.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Cervical dysplasia | Reproductive system and breast disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Pulmonary arterial hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Air embolism | Vascular disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Shock | Vascular disorders | MedDRA 28.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Right ventricular failure | Cardiac disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Haemoglobin increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Iron deficiency | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Pulmonary arterial hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Telangiectasia | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
|
Study was stopped early due to loss of clinical equipoise based on robust evidence of clinical benefit of sotatercept demonstrated in previous studies.
If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. Authorship will be determined by mutual agreement and in line with International Committee of Medical Journal Editors (ICMJE) authorship requirements.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme LLC | 1-800-672-6372 | ClinicalTrialsDisclosure@msd.com |
| Mar 24, 2026 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000081029 | Pulmonary Arterial Hypertension |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C542017 | ACE-011 |
Not provided
Not provided
Not provided
|
|
|
|
| WHO FC III |
|
|
|
| Triple |
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Placebo Plus Background PAH Therapy |
Participants received placebo subcutaneously (SC) every 21 days plus background PAH therapy. |
|
|
|
| Participants |
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
|
|
Participants received placebo subcutaneously (SC) every 21 days plus background PAH therapy. |
|
|
Participants received placebo subcutaneously (SC) every 21 days plus background PAH therapy.
|
|
|
|
|
|
| Participants |
|
|
|