A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (MK-7962-003/A011-11)(STELLAR)
NCT ID: NCT04576988
Last Updated: 2024-09-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
324 participants
INTERVENTIONAL
2021-01-25
2022-12-06
Brief Summary
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Detailed Description
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The primary efficacy endpoint of the study is exercise capacity, as measured by the 6-minute walk distance (6MWD) measured at 24 week following initiation of treatment.
Study duration will be approximately 2 years. A stratified Wilcoxon test will be used for analysis of the primary endpoint, with appropriate imputation for missing data, as detailed in the Statistical Analysis Plan. An unblinded, external, independent Data Monitoring Committee (DMC) will monitor participant safety throughout the course of the study. Participants completing this study will be eligible to receive sotatercept in a separate, open-label extension study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Sotatercept plus background PAH therapy
Sotatercept at a starting dose of 0.3 mg/kg with a target dose of 0.7 mg/kg administered subcutaneously (SC) every 21 days plus background PAH therapy
Sotatercept
Sotatercept at a starting dose of 0.3 mg/kg with a target dose of 0.7 mg/kg administered subcutaneously (SC) every 21 days plus background PAH therapy.
Background PAH Therapy
Background PAH therapy may consist of the following drug classes: an endothelin-receptor antagonist (ERA), a phosphodiesterase 5 (PDE5) inhibitor, a soluble guanylate cyclase stimulator, and/or a prostacyclin analogue or receptor agonist.
Placebo plus background PAH therapy
Placebo administered (SC) every 21 days plus background PAH therapy
Placebo
Placebo administered subcutaneously (SC) every 21 days plus background PAH therapy.
Background PAH Therapy
Background PAH therapy may consist of the following drug classes: an endothelin-receptor antagonist (ERA), a phosphodiesterase 5 (PDE5) inhibitor, a soluble guanylate cyclase stimulator, and/or a prostacyclin analogue or receptor agonist.
Interventions
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Sotatercept
Sotatercept at a starting dose of 0.3 mg/kg with a target dose of 0.7 mg/kg administered subcutaneously (SC) every 21 days plus background PAH therapy.
Placebo
Placebo administered subcutaneously (SC) every 21 days plus background PAH therapy.
Background PAH Therapy
Background PAH therapy may consist of the following drug classes: an endothelin-receptor antagonist (ERA), a phosphodiesterase 5 (PDE5) inhibitor, a soluble guanylate cyclase stimulator, and/or a prostacyclin analogue or receptor agonist.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Documented diagnostic right heart catheterization (RHC) at any time prior to screening confirming the diagnosis of World Health Organization (WHO) pulmonary arterial hypertension (PAH) Group 1 in any of the following subtypes:
* Idiopathic PAH
* Heritable PAH
* Drug/toxin-induced PAH
* PAH associated with connective tissue disease
* PAH associated with simple, congenital systemic to pulmonary shunts at least 1 year following repair
* Symptomatic PAH classified as WHO Functional Class (FC) II or III
* Baseline RHC performed during the Screening Period documenting a minimum pulmonary vascular resistance (PVR) of ≥ 5 Wood units (WU) and a pulmonary capillary wedge pressure (PCWP) or left ventricular end-diastolic pressure of ≤ 15 mmHg.
* On stable doses of background PAH therapy and diuretics (i.e., patient-specific dose goal for each therapy already achieved) for at least 90 days prior to screening; for infusion prostacyclins, dose adjustment within 10% of optimal dose is allowed per medical practice
* Background PAH therapy refers to approved PAH-specific medications and may consist of monotherapy or combination therapy with ERA, PDE5 inhibitors, soluble guanylate cyclase stimulators, and/or prostacyclin analogues or receptor agonists. Background PAH therapy should be stable at least 90 days prior to screening and remain stable throughout the study
* Stable diuretic therapy is defined as no addition of a new diuretic and no switching of a pre-existent oral diuretic to parenteral administration; however, dose adjustments (up or down) in pre-existent oral diuretics are acceptable
* 6-Minute Walk Distance (6MWD) ≥ 150 and ≤ 500 m repeated twice at screening (measured at least 4 hours apart, but no longer than 1 week), and both values are within 15% of each other (calculated from the highest value)
* Females of childbearing potential must:
* Have 2 negative urine or serum pregnancy tests as verified by the investigator prior to starting study therapy; she must agree to ongoing urine or serum pregnancy testing during the study and until 8 weeks after the last dose of the study drug
* If sexually active, have used, and agree to use, highly effective contraception 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 treatment
* 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 treatment
* Male participants must:
* Agree to use a condom, defined as a male latex condom or nonlatex 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 treatment
* Ability to adhere to study visit schedule and understand and comply with all protocol requirements
* Ability to understand and provide written informed consent
Exclusion Criteria
* Diagnosis of the following PAH Group 1 subtypes: human immunodeficiency virus (HIV)-associated PAH and PAH associated with portal hypertension. Exclusions in PAH Group I should also include schistosomiasis associate PAH and pulmonary veno occlusive disease
* Hemoglobin (Hgb) at screening above gender-specific upper limit of normal (ULN), per local laboratory test
* Baseline platelet count \< 50,000/mm\^3 (\< 50.0 x 109/L) at screening
* Uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure \> 160 mmHg or sitting diastolic blood pressure \> 100 mmHg during screening visit after a period of rest
* Baseline systolic blood pressure \< 90 mmHg at screening
* Pregnant or breastfeeding women
* Any of the following clinical laboratory values at the screening visit:
* Estimated glomerular filtration rate (eGFR) \< 30 mL/min/m2 (as defined by the Modification of Diet in Renal Disease \[MDRD\] equation)
* Serum alanine aminotransferase, aspartate aminotransferase, or total bilirubin levels \> 3 × ULN (bilirubin criterion waived if there is a documented history of Gilbert's syndrome)
* Currently enrolled in or have completed any other investigational product study within 30 days for small molecule drugs or within 5 half-lives for biologics prior to the date of signed informed consent
* Prior exposure to sotatercept (ACE-011) or luspatercept (ACE 536) and/or excipients or known allergic reaction to either one
* History of full pneumonectomy
* Pulmonary function test (PFT) values of forced vital capacity (FVC) \< 60% predicted at the screening visit or within 6 months prior to the screening visit. If PFT is not available, a chest CT scan showing more than mild interstitial lung disease (ILD) at the screening visit or 1 year prior to it
* 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)
* History of more than mild obstructive sleep apnea that is untreated
* Known history of portal hypertension or chronic liver disease, including hepatitis B and/or hepatitis C (with evidence of recent infection and/or active virus replication), defined as mild to severe hepatic impairment (Child-Pugh Class A-C)
* History of restrictive, constrictive or congestive cardiomyopathy
* History of atrial septostomy within 180 days prior to the screening visit
* Electrocardiogram (ECG) with Fridericia's corrected QT interval (QTcF) \> 500 ms during the screening period
* Personal or family history of long QT syndrome (LQTS) or sudden cardiac death
* Left ventricular ejection fraction \< 45% on historical echocardiogram within 6 months prior to the screening visit
* Any symptomatic coronary disease events (prior myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft surgery, or cardiac anginal chest pain) within 6 months prior to the screening visit. Note: Anginal pain can be ignored as an exclusion criterion if coronary angiography shows no obstructions
* 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, vasopressin) within 30 days prior to the screening visit
18 Years
ALL
No
Sponsors
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Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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Arizona Pulmonary Specialists (Site 1010)
Phoenix, Arizona, United States
Pulmonary Associates, PA (Site 1008)
Phoenix, Arizona, United States
University of Arizona (Site 1006)
Tucson, Arizona, United States
University of California San Diego Medical Center (Site 1002)
San Diego, California, United States
University of California - Davis Medical Center (Site 1064)
Sherman Oaks, California, United States
Stanford University Medical Center (Site 1024)
Stanford, California, United States
Harbor UCLA Medical Center (Site 1028)
Torrance, California, United States
University of Colorado Hospital (Site 1013)
Aurora, Colorado, United States
The George Washington University Medical Faculty Associates (Site 1025)
Washington D.C., District of Columbia, United States
Mayo Clinic Jacksonville (Site 1045)
Jacksonville, Florida, United States
University of South Florida (Site 1043)
Tampa, Florida, United States
The Emory Clinic (Site 1030)
Atlanta, Georgia, United States
Norton Pulmonary Specialists (Site 1066)
Louisville, Kentucky, United States
Tufts Medical Center - PPDS (Site 1012)
Boston, Massachusetts, United States
Brigham and Women's Hospital (Site 1014)
Boston, Massachusetts, United States
University of Michigan (Site 1011)
Ann Arbor, Michigan, United States
University of Minnesota (Site 1062)
Minneapolis, Minnesota, United States
Mayo Clinic (Site 1023)
Rochester, Minnesota, United States
University of Kansas Medical Center (Site 1020)
Kansas City, Missouri, United States
Washington University School of Medicine (Site 1022)
St Louis, Missouri, United States
Nebraska Medical Center (Site 1053)
Omaha, Nebraska, United States
Renown Institute for Heart & Vascular Health (Site 1055)
Reno, Nevada, United States
New York Presbyterian Hospital (Site 1046)
New York, New York, United States
Duke University Medical Center (Site 1026)
Durham, North Carolina, United States
University of Cincinnati Medical Center (Site 1035)
Cincinnati, Ohio, United States
The Carl and Edyth Lindner Center for Research and Education at the Christ Hospital (Site 1001)
Cincinnati, Ohio, United States
University Hospitals Cleveland Medical Center (Site 1005)
Cleveland, Ohio, United States
The Ohio State University Wexner Medical Center (Site 1032)
Columbus, Ohio, United States
Oregon Health and Science University (Site 1054)
Portland, Oregon, United States
University of Pennsylvania (Site 1047)
Philadelphia, Pennsylvania, United States
UPMC Presbyterian. UPMC Presbyterian Hospital (Site 1059)
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital (Site 1033)
Providence, Rhode Island, United States
Medical University of South Carolina - PPDS (Site 1003)
Charleston, South Carolina, United States
Statcare Pulmonary Consultants - Knoxville (Site 1031)
Knoxville, Tennessee, United States
Vanderbilt University Medical Center (Site 1027)
Nashville, Tennessee, 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 Utah - PPDS (Site 1049)
Salt Lake City, Utah, United States
University of Washington Medical Center - Montlake (Site 1067)
Seattle, Washington, United States
Hospital Universitario Austral ( Site 1901)
Pilar, Buenos Aires, Argentina
Instituto de Investigaciones Clinicas Quilmes ( Site 1903)
Quilmes, Buenos Aires, Argentina
Centro Medico Dra De Salvo ( Site 1904)
Buenos Aires, Buenos Aires F.D., Argentina
Sanatorio Parque ( Site 1905)
Rosario, Santa Fe Province, Argentina
Hospital Provincial Dr. Jose M. Cullen ( Site 1902)
Santa Fe, , Argentina
Royal Prince Alfred Hospital ( Site 1106)
Camperdown, New South Wales, Australia
Saint Vincents Hospital Sydney ( Site 1102)
Darlinghurst, New South Wales, Australia
John Hunter Hospital ( Site 1101)
New Lambton, New South Wales, Australia
Westmead Hospital ( Site 1105)
Westmead, New South Wales, Australia
Prince Charles Hospital ( Site 1104)
Chermside, Queensland, Australia
The Alfred Hospital ( Site 1110)
Melbourne, Victoria, Australia
Hopital Erasme ( Site 1402)
Brussels, Bruxelles-Capitale, Region de, Belgium
U.Z.-Gasthuisberg ( Site 1401)
Leuven, Vlaams-Brabant, Belgium
Irmandade da Santa Casa de Misericordia de Porto Alegre ( Site 1805)
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Dia do Pulmao ( Site 1802)
Blumenau, Santa Catarina, Brazil
Instituto do Coracao - HC FMUSP ( Site 1803)
São Paulo, , Brazil
University Of Alberta Hospital ( Site 2101)
Edmonton, Alberta, Canada
University of Ottawa Heart Institute ( Site 2104)
Ottawa, Ontario, Canada
Jewish General Hospital ( Site 2103)
Montreal, Quebec, Canada
Fakultni Nemocnice Olomouc ( Site 2203)
Olomouc, Olomoucký kraj, Czechia
Institut Klinicke a Experimentalni Mediciny ( Site 2202)
Prague, Praha 4, Czechia
Vseobecna fakultni nemocnice v Praze ( Site 2201_
Prague, Praha, Hlavni Mesto, Czechia
Hopital Pasteur (Site 1311)
Nice, Alpes-Maritimes, France
Hopitaux Universitaires de Strasbourg ( Site 1307)
Strasbourg, Bas-Rhin, France
CHRU Brest - Hopital Cavale Blanche (Site 1314)
Brest, Finistere, France
Groupe Hospitalier Sud ( Site 1312)
Pessac, Gironde, France
CHU de Toulouse - Hopital Larrey ( Site 1315)
Toulouse, Haute-Garonne, France
Hopital Arnaud de Villeneuve ( Site 1301)
Montpellier, Herault, France
CHU de Grenoble - Hopital Michallon ( Site 1303)
Grenoble, Isere, France
CHU Nantes - Hopital Laennec (Site 1309)
Nantes, Loire-Atlantique, France
CHU Angers (Site 1313)
Angers, Maine-et-Loire, France
C.H.U. de Nancy. Hopital de Brabois Adultes ( Site 1308)
Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France
CHRU Lille ( Site 1306)
Lille, Nord, France
Centre Hospitalier Universitaire de Saint-Etienne ( Site 1302)
Saint-Priest-en-Jarez, Pays de la Loire Region, France
Centre Hospitalier Universitaire de Bicetre ( Site 1304)
Le Kremlin-Bicêtre, Val-de-Marne, France
Thoraxklinik-Heidelberg gGmbH (Site 1509)
Heidelberg, Baden-Wurttemberg, Germany
Krankenhaus Neuwittelsbach (Site 1510)
Munich, Bavaria, Germany
Universitaetsklinik Regensburg (Site 1503)
Regensburg, Bavaria, Germany
Universitaetsklinikum Giessen und Marburg GmbH ( Site 1512)
Giessen, Hesse, Germany
Medizinische Hochschule Hannover (Site 1505)
Hanover, Lower Saxony, Germany
Uniklinik Köln, Institut für Kliniche Chemie ( Site 1511)
Cologne, North Rhine-Westphalia, Germany
Universitaetsklinikum Carl Gustav Carus der TU Dresden (Site 1501)
Dresden, Saxony, Germany
Universitätsklinikum Halle (Site 1502)
Halle, Saxony-Anhalt, Germany
DRK Kliniken Berlin Westend ( Site 1507)
Berlin, , Germany
Lady Davis Carmel Medical Center (Site 1705)
Haifa, , Israel
Meir Medical Center (Site 1707)
Kfar Saba, , Israel
Rabin Medical Center (Site 1703)
Petah Tikva, , Israel
Sheba Medical Center (Site 1701)
Tel Litwinsky, , Israel
Universita "La Sapienza" Policlinico Umberto I (Site 2402)
Roma, , Italy
CIMAB SA de CV (Site 2502)
Torreón, Coahuila, Mexico
Unidad de Investigacion Clinica en Medicina, S.C. (Site 2505)
Monterrey, Nuevo León, Mexico
Operadora de Hospitales Angeles. S.A. de C.V. -Sucursal Lomas (Site 2501)
Huixquilucan, , Mexico
Maastricht University Medical Center (Site 2603)
Maastricht, Limburg, Netherlands
VU Medisch Centrum (Site 2601)
Amsterdam, North Holland, Netherlands
University of Otago, Wellington (Site 2701)
Christchurch, Canterbury, New Zealand
Waikato District Health Board (Site 2702)
Hamilton, Waikato Region, New Zealand
Greenlane Clinical Centre (Site 2703)
Auckland, , New Zealand
Krakowski Szpital Specjalistyczny im. Jana Pawla II (Site 2801)
Krakow, Lesser Poland Voivodeship, Poland
Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina (Site 2802)
Otwock, Masovian Voivodeship, Poland
Uniwersytecki Szpital Kliniczny w Bialymstoku (Site 2803)
Bialystok, Podlaskie Voivodeship, Poland
Clinical Center of Serbia (Site 2901)
Belgrade, Beograd, Serbia
Institute of Cardiovascular Diseases Dedinje (Site 2903)
Belgrade, Beograd, Serbia
University Clinical Center Nis (Site 2904)
Niš, Nisavski Okrug, Serbia
Gachon University Gil Medical Center (Site 3103)
Incheon, , South Korea
Seoul National University Hospital (Site 3102)
Seoul, , South Korea
Severance Hospital Yonsei University Health System - PPDS (Site 3101)
Seoul, , South Korea
Hospital Universitario Marques de Valdecilla (Site 1601)
Santander, Cantabria, Spain
Hospital Universitario Puerta de Hierro-Majadahonda (Site 1604)
Majadahonda, Madrid, Spain
Hospital Universitari Vall d'Hebron (Site 1605)
Barcelona, , Spain
Hospital Clinic de Barcelona (Site 1602)
Barcelona, , Spain
Hospital Universitario Ramon y Cajal (Site 1609)
Madrid, , Spain
Hospital Universitario Marques de Valdecilla (Site 1603)
Madrid, , Spain
Hospital Clinico Universitario de Salamanca (Site 1608)
Salamanca, , Spain
Akademiska Sjukhuset (Site 3204)
Uppsala, Uppsala County, Sweden
Sahlgrenska Universitets Sjukhuset (Site 3201)
Gothenburg, Västra Götaland County, Sweden
Hopitaux Universitaires de Geneve HUG (Site 3302)
Thônex, Canton of Geneva, Switzerland
Universitaetsspital Zuerich (Site 3301)
Zurich, , Switzerland
Golden Jubilee National Hospital (Site 1204)
Glasgow, Glasgow City, United Kingdom
Royal Free London NHS Foundation Trust (Site 1202)
London, London, City of, United Kingdom
Royal Brompton Hospital (Site 1206)
London, London, City of, United Kingdom
Imperial College Healthcare NHS Trust (Site 1203)
London, London, City of, United Kingdom
Countries
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References
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Hoeper MM, Badesch DB, Ghofrani HA, Gibbs JSR, Gomberg-Maitland M, McLaughlin VV, Preston IR, Souza R, Waxman AB, Grunig E, Kopec G, Meyer G, Olsson KM, Rosenkranz S, Xu Y, Miller B, Fowler M, Butler J, Koglin J, de Oliveira Pena J, Humbert M; STELLAR Trial Investigators. Phase 3 Trial of Sotatercept for Treatment of Pulmonary Arterial Hypertension. N Engl J Med. 2023 Apr 20;388(16):1478-1490. doi: 10.1056/NEJMoa2213558. Epub 2023 Mar 6.
Alsumali A, McLaughlin V, Chevure J, Klok R, Zhang W, Martinez EC, Pausch C, De Oliveira Pena J, van de Wetering G, Jootun M, Lautsch D, Hoeper MM. Long-Term Mortality and Morbidity Impact on Patients with Pulmonary Arterial Hypertension (PAH) If Access to Sotatercept Is Delayed: A Simulation Model. Adv Ther. 2025 Aug;42(8):3902-3921. doi: 10.1007/s12325-025-03241-4. Epub 2025 Jun 17.
McLaughlin V, Alsumali A, Liu R, Klok R, Martinez EC, Nourhussein I, Bernotas D, Chevure J, Pausch C, De Oliveira Pena J, Lautsch D, Hoeper MM. Population Health Model Predicting the Long-Term Impact of Sotatercept on Morbidity and Mortality in Patients with Pulmonary Arterial Hypertension (PAH). Adv Ther. 2024 Jan;41(1):130-151. doi: 10.1007/s12325-023-02684-x. Epub 2023 Oct 18.
Souza R, Badesch DB, Ghofrani HA, Gibbs JSR, Gomberg-Maitland M, McLaughlin VV, Preston IR, Waxman AB, Grunig E, Kopec G, Meyer G, Olsson KM, Rosenkranz S, Lin J, Johnson-Levonas AO, de Oliveira Pena J, Humbert M, Hoeper MM. Effects of sotatercept on haemodynamics and right heart function: analysis of the STELLAR trial. Eur Respir J. 2023 Sep 21;62(3):2301107. doi: 10.1183/13993003.01107-2023. Print 2023 Sep.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Merck Clinical Trials Information
Plain Language Summary
Other Identifiers
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7962-003
Identifier Type: OTHER
Identifier Source: secondary_id
2020-004142-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
7962-003
Identifier Type: -
Identifier Source: org_study_id
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