A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (MK-7962-003/A011-11)(STELLAR)

NCT04576988 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: 7962-0032020-004142-11
• Study Type: interventional
• Target: 324
• Locations: 20 countries
• Sites: 117

Brief Summary

The objectives of this study are to evaluate the efficacy and safety of sotatercept (MK-7962) treatment (plus background pulmonary arterial hypertension (PAH) therapy) versus placebo (plus background PAH therapy) at 24 weeks in adults with PAH. The primary hypothesis of the study is that the participants receiving sotatercept will have improved 6-minute walk distance (6MWD) at 24 weeks compared to participants receiving placebo.

Conditions

Pulmonary Arterial Hypertension

Keywords

Pulmonary Hypertension

Outcome Measures

Primary Outcomes (3)

• Change From Baseline in 6-Minute Walk Distance (6MWD) at Week 24

  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). Per protocol, change from baseline in 6MWD at Week 24 was reported for DBPC period.

  Baseline and Week 24

• Number of Participants Who Experienced an Adverse Event (AE)

  An AE was any untoward medical occurrence in a study participant administered a study drug, which did 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 was considered related to the study drug. Per protocol, the number of participants who reported an AE were reported for DBPC period.

  Up to approximately 24 weeks

• Number of Participants Who Discontinued Study Treatment Due to an AE

  An AE was any untoward medical occurrence in a study participant administered a study drug, which did 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 was considered related to the study drug. Per protocol, the number of participants who discontinued study treatment due to an AE were reported for DBPC period.

  Up to approximately 24 weeks

Secondary Outcomes (9)

• Change From Baseline in the Percentage of Participants Achieving Multicomponent Improvement at Week 24

  Baseline and Week 24

• Change From Baseline in Pulmonary Vascular Resistance (PVR) at Week 24

  Baseline and Week 24

• Change From Baseline in NT-proBNP Levels at Week 24

  Baseline and Week 24

• Change From Baseline in the Percentage of Participants Who Improve in WHO FC at Week 24

  Baseline and Week 24

• Time to Death or the First Occurrence of Clinical Worsening Event

  Up to approximately 18 months

Study Arms (2)

Sotatercept plus background PAH therapy

EXPERIMENTAL

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

Biological: Sotatercept; Drug: Background PAH Therapy

Placebo plus background PAH therapy

PLACEBO COMPARATOR

Placebo administered (SC) every 21 days plus background PAH therapy

Drug: Placebo; Drug: Background PAH Therapy

Interventions

Sotatercept BIOLOGICAL

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.

Also known as: MK-7962, ACE-011

Sotatercept plus background PAH therapy

Placebo DRUG

Placebo administered subcutaneously (SC) every 21 days plus background PAH therapy.

Placebo plus background PAH therapy

Background PAH Therapy DRUG

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; Sotatercept plus background PAH therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• 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
• 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

You may not qualify if:

• Diagnosis of pulmonary hypertension WHO Groups 2, 3, 4, or 5
• 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

Sponsors & Collaborators

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

Study Sites (120)

Arizona Pulmonary Specialists (Site 1010)

Phoenix, Arizona, 85012, United States

Location

Pulmonary Associates, PA (Site 1008)

Phoenix, Arizona, 85032, United States

Location

University of Arizona (Site 1006)

Tucson, Arizona, 85724, United States

Location

University of California San Diego Medical Center (Site 1002)

San Diego, California, 92037, United States

Location

University of California - Davis Medical Center (Site 1064)

Sherman Oaks, California, 95817, United States

Location

Stanford University Medical Center (Site 1024)

Stanford, California, 94305, United States

Location

Harbor UCLA Medical Center (Site 1028)

Torrance, California, 90502, United States

Location

University of Colorado Hospital (Site 1013)

Aurora, Colorado, 80045, United States

Location

The George Washington University Medical Faculty Associates (Site 1025)

Washington D.C., District of Columbia, 20037, United States

Location

Mayo Clinic Jacksonville (Site 1045)

Jacksonville, Florida, 32256, United States

Location

University of South Florida (Site 1043)

Tampa, Florida, 33606, United States

Location

The Emory Clinic (Site 1030)

Atlanta, Georgia, 30322, United States

Location

Norton Pulmonary Specialists (Site 1066)

Louisville, Kentucky, 40202, United States

Location

Tufts Medical Center - PPDS (Site 1012)

Boston, Massachusetts, 02111, United States

Location

Brigham and Women's Hospital (Site 1014)

Boston, Massachusetts, 02115, United States

Location

University of Michigan (Site 1011)

Ann Arbor, Michigan, 48109-5936, United States

Location

University of Minnesota (Site 1062)

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic (Site 1023)

Rochester, Minnesota, 55905, United States

Location

University of Kansas Medical Center (Site 1020)

Kansas City, Missouri, 66160-7232, United States

Location

Washington University School of Medicine (Site 1022)

St Louis, Missouri, 63110, United States

Location

Nebraska Medical Center (Site 1053)

Omaha, Nebraska, 68105, United States

Location

Renown Institute for Heart & Vascular Health (Site 1055)

Reno, Nevada, 89502-1262, United States

Location

New York Presbyterian Hospital (Site 1046)

New York, New York, 10032, United States

Location

Duke University Medical Center (Site 1026)

Durham, North Carolina, 27710, United States

Location

University of Cincinnati Medical Center (Site 1035)

Cincinnati, Ohio, 45219-2316, United States

Location

The Carl and Edyth Lindner Center for Research and Education at the Christ Hospital (Site 1001)

Cincinnati, Ohio, 45219, United States

Location

University Hospitals Cleveland Medical Center (Site 1005)

Cleveland, Ohio, 44106, United States

Location

The Ohio State University Wexner Medical Center (Site 1032)

Columbus, Ohio, 43210, United States

Location

Oregon Health and Science University (Site 1054)

Portland, Oregon, 97232, United States

Location

University of Pennsylvania (Site 1047)

Philadelphia, Pennsylvania, 19104, United States

Location

UPMC Presbyterian. UPMC Presbyterian Hospital (Site 1059)

Pittsburgh, Pennsylvania, 15213, United States

Location

Rhode Island Hospital (Site 1033)

Providence, Rhode Island, 02903, United States

Location

Medical University of South Carolina - PPDS (Site 1003)

Charleston, South Carolina, 29425-8900, United States

Location

Statcare Pulmonary Consultants - Knoxville (Site 1031)

Knoxville, Tennessee, 37919, United States

Location

Vanderbilt University Medical Center (Site 1027)

Nashville, Tennessee, 37232, United States

Location

CHI St. Luke's Health Baylor College of Medicine Medical Center (Site 1044)

Houston, Texas, 77030, United States

Location

Houston Methodist Hospital (Site 1009)

Houston, Texas, 77030, United States

Location

University of Utah - PPDS (Site 1049)

Salt Lake City, Utah, 84132, United States

Location

University of Washington Medical Center - Montlake (Site 1067)

Seattle, Washington, 98195-0001, United States

Location

Hospital Universitario Austral ( Site 1901)

Pilar, Buenos Aires, B1629ODT, Argentina

Location

Instituto de Investigaciones Clinicas Quilmes ( Site 1903)

Quilmes, Buenos Aires, B1878GEG, Argentina

Location

Centro Medico Dra De Salvo ( Site 1904)

Buenos Aires, Buenos Aires F.D., C1426ABP, Argentina

Location

Sanatorio Parque ( Site 1905)

Rosario, Santa Fe Province, 2000, Argentina

Location

Hospital Provincial Dr. Jose M. Cullen ( Site 1902)

Santa Fe, S2732XAA, Argentina

Location

Royal Prince Alfred Hospital ( Site 1106)

Camperdown, New South Wales, 2050, Australia

Location

Saint Vincents Hospital Sydney ( Site 1102)

Darlinghurst, New South Wales, 2010, Australia

Location

John Hunter Hospital ( Site 1101)

New Lambton, New South Wales, 2305, Australia

Location

Westmead Hospital ( Site 1105)

Westmead, New South Wales, 2145, Australia

Location

Prince Charles Hospital ( Site 1104)

Chermside, Queensland, 4032, Australia

Location

The Alfred Hospital ( Site 1110)

Melbourne, Victoria, 3004, Australia

Location

Hopital Erasme ( Site 1402)

Brussels, Bruxelles-Capitale, Region de, 1070, Belgium

Location

U.Z.-Gasthuisberg ( Site 1401)

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Irmandade da Santa Casa de Misericordia de Porto Alegre ( Site 1805)

Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

Location

Hospital Dia do Pulmao ( Site 1802)

Blumenau, Santa Catarina, 89030-101, Brazil

Location

Instituto do Coracao - HC FMUSP ( Site 1803)

São Paulo, 05403-000, Brazil

Location

University Of Alberta Hospital ( Site 2101)

Edmonton, Alberta, T6G 2E1, Canada

Location

University of Ottawa Heart Institute ( Site 2104)

Ottawa, Ontario, K1Y 4W7, Canada

Location

Jewish General Hospital ( Site 2103)

Montreal, Quebec, H3T 1E2, Canada

Location

Fakultni Nemocnice Olomouc ( Site 2203)

Olomouc, Olomoucký kraj, 779 00, Czechia

Location

Institut Klinicke a Experimentalni Mediciny ( Site 2202)

Prague, Praha 4, 140 21, Czechia

Location

Vseobecna fakultni nemocnice v Praze ( Site 2201_

Prague, Praha, Hlavni Mesto, 128 08, Czechia

Location

Hopital Pasteur (Site 1311)

Nice, Alpes-Maritimes, 06002, France

Location

Hopitaux Universitaires de Strasbourg ( Site 1307)

Strasbourg, Bas-Rhin, 67000, France

Location

CHRU Brest - Hopital Cavale Blanche (Site 1314)

Brest, Finistere, 29609, France

Location

Groupe Hospitalier Sud ( Site 1312)

Pessac, Gironde, 33604, France

Location

CHU de Toulouse - Hopital Larrey ( Site 1315)

Toulouse, Haute-Garonne, 31059, France

Location

Hopital Arnaud de Villeneuve ( Site 1301)

Montpellier, Herault, 34090, France

Location

CHU de Grenoble - Hopital Michallon ( Site 1303)

Grenoble, Isere, 38043, France

Location

CHU Nantes - Hopital Laennec (Site 1309)

Nantes, Loire-Atlantique, 44093, France

Location

CHU Angers (Site 1313)

Angers, Maine-et-Loire, 49100, France

Location

C.H.U. de Nancy. Hopital de Brabois Adultes ( Site 1308)

Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54500, France

Location

CHRU Lille ( Site 1306)

Lille, Nord, 59037, France

Location

Centre Hospitalier Universitaire de Saint-Etienne ( Site 1302)

Saint-Priest-en-Jarez, Pays de la Loire Region, 42055, France

Location

Centre Hospitalier Universitaire de Bicetre ( Site 1304)

Le Kremlin-Bicêtre, Val-de-Marne, 94270, France

Location

Thoraxklinik-Heidelberg gGmbH (Site 1509)

Heidelberg, Baden-Wurttemberg, 69126, Germany

Location

Krankenhaus Neuwittelsbach (Site 1510)

Munich, Bavaria, 80639, Germany

Location

Universitaetsklinik Regensburg (Site 1503)

Regensburg, Bavaria, 93053, Germany

Location

Universitaetsklinikum Giessen und Marburg GmbH ( Site 1512)

Giessen, Hesse, 35392, Germany

Location

Medizinische Hochschule Hannover (Site 1505)

Hanover, Lower Saxony, 30625, Germany

Location

Uniklinik Köln, Institut für Kliniche Chemie ( Site 1511)

Cologne, North Rhine-Westphalia, 50937, Germany

Location

Universitaetsklinikum Carl Gustav Carus der TU Dresden (Site 1501)

Dresden, Saxony, 01307, Germany

Location

Universitätsklinikum Halle (Site 1502)

Halle, Saxony-Anhalt, 06120, Germany

Location

DRK Kliniken Berlin Westend ( Site 1507)

Berlin, 14050, Germany

Location

Lady Davis Carmel Medical Center (Site 1705)

Haifa, 34362, Israel

Location

Meir Medical Center (Site 1707)

Kfar Saba, 4428164, Israel

Location

Rabin Medical Center (Site 1703)

Petah Tikva, 4941492, Israel

Location

Sheba Medical Center (Site 1701)

Tel Litwinsky, 5265601, Israel

Location

Universita "La Sapienza" Policlinico Umberto I (Site 2402)

Roma, 00161, Italy

Location

CIMAB SA de CV (Site 2502)

Torreón, Coahuila, 27000, Mexico

Location

Unidad de Investigacion Clinica en Medicina, S.C. (Site 2505)

Monterrey, Nuevo León, 64718, Mexico

Location

Operadora de Hospitales Angeles. S.A. de C.V. -Sucursal Lomas (Site 2501)

Huixquilucan, 52763, Mexico

Location

Maastricht University Medical Center (Site 2603)

Maastricht, Limburg, 6229 HX, Netherlands

Location

VU Medisch Centrum (Site 2601)

Amsterdam, North Holland, 1081 HV, Netherlands

Location

University of Otago, Wellington (Site 2701)

Christchurch, Canterbury, 8011, New Zealand

Location

Waikato District Health Board (Site 2702)

Hamilton, Waikato Region, 3204, New Zealand

Location

Greenlane Clinical Centre (Site 2703)

Auckland, 1051, New Zealand

Location

Krakowski Szpital Specjalistyczny im. Jana Pawla II (Site 2801)

Krakow, Lesser Poland Voivodeship, 31-202, Poland

Location

Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina (Site 2802)

Otwock, Masovian Voivodeship, 05-400, Poland

Location

Uniwersytecki Szpital Kliniczny w Bialymstoku (Site 2803)

Bialystok, Podlaskie Voivodeship, 15-276, Poland

Location

Clinical Center of Serbia (Site 2901)

Belgrade, Beograd, 11000, Serbia

Location

Institute of Cardiovascular Diseases Dedinje (Site 2903)

Belgrade, Beograd, 116550, Serbia

Location

University Clinical Center Nis (Site 2904)

Niš, Nisavski Okrug, 1800, Serbia

Location

Gachon University Gil Medical Center (Site 3103)

Incheon, 21565, South Korea

Location

Seoul National University Hospital (Site 3102)

Seoul, 03080, South Korea

Location

Severance Hospital Yonsei University Health System - PPDS (Site 3101)

Seoul, 03722, South Korea

Location

Hospital Universitario Marques de Valdecilla (Site 1601)

Santander, Cantabria, 39008, Spain

Location

Hospital Universitario Puerta de Hierro-Majadahonda (Site 1604)

Majadahonda, Madrid, 28222, Spain

Location

Hospital Universitari Vall d'Hebron (Site 1605)

Barcelona, 08035, Spain

Location

Hospital Clinic de Barcelona (Site 1602)

Barcelona, 08036, Spain

Location

Hospital Universitario Ramon y Cajal (Site 1609)

Madrid, 28034, Spain

Location

Hospital Universitario Marques de Valdecilla (Site 1603)

Madrid, 28041, Spain

Location

Hospital Clinico Universitario de Salamanca (Site 1608)

Salamanca, 37007, Spain

Location

Akademiska Sjukhuset (Site 3204)

Uppsala, Uppsala County, 751 85, Sweden

Location

Sahlgrenska Universitets Sjukhuset (Site 3201)

Gothenburg, Västra Götaland County, 413 45, Sweden

Location

Hopitaux Universitaires de Geneve HUG (Site 3302)

Thônex, Canton of Geneva, 1226, Switzerland

Location

Universitaetsspital Zuerich (Site 3301)

Zurich, 8091, Switzerland

Location

Golden Jubilee National Hospital (Site 1204)

Glasgow, Glasgow City, G81 4DY, United Kingdom

Location

Royal Free London NHS Foundation Trust (Site 1202)

London, London, City of, NW3 2QG, United Kingdom

Location

Royal Brompton Hospital (Site 1206)

London, London, City of, SW3 6NP, United Kingdom

Location

Imperial College Healthcare NHS Trust (Site 1203)

London, London, City of, W12 0HS, United Kingdom

Location

Related Publications (4)

• 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.

  PMID: 36877098 RESULT

• 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.

  PMID: 40526255 DERIVED

• 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.

  PMID: 37851297 DERIVED

• 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.

  PMID: 37696565 DERIVED

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Pulmonary Arterial Hypertension; Hypertension, Pulmonary

Interventions

ACE-011

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme LLC

ClinicalTrialsDisclosure@msd.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Study participants, care providers. Investigators and outcomes assessor will be masked to the study intervention until the final participant completes the 24-week efficacy assessment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be randomized to one of two treatment arms to receive either sotatercept (0.7 mg/kg) by subcutaneous administration once every 3 weeks, or placebo. All participants will be on concurrent, stable background PAH therapy. Randomization will be stratified by baseline WHO Functional Class (Class II or III) and by background PAH therapy (mono/double or triple therapy)

Study Record Dates

• First Submitted: September 28, 2020
• First Posted: October 6, 2020
• Study Start: January 25, 2021
• Primary Completion: August 26, 2022
• Study Completion: December 6, 2022
• Last Updated: September 19, 2024
• Results First Posted: August 23, 2023

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share

Locations

SE (2); CH (2); KR (3); CA (3); IT (1); BR (3); AU (6); NZ (3); DE (9); BE (2); NL (2); ME (3); FR (13); PL (3); ES (7); IL (4); GB (4); AR (5); CZ (3); US (39)