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

• ClinicalTrials.gov Identifier: NCT04576988
• Recruitment Status: Completed
• First Posted: October 6, 2020
• Results First Posted: August 23, 2023
• Last Update Posted: March 28, 2024
• Sponsor: Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
• Information provided by (Responsible Party): Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pulmonary Arterial Hypertension	Biological: Sotatercept; Drug: Placebo; Drug: Background PAH Therapy	Phase 3

Detailed Description:

This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, parallel-group study in subjects with symptomatic PAH who present with idiopathic or heritable PAH, PAH associated with connective tissue diseases (CTD), drug or toxin induced, post shunt correction PAH, or PAH presenting at least 1 year following the correction of congenital heart defects (CHDs), and currently on background PAH therapy.

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 324 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 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)
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: 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.
• Primary Purpose: Treatment
• Official Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Compare the Efficacy and Safety of Sotatercept Versus Placebo When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH
• Actual Study Start Date: January 25, 2021
• Actual Primary Completion Date: August 26, 2022
• Actual Study Completion Date: December 6, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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	Biological: 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.; Other Names: MK-7962; ACE-011; Drug: 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 Comparator: Placebo plus background PAH therapy; Placebo administered (SC) every 21 days plus background PAH therapy	Drug: Placebo; Placebo administered subcutaneously (SC) every 21 days plus background PAH therapy.; Drug: 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.

Outcome Measures

Primary Outcome Measures :

1. Change From Baseline in 6-Minute Walk Distance (6MWD) at Week 24 [ Time Frame: Baseline and 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.
2. Number of Participants Who Experienced an Adverse Event (AE) [ Time Frame: Up to approximately 24 weeks ]
   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.
3. Number of Participants Who Discontinued Study Treatment Due to an AE [ Time Frame: Up to approximately 24 weeks ]
   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.

Secondary Outcome Measures :

1. Change From Baseline in the Percentage of Participants Achieving Multicomponent Improvement at Week 24 [ Time Frame: Baseline and Week 24 ]
   Multicomponent Improvement was defined as consisting of all of the following: (a) Improvement in 6MWD (increase ≥30 meters) (b) Improvement in N-terminal pro b-type natriuretic peptide (NT-proBNP; decrease in NT-proBNP ≥30%) or maintenance/achievement of NT-proBNP level <300 ng/L (c) Improvement in World Health Organization (WHO) Functional Class (FC) or maintenance of WHO FC II. Per protocol, change from baseline in the percentage of participants achieving multicomponent improvement at Week 24 was reported for DBPC period.
2. Change From Baseline in Pulmonary Vascular Resistance (PVR) at Week 24 [ Time Frame: Baseline and Week 24 ]
   PVR is a hemodynamic variable of pulmonary circulation and was measured by right heart catheterization (RHC). Per protocol, the change from baseline in PVR at Week 24 was reported for DBPC period.
3. Change From Baseline in NT-proBNP Levels at Week 24 [ Time Frame: Baseline and Week 24 ]
   NT-proBNP is a circulating biomarker that reflects myocardial stretch. Per protocol, the change from baseline in NT-proBNP level at Week 24 was reported for DBPC period.
4. Change From Baseline in the Percentage of Participants Who Improve in WHO FC at Week 24 [ Time Frame: Baseline and Week 24 ]
   The severity of participant's pulmonary arterial hypertension (PAH) symptoms will be graded using the WHO FC system. WHO functional classification for PAH ranges from Class I (no limitation in physical activity, no dyspnea with normal activity), Class II (slight limitation of physical activity), Class III (marked limitation of physical activity) and Class IV (cannot perform a physical activity without any symptoms, dyspnea at rest). Participants who improve in WHO FC were classified into "Improved", "No change" and "Worsened". Improvement = reduction in FC, worsened = increase in FC and no change = no change in FC. Per protocol, change from baseline in the percentage of participants who improve in WHO FC at Week 24 were reported for DBPC period.
5. Time to Death or the First Occurrence of Clinical Worsening Event [ Time Frame: Up to approximately 18 months ]
   Clinical Worsening events are defined as any of the following: worsening-related listing for lung and/or heart transplant; need to initiate rescue therapy with an approved background PAH therapy or the need to increase the dose of infusion prostacyclin by 10% or more; need for atrial septostomy; hospitalization for worsening of PAH (≥ 24 hours); or deterioration of PAH defined by both of the following events occurring at any time: worsened WHO FC and decrease in 6MWD by ≥15% confirmed by 2 tests at least 4 hours apart, but no more than 1 week. Per protocol, time to death or the first occurrence of clinical worsening event was reported.
6. Change From Baseline in Percentage of Participants Who Maintain or Achieve a Low Risk Score Using the Simplified French Risk Score Calculator at Week 24 [ Time Frame: Baseline and Week 24 ]
   The simplified French risk scoring system was based on the 2015 European Society of Cardiology (ESC)/European Respiratory Society (ERS) guidelines for the diagnosis and treatment of pulmonary hypertension (PH). In this study, the noninvasive parameters were used to determine the score. 'Low risk' was defined as attaining or maintaining all 3 low-risk criteria: WHO FC I or II, 6MWD > 440 m, and NT-proBNP <300 ng/L. Per protocol, change from baseline in percentage of participants who maintained or achieved a low risk score using the simplified French risk score calculator at Week 24 was reported for DBPC period.
7. Change From Baseline in the Physical Impacts Domain Score of Pulmonary Arterial Hypertension - Symptoms and Impact (PAH-SYMPACT®) at Week 24 [ Time Frame: Baseline and Week 24 ]
   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. Per protocol, change from baseline in the physical impacts domain score at Week 24 was reported for DBPC period.
8. Change From Baseline in the Cardiopulmonary Symptoms Domain Score of PAH-SYMPACT® at Week 24 [ Time Frame: Baseline and Week 24 ]
   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. Per protocol, change from baseline in the cardiopulmonary domain score at Week 24 was reported for DBPC period.
9. Change From Baseline in the Cognitive/Emotional Impacts Domain Score of PAH-SYMPACT® at Week 24 [ Time Frame: Baseline and Week 24 ]
   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. Per protocol, change from baseline in the cognitive/emotional impacts domain score at Week 24 was reported for DBPC period.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Key Inclusion Criteria:

• 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.
• 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

Key Exclusion Criteria:

• Diagnosis of pulmonary hypertension 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. 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

Contacts and Locations

Locations

United States, Arizona

Arizona Pulmonary Specialists (Site 1010)

Phoenix, Arizona, United States, 85012

Pulmonary Associates, PA (Site 1008)

Phoenix, Arizona, United States, 85032

University of Arizona (Site 1006)

Tucson, Arizona, United States, 85724

United States, California

University of California San Diego Medical Center (Site 1002)

San Diego, California, United States, 92037

University of California - Davis Medical Center (Site 1064)

Sherman Oaks, California, United States, 95817

Stanford University Medical Center (Site 1024)

Stanford, California, United States, 94305

Harbor UCLA Medical Center (Site 1028)

Torrance, California, United States, 90502

United States, Colorado

University of Colorado Hospital (Site 1013)

Aurora, Colorado, United States, 80045

United States, District of Columbia

The George Washington University Medical Faculty Associates (Site 1025)

Washington, District of Columbia, United States, 20037

United States, Florida

Mayo Clinic Jacksonville (Site 1045)

Jacksonville, Florida, United States, 32256

University of South Florida (Site 1043)

Tampa, Florida, United States, 33606

United States, Georgia

The Emory Clinic (Site 1030)

Atlanta, Georgia, United States, 30322

United States, Kentucky

Norton Pulmonary Specialists (Site 1066)

Louisville, Kentucky, United States, 40202

United States, Massachusetts

Tufts Medical Center - PPDS (Site 1012)

Boston, Massachusetts, United States, 02111

Brigham and Women's Hospital (Site 1014)

Boston, Massachusetts, United States, 02115

United States, Michigan

University of Michigan (Site 1011)

Ann Arbor, Michigan, United States, 48109-5936

United States, Minnesota

University of Minnesota (Site 1062)

Minneapolis, Minnesota, United States, 55455

Mayo Clinic (Site 1023)

Rochester, Minnesota, United States, 55905

United States, Missouri

University of Kansas Medical Center (Site 1020)

Kansas City, Missouri, United States, 66160-7232

Washington University School of Medicine (Site 1022)

Saint Louis, Missouri, United States, 63110

United States, Nebraska

Nebraska Medical Center (Site 1053)

Omaha, Nebraska, United States, 68105

United States, Nevada

Renown Institute for Heart & Vascular Health (Site 1055)

Reno, Nevada, United States, 89502-1262

United States, New York

New York Presbyterian Hospital (Site 1046)

New York, New York, United States, 10032

United States, North Carolina

Duke University Medical Center (Site 1026)

Durham, North Carolina, United States, 27710

United States, Ohio

University of Cincinnati Medical Center (Site 1035)

Cincinnati, Ohio, United States, 45219-2316

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

Cincinnati, Ohio, United States, 45219

University Hospitals Cleveland Medical Center (Site 1005)

Cleveland, Ohio, United States, 44106

The Ohio State University Wexner Medical Center (Site 1032)

Columbus, Ohio, United States, 43210

United States, Oregon

Oregon Health and Science University (Site 1054)

Portland, Oregon, United States, 97232

United States, Pennsylvania

University of Pennsylvania (Site 1047)

Philadelphia, Pennsylvania, United States, 19104

UPMC Presbyterian. UPMC Presbyterian Hospital (Site 1059)

Pittsburgh, Pennsylvania, United States, 15213

United States, Rhode Island

Rhode Island Hospital (Site 1033)

Providence, Rhode Island, United States, 02903

United States, South Carolina

Medical University of South Carolina - PPDS (Site 1003)

Charleston, South Carolina, United States, 29425-8900

United States, Tennessee

Statcare Pulmonary Consultants - Knoxville (Site 1031)

Knoxville, Tennessee, United States, 37919

Vanderbilt University Medical Center (Site 1027)

Nashville, Tennessee, United States, 37232

United States, Texas

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

Houston, Texas, United States, 77030

Houston Methodist Hospital (Site 1009)

Houston, Texas, United States, 77030

United States, Utah

University of Utah - PPDS (Site 1049)

Salt Lake City, Utah, United States, 84132

United States, Washington

University of Washington Medical Center - Montlake (Site 1067)

Seattle, Washington, United States, 98195-0001

Argentina

Hospital Universitario Austral ( Site 1901)

Pilar, Buenos Aires, Argentina, B1629ODT

Instituto de Investigaciones Clinicas Quilmes ( Site 1903)

Quilmes, Buenos Aires, Argentina, B1878GEG

Centro Medico Dra De Salvo ( Site 1904)

Ciudad Autonoma de Buenos Aires, Caba, Argentina, C1426ABP

Sanatorio Parque ( Site 1905)

Rosario, Santa Fe, Argentina, 2000

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

Santa Fe, Argentina, S2732XAA

Australia, New South Wales

Royal Prince Alfred Hospital ( Site 1106)

Camperdown, New South Wales, Australia, 2050

Saint Vincents Hospital Sydney ( Site 1102)

Darlinghurst, New South Wales, Australia, 2010

John Hunter Hospital ( Site 1101)

New Lambton, New South Wales, Australia, 2305

Westmead Hospital ( Site 1105)

Westmead, New South Wales, Australia, 2145

Australia, Queensland

Prince Charles Hospital ( Site 1104)

Chermside, Queensland, Australia, 4032

Australia, Victoria

The Alfred Hospital ( Site 1110)

Melbourne, Victoria, Australia, 3004

Belgium

Hopital Erasme ( Site 1402)

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

U.Z.-Gasthuisberg ( Site 1401)

Leuven, Vlaams-Brabant, Belgium, 3000

Brazil

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

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

Hospital Dia do Pulmao ( Site 1802)

Blumenau, Santa Catarina, Brazil, 89030-101

Instituto do Coracao - HC FMUSP ( Site 1803)

Sao Paulo, Brazil, 05403-000

Canada, Alberta

University Of Alberta Hospital ( Site 2101)

Edmonton, Alberta, Canada, T6G 2E1

Canada, Ontario

University of Ottawa Heart Institute ( Site 2104)

Ottawa, Ontario, Canada, K1Y 4W7

Canada, Quebec

Jewish General Hospital ( Site 2103)

Montreal, Quebec, Canada, H3T 1E2

Czechia

Fakultni Nemocnice Olomouc ( Site 2203)

Olomouc, Olomoucky Kraj, Czechia, 779 00

Institut Klinicke a Experimentalni Mediciny ( Site 2202)

Prague, Praha 4, Czechia, 140 21

Vseobecna fakultni nemocnice v Praze ( Site 2201_

Praha, Praha, Hlavni Mesto, Czechia, 128 08

France

Hopital Pasteur (Site 1311)

Nice, Alpes-Maritimes, France, 06002

Hopitaux Universitaires de Strasbourg ( Site 1307)

Strasbourg, Bas-Rhin, France, 67000

CHRU Brest - Hopital Cavale Blanche (Site 1314)

Brest, Finistere, France, 29609

Groupe Hospitalier Sud ( Site 1312)

Pessac, Gironde, France, 33604

CHU de Toulouse - Hopital Larrey ( Site 1315)

Toulouse, Haute-Garonne, France, 31059

Hopital Arnaud de Villeneuve ( Site 1301)

Montpellier, Herault, France, 34090

CHU de Grenoble - Hopital Michallon ( Site 1303)

Grenoble, Isere, France, 38043

CHU Nantes - Hopital Laennec (Site 1309)

Nantes, Loire-Atlantique, France, 44093

Centre Hospitalier Universitaire de Saint-Etienne ( Site 1302)

Saint-Priest-en-Jarez, Loire, France, 42055

CHU Angers (Site 1313)

Angers, Maine-et-Loire, France, 49100

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

Vandoeuvre Les Nancy, Meurthe-et-Moselle, France, 54500

CHRU Lille ( Site 1306)

Lille, Nord, France, 59037

Centre Hospitalier Universitaire de Bicetre ( Site 1304)

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

Germany

Thoraxklinik-Heidelberg gGmbH (Site 1509)

Heidelberg, Baden-Wurttemberg, Germany, 69126

Krankenhaus Neuwittelsbach (Site 1510)

Muenchen, Bayern, Germany, 80639

Universitaetsklinik Regensburg (Site 1503)

Regensburg, Bayern, Germany, 93053

Universitaetsklinikum Giessen und Marburg GmbH ( Site 1512)

Giessen, Hessen, Germany, 35392

Medizinische Hochschule Hannover (Site 1505)

Hannover, Niedersachsen, Germany, 30625

Uniklinik Köln, Institut für Kliniche Chemie ( Site 1511)

Köln, Nordrhein-Westfalen, Germany, 50937

Universitätsklinikum Halle (Site 1502)

Halle (Saale), Sachsen-Anhalt, Germany, 06120

Universitaetsklinikum Carl Gustav Carus der TU Dresden (Site 1501)

Dresden, Sachsen, Germany, 01307

DRK Kliniken Berlin Westend ( Site 1507)

Berlin, Germany, 14050

Israel

Lady Davis Carmel Medical Center (Site 1705)

Haifa, Israel, 34362

Meir Medical Center (Site 1707)

Kefar Saba, Israel, 4428164

Rabin Medical Center (Site 1703)

Petah Tikva, Israel, 4941492

Sheba Medical Center (Site 1701)

Tel Hashomer, Israel, 5265601

Italy

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

Roma, Italy, 00161

Korea, Republic of

Gachon University Gil Medical Center (Site 3103)

Incheon, Korea, Republic of, 21565

Seoul National University Hospital (Site 3102)

Seoul, Korea, Republic of, 03080

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

Seoul, Korea, Republic of, 03722

Mexico

CIMAB SA de CV (Site 2502)

Torreon, Coahuila, Mexico, 27000

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

Monterrey, Nuevo Leon, Mexico, 64718

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

Huixquilucan, Mexico, 52763

Netherlands

Maastricht University Medical Center (Site 2603)

Maastricht, Limburg, Netherlands, 6229 HX

VU Medisch Centrum (Site 2601)

Amsterdam, Noord-Holland, Netherlands, 1081 HV

New Zealand

University of Otago, Wellington (Site 2701)

Christchurch, Canterbury, New Zealand, 8011

Waikato District Health Board (Site 2702)

Hamilton, Waikato, New Zealand, 3204

Greenlane Clinical Centre (Site 2703)

Auckland, New Zealand, 1051

Poland

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

Krakow, Malopolskie, Poland, 31-202

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

Otwock, Mazowieckie, Poland, 05-400

Uniwersytecki Szpital Kliniczny w Bialymstoku (Site 2803)

Bialystok, Podlaskie, Poland, 15-276

Serbia

Clinical Center of Serbia (Site 2901)

Belgrade, Beograd, Serbia, 11000

Institute of Cardiovascular Diseases Dedinje (Site 2903)

Belgrade, Beograd, Serbia, 116550

University Clinical Center Nis (Site 2904)

Nis, Nisavski Okrug, Serbia, 1800

Spain

Hospital Universitario Marques de Valdecilla (Site 1601)

Santander, Cantabria, Spain, 39008

Hospital Universitario Puerta de Hierro-Majadahonda (Site 1604)

Majadahonda, Madrid, Spain, 28222

Hospital Universitari Vall d'Hebron (Site 1605)

Barcelona, Spain, 08035

Hospital Clinic de Barcelona (Site 1602)

Barcelona, Spain, 08036

Hospital Universitario Ramon y Cajal (Site 1609)

Madrid, Spain, 28034

Hospital Universitario Marques de Valdecilla (Site 1603)

Madrid, Spain, 28041

Hospital Clinico Universitario de Salamanca (Site 1608)

Salamanca, Spain, 37007

Sweden

Akademiska Sjukhuset (Site 3204)

Uppsala, Uppsala Lan, Sweden, 751 85

Sahlgrenska Universitets Sjukhuset (Site 3201)

Goteborg, Vastra Gotalands Lan, Sweden, 413 45

Switzerland

Hopitaux Universitaires de Geneve HUG (Site 3302)

Thonex, Geneve, Switzerland, 1226

Universitaetsspital Zuerich (Site 3301)

Zurich, Switzerland, 8091

United Kingdom

Golden Jubilee National Hospital (Site 1204)

Glasgow, Glasgow City, United Kingdom, G81 4DY

Royal Free London NHS Foundation Trust (Site 1202)

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

Royal Brompton Hospital (Site 1206)

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

Imperial College Healthcare NHS Trust (Site 1203)

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

Sponsors and Collaborators

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

Investigators

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

  Study Documents (Full-Text)

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

Study Protocol and Statistical Analysis Plan  [PDF] October 6, 2021

More Information

Additional Information:

Merck Clinical Trials Information 

Publications of Results:

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.

• Responsible Party: Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
• ClinicalTrials.gov Identifier: NCT04576988
• Other Study ID Numbers: 7962-003; 7962-003 ( Other Identifier: Merck ); 2020-004142-11 ( EudraCT Number )
• First Posted: October 6, 2020
• Results First Posted: August 23, 2023
• Last Update Posted: March 28, 2024
• Last Verified: March 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
• URL: http://engagezone.msd.com/ds_documentation.php

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

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

Pulmonary Hypertension

Additional relevant MeSH terms:

Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension; Vascular Diseases; Cardiovascular Diseases; Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases