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AzTrials

Pulmonary Arterial HypertensionPhase 3NCT04576988

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

A Phase 3 study testing Sotatercept and Background PAH Therapy in people with Pulmonary Arterial Hypertension, run by Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA at 120 sites in 21 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pulmonary Arterial Hypertension
What is being tested?
Sotatercept and Background PAH Therapy
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
324 participants
Where
120 sitesin 21 countries
Study dates
25 Jan 2021to 6 Dec 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

120 sites in 21 countries.

120 sites in 21 countries

United States39 sites

  • University of Michigan (Site 1011)

    Ann Arbor, Michigan, 48109-5936

  • The Emory Clinic (Site 1030)

    Atlanta, Georgia, 30322

  • University of Colorado Hospital (Site 1013)

    Aurora, Colorado, 80045

  • Tufts Medical Center - PPDS (Site 1012)

    Boston, Massachusetts, 02111

  • Brigham and Women's Hospital (Site 1014)

    Boston, Massachusetts, 02115

  • Medical University of South Carolina - PPDS (Site 1003)

    Charleston, South Carolina, 29425-8900

  • University of Cincinnati Medical Center (Site 1035)

    Cincinnati, Ohio, 45219-2316

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

    Cincinnati, Ohio, 45219

  • University Hospitals Cleveland Medical Center (Site 1005)

    Cleveland, Ohio, 44106

  • The Ohio State University Wexner Medical Center (Site 1032)

    Columbus, Ohio, 43210

  • Duke University Medical Center (Site 1026)

    Durham, North Carolina, 27710

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

    Houston, Texas, 77030

  • Houston Methodist Hospital (Site 1009)

    Houston, Texas, 77030

  • Mayo Clinic Jacksonville (Site 1045)

    Jacksonville, Florida, 32256

  • University of Kansas Medical Center (Site 1020)

    Kansas City, Missouri, 66160-7232

  • Statcare Pulmonary Consultants - Knoxville (Site 1031)

    Knoxville, Tennessee, 37919

  • Norton Pulmonary Specialists (Site 1066)

    Louisville, Kentucky, 40202

  • University of Minnesota (Site 1062)

    Minneapolis, Minnesota, 55455

  • Vanderbilt University Medical Center (Site 1027)

    Nashville, Tennessee, 37232

  • New York Presbyterian Hospital (Site 1046)

    New York, New York, 10032

  • Nebraska Medical Center (Site 1053)

    Omaha, Nebraska, 68105

  • University of Pennsylvania (Site 1047)

    Philadelphia, Pennsylvania, 19104

  • Arizona Pulmonary Specialists (Site 1010)

    Phoenix, Arizona, 85012

  • Pulmonary Associates, PA (Site 1008)

    Phoenix, Arizona, 85032

  • UPMC Presbyterian. UPMC Presbyterian Hospital (Site 1059)

    Pittsburgh, Pennsylvania, 15213

  • Oregon Health and Science University (Site 1054)

    Portland, Oregon, 97232

  • Rhode Island Hospital (Site 1033)

    Providence, Rhode Island, 02903

  • Renown Institute for Heart & Vascular Health (Site 1055)

    Reno, Nevada, 89502-1262

  • Mayo Clinic (Site 1023)

    Rochester, Minnesota, 55905

  • University of Utah - PPDS (Site 1049)

    Salt Lake City, Utah, 84132

  • University of California San Diego Medical Center (Site 1002)

    San Diego, California, 92037

  • University of Washington Medical Center - Montlake (Site 1067)

    Seattle, Washington, 98195-0001

  • University of California - Davis Medical Center (Site 1064)

    Sherman Oaks, California, 95817

  • Washington University School of Medicine (Site 1022)

    St Louis, Missouri, 63110

  • Stanford University Medical Center (Site 1024)

    Stanford, California, 94305

  • University of South Florida (Site 1043)

    Tampa, Florida, 33606

  • Harbor UCLA Medical Center (Site 1028)

    Torrance, California, 90502

  • University of Arizona (Site 1006)

    Tucson, Arizona, 85724

  • The George Washington University Medical Faculty Associates (Site 1025)

    Washington D.C., District of Columbia, 20037

Other trials in United States

France13 sites

  • CHU Angers (Site 1313)

    Angers, Maine-et-Loire, 49100

  • CHRU Brest - Hopital Cavale Blanche (Site 1314)

    Brest, Finistere, 29609

  • CHU de Grenoble - Hopital Michallon ( Site 1303)

    Grenoble, Isere, 38043

  • Centre Hospitalier Universitaire de Bicetre ( Site 1304)

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

  • CHRU Lille ( Site 1306)

    Lille, Nord, 59037

  • Hopital Arnaud de Villeneuve ( Site 1301)

    Montpellier, Herault, 34090

  • CHU Nantes - Hopital Laennec (Site 1309)

    Nantes, Loire-Atlantique, 44093

  • Hopital Pasteur (Site 1311)

    Nice, Alpes-Maritimes, 06002

  • Groupe Hospitalier Sud ( Site 1312)

    Pessac, Gironde, 33604

  • Centre Hospitalier Universitaire de Saint-Etienne ( Site 1302)

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

  • Hopitaux Universitaires de Strasbourg ( Site 1307)

    Strasbourg, Bas-Rhin, 67000

  • CHU de Toulouse - Hopital Larrey ( Site 1315)

    Toulouse, Haute-Garonne, 31059

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

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

Other trials in France

Germany9 sites

  • DRK Kliniken Berlin Westend ( Site 1507)

    Berlin, 14050

  • Uniklinik Köln, Institut für Kliniche Chemie ( Site 1511)

    Cologne, North Rhine-Westphalia, 50937

  • Universitaetsklinikum Carl Gustav Carus der TU Dresden (Site 1501)

    Dresden, Saxony, 01307

  • Universitaetsklinikum Giessen und Marburg GmbH ( Site 1512)

    Giessen, Hesse, 35392

  • Universitätsklinikum Halle (Site 1502)

    Halle, Saxony-Anhalt, 06120

  • Medizinische Hochschule Hannover (Site 1505)

    Hanover, Lower Saxony, 30625

  • Thoraxklinik-Heidelberg gGmbH (Site 1509)

    Heidelberg, Baden-Wurttemberg, 69126

  • Krankenhaus Neuwittelsbach (Site 1510)

    Munich, Bavaria, 80639

  • Universitaetsklinik Regensburg (Site 1503)

    Regensburg, Bavaria, 93053

Other trials in Germany

Spain7 sites

  • Hospital Universitari Vall d'Hebron (Site 1605)

    Barcelona, 08035

  • Hospital Clinic de Barcelona (Site 1602)

    Barcelona, 08036

  • Hospital Universitario Ramon y Cajal (Site 1609)

    Madrid, 28034

  • Hospital Universitario Marques de Valdecilla (Site 1603)

    Madrid, 28041

  • Hospital Universitario Puerta de Hierro-Majadahonda (Site 1604)

    Majadahonda, Madrid, 28222

  • Hospital Clinico Universitario de Salamanca (Site 1608)

    Salamanca, 37007

  • Hospital Universitario Marques de Valdecilla (Site 1601)

    Santander, Cantabria, 39008

Other trials in Spain

Australia6 sites

  • Royal Prince Alfred Hospital ( Site 1106)

    Camperdown, New South Wales, 2050

  • Prince Charles Hospital ( Site 1104)

    Chermside, Queensland, 4032

  • Saint Vincents Hospital Sydney ( Site 1102)

    Darlinghurst, New South Wales, 2010

  • The Alfred Hospital ( Site 1110)

    Melbourne, Victoria, 3004

  • John Hunter Hospital ( Site 1101)

    New Lambton, New South Wales, 2305

  • Westmead Hospital ( Site 1105)

    Westmead, New South Wales, 2145

Other trials in Australia

Argentina5 sites

  • Centro Medico Dra De Salvo ( Site 1904)

    Buenos Aires, Buenos Aires F.D., C1426ABP

  • Hospital Universitario Austral ( Site 1901)

    Pilar, Buenos Aires, B1629ODT

  • Instituto de Investigaciones Clinicas Quilmes ( Site 1903)

    Quilmes, Buenos Aires, B1878GEG

  • Sanatorio Parque ( Site 1905)

    Rosario, Santa Fe Province, 2000

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

    Santa Fe, S2732XAA

Other trials in Argentina

Israel4 sites

  • Lady Davis Carmel Medical Center (Site 1705)

    Haifa, 34362

  • Meir Medical Center (Site 1707)

    Kfar Saba, 4428164

  • Rabin Medical Center (Site 1703)

    Petah Tikva, 4941492

  • Sheba Medical Center (Site 1701)

    Tel HaShomer, 5265601

Other trials in Israel

United Kingdom4 sites

  • Golden Jubilee National Hospital (Site 1204)

    Glasgow, Glasgow City, G81 4DY

  • Royal Free London NHS Foundation Trust (Site 1202)

    London, London, City of, NW3 2QG

  • Royal Brompton Hospital (Site 1206)

    London, London, City of, SW3 6NP

  • Imperial College Healthcare NHS Trust (Site 1203)

    London, London, City of, W12 0HS

Other trials in United Kingdom

Brazil3 sites

  • Hospital Dia do Pulmao ( Site 1802)

    Blumenau, Santa Catarina, 89030-101

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

    Porto Alegre, Rio Grande do Sul, 90020-090

  • Instituto do Coracao - HC FMUSP ( Site 1803)

    São Paulo, 05403-000

Other trials in Brazil

Canada3 sites

  • University Of Alberta Hospital ( Site 2101)

    Edmonton, Alberta, T6G 2E1

  • Jewish General Hospital ( Site 2103)

    Montreal, Quebec, H3T 1E2

  • University of Ottawa Heart Institute ( Site 2104)

    Ottawa, Ontario, K1Y 4W7

Other trials in Canada

Czechia3 sites

  • Fakultni Nemocnice Olomouc ( Site 2203)

    Olomouc, Olomouc Region, 779 00

  • Institut Klinicke a Experimentalni Mediciny ( Site 2202)

    Prague, Praha 4, 140 21

  • Vseobecna fakultni nemocnice v Praze ( Site 2201_

    Prague, Praha, Hlavni Mesto, 128 08

Other trials in Czechia

Mexico3 sites

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

    Huixquilucan, 52763

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

    Monterrey, Nuevo León, 64718

  • CIMAB SA de CV (Site 2502)

    Torreón, Coahuila, 27000

Other trials in Mexico

New Zealand3 sites

  • Greenlane Clinical Centre (Site 2703)

    Auckland, 1051

  • University of Otago, Wellington (Site 2701)

    Christchurch, Canterbury, 8011

  • Waikato District Health Board (Site 2702)

    Hamilton, Waikato Region, 3204

Other trials in New Zealand

Poland3 sites

  • Uniwersytecki Szpital Kliniczny w Bialymstoku (Site 2803)

    Bialystok, Podlaskie Voivodeship, 15-276

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

    Krakow, Lesser Poland Voivodeship, 31-202

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

    Otwock, Masovian Voivodeship, 05-400

Other trials in Poland

Serbia3 sites

  • Clinical Center of Serbia (Site 2901)

    Belgrade, Beograd, 11000

  • Institute of Cardiovascular Diseases Dedinje (Site 2903)

    Belgrade, Beograd, 116550

  • University Clinical Center Nis (Site 2904)

    Niš, Nisavski Okrug, 1800

Other trials in Serbia

South Korea3 sites

  • Gachon University Gil Medical Center (Site 3103)

    Incheon, 21565

  • Seoul National University Hospital (Site 3102)

    Seoul, 03080

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

    Seoul, 03722

Other trials in South Korea

Belgium2 sites

  • Hopital Erasme ( Site 1402)

    Brussels, Bruxelles-Capitale, Region de, 1070

  • U.Z.-Gasthuisberg ( Site 1401)

    Leuven, Vlaams-Brabant, 3000

Other trials in Belgium

Netherlands2 sites

  • VU Medisch Centrum (Site 2601)

    Amsterdam, North Holland, 1081 HV

  • Maastricht University Medical Center (Site 2603)

    Maastricht, Limburg, 6229 HX

Other trials in Netherlands

Sweden2 sites

  • Sahlgrenska Universitets Sjukhuset (Site 3201)

    Gothenburg, Västra Götaland County, 413 45

  • Akademiska Sjukhuset (Site 3204)

    Uppsala, Uppsala County, 751 85

Other trials in Sweden

Switzerland2 sites

  • Hopitaux Universitaires de Geneve HUG (Site 3302)

    Thônex, Canton of Geneva, 1226

  • Universitaetsspital Zuerich (Site 3301)

    Zurich, 8091

Other trials in Switzerland

Italy1 site

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

    Roma, 00161

Other trials in Italy

About this study

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

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.

Read the 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.

Being tested
Sotatercept, Placebo, Background PAH Therapy
Keywords
Pulmonary Hypertension
Medical subject headings
Pulmonary Arterial Hypertension, Hypertension, Pulmonary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SotaterceptBiological

    Also called MK-7962, ACE-011

    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.

  • PlaceboDrug

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

  • Background PAH TherapyDrug

    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.

Study groups in NCT04576988
Study groupRoleWhat they receive
Sotatercept plus background PAH therapyExperimentalSotatercept 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
Receives: Biological: Sotatercept; Drug: Background PAH Therapy
Placebo plus background PAH therapyPlacebo comparatorPlacebo administered (SC) every 21 days plus background PAH therapy
Receives: Drug: Placebo; Drug: Background PAH Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline and Week 24

  2. 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.

    Measured: Up to approximately 24 weeks

  3. 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.

    Measured: Up to approximately 24 weeks

Secondary outcomes (9)

  1. Change From Baseline in the Percentage of Participants Achieving Multicomponent Improvement at 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.

    Measured: Baseline and Week 24

  2. Change From Baseline in Pulmonary Vascular Resistance (PVR) at 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.

    Measured: Baseline and Week 24

  3. Change From Baseline in NT-proBNP Levels at 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.

    Measured: Baseline and Week 24

  4. Change From Baseline in the Percentage of Participants Who Improve in WHO FC at 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.

    Measured: Baseline and Week 24

  5. Time to Death or the First Occurrence of Clinical Worsening Event

    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.

    Measured: Up to approximately 18 months

  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

    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.

    Measured: Baseline and Week 24

  7. Change From Baseline in the Physical Impacts Domain Score of Pulmonary Arterial Hypertension - Symptoms and Impact (PAH-SYMPACT®) at 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.

    Measured: Baseline and Week 24

  8. Change From Baseline in the Cardiopulmonary Symptoms Domain Score of PAH-SYMPACT® at 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.

    Measured: Baseline and Week 24

  9. Change From Baseline in the Cognitive/Emotional Impacts Domain Score of PAH-SYMPACT® at 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.

    Measured: Baseline and Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Oct 2020
  2. Study start25 Jan 2021
  3. Primary completion26 Aug 2022
  4. Study completion6 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
324 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04576988
Sponsor's protocol ID
7962-003
Other IDs
7962-003, 2020-004142-11
Status last verified
Sep 2024
First submitted
28 Sep 2020
Last updated
19 Sep 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Publications

  • 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.

    PubMed 36877098

  • Dutta S, Shah R, Singhal S, Singh M, Dholariya S, Chawla S, Katoch C. A systematic review and meta-analysis of safety and efficacy parameters of sotatercept in the therapy of pulmonary arterial hypertension. Expert Opin Drug Saf. 2026 Jun 9:1-13. doi: 10.1080/14740338.2026.2685360. Online ahead of print.

    PubMed 42246435

  • 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.

    PubMed 40526255

  • 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.

    PubMed 37851297

  • 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.

    PubMed 37696565

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sotatercept and Background PAH Therapy in people with Pulmonary Arterial Hypertension, run by Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA at 120 sites in 21 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 120 sites in United States, France, Germany, Spain, Australia and 16 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in 6-Minute Walk Distance (6MWD) at Week 24 (time frame: Baseline and Week 24). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04576988, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024; AzTrials last refreshed its copy on 8 Nov 2026.

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