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

NCT ID: NCT04576988

Last Updated: 2024-09-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

324 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-25

Study Completion Date

2022-12-06

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pulmonary Arterial Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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)
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
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.

Study Groups

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Sotatercept plus background PAH therapy

Sotatercept at a starting dose of 0.3 mg/kg with a target dose of 0.7 mg/kg administered subcutaneously (SC) every 21 days plus background PAH therapy

Group Type EXPERIMENTAL

Sotatercept

Intervention Type 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.

Background PAH Therapy

Intervention Type 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

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Background PAH Therapy

Intervention Type 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.

Interventions

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Sotatercept

Sotatercept at a starting dose of 0.3 mg/kg with a target dose of 0.7 mg/kg administered subcutaneously (SC) every 21 days plus background PAH therapy.

Intervention Type BIOLOGICAL

Placebo

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

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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MK-7962 ACE-011

Eligibility Criteria

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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

* Background PAH therapy refers to approved PAH-specific medications and may consist of monotherapy or combination therapy with ERA, PDE5 inhibitors, soluble guanylate cyclase stimulators, and/or prostacyclin analogues or receptor agonists. Background PAH therapy should be stable at least 90 days prior to screening and remain stable throughout the study
* Stable diuretic therapy is defined as no addition of a new diuretic and no switching of a pre-existent oral diuretic to parenteral administration; however, dose adjustments (up or down) in pre-existent oral diuretics are acceptable
* 6-Minute Walk Distance (6MWD) ≥ 150 and ≤ 500 m repeated twice at screening (measured at least 4 hours apart, but no longer than 1 week), and both values are within 15% of each other (calculated from the highest value)
* Females of childbearing potential must:

* Have 2 negative urine or serum pregnancy tests as verified by the investigator prior to starting study therapy; she must agree to ongoing urine or serum pregnancy testing during the study and until 8 weeks after the last dose of the study drug
* If sexually active, have used, and agree to use, highly effective contraception without interruption, for at least 28 days prior to starting the investigational product, during the study (including dose interruptions), and for 16 weeks (112 days) after discontinuation of study treatment
* Refrain from breastfeeding a child or donating blood, eggs, or ovum for the duration of the study and for at least 16 weeks (112 days) after the last dose of study treatment
* Male participants must:
* Agree to use a condom, defined as a male latex condom or nonlatex condom NOT made out of natural (animal) membrane (e.g., polyurethane), during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 16 weeks (112 days) following investigational product discontinuation, even if he has undergone a successful vasectomy
* Refrain from donating blood or sperm for the duration of the study and for 16 weeks (112 days) after the last dose of study treatment
* Ability to adhere to study visit schedule and understand and comply with all protocol requirements
* Ability to understand and provide written informed consent

Exclusion Criteria

* Diagnosis of 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

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Arizona Pulmonary Specialists (Site 1010)

Phoenix, Arizona, United States

Site Status

Pulmonary Associates, PA (Site 1008)

Phoenix, Arizona, United States

Site Status

University of Arizona (Site 1006)

Tucson, Arizona, United States

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University of California San Diego Medical Center (Site 1002)

San Diego, California, United States

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University of California - Davis Medical Center (Site 1064)

Sherman Oaks, California, United States

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Stanford University Medical Center (Site 1024)

Stanford, California, United States

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Harbor UCLA Medical Center (Site 1028)

Torrance, California, United States

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University of Colorado Hospital (Site 1013)

Aurora, Colorado, United States

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The George Washington University Medical Faculty Associates (Site 1025)

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

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Mayo Clinic Jacksonville (Site 1045)

Jacksonville, Florida, United States

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University of South Florida (Site 1043)

Tampa, Florida, United States

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The Emory Clinic (Site 1030)

Atlanta, Georgia, United States

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Norton Pulmonary Specialists (Site 1066)

Louisville, Kentucky, United States

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Tufts Medical Center - PPDS (Site 1012)

Boston, Massachusetts, United States

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Brigham and Women's Hospital (Site 1014)

Boston, Massachusetts, United States

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University of Michigan (Site 1011)

Ann Arbor, Michigan, United States

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University of Minnesota (Site 1062)

Minneapolis, Minnesota, United States

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Mayo Clinic (Site 1023)

Rochester, Minnesota, United States

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University of Kansas Medical Center (Site 1020)

Kansas City, Missouri, United States

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Washington University School of Medicine (Site 1022)

St Louis, Missouri, United States

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Nebraska Medical Center (Site 1053)

Omaha, Nebraska, United States

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Renown Institute for Heart & Vascular Health (Site 1055)

Reno, Nevada, United States

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New York Presbyterian Hospital (Site 1046)

New York, New York, United States

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Duke University Medical Center (Site 1026)

Durham, North Carolina, United States

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University of Cincinnati Medical Center (Site 1035)

Cincinnati, Ohio, United States

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

Cincinnati, Ohio, United States

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University Hospitals Cleveland Medical Center (Site 1005)

Cleveland, Ohio, United States

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The Ohio State University Wexner Medical Center (Site 1032)

Columbus, Ohio, United States

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Oregon Health and Science University (Site 1054)

Portland, Oregon, United States

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University of Pennsylvania (Site 1047)

Philadelphia, Pennsylvania, United States

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UPMC Presbyterian. UPMC Presbyterian Hospital (Site 1059)

Pittsburgh, Pennsylvania, United States

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Rhode Island Hospital (Site 1033)

Providence, Rhode Island, United States

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Medical University of South Carolina - PPDS (Site 1003)

Charleston, South Carolina, United States

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Statcare Pulmonary Consultants - Knoxville (Site 1031)

Knoxville, Tennessee, United States

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Vanderbilt University Medical Center (Site 1027)

Nashville, Tennessee, United States

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

Houston, Texas, United States

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Houston Methodist Hospital (Site 1009)

Houston, Texas, United States

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University of Utah - PPDS (Site 1049)

Salt Lake City, Utah, United States

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University of Washington Medical Center - Montlake (Site 1067)

Seattle, Washington, United States

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Hospital Universitario Austral ( Site 1901)

Pilar, Buenos Aires, Argentina

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Instituto de Investigaciones Clinicas Quilmes ( Site 1903)

Quilmes, Buenos Aires, Argentina

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Centro Medico Dra De Salvo ( Site 1904)

Buenos Aires, Buenos Aires F.D., Argentina

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Sanatorio Parque ( Site 1905)

Rosario, Santa Fe Province, Argentina

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

Santa Fe, , Argentina

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Royal Prince Alfred Hospital ( Site 1106)

Camperdown, New South Wales, Australia

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Saint Vincents Hospital Sydney ( Site 1102)

Darlinghurst, New South Wales, Australia

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John Hunter Hospital ( Site 1101)

New Lambton, New South Wales, Australia

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Westmead Hospital ( Site 1105)

Westmead, New South Wales, Australia

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Prince Charles Hospital ( Site 1104)

Chermside, Queensland, Australia

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The Alfred Hospital ( Site 1110)

Melbourne, Victoria, Australia

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Hopital Erasme ( Site 1402)

Brussels, Bruxelles-Capitale, Region de, Belgium

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U.Z.-Gasthuisberg ( Site 1401)

Leuven, Vlaams-Brabant, Belgium

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

Porto Alegre, Rio Grande do Sul, Brazil

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Hospital Dia do Pulmao ( Site 1802)

Blumenau, Santa Catarina, Brazil

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Instituto do Coracao - HC FMUSP ( Site 1803)

São Paulo, , Brazil

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University Of Alberta Hospital ( Site 2101)

Edmonton, Alberta, Canada

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University of Ottawa Heart Institute ( Site 2104)

Ottawa, Ontario, Canada

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Jewish General Hospital ( Site 2103)

Montreal, Quebec, Canada

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Fakultni Nemocnice Olomouc ( Site 2203)

Olomouc, Olomoucký kraj, Czechia

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Institut Klinicke a Experimentalni Mediciny ( Site 2202)

Prague, Praha 4, Czechia

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Vseobecna fakultni nemocnice v Praze ( Site 2201_

Prague, Praha, Hlavni Mesto, Czechia

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Hopital Pasteur (Site 1311)

Nice, Alpes-Maritimes, France

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Hopitaux Universitaires de Strasbourg ( Site 1307)

Strasbourg, Bas-Rhin, France

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CHRU Brest - Hopital Cavale Blanche (Site 1314)

Brest, Finistere, France

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Groupe Hospitalier Sud ( Site 1312)

Pessac, Gironde, France

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CHU de Toulouse - Hopital Larrey ( Site 1315)

Toulouse, Haute-Garonne, France

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Hopital Arnaud de Villeneuve ( Site 1301)

Montpellier, Herault, France

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CHU de Grenoble - Hopital Michallon ( Site 1303)

Grenoble, Isere, France

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CHU Nantes - Hopital Laennec (Site 1309)

Nantes, Loire-Atlantique, France

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CHU Angers (Site 1313)

Angers, Maine-et-Loire, France

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

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

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CHRU Lille ( Site 1306)

Lille, Nord, France

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Centre Hospitalier Universitaire de Saint-Etienne ( Site 1302)

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

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Centre Hospitalier Universitaire de Bicetre ( Site 1304)

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

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Thoraxklinik-Heidelberg gGmbH (Site 1509)

Heidelberg, Baden-Wurttemberg, Germany

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Krankenhaus Neuwittelsbach (Site 1510)

Munich, Bavaria, Germany

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Universitaetsklinik Regensburg (Site 1503)

Regensburg, Bavaria, Germany

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Universitaetsklinikum Giessen und Marburg GmbH ( Site 1512)

Giessen, Hesse, Germany

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Medizinische Hochschule Hannover (Site 1505)

Hanover, Lower Saxony, Germany

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Uniklinik Köln, Institut für Kliniche Chemie ( Site 1511)

Cologne, North Rhine-Westphalia, Germany

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Universitaetsklinikum Carl Gustav Carus der TU Dresden (Site 1501)

Dresden, Saxony, Germany

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Universitätsklinikum Halle (Site 1502)

Halle, Saxony-Anhalt, Germany

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DRK Kliniken Berlin Westend ( Site 1507)

Berlin, , Germany

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Lady Davis Carmel Medical Center (Site 1705)

Haifa, , Israel

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Meir Medical Center (Site 1707)

Kfar Saba, , Israel

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Rabin Medical Center (Site 1703)

Petah Tikva, , Israel

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Sheba Medical Center (Site 1701)

Tel Litwinsky, , Israel

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

Roma, , Italy

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CIMAB SA de CV (Site 2502)

Torreón, Coahuila, Mexico

Site Status

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

Monterrey, Nuevo León, Mexico

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

Huixquilucan, , Mexico

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Maastricht University Medical Center (Site 2603)

Maastricht, Limburg, Netherlands

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VU Medisch Centrum (Site 2601)

Amsterdam, North Holland, Netherlands

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University of Otago, Wellington (Site 2701)

Christchurch, Canterbury, New Zealand

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Waikato District Health Board (Site 2702)

Hamilton, Waikato Region, New Zealand

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Greenlane Clinical Centre (Site 2703)

Auckland, , New Zealand

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

Krakow, Lesser Poland Voivodeship, Poland

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

Otwock, Masovian Voivodeship, Poland

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Uniwersytecki Szpital Kliniczny w Bialymstoku (Site 2803)

Bialystok, Podlaskie Voivodeship, Poland

Site Status

Clinical Center of Serbia (Site 2901)

Belgrade, Beograd, Serbia

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Institute of Cardiovascular Diseases Dedinje (Site 2903)

Belgrade, Beograd, Serbia

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University Clinical Center Nis (Site 2904)

Niš, Nisavski Okrug, Serbia

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Gachon University Gil Medical Center (Site 3103)

Incheon, , South Korea

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Seoul National University Hospital (Site 3102)

Seoul, , South Korea

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

Seoul, , South Korea

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Hospital Universitario Marques de Valdecilla (Site 1601)

Santander, Cantabria, Spain

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Hospital Universitario Puerta de Hierro-Majadahonda (Site 1604)

Majadahonda, Madrid, Spain

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Hospital Universitari Vall d'Hebron (Site 1605)

Barcelona, , Spain

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Hospital Clinic de Barcelona (Site 1602)

Barcelona, , Spain

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Hospital Universitario Ramon y Cajal (Site 1609)

Madrid, , Spain

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Hospital Universitario Marques de Valdecilla (Site 1603)

Madrid, , Spain

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Hospital Clinico Universitario de Salamanca (Site 1608)

Salamanca, , Spain

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Akademiska Sjukhuset (Site 3204)

Uppsala, Uppsala County, Sweden

Site Status

Sahlgrenska Universitets Sjukhuset (Site 3201)

Gothenburg, Västra Götaland County, Sweden

Site Status

Hopitaux Universitaires de Geneve HUG (Site 3302)

Thônex, Canton of Geneva, Switzerland

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Universitaetsspital Zuerich (Site 3301)

Zurich, , Switzerland

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Golden Jubilee National Hospital (Site 1204)

Glasgow, Glasgow City, United Kingdom

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Royal Free London NHS Foundation Trust (Site 1202)

London, London, City of, United Kingdom

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Royal Brompton Hospital (Site 1206)

London, London, City of, United Kingdom

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Imperial College Healthcare NHS Trust (Site 1203)

London, London, City of, United Kingdom

Site Status

Countries

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United States Argentina Australia Belgium Brazil Canada Czechia France Germany Israel Italy Mexico Netherlands New Zealand Poland Serbia South Korea Spain Sweden Switzerland United Kingdom

References

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Hoeper MM, Badesch DB, Ghofrani HA, Gibbs JSR, Gomberg-Maitland M, McLaughlin VV, Preston IR, Souza R, Waxman AB, Grunig E, Kopec G, Meyer G, Olsson KM, Rosenkranz S, Xu Y, Miller B, Fowler M, Butler J, Koglin J, de Oliveira Pena J, Humbert M; STELLAR Trial Investigators. Phase 3 Trial of Sotatercept for Treatment of Pulmonary Arterial Hypertension. N Engl J Med. 2023 Apr 20;388(16):1478-1490. doi: 10.1056/NEJMoa2213558. Epub 2023 Mar 6.

Reference Type RESULT
PMID: 36877098 (View on PubMed)

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.

Reference Type DERIVED
PMID: 40526255 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37851297 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37696565 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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Other Identifiers

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7962-003

Identifier Type: OTHER

Identifier Source: secondary_id

2020-004142-11

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

7962-003

Identifier Type: -

Identifier Source: org_study_id

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