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New hope for severe lung disease: drug delays death and hospitalization

NCT ID NCT04896008

Disease control Sponsor: Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a drug called sotatercept in 173 people with severe pulmonary arterial hypertension (PAH), a serious lung condition that makes the heart work too hard. Participants received either the drug or a placebo on top of their usual treatments. The goal was to see if the drug could delay death, the need for a lung transplant, or hospitalization due to worsening PAH.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

173 people

The number who actually took part.

Started

Dec 2021

Finished

Feb 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Documented diagnostic right heart catheterization prior to screening confirming the diagnosis of WHO PAH Group 1 in any of the following subtypes: * Idiopathic PAH * Heritable PAH * Drug/toxin-induced PAH * PAH associated with CTD * PAH associated with simple, congenital systemic to pulmonary shunts at least 1 year following repair * Symptomatic PAH classified as WHO FC III or IV * REVEAL Lite 2.0 risk score of ≥9 * Right heart catheterization performed during screening (or within 2 weeks prior to screening, if done at the clinical study site) documenting a minimum PVR of ≥5 Wood units and a pulmonary capillary wedge pressure (PCWP) or left ventricular end-diastolic pressure (LVEDP) of ≤15 mmHg * Clinically stable and on stable doses of maximum tolerated (per investigator's judgment) double or triple background PAH therapies for at least 30 days prior to screening * Females of childbearing potential must: * Have 2 negative urine or serum pregnancy tests as verified by the investigator prior to starting study therapy; must agree to ongoing urine or serum pregnancy testing during the course of the study and until 8 weeks after the last dose of the study drug * If sexually active with a male partner, have used, and agree to use highly effective contraception without interruption per protocol; 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 (PH) WHO Groups 2, 3, 4, or 5 * Diagnosis of the following PAH Group 1 subtypes: human immunodeficiency virus-associated PAH and PAH associated with portal hypertension * Diagnosis of pulmonary veno-occlusive diseases or pulmonary capillary hemangiomatosis or overt signs of capillary and/or venous involvement * Hemoglobin at screening above gender-specific upper limit of normal (ULN), per local laboratory test * Baseline platelet count \<50,000/mm3 (\<50.0 x 109/L) at screening * Baseline systolic blood pressure \<85 mmHg at screening * Pregnant or breastfeeding women * Serum alanine aminotransferase or aspartate aminotransferase levels or total bilirubin \>3.0×ULN * 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 or known allergic reaction to sotatercept, its excipients or luspatercept * History of pneumonectomy * Untreated more than mild obstructive sleep apnea * History of known pericardial constriction * History of restrictive or congestive cardiomyopathy * Electrocardiogram (ECG) with Fridericia's corrected QT interval (QTcF) \>500 ms during the screening period * Personal or family history of long QT syndrome or sudden cardiac death * Left ventricular ejection fraction \<45% on historical echocardiogram within 1 year prior to the screening visit * Any current or prior history of symptomatic coronary disease (prior myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft surgery, or cardiac anginal chest pain) in the past 6 months prior to the screening visit * Cerebrovascular accident within 3 months prior to the screening visit * Significant (≥ 2+ regurgitation) mitral regurgitation or aortic regurgitation valvular disease * Currently on dialysis or anticipated need for dialysis within the next 12 months

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Conditions

The condition(s) this trial relates to.

hypertensive disorder pulmonary arterial hypertension

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pulmonary arterial hypertension

Contacts and locations

Locations

  • AdventHealth Medical Group Advanced Lung Disease ( Site 1058)

    Orlando, Florida, 32804, United States

  • Arizona Pulmonary Specialists ( Site 1010)

    Phoenix, Arizona, 85013, United States

  • Brigham and Women's Hospital ( Site 1014)

    Boston, Massachusetts, 02115, United States

  • CHRU Lille ( Site 1306)

    Lille, Nord, 59037, France

  • CHU Bicêtre ( Site 1304)

    Le Kremlin-Bicêtre, Val-de-Marne, 94275, France

  • CHU de Nancy - Hôpital de Brabois Adultes ( Site 1308)

    Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54511, France

  • CHU de Poitiers ( Site 1316)

    Poitiers, Vienne, 86021, France

  • Centre Hospitalier Universitaire de Toulouse. ( Site 1315)

    Toulouse, Haute-Garonne, 31059, France

  • David Geffen School of Medicine at UCLA ( Site 1068)

    Los Angeles, California, 90095, United States

  • Duke University Medical Center ( Site 1026)

    Durham, North Carolina, 27713, United States

  • Hospital Universitario "Dr. Jose Eleuterio Gonzalez" ( Site 2504)

    Monterrey, Nuevo León, 64460, Mexico

  • Hospital Universitario 12 de Octubre ( Site 1603)

    Madrid, 28041, Spain

  • Hôpital Erasme ( Site 1402)

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

  • Hôpital Louis Pradel ( Site 1317)

    Bron, Rhone, 69500, France

  • Hôpitaux Universitaires de Strasbourg ( Site 1307)

    Strasbourg, Bas-Rhin, 67000, France

  • Imperial College Healthcare NHS Trust ( Site 1203)

    London, London, City of, W2 1NY, United Kingdom

  • Instituto Nacional De Cardiologia Dr. Ignacio Chavez ( Site 2503)

    Mexico City, Mexico City, 14080, Mexico

  • Jewish General Hospital ( Site 2103)

    Montreal, Quebec, H3T 1E2, Canada

  • John Hunter Hospital ( Site 1101)

    New Lambton Heights, New South Wales, 2305, Australia

  • Krankenhaus Neuwittelsbach ( Site 1510)

    München, Bavaria, 80639, Germany

  • La Sapienza-Università di Roma-Policlinico Umberto I ( Site 2402)

    Roma, 161, Italy

  • Lady Davis Carmel Medical Center ( Site 1705)

    Haifa, 34362, Israel

  • Mayo Clinic Jacksonville - PPDS ( Site 1045)

    Jacksonville, Florida, 32224, United States

  • Medical College of Wisconsin - Froedtert Hospital ( Site 1051)

    Milwaukee, Wisconsin, 53226, United States

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

    Charleston, South Carolina, 29425, United States

  • Medizinische Hochschule Hannover ( Site 1505)

    Hanover, Lower Saxony, 30625, Germany

  • Northside Hospital ( Site 1073)

    Atlanta, Georgia, 30342, United States

  • Ospedale S. Giuseppe Multimedica ( Site 2403)

    Milan, Lombardy, 20123, Italy

  • Peter Lougheed Centre ( Site 2102)

    Calgary, Alberta, T1Y 6J4, Canada

  • Royal Brompton Hospital ( Site 1206)

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

  • Royal Papworth Hospital ( Site 1208)

    Cambridge, Cambridgeshire, CB23 3RE, United Kingdom

  • St Vincent's Hospital Sydney ( Site 1102)

    Darlinghurst, New South Wales, 2010, Australia

  • Statcare Pulmonary Consultants - Knoxville ( Site 1031)

    Knoxville, Tennessee, 37909, United States

  • The Cleveland Clinic Foundation. ( Site 1065)

    Cleveland, Ohio, 44103-3736, United States

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

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

  • Thoraxklinik-Heidelberg gGmbH ( Site 1509)

    Heidelberg, Baden-Wurttemberg, 69126, Germany

  • Tufts Medical Center - PPDS ( Site 1012)

    Boston, Massachusetts, 02111, United States

  • UZ Leuven Campus Gasthuisberg ( Site 1401)

    Leuven, Vlaams-Brabant, 3000, Belgium

  • Unidad de Investigación Clínica en Medicina, S.C ( Site 2505)

    Monterrey, Nuevo León, 64718, Mexico

  • Uniklinik Köln ( Site 1511)

    Cologne, North Rhine-Westphalia, 50937, Germany

  • Universitaetsklinikum Giessen und Marburg GmbH ( Site 1512)

    Giessen, Hesse, 35392, Germany

  • University Of Iowa Hospitals and Clinics ( Site 1050)

    Iowa City, Iowa, 52242, United States

  • University Of Texas Southwestern Medical Center ( Site 1038)

    Dallas, Texas, 75390, United States

  • University of California Irvine ( Site 1086)

    Orange, California, 92868-2994, United States

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

    San Diego, California, 92037, United States

  • University of California San Francisco ( Site 1019)

    San Francisco, California, 94118, United States

  • University of Cincinnati Medical Center ( Site 1035)

    Cincinnati, Ohio, 45267-0558, United States

  • University of Colorado Hospital ( Site 1013)

    Aurora, Colorado, 80045, United States

  • University of Kansas Medical Center ( Site 1020)

    Kansas City, Kansas, 66160, United States

  • University of Michigan ( Site 1011)

    Ann Arbor, Michigan, 48109, United States

  • University of Nebraska Medical Center ( Site 1053)

    Omaha, Nebraska, 68105, United States

  • University of New Mexico Health Sciences Center ( Site 1048)

    Albuquerque, New Mexico, 87131, United States

  • University of Rochester Medical Center - PPDS ( Site 1039)

    Rochester, New York, 14642-0001, United States

  • Universitätsklinikum Carl Gustav Carus an der TU Dresden. ( Site 1501)

    Dresden, Saxony, 01307, Germany

  • Universitätsklinikum des Saarlandes ( Site 1513)

    Homburg, Saarland, 66424, Germany

  • VU Medisch Centrum ( Site 2601)

    Amsterdam, North Holland, 1081 HV, Netherlands

  • Washington University School of Medicine ( Site 1022)

    St Louis, Missouri, 63110, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.