New hope for PAH patients: Long-Term sotatercept trial launches
NCT ID NCT07218029
First seen Jun 27, 2026 · Last updated Sep 10, 2026 · Updated 17 times
Summary
This long-term study follows people with pulmonary arterial hypertension (PAH) who previously took part in sotatercept trials. Sotatercept is a targeted therapy that aims to stop PAH from getting worse. Researchers will monitor safety, side effects, and how well patients tolerate the drug over time.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- sotatercept
- What this could lead to
- If it works, this could provide a long-term treatment option that slows PAH progression and improves daily function.
- What could go wrong
- This is an open-label study without a placebo group, so results may be less conclusive. Side effects or lack of long-term benefit are possible.
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
-
About 815 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
May 2021
- Expected to finish
-
Dec 2028
An estimate. End dates often move.
- 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 years and older
- 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 Hide 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: The main inclusion criteria include but are not limited to the following: * Has completed their current respective PAH sotatercept clinical study and its requirements, and must not have discontinued early * Is willing to adhere to the study visit schedule, and understands and will comply with all protocol requirements * Must have the ability to understand and provide documented informed consent Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Did not participate in a sotatercept PAH parent study * Missed more than the equivalent of 4 consecutive doses between the end of parent study and the start of this study. * Presence of an ongoing serious adverse event that occurred during a PAH sotatercept clinical study that is assessed to be possibly or probably related to sotatercept * Is a female who is pregnant or breastfeeding * Is or has an immediate family member who is investigational site or Sponsor staff directly involved with this study * Is currently enrolled in another investigational product study other than a sotatercept study * Is incapacitated
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Pulmonary arterial hypertension are added.
By submitting, you agree to our Terms of use
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The study's own enquiry address
This study publishes an address for enquiries. See it below .
-
The places running it
21 sites in 6 countries. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
Enter your email to view the contact information for this study.
By submitting, you agree to our Terms of use
Study contacts
-
Contact
Email: •••••@•••••
Locations
-
A.O.R.N. Ospedale dei Colli - Monaldi V. ( Site 2407)
ACTIVE_NOT_RECRUITINGNaples, 80131, Italy
-
AHEPA University General Hospital of Thessaloniki-1st Cardiology Clinic ( Site 3601)
ACTIVE_NOT_RECRUITINGThessaloniki, 546 36, Greece
-
AOU Policlinico Umberto I ( Site 2402)
ACTIVE_NOT_RECRUITINGRome, Roma, 00161, Italy
-
ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 3604)
ACTIVE_NOT_RECRUITINGAthens, Attica, 124 62, Greece
-
Aarhus Universitetshospital, Skejby ( Site 3801)
ACTIVE_NOT_RECRUITINGAarhus, Central Jutland, 8200, Denmark
-
AdventHealth Orlando ( Site 1058)
ACTIVE_NOT_RECRUITINGOrlando, Florida, 32803, United States
-
Amsterdam UMC, locatie VUmc ( Site 2601)
ACTIVE_NOT_RECRUITINGAmsterdam, North Holland, 1081 HV, Netherlands
-
Arizona Pulmonary Specialists ( Site 1010)
RECRUITINGScottsdale, Arizona, 85258, United States
-
Brigham and Women's Hospital ( Site 1014)
RECRUITINGBoston, Massachusetts, 02115, United States
-
CHI St. Luke's Health Baylor College of Medicine Medical Center ( Site 1044)
ACTIVE_NOT_RECRUITINGHouston, Texas, 77030, United States
-
CHU Angers ( Site 1313)
ACTIVE_NOT_RECRUITINGAngers, Maine-et-Loire, 49100, France
-
CHU Bordeaux Haut-Leveque ( Site 1312)
RECRUITINGPessac, Aquitaine, 33604, France
-
CHU de Grenoble Hopital Nord ( Site 1303)
ACTIVE_NOT_RECRUITINGLa Tronche, Isere, 38700, France
-
CHU de la Miletrie Poitiers ( Site 1316)
RECRUITINGPoitiers, Vienne, 86021, France
-
Carmel Hospital ( Site 1705)
ACTIVE_NOT_RECRUITINGHaifa, 3436212, Israel
-
Centre Hospitalier Universitaire de Nice - Hopital Pasteur ( Site 1311)
RECRUITINGNice, Alpes-Maritimes, 06300, France
-
Centre Hospitalier Universitaire de Saint Étienne- Hôpital Nord-Medecine Vasculaire et Therapeutique ( Site 1302)
RECRUITINGSaint-Étienne-de-Montluc, Pays de la Loire Region, 42055, France
-
Cleveland Clinic Main ( Site 1065)
ACTIVE_NOT_RECRUITINGCleveland, Ohio, 44195, United States
-
Clínica Imbanaco S.A.S ( Site 3404)
ACTIVE_NOT_RECRUITINGCali, Valle del Cauca Department, 760042, Colombia
-
DRK Kliniken Berlin Westend ( Site 1507)
ACTIVE_NOT_RECRUITINGBerlin, 14050, Germany
-
Duke University Medical Center ( Site 1026)
ACTIVE_NOT_RECRUITINGDurham, North Carolina, 27710-4000, United States
-
Europejskie Centrum Zdrowia Otwock ( Site 2802)
ACTIVE_NOT_RECRUITINGOtwock, Masovian Voivodeship, 05-400, Poland
-
Fiona Stanley Hospital ( Site 1103)
ACTIVE_NOT_RECRUITINGMurdoch, Western Australia, 6150, Australia
-
Fondazione IRCCS San Gerardo dei Tintori ( Site 2406)
ACTIVE_NOT_RECRUITINGMonza, Lombardy, 20900, Italy
-
Freeman Hospital ( Site 1205)
ACTIVE_NOT_RECRUITINGNewcastle upon Tyne, NE7 7DN, United Kingdom
-
Froedtert Hospital & the Medical College of Wisconsin ( Site 1051)
ACTIVE_NOT_RECRUITINGMilwaukee, Wisconsin, 53226, United States
-
Fundación Neumológica Colombiana ( Site 3403)
ACTIVE_NOT_RECRUITINGBogotá, Bogota D.C., 110131, Colombia
-
Gachon University Gil Medical Center ( Site 3103)
ACTIVE_NOT_RECRUITINGIncheon, 21565, South Korea
-
George Washington University Medical Faculty Associates ( Site 1025)
ACTIVE_NOT_RECRUITINGWashington D.C., District of Columbia, 20037, United States
-
Golden Jubilee National Hospital ( Site 1204)
ACTIVE_NOT_RECRUITINGGlasgow, Glasgow City, G81 4DY, United Kingdom
-
HOSPITAL GENERAL UNIVERSITARIO DE TOLEDO ( Site 1607)
ACTIVE_NOT_RECRUITINGToledo, 45007, Spain
-
Haddasah Medical Center ( Site 1711)
ACTIVE_NOT_RECRUITINGJerusalem, 9112001, Israel
-
Hammersmith Hospital ( Site 1203)
ACTIVE_NOT_RECRUITINGLondon, London, City of, W12 0HS, United Kingdom
-
Hopital Cavale Blanche ( Site 1314)
RECRUITINGBrest, Finistere, 29609, France
-
Hopital Larrey ( Site 1315)
ACTIVE_NOT_RECRUITINGToulouse, Haute-Garonne, 31400, France
-
Hopital Nord Laennec ( Site 1309)
RECRUITINGSaint-Herblain, Loire-Atlantique, 44800, France
-
Hospital Clinic de Barcelona ( Site 1602)
ACTIVE_NOT_RECRUITINGBarcelona, 08036, Spain
-
Hospital Dia do Pulmao ( Site 1802)
RECRUITINGBlumenau, Santa Catarina, 89010-000, Brazil
-
Hospital Garcia de Orta ( Site 3501)
ACTIVE_NOT_RECRUITINGAlmada, Setúbal District, 2805-267, Portugal
-
Hospital General Universitario Ramon y Cajal ( Site 1609)
ACTIVE_NOT_RECRUITINGMadrid, 28048, Spain
-
Hospital Madre Teresa ( Site 1804)
RECRUITINGBelo Horizonte, Minas Gerais, 30441-070, Brazil
-
Hospital Provincial Dr. Jose M. Cullen ( Site 1902)
ACTIVE_NOT_RECRUITINGSanta Fe, S3000EOZ, Argentina
-
Hospital Provincial del Centenario ( Site 1912)
ACTIVE_NOT_RECRUITINGRosario, Santa Fe Province, S2002KDS, Argentina
-
Hospital Pulido Valente ( Site 3503)
ACTIVE_NOT_RECRUITINGLisbon, 1769-001, Portugal
-
Hospital Sao Paulo ( Site 1806)
RECRUITINGSão Paulo, São Paulo, 04024-002, Brazil
-
Hospital Universitari Vall D Hebron ( Site 1605)
ACTIVE_NOT_RECRUITINGBarcelona, Catalonia, 08035, Spain
-
Hospital Universitario 12 de Octubre ( Site 1603)
ACTIVE_NOT_RECRUITINGMadrid, Madrid, Comunidad de, 28041, Spain
-
Hospital Universitario La Paz ( Site 1610)
ACTIVE_NOT_RECRUITINGMadrid, 28046, Spain
-
Hospital Universitario Marques de Valdecilla ( Site 1601)
ACTIVE_NOT_RECRUITINGSantander, Cantabria, 39008, Spain
-
Hospital Universitario Puerta de Hierro-Majadahonda ( Site 1604)
ACTIVE_NOT_RECRUITINGMajadahonda, Madrid, 28222, Spain
-
Hospital Universitario de Son Espases ( Site 1611)
ACTIVE_NOT_RECRUITINGPalma de Mallorca, Balearic Islands, 07120, Spain
-
Houston Methodist Hospital ( Site 1009)
ACTIVE_NOT_RECRUITINGHouston, Texas, 77030, United States
-
Hôpital Louis Pradel ( Site 1317)
RECRUITINGLyon, Rhone, 69677, France
-
Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre-Pneumologie ( Site 1304)
RECRUITINGLe Kremlin-Bicêtre, Val-de-Marne, 94275, France
-
Institut Coeur Poumon - CHRU de Lille ( Site 1306)
RECRUITINGLille, Hauts-de-France, 59037, France
-
Institut Klinicke a Experimentalni Mediciny ( Site 2202)
ACTIVE_NOT_RECRUITINGPrague, Praha 4, 140 21, Czechia
-
Institute for Cardiovascular Diseases Dedinje ( Site 2903)
ACTIVE_NOT_RECRUITINGBelgrade, 11000, Serbia
-
Institute for pulmonary diseases of Vojvodina ( Site 2906)
ACTIVE_NOT_RECRUITINGNovi Sad, Beograd, 21000, Serbia
-
Instituto Cardiovascular de Rosario ( Site 1906)
ACTIVE_NOT_RECRUITINGRosario, Santa Fe Province, S2000DSR, Argentina
-
Instituto Médico Río Cuarto ( Site 1907)
ACTIVE_NOT_RECRUITINGRío Cuarto, Córdoba Province, X5800AEV, Argentina
-
Instituto Nacional de Cardiologia Ignacio Chavez ( Site 2503)
RECRUITINGMexico City, Mexico City, 14080, Mexico
-
Instituto de Investigaciones Clinicas Quilmes ( Site 1903)
ACTIVE_NOT_RECRUITINGQuilmes, Buenos Aires, B1878GEG, Argentina
-
Instituto do Coracao - HCFMUSP ( Site 1803)
RECRUITINGSão Paulo, 05403-000, Brazil
-
Irmandade da Santa Casa de Misericórdia de Porto Alegre ( Site 1805)
ACTIVE_NOT_RECRUITINGPorto Alegre, Rio Grande do Sul, 90020-090, Brazil
-
Jeffrey S. Sager, MD Medical Corporation ( Site 1060)
ACTIVE_NOT_RECRUITINGSanta Barbara, California, 93105-5316, United States
-
John Hunter Hospital ( Site 1101)
ACTIVE_NOT_RECRUITINGNew Lambton Heights, New South Wales, 2305, Australia
-
Johns Hopkins University ( Site 1036)
ACTIVE_NOT_RECRUITINGBaltimore, Maryland, 21287, United States
-
Kaohsiung Veteran General Hospital ( Site 3702)
ACTIVE_NOT_RECRUITINGKaohsiung City, 813, Taiwan
-
Klinicki Bolnicki Centar Split ( Site 3901)
ACTIVE_NOT_RECRUITINGSplit, Split-Dalmatia County, 21000, Croatia
-
Krakowski Szpital Specjalistyczny im. Jana Pawla II ( Site 2801)
ACTIVE_NOT_RECRUITINGKrakow, Lesser Poland Voivodeship, 31-202, Poland
-
Krankenhaus Neuwittelsbach ( Site 1510)
ACTIVE_NOT_RECRUITINGMunich, Bavaria, 80639, Germany
-
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center ( Site 1028)
ACTIVE_NOT_RECRUITINGTorrance, California, 90502, United States
-
Mayo Clinic Jacksonville ( Site 1045)
ACTIVE_NOT_RECRUITINGJacksonville, Florida, 32224, United States
-
Medical University of South Carolina ( Site 1003)
RECRUITINGCharleston, South Carolina, 29425, United States
-
Medizinische Hochschule Hannover ( Site 1505)
ACTIVE_NOT_RECRUITINGHanover, Lower Saxony, 30625, Germany
-
Meir Medical Center ( Site 1707)
COMPLETEDKfar Saba, 4428164, Israel
-
National Cheng Kung University Hospital ( Site 3703)
ACTIVE_NOT_RECRUITINGTainan, 704302, Taiwan
-
Norton Pulmonary Specialists ( Site 1066)
ACTIVE_NOT_RECRUITINGLouisville, Kentucky, 40202, United States
-
Nouvel Hôpital Civil (NHC) ( Site 1307)
ACTIVE_NOT_RECRUITINGStrasbourg, Bas-Rhin, 67000, France
-
Ohio State University Wexner Medical Center ( Site 1032)
ACTIVE_NOT_RECRUITINGColumbus, Ohio, 43210, United States
-
Onassis Cardiac Surgery Center ( Site 3602)
ACTIVE_NOT_RECRUITINGAthens, Attica, 176 74, Greece
-
Oregon Health & Science University ( Site 1054)
ACTIVE_NOT_RECRUITINGPortland, Oregon, 97239, United States
-
Ospedale San Giuseppe ( Site 2403)
ACTIVE_NOT_RECRUITINGMilan, Milano, 20123, Italy
-
Papworth Hospital NHS Foundation Trust ( Site 1208)
ACTIVE_NOT_RECRUITINGCambridge, Cambridgeshire, CB2 0AY, United Kingdom
-
Peter Lougheed Centre ( Site 2102)
ACTIVE_NOT_RECRUITINGCalgary, Alberta, T1Y 6J4, Canada
-
Pulmonary Associates, PA ( Site 1008)
ACTIVE_NOT_RECRUITINGPhoenix, Arizona, 85032, United States
-
Rabin Medical Center ( Site 1703)
ACTIVE_NOT_RECRUITINGPetah Tikva, 4941492, Israel
-
Radboud University Nijmegen Medical Centre ( Site 2605)
ACTIVE_NOT_RECRUITINGNijmegen, Gelderland, 6525 GA, Netherlands
-
Rhode Island Hospital ( Site 1033)
ACTIVE_NOT_RECRUITINGProvidence, Rhode Island, 02903, United States
-
Rigshospitalet ( Site 3802)
ACTIVE_NOT_RECRUITINGKøbenhavn Ø, Capital Region, 2100, Denmark
-
Royal Adelaide Hospital ( Site 1109)
ACTIVE_NOT_RECRUITINGAdelaide, South Australia, 5000, Australia
-
Royal Brompton Hospital ( Site 1206)
ACTIVE_NOT_RECRUITINGLondon, London, City of, SW3 6NP, United Kingdom
-
Royal Free Hospital ( Site 1202)
ACTIVE_NOT_RECRUITINGLondon, London, City of, NW3 2QG, United Kingdom
-
Royal Hallamshire Hospital ( Site 1207)
ACTIVE_NOT_RECRUITINGSheffield, S10 2JF, United Kingdom
-
Royal Hobart Hospital ( Site 1107)
ACTIVE_NOT_RECRUITINGHobart, Tasmania, 7000, Australia
-
Royal Prince Alfred Hospital ( Site 1106)
ACTIVE_NOT_RECRUITINGCamperdown, New South Wales, 2050, Australia
-
Sahlgrenska Universitetssjukhuset ( Site 3201)
ACTIVE_NOT_RECRUITINGGothenburg, Västra Götaland County, 41346, Sweden
-
Saint Vincents Hospital Sydney ( Site 1102)
RECRUITINGDarlinghurst, New South Wales, 2010, Australia
-
Samsung Medical Center ( Site 3106)
ACTIVE_NOT_RECRUITINGSeoul, 06351, South Korea
-
Sanatorio Allende ( Site 1908)
ACTIVE_NOT_RECRUITINGCórdoba, X5021FPQ, Argentina
-
Sanatorio Parque ( Site 1905)
ACTIVE_NOT_RECRUITINGRosario, Santa Fe Province, S2000CUB, Argentina
-
Severance Hospital, Yonsei University Health System ( Site 3101)
ACTIVE_NOT_RECRUITINGSeoul, 03722, South Korea
-
Sheba Medical Center ( Site 1701)
ACTIVE_NOT_RECRUITINGRamat Gan, 5265601, Israel
-
St. Joseph's Healthcare Hamilton ( Site 2105)
RECRUITINGHamilton, Ontario, L8N 4A6, Canada
-
Tampa General Hospital ( Site 1043)
ACTIVE_NOT_RECRUITINGTampa, Florida, 33606, United States
-
The Carl and Edyth Lindner Center for Research and Education at the Christ Hospital ( Site 1001)
ACTIVE_NOT_RECRUITINGCincinnati, Ohio, 45219, United States
-
The Prince Charles Hospital ( Site 1104)
ACTIVE_NOT_RECRUITINGChermside, New South Wales, 4032, Australia
-
Thoraxklinik-Heidelberg gGmbH ( Site 1509)
ACTIVE_NOT_RECRUITINGHeidelberg, Baden-Wurttemberg, 69126, Germany
-
Tufts Medical Center ( Site 1012)
ACTIVE_NOT_RECRUITINGBoston, Massachusetts, 02111, United States
-
UC Davis - Medial Center ( Site 1064)
RECRUITINGSacramento, California, 95817, United States
-
UC Irvine Health Medical Center ( Site 1086)
ACTIVE_NOT_RECRUITINGOrange, California, 92868, United States
-
UCSF Helen Diller Medical Center at Parnassus Heights ( Site 1019)
ACTIVE_NOT_RECRUITINGSan Francisco, California, 94143, United States
-
UKGM Gießen/Marburg ( Site 1512)
ACTIVE_NOT_RECRUITINGGiessen, Hesse, 35392, Germany
-
UZ Leuven ( Site 1401)
ACTIVE_NOT_RECRUITINGLeuven, Vlaams-Brabant, 3000, Belgium
-
Unidad de Investigacion Clinica en Medicina, S.C. ( Site 2505)
RECRUITINGMonterrey, Nuevo León, 64718, Mexico
-
Universitaetsklinik Regensburg ( Site 1503)
ACTIVE_NOT_RECRUITINGRegensburg, Bavaria, 93053, Germany
-
Universitaetsklinikum Carl Gustav Carus ( Site 1501)
ACTIVE_NOT_RECRUITINGDresden, Saxony, 01307, Germany
-
Universitaetsklinikum Koeln ( Site 1511)
ACTIVE_NOT_RECRUITINGCologne, North Rhine-Westphalia, 50937, Germany
-
University Clinical Hospital Center of Serbia ( Site 2901)
ACTIVE_NOT_RECRUITINGBelgrade, Beograd, 11000, Serbia
-
University Of Nebraska Medical Center ( Site 1053)
ACTIVE_NOT_RECRUITINGOmaha, Nebraska, 68198-5990, United States
-
University of Alberta Hospital ( Site 2101)
ACTIVE_NOT_RECRUITINGEdmonton, Alberta, T6G 2B7, Canada
-
University of Arizona ( Site 1006)
ACTIVE_NOT_RECRUITINGTucson, Arizona, 85724-0001, United States
-
University of California San Diego Health ( Site 1002)
ACTIVE_NOT_RECRUITINGLa Jolla, California, 92039, United States
-
University of Cincinnati Medical Center ( Site 1035)
ACTIVE_NOT_RECRUITINGCincinnati, Ohio, 45219, United States
-
University of Colorado Hospital ( Site 1013)
ACTIVE_NOT_RECRUITINGAurora, Colorado, 80045, United States
-
University of Kansas Medical Center ( Site 1020)
ACTIVE_NOT_RECRUITINGKansas City, Kansas, 66160, United States
-
University of Minnesota ( Site 1062)
ACTIVE_NOT_RECRUITINGMinneapolis, Minnesota, 55455, United States
-
University of Pittsburgh Medical Center - Presbyterian Hosp. ( Site 1059)
ACTIVE_NOT_RECRUITINGPittsburgh, Pennsylvania, 15213, United States
-
University of Texas Southwestern Medical Center ( Site 1038)
ACTIVE_NOT_RECRUITINGDallas, Texas, 75390, United States
-
UniversitätsSpital Zürich ( Site 3301)
ACTIVE_NOT_RECRUITINGZurich, 8091, Switzerland
-
Universitätsklinikum Halle ( Site 1502)
ACTIVE_NOT_RECRUITINGHalle, Saxony-Anhalt, 06120, Germany
-
Universitätsklinikum Leipzig ( Site 1508)
ACTIVE_NOT_RECRUITINGLeipzig, Saxony, 04103, Germany
-
Université Libre de Bruxelles - Hôpital Erasme ( Site 1402)
ACTIVE_NOT_RECRUITINGBrussels, Bruxelles-Capitale, Region de, 1070, Belgium
-
Vseobecna fakultni nemocnice v Praze ( Site 2201)
ACTIVE_NOT_RECRUITINGPrague, 128 08, Czechia
-
Waikato Hospital ( Site 2702)
ACTIVE_NOT_RECRUITINGHamilton, Waikato Region, 3240, New Zealand
-
Weill Cornell Medical Center ( Site 1046)
ACTIVE_NOT_RECRUITINGNew York, New York, 10021, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can Device-Preserved donor lungs boost transplant success?
- A 10-Question survey could give brazilian pulmonary hypertension patients a voice in their care
- Experimental blood pressure drug put to the test in healthy volunteers
- Can a new drug keep pulmonary arterial hypertension in check over the long haul?
- Could light leg workouts revive Oxygen-Starved muscles in PAH?
- Texting therapy: could a simple phone message boost exercise and quality of life in a rare lung disease?