Clinical trial • Phase II • Cardiology
SOTATERCEPT for Pulmonary Hypertension | Heart failure with preserved ejection fraction (HFpEF)
Phase II trial of SOTATERCEPT for Pulmonary Hypertension | Heart failure with preserved ejection fraction (HFpEF). 69 participants.
Overview
- Trial Therapeutic Area
- Cardiology
- Trial Disease
- Pulmonary Hypertension | Heart failure with preserved ejection fraction (HFpEF)
- Trial Stage
- Phase II
- Drug Modality
- Peptide/protein/enzyme
Key dates
- Initial CTIS Submission Date
- 08-01-2025
- First CTIS Authorization Date
- 28-04-2025
Trial design
Phase II trial in Belgium, France, Germany and others.
- Target Sample Size
- 69
- Trial Duration For Participant
- 1260
Eligibility
Recruits 69 No vulnerable populations selected. Trial enrols adult patients; informed consent required from participants. No assent or minor consent procedures are specified..
- Pregnancy Exclusion
- Is pregnant or breastfeeding
- Vulnerable Population
- No vulnerable populations selected. Trial enrols adult patients; informed consent required from participants. No assent or minor consent procedures are specified.
Inclusion criteria
- {"criterion_text":"- Completed MK-7962-007 (CADENCE) (Visit 9 and EOT visit) without discontinuing study intervention and is able to safely enroll into MK-7962-007 (HARMONIZE)"}
Exclusion criteria
- {"criterion_text":"- Has a diagnosis of pulmonary hypertension (PH) in world health organization (WHO) Group 1, WHO Group 3, WHO Group 4, or WHO Group 5\n- Has had a study intervention interruption\n- Is pregnant or breastfeeding\n- Has chronic liver disease with severe hepatic impairment and/or cirrhosis (eg, hepatic encephalopathy)\n- Anticipation of more than 1 valve replacement or repair (mechanical or biomechanical) and/or have undergone more than 1 valve replacement or repair\n- Has severe tricuspid regurgitation due to primary valvular disease (eg, from endocarditis, carcinoid, or mechanical destruction)\n- Anticipated or undergone heart transplant or ventricular assist device implantation\n- Has had prior exposure to luspatercept"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Number of Participants Who Experience an Adverse Event (AE)","definition_or_measurement_approach":"Count of participants who experience any adverse event (AE) as recorded during the study."}
- {"endpoint_text":"- Number of Participants Who Discontinue Study Treatment Due to an AE","definition_or_measurement_approach":"Count of participants who discontinue study treatment because of an adverse event (AE)."}
Secondary endpoints
- {"endpoint_text":"- Change From Baseline in Pulmonary Vascular Resistance (PVR) at Week 48","definition_or_measurement_approach":"Change from baseline in PVR measured at Week 48."}
- {"endpoint_text":"- Change From Baseline in the 6-Minute Walk Distance (6MWD) at Week 48","definition_or_measurement_approach":"Change from baseline in 6MWD measured at Week 48."}
- {"endpoint_text":"- Change From Baseline in the 6MWD at Week 126","definition_or_measurement_approach":"Change from baseline in 6MWD measured at Week 126."}
- {"endpoint_text":"- Change From Baseline in the 6MWD at Week 174","definition_or_measurement_approach":"Change from baseline in 6MWD measured at Week 174."}
- {"endpoint_text":"- Change From Baseline in New York Heart Association Functional Class (NYHA FC) at Week 48","definition_or_measurement_approach":"Change from baseline in NYHA functional class measured at Week 48."}
- {"endpoint_text":"- Change From Baseline in NYHA FC at Week 126","definition_or_measurement_approach":"Change from baseline in NYHA functional class measured at Week 126."}
- {"endpoint_text":"- Change From Baseline in NYHA FC at Week 174","definition_or_measurement_approach":"Change from baseline in NYHA functional class measured at Week 174."}
- {"endpoint_text":"- Change From Baseline in N-terminal Pro-hormone Brain Natriuretic Peptide (NT-proBNP) at Week 48","definition_or_measurement_approach":"Change from baseline in NT-proBNP concentration measured at Week 48."}
- {"endpoint_text":"- Change From Baseline in NT-proBNP at Week 126","definition_or_measurement_approach":"Change from baseline in NT-proBNP concentration measured at Week 126."}
- {"endpoint_text":"- Change From Baseline in NT-proBNP at Week 174","definition_or_measurement_approach":"Change from baseline in NT-proBNP concentration measured at Week 174."}
- {"endpoint_text":"- Change From Week 24 in PVR at Week 48","definition_or_measurement_approach":"Change in PVR from Week 24 to Week 48."}
- {"endpoint_text":"- Change From Week 24 in 6MWD at Week 48","definition_or_measurement_approach":"Change in 6MWD from Week 24 to Week 48."}
- {"endpoint_text":"- Change From Week 24 in NYHA FC at Week 48","definition_or_measurement_approach":"Change in NYHA functional class from Week 24 to Week 48."}
Recruitment
- Planned Sample Size
- 69
- Recruitment Window Months
- 48
- Consent Approach
- Informed consent is obtained from adult participants. Subject information and main consent forms (L1_ICF_Main consent) and optional consent documents are provided; consent documents are available in country-specific languages as indicated in submitted documents (examples include English, Swedish, Spanish, Italian, French, Polish, German, Dutch). Optional ICFs (e.g. pregnancy follow-up, optional eCOA Greenphire forms) are provided where applicable.
Geography
- Total Number Of Sites
- 27
- Total Number Of Participants
- 63
Belgium
- Earliest CTIS Part Ii Submission Date
- 27-03-2025
- Latest Decision Or Authorization Date
- 15-09-2025
- Processing Time Days
- 172
- Number Of Sites
- 1
- Number Of Participants
- 1
Sites
- Site Name
- Hopital Erasme
- Department Name
- Cardiology
- Principal Investigator Name
- Jean-Luc Vachiéry
- Principal Investigator Email
- jean.luc.vachiery@hubruxelles.be
- Contact Person Name
- Jean-Luc Vachiéry
- Contact Person Email
- jean.luc.vachiery@hubruxelles.be
France
- Earliest CTIS Part Ii Submission Date
- 22-01-2025
- Latest Decision Or Authorization Date
- 19-08-2025
- Processing Time Days
- 209
- Number Of Sites
- 6
- Number Of Participants
- 14
Sites
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Cardiology and vascular disease
- Principal Investigator Name
- Laurianne Le Gloan
- Principal Investigator Email
- laurianne.legloan@gmail.com
- Contact Person Name
- Laurianne Le Gloan
- Contact Person Email
- laurianne.legloan@gmail.com
- Site Name
- Centre Hospitalier Regional D'Angers
- Department Name
- Department of Respiratory and Sleep Medicine
- Principal Investigator Name
- Frederic Gagnadoux
- Principal Investigator Email
- Fgagnadoux@chu-angers.fr
- Contact Person Name
- Frederic Gagnadoux
- Contact Person Email
- Fgagnadoux@chu-angers.fr
- Site Name
- Centre Hospitalier Universitaire De Montpellier
- Department Name
- Cardiology
- Principal Investigator Name
- Francois Roubille
- Principal Investigator Email
- f-roubille@chu-montpellier.fr
- Contact Person Name
- Francois Roubille
- Contact Person Email
- f-roubille@chu-montpellier.fr
- Site Name
- Bicetre Hospital
- Department Name
- Service de pneumologie et réanimation respiratoire
- Principal Investigator Name
- David MONTANI
- Principal Investigator Email
- david.montani@bct.aphp.fr
- Contact Person Name
- David MONTANI
- Contact Person Email
- david.montani@bct.aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Nice
- Department Name
- Cardiologie
- Principal Investigator Name
- Delphine Baudouy
- Principal Investigator Email
- baudouy.d@chu-nice.fr
- Contact Person Name
- Delphine Baudouy
- Contact Person Email
- baudouy.d@chu-nice.fr
- Site Name
- Centre Hospitalier Universitaire Rouen
- Department Name
- Service de Pneumologie, Oncologie Thoracique Tel: 02 32 88 59 92 et Soins Intensifs Respiratoires
- Principal Investigator Name
- Elise Artaud-Macari
- Principal Investigator Email
- Elise.artaud-macari@chu-rouen.fr
- Contact Person Name
- Elise Artaud-Macari
- Contact Person Email
- Elise.artaud-macari@chu-rouen.fr
Germany
- Earliest CTIS Part Ii Submission Date
- 27-03-2025
- Latest Decision Or Authorization Date
- 01-10-2025
- Processing Time Days
- 188
- Number Of Sites
- 8
- Number Of Participants
- 12
Sites
- Site Name
- Technische Universitaet Dresden
- Department Name
- Medizinische Klinik I, Pneumologie
- Principal Investigator Name
- Michael Halank
- Principal Investigator Email
- pulmo.studien@ukdd.de
- Contact Person Name
- Michael Halank
- Contact Person Email
- pulmo.studien@ukdd.de
- Site Name
- Thoraxklinik Heidelberg gGmbH
- Department Name
- Universitaetsklinikum Heidelberg
- Principal Investigator Name
- Ekkehard Grünig
- Principal Investigator Email
- PH-Studies.THOR@med.uni-heidelberg.de
- Contact Person Name
- Ekkehard Grünig
- Contact Person Email
- PH-Studies.THOR@med.uni-heidelberg.de
- Site Name
- Kerckhoff-Klinik GmbH
- Department Name
- Kardiologie
- Principal Investigator Name
- Andreas Rieth
- Principal Investigator Email
- forschung-und-lehre@kerckhoff-klinik.de
- Contact Person Name
- Andreas Rieth
- Contact Person Email
- forschung-und-lehre@kerckhoff-klinik.de
- Site Name
- Justus-Liebig-Universitaet Giessen
- Department Name
- Medizinische Klinik und Poliklinik II
- Principal Investigator Name
- Ardeschir Ghofrani
- Principal Investigator Email
- Ardeschir.Ghofrani@innere.med.uni-giessen.de
- Contact Person Name
- Ardeschir Ghofrani
- Contact Person Email
- Ardeschir.Ghofrani@innere.med.uni-giessen.de
- Site Name
- Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
- Department Name
- Zentrum für Kardiologie, Kardiologie I
- Principal Investigator Name
- Kai-Helge Schmidt
- Principal Investigator Email
- studienzentrum-zfk@unimedizin-mainz.de
- Contact Person Name
- Kai-Helge Schmidt
- Contact Person Email
- studienzentrum-zfk@unimedizin-mainz.de
- Site Name
- DRK Kliniken Berlin
- Department Name
- Klinik für Innere Medizin, Kardiologie
- Principal Investigator Name
- Christian Opitz
- Principal Investigator Email
- c.opitz@drk-kliniken-berlin.de
- Contact Person Name
- Christian Opitz
- Contact Person Email
- c.opitz@drk-kliniken-berlin.de
- Site Name
- Krankenhaus Neuwittelsbach
- Department Name
- Zentrum für Lungenhochdruck
- Principal Investigator Name
- Hanno Leuchte
- Principal Investigator Email
- Sekretariat.MED2@krankenhaus-neuwittelsbach.de
- Contact Person Name
- Hanno Leuchte
- Contact Person Email
- Sekretariat.MED2@krankenhaus-neuwittelsbach.de
- Site Name
- University Hospital Cologne AöR
- Department Name
- Innere Medizin III
- Principal Investigator Name
- Stephan Rosenkranz
- Principal Investigator Email
- stephan.rosenkranz@uk-koeln.de
- Contact Person Name
- Stephan Rosenkranz
- Contact Person Email
- stephan.rosenkranz@uk-koeln.de
Italy
- Earliest CTIS Part Ii Submission Date
- 03-03-2025
- Latest Decision Or Authorization Date
- 21-08-2025
- Processing Time Days
- 171
- Number Of Sites
- 3
- Number Of Participants
- 7
Sites
- Site Name
- Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
- Department Name
- "Dipartimento Cardiovascolare e Unità di Cardiologia - Cardiologia 1 "
- Principal Investigator Name
- Michele Senni
- Principal Investigator Email
- msenni@asst-pg23.it
- Contact Person Name
- Michele Senni
- Contact Person Email
- msenni@asst-pg23.it
- Site Name
- Azienda Ospedaliero-Universitaria Policlinico Umberto I
- Department Name
- "Dipartimento di Scienze Cliniche Internistiche Anestesiologiche e Cardiovascolari. VIII Padiglione"
- Principal Investigator Name
- Roberto Badagliacca
- Principal Investigator Email
- roberto.badagliacca@uniroma1.it
- Contact Person Name
- Roberto Badagliacca
- Contact Person Email
- roberto.badagliacca@uniroma1.it
- Site Name
- Fondazione IRCCS Policlinico San Matteo
- Department Name
- UOC Cardiologia 1
- Principal Investigator Name
- Laura Scelsi
- Principal Investigator Email
- l.scelsi@smatteo.pv.it
- Contact Person Name
- Laura Scelsi
- Contact Person Email
- l.scelsi@smatteo.pv.it
Spain
- Earliest CTIS Part Ii Submission Date
- 27-03-2025
- Latest Decision Or Authorization Date
- 20-08-2025
- Processing Time Days
- 146
- Number Of Sites
- 5
- Number Of Participants
- 16
Sites
- Site Name
- Hospital Universitario De Toledo
- Department Name
- Dept. of Cardiology
- Principal Investigator Name
- Maria Lazaro Salvador
- Principal Investigator Email
- maria.lasal@gmail.com
- Contact Person Name
- Maria Lazaro Salvador
- Contact Person Email
- maria.lasal@gmail.com
- Site Name
- Hospital Costa Del Sol
- Department Name
- Dept. of Cardiology
- Principal Investigator Name
- Rafael Bravo Marques
- Principal Investigator Email
- rafabravomarques@gmail.com
- Contact Person Name
- Rafael Bravo Marques
- Contact Person Email
- rafabravomarques@gmail.com
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Dept. of Neumology
- Principal Investigator Name
- Isabel Blanco Vich
- Principal Investigator Email
- iblanco2@clinic.cat
- Contact Person Name
- Isabel Blanco Vich
- Contact Person Email
- iblanco2@clinic.cat
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Dept. of Cardiology
- Principal Investigator Name
- Alejandro Cruz Utrilla
- Principal Investigator Email
- alejandro.cruz@salud.madrid.org
- Contact Person Name
- Alejandro Cruz Utrilla
- Contact Person Email
- alejandro.cruz@salud.madrid.org
- Site Name
- Hospital Universitario Virgen De La Macarena
- Department Name
- Dept. of Cardiology
- Principal Investigator Name
- Alejandro Recio Mayoral
- Principal Investigator Email
- jandrorm@hotmail.com
- Contact Person Name
- Alejandro Recio Mayoral
- Contact Person Email
- jandrorm@hotmail.com
Sweden
- Earliest CTIS Part Ii Submission Date
- 22-01-2025
- Latest Decision Or Authorization Date
- 25-08-2025
- Processing Time Days
- 215
- Number Of Sites
- 1
- Number Of Participants
- 1
Sites
- Site Name
- Sahlgrenska University Hospital-Vaestra Goetalandsregionen
- Department Name
- Cardiology Research Unit
- Principal Investigator Name
- Clara Hjalmarsson
- Principal Investigator Email
- clara.hjalmarsson@vgregion.se
- Contact Person Name
- Clara Hjalmarsson
- Contact Person Email
- clara.hjalmarsson@vgregion.se
Poland
- Earliest CTIS Part Ii Submission Date
- 26-03-2025
- Latest Decision Or Authorization Date
- 06-11-2025
- Processing Time Days
- 225
- Number Of Sites
- 3
- Number Of Participants
- 12
Sites
- Site Name
- Wojewodzki Szpital Specjalistyczny Im. Stefana Kardynala Wyszynskiego Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Lublinie
- Department Name
- Oddział Kardiologii, Pododdział Intensywnego Nadzoru Kardiologicznego, Pododdział Rehabilitacji Kard
- Principal Investigator Name
- Piotr Błaszczak
- Principal Investigator Email
- lubkard@szpital.lublin.pl
- Contact Person Name
- Piotr Błaszczak
- Contact Person Email
- lubkard@szpital.lublin.pl
- Site Name
- Krakowski Szpital Specjalistyczny Im. Sw. Jana Pawla II
- Department Name
- Oddział Kliniczny Chorób Serca i Naczyń z Pododdziałem Intensywnego Nadzoru Kardiologicznego
- Principal Investigator Name
- Grzegorz Kopeć
- Principal Investigator Email
- g.kopec@szpitaljp2.krakow.pl
- Contact Person Name
- Grzegorz Kopeć
- Contact Person Email
- g.kopec@szpitaljp2.krakow.pl
- Site Name
- Uniwersytecki Szpital Kliniczny W Bialymstoku
- Department Name
- Klinika Kardiologii i Chorób Wewnętrznych z Odziałem Intensywnego Nadzoru Kardiologicznego
- Principal Investigator Name
- Karol Kamiński
- Principal Investigator Email
- kardio@uskwb.pl
- Contact Person Name
- Karol Kamiński
- Contact Person Email
- kardio@uskwb.pl
Sponsor
Primary sponsor
- Full Name
- Merck Sharp & Dohme LLC
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Signant Health Global LLC
- Responsibilities
- eCOA
- Name
- PPD Global Central Labs
- Name
- Parexel International Corp.
- Responsibilities
- EUB services (call center and medical services)
- Name
- Almac Clinical Technologies LLC
- Name
- Fortrea Inc.
- Name
- PPD Development LP
- Name
- Icon Clinical Research LLC
- Responsibilities
- Imaging- ECG and ECHO
Third parties
- {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"eCOA","organisation_type":"Pharmaceutical company"}
- {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"EUB services (call center and medical services)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Fortrea Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Icon Clinical Research LLC","duties_or_roles":"Imaging- ECG and ECHO","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Baim Institute For Clinical Research Inc.","duties_or_roles":"PVR Overread","organisation_type":"Educational Institution"}
Investigational products
- Investigational Product Name
- sotatercept (SOTATERCEPT)
- Active Substance
- SOTATERCEPT
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- SUBCUTANEOUS
- Route
- SUBCUTANEOUS
- Authorisation Status
- No marketing authorisation number listed
- Maximum Dose
- 48.5 mg/kg (max total dose amount as specified)
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