Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruitment ended
Participants planned
132
Countries
7
Sites
27
Pulmonary Hypertension
To evaluate the long-term safety and tolerability of sotatercept for up to 42 months of treatment
Key facts
- Sponsor
- Merck Sharp & Dohme LLC
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 26 May 2025 → ongoing
- Decision date (initial)
- 2025-04-29
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Merck Sharp & Dohme LLC
External identifiers
- EU CT number
- 2024-515773-99-00
- WHO UTN
- U1111-1309-2142
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Dose response, Pharmacodynamic, Efficacy, Pharmacokinetic, Therapy, Safety
To evaluate the long-term safety and tolerability of sotatercept for up to 42 months of treatment
Secondary objectives 1
- To evaluate the long-term efficacy of sotatercept for up to 42 months of treatment
Conditions and MedDRA coding
Pulmonary Hypertension
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10020787 | Hypertension pulmonary | 10038738 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- 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 8
- Has a diagnosis of pulmonary hypertension (PH) in world health organization (WHO) Group 1, WHO Group 3, WHO Group 4, or WHO Group 5
- Has had a study intervention interruption
- Is pregnant or breastfeeding
- Has chronic liver disease with severe hepatic impairment and/or cirrhosis (eg, hepatic encephalopathy)
- Anticipation of more than 1 valve replacement or repair (mechanical or biomechanical) and/or have undergone more than 1 valve replacement or repair
- Has severe tricuspid regurgitation due to primary valvular disease (eg, from endocarditis, carcinoid, or mechanical destruction)
- Anticipated or undergone heart transplant or ventricular assist device implantation
- Has had prior exposure to luspatercept
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Number of Participants Who Experience an Adverse Event (AE)
- Number of Participants Who Discontinue Study Treatment Due to an AE
Secondary endpoints 13
- Change From Baseline in Pulmonary Vascular Resistance (PVR) at Week 48
- Change From Baseline in the 6-Minute Walk Distance (6MWD) at Week 48
- Change From Baseline in the 6MWD at Week 126
- Change From Baseline in the 6MWD at Week 174
- Change From Baseline in New York Heart Association Functional Class (NYHA FC) at Week 48
- Change From Baseline in NYHA FC at Week 126
- Change From Baseline in NYHA FC at Week 174
- Change From Baseline in N-terminal Pro-hormone Brain Natriuretic Peptide (NT-proBNP) at Week 48
- Change From Baseline in NT-proBNP at Week 126
- Change From Baseline in NT-proBNP at Week 174
- Change From Week 24 in PVR at Week 48
- Change From Week 24 in 6MWD at Week 48
- Change From Week 24 in NYHA FC at Week 48
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 4
SUB189200 · Substance
- Active substance
- Sotatercept
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 0.7 mg/kg milligram(s)/kilogram
- Max total dose
- 48.5 mg/kg milligram(s)/kilogram
- Max treatment duration
- 42 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD9659365 · Product
- Active substance
- Sotatercept
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 0.7 mg/kg milligram(s)/kilogram
- Max total dose
- 48.5 mg/kg milligram(s)/kilogram
- Max treatment duration
- 42 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- MERCK & CO. INC.
- Paediatric formulation
- No
- Orphan designation
- No
SUB189200 · Substance
- Active substance
- Sotatercept
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 0.7 mg/kg milligram(s)/kilogram
- Max total dose
- 48.5 mg/kg milligram(s)/kilogram
- Max treatment duration
- 42 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD9659366 · Product
- Active substance
- Sotatercept
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 0.7 mg/kg milligram(s)/kilogram
- Max total dose
- 48.5 mg/kg milligram(s)/kilogram
- Max treatment duration
- 42 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- MERCK & CO. INC.
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Merck Sharp & Dohme LLC
- Sponsor organisation
- Merck Sharp & Dohme LLC
- Address
- 126 East Lincoln Avenue, P. O. Box 2000 P. O. Box 2000
- City
- Rahway
- Postcode
- 07065-4607
- Country
- United States
Scientific contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- Alessia Urbinati
Public contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- Alessia Urbinati
Third parties 8
| Organisation | City, country | Duties |
|---|---|---|
| Signant Health Global LLC ORG-100040604
|
Blue Bell, United States | Other |
| PPD Global Central Labs ORG-100046496
|
Zaventem, Belgium | Laboratory analysis |
| Parexel International Corp. ORG-100007310
|
Auburndale, United States | Other |
| Almac Clinical Technologies LLC ORG-100043036
|
Souderton, United States | Interactive response technologies (IRT) |
| Fortrea Inc. ORG-100012602
|
Durham, United States | On site monitoring |
| PPD Development LP ORG-100011560
|
Richmond, United States | Laboratory analysis |
| Icon Clinical Research LLC ORG-100039864
|
Rochester, United States | Other |
| Baim Institute For Clinical Research Inc. ORG-100047493
|
Boston, United States | Other |
Locations
7 EU/EEA countries · 27 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruitment ended | 1 | 1 |
| France | Ongoing, recruitment ended | 14 | 6 |
| Germany | Ongoing, recruitment ended | 12 | 8 |
| Italy | Ongoing, recruitment ended | 7 | 3 |
| Poland | Ongoing, recruitment ended | 12 | 3 |
| Spain | Ongoing, recruitment ended | 16 | 5 |
| Sweden | Ongoing, recruitment ended | 1 | 1 |
| Rest of world
Canada, Israel, United States
|
— | 69 | — |
Investigational sites
Hopital Erasme
Cardiology, Lennikse Baan 808, 1070, Anderlecht
Centre Hospitalier Universitaire De Montpellier
Cardiology, 371 Avenue Du Doyen Gaston Giraud, 34090, Montpellier
Centre Hospitalier Regional D'Angers
Department of Respiratory and Sleep Medicine, 4 Rue Larrey, 49100, Angers
Centre Hospitalier Universitaire De Nice
Cardiologie, 30 Voie Romaine, 06000, Nice
Centre Hospitalier Universitaire Rouen
Service de Pneumologie, Oncologie Thoracique Tel: 02 32 88 59 92 et Soins Intensifs Respiratoires, 1 Rue De Germont, 76000, Rouen
Centre Hospitalier Universitaire De Nantes
Cardiology and vascular disease, Boulevard Du Professeur Jacques Monod, 44800, Saint Herblain
Bicetre Hospital
Service de pneumologie et réanimation respiratoire, 78 Rue Du General Leclerc, 94275, Le Kremlin Bicetre Cedex
Kerckhoff-Klinik GmbH
Kardiologie, Benekestrasse 2-8, 61231, Bad Nauheim
DRK Kliniken Berlin
Klinik für Innere Medizin, Kardiologie, Spandauer Damm 130, 14050, Berlin
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Zentrum für Kardiologie, Kardiologie I, Langenbeckstrasse 1, Oberstadt, Mainz
Technische Universitaet Dresden
Medizinische Klinik I, Pneumologie, Fetscherstrasse 74, Johannstadt-Nord, Dresden
University Hospital Cologne AöR
Innere Medizin III, Kerpener Strasse 62, Lindenthal, Cologne
Thoraxklinik Heidelberg gGmbH
Universitaetsklinikum Heidelberg, Roentgenstrasse 1, Rohrbach, Heidelberg
Justus-Liebig-Universitaet Giessen
Medizinische Klinik und Poliklinik II, Klinikstrasse 33, 35392, Giessen
Krankenhaus Neuwittelsbach
Zentrum für Lungenhochdruck, Renatastrasse 71a, Neuhausen-Nymphenburg, Munich
Azienda Ospedaliero-Universitaria Policlinico Umberto I
"Dipartimento di Scienze Cliniche Internistiche Anestesiologiche e Cardiovascolari. VIII Padiglione", Viale Del Policlinico 155, 00161, Rome
Fondazione IRCCS Policlinico San Matteo
UOC Cardiologia 1, Viale Camillo Golgi 19, 27100, Pavia
Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
"Dipartimento Cardiovascolare e Unità di Cardiologia - Cardiologia 1 ", Piazza Oms 1, 24127, Bergamo
Uniwersytecki Szpital Kliniczny W Bialymstoku
Klinika Kardiologii i Chorób Wewnętrznych z Odziałem Intensywnego Nadzoru Kardiologicznego, Ul. Marii Curie-Sklodowskiej 24a, 15-276, Bialystok
Krakowski Szpital Specjalistyczny Im. Sw. Jana Pawla II
Oddział Kliniczny Chorób Serca i Naczyń z Pododdziałem Intensywnego Nadzoru Kardiologicznego, Ul. Pradnicka 80, 31-202, Cracow
Wojewodzki Szpital Specjalistyczny Im. Stefana Kardynala Wyszynskiego Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Lublinie
Oddział Kardiologii, Pododdział Intensywnego Nadzoru Kardiologicznego, Pododdział Rehabilitacji Kard, Aleja Krasnicka 100, 20-718, Lublin
Hospital Universitario Virgen De La Macarena
Dept. of Cardiology, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Hospital Universitario 12 De Octubre
Dept. of Cardiology, Avenida De Cordoba Sn, 28041, Madrid
Hospital Clinic De Barcelona
Dept. of Neumology, Calle Villarroel 170, 08036, Barcelona
Hospital Universitario De Toledo
Dept. of Cardiology, Avenue Del Rio Guadiana Sn, 45007, Toledo
Hospital Costa Del Sol
Dept. of Cardiology, Terreno Autovia Mediterraneo A-7 S/n, 29603, Marbella
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Belgium | 2025-08-04 | 2025-08-07 | 2025-08-07 | ||
| France | 2025-05-26 | 2025-05-26 | 2025-09-05 | ||
| Germany | 2025-06-11 | 2025-06-16 | 2026-03-30 | ||
| Italy | 2025-06-13 | 2025-07-28 | 2025-09-10 | ||
| Poland | 2025-10-07 | 2025-11-14 | 2026-02-10 | ||
| Spain | 2025-07-01 | 2025-07-03 | 2025-09-03 | ||
| Sweden | 2025-06-04 | 2025-09-04 | 2025-09-04 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 43 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2024-515773-99_SM01_for pub | 02R |
| Protocol (for publication) | D4_Copyright statement_EN_Borg scale_IN_for pub | 04DEC2024 |
| Protocol (for publication) | D4_Copyright statement_EN_eCOA tablet_IN_for pub | 04DEC2024 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_BEL_EN_IN_for pub | 11DEC2024 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_DEU_EN_IN_for pub | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_FRA_FR_SM01_for pub | 09JUN2025 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_ITA_EN_IN_for pub | 09DEC2024 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_POL_PL_IN_for pub | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_SWE_SV_IN_for pub | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_ESP_ES_IN_for pub | 26NOV2024R |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Brochure_FRA_FR_SM01_for pub | 09JUN2025 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Brochure_BEL_EN_SM01_for pub | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Brochure_BEL_FR_SM01_for pub | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Brochure_BEL_NL_SM01_for pub | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Brochure_ITA_IT_SM01_for pub | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent adult_ESP_ES_SM01_for pub | AM01v1.00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_BEL_EN_SM01-RFI002_for pub | AM01v1-00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_BEL_FR_SM01-RFI002_for pub | AM01v1-00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_BEL_NL_SM01-RFI002_for pub | AM01v1-00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_DEU_DE_SM01_for pub | AM01 v1.0R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_FRA_FR_SM01_for pub | AM01v1.00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_ITA_IT_SM01_for pub | AM01v1.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_POL_PL_SM01_for pub | 1.00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_SWE_SV_SM01_for pub | AM01v1.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main data privacy_ITA_IT_IN_for pub | 11DEC2024 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_DILI sample_ITA_IT_IN_for pub | 06DEC2024 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_Greenphire adults_BEL_EN_IN_for pub | 0.01 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_Greenphire adults_BEL_FR_IN_for pub | 0.01 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_Greenphire adults_BEL_NL_IN_for pub | 0.01 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_Greenphire adults_POL_PL_SM02_for pub | 01 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_Greenphire adults_SWE_SV_IN_for pub | 0.01 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_pregnancy follow-up_ESP_ES_IN_for pub | 0.00 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC RSI_WINREVAIR MERCK SHARP AND DOHME B-V_SM01_for pub | 28MAR2025 |
| Synopsis of the protocol (for publication) | D1_PPLS_2024-515773-99_BEL_DE_IN_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2024-515773-99_BEL_FR_IN_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2024-515773-99_BEL_NL_IN-RFI006_for pub | 2-0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2024-515773-99_DEU_DE_SM01_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2024-515773-99_ESP_ES_IN_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2024-515773-99_FRA_FR_IN_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2024-515773-99_IN_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2024-515773-99_ITA_IT_IN_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2024-515773-99_POL_PL_IN_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2024-515773-99_SWE_SV_IN_for pub | 1.0 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-08 | Germany | Acceptable 2025-04-28
|
2025-04-28 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-06-19 | Germany | Acceptable 2025-08-19
|
2025-08-19 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-10-01 | Germany | Acceptable 2025-08-19
|
2025-10-01 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-10-02 | Acceptable | 2025-11-06 | |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-11-20 | Germany | Acceptable | 2025-11-20 |