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| ID | Type | Description | Link |
|---|---|---|---|
| jRCT2031230046 | Registry Identifier | jRCT | |
| MK-7962-020 | Other Identifier | MSD |
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This local Phase 3 study is planned to confirm the efficacy and safety in Japanese PAH participants. The primary population of this study is Japanese PAH participants with World Health Organization Functional Class (WHO FC) II or III while the study includes PAH participants with WHO FC I or IV as other populations. There are no hypotheses for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sotatercept | Experimental | Participants on background PAH therapy will receive sotatercept subcutaneous (SC) injections at a starting dose of 0.3 mg/kg with a target dose of 0.7 mg/kg every 3 weeks up to 24 weeks. Thereafter, participants may choose to receive the sotatercept treatment at same dose and schedule in the extension treatment period from Week 24 until up to 6 months after sotatercept becomes locally commercially available and reimbursed in Japan. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sotatercept | Biological | SC injection at a starting dose of 0.3 mg/kg with a target dose of 0.7 mg/kg every 21 days plus background PAH therapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Pulmonary Vascular Resistance (PVR) From Baseline at Week 24 | PVR was the resistance against blood flow from the pulmonary artery to the left atrium. PVR was measured in dyn*sec/cm^5 by right heart catheterization (RHC). RHC was performed during the screening period (baseline) and Week 24. Per protocol, the change in PVR from baseline at Week 24 was reported for the primary treatment period. | Baseline and Week 24 |
| Number of Participants Who Experienced an Adverse Event (AE) | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Per protocol, the number of participants who experienced an AE were reported for the primary treatment period. | Up to ~24 weeks |
| Number of Participants Who Discontinued Study Intervention Due to AEs | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Per protocol, the number of participants who discontinued study treatment due to AEs were reported for the primary treatment period. | Up to ~24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Six-Minute Walk Distance (6MWD) at Week 24 | The 6MWD was the distance walked in 6 minutes as a measure of functional capacity was measured during the screening period (baseline) and at Week 24. This was assessed using the 6-minute walk test (6MWT). Per protocol, the change from baseline in 6MWD at Week 24 was reported for the primary treatment period. | Baseline and Week 24 |
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Inclusion Criteria:
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:
PAH classified as WHO functional class (FC) I or symptomatic PAH classified as WHO FC II to IV
On stable doses of background PAH therapy and diuretics (if applicable) for at least 90 days prior to screening
Exclusion Criteria
Diagnosis of PH WHO Groups 2, 3, 4, or 5
Diagnosis of the following PAH Group 1 subtypes:
Is on the waiting list for lung transplant
Pregnant or breastfeeding women
History of full or partial 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.
Initiation of an exercise program for cardiopulmonary rehabilitation within 90 days prior to the screening visit or planned initiation during the study.
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.
History of restrictive, constrictive, or congestive cardiomyopathy.
History of atrial septostomy within 180 days prior to the screening visit.
Personal or family history of long QT syndrome (LQTS) or sudden cardiac death.
Left ventricular ejection fraction (LVEF) < 45% on historical Echocardiogram (ECHO) within 6 months prior to the screening visit.
Any symptomatic coronary disease events within 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, mitral stenosis and more than mild aortic valve stenosis.
Prior exposure to sotatercept or luspatercept or history of allergic or anaphylactic reaction or hypersensitivity to recombinant proteins or excipients in investigational product
Received intravenous inotropes (e.g., dobutamine, dopamine, norepinephrine, vasopressin) within 30 days prior to the screening visit
Currently enrolled in or have completed any other investigational product study within 30 days
Weight at the screening is over 85 kg
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nagoya University Hospital ( Site 2010) | Nagoya | Aichi-ken | 466-8560 | Japan | ||
| Chiba Saiseikai Narashino hospital ( Site 2004) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41618947 | Result | Matsubara H, Tanabe N, Ogo T, Abe K, Inami T, Maeda Y, Arano I, Shirakawa M, Sakai R, Cornell AG; Sotatercept Study 020 Investigators. Phase 3, Open-Label Multicenter Study of Sotatercept in Japanese Participants With Pulmonary Arterial Hypertension. JACC Asia. 2026 Mar;6(3):297-309. doi: 10.1016/j.jacasi.2025.12.009. Epub 2026 Jan 31. |
| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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All allocated participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sotatercept | Participants on background PAH therapy received sotatercept subcutaneous (SC) injections at a starting dose of 0.3 mg/kg with a target dose of 0.7 mg/kg every 3 weeks up to 24 weeks. Thereafter, participants received sotatercept at the same dose and schedule in the extension treatment period Week 24 to Week 42. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Primary Treatment Period |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 24, 2024 |
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| Percentage of Participants With Improvement in World Health Organization Functional Class (WHO FC) at Week 24 | The severity of participant's pulmonary arterial hypertension (PAH) symptoms will be graded using the WHO FC system. WHO functional classification for PAH ranges from Class I (no limitation in physical activity, no dyspnea with normal activity), Class II (slight limitation of physical activity), Class III (marked limitation of physical activity) and Class IV (cannot perform a physical activity without any symptoms, dyspnea at rest). Participants who improve in WHO FC were classified into "Improved", "No change" and "Worsened". Improvement = reduction in FC, worsened = increase in FC and no change = no change in FC. Per protocol, the percentage of participants with improvement in WHO FC at Week 24 were presented for the primary treatment period. | Baseline and Week 24 |
| Change From Baseline in N-terminal proB-type Natriuretic Peptide (NT-proBNP) at Week 24 | NT-proBNP is an established marker of ventricular dysfunction in participants with PAH. NT-proBNP was measured at Day 1 (baseline) and at Week 24. The change from baseline in NT-proBNP at Week 24 was reported for the primary treatment period. | Baseline and Week 24 |
| Narashino |
| Chiba |
| 275-8580 |
| Japan |
| Kurume University Hospital ( Site 2014) | Kurume | Fukuoka | 830-0011 | Japan |
| Kure Kyosai Hospital ( Site 2017) | Kure | Hiroshima | 7378505 | Japan |
| Sapporo Medical University Hospital ( Site 2018) | Sapporo | Hokkaido | 060-8543 | Japan |
| Hokkaido University Hospital ( Site 2001) | Sapporo | Hokkaido | 060-8648 | Japan |
| Kobe University Hospital ( Site 2012) | Kobe | Hyōgo | 650-0017 | Japan |
| Tohoku University Hospital ( Site 2002) | Sendai | Miyagi | 980-8574 | Japan |
| National Cerebral and Cardiovascular Center ( Site 2011) | Suita | Osaka | 564-8565 | Japan |
| Hamamatsu University Hospital ( Site 2016) | Hamamatsu | Shizuoka | 431-3192 | Japan |
| The University of Tokyo Hospital ( Site 2006) | Bunkyo-ku | Tokyo | 113-8654 | Japan |
| Kyorin University Hospital ( Site 2005) | Mitaka | Tokyo | 181-8611 | Japan |
| Chiba University Hospital ( Site 2003) | Chiba | 260-8677 | Japan |
| Kyushu University Hospital ( Site 2015) | Fukuoka | 812-8582 | Japan |
| National Hospital Organization Okayama Medical Center ( Site 2013) | Okayama | 701-1192 | Japan |
| International University of Health and Welfare Mita Hospital ( Site 2008) | Tokyo | 108-8329 | Japan |
| Keio university hospital ( Site 2007) | Tokyo | 1608582 | Japan |
| COMPLETED |
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| NOT COMPLETED |
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| Extension Treatment Period |
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All allocated participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Sotatercept | Participants on background PAH therapy received sotatercept subcutaneous (SC) injections at a starting dose of 0.3 mg/kg with a target dose of 0.7 mg/kg every 3 weeks up to 24 weeks. Thereafter, participants received sotatercept at the same dose and schedule in the extension treatment period Week 24 to Week 42. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Pulmonary Vascular Resistance (PVR) at Baseline | PVR was the resistance against blood flow from the pulmonary artery to the left atrium. PVR was measured by right heart catheterization (RHC). PVR was categorized as ≤800 dyn*sec/cm^5 and >800 dyn*sec/cm^5. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Pulmonary Vascular Resistance (PVR) From Baseline at Week 24 | PVR was the resistance against blood flow from the pulmonary artery to the left atrium. PVR was measured in dyn*sec/cm^5 by right heart catheterization (RHC). RHC was performed during the screening period (baseline) and Week 24. Per protocol, the change in PVR from baseline at Week 24 was reported for the primary treatment period. | All participants who received at least one dose of study intervention in the primary treatment period. | Posted | Median | Full Range | dynes*sec/cm^5 | Baseline and Week 24 |
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| Primary | Number of Participants Who Experienced an Adverse Event (AE) | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Per protocol, the number of participants who experienced an AE were reported for the primary treatment period. | All participants who received at least one dose of study intervention in the primary treatment period. | Posted | Count of Participants | Participants | Up to ~24 weeks |
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| Primary | Number of Participants Who Discontinued Study Intervention Due to AEs | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Per protocol, the number of participants who discontinued study treatment due to AEs were reported for the primary treatment period. | All participants who received at least one dose of study intervention in the primary treatment period. | Posted | Count of Participants | Participants | Up to ~24 weeks |
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| Secondary | Change From Baseline in Six-Minute Walk Distance (6MWD) at Week 24 | The 6MWD was the distance walked in 6 minutes as a measure of functional capacity was measured during the screening period (baseline) and at Week 24. This was assessed using the 6-minute walk test (6MWT). Per protocol, the change from baseline in 6MWD at Week 24 was reported for the primary treatment period. | All participants who received at least one dose of study intervention in the primary treatment period. | Posted | Median | Full Range | Meter | Baseline and Week 24 |
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| Secondary | Percentage of Participants With Improvement in World Health Organization Functional Class (WHO FC) at Week 24 | The severity of participant's pulmonary arterial hypertension (PAH) symptoms will be graded using the WHO FC system. WHO functional classification for PAH ranges from Class I (no limitation in physical activity, no dyspnea with normal activity), Class II (slight limitation of physical activity), Class III (marked limitation of physical activity) and Class IV (cannot perform a physical activity without any symptoms, dyspnea at rest). Participants who improve in WHO FC were classified into "Improved", "No change" and "Worsened". Improvement = reduction in FC, worsened = increase in FC and no change = no change in FC. Per protocol, the percentage of participants with improvement in WHO FC at Week 24 were presented for the primary treatment period. | All participants who received at least one dose of study intervention in the primary treatment period. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline and Week 24 |
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| Secondary | Change From Baseline in N-terminal proB-type Natriuretic Peptide (NT-proBNP) at Week 24 | NT-proBNP is an established marker of ventricular dysfunction in participants with PAH. NT-proBNP was measured at Day 1 (baseline) and at Week 24. The change from baseline in NT-proBNP at Week 24 was reported for the primary treatment period. | All participants who received at least one dose of study intervention in primary treatment period. | Posted | Median | Full Range | pg/mL | Baseline and Week 24 |
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Up to approximately 42 weeks (Primary treatment period: Weeks 1-24 & extension Treatment Period: Weeks 24-42)
All-cause mortality was reported on all allocated participants. Serious and nonserious AEs were reported in all participants who received a dose of study intervention.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sotatercept - Primary Treatment Period | Participants on background PAH therapy received sotatercept subcutaneous (SC) injections at a starting dose of 0.3 mg/kg with a target dose of 0.7 mg/kg every 3 weeks up to 24 weeks. | 0 | 46 | 6 | 46 | 36 | 46 |
| EG001 | Sotatercept - Extension Treatment Period | Participants on background PAH therapy received sotatercept subcutaneous (SC) injections at a starting dose of 0.3 mg/kg with a target dose of 0.7 mg/kg every 3 weeks from Week 24 to Week 42. | 0 | 45 | 2 | 45 | 12 | 45 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Large intestine polyp | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Bacteraemia | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Catheter site infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
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| Loss of consciousness | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
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| Device physical property issue | Product Issues | MedDRA 27.0 | Systematic Assessment |
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| Pulmonary arterial hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | MedDRA 27.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Malaise | General disorders | MedDRA 27.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 27.0 | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Haemoglobin increased | Investigations | MedDRA 27.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
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| Telangiectasia | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
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If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme LLC | 1-800-672-6372 | ClinicalTrialsDisclosure@msd.com |
| Feb 6, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000081029 | Pulmonary Arterial Hypertension |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C542017 | ACE-011 |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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