Pulmonary Arterial HypertensionPhase 2NCT07646860
A Study of Sotatercept (MK-7962) in Japanese Children With Pulmonary Arterial Hypertension (PAH) (MK-7962-032)
A Phase 2 study testing Sotatercept in people with Pulmonary Arterial Hypertension, run by Merck Sharp & Dohme LLC at 3 sites in Japan.
Trial summary
The goal of this study is to learn about the safety of sotatercept and how well Japanese children tolerate it, when taken along with standard (usual) pulmonary arterial hypertension (PAH) treatment. Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- Sotatercept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 3 sitesJapan
- Study dates
- 17 Sep 2026to 16 May 2031
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The main inclusion criteria include but are not limited to the following:
- Has pulmonary arterial hypertension (PAH, World Health Organization Group 1) confirmed by a prior right heart catheterization
- Has idiopathic, heritable, drug- or toxin-induced PAH, connective tissue disease-associated PAH, repaired congenital heart disease-associated PAH, or PAH with coincidental shunt
- Has PAH classified as World Health Organization Functional Class I, or symptomatic World Health Organization Functional Class II to IV
- Has been receiving stable standard-of-care background therapy for PAH for at least 90 days
- Is Japanese
Who cannot join
- The main exclusion criteria include but are not limited to the following:
- History of left-sided heart disease
- Has severe congenital or developmental abnormalities of the lung, thorax, and/or diaphragm
- History of Eisenmenger syndrome, Potts shunt, or recent atrial septostomy within 180 days
- Has unrepaired or residual cardiac shunt with Qp/Qs >1.5
- Has pulmonary veno-occlusive disease, pulmonary capillary hemangiomatosis, or overt signs of pulmonary capillary and/or venous involvement
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- PAH associated with portal hypertension
- Known visceral arteriovenous malformations
- History of full or partial pneumonectomy
- Untreated more than mild obstructive sleep apnea
- History of known pericardial constriction
- Family history of sudden cardiac death or long QT syndrome
- History of symptomatic coronary disease within 6 months or cerebrovascular accident within 3 months
- Prior treatment with sotatercept or luspatercept
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Japan3 sites, 3 recruiting
- Recruiting
Osaka Prefectural Hospital Organization Osaka Women's and Children's Hospital ( Site 3203)
Izumi, Osaka, 594-1101
Study Coordinator, +81-725-56-1260
- Recruiting
National Center for Child Health and Development ( Site 3202)
Setagaya City, Tokyo, 157-8535
Study Coordinator, +81-3-3416-0181
- Recruiting
The University of Osaka Hospital ( Site 3201)
Suita, Osaka, 565-0871
Study Coordinator, +81-6-6879-5111
About this study
Official title: A Phase 2 Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Sotatercept (MK-7962) in Japanese Children From 1 to Less Than 18 Years of Age With PAH on Standard of Care.
The goal of this study is to learn about the safety of sotatercept and how well Japanese children tolerate it, when taken along with standard (usual) pulmonary arterial hypertension (PAH) treatment. Researchers also want to learn what happens to it in a person's body over time and whether it lowers resistance in blood vessels in the lungs.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- Sotatercept
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SotaterceptBiological
Also called MK-7962, ACE-011, ActRIIA-IgG1Fc, WINREVAIR®
Sotatercept subcutaneous injection every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Sotatercept | Experimental | Participants receive sotatercept by subcutaneous injection every 3 weeks (Q3W) for up to approximately 24 weeks while continuing standard-of-care background therapy for PAH. Participants start at a dose of 0.3 mg/kg Q3W, and may titrate up to the target dose of 0.7 mg/kg SC injection Q3W starting at Week 6 based on protocol-defined dose-escalation guidance. After Week 24, participants who meet certain requirements may choose to continue receiving sotatercept for up to 58 months. Receives: Biological: Sotatercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With One or More Adverse Events
An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Measured: Up to approximately 24 weeks
Number of Participants Who Discontinue Study Intervention Due to an Adverse Event
An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Measured: Up to approximately 24 weeks
Laboratory Parameter (Hematology): Concentration of Hemoglobin
Hematological parameters will be investigated in blood samples from participants by means of clinical laboratory assays and evaluated by the investigator. The concentration of hemoglobin will be presented.
Measured: Up to approximately 24 weeks
Laboratory Parameter (Hematology): Hematocrit
Hematological parameters will be investigated in blood samples from participants by means of clinical laboratory assays and evaluated by the investigator. The hematocrit will be presented.
Measured: Up to approximately 24 weeks
Laboratory Parameter (Hematology): Red Blood Cell (RBC) Count
Hematological parameters will be investigated in blood samples from participants by means of clinical laboratory assays and evaluated by the investigator. The RBC count will be presented.
Measured: Up to approximately 24 weeks
Laboratory Parameter (Hematology): Reticulocyte Count
Hematological parameters will be investigated in blood samples from participants by means of clinical laboratory assays and evaluated by the investigator. The reticulocyte count will be presented.
Measured: Up to approximately 24 weeks
Laboratory Parameter (Hematology): Platelet Count
Hematological parameters will be investigated in blood samples from participants by means of clinical laboratory assays and evaluated by the investigator. The platelet count will be presented.
Measured: Up to approximately 24 weeks
Blood Pressure (BP)
BP will be assessed while the participant was seated after a period of rest in a quiet setting with no distractions (eg, television and cell phones).
Measured: Up to approximately 24 weeks
Number of Participants with Detectable Anti-Drug Antibodies (ADAs)
Blood samples will be collected to assess antidrug antibodies to sotatercept. The number of participants with detectable ADAs at any time during the study will be presented.
Measured: Up to approximately 24 weeks
Number of Participants with Detectable Neutralizing Antibodies to Sotatercept
Neutralizing antibody analysis will be performed on blood samples for participants who are confirmed as antidrug antibody-positive. The number of participants with detectable neutralizing antibodies at any time during the study will be presented.
Measured: Up to approximately 24 weeks
Serum Trough Concentration (Ctrough) of Sotatercept
Serum samples collected predose will be used to determine serum trough concentration (Ctrough) of sotatercept.
Measured: At designated time points and up to approximately 24 weeks
Change From Baseline in Pulmonary Vascular Resistance Index (PVRI)
The change from baseline in PVRI will be presented.
Measured: Baseline and Week 24
Secondary outcomes (13)
Mean Change from Baseline in 6-Minute Walk Distance (6MWD)
6MWD will be assessed using the 6-minute walk test (6MWT).
Measured: Baseline and Week 24
Mean Change from Baseline in N-terminal Prohormone B-type Natriuretic Peptide (NT-proBNP)
The change from baseline in plasma NT-proBNP levels will be reported.
Measured: Baseline and Week 24
Percentage of Participants Who Either Improved or Maintained Their World Health Organization Functional Class (WHO FC)
The severity of an individual's PAH symptoms will be graded using the WHO FC system. WHO functional classification for PAH range 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). The change from baseline in WHO FC will be classified into "Improved", "No change" and "Worsened". Improvement = reduction in FC, worsened = increase in FC and no change = no change in FC.
Measured: Baseline and Week 24
Number of Participants With One or More Adverse Events
An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Measured: From Week 24 up to approximately 58 months
Number of Participants Who Discontinue Study Intervention Due to an Adverse Event
An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Measured: From Week 24 up to approximately 58 months
Laboratory Parameter (Hematology): Concentration of Hemoglobin
Hematological parameters will be investigated in blood samples from participants by means of clinical laboratory assays and evaluated by the investigator. The concentration of hemoglobin will be presented.
Measured: From Week 24 up to approximately 58 months
Laboratory Parameter (Hematology): Hematocrit
Hematological parameters will be investigated in blood samples from participants by means of clinical laboratory assays and evaluated by the investigator. The hematocrit will be presented.
Measured: From Week 24 up to approximately 58 months
Laboratory Parameter (Hematology): Red Blood Cell (RBC) Count
Hematological parameters will be investigated in blood samples from participants by means of clinical laboratory assays and evaluated by the investigator. The RBC count will be presented.
Measured: From Week 24 up to approximately 58 months
Laboratory Parameter (Hematology): Reticulocyte Count
Hematological parameters will be investigated in blood samples from participants by means of clinical laboratory assays and evaluated by the investigator. The reticulocyte count will be presented.
Measured: From Week 24 up to approximately 58 months
Laboratory Parameter (Hematology): Platelet Count
Hematological parameters will be investigated in blood samples from participants by means of clinical laboratory assays and evaluated by the investigator. The platelet count will be presented.
Measured: From Week 24 up to approximately 58 months
Blood Pressure (BP)
BP will be assessed while the participant was seated after a period of rest in a quiet setting with no distractions (eg, television and cell phones).
Measured: From Week 24 up to approximately 58 months
Number of Participants with Detectable ADAs
Blood samples will be collected to assess antidrug antibodies to sotatercept. The number of participants with detectable ADAs at any time during the study will be presented.
Measured: From Week 24 up to approximately 58 months
Number of Participants with Detectable Neutralizing Antibodies to Sotatercept
Neutralizing antibody analysis will be performed on blood samples for participants who are confirmed as ADA-positive. The number of participants with detectable neutralizing antibodies at any time during the study will be presented.
Measured: From Week 24 up to approximately 58 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start17 Sep 2026
- Primary completion24 May 2029 (estimated)
- Study completion16 May 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07646860
- Sponsor's protocol ID
- 7962-032
- Other IDs
- MK-7962-032
- Status last verified
- Sep 2026
- First submitted
- 9 Jun 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf