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NCT Number: NCT07646860

A Study of Sotatercept (MK-7962) in Japanese Children With Pulmonary Arterial Hypertension (PAH) (MK-7962-032)

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.

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Key information

Conditions

Pulmonary Arterial Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases

Age range

1 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

National Center for Child Health and Development ( Site 3202)

Setagaya City, Tokyo, 157-8535, Japan

Location status: Recruiting

Location contact

Study Coordinator

CONTACT

+81-3-3416-0181

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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
  • 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

Treatment and study plan

Sotatercept

Biological

Sotatercept subcutaneous injection every 3 weeks

Other names: MK-7962, ACE-011, ActRIIA-IgG1Fc, WINREVAIR®

Primary outcomes

  1. Number of Participants With One or More Adverse Events

    Time frame: Up to approximately 24 weeks

    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.

  2. Number of Participants Who Discontinue Study Intervention Due to an Adverse Event

    Time frame: Up to approximately 24 weeks

    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.

  3. Laboratory Parameter (Hematology): Concentration of Hemoglobin

    Time frame: Up to approximately 24 weeks

    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.

  4. Laboratory Parameter (Hematology): Hematocrit

    Time frame: Up to approximately 24 weeks

    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.

  5. Laboratory Parameter (Hematology): Red Blood Cell (RBC) Count

    Time frame: Up to approximately 24 weeks

    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.

  6. Laboratory Parameter (Hematology): Reticulocyte Count

    Time frame: Up to approximately 24 weeks

    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.

  7. Laboratory Parameter (Hematology): Platelet Count

    Time frame: Up to approximately 24 weeks

    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.

  8. Blood Pressure (BP)

    Time frame: Up to approximately 24 weeks

    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).

  9. Number of Participants with Detectable Anti-Drug Antibodies (ADAs)

    Time frame: Up to approximately 24 weeks

    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.

  10. Number of Participants with Detectable Neutralizing Antibodies to Sotatercept

    Time frame: Up to approximately 24 weeks

    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.

  11. Serum Trough Concentration (Ctrough) of Sotatercept

    Time frame: At designated time points and up to approximately 24 weeks

    Serum samples collected predose will be used to determine serum trough concentration (Ctrough) of sotatercept.

  12. Change From Baseline in Pulmonary Vascular Resistance Index (PVRI)

    Time frame: Baseline and Week 24

    The change from baseline in PVRI will be presented.

Secondary outcomes

  1. Mean Change from Baseline in 6-Minute Walk Distance (6MWD)

    Time frame: Baseline and Week 24

    6MWD will be assessed using the 6-minute walk test (6MWT).

  2. Mean Change from Baseline in N-terminal Prohormone B-type Natriuretic Peptide (NT-proBNP)

    Time frame: Baseline and Week 24

    The change from baseline in plasma NT-proBNP levels will be reported.

  3. Percentage of Participants Who Either Improved or Maintained Their World Health Organization Functional Class (WHO FC)

    Time frame: Baseline and Week 24

    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.

  4. Number of Participants With One or More Adverse Events

    Time frame: From Week 24 up to approximately 58 months

    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.

  5. Number of Participants Who Discontinue Study Intervention Due to an Adverse Event

    Time frame: From Week 24 up to approximately 58 months

    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.

  6. Laboratory Parameter (Hematology): Concentration of Hemoglobin

    Time frame: From Week 24 up to approximately 58 months

    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.

  7. Laboratory Parameter (Hematology): Hematocrit

    Time frame: From Week 24 up to approximately 58 months

    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.

  8. Laboratory Parameter (Hematology): Red Blood Cell (RBC) Count

    Time frame: From Week 24 up to approximately 58 months

    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.

  9. Laboratory Parameter (Hematology): Reticulocyte Count

    Time frame: From Week 24 up to approximately 58 months

    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.

  10. Laboratory Parameter (Hematology): Platelet Count

    Time frame: From Week 24 up to approximately 58 months

    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.

  11. Blood Pressure (BP)

    Time frame: From Week 24 up to approximately 58 months

    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).

  12. Number of Participants with Detectable ADAs

    Time frame: From Week 24 up to approximately 58 months

    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.

  13. Number of Participants with Detectable Neutralizing Antibodies to Sotatercept

    Time frame: From Week 24 up to approximately 58 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Toll Free Number

CONTACT

[email protected]

1-888-577-8839

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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.

Important dates

Study start
2026
Primary completion
2029
Study completion
2031
First posted
Jun 15, 2026
Registry last updated
Aug 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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