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

NCT07646860 | Not Yet Recruiting Phase 2

• 2 other identifiers: 7962-032MK-7962-032
• Study Type: interventional
• Target: 6
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Outcome Measures

Primary Outcomes (12)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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).

  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.

  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.

  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.

  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.

  Baseline and Week 24

Secondary Outcomes (13)

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

  Baseline and Week 24

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

  Baseline and Week 24

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

  Baseline and Week 24

• Number of Participants With One or More Adverse Events

  From Week 24 up to approximately 58 months

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

  From Week 24 up to approximately 58 months

Study Arms (1)

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.

Biological: Sotatercept

Interventions

Sotatercept BIOLOGICAL

Sotatercept subcutaneous injection every 3 weeks

Also known as: MK-7962, ACE-011, ActRIIA-IgG1Fc, WINREVAIR®

Sotatercept

Eligibility Criteria

• Age: 1 Year - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Links

• Merck Clinical Trials Information

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Interventions

ACE-011

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: June 15, 2026
• Study Start (Estimated): August 31, 2026
• Primary Completion (Estimated): May 24, 2029
• Study Completion (Estimated): May 16, 2031
• Last Updated: June 15, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share