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

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT07646860
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Pulmonary Arterial Hypertension

Eligibility Criteria

Sex
ALL
Age
1 Year - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Sotatercept — BIOLOGICAL
    Sotatercept subcutaneous injection every 3 weeks

Study Details

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.

Key Dates

First listed
Jun 15, 2026
Start date
Aug 31, 2026
Status verified
Jun 2026
Primary completion
May 24, 2029
Completion
May 16, 2031

Study Design

Enrollment
6 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Sotatercept
    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.

Primary Outcome Measure

Number of Participants With One or More Adverse Events [ Time Frame: Up to approximately 24 weeks ]

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