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A Phase 2 Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Sotatercept (MK-7962) in Children from 1 to Less Than 18 Years of Age With PAH on Standard of Care

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-504861-22-00
Acronym
MK-7962-008
Enrollment
22
Registered
2023-11-27
Start date
2023-05-05
Completion date
Unknown
Last updated
2025-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary arterial hypertension

Brief summary

Serum Trough Concentration (Ctrough) of Sotatercept, Area Under the Curve at Steady State (AUCss) of Sotatercept, Area Under the Curve from 0 to 3 weeks (AUC0-3 weeks) of Sotatercept, Percentage of Participants Who Experience at Least 1 Adverse Event (AE), Percentage of Participants Who Discontinue Study Drug Due to an AE, Laboratory Parameter (Hematology): Concentration of Hemoglobin, Laboratory Parameter (Hematology): Hematocrit, Laboratory Parameter (Hematology): RBC Count, Laboratory Parameter (Hematology): Reticulocyte Count, Laboratory Parameter (Hematology): Platelet Count, Blood Pressure (BP), Titer of Anti-drug Antibody (ADA) to Sotatercept

Detailed description

Mean Change from Baseline in 6-Minute Walk Distance (6MWD) (Cohorts 1 and 2), Mean Change from Baseline in Tricuspid Annular Plane Systolic Excursion (TAPSE), Mean Change from Baseline in Pulmonary Artery Systolic Pressure (PASP), Mean Change from Baseline in Right Ventricular Fractional Area Change (RVFAC), Mean Change from Baseline in Eccentricity Index, Mean Change from Baseline in Right Ventricular (RV) Function (Cohorts 1 and 2), Mean Change from Baseline on Cardiac Output (Cohorts 1 and 2), Mean Change from Baseline in Pulmonary Arterial Pressure (PAP) (Cohorts 1 and 2), Mean Change from Baseline in Pediatric Quality of Life (PedsQL) Generic Score, Mean Change from Baseline in N-terminal Prohormone B-type Natriuretic Peptide (NT-proBNP), Percentage of Participants who Either Improved or Maintained Their World Health Organization Functional Class (WHO FC)

Interventions

DRUGSOTATERCEPT
DRUGsotatercept

Sponsors

Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
0 Years to 17 Years

Design outcomes

Primary

MeasureTime frame
Serum Trough Concentration (Ctrough) of Sotatercept, Area Under the Curve at Steady State (AUCss) of Sotatercept, Area Under the Curve from 0 to 3 weeks (AUC0-3 weeks) of Sotatercept, Percentage of Participants Who Experience at Least 1 Adverse Event (AE), Percentage of Participants Who Discontinue Study Drug Due to an AE, Laboratory Parameter (Hematology): Concentration of Hemoglobin, Laboratory Parameter (Hematology): Hematocrit, Laboratory Parameter (Hematology): RBC Count, Laboratory Parameter (Hematology): Reticulocyte Count, Laboratory Parameter (Hematology): Platelet Count, Blood Pressure (BP), Titer of Anti-drug Antibody (ADA) to Sotatercept

Secondary

MeasureTime frame
Mean Change from Baseline in 6-Minute Walk Distance (6MWD) (Cohorts 1 and 2), Mean Change from Baseline in Tricuspid Annular Plane Systolic Excursion (TAPSE), Mean Change from Baseline in Pulmonary Artery Systolic Pressure (PASP), Mean Change from Baseline in Right Ventricular Fractional Area Change (RVFAC), Mean Change from Baseline in Eccentricity Index, Mean Change from Baseline in Right Ventricular (RV) Function (Cohorts 1 and 2), Mean Change from Baseline on Cardiac Output (Cohorts 1 and 2), Mean Change from Baseline in Pulmonary Arterial Pressure (PAP) (Cohorts 1 and 2), Mean Change from Baseline in Pediatric Quality of Life (PedsQL) Generic Score, Mean Change from Baseline in N-terminal Prohormone B-type Natriuretic Peptide (NT-proBNP), Percentage of Participants who Either Improved or Maintained Their World Health Organization Functional Class (WHO FC)

Countries

France, Germany, Netherlands, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026