An Open-Label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH (MK-7962-004)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-509138-21-00

Acronym

A011-12

Enrollment

420

Registered

2024-09-24

Start date

2021-08-26

Completion date

Unknown

Last updated

2025-11-10

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

Conditions

Pulmonary Arterial Hypertension (PAH)

Brief summary

• Adverse events (AEs) • Anti-drug antibodies (ADA) • Clinical laboratory assessments (hematology) • Vital signs • 12-lead electrocardiogram (ECG)

Detailed description

• 6-minute walk distance (6MWD) • N-terminal pro-hormone B-type natriuretic peptide • World Health Organization (WHO) functional class • Pulmonary vascular resistance • Simplified French Risk score

Interventions

DRUGsotatercept

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
• Adverse events (AEs) • Anti-drug antibodies (ADA) • Clinical laboratory assessments (hematology) • Vital signs • 12-lead electrocardiogram (ECG)	—

Secondary

Measure	Time frame
• 6-minute walk distance (6MWD) • N-terminal pro-hormone B-type natriuretic peptide • World Health Organization (WHO) functional class • Pulmonary vascular resistance • Simplified French Risk score	—

Countries

Austria, Belgium, Croatia, Czechia, Denmark, France, Germany, Greece, Italy, Netherlands, Poland, Portugal, Spain, Sweden

Outcome results

None listed

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