A Study of Sotatercept in Japanese Pulmonary Arterial Hypertension (PAH) Participants (MK-7962-020)

Merck Sharp & Dohme (MSD)

Status and phase: Active, not recruiting; Phase 3

Conditions: Pulmonary Arterial Hypertension

Treatments: Biological: Sotatercept

Study type: Interventional

Funder types: Industry

Identifiers

NCT05818137

MK-7962-020 (Other Identifier)

jRCT2031230046 (Registry Identifier)

7962-020

Details and patient eligibility

About

This local Phase 3 study is planned to confirm the efficacy and safety in Japanese PAH participants. The primary population of this study is Japanese PAH participants with World Health Organization Functional Class (WHO FC) II or III while the study includes PAH participants with WHO FC I or IV as other populations. There are no hypotheses for this study.

Enrollment: 46 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Documented diagnostic right heart catheterization (RHC) at any time prior to screening confirming the diagnosis of World Health Organization (WHO) pulmonary arterial hypertension (PAH) Group 1 in any of the following subtypes:

  • Idiopathic PAH
  • Heritable PAH
  • Drug/toxin-induced PAH
  • PAH associated with connective tissue disease
  • PAH associated with simple, congenital systemic-to-pulmonary shunts at least 1 year following repair

• PAH classified as WHO functional class (FC) I or symptomatic PAH classified as WHO FC II to IV

• On stable doses of background PAH therapy and diuretics (if applicable) for at least 90 days prior to screening

Exclusion Criteria

• Diagnosis of PH WHO Groups 2, 3, 4, or 5

• Diagnosis of the following PAH Group 1 subtypes:

  • Human immunodeficiency virus (HIV)-associated PAH
  • PAH associated with portal hypertension
  • Schistosomiasis-associated PAH
  • PAH with features of significant venous/capillary pulmonary veno-occlusive disease/pulmonary capillary hemangiomatosis (PVOD/PCH) involvement

• Is on the waiting list for lung transplant

• Pregnant or breastfeeding women

• History of full or partial pneumonectomy

• Pulmonary function test (PFT) values of forced vital capacity (FVC) < 60% predicted at the screening visit or within 6 months prior to the screening visit.

• Initiation of an exercise program for cardiopulmonary rehabilitation within 90 days prior to the screening visit or planned initiation during the study.

• History of more than mild obstructive sleep apnea that is untreated

• Known history of portal hypertension or chronic liver disease, including hepatitis B and/or hepatitis C (with evidence of recent infection and/or active virus replication), defined as mild to severe hepatic impairment.

• History of restrictive, constrictive, or congestive cardiomyopathy.

• History of atrial septostomy within 180 days prior to the screening visit.

• Personal or family history of long QT syndrome (LQTS) or sudden cardiac death.

• Left ventricular ejection fraction (LVEF) < 45% on historical Echocardiogram (ECHO) within 6 months prior to the screening visit.

• Any symptomatic coronary disease events within 6 months prior to the screening visit.

• Cerebrovascular accident within 3 months prior to the screening visit.

• Significant (≥ 2+ regurgitation) mitral regurgitation or aortic regurgitation valvular disease, mitral stenosis and more than mild aortic valve stenosis.

• Prior exposure to sotatercept or luspatercept or history of allergic or anaphylactic reaction or hypersensitivity to recombinant proteins or excipients in investigational product

• Received intravenous inotropes (e.g., dobutamine, dopamine, norepinephrine, vasopressin) within 30 days prior to the screening visit

• Currently enrolled in or have completed any other investigational product study within 30 days

• Weight at the screening is over 85 kg

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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46 participants in 1 patient group

Sotatercept

Experimental group

Description:

Participants on background PAH therapy will receive sotatercept subcutaneous (SC) injections at a starting dose of 0.3 mg/kg with a target dose of 0.7 mg/kg every 3 weeks up to 24 weeks. Thereafter, participants may choose to receive the sotatercept treatment at same dose and schedule in the extension treatment period from Week 24 to Week 42.

Treatment:

Biological: Sotatercept