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

NCT ID: NCT05818137

Last Updated: 2026-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-10
• Study Completion Date: 2025-11-06

Brief Summary

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.

Conditions

Pulmonary Arterial Hypertension

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sotatercept

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 until up to 6 months after sotatercept becomes locally commercially available and reimbursed in Japan.

Group Type: EXPERIMENTAL

Sotatercept

Intervention Type: BIOLOGICAL

SC injection at a starting dose of 0.3 mg/kg with a target dose of 0.7 mg/kg every 21 days plus background PAH therapy.

Interventions

Sotatercept

SC injection at a starting dose of 0.3 mg/kg with a target dose of 0.7 mg/kg every 21 days plus background PAH therapy.

Intervention Type: BIOLOGICAL

Other Intervention Names

MK-7962; ActRIIA-IgG1Fc; ACE-011

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

Nagoya University Hospital ( Site 2010)

Nagoya, Aichi-ken, Japan

Chiba Saiseikai Narashino hospital ( Site 2004)

Narashino, Chiba, Japan

Kurume University Hospital ( Site 2014)

Kurume, Fukuoka, Japan

Kure Kyosai Hospital ( Site 2017)

Kure, Hiroshima, Japan

Sapporo Medical University Hospital ( Site 2018)

Sapporo, Hokkaido, Japan

Hokkaido University Hospital ( Site 2001)

Sapporo, Hokkaido, Japan

Kobe University Hospital ( Site 2012)

Kobe, Hyōgo, Japan

Tohoku University Hospital ( Site 2002)

Sendai, Miyagi, Japan

National Cerebral and Cardiovascular Center ( Site 2011)

Suita, Osaka, Japan

Hamamatsu University Hospital ( Site 2016)

Hamamatsu, Shizuoka, Japan

The University of Tokyo Hospital ( Site 2006)

Bunkyo-ku, Tokyo, Japan

Kyorin University Hospital ( Site 2005)

Mitaka, Tokyo, Japan

Chiba University Hospital ( Site 2003)

Chiba, , Japan

Kyushu University Hospital ( Site 2015)

Fukuoka, , Japan

National Hospital Organization Okayama Medical Center ( Site 2013)

Okayama, , Japan

International University of Health and Welfare Mita Hospital ( Site 2008)

Tokyo, , Japan

Keio university hospital ( Site 2007)

Tokyo, , Japan

Countries

Japan

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://www.merckclinicaltrials.com/

Merck Clinical Trials Information

Other Identifiers

jRCT2031230046

Identifier Type: REGISTRY

Identifier Source: secondary_id

MK-7962-020

Identifier Type: OTHER

Identifier Source: secondary_id

7962-020

Identifier Type: -

Identifier Source: org_study_id