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

NCT05818137 | Completed Phase 3 Results FDA Drug

• 3 other identifiers: 7962-020jRCT2031230046MK-7962-020
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 17

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

Outcome Measures

Primary Outcomes (3)

• Change From Pulmonary Vascular Resistance (PVR) From Baseline at Week 24

  PVR was the resistance against blood flow from the pulmonary artery to the left atrium. PVR was measured in dyn\*sec/cm\^5 by right heart catheterization (RHC). RHC was performed during the screening period (baseline) and Week 24. Per protocol, the change in PVR from baseline at Week 24 was reported for the primary treatment period.

  Baseline and Week 24

• Number of Participants Who Experienced an Adverse Event (AE)

  An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Per protocol, the number of participants who experienced an AE were reported for the primary treatment period.

  Up to ~24 weeks

• Number of Participants Who Discontinued Study Intervention Due to AEs

  An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Per protocol, the number of participants who discontinued study treatment due to AEs were reported for the primary treatment period.

  Up to ~24 weeks

Secondary Outcomes (3)

• Change From Baseline in Six-Minute Walk Distance (6MWD) at Week 24

  Baseline and Week 24

• Percentage of Participants With Improvement in World Health Organization Functional Class (WHO FC) at Week 24

  Baseline and Week 24

• Change From Baseline in N-terminal proB-type Natriuretic Peptide (NT-proBNP) at Week 24

  Baseline and Week 24

Study Arms (1)

Sotatercept

EXPERIMENTAL

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.

Biological: Sotatercept

Interventions

Sotatercept 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.

Also known as: MK-7962, ActRIIA-IgG1Fc, ACE-011

Sotatercept

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (17)

Nagoya University Hospital ( Site 2010)

Nagoya, Aichi-ken, 466-8560, Japan

Location

Chiba Saiseikai Narashino hospital ( Site 2004)

Narashino, Chiba, 275-8580, Japan

Location

Kurume University Hospital ( Site 2014)

Kurume, Fukuoka, 830-0011, Japan

Location

Kure Kyosai Hospital ( Site 2017)

Kure, Hiroshima, 7378505, Japan

Location

Sapporo Medical University Hospital ( Site 2018)

Sapporo, Hokkaido, 060-8543, Japan

Location

Hokkaido University Hospital ( Site 2001)

Sapporo, Hokkaido, 060-8648, Japan

Location

Kobe University Hospital ( Site 2012)

Kobe, Hyōgo, 650-0017, Japan

Location

Tohoku University Hospital ( Site 2002)

Sendai, Miyagi, 980-8574, Japan

Location

National Cerebral and Cardiovascular Center ( Site 2011)

Suita, Osaka, 564-8565, Japan

Location

Hamamatsu University Hospital ( Site 2016)

Hamamatsu, Shizuoka, 431-3192, Japan

Location

The University of Tokyo Hospital ( Site 2006)

Bunkyo-ku, Tokyo, 113-8654, Japan

Location

Kyorin University Hospital ( Site 2005)

Mitaka, Tokyo, 181-8611, Japan

Location

Chiba University Hospital ( Site 2003)

Chiba, 260-8677, Japan

Location

Kyushu University Hospital ( Site 2015)

Fukuoka, 812-8582, Japan

Location

National Hospital Organization Okayama Medical Center ( Site 2013)

Okayama, 701-1192, Japan

Location

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

Tokyo, 108-8329, Japan

Location

Keio university hospital ( Site 2007)

Tokyo, 1608582, Japan

Location

Related Publications (1)

• Matsubara H, Tanabe N, Ogo T, Abe K, Inami T, Maeda Y, Arano I, Shirakawa M, Sakai R, Cornell AG; Sotatercept Study 020 Investigators. Phase 3, Open-Label Multicenter Study of Sotatercept in Japanese Participants With Pulmonary Arterial Hypertension. JACC Asia. 2026 Mar;6(3):297-309. doi: 10.1016/j.jacasi.2025.12.009. Epub 2026 Jan 31.

  PMID: 41618947 RESULT

Related Links

• Merck Clinical Trials Information

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Interventions

ACE-011

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme LLC

ClinicalTrialsDisclosure@msd.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2023
• First Posted: April 18, 2023
• Study Start: May 10, 2023
• Primary Completion: March 12, 2024
• Study Completion: November 6, 2025
• Last Updated: March 3, 2026
• Results First Posted: February 27, 2025

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

JP (17)