- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05818137
A Study of Sotatercept in Japanese Pulmonary Arterial Hypertension (PAH) Participants (MK-7962-020)
March 26, 2024 updated by: Merck Sharp & Dohme LLC
A Phase 3 Non-randomized, Non-controlled, Open Label Clinical Study to Evaluate the Efficacy and Safety of MK-7962 (Sotatercept) add-on to Background Therapy in Japanese Participants With Pulmonary Arterial Hypertension (PAH)
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
46
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Toll Free Number
- Phone Number: 1-888-577-8839
- Email: Trialsites@merck.com
Study Locations
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Chiba, Japan, 260-8677
- Chiba University Hospital ( Site 2003)
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Fukuoka, Japan, 812-8582
- Kyushu University Hospital ( Site 2015)
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Okayama, Japan, 701-1192
- National Hospital Organization Okayama Medical Center ( Site 2013)
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Tokyo, Japan, 108-8329
- International University of Health and Welfare Mita Hospital ( Site 2008)
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Tokyo, Japan, 1608582
- Keio university hospital ( Site 2007)
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Aichi
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Nagoya-Shi, Aichi, Japan, 466-8560
- Nagoya University Hospital ( Site 2010)
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Chiba
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Narashino, Chiba, Japan, 275-8580
- Chiba Saiseikai Narashino hospital ( Site 2004)
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Fukuoka
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Kurume, Fukuoka, Japan, 830-0011
- Kurume University Hospital ( Site 2014)
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Hiroshima
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Kure, Hiroshima, Japan, 7378505
- Kure Kyosai Hospital ( Site 2017)
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Hokkaido
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Sapporo, Hokkaido, Japan, 060-8543
- Sapporo Medical University Hospital ( Site 2018)
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Sapporo, Hokkaido, Japan, 060-8648
- Hokkaido University Hospital ( Site 2001)
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Hyogo
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Kobe, Hyogo, Japan, 650-0017
- Kobe University Hospital ( Site 2012)
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Miyagi
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Sendai-shi, Miyagi, Japan, 980-8574
- Tohoku University Hospital ( Site 2002)
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Osaka
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Suita, Osaka, Japan, 564-8565
- National Cerebral and Cardiovascular Center ( Site 2011)
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Shizuoka
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Hamamatsu, Shizuoka, Japan, 431-3192
- Hamamatsu University Hospital ( Site 2016)
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Tokyo
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Bunkyo-ku, Tokyo, Japan, 113-8654
- The University of Tokyo Hospital ( Site 2006)
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Mitaka, Tokyo, Japan, 181-8611
- Kyorin University Hospital ( Site 2005)
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
Documented diagnostic RHC at any time prior to screening confirming the diagnosis of WHO 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 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 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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 continue receiving the treatment until approval of sotatercept in Japan.
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Pulmonary Vascular Resistance (PVR) from Baseline at Week 24
Time Frame: Baseline and Week 24
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PVR is the resistance against blood flow from the pulmonary artery to the left atrium.
PVR is measured in dyn∙sec/cm^5 by right heart catheterization (RHC).
RHC will be performed during the screening period (baseline) and Week 24.
The change in PVR from baseline at Week 24 will be presented.
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Baseline and Week 24
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Number of Participants experiencing Adverse Events (AEs)
Time Frame: Up to ~24 weeks
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An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
The number of participants experiencing AEs will be reported.
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Up to ~24 weeks
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Number of Participants who Discontinue Study Intervention due to AEs
Time Frame: Up to ~24 weeks
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An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
The number of participants discontinuing study treatment due to AEs will be reported.
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Up to ~24 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in Six-minute walk distance (6MWD) at Week 24
Time Frame: Baseline and Week 24
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The distance walked in meters in 6 minutes will be measured during the screening period (baseline) and at Week 24.
The change from baseline in 6MWD at Week 24 will be presented.
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Baseline and Week 24
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Proportion of participants with improvement in WHO FC or maintenance of WHO FC II (in participants with WHO FC II at baseline)/WHO FC I (in participants with WHO FC I at baseline) at Week 24
Time Frame: Baseline and Week 24
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Participants will have their pulmonary hypertension measured and classified during the screening period (baseline) and Week 24 as one of four categories of the WHO FC assessment ranging from I = no symptoms of pulmonary arterial hypertension with exercise or at rest to IV = symptoms at rest and severe symptoms with any activity.
The proportion of participants with improvement or maintenance in WHO FC at Week 24 will be presented.
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Baseline and Week 24
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Change from baseline in N-terminal proB-type natriuretic peptide (NT-proBNP) at Week 24
Time Frame: Baseline and Week 24
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NT-proBNP is an established marker of ventricular dysfunction in participants with PAH.
NT-proBNP will be measured at Day 1 (baseline) and at Week 24.
The change from baseline in NT-proBNP at Week 24 will be presented.
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Baseline and Week 24
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Medical Director, Merck Sharp & Dohme LLC
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 10, 2023
Primary Completion (Actual)
March 12, 2024
Study Completion (Estimated)
August 13, 2025
Study Registration Dates
First Submitted
April 5, 2023
First Submitted That Met QC Criteria
April 5, 2023
First Posted (Actual)
April 18, 2023
Study Record Updates
Last Update Posted (Actual)
March 27, 2024
Last Update Submitted That Met QC Criteria
March 26, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 7962-020
- jRCT2031230046 (Registry Identifier: jRCT)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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