Clinical trial NCT05818137: A Study of Sotatercept in Japanese Pulmonary Arterial Hypertension (PAH) Participants (MK-7962-020)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Pulmonary Arterial Hypertension
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2023-04-18
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change From Pulmonary Vascular Resistance (PVR) From Baseline at Week 24
timeFrame: Baseline and Week 24
measure: Number of Participants Who Experienced an Adverse Event (AE)
timeFrame: Up to ~24 weeks
measure: Number of Participants Who Discontinued Study Intervention Due to AEs
timeFrame: Up to ~24 weeks
Secondary outcomes:
measure: Change From Baseline in Six-Minute Walk Distance (6MWD) at Week 24
timeFrame: Baseline and Week 24
measure: Percentage of Participants With Improvement in World Health Organization Functional Class (WHO FC) at Week 24
timeFrame: Baseline and Week 24
measure: Change From Baseline in N-terminal proB-type Natriuretic Peptide (NT-proBNP) at Week 24
timeFrame: Baseline and Week 24
Other outcomes:
Locations:
city: Nagoya-Shi
country: Japan
facility: Nagoya University Hospital ( Site 2010)
state: Aichi
city: Narashino
country: Japan
facility: Chiba Saiseikai Narashino hospital ( Site 2004)
state: Chiba
city: Kurume
country: Japan
facility: Kurume University Hospital ( Site 2014)
state: Fukuoka
city: Kure
country: Japan
facility: Kure Kyosai Hospital ( Site 2017)
state: Hiroshima
city: Sapporo
country: Japan
facility: Sapporo Medical University Hospital ( Site 2018)
state: Hokkaido
city: Sapporo
country: Japan
facility: Hokkaido University Hospital ( Site 2001)
state: Hokkaido
city: Kobe
country: Japan
facility: Kobe University Hospital ( Site 2012)
state: Hyogo
city: Sendai-shi
country: Japan
facility: Tohoku University Hospital ( Site 2002)
state: Miyagi
city: Suita
country: Japan
facility: National Cerebral and Cardiovascular Center ( Site 2011)
state: Osaka
city: Hamamatsu
country: Japan
facility: Hamamatsu University Hospital ( Site 2016)
state: Shizuoka
city: Bunkyo-ku
country: Japan
facility: The University of Tokyo Hospital ( Site 2006)
state: Tokyo
city: Mitaka
country: Japan
facility: Kyorin University Hospital ( Site 2005)
state: Tokyo
city: Chiba
country: Japan
facility: Chiba University Hospital ( Site 2003)
city: Fukuoka
country: Japan
facility: Kyushu University Hospital ( Site 2015)
city: Okayama
country: Japan
facility: National Hospital Organization Okayama Medical Center ( Site 2013)
city: Tokyo
country: Japan
facility: International University of Health and Welfare Mita Hospital ( Site 2008)
city: Tokyo
country: Japan
facility: Keio university hospital ( Site 2007)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: