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A Study of Sotatercept (MK-7962) in Japanese Children With Pulmonary Arterial Hypertension (PAH) (MK-7962-032)

9. juni 2026 opdateret af: Merck Sharp & Dohme LLC

A Phase 2 Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Sotatercept (MK-7962) in Japanese Children From 1 to Less Than 18 Years of Age With PAH on Standard of Care.

The goal of this study is to learn about the safety of sotatercept and how well Japanese children tolerate it, when taken along with standard (usual) pulmonary arterial hypertension (PAH) treatment. Researchers also want to learn what happens to it in a person's body over time and whether it lowers resistance in blood vessels in the lungs.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

6

Fase

  • Fase 2

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

  • Has pulmonary arterial hypertension (PAH, World Health Organization Group 1) confirmed by a prior right heart catheterization
  • Has idiopathic, heritable, drug- or toxin-induced PAH, connective tissue disease-associated PAH, repaired congenital heart disease-associated PAH, or PAH with coincidental shunt
  • Has PAH classified as World Health Organization Functional Class I, or symptomatic World Health Organization Functional Class II to IV
  • Has been receiving stable standard-of-care background therapy for PAH for at least 90 days
  • Is Japanese

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

  • History of left-sided heart disease
  • Has severe congenital or developmental abnormalities of the lung, thorax, and/or diaphragm
  • History of Eisenmenger syndrome, Potts shunt, or recent atrial septostomy within 180 days
  • Has unrepaired or residual cardiac shunt with Qp/Qs >1.5
  • Has pulmonary veno-occlusive disease, pulmonary capillary hemangiomatosis, or overt signs of pulmonary capillary and/or venous involvement
  • PAH associated with portal hypertension
  • Known visceral arteriovenous malformations
  • History of full or partial pneumonectomy
  • Untreated more than mild obstructive sleep apnea
  • History of known pericardial constriction
  • Family history of sudden cardiac death or long QT syndrome
  • History of symptomatic coronary disease within 6 months or cerebrovascular accident within 3 months
  • Prior treatment with sotatercept or luspatercept

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Sotatercept
Participants receive sotatercept by subcutaneous injection every 3 weeks (Q3W) for up to approximately 24 weeks while continuing standard-of-care background therapy for PAH. Participants start at a dose of 0.3 mg/kg Q3W, and may titrate up to the target dose of 0.7 mg/kg SC injection Q3W starting at Week 6 based on protocol-defined dose-escalation guidance. After Week 24, participants who meet certain requirements may choose to continue receiving sotatercept for up to 58 months.
Biologisk: Sotatercept
Sotatercept subcutaneous injection every 3 weeks
Andre navne:
  • ACE-011
  • MK-7962
  • ActRIIA-IgG1Fc
  • WINREVAIR®

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants With One or More Adverse Events
Tidsramme: Up to approximately 24 weeks
An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Up to approximately 24 weeks
Number of Participants Who Discontinue Study Intervention Due to an Adverse Event
Tidsramme: Up to approximately 24 weeks
An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Up to approximately 24 weeks
Laboratory Parameter (Hematology): Concentration of Hemoglobin
Tidsramme: Up to approximately 24 weeks
Hematological parameters will be investigated in blood samples from participants by means of clinical laboratory assays and evaluated by the investigator. The concentration of hemoglobin will be presented.
Up to approximately 24 weeks
Laboratory Parameter (Hematology): Hematocrit
Tidsramme: Up to approximately 24 weeks
Hematological parameters will be investigated in blood samples from participants by means of clinical laboratory assays and evaluated by the investigator. The hematocrit will be presented.
Up to approximately 24 weeks
Laboratory Parameter (Hematology): Red Blood Cell (RBC) Count
Tidsramme: Up to approximately 24 weeks
Hematological parameters will be investigated in blood samples from participants by means of clinical laboratory assays and evaluated by the investigator. The RBC count will be presented.
Up to approximately 24 weeks
Laboratory Parameter (Hematology): Reticulocyte Count
Tidsramme: Up to approximately 24 weeks
Hematological parameters will be investigated in blood samples from participants by means of clinical laboratory assays and evaluated by the investigator. The reticulocyte count will be presented.
Up to approximately 24 weeks
Laboratory Parameter (Hematology): Platelet Count
Tidsramme: Up to approximately 24 weeks
Hematological parameters will be investigated in blood samples from participants by means of clinical laboratory assays and evaluated by the investigator. The platelet count will be presented.
Up to approximately 24 weeks
Blood Pressure (BP)
Tidsramme: Up to approximately 24 weeks
BP will be assessed while the participant was seated after a period of rest in a quiet setting with no distractions (eg, television and cell phones).
Up to approximately 24 weeks
Number of Participants with Detectable Anti-Drug Antibodies (ADAs)
Tidsramme: Up to approximately 24 weeks
Blood samples will be collected to assess antidrug antibodies to sotatercept. The number of participants with detectable ADAs at any time during the study will be presented.
Up to approximately 24 weeks
Number of Participants with Detectable Neutralizing Antibodies to Sotatercept
Tidsramme: Up to approximately 24 weeks
Neutralizing antibody analysis will be performed on blood samples for participants who are confirmed as antidrug antibody-positive. The number of participants with detectable neutralizing antibodies at any time during the study will be presented.
Up to approximately 24 weeks
Serum Trough Concentration (Ctrough) of Sotatercept
Tidsramme: At designated time points and up to approximately 24 weeks
Serum samples collected predose will be used to determine serum trough concentration (Ctrough) of sotatercept.
At designated time points and up to approximately 24 weeks
Change From Baseline in Pulmonary Vascular Resistance Index (PVRI)
Tidsramme: Baseline and Week 24
The change from baseline in PVRI will be presented.
Baseline and Week 24

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Gennemsnitlig ændring fra baseline i N-terminalt prohormon B-type natriuretisk peptid (NT-proBNP)
Tidsramme: Baseline og uge 24
Ændringen fra baseline i plasma NT-proBNP niveauer vil blive rapporteret.
Baseline og uge 24
Procentdel af deltagere, der enten forbedrede eller vedligeholdt deres funktionsklasse fra Verdenssundhedsorganisationen (WHO FC)
Tidsramme: Baseline og uge 24
Sværhedsgraden af ​​en persons PAH-symptomer vil blive bedømt ved hjælp af WHO FC-systemet. WHOs funktionelle klassificering for PAH spænder fra klasse I (ingen begrænsning i fysisk aktivitet, ingen dyspnø ved normal aktivitet), klasse II (let begrænsning af fysisk aktivitet), klasse III (markant begrænsning af fysisk aktivitet) og klasse IV (kan ikke udføre en fysisk aktivitet) aktivitet uden symptomer, dyspnø i hvile). Ændringen fra baseline i WHO FC vil blive klassificeret i "Forbedret", "Ingen ændring" og "Forværret". Forbedring = reduktion i FC, forværret = stigning i FC og ingen ændring = ingen ændring i FC.
Baseline og uge 24
Mean Change from Baseline in 6-Minute Walk Distance (6MWD)
Tidsramme: Baseline and Week 24
6MWD will be assessed using the 6-minute walk test (6MWT).
Baseline and Week 24
Number of Participants With One or More Adverse Events
Tidsramme: From Week 24 up to approximately 58 months
An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
From Week 24 up to approximately 58 months
Number of Participants Who Discontinue Study Intervention Due to an Adverse Event
Tidsramme: From Week 24 up to approximately 58 months
An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
From Week 24 up to approximately 58 months
Laboratory Parameter (Hematology): Concentration of Hemoglobin
Tidsramme: From Week 24 up to approximately 58 months
Hematological parameters will be investigated in blood samples from participants by means of clinical laboratory assays and evaluated by the investigator. The concentration of hemoglobin will be presented.
From Week 24 up to approximately 58 months
Laboratory Parameter (Hematology): Hematocrit
Tidsramme: From Week 24 up to approximately 58 months
Hematological parameters will be investigated in blood samples from participants by means of clinical laboratory assays and evaluated by the investigator. The hematocrit will be presented.
From Week 24 up to approximately 58 months
Laboratory Parameter (Hematology): Red Blood Cell (RBC) Count
Tidsramme: From Week 24 up to approximately 58 months
Hematological parameters will be investigated in blood samples from participants by means of clinical laboratory assays and evaluated by the investigator. The RBC count will be presented.
From Week 24 up to approximately 58 months
Laboratory Parameter (Hematology): Reticulocyte Count
Tidsramme: From Week 24 up to approximately 58 months
Hematological parameters will be investigated in blood samples from participants by means of clinical laboratory assays and evaluated by the investigator. The reticulocyte count will be presented.
From Week 24 up to approximately 58 months
Laboratory Parameter (Hematology): Platelet Count
Tidsramme: From Week 24 up to approximately 58 months
Hematological parameters will be investigated in blood samples from participants by means of clinical laboratory assays and evaluated by the investigator. The platelet count will be presented.
From Week 24 up to approximately 58 months
Blood Pressure (BP)
Tidsramme: From Week 24 up to approximately 58 months
BP will be assessed while the participant was seated after a period of rest in a quiet setting with no distractions (eg, television and cell phones).
From Week 24 up to approximately 58 months
Number of Participants with Detectable ADAs
Tidsramme: From Week 24 up to approximately 58 months
Blood samples will be collected to assess antidrug antibodies to sotatercept. The number of participants with detectable ADAs at any time during the study will be presented.
From Week 24 up to approximately 58 months
Number of Participants with Detectable Neutralizing Antibodies to Sotatercept
Tidsramme: From Week 24 up to approximately 58 months
Neutralizing antibody analysis will be performed on blood samples for participants who are confirmed as ADA-positive. The number of participants with detectable neutralizing antibodies at any time during the study will be presented.
From Week 24 up to approximately 58 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Merck Sharp & Dohme LLC

Efterforskere

  • Studieleder: Medical Director, Merck Sharp & Dohme LLC

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

31. august 2026

Primær færdiggørelse (Anslået)

24. maj 2029

Studieafslutning (Anslået)

16. maj 2031

Datoer for studieregistrering

Først indsendt

9. juni 2026

Først indsendt, der opfyldte QC-kriterier

9. juni 2026

Først opslået (Faktiske)

15. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 7962-032
  • MK-7962-032 (Anden identifikator: MSD)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Pulmonal arteriel hypertension

Kliniske forsøg med Sotatercept

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