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

7 september 2026 uppdaterad av: 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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

6

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Japan
    • Osaka
      • Izumi, Osaka, Japan, 594-1101
        • Rekrytering
        • Osaka Prefectural Hospital Organization Osaka Women's and Children's Hospital ( Site 3203)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: +81-725-56-1260
      • Suita, Osaka, Japan, 565-0871
        • Rekrytering
        • The University of Osaka Hospital ( Site 3201)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: +81-6-6879-5111
    • Tokyo
      • Setagaya City, Tokyo, Japan, 157-8535
        • Rekrytering
        • National Center for Child Health and Development ( Site 3202)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: +81-3-3416-0181

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Barn

Tar emot friska volontärer

Nej

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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
Andra namn:
  • ACE-011
  • MK-7962
  • ActRIIA-IgG1Fc
  • WINREVAIR®

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Number of Participants With One or More Adverse Events
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: Baseline and Week 24
The change from baseline in PVRI will be presented.
Baseline and Week 24

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Genomsnittlig förändring från baslinjen i N-terminal prohormon B-typ natriuretisk peptid (NT-proBNP)
Tidsram: Baslinje och vecka 24
Förändringen från baslinjen i plasmanivåer av NT-proBNP kommer att rapporteras.
Baslinje och vecka 24
Andel av deltagare som antingen förbättrat eller bibehållit sin funktionsklass från Världshälsoorganisationen (WHO FC)
Tidsram: Baslinje och vecka 24
Svårighetsgraden av en individs PAH-symtom kommer att bedömas med hjälp av WHO FC-systemet. WHO:s funktionsklassificering för PAH sträcker sig från klass I (ingen begränsning i fysisk aktivitet, ingen dyspné vid normal aktivitet), klass II (lätt begränsning av fysisk aktivitet), klass III (markerad begränsning av fysisk aktivitet) och klass IV (kan inte utföra en fysisk aktivitet). aktivitet utan några symtom, dyspné i vila). Förändringen från baslinjen i WHO FC kommer att klassificeras i "Förbättrad", "Ingen förändring" och "Försämrad". Förbättring = minskning av FC, försämrad = ökning av FC och ingen förändring = ingen förändring i FC.
Baslinje och vecka 24
Mean Change from Baseline in 6-Minute Walk Distance (6MWD)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Merck Sharp & Dohme LLC

Utredare

  • Studierektor: Medical Director, Merck Sharp & Dohme LLC

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

25 september 2026

Primärt slutförande (Beräknad)

24 maj 2029

Avslutad studie (Beräknad)

16 maj 2031

Studieregistreringsdatum

Först inskickad

9 juni 2026

Först inskickad som uppfyllde QC-kriterierna

9 juni 2026

Första postat (Faktisk)

15 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

9 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

7 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 7962-032
  • MK-7962-032 (Annan identifierare: MSD)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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

Läkemedels- och apparatinformation, studiedokument

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Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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