Study to Evaluate Sotatercept (MK-7962) in Children With Pulmonary Arterial Hypertension (PAH) (MK-7962-008)

Last updated: March 21, 2025
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Active - Recruiting

Phase

2

Condition

Pulmonary Arterial Hypertension

Vascular Diseases

Stress

Treatment

Sotatercept

Clinical Study ID

NCT05587712
7962-008
2022-000478-25
U1111-1290-2858
2023-504861-22
MK-7962-008
  • Ages 1-17
  • All Genders

Study Summary

The primary objectives of the study are to evaluate the safety and tolerability, and pharmacokinetics (PK) of sotatercept over 24 weeks of treatment in children ≥1 to <18 years of age with PAH World Health Organization (WHO) Group 1 on standard of care (SoC). There is no formal hypothesis.

Eligibility Criteria

Inclusion

Inclusion Criteria

  • Documented, historic diagnostic right heart catheterization (RHC) any time before Screening confirming the diagnosis of PAH WHO Group 1 in any of the following subtypes:

  • Idiopathic pulmonary arterial hypertension (IPAH)

  • Heritable PAH

  • Drug/toxin-induced PAH

  • PAH associated with connective tissue disease

  • PAH-congenital heart disease (CHD) with shunt closure >6 months before Screening and subsequently confirmed by RHC before Screening

  • PAH with coincidental shunt.

  • Must be on a stable dose(s) of background PAH therapy (phosphdiesterase-5 (PDE5) inhibitors, endothelin receptor antagonists (ERAs), soluble guanylate cyclase stimulators (sGCS), or prostanoids [including subcutaneous and intravenous])

  • If male, agree to the following during the intervention period and for at least 16 weeks (112 days) after the last dose of study intervention:

  • Abstains from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agrees to remain abstinent or

  • Uses contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause, documented from the site personnel's review of the participant's medical records, medical examination, or medical history interview) as detailed below:

  • Uses a male condom plus partner use of an additional contraceptive method when having penile-vaginal intercourse with a woman of childbearing potential (WOCBP) who is not currently pregnant Note: Men with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse or use a male condom during each episode of penile-vaginal penetration.

  • If female, must be either not a WOCBP or use a contraceptive method that is highly effective or be abstinent from heterosexual intercourse during the intervention period and for at least 16 weeks (112 days) after the last dose of study intervention

  • If male, agrees to refrain from donating blood or sperm for the duration of the study and for 16 weeks (112 days) after the last dose of study intervention

  • If female, agrees to refrain from donating blood, eggs, or ovum for the duration of the study and for at least 16 weeks (112 days) after the last dose of study intervention

Exclusion Criteria

  • History of left-sided heart disease, including valvular disease (eg, moderate or greater mitral or aortic regurgitation or stenosis), left ventricular outflow tract obstruction, and/or left heart failure (eg, restrictive or dilated cardiomyopathy)

  • Severe (as based on the opinion of the investigator) congenital or developmental abnormalities of the lung, thorax, and/or diaphragm

  • History of Eisenmenger syndrome, Potts shunt, or atrial septostomy

  • Unrepaired or residual cardiac shunt

  • Diagnosis of pulmonary veno-occlusive diseases, pulmonary capillary hemangiomatosis, or overt signs of capillary and/or venous involvement

  • PAH associated with portal hypertension

  • Known visceral (lung, liver, or brain) arteriovenous malformation(s)

  • 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

  • Any current or prior history of symptomatic coronary disease (myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft surgery, or cardiac anginal chest pain) within 6 months before Screening

  • Cerebrovascular accident within 3 months before Screening

  • Prior exposure to sotatercept or luspatercept or has had an allergic reaction to any of their excipients

Study Design

Total Participants: 42
Treatment Group(s): 1
Primary Treatment: Sotatercept
Phase: 2
Study Start date:
January 19, 2023
Estimated Completion Date:
September 21, 2028

Connect with a study center

  • The Children's Hospital at Westmead ( Site 0001)

    Westmead, New South Wales 2145
    Australia

    Active - Recruiting

  • Clinica Somer-Unidad de Investigacion y Docencia ( Site 0205)

    Rionegro, Antioquia 054040
    Colombia

    Active - Recruiting

  • Clínica Imbanaco S.A.S ( Site 0203)

    Cali, Valle Del Cauca 760042
    Colombia

    Active - Recruiting

  • Fundacion Valle del Lili- CIC ( Site 0200)

    Cali, Valle Del Cauca 760032
    Colombia

    Active - Recruiting

  • Fundación Valle del Lili ( Site 0200)

    Cali, Valle Del Cauca 760032
    Colombia

    Active - Recruiting

  • CHU de Toulouse - Hôpital des Enfants ( Site 0302)

    Toulouse, Haute-Garonne 31059
    France

    Active - Recruiting

  • Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone ( Site 0303)

    Marseille, Provence-Alpes-Cote-d Azur 13005
    France

    Active - Recruiting

  • Hôpital Universitaire Necker Enfants Malades ( Site 0300)

    Paris, 75015
    France

    Active - Recruiting

  • Universitaetsklinikum Heidelberg ( Site 0401)

    Heidelberg, Baden-Wurttemberg 69120
    Germany

    Active - Recruiting

  • Klinikum der Universität München Großhadern ( Site 0404)

    München, Bayern 81337
    Germany

    Active - Recruiting

  • Medizinische Hochschule Hannover ( Site 0405)

    Hannover, Niedersachsen 30625
    Germany

    Active - Recruiting

  • Schneider Children's Medical Center ( Site 0603)

    Petah-Tikva, 4920235
    Israel

    Active - Recruiting

  • Sheba Medical Center ( Site 0601)

    Ramat Gan, 5265601
    Israel

    Active - Recruiting

  • University Medical Center Groningen ( Site 0900)

    Groningen, 9713GZ
    Netherlands

    Active - Recruiting

  • Centrum Zdrowia Dziecka w Warszawie-Klinika Kardiologii ( Site 1103)

    Warszawa, Mazowieckie 04-730
    Poland

    Active - Recruiting

  • Uniwersyteckie Centrum Kliniczne-Klinika Kardiologii Dziecięcej i Wad Wrodzonych Serca ( Site 1102)

    Gdańsk, Pomorskie 80-952
    Poland

    Active - Recruiting

  • Wits Clinical Research-Wits Clinical Research Bara ( Site 1201)

    Johannesburg, Soweto, Gauteng 2013
    South Africa

    Active - Recruiting

  • Hospital Universitario Ramón y Cajal ( Site 1300)

    Madrid, Madrid, Comunidad De 28034
    Spain

    Active - Recruiting

  • Hospital Universitari i Politecnic La Fe ( Site 1303)

    València, Valencia 46026
    Spain

    Active - Recruiting

  • Hospital Universitari Vall d'Hebron ( Site 1302)

    Barcelona, 08035
    Spain

    Active - Recruiting

  • HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 1301)

    Madrid, 28007
    Spain

    Active - Recruiting

  • Ankara Bilkent Şehir Hastanesi. ( Site 1403)

    Ankara, 06800
    Turkey

    Active - Recruiting

  • Ankara City Hospital ( Site 1403)

    Ankara, 06800
    Turkey

    Active - Recruiting

  • Gazi University Health Research and Application Center Gazi -Çocuk Sağlığı ve Hastalıkları Anabilim

    Ankara, 06560
    Turkey

    Active - Recruiting

  • Hacettepe Universite Hastaneleri ( Site 1400)

    Ankara, 06100
    Turkey

    Active - Recruiting

  • Mehmet Akif Ersoy Research and Training Hospital ( Site 1404)

    Istanbul, 34303
    Turkey

    Active - Recruiting

  • Great Ormond Street Hospital For Children NHS Foundation Trust ( Site 1500)

    London, London, City Of WC1N 3JH
    United Kingdom

    Active - Recruiting

  • The Regents of the University of California - Los Angeles (UCLA Pediatrics) ( Site 1606)

    Los Angeles, California 90095
    United States

    Active - Recruiting

  • Stanford University School of Medicine ( Site 1603)

    Palo Alto, California 94304
    United States

    Active - Recruiting

  • UCSF Benioff Children's Hospital San Francisco ( Site 1611)

    San Francisco, California 94158
    United States

    Active - Recruiting

  • Children's Hospital Colorado ( Site 1609)

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • Children's National Medical Center ( Site 1600)

    Washington, District of Columbia 20010
    United States

    Active - Recruiting

  • Cincinnati Children's Hospital Medical Center ( Site 1602)

    Cincinnati, Ohio 45245
    United States

    Active - Recruiting

  • Children's Hospital of Philadelphia (CHOP) ( Site 1608)

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • Monroe Carell Jr. Children's Hospital ( Site 1601)

    Nashville, Tennessee 37232
    United States

    Active - Recruiting

  • Seattle Children's Hospital ( Site 1605)

    Seattle, Washington 98105
    United States

    Active - Recruiting

  • Children's Wisconsin ( Site 1610)

    Milwaukee, Wisconsin 53226
    United States

    Active - Recruiting

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