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Phase 2Recruiting

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

Sponsored by Merck Sharp & Dohme LLC

About this study

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.

Where this study is enrolling (9)

  • Stanford University School of Medicine ( Site 1603)

    Palo Alto, California

    Call 650-497-8000

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

    San Francisco, California

    Call 415-476-3831

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

    Los Angeles, California

    Call 310-267-7667

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  • Children's Hospital Colorado ( Site 1609)

    Aurora, Colorado

    Call 720-777-6427

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  • Children's National Medical Center ( Site 1600)

    Washington D.C., District of Columbia

    Call 202-476-2130

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Show all 9 locations

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

    Cincinnati, Ohio

    Call 513-636-7072

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

    Philadelphia, Pennsylvania

    Call 215-590-7000

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  • Seattle Children's Hospital ( Site 1605)

    Seattle, Washington

    Call 206-987-2000

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  • Children's Wisconsin ( Site 1610)

    Milwaukee, Wisconsin

    Call 414-266-2000

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Who can participate

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

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.