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

Recruiting now · Phase 2

Conditions studied: Pulmonary Arterial Hypertension

In brief

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.

Key facts

Study ID

NCT05587712

Run by

Merck Sharp & Dohme LLC

People needed

42

Starts

2023-01-19

Expected to finish

2028-09-21

Last updated by the study team

2026-04-20

Who can join

Age: 1 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Great Ormond Street Hospital For Children NHS Foundation Trust ( Site 1500) — London, London, City of, United Kingdom (enrolling)
• Stanford University School of Medicine ( Site 1603) — Palo Alto, California, United States (enrolling)
• UCSF Benioff Children's Hospital San Francisco ( Site 1611) — San Francisco, California, United States (enrolling)
• Children's Hospital Colorado ( Site 1609) — Aurora, Colorado, United States (enrolling)
• Children's National Medical Center ( Site 1600) — Washington D.C., District of Columbia, United States (enrolling)
• Cincinnati Children's Hospital Medical Center ( Site 1602) — Cincinnati, Ohio, United States (enrolling)
• Children's Hospital of Philadelphia (CHOP) ( Site 1608) — Philadelphia, Pennsylvania, United States (enrolling)
• The Regents of the University of California - Los Angeles (UCLA Pediatrics) ( Site 1606) — Los Angeles, California, United States (enrolling)
• Seattle Children's Hospital ( Site 1605) — Seattle, Washington, United States (enrolling)
• Children's Wisconsin ( Site 1610) — Milwaukee, Wisconsin, United States (enrolling)
• The Children's Hospital at Westmead ( Site 0001) — Westmead, New South Wales, Australia (enrolling)
• Clinica Somer-Unidad de Investigacion y Docencia ( Site 0205) — Rionegro, Antioquia, Colombia (enrolling)
• Fundación Valle del Lili ( Site 0200) — Cali, Valle del Cauca Department, Colombia (enrolling)
• Clínica Imbanaco S.A.S ( Site 0203) — Cali, Valle del Cauca Department, Colombia (enrolling)
• CHU de Toulouse - Hôpital des Enfants ( Site 0302) — Toulouse, Haute-Garonne, France (enrolling)
• Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone ( Site 0303) — Marseille, Provence-Alpes-Côte d'Azur Region, France (enrolling)
• Hôpital Universitaire Necker Enfants Malades ( Site 0300) — Paris, France (enrolling)
• Universitaetsklinikum Heidelberg ( Site 0401) — Heidelberg, Baden-Wurttemberg, Germany (enrolling)
• Klinikum der Universität München Großhadern ( Site 0404) — München, Bavaria, Germany (enrolling)
• Medizinische Hochschule Hannover ( Site 0405) — Hanover, Lower Saxony, Germany (enrolling)
• Schneider Children's Medical Center ( Site 0603) — Petah Tikva, Israel (enrolling)
• Sheba Medical Center ( Site 0601) — Ramat Gan, Israel (enrolling)
• University Medical Center Groningen ( Site 0900) — Groningen, Netherlands (enrolling)
• Centrum Zdrowia Dziecka w Warszawie-Klinika Kardiologii ( Site 1103) — Warsaw, Masovian Voivodeship, Poland (enrolling)
• Uniwersyteckie Centrum Kliniczne-Klinika Kardiologii Dziecięcej i Wad Wrodzonych Serca ( Site 1102) — Gdansk, Pomeranian Voivodeship, Poland (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.