← Back to searchRecruitingRecruiting
Study to Evaluate Sotatercept (MK-7962) in Children With Pulmonary Arterial Hypertension (PAH) (MK-7962-008)
NCT05587712 · Merck Sharp & Dohme LLC
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
A Phase 2 Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Sotatercept (MK-7962) in Children From 1 to Less Than 18 Years of Age With PAH on Standard of Care
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.
Eligibility criteria
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
Enrollment target: 42 participants
Allocation: na
Masking: none
Age groups: child
Timeline
Starts: 2023-01-19
Estimated completion: 2028-09-21
Last updated: 2026-04-06
Interventions
Drug: Sotatercept
Primary outcomes
- • Serum Trough Concentration (Ctrough) of Sotatercept (Predose Day 1, Day 21, Day 42, Day 63, Day 84, Day105, Day 126, Day 147, Day 168, Day 189. Postdose Day 7, Day 14, Day 64, Day 69 and Day 76)
- • Area Under the Curve at Steady State (AUCss) of Sotatercept (Predose Day 1, Day 21, Day 42, Day 63, Day 84, Day105, Day 126, Day 147, Day 168, Day 189. Postdose Day 7, Day 14, Day 64, Day 69 and Day 76)
- • Area Under the Curve from 0 to 3 weeks (AUC0-3 weeks) of Sotatercept (Predose Day 1, Day 7, Day 14, and Predose Day 21)
Sponsor
Merck Sharp & Dohme LLC · industry
Contacts & investigators
ContactToll Free Number · contact · Trialsites@msd.com · 1-888-577-8839
InvestigatorMedical Director · study_director, Merck Sharp & Dohme LLC
All locations (35)
The Regents of the University of California - Los Angeles (UCLA Pediatrics) ( Site 1606)Recruiting
Los Angeles, California, United States
Stanford University School of Medicine ( Site 1603)Recruiting
Palo Alto, California, United States
UCSF Benioff Children's Hospital San Francisco ( Site 1611)Recruiting
San Francisco, California, United States
Children's Hospital Colorado ( Site 1609)Recruiting
Aurora, Colorado, United States
Children's National Medical Center ( Site 1600)Recruiting
Washington D.C., District of Columbia, United States
Cincinnati Children's Hospital Medical Center ( Site 1602)Recruiting
Cincinnati, Ohio, United States
Children's Hospital of Philadelphia (CHOP) ( Site 1608)Recruiting
Philadelphia, Pennsylvania, United States
Monroe Carell Jr. Children's Hospital ( Site 1601)Completed
Nashville, Tennessee, United States
Seattle Children's Hospital ( Site 1605)Recruiting
Seattle, Washington, United States
Children's Wisconsin ( Site 1610)Recruiting
Milwaukee, Wisconsin, United States
The Children's Hospital at Westmead ( Site 0001)Recruiting
Westmead, New South Wales, Australia
Clinica Somer-Unidad de Investigacion y Docencia ( Site 0205)Recruiting
Rionegro, Antioquia, Colombia
Fundación Valle del Lili ( Site 0200)Recruiting
Cali, Valle del Cauca Department, Colombia
Clínica Imbanaco S.A.S ( Site 0203)Recruiting
Cali, Valle del Cauca Department, Colombia
CHU de Toulouse - Hôpital des Enfants ( Site 0302)Recruiting
Toulouse, Haute-Garonne, France
Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone ( Site 0303)Recruiting
Marseille, Provence-Alpes-Côte d'Azur Region, France
Hôpital Universitaire Necker Enfants Malades ( Site 0300)Recruiting
Paris, France
Universitaetsklinikum Heidelberg ( Site 0401)Recruiting
Heidelberg, Baden-Wurttemberg, Germany
Klinikum der Universität München Großhadern ( Site 0404)Recruiting
München, Bavaria, Germany
Medizinische Hochschule Hannover ( Site 0405)Recruiting
Hanover, Lower Saxony, Germany
Schneider Children's Medical Center ( Site 0603)Recruiting
Petah Tikva, Israel
Sheba Medical Center ( Site 0601)Recruiting
Ramat Gan, Israel
University Medical Center Groningen ( Site 0900)Recruiting
Groningen, Netherlands
Centrum Zdrowia Dziecka w Warszawie-Klinika Kardiologii ( Site 1103)Recruiting
Warsaw, Masovian Voivodeship, Poland
Uniwersyteckie Centrum Kliniczne-Klinika Kardiologii Dziecięcej i Wad Wrodzonych Serca ( Site 1102)Recruiting
Gdansk, Pomeranian Voivodeship, Poland
Wits Clinical Research-Wits Clinical Research Bara ( Site 1201)Recruiting
Johannesburg, Soweto, Gauteng, South Africa
Hospital Universitario Ramón y Cajal ( Site 1300)Recruiting
Madrid, Madrid, Comunidad de, Spain
Hospital Universitari i Politecnic La Fe ( Site 1303)Recruiting
Valencia, Valencia, Spain
Hospital Universitari Vall d'Hebron ( Site 1302)Recruiting
Barcelona, Spain
HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 1301)Recruiting
Madrid, Spain
Hacettepe Universite Hastaneleri ( Site 1400)Recruiting
Ankara, Turkey (Türkiye)
Gazi University Health Research and Application Center Gazi -Çocuk Sağlığı ve Hastalıkları Anabilim ( Site 1402)Recruiting
Ankara, Turkey (Türkiye)
Ankara Bilkent Şehir Hastanesi. ( Site 1403)Recruiting
Ankara, Turkey (Türkiye)
Mehmet Akif Ersoy Research and Training Hospital ( Site 1404)Recruiting
Istanbul, Turkey (Türkiye)
Great Ormond Street Hospital For Children NHS Foundation Trust ( Site 1500)Recruiting
London, London, City of, United Kingdom