Study to Evaluate Sotatercept (MK-7962) in Children With Pulmonary Arterial Hypertension (PAH) (MK-7962-008)
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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 1 Year to 17 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 24 weeks
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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)."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests sotatercept (MK-7962) in children ages 1 to under 18 with pulmonary arterial hypertension (PAH), a type of high blood pressure in the lungs. Over 24 weeks, researchers will check its safety, side effects, and how the body handles it. Children will also stay on their usual PAH treatment.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have WHO Group 1 PAH confirmed before screening by a right heart catheter test, which measures pressure inside the heart and lung blood vessels.
- Have an allowed type of PAH: no known cause, inherited, caused by drugs or toxins, or linked to a disease of the body's support tissues.
- PAH linked to a heart defect may also qualify if an abnormal blood flow opening was closed more than 6 months before screening and PAH was confirmed afterward. PAH with an unrelated opening may also qualify.
- Be taking stable doses of PAH medicines.
- Male participants must follow the study's rules for avoiding pregnancy during treatment and for at least 16 weeks afterward. These include not having vaginal sex or using condoms plus a partner's birth control, with some exceptions.
- Female participants who can become pregnant must use highly effective birth control or not have sex that could cause pregnancy during treatment and for at least 16 weeks afterward.
- Do not donate blood, sperm, or eggs, as applicable, during the study and for at least 16 weeks after the last dose.
Who can't join
- Have a history of disease on the left side of the heart, such as certain valve problems, blocked blood flow, or heart failure; or a tight sac around the heart.
- Have severe lung, chest, or breathing-muscle problems present from birth or development; have had all or part of a lung removed; or have untreated sleep apnea that is more than mild (breathing pauses during sleep).
- Have Eisenmenger syndrome, a heart defect with high lung blood pressure; a Potts shunt or atrial septostomy, procedures that create blood flow openings; or an unrepaired or remaining abnormal heart opening.
- Have certain diseases or signs of disease in the lungs' small blood vessels or veins, or PAH linked to high pressure in the vein carrying blood to the liver.
- Have known abnormal connections between arteries and veins in the lungs, liver, or brain.
- Have a family history of sudden heart-related death or long QT syndrome, a heart rhythm disorder.
- Have had heart artery disease with symptoms, a heart attack, or a procedure to open or bypass heart arteries within 6 months before screening; or a stroke within 3 months before screening.
- Have received sotatercept or luspatercept before, or had an allergic reaction to any of their added ingredients.
Simplified for readability. The official criteria below are what the study team uses.
Official 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 sites (10)
CA
- The Regents of the University of California - Los Angeles (UCLA Pediatrics) ( Site 1606) · Los Angeles, CA 90095Study Coordinator · Study contact · 310-267-7667More trials in Los Angeles
- Stanford University School of Medicine ( Site 1603) · Palo Alto, CA 94304Study Coordinator · Study contact · 650-497-8000More trials in Palo Alto
- UCSF Benioff Children's Hospital San Francisco ( Site 1611) · San Francisco, CA 94158Study Coordinator · Study contact · 415-476-3831More trials in San Francisco
CO
- Children's Hospital Colorado ( Site 1609) · Aurora, CO 80045Study Coordinator · Study contact · 720-777-6427More trials in Aurora
DC
- Children's National Medical Center ( Site 1600) · Washington D.C., DC 20010Study Coordinator · Study contact · 202-476-2130More trials in Washington D.C.
OH
- Cincinnati Children's Hospital Medical Center ( Site 1602) · Cincinnati, OH 45229Study Coordinator · Study contact · 513-636-7072More trials in Cincinnati
PA
- Children's Hospital of Philadelphia (CHOP) ( Site 1608) · Philadelphia, PA 19104Study Coordinator · Study contact · 267-426-0120More trials in Philadelphia
TN
- Monroe Carell Jr. Children's Hospital ( Site 1601) · Nashville, TN 37232More trials in Nashville
WA
- Seattle Children's Hospital ( Site 1605) · Seattle, WA 98105Study Coordinator · Study contact · 206-987-2000More trials in Seattle
WI
- Children's Wisconsin ( Site 1610) · Milwaukee, WI 53226Study Coordinator · Study contact · 414-266-2000More trials in Milwaukee