Study of Sotatercept in Newly Diagnosed Intermediate- and High-Risk PAH Participants (MK-7962-005/A011-13)

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Pulmonary Arterial Hypertension

In brief

The objective of this study is to evaluate the effects of sotatercept (MK-7962, formerly called ACE-011) treatment (plus background pulmonary arterial hypertension \[PAH\] therapy) versus placebo (plus background PAH therapy) on time to clinical worsening (TTCW) in participants who are newly diagnosed with PAH and are at intermediate or high-risk of disease progression.

Key facts

Study ID

NCT04811092

Run by

Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA

People needed

321

Starts

2022-03-18

Expected to finish

2025-04-03

Last updated by the study team

2026-06-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Inclusion criteria include but are not limited to:
• Documented diagnostic right heart catheterization (RHC) within 12 months of screening documenting a minimum pulmonary vascular resistance (PVR) of ≥ 4 Wood units and pulmonary capillary wedge pressure (PCWP) or left ventricular end-diastolic pressure (LVEDP) of ≤ 15 mmHg, with the diagnosis of WHO PAH Group 1 in any of the following subtypes:
• Idiopathic PAH
• Heritable PAH
• Drug/toxin-induced PAH
• PAH associated with connective tissue disease
• PAH associated with simple, congenital systemic to pulmonary shunts at least 1 year following repair
• Symptomatic PAH classified as World Health Organization (WHO) Functional Class (FC) II or III
• Either Registry to Evaluate Early and Long-term PAH Disease Management (REVEAL) Lite 2 Risk Score ≥ 6 or Comparative, Prospective Registry of Newly Initiated Therapies for Pulmonary Hypertension (COMPERA) 2.0 risk score ≥2 (intermediate to-low-risk or above)
• Diagnosis of PAH within 12 months of screening and on stable doses of a double or triple combination of background PAH therapies and diuretics (if any) for at least 90 days prior to screening
• Six-minute walk distance ≥ 150 m repeated twice at screening at least 4 hours apart, but no longer than 1 week apart, and both values are within 15% of each other (calculated from the highest value)
• Females of childbearing potential must meet the following criteria:
• Have 2 negative urine or serum pregnancy tests as verified by the investigator prior to starting study drug administration; she must agree to ongoing urine or serum pregnancy testing during the course of the study and until 8 weeks after the last dose of the study drug
• If sexually active with a male partner, have used highly effective contraception without interruption, for at least 28 days prior to starting the investigational product AND agreed to use the same highly effective contraception in combination with a barrier method during the study (including dose interruptions) and for 16 weeks (112 days) after discontinuation of study treatment
• Refrain from breastfeeding a child or 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 treatment
• Male participants must meet the following criteria:
• Agree to use a condom, defined as a male latex condom or nonlatex condom NOT made out of natural (animal) membrane (e.g., polyurethane), during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions, and for at least 16 weeks (112 days) following investigational product discontinuation, even if he has undergone a successful vasectomy
• Refrain from donating blood or sperm for the duration of the study and for 16 weeks (112 days) after the last dose of study treatment

You may not qualify if…

• Exclusion Criteria include but are not limited to:
• Diagnosis of pulmonary hypertension (PH) WHO Groups 2, 3, 4, or 5
• Diagnosis of the following PAH Group 1 subtypes: human immunodeficiency virus (HIV)-associated PAH and PAH associated with portal hypertension, schistosomiasis-associated PAH, pulmonary veno occlusive disease, and pulmonary capillary hemangiomatosis
• Hemoglobin at screening above gender-specific upper limit of normal (ULN), per local laboratory test
• Uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure (BP) > 180 mmHg or sitting diastolic BP > 110 mmHg during the Screening Visit after a period of rest
• Baseline systolic BP < 90 mmHg at screening
• Pregnant or breastfeeding women
• Any of the following clinical laboratory values at the Screening Visit:
• Estimated glomerular filtration rate < 30 mL/min/1.73 m\^2 (as defined by The Modification of Diet in Renal Disease [MDRD] equation)
• Serum alanine aminotransferase, aspartate aminotransferase, and total bilirubin levels > 3 × ULN
• Platelet count < 50,000/mm\^3 (< 50.0 × 10\^9 /L)
• Currently enrolled in or have completed any other investigational product study within 30 days for small molecule drugs or within 5 half-lives for investigational biologics prior to the date of documented informed consent
• Known allergic reaction to sotatercept (ACE-011), its excipients, or luspatercept
• History of pneumonectomy
• Pulmonary function test values of forced vital capacity < 60% predicted within 1 year prior to the Screening Visit
• Stopped receiving any PH chronic general supportive therapy (e.g., diuretics, oxygen, anticoagulants, and digoxin) within 60 days prior to the Screening Visit
• Initiation of an exercise program for cardiopulmonary rehabilitation within 90 days prior to the Screening Visit or planned initiation during the study (participants who are stable in the maintenance phase of a program and who will continue for the duration of the study are eligible)
• Untreated more than mild obstructive sleep apnea
• History of known pericardial constriction
• History of restrictive or congestive cardiomyopathy
• History of atrial septostomy within 180 days prior to the Screening Visit
• Electrocardiogram with Fridericia's corrected QT interval > 500 ms during the Screening Period
• Personal or family history of long QT syndrome or sudden cardiac death
• Left ventricular ejection fraction < 50% on historical echocardiogram (ECHO) within 1 year prior to the Screening Visit
• Any current or prior history of symptomatic coronary disease (prior myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft surgery, or cardiac anginal chest pain) in the past 6 months prior to the Screening Visit

Where it is running

• University of Arizona ( Site 1006) — Tucson, Arizona, United States
• University of California San Diego ( Site 1002) — La Jolla, California, United States
• UCLA Medical Center ( Site 1068) — Los Angeles, California, United States
• University of California Irvine ( Site 1086) — Orange, California, United States
• Santa Barbara Pulmonary Associates ( Site 1060) — Santa Barbara, California, United States
• University of California Davis Medical Center ( Site 1064) — Sherman Oaks, California, United States
• University of Colorado Hospital ( Site 1013) — Aurora, Colorado, United States
• AdventHealth Medical Group Advanced Lung Disease ( Site 1058) — Orlando, Florida, United States
• University of Iowa Hospital and Clinics ( Site 1050) — Iowa City, Iowa, United States
• Johns Hopkins Hospital ( Site 1036) — Baltimore, Maryland, United States
• Tufts Medical Center - PPDS ( Site 1014) — Boston, Massachusetts, United States
• Boston Medical Center ( Site 1012) — Boston, Massachusetts, United States
• University of Michigan ( Site 1011) — Ann Arbor, Michigan, United States
• University of Kansas Medical Center ( Site 1020) — Kansas City, Missouri, United States
• Washington University School of Medicine ( Site 1022) — St Louis, Missouri, United States
• University of New Mexico, Health Sciences Center ( Site 1048) — Albuquerque, New Mexico, United States
• NYU Langone Health ( Site 1052) — New York, New York, United States
• University of North Carolina at Chapel Hill ( Site 1042) — Chapel Hill, North Carolina, United States
• The Carl and Edyth Lindner Center for Research and Education at the Christ Hospital ( Site 1001) — Cincinnati, Ohio, United States
• University of Cincinnati ( Site 1035) — Cincinnati, Ohio, United States
• The Cleveland Clinic Foundation Taussig Cancer Center ( Site 1065) — Cleveland, Ohio, United States
• Nazih Zuhdi Transplantation Institute ( Site 1084) — Oklahoma City, Oklahoma, United States
• Oregon Health & Science University ( Site 1054) — Portland, Oregon, United States
• Medical University of South Carolina ( Site 1003) — Charleston, South Carolina, United States
• Arizona Pulmonary Specialists ( Site 1010) — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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