Last updated 58 days ago

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

444 patients around the world

Available in Argentina, United States, Brazil, Spain

This is a phase 3, randomized, double-blind, placebo-controlled study to evaluate sotatercept when added to background PAH therapy in newly diagnosed intermediate- or high risk PAH participants. Participants enrolled in the study will have a diagnosis within 12 months of study screening of symptomatic PAH (World Health Organization (WHO) Group 1, classified as functional class (FC) II or III) and presentation of idiopathic or heritable PAH, PAH associated with connective tissue diseases (CTD), drug- or toxin- induced PAH, post shunt correction PAH, or PAH presenting at least 1 year following the correction of congenital heart defects.

Acceleron Pharma Inc.

1Research sites

444Patients around the world

Requirements for the patient

From 18 Years

All Gender

Medical requirements

: Eligible participants must meet all of the following criteria to be enrolled in the study: 1. Age ≥ 18 years
Eligible participants must meet all of the following criteria to be enrolled in the study: 2. Documented diagnostic right heart catheterization (RHC) within 12 months of screening documenting a minimum 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
Eligible participants must meet all of the following criteria to be enrolled in the study: 3. Symptomatic PAH classified as WHO FC II or III
Eligible participants must meet all of the following criteria to be enrolled in the study: 4. 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)
Eligible participants must meet all of the following criteria to be enrolled in the study: 5. Diagnosis of PAH within 12 months of screening and on stable doses of a double combination of background PAH therapies and diuretics for at least 90 days prior to screening
Eligible participants must meet all of the following criteria to be enrolled in the study: 6. 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)
Eligible participants must meet all of the following criteria to be enrolled in the study: 7. 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
Eligible participants must meet all of the following criteria to be enrolled in the study: 8. 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
Eligible participants must meet all of the following criteria to be enrolled in the study: 9. Ability to adhere to study visit schedule and understand and comply with all protocol requirements
Eligible participants must meet all of the following criteria to be enrolled in the study: 10. Ability to understand and provide written informed consent

: Participants will be excluded from the study if any of the following criteria are met: 1. Diagnosis of pulmonary hypertension (PH) WHO Groups 2, 3, 4, or 5
Participants will be excluded from the study if any of the following criteria are met: 2. 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

Sites

Instituto de Investigaciones Clínicas Quilmes

Recruiting

Sarmiento 315, Quilmes, Buenos Aires, Argentina

StudyHYPERION

SponsorAcceleron Pharma Inc.

Study typeInterventional

Requirements

From 18 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT04811092