Study of Sotatercept in Newly Diagnosed Intermediate- and High-risk PAH Patients

  • STATUS
    Recruiting
  • End date
    Aug 6, 2028
  • participants needed
    662
  • sponsor
    Acceleron Pharma Inc.
Updated on 6 November 2021

Summary

The objective of this study is to evaluate the effects of sotatercept treatment (plus background 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.

Description

Study A011-13 is 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 patients.

Participants enrolled in the study will have a diagnosis within 6 months of study screening of symptomatic PAH (WHO Group 1, classified as FC II or III) and presentation of idiopathic or heritable PAH, PAH associated with connective tissue diseases (CTD), drug- or toxininduced PAH, post shunt correction PAH, or PAH presenting at least 1 year following the correction of congenital heart defects.

Details
Condition Pulmonary Arterial Hypertension
Treatment Placebo, Sotatercept
Clinical Study IdentifierNCT04811092
SponsorAcceleron Pharma Inc.
Last Modified on6 November 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Eligible participants must meet all of the following criteria to be enrolled
in the study
Age 18 years
Documented diagnostic right heart catheterization (RHC) within 6 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
Symptomatic PAH classified as WHO FC II or III
REVEAL Lite 2 Risk Score 6
Diagnosis of PAH within 6 months of screening and on stable doses of a double combination of background PAH therapies for at least 90 days prior to screening. A triple combination of therapies, with stable doses for 90 days, may be allowed per local standard-of-care guidelines, but is restricted to 10% of the study population
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, have used, and agree to use, highly effective contraception without interruption, for at least 28 days prior to starting the investigational product, 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
Ability to adhere to study visit schedule and understand and comply with all protocol requirements
Ability to understand and provide written informed consent

Exclusion Criteria

Participants will be excluded from the study if any of the following criteria
are met
Diagnosis of PAH 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
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) > 160 mmHg or sitting diastolic BP > 100 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/m2 (as defined by MDRD equation)
Serum alanine aminotransferase or aspartate aminotransferase levels > 3 ULN or total bilirubin > 1.5 ULN
Platelet count < 50,000/mm3 (< 50.0 109 /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 biologics prior to the date of signed informed consent
Known allergic reaction to sotatercept (ACE-011)
History of pneumonectomy
Pulmonary function test values of forced vital capacity < 60% predicted within 1 year prior to the Screening Visit
Stopped receiving any pulmonary hypertension 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 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
18\. Electrocardiogram with Fridericia's corrected QT interval > 450 ms (or > 500 ms if right bundle branch abnormality is present) during the Screening Period
Personal or family history of long QT syndrome or sudden cardiac death
Left ventricular ejection fraction < 50% on historical echocardiogram within 1 year prior to the Screening Visit or pulmonary capillary wedge pressure > 15 mmHg as determined by historical RHC within 6 months 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
Cerebrovascular accident within 3 months prior to the Screening Visit
Acutely decompensated heart failure within 30 days prior to the Screening Visit, as per investigator assessment
Significant ( 2+ regurgitation) mitral regurgitation or aortic regurgitation valvular disease
Received intravenous inotropes (e.g., dobutamine, dopamine, norepinephrine, and vasopressin) within 30 days prior to the Screening Visit
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