A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy in Newly Diagnosed Intermediate- and High-risk PAH Patients. - A Phase 3 Study of Sotatercept in Newly Diagnosed Intermediate- and High-risk PAH Patients

ACCELERON PHARMA INC.0 sites662 target enrollmentSeptember 9, 2021

Overview

No summary available.

Registry

who.int

Start Date

September 9, 2021

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\. Age \= 18 years
•2\. 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 enddiastolic 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
•3\. Symptomatic PAH classified as WHO FC II or III
•4\. REVEAL Lite 2 risk score \= 6
•5\. 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.

•1\. Diagnosis of PAH WHO Groups 2, 3, 4, or 5
•2\. Diagnosis of the following PAH Group 1 subtypes: human immunodeficiency virus (HIV)\-associated PAH and PAH associated with portal hypertension
•3\. Hemoglobin at screening above gender\-specific upper limit of normal (ULN), per local laboratory test
•4\. 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
•5\. Baseline systolic BP \< 90 mmHg at screening
•6\. Pregnant or breastfeeding women
•7\. Any of the following clinical laboratory values at the Screening
•\-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)
•8\. Currently enrolled in or have completed any other investigational product study within 30 days for small\-molecule drugs or within 5 halflives for biologics prior to the date of signed informed consent