A Phase 3 Study of Sotatercept in Participants with PAH WHO FC III or FC IV at High Risk of Mortality

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Sotatercept When Added to Maximum Tolerated Background Therapy in Participants With Pulmonary Arterial Hypertension (PAH) World Health Organization (WHO) Functional Class (FC) III or FC IV at High Risk of Mortality

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Overview
Principal Investigator: Harrison Farber, MD

This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, parallel-group study. The objective of this study is to evaluate the effects of sotatercept treatment (plus maximum tolerated background PAH therapy) versus placebo (plus maximum tolerated background PAH therapy) on time to first event of all-cause death, lung transplantation, or PAH worsening related hospitalization of ≥ 24 hours, in participants with WHO FC III or FC IV PAH at high risk of mortality. Maximum study duration for a given participant in this study will be up to approximately 49 months as follows:

  • Screening Period (up to 4 weeks)
  • DBPC Treatment Period (until event occurrence, up to approximately 46 months)
  • Follow-up Period (up to 8 weeks)

Study details
Inclusion Criteria
  • Symptomatic PAH classified as WHO FC III or IV
  • REVEAL Lite 2 risk score of ≥ 10
  • Clinically stable and on stable doses of maximum tolerated (per investigator’s judgment)double or triple background PAH therapies for at least 30 days prior to screening
Exclusion Criteria
  • Diagnosis of PAH WHO Groups 2, 3, 4, or 5
  • Diagnosis of the following PAH Group 1 subtypes: human immunodeficiency virus-associated PAH and PAH associated with portal hypertension
  • Baseline systolic BP < 85 mmHg at screening
Study Requirements

Patients may participate in this study for up to approximately 49 months (approximately 4 years) which includes the follow-up period. Patients will come to site approximately every 21 days unless the patient has a home health care visit. An estimated amount of 3 teaspoons/18 mL of blood will be collected at screening. An estimated amount of 11 teaspoons/58 mL will be collected at visit 1. For those visits where blood is collected after visit 1, an estimated amount of 5 teaspoons/28 mL will be collected. Depending upon how long you participate it is expected on average the total amount of blood collected per year is 20 teaspoons/112 mL.