A Phase 3, Multicenter, Open-Label, Randomized Trial to Compare the Efficacy and Safety of Elritercept versus Epoetin Alfa for the Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes in ESA-naïve Adult Participants Who Require Red Blood Cell Transfusions (NCT07422480)

This trial is a phase 3 trial comparing Elritercept versus Epoetin Alfa in untreated patients who suffer from Anemia and require regular red blood cell transfusions due to their lower-risk MDS. This study aims to determine how well Elritercept works in improving Anemia symptoms and reducing need for red blood cell transfusions when compared to Epoetin Alfa, the standard therapy patients receive for this condition. Patients will be randomly assigned to received either Elritercept or Epoetin Alfa throughout the course of the trial and their outcomes will be compared.

Trial phase

Phase 3

Trial participation type

This trial has been designed for the Clinical Research of a Drug.

Principal investigator

A/Prof Shaun Fleming

Key inclusion data

INCLUSION: Documented diagnosis of myelodysplastic syndrome(s) (MDS) according to WHO 2016 and classification of very low, low, or intermediate-risk disease; Participant requires RBC transfusions. A transfusion requirement of 2 to 6 packed red blood cells (pRBCs) units/8 weeks confirmed for a minimum of 8 weeks immediately preceding randomization. EXCLUSION: Prior treatment with Epoetin Alfa, Darbeopoetin, Luspatercept, sotatercept, imetelstat, or elritercept; Prior treatment with any agent or investigational agent intended for treatment of MDS; Anemia due to any other known cause