A Phase 3, Double-blind, Randomized Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Placebo for the Treatment of Anemia Due to the IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes in Subjects With Ring Sideroblasts Who Require Red Blood Cell Transfusions.
The study will be conducted in compliance with the International Council on Harmonisation
(ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good
Clinical Practice (GCP) and applicable regulatory requirements.
This is a Phase 3, double-blind, randomized, placebo-controlled, multicentre study to
determine the efficacy and safety of luspatercept (ACE-536) versus placebo in subjects with
anemia due to International Prognostic Scoring System-Revised (IPSS-R) very low, low, or
intermediate Myelodysplastic syndrome (MDS) with ring sideroblasts (≥ 15%) who require Red
blood cell (RBC) transfusions.
View this trial on ClinicalTrials.gov
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