A Study to Evaluate the Efficacy, Drug Levels and Safety of Luspatercept (ACE-536) for the Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes in Chinese and Japanese Participants With Ring Sideroblasts Who Require Red Blood Cell Transfusions

Summary

The purpose of this study is to evaluate the efficacy and safety of luspatercept (ACE-536) for the treatment of anemia due to Revised International Prognostic Scoring System (IPSS-R) very low, low, or intermediate risk myelodysplastic syndromes (MDS) in Chinese and Japanese participants with ring sideroblasts who require Red Blood Cells (RBC) transfusions.

Timeline

Start

2020-11-30

Primary completion

2023-09-29

Completion

2026-04-08

Publications

• Chang C, Suzuki T, Liang Y, Tong H, Usuki K, Liu Q, Wu Y, Fujisaki T, Han B, Huang R, Morita Y, Miao M, Nakashima Y, Tian YO, Pu J, Aggarwal D, Pozharskaya V, Shi W, Xiao Z, Mitani K. Safety and efficacy of luspatercept in treating anemia associated with myelodysplastic syndrome with ring sideroblasts in Asian patients who require red blood cell transfusions: a phase II bridging study. Ther Adv Hematol. 2025 Feb 20;16:20406207251321715. doi: 10.1177/20406207251321715. eCollection 2025.

Drugs

Indications