A Study of Elritercept to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Who Need Regular Blood Transfusions

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorTakeda

About this trial

The main aim of this study is to find out how well elritercept works in lowering the need for RBC transfusions. Other aims are to learn how well elritercept works in reducing the need for RBC transfusions over longer periods of time or in adults with high transfusion needs. The study will also check on how safe elritercept is and how well it is tolerated.

Eligibility criteria

Qualifiers

Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information and/or protected personal data in accordance with national and local study participant data protections and privacy regulations.

Male or female greater than or equal to (≥)18 years of age at the time of signing informed consent.

Diagnosis of MDS with or without RS (as determined in an evaluable bone marrow aspirate, read by an independent central reader to confirm diagnosis at Screening) according to the World Health Organization 2016 classification that meets the International Prognostic Scoring System-Revised (IPSS-R) classification of very low, low, or intermediate risk disease.

Less than 5% blasts in an evaluable bone marrow aspirate collected at Screening, read by an independent central reader.

Disqualifiers

Del(5q) MDS or therapy-related (secondary) MDS.

Anemia due to any other known cause (e.g., thalassemia, hemolytic anemia, bleeding events, or deficiency of iron, B12, and/or folate).

Receipt of RBC transfusion for any reason(s) other than underlying MDS within 16 weeks before randomization.

New York Heart Association heart disease class III or IV;

Trial design

Treatments tested in this trial

  • Elritercept
  • Placebo

Treatment groups

225 Participants
are divided into 2 treatment groups

Sponsors and collaborators