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.
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.
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;
Parallel
Elritercept
DrugElritercept (TAK-226, KER-050) administered subcutaneously every 4 weeks.
Placebo
DrugElritercept (TAK-226, KER-050) matching-placebo administered subcutaneously every 4 weeks.
Percentage of Participants Achieving Transfusion Independence (TI) for ≥8 Weeks
Transfusion independence is defined as the absence of any red blood cells (RBC) transfusions in a period of at least 8 weeks after the first dose of the study treatment through week 24.
Percentage of Participants Achieving TI for ≥24 Weeks
Transfusion independence is defined as the absence of any RBC transfusions in a period of at least 24 weeks after the first dose of the study treatment through week 48.
Percentage of Participants with High-transfusion Burden (HTB) Achieving TI for ≥8 weeks
Transfusion independence is defined as the absence of any RBC transfusions in a period of at least 8 weeks after the first dose of the study treatment through week 24.
Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
An adverse event (AE) is defined as any untoward medical occurrence, in a clinical study participant administered a medicinal product, that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not it is related to study treatment. A TEAE is defined as an AE that commences on or after the first dose of the study treatment and within 60 days after the last dose of the study treatment, or analysis cutoff date, whichever is earlier. An SAE is any untoward medical occurrence that, at any dose: results in death, is life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event.
Change from Baseline in Clinical Laboratory Values, Vital Signs, and Electrocardiograms (ECGs)
Change from baseline in clinical laboratory values, vital signs, and ECGs will be assessed.