Takeda
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.
This is a Phase 3, double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of elritercept (TAK-226, KER-050) versus placebo. Elritercept (TAK-226, KER-050) is an investigational medicinal product being developed for the treatment of anemia in adult participants with a diagnosis of lower-risk myelodysplastic neoplasms/syndromes. After all required Screening Period assessments are completed, and eligibility is confirmed, participants will be randomized and enter the Primary Phase of the Double-Blind Treatment Period. Participants will be randomly assigned in a 2:1…
Inclusion Criteria: * 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 He…
Elritercept (TAK-226, KER-050) administered subcutaneously every 4 weeks.
Elritercept (TAK-226, KER-050) matching-placebo administered subcutaneously every 4 weeks.