Elritercept vs Epoetin Alfa in ESA-Naïve LR-MDS with Transfusion-Dependent Anaemia (TAK-226-3001)
Research type
Research Study
Full title
Phase 3, Multicenter, Open-Label, Randomized Trial to Compare the Efficacy and Safety of Elritercept versus Epoetin Alfa for the Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes in ESA-naïve Adult Participants Who Require Red Blood Cell Transfusions
IRAS ID
1013345
Contact name
Alexander Vorog
Contact email
Sponsor organisation
Takeda Development Center Americas, Inc.
Research summary
This study is looking at the safety and effectiveness of a new medicine called Elritercept (TAK-226) compared to Epoetin alfa in adults with a mild bone marrow disorder called lower-risk myelodysplastic syndrome (LR-MDS). People with LR-MDS often have anaemia (low red blood cells) and need blood transfusions. Current treatment options are limited, so researchers are exploring better solutions.
Study Medications:
Elritercept (TAK-226): A lab-made protein that helps bone marrow make more red blood cells by blocking natural proteins that slow blood cell production.
Epoetin alfa: A commonly used medicine that stimulates red blood cell production.How Treatment Is Assigned
Patients will have a 50% chance of being randomly assigned (like flipping a coin) to one of two groups:
Elritercept (TAK-226): Given once every 28 days (monthly) by injection under the skin.
Epoetin alfa: Given once every 7 days (weekly) by injection under the skin.Study Timeline
The total time the participant spends in the study may vary. It depends on how they respond to the treatment and whether any side effects or other reasons require stopping the study early. The study will consist of the following phases:
Screening: Up to 42 days before starting treatment.
Treatment: At least 24 weeks (6 months), then the participants condition will be checked and treatment may continue.
Safety Follow-Up: Visits at 1 and 2 months after treatment ends to check for any ongoing effects.
Survival Follow-Up: Contact every 3 months to ask about new treatments and health updates.Approximately 210 to 300 patients will be participating in this study at about 150 sites in 28 countries across the world including the United Kingdom.
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
26/SC/0012
Date of REC Opinion
10 Feb 2026
REC opinion
Further Information Favourable Opinion