A Study to Compare Elritercept With Epoetin Alfa to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Who Need Regular Blood Transfusions
NCT07422480 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300
Last updated 2026-03-09
Summary
The main aim of this study is to assess how elritercept works in lowering the need for RBC (red blood cell) transfusions and how safe elritercept is when compared with epoetin alfa. Other aims are to learn if elritercept improves tiredness as reported by participants without needing RBC transfusion compared with epoetin alfa, the RBC transfusion burden and quality of life compared with epoetin alfa. The study also aims to find out the extent of the immune response to elritercept. The study will also check on the medical problems (safety) of elritercept.
Conditions
Interventions
- DRUG
-
Elritercept
Elritercept, SC, injection.
- DRUG
-
Epoetin Alfa
Epoetin Alfa SC injection.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Study Director · Takeda
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-04-01
- Primary Completion
- 2029-04-30
- Completion
- 2033-10-01
- FDA Drug
- Yes
Countries
- United States
- Argentina
- Australia
- Belgium
- Brazil
- Bulgaria
- Canada
- France
- Germany
- Greece
- Hungary
- India
- Ireland
- Italy
- Japan
- Lithuania
- Malaysia
- Mexico
- Netherlands
- Norway
- Poland
- Romania
- South Korea
- Spain
- Taiwan
- Thailand
- Turkey (Türkiye)
- United Kingdom
Study Locations
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