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

Conditions

• Anemia
• Myelodysplastic Syndrome

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Elritercept — DRUG
  Elritercept, SC, injection.
• Epoetin Alfa — DRUG
  Epoetin Alfa SC injection.

Study Details

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.

Key Dates

Start date

May 21, 2026

Status verified

Jun 2026

Primary completion

Apr 30, 2029

Completion

Oct 1, 2033

Study Design

Enrollment

300 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Elritercept
  Participants will receive a starting dose of elritercept at 3.75 milligrams per kilogram (mg/kg) administered subcutaneously (SC) once every 4 weeks, and may have the dose escalated to 5.0 mg/kg if needed,
• Active Comparator: Epoetin Alfa
  Participants will receive a starting dose of epoetin Alfa at 450 international units per kilograms (IU/kg) administered SC once every week, and may have the dose escalated up to 1050 IU/kg.

Primary Outcome Measure

Proportion of Participants who are RBC Transfusion Independent (RBC-TI) for any Consecutive Greater Than Equal to (≥) 12-Week Period From Day 1 Through 24 Weeks With Concurrent Mean Hemoglobin (Hgb) Increase ≥ 1.5 Grams per Deciliter (g/dL) From Baseline [ Time Frame: From Cycle 1 Day 1 through Week 24 (each cycle is 28 days) ]

Central Contacts

• Takeda Contact
  +1-877-825-3327
  [email protected]

Locations (24)

Find similar trials in Gilbert, AZ

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