A Study of Elritercept to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Who Need Regular Blood Transfusions

NCT06499285 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 225

Last updated 2026-05-13

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Elritercept

Elritercept (TAK-226, KER-050) administered subcutaneously every 4 weeks.

DRUG

Placebo

Elritercept (TAK-226, KER-050) matching-placebo administered subcutaneously every 4 weeks.

Sponsors & Collaborators

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-06
Primary Completion
2028-05-01
Completion
2032-05-01
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Brazil
  • Bulgaria
  • Canada
  • Chile
  • Czechia
  • France
  • Germany
  • Hungary
  • India
  • Ireland
  • Israel
  • Italy
  • Lithuania
  • Peru
  • Poland
  • South Africa
  • South Korea
  • Spain
  • Sweden
  • Switzerland
  • Taiwan
  • Thailand
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06499285 on ClinicalTrials.gov