FindTrial
Sign In

A 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

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-523544-12-00
Enrollment
16
Registered
2026-04-17
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myelodysplastic neoplasms/syndromes (MDS)

Brief summary

Proportion of participants who are RBC-TI for any consecutive ≥12-week period from Cycle 1 Day 1 (C1D1) through Week 24 with concurrent mean Hgb increase ≥1.5 g/dL from baseline

Detailed description

Key Secondary Endpoint: Proportion of participants who are RBC-TI for any consecutive ≥16-week period from C1D1 through Week 24., Key Secondary Endpoint: Proportion of participants who are RBC-TI for any consecutive ≥12-week period from C1D1 through Week 24., Key Secondary Endpoint: Proportion of participants who are RBC-TI for a consecutive 24-week period from C1D1., For further details please refer to the Protocol

Interventions

DRUGERYTHROPOIETIN
DRUGElritercept

Sponsors

Takeda Development Center Americas Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Proportion of participants who are RBC-TI for any consecutive ≥12-week period from Cycle 1 Day 1 (C1D1) through Week 24 with concurrent mean Hgb increase ≥1.5 g/dL from baseline—

Secondary

MeasureTime frame
Key Secondary Endpoint: Proportion of participants who are RBC-TI for any consecutive ≥16-week period from C1D1 through Week 24., Key Secondary Endpoint: Proportion of participants who are RBC-TI for any consecutive ≥12-week period from C1D1 through Week 24., Key Secondary Endpoint: Proportion of participants who are RBC-TI for a consecutive 24-week period from C1D1., For further details please refer to the Protocol—

Outcome results

None listed

Source: EU CTIS · Data processed: Apr 18, 2026