A Phase 3, Open-label, Randomized Study to Compare the Efficacy and Safety of Luspatercept (ACE 536) vs Epoetin Alfa for the Treatment of Anemia Due to Revised International Prognostic Scoring System (IPSS-R) Very Low, Low, or Intermediate Risk Myelodysplastic Syndrome (MDS) in Erythropoiesis-stimulating Agent (ESA)-naive Participants who are Non-transfusion Dependent (NTD): The “ELEMENT-MDS” Trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-500430-29-00

Acronym

CA056-025

Enrollment

162

Registered

2023-10-03

Start date

2023-10-11

Completion date

Unknown

Last updated

2025-12-05

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

Conditions

Myelodysplastic Syndrome (MDS)

Brief summary

Conversion to TD (IWG 2018 defined as ≥ 3 units/16 weeks) during any continuous 16-week interval within the 96-week Treatment Period

Detailed description

Achievement of an increase in mean Hb values from baseline of ≥ 1.5 g/dL in any continuous 16-week interval within the 48-week Treatment Period in the absence of transfusion

Interventions

DRUGBinocrit 40

DRUG000 IU/1 ML solution for injection in a pre-filled syringe

DRUGBinocrit 20

DRUG000 IU/0.5 mL solution for injection in a pre-filled syringe

DRUGBinocrit 2

DRUG000 IU/1 mL solution for injection in a pre-filled syringe

DRUGBinocrit 6

DRUG000 IU/0.6 ML solution for injection in a pre-filled syringe

DRUGBinocrit 4

DRUG000 IU/0.4 ML solution for injection in a pre-filled syringe

DRUGReblozyl 75 mg powder for solution for injection

DRUGReblozyl 25 mg powder for solution for injection

DRUGBinocrit 30

DRUG000 IU/0.75 ML solution for injection in a pre-filled syringe

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Conversion to TD (IWG 2018 defined as ≥ 3 units/16 weeks) during any continuous 16-week interval within the 96-week Treatment Period	—

Secondary

Measure	Time frame
Achievement of an increase in mean Hb values from baseline of ≥ 1.5 g/dL in any continuous 16-week interval within the 48-week Treatment Period in the absence of transfusion	—

Countries

Czechia, France, Germany, Greece, Hungary, Italy, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 8, 2026