Authorised Therapeutic confirmatory (Phase III) myelodysplastic neoplasms/syndromes (MDS)

A study of elritercept to treat transfusion-dependent anemia due to very low, low, or intermediate risk myelodysplastic syndromes

EU CTIS ID: 2024-516009-22-00

What this study is testing

To evaluate the efficacy of elritercept in reducing red blood cell (RBC) transfusions

  • Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • 1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information and/or protected personal data in accordance with national and local study participant data protections and privacy regulations.
  • 2. Male or female ≥ 18 years of age at the time of signing informed consent.
  • 3. Diagnosis of MDS with or without RS (as determined in an evaluable bone marrow aspirate collected at Screening, read by an independent central reader) according to WHO 2016 classification that meets the IPSS-R classification of very low, low, or intermediate risk MDS.
  • 4. Transfusion-dependence assessed in the 16 weeks immediately preceding randomization in two 8-week blocks, classified as either: a. LTB, defined as 4 to 7 RBC units per 16 weeks; or b. HTB, defined as ≥ 8 RBC units per 16 weeks; and c. For all participants: - Only transfusion events for a pretransfusion Hgb < 10 g/dL are counted toward eligibility; - At least 1 transfusion event in each 8-week period and a minimum of 2 transfusion events separated by ≥ 7 days within the 16-week period immediately preceding randomization; and No consecutive 56-day period can be RBC transfusion-free during the 16-week period immediately preceding randomization.
  • 5. Refractory or intolerant to prior ESA treatment (discontinued ≥ 4 weeks before randomization), or unlikely to respond to ESA treatment
  • 6. Less than 5% blasts in an evaluable bone marrow aspirate collected at Screening, read by an independent central reader

You likely can't join if

  • 1. Del(5q) MDS or therapy-related (secondary) MDS
  • 11. Active infection requiring intravenous treatment (e.g., antibiotics, antifungals, or antivirals) within 28 days, or oral treatment within 14 days before randomization.
  • 12. History of or known active or chronic infection with HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV). Participants without known positive history of HIV, HBV, and/or HCV do not require further testing, unless testing is mandated per local guidelines.
  • 13. Body mass index ≥ 40 kg/m2
  • 14. Major surgery within 28 days before randomization
  • 16. Prior use of elritercept, luspatercept, sotatercept.
See the full eligibility criteria
Who can join
  • 1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information and/or protected personal data in accordance with national and local study participant data protections and privacy regulations.
  • 2. Male or female ≥ 18 years of age at the time of signing informed consent.
  • 3. Diagnosis of MDS with or without RS (as determined in an evaluable bone marrow aspirate collected at Screening, read by an independent central reader) according to WHO 2016 classification that meets the IPSS-R classification of very low, low, or intermediate risk MDS.
  • 4. Transfusion-dependence assessed in the 16 weeks immediately preceding randomization in two 8-week blocks, classified as either: a. LTB, defined as 4 to 7 RBC units per 16 weeks; or b. HTB, defined as ≥ 8 RBC units per 16 weeks; and c. For all participants: - Only transfusion events for a pretransfusion Hgb < 10 g/dL are counted toward eligibility; - At least 1 transfusion event in each 8-week period and a minimum of 2 transfusion events separated by ≥ 7 days within the 16-week period immediately preceding randomization; and No consecutive 56-day period can be RBC transfusion-free during the 16-week period immediately preceding randomization.
  • 5. Refractory or intolerant to prior ESA treatment (discontinued ≥ 4 weeks before randomization), or unlikely to respond to ESA treatment
  • 6. Less than 5% blasts in an evaluable bone marrow aspirate collected at Screening, read by an independent central reader
  • 7. Eastern Cooperative Oncology Group performance status of 0 to 2
  • 8. Females of childbearing potential and sexually active males must agree to use adequate methods
What rules you out
  • 1. Del(5q) MDS or therapy-related (secondary) MDS
  • 11. Active infection requiring intravenous treatment (e.g., antibiotics, antifungals, or antivirals) within 28 days, or oral treatment within 14 days before randomization.
  • 12. History of or known active or chronic infection with HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV). Participants without known positive history of HIV, HBV, and/or HCV do not require further testing, unless testing is mandated per local guidelines.
  • 13. Body mass index ≥ 40 kg/m2
  • 14. Major surgery within 28 days before randomization
  • 16. Prior use of elritercept, luspatercept, sotatercept.
  • 17. Prior use of hypomethylating agents (HMA), isocitrate dehydrogenase inhibitor, lenalidomide, imetelstat, or immune-suppressive therapy given for treatment of MDS
  • 18. Iron chelation therapy initiated within 8 weeks before randomization. Participants on stable doses of iron chelation therapy for ≥ 8 weeks are allowed
  • 19. Vitamin B12 or folate therapy initiated within 4 weeks before randomization. Participants on stable replacement doses for ≥ 4 weeks and without concurrent vitamin B12 or folate deficiency are allowed
  • 24. Serum EPO level ≥ 500 U/L
  • 25. Platelet count ≥ 450 × 109/L or ≤ 25 × 109/L
  • 2. Anemia due to any other known cause (e.g., thalassemia, hemolytic anemia, bleeding events, or deficiency of iron, B12, and/or folate).
  • 26. Absolute neutrophil count ≤ 500/μL
  • 27. Serum aspartate aminotransferase or alanine aminotransferase ≥ 3 × the upper limit of normal
  • 28. Total bilirubin ≥ 2 × ULN unless attributable to Gilbert's syndrome
  • 29. Ferritin ≤ 50 μg/L
  • 30. Folate ≤ 2.0 ng/mL
  • 31. Vitamin B12 ≤ 200 pg/mL
  • 32. Estimated glomerular filtration rate < 30 mL/min/1.73m2 as determined by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation
  • 33. Pregnant or lactating female
  • 3. Receipt of RBC transfusion for any reason(s) other than underlying MDS within 16 weeks before randomization.
  • 4. Clinically significant cardiovascular disease
  • 5. Known ejection fraction < 35%, confirmed by a local echocardiogram performed during Screening, or other assessment performed echocardiogram if collected within 6 months before Screening
  • 6. Child-Pugh class C hepatic impairment
  • 7. Stroke, deep vein thrombosis, or pulmonary embolism within 6 months before Screening
  • 8. Any known history of AML
  • 9. Prior history of malignancies, other than MDS, unless participant has been free of the disease (including completion of any treatment, including maintenance, for prior malignancy) for ≥ 5 years.

The study team makes the final eligibility decision.

Where it's taking place

  • Israel
  • Chile
  • Canada
  • United Kingdom
  • Korea, Republic of
  • Brazil
  • Thailand
  • Turkey
  • Australia
  • Taiwan
  • United States
  • South Africa
  • Peru

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Israel; Chile; Canada; United Kingdom; Korea, Republic of; Brazil and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.