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New treatment option for Myelodysplastic Syndromes
Official title A Study of Elritercept to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Who Need Regular Blood Transfusions
ClinicalTrials.gov ID: NCT06499285
What this study is testing
What is Elritercept?
Elritercept is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for myelodysplastic syndromes.
Also referred to as KER-050, TAK-226.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Time commitment: about 24 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health...
- Male or female greater than or equal to (≥)18 years of age at the time of signing informed consent.
- Diagnosis of MDS with or without RS (as determined in an evaluable bone marrow aspirate, read by an independent central reader to confirm diagnosis...
- Transfusion dependence assessed in the 16 weeks immediately preceding randomization in two 8-week blocks, classified as either: a. Low-transfusion...
- Refractory or intolerant to prior erythropoiesis-stimulating agent (ESA) treatment (discontinued ≥4 weeks before randomization), or unlikely to...
You likely can't join if
- Del(5q) MDS or therapy-related (secondary) MDS.
- Anemia due to any other known cause (e.g., thalassemia, hemolytic anemia, bleeding events, or deficiency of iron, B12, and/or folate).
- Receipt of RBC transfusion for any reason(s) other than underlying MDS within 16 weeks before randomization.
- Clinically significant cardiovascular disease defined as:
- New York Heart Association heart disease class III or IV;
- Fridericia corrected QT (QTcF) interval \>500 milliseconds during Screening;
See the full eligibility criteria
Who can join
- 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...
- Male or female greater than or equal to (≥)18 years of age at the time of signing informed consent.
- Diagnosis of MDS with or without RS (as determined in an evaluable bone marrow aspirate, read by an independent central reader to confirm diagnosis at Screening) according to the World Health Organization 2016...
- Transfusion dependence assessed in the 16 weeks immediately preceding randomization in two 8-week blocks, classified as either: a. Low-transfusion burden (LTB), defined as 4 to 7 red blood cells (RBC) units per 16...
- Refractory or intolerant to prior erythropoiesis-stimulating agent (ESA) treatment (discontinued ≥4 weeks before randomization), or unlikely to respond to ESA treatment, defined as follows: a. Refractory to prior ESA...
- Less than 5% blasts in an evaluable bone marrow aspirate collected at Screening, read by an independent central reader.
- Eastern Cooperative Oncology Group performance status of 0 to 2.
- Females of childbearing potential and sexually active males must agree to use highly effective methods of contraception.
- In the opinion of the Investigator, the participant is able and willing to comply with the requirements of the protocol (e.g., all study procedures, return for follow-up visits).
What rules you out
- Del(5q) MDS or therapy-related (secondary) MDS.
- Anemia due to any other known cause (e.g., thalassemia, hemolytic anemia, bleeding events, or deficiency of iron, B12, and/or folate).
- Receipt of RBC transfusion for any reason(s) other than underlying MDS within 16 weeks before randomization.
- Clinically significant cardiovascular disease defined as:
- New York Heart Association heart disease class III or IV;
- Fridericia corrected QT (QTcF) interval \>500 milliseconds during Screening;
- Presence of uncontrolled hypertension defined as mean systolic blood pressure ≥160 millimeters of mercury (mm Hg) or diastolic blood pressure ≥100 mm Hg during Screening; or
- Uncontrolled arrhythmia, myocardial infarction, or unstable angina within 6 months before Screening.
- Known ejection fraction \<35%, confirmed by a local echocardiogram performed during Screening, or a previously performed echocardiogram if collected within 6 months before Screening.
- Child-Pugh class C hepatic impairment.
- Stroke, deep vein thrombosis, or pulmonary embolism within 6 months before Screening.
- Any known history of acute myeloid leukemia (AML).
- 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. However, participants...
- Basal or squamous cell carcinoma of the skin;
- Carcinoma in situ of the cervix;
- Carcinoma in situ of the breast; and/or
- Incidental histologic finding of prostate cancer (T1a or T1b using the tumor, node, metastasis [TNM] clinical staging system).
- History of solid organ or bone marrow transplantation.
- Active infection requiring intravenous treatment (e.g., antibiotics, antifungals, or antivirals) within 28 days, or oral treatment within 14 days before randomization.
- History of or known active 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...
- Body mass index ≥ 40 kilograms per meter square (kg/m\^2).
- Major surgery within 28 days before randomization.
- History of allergy/anaphylaxis to investigational medicinal product (IMP) excipients (refer to the current elritercept IB for a list of excipients) or recombinant proteins.
- Prior use of elritercept, luspatercept, or sotatercept.
- Prior use of hypomethylating agents (HMAs), isocitrate dehydrogenase inhibitor, lenalidomide, imetelstat, or immunosuppressive therapy given for treatment of MDS.
- Iron chelation therapy initiated within 8 weeks before randomization. Participants on stable doses of iron chelation therapy for ≥ 8 weeks are allowed.
- Vitamin B12 or folate therapy initiated within 4 weeks before randomization. Participants on stable replacement doses for ≥ 4 weeks and without ongoing concurrent vitamin B12 or folate deficiency are allowed.
- Androgen use within 8 weeks before randomization. Participants on stable androgen dosing for hypogonadism for ≥ 8 weeks are allowed.
- High-dose corticosteroid use within 4 weeks before randomization. Participants on stable chronic steroid doses of prednisone lesser than or equal to (≤) 10 mg/day or corticosteroid equivalent for ≥ 4 weeks are...
- Treatment with any investigational drug within 28 days before Screening or, if the half-life of the product is known, within 5 times the half-life before Screening, whichever is longer.
- Ongoing participation in another treatment clinical study.
- Serum EPO level \>500 U/L.
- Platelet count ≥450 × 10\^9/L or ≤25 × 10\^9/L.
- Absolute neutrophil count ≤ 500/µL.
- Serum aspartate aminotransferase or alanine aminotransferase ≥3 × the upper limit of normal (ULN).
- Total bilirubin ≥2 × ULN unless attributable to Gilbert's syndrome.
- Ferritin ≤ 50 micrograms per litre (μg/L).
- Folate ≤2.0 nanograms per milliliter (ng/mL).
- Vitamin B12 ≤200 picograms per milliliter (pg/mL).
- Estimated glomerular filtration rate \<30 milliliters per minute per 1.73 meter square (mL/min/1.73m\^2) as determined by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Collaboration equation.
- Pregnant or lactating female.
- Any other condition not specifically noted above that, in the opinion of the Investigator, would preclude the participant from participating in the study or could confound interpretation of data from the study.
- Investigational site staff members directly involved in the conduct of the study and site staff members otherwise supervised by the Investigator, employees of the Sponsor or contract research organization (CRO) directly...
- For Participants in France: Persons under court protection, persons not affiliated with a social security system, and protected adults (per applicable French law [Art. L. 1121-6, Art. L. 1121-8, Art. L. 1121-8-1]).
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Glendale, California, United States
- La Jolla, California, United States
- New Haven, Connecticut, United States
- Miami, Florida, United States
- Tampa, Florida, United States
- Peoria, Illinois, United States
- Louisville, Kentucky, United States
- Columbia, Maryland, United States
- Kansas City, Missouri, United States
- Henderson, Nevada, United States
- Lake Success, New York, United States
- Westbury, New York, United States
- Winston-Salem, North Carolina, United States
- Canton, Ohio, United States
- Cleveland, Ohio, United States
- Knoxville, Tennessee, United States
- Memphis, Tennessee, United States
- Nashville, Tennessee, United States
- Denison, Texas, United States
+ 130 more site(s).
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 study runs about 24 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; Glendale, California, United States; La Jolla, California, United States; New Haven, Connecticut, United States; Miami, Florida, United States; Tampa, Florida, United States and 144 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.