Myelodysplastic Syndromes study: Elritercept
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?
An investigational subcutaneous injectable medicine being studied to treat anemia in adults with lower‑risk myelodysplastic syndromes. It is designed to bind and neutralize certain activin and growth‑factor proteins that can suppress red blood cell production.
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 study aims to find out how well elritercept reduces the need for red blood cell transfusions and to assess its safety and tolerability.
- Who it's for
- Adults with very low, low, or intermediate‑risk myelodysplastic syndromes who require regular blood transfusions.
- What's involved
- Participants will receive elritercept and have regular check‑ups, blood tests, and monitoring of transfusion requirements.
- Time commitment
- The trial involves ongoing visits and tests over the treatment period, with the exact schedule determined by the study protocol.
- 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 sample, read by an independent central reader to confirm diagnosis at...
- Transfusion dependence assessed in the 16 weeks immediately preceding randomization in two 8-week blocks, classified as either: a.
- 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, secondary MDS (MDS with a documented history of prior exposure to chemotherapy, radiotherapy, or other leukemogenic agents that is...
- 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.
- 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...
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 sample, 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. LTB, defined as 4 to 7 RBC units per 16 weeks; or b.
- 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.
- Less than 5 percent (%) blasts in an evaluable bone marrow sample collected at Screening.
- 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, secondary MDS (MDS with a documented history of prior exposure to chemotherapy, radiotherapy, or other leukemogenic agents that is considered causally related to the development of 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.
- 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).
- 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).
- Early papillary thyroid cancer (stage I [T1-T2, N0, M0]).
- 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.
- Active infection with HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV). Participants with a history of HIV infection may be enrolled if they are receiving antiretroviral therapy and have a documented CD4+ T cell...
- 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 or decreasing 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 systemic corticosteroid use within 4 weeks before randomization. Participants on stable chronic steroid doses of prednisone lesser than or equal to (≤) 10 milligrams per day (mg/day) or corticosteroid...
- 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 ≥800 × 10\^9 per liter (/L) or ≤25 × 10\^9/L.
- Absolute neutrophil count ≤ 500 per microliter (/µL).
- Serum aspartate aminotransferase or alanine aminotransferase ≥3 × the upper limit of normal (ULN).
- Total bilirubin ≥2 × ULN unless attributable to Gilbert's syndrome. Participants with known history of Gilbert syndrome with unconjugated bilirubin \< 3 × ULN are allowed.
- 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 CRO directly involved in the conduct of the...
- 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 is enrolling
- 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
- Monroe, Louisiana, United States
- Columbia, Maryland, United States
- Kansas City, Missouri, United States
- Henderson, Nevada, 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
- Nashville, Tennessee, United States
- Denison, Texas, United States
- Houston, Texas, United States
+ 114 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, but 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?
This study is enrolling now at 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 128 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.