Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Elritercept, KER-050
TAK-226 · 6 trials · 5 indications
RBC-TI is defined as no RBC transfusions administered for the specified time period during study treatment.
RBC-TI is defined as no red blood cell (RBC) transfusions administered for the specified time period during study treatment.
Transfusion independence is defined as the absence of any red blood cells (RBC) transfusions in a period of at least 8 weeks after the first dose of the study treatment through week 24.
Transfusion independence is defined as the absence of any red blood cells (RBC) transfusions in a period of at least 8 weeks after the first dose of the study treatment through week 24.
AE:any untoward medical occurrence (MO) in clinical study participant administered medicinal product not necessarily having causal relationship with treatment.Severe AE medically significant AE but not immediately life-threatening;may result in hospitalization/ prolonged hospital stay;disability.SAE:any untoward MO that,at any dose results in death,is life-threatening,requires in-patient hospitalization/ prolongation of existing hospitalization,results in persistent or significant disability/incapacity,is congenital anomaly/birth defect,is medically important event.DLT: any following safety events-death,Grade 4 neutropenia/ thrombocytopenia \>7 days,Grade 3 thrombocytopenia with bleeding,Neutropenic fever,assessments meeting Hy's law,Grade ≥3 nonhematologic treatment-emergent adverse events(TEAEs),elevated hemoglobin(Hgb)/ platelet count requiring dose modification, other safety event considered by Safety Review Committee(SRC) to be significant to warrant categorization as DLT.
An AE is defined as any untoward medical occurrence in a clinical study participant administered a medicinal product that does not necessarily have a causal relationship with this treatment. Severe AE is defined as an AE which is medically significant but not immediately life-threatening; may result in hospitalization or prolonged hospital stay; disabling. An SAE is any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event.
An AE is defined as any untoward medical occurrence, in a clinical study participant administered a medicinal product, that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not it is related to the medicinal (investigational) product. An SAE is any untoward medical occurrence that, at any dose: results in death, is life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event.
| Arm | Type | Description |
|---|---|---|
| Elritercept | EXPERIMENTAL | Participants will receive elritercept at a starting dose of 3.75 milligrams per kilogram (mg/kg) subcutaneously (SC) once every 4 weeks (Q4W) on Day 1 of each 28-day cycle for approximately 36 weeks during the double-blinded treatment period, with possible up-titration to 5.0 mg/kg from Cycle 3 Day 1 based on response and safety/tolerability. Participants may continue to receive elritercept during the extended open-label treatment period. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive elritercept-matching placebo with equivalent volume to elritercept SC Q4W on Day 1 of each 28-day cycle for approximately 36 weeks during the double-blinded treatment period. Eligible participants may initiate elritercept at a starting dose of 3.75 mg/kg SC Q4W on Day 1 of each 28-day cycle during the extended open-label treatment period, with possible up-titration to 5.0 mg/kg after 2 cycles, based on response and safety/tolerability. |
| Epoetin Alfa | ACTIVE_COMPARATOR | Participants will receive epoetin alfa at a starting dose of 450 international units per kilograms (IU/kg) administered SC once every week, and may have the dose escalated up to 1050 IU/kg (maximum 80,000 IU). |
| TAK-226 | EXPERIMENTAL | Participants will receive the study drug, TAK-226, administered subcutaneously every four weeks (Q4W) for approximately one year during Treatment Period. |
| Arm 1A: Elritercept | EXPERIMENTAL | Participants with anemia who have discontinued Janus Kinase (JAK) inhibitor(s) or are intolerant or ineligible for JAK inhibitor(s) will be administered escalating doses of elritercept, starting at 0.75 milligrams per kilograms (mg/kg) followed by 1.5 mg/kg and 4.5 mg/kg subcutaneously (SC), every 4 weeks for 13 cycles for a total Treatment Period of 52 weeks. Each cycle is 28 days. |
| Arm 1B: Elritercept + Ruxolitinib | EXPERIMENTAL | Participants with anemia who have been receiving ruxolitinib for ≥8 weeks prior to Cycle 1 Day 1 (C1D1) and are on a stable dose for ≥4 weeks prior to C1D1 will be administered escalating doses of elritercept, starting at 0.75 mg/kg and followed by 1.5 mg/kg and 4.5 mg/kg, SC, every 4 weeks for 13 cycles in combination with ruxolitinib therapy for a total Treatment Period of 52 weeks. Each cycle is 28 days. |
| Arm 2A: Elritercept | EXPERIMENTAL | Participants with with anemia who have discontinued JAK inhibitor(s) or are intolerant or ineligible for JAK inhibitor(s) will be administered elritercept, 3.75 mg/kg, SC, every 4 weeks for 13 cycles for a total Treatment Period of 52 weeks. Each cycle is 28 days. |
| Arm 2B: Elritercept + Ruxolitinib | EXPERIMENTAL | Participants with anemia who have been receiving ruxolitinib for ≥8 weeks prior to C1D1 and are on a stable dose for ≥4 weeks prior to C1D1 will be administered elritercept, 3.75 mg/kg, SC, every 4 weeks for 13 cycles in combination with ruxolitinib therapy for a total Treatment Period of 52 weeks. Each cycle is 28 days. |
| Experimental: Arm 2C: Elritercept (Brazil Only) | EXPERIMENTAL | Participants from Brazil with anemia who have received no prior treatment with JAK inhibitor(s) and have no access to JAK inhibitor therapy will be administered elritercept, 3.75 mg/kg, SC, every 4 weeks for 13 cycles for a total Treatment Period of 52 weeks. Each cycle is 28 days. |
| Long-Term Extension | EXPERIMENTAL | Participants from Arms 1A, 1B, 2A, 2B and 2C benefiting from the continued elritercept treatment as a monotherapy or in combination with ruxolitinib can continue to receive elritercept in this long-term extension phase until elritercept becomes commercially available or until elritercept is no longer being developed for the treatment of MF. |
| Part 1: Elritercept Cohort 1 | EXPERIMENTAL | Participants will be administered elritercept at 0.75 milligrams per kilogram (mg/kg), subcutaneous (SC) injection, every 4 weeks on Day 1 of each cycle for up to 4 cycles (each cycle = 28 days). Following the above dose regimen, participants will continue to receive elritercept, administered SC, on Day 1, every 4 weeks up to 24 cycles (each cycle = 28 days). |
| Part 1: Elritercept Cohort 2 | EXPERIMENTAL | Participants will be administered elritercept at 1.5 mg/kg, SC injection, every 4 weeks on Day 1 of each cycle for up to 4 cycles (each cycle = 28 days). Following the above dose regimen, participants will continue to receive elritercept, administered SC, on Day 1, every 4 weeks up to 24 cycles (each cycle = 28 days). |
| Part 1: Elritercept Cohort 3 | EXPERIMENTAL | Participants will be administered elritercept at 2.5 mg/kg, SC injection, every 4 weeks on Day 1 of each cycle for up to 4 cycles (each cycle = 28 days). Following the above dose regimen, participants will continue to receive elritercept, administered SC, on Day 1, every 4 weeks up to 24 cycles (each cycle = 28 days). |
| Part 1: Elritercept Cohort 4 | EXPERIMENTAL | Participants will be administered elritercept at 3.75 mg/kg, SC injection, every 4 weeks on Day 1 of each cycle for up to 4 cycles (each cycle = 28 days). Following the above dose regimen, participants will continue to receive elritercept, administered SC, on Day 1, every 4 weeks up to 24 cycles (each cycle = 28 days). |
| Part 1: Elritercept Cohort 5 | EXPERIMENTAL | Participants will be administered elritercept at 5.0 mg/kg, SC injection, every 4 weeks on Day 1 of each cycle for up to 4 cycles (each cycle = 28 days). Following the above dose regimen, participants will continue to receive elritercept, administered SC, on Day 1, every 4 weeks up to 24 cycles(each cycle = 28 days). |
| Part 2: Elritercept Dose Confirmation Cohort A | EXPERIMENTAL | Participants with ring sideroblasts (RS)-positive Myelodysplastic syndrome (MDS) who are requiring red blood cell (RBC) transfusions will be administered Elritercept at 3.75 mg/kg, SC injection, on Day 1, every 4 weeks for up to 24 cycles (each cycle = 28 days). The dose can be modified based on participant's response. |
| Part 2: Elritercept Dose Confirmation Cohort B | EXPERIMENTAL | Participants with non-RS MDS who are requiring RBC transfusions will be administered Elritercept at 3.75 mg/kg, SC injection, on Day 1, every 4 weeks for up to 24 cycles (each cycle = 28 days). The dose can be modified based on participant's response. |
| Part 2: Elritercept Dose Confirmation Cohort C | EXPERIMENTAL | Participants who are non-transfused with either RS-positive MDS or non-RS MDS will be administered Elritercept at 3.75 mg/kg, SC injection, on Day 1, every 4 weeks for up to 24 cycles (each cycle = 28 days). The dose can be modified based on participant's response. |
| Experimental: Part 2: Elritercept Dose Confirmation Cohort D | EXPERIMENTAL | Participants with chronic myelomonocytic leukemia (CMML) and anemia will be administered Elritercept at 3.75 mg/kg, SC injection, on Day 1, every 4 weeks for up to 24 cycles (each cycle = 28 days). The dose can be modified based on participant's response. |
| Part 2: Elritercept Dose Confirmation Cohort E | EXPERIMENTAL | Participants with MDS (either RS-positive or non-RS) who are requiring RBC transfusions, have iron-overload, and are receiving iron chelation therapy will be administered Elritercept at 3.75 mg/kg, SC injection, on Day 1, every 4 weeks for up to 24 cycles (each cycle = 28 days). The dose can be modified based on participant's response. |
| Part 2: Elritercept Dose Confirmation Cohort F | EXPERIMENTAL | Participants with MDS (either RS-positive or non-RS) who are requiring RBC transfusions, have iron-overload, and are not receiving iron chelation therapy will be administered Elritercept at 3.75 mg/kg, SC injection, on Day 1, every 4 weeks for up to 24 cycles (each cycle = 28 days). The dose can be modified based on participant's response. |
| Part 2: Elritercept Dose Confirmation Cohort G | EXPERIMENTAL | Participants with MDS (either RS-positive or non-RS) who have relapsed after treatment with luspatercept, become refractory to luspatercept treatment, or are intolerant to luspatercept treatment will be administered Elritercept at 3.75 mg/kg, SC injection, on Day 1, every 4 weeks for up to 24 cycles (each cycle = 28 days). The dose can be modified based on participant's response. |
| Long-term Extension Cohort | EXPERIMENTAL | Participants from Part 1 and 2 cohorts who may have potential benefit from continued elritercept treatment, in the opinion of the Investigator, may elect to continue in the LTE at the same dose they were being administered in Part 1 and 2, SC injection, on day 1, every 4 weeks until end of treatment (EOT) (approximately 122 months). |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Elritercept-matching placebo |
| Elritercept | DRUG | Elritercept, SC, injection |
| Epoetin Alfa | DRUG | Epoetin Alfa, SC injection. |
| TAK-226 | DRUG | TAK-226 subcutaneous injection |
| Ruxolitinib | DRUG | Ruxolitinib tablet. |
Inclusion Criteria: 1. Aged ≥18 years at the time of signing the informed consent form (ICF). 2. Able to understand the purpose and risks of the trial and voluntarily sign an ICF. 3. Diagnosed with primary myelofibrosis (PMF), post-essential thrombocythemia (post-ET MF) or post-polycythemia vera (p...
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TAK-226 is an investigational small molecule being studied for the treatment of anemia in patients with lower-risk myelodysplastic syndromes (MDS). It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.
TAK-226 is being developed by Takeda Pharmaceutical Company Limited, a global biopharmaceutical company listed on the stock exchange under the ticker symbol TAK. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug.
TAK-226 is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and effectiveness for treating anemia in patients with lower-risk myelodysplastic syndromes.
TAK-226 is being evaluated in a Phase 2 clinical trial with the identifier NCT07319845. This study is titled 'A Study of TAK-226 for Anemia in Japanese Patients With Lower-Risk Myelodysplastic Syndromes' and is currently recruiting participants in Japan. The trial is an uncontrolled, open-label study with an enrollment target of 42 patients.
No, TAK-226 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for the treatment of anemia in patients with lower-risk myelodysplastic syndromes. The drug has not yet completed clinical trials or received regulatory approval from the FDA or other health authorities.