Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as TAK-226, KER-050
Elritercept · 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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Elritercept is an investigational small molecule being developed for myelodysplastic syndrome and myelofibrosis, two blood cancers in the oncology area. The clinical program focuses on treating anemia in adults with these conditions, including patients who need regular blood transfusions and patients taking ruxolitinib.
Elritercept is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is running the Phase 3 and Phase 2 clinical program for the drug across myelodysplastic syndrome and myelofibrosis.
Elritercept is in Phase 3 clinical development. It is investigational and is being studied in three Phase 3 trials plus one Phase 2 trial, all currently recruiting. The program spans myelodysplastic syndrome and myelofibrosis, with a combined planned enrollment of 735 patients across the studies.
Elritercept is being studied in four recruiting trials. Phase 3 studies include NCT07623161 comparing elritercept to placebo in myelofibrosis with anemia during ruxolitinib treatment, NCT07422480 comparing it to epoetin alfa in lower risk myelodysplastic syndromes, and NCT06499285 in very low, low, or intermediate risk myelodysplastic syndromes. Phase 2 NCT05037760 tests elritercept alone or with ruxolitinib in myelofibrosis.
The elritercept trials are randomized, double-blind, and controlled, with adult patients aged 18 and older enrolled across sites in North America, Europe, Asia, Latin America, and other regions. The Phase 3 studies compare elritercept against placebo or epoetin alfa, while the Phase 2 study evaluates elritercept alone or combined with ruxolitinib.
Elritercept is not approved and remains an investigational drug in clinical development. Takeda is conducting Phase 3 trials in myelodysplastic syndrome and myelofibrosis, and the program has not reported completed trials. Availability outside clinical research would depend on future regulatory review.