{"preliminary_commentary":{"by_channel":{"youtube":2,"x_thread":1},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this."},"free_build":{"available":false},"commentary_summary":null,"drugs_tested":[["elritercept (KER-050)"]],"indication":"anemia in very-low/low/intermediate-risk myelodysplastic syndromes","name":"NCT04419649","nct_id":"NCT04419649","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct04419649. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"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).","label":"Part 1: Elritercept Cohort 1","type":"EXPERIMENTAL"},{"description":"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).","label":"Part 1: Elritercept Cohort 2","type":"EXPERIMENTAL"},{"description":"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).","label":"Part 1: Elritercept Cohort 3","type":"EXPERIMENTAL"},{"description":"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).","label":"Part 1: Elritercept Cohort 4","type":"EXPERIMENTAL"},{"description":"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).","label":"Part 1: Elritercept Cohort 5","type":"EXPERIMENTAL"},{"description":"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.","label":"Part 2: Elritercept Dose Confirmation Cohort A","type":"EXPERIMENTAL"},{"description":"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.","label":"Part 2: Elritercept Dose Confirmation Cohort B","type":"EXPERIMENTAL"},{"description":"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.","label":"Part 2: Elritercept Dose Confirmation Cohort C","type":"EXPERIMENTAL"},{"description":"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.","label":"Experimental: Part 2: Elritercept Dose Confirmation Cohort D","type":"EXPERIMENTAL"},{"description":"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.","label":"Part 2: Elritercept Dose Confirmation Cohort E","type":"EXPERIMENTAL"},{"description":"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.","label":"Part 2: Elritercept Dose Confirmation Cohort F","type":"EXPERIMENTAL"},{"description":"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.","label":"Part 2: Elritercept Dose Confirmation Cohort G","type":"EXPERIMENTAL"},{"description":"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).","label":"Long-term Extension Cohort","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2031-10-30","type":"ESTIMATED"},"conditions":["Myelodysplastic Syndromes","Cytopenia"],"enrollment":{"count":210,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"Elritercept","otherNames":["KER-050","TAK-226"],"type":"DRUG"}],"last_update":"2026-10-19","lead_sponsor":"Takeda","official_title":"A Phase 2, Open-Label, Ascending Dose Study of KER-050 for the Treatment of Anemia in Patients With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS)","overall_status":"RECRUITING","phases":["PHASE2"],"primary_completion_date":{"date":"2029-10-30","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)","timeFrame":"From treatment initiation to end of study (up to 11.2 years)"}],"references":[],"start_date":{"date":"2020-08-19","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study of Elritercept to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS)","url":"https://clinicaltrials.gov/study/NCT04419649"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.1","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/nct04419649"}