Elritercept vs Epoetin Alfa for Anemia
(ELRiSE MDS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called elritercept to determine if it can reduce the need for blood transfusions in people with anemia caused by myelodysplastic syndrome (MDS), a condition where the bone marrow doesn't produce enough healthy blood cells. Researchers aim to assess whether elritercept is safer and more effective than the current treatment, epoetin alfa, particularly in reducing tiredness and improving quality of life. They also monitor for any immune responses to elritercept. This trial may suit individuals diagnosed with certain types of MDS who require regular red blood cell transfusions to manage their anemia. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you must stop taking your current medications. However, certain medications like epoetin alfa, darbepoetin, and others listed in the exclusion criteria should not have been used recently. It's best to discuss your current medications with the trial team to see if they might affect your eligibility.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that elritercept is generally safe for use. Studies have found no serious side effects that limit dosage. Most side effects are mild, such as stomach issues, and serious problems are rare. This suggests that elritercept is relatively safe for humans based on trials conducted so far.12345
Why do researchers think this study treatment might be promising for anemia?
Elritercept is unique because it targets anemia differently than most standard treatments, such as erythropoiesis-stimulating agents like epoetin alfa. While epoetin alfa works by stimulating red blood cell production through erythropoietin receptors, elritercept acts on a different pathway, potentially leading to more effective or sustained results. Additionally, elritercept is administered subcutaneously once every four weeks, which could offer greater convenience compared to the weekly injections required for epoetin alfa. Researchers are excited because these features might improve patient outcomes and adherence to treatment.
What evidence suggests that this trial's treatments could be effective for anemia?
This trial will compare Elritercept with Epoetin Alfa for treating anemia. Research has shown that Elritercept may help treat anemia. In earlier studies, 30.4% of patients temporarily stopped needing red blood cell (RBC) transfusions. Additionally, 82.8% of patients experienced an increase in hemoglobin, which is crucial for healthy blood. Elritercept also improves other blood components, such as platelets. These findings suggest that Elritercept could reduce the need for transfusions and enhance overall blood health for people with anemia.12678
Who Is on the Research Team?
Study Director
Principal Investigator
Takeda
Are You a Good Fit for This Trial?
This trial is for adults (18+) with very low, low, or intermediate risk myelodysplastic syndromes who need regular red blood cell transfusions and have hemoglobin below 11. They must not have certain genetic abnormalities, severe heart issues, recent major surgery, uncontrolled infections, or other serious health problems.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either elritercept or epoetin alfa to assess efficacy and safety in reducing RBC transfusion needs
Follow-up
Participants are monitored for safety and effectiveness after treatment
Extension
Participants may continue to be monitored for long-term outcomes and safety
What Are the Treatments Tested in This Trial?
Interventions
- Elritercept
- Epoetin Alfa
Trial Overview
The study compares two treatments—elritercept and epoetin alfa—to see which better reduces the need for blood transfusions in people with MDS-related anemia. Participants are randomly assigned to one of the two groups.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants will receive a starting dose of elritercept at 3.75 milligrams per kilogram (mg/kg) administered subcutaneously (SC) once every 4 weeks, and may have the dose escalated to 5.0 mg/kg if needed,
Participants will receive a starting dose of epoetin Alfa at 450 international units per kilograms (IU/kg) administered SC once every week, and may have the dose escalated up to 1050 IU/kg.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Takeda
Lead Sponsor
Dr. Naoyoshi Hirota
Takeda
Chief Medical Officer since 2020
MD from University of Tokyo
Christophe Weber
Takeda
Chief Executive Officer since 2015
PhD in Molecular Biology from Université de Montpellier
Citations
1.
ashpublications.org
ashpublications.org/ashclinicalnews/news/8751/The-Efficacy-and-Safety-of-Elritercept-in-AdultThe Efficacy and Safety of Elritercept in Adult Participants With ...
Elritercept, by not only improving hemoglobin levels and reducing transfusion dependence but also enhancing other cell lineages and improving ...
Hematological and clinical improvements with elritercept ...
By wk 24, among TD pts with at least 12 wks of Hgb/RBC transfusion recorded, 30.4% (7/23) achieved RBC transfusion independence (TI), 17.4% (4/23) achieved TI ...
3.
ir.kerostx.com
ir.kerostx.com/news-releases/news-release-details/keros-therapeutics-presents-clinical-data-its-elritercept/Keros Therapeutics Presents Clinical Data from its Elritercept ...
Increases in hemoglobin were observed in 82.8% (n=24/29) of evaluable non-transfusion dependent patients in both arms over a 12-week period ...
4.
bloodcancerstoday.com
bloodcancerstoday.com/post/elritercept-relieves-anemia-and-improves-symptoms-in-myelofibrosisElritercept Relieves Anemia and Improves Symptoms in ...
Moreover, elritercept was associated with improvements in hemoglobin levels, transfusion burden, and platelet counts, indicating that the drug ...
A Study of Elritercept to Treat Anemia in Adults With Very ...
41.3% (n=26/63) of the TI-evaluable patients achieved TI for at least eight weeks over the first 24 weeks of treatment. 16 of those 26 patients (61.5%) achieved ...
Elritercept, a modified activin receptor IIA ligand trap ... - PMC
Elritercept was generally well tolerated at all dose levels, with no dose-limiting toxicities observed after single or multiple doses.
Pharmacokinetic/Pharmacodynamic Analysis of Elritercept ...
The safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of elritercept are being evaluated in two phase 2 trials in patients with lower-risk ...
8.
hmpgloballearningnetwork.com
hmpgloballearningnetwork.com/site/onc/conference-coverage/elritercept-plus-ruxolitinib-demonstrates-favorable-safety-and-strongElritercept Plus Ruxolitinib Demonstrates Favorable Safety ...
Safety: The regimen was well tolerated, with mostly grade 1–2 gastrointestinal AEs (notably diarrhea) and few grade ≥ 3 events. Clinical ...
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