300 Participants NeededMy employer runs this trial

Elritercept vs Epoetin Alfa for Anemia

(ELRiSE MDS Trial)

Recruiting at 184 trial locations
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human 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?

SD

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

Able to understand the purpose and risks of the trial and voluntarily sign an ICF prior to any trial-related procedures being conducted and authorization to use protected health information and personal data in accordance to national and local privacy regulations
Bone marrow less than (<) 5% blasts in an evaluable bone marrow collected at screening and confirmed by central pathology independent reviewer
Hgb <11.0 g/dL after last RBC transfusion preceding randomization
See 5 more

Exclusion Criteria

I have MDS with del(5q), unclassifiable MDS, or secondary MDS.
Known ejection fraction <35%
I do not have an active infection needing IV antibiotics right now.
See 20 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either elritercept or epoetin alfa to assess efficacy and safety in reducing RBC transfusion needs

24 weeks
Every 4 weeks for elritercept, weekly for epoetin alfa

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 weeks

Extension

Participants may continue to be monitored for long-term outcomes and safety

Up to 48 weeks

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

Group I: ElriterceptExperimental Treatment1 Intervention
Group II: Epoetin AlfaActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Takeda

Lead Sponsor

Trials
1,255
Recruited
4,219,000+
Dr. Naoyoshi Hirota profile image

Dr. Naoyoshi Hirota

Takeda

Chief Medical Officer since 2020

MD from University of Tokyo

Christophe Weber profile image

Christophe Weber

Takeda

Chief Executive Officer since 2015

PhD in Molecular Biology from Université de Montpellier

Citations

The 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 ...

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 ...

Elritercept 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 ...

Elritercept 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 ...