Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 3interventionalRules rewrite

Phase 3: testing Elritercept for Myelodysplastic Syndromes

The main aim of this study is to find out how well elritercept works in lowering the need for RBC transfusions. Other aims are to learn how well elritercept works in reducing the need for RBC transfusions over longer periods of time or in adults with high transfusion needs.

Official registry: https://clinicaltrials.gov/study/NCT06499285 · Takeda · enrollment listed as 225

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Elritercept, or Placebo. The registry lists allocation as randomized. The main aim of this study is to find out how well elritercept works in lowering the need for RBC transfusions.

They plan to enroll about 225 people at 182 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Elritercept (KER-050) for the Treatment of Transfusion-Dependent Anemia in Adult Participants With Very Low-, Low-, or Intermediate-Risk Myelodysplastic Syndromes (MDS) (RENEW)

Interventions: Elritercept, Placebo

Primary outcome (registry wording): Percentage of Participants Achieving Transfusion Independence (TI) for ≥8 Weeks

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • Transfusion dependence assessed in the 16 weeks immediately preceding randomization in two 8-week blocks, classified as either:
  • Refractory or intolerant to prior erythropoiesis-stimulating agent (ESA) treatment (discontinued ≥4 weeks before randomization), or unlikely to respond to ESA treatment, defined as follows:
  • b. Intolerant to prior ESA treatment: documentation of discontinuation of a prior ESA-containing regimen, either as a single agent or combination (e.g., with G-CSF), at any time after introduction due to intolerance or an AE
  • c. Unlikely to respond to ESA treatment: low chance of response to ESA based on an endogenous serum EPO level greater than (\>)200 units per liter (U/L)
  • Less than 5 percent (%) blasts in an evaluable bone marrow sample collected at Screening
  • Eastern Cooperative Oncology Group performance status of 0 to 2
  • Females of childbearing potential and sexually active males must agree to use highly effective methods of contraception

Public study contact (from the registry)

Takeda Contact

+1-877-825-3327

medinfoUS@takeda.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

182 listed

+ 157 sites outside the US on the same record

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FAQ about this NCT record

Is NCT06499285 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06499285?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06499285?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary