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ELRiSE MDSNCT07422480

A Study to Compare Elritercept With Epoetin Alfa to Treat Anemia in Adults With Lower Risk Myelodysplastic Syndromes (LR-MDS) Who Need Regular Blood Transfusions

StatusRecruiting
PhasePhase 3
SponsorTakeda
Primary completion (estimated)
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Record History

All 7 versions: 7 with changes below. See every version on ClinicalTrials.gov ↗

  1. Trial sites expanded: 162 → 166 locations
  2. Eligibility criteria expanded, about 56 words
    • Secondary endpoints revised (28)
    • Site details revised at 21 of 162 sites
    • Study title shortened, about 4 words
  3. Eligibility criteria expanded, about 50 words
    • Primary endpoints: details revised at 1 of 1 entry
    • Trial sites expanded: 156 → 162 locations
    • Secondary endpoints: details revised at 2 of 28 entries
  4. Study sites: 154 to 156v4
  5. Trial sites expanded: 146 → 154 locations
    • Start date changed from estimate of Apr 1, 2026 to May 21, 2026
    v3
  6. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 146
    v2
  7. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Proportion of Participants who are RBC Transfusion Independent (RBC-TI) for any Consecutive Greater Than Equal to (≥) 12-Week Period From Day 1 Through 24 Weeks With Concurrent Mean Hemoglobin (Hgb) Increase ≥ 1.5 Grams per Deciliter (g/dL) From Baseline
Timeframe: From Cycle 1 Day 1 through Week 24 (each cycle is 28 days)

Secondary (28)

Proportion of Participants who are RBC-TI for any Consecutive ≥16-Week Period From Day 1 to 24 Weeks
Proportion of Participants who are RBC-TI for any Consecutive ≥12-Week Period From Day 1 to 24 Weeks
Proportion of Participants who are RBC-TI for a Consecutive 24-Week Period From Day 1
Proportion of Participants Who Have Meaningful Improvement or Maintain a High Score With no Meaningful Deterioration in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Score With no RBC Transfusions Based on the Average of Scores
Proportion of Participants who Achieved Hematological Improvement-Erythroid (HI-E) for a Minimum 8-Week Period From Day 1 to 24 Weeks
Show 23 moreShow less
Proportion of Participants who Achieved Hematological Improvement-Erythroid (HI-E) for a Minimum 12-Week Period From Day 1 to 48 Weeks
Proportion of Participants who are RBC-TI for a Minimum Consecutive 8-Week Period From Day 1 to 24 Weeks
Proportion of Participants who are RBC-TI for a Minimum Consecutive 24-Week Period From Day 1 to 48 Weeks
Time From Date of First Dose to First Onset of Achieving RBC-TI
Mean Hgb Change From Baseline Through 24 Weeks and 48 Weeks
Maximum Duration of RBC-TI for Participants who Achieved RBC-TI for a Consecutive ≥12 Weeks and ≥16 Weeks
Total Number of Packed Red Blood Cells (pRBC) Units Received During the Study Treatment
Monthly Average of pRBC Units Received During Study Treatment Period
Time From Date of First Dose of Study Drug to Date of First RBC Transfusion Received During Treatment Period
Time From Date of First Dose of Study Drug to First Onset of Achieving HI-E for Minimum Consecutive 8 Weeks Period
Proportion of Participants with Meaningful Improvement in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Scale Scores
Proportion of Participants with Meaningful Improvement in FACT-Anemia (FACT-An) Scale Scores
Proportion of Participants with Meaningful Improvement in FACIT-Fatigue Scale Scores
Time to Confirmed Improvement and Time to Confirmed Deterioration in EORTC QLQ-C30 Scale Scores
Time to Confirmed Improvement and Time to Confirmed Deterioration in FACT-An Scale Scores
Time to Confirmed Improvement and Time to Confirmed Deterioration in FACIT-Fatigue Scale Scores
Average Changes in EORTC QLQ-C 30 Scale Scores Through 48 Weeks
Average Changes in FACT-An Scale Scores Through 48 Weeks
Average Changes in FACIT-Fatigue Scale Scores Through 48 Weeks
Concentration of Study Drug in Plasma Over Time Data for Participants Treated With Elritercept
Proportion of Participants Treated with Elritercept with Antidrug Antibodies (ADA)
Time from Randomization to First Diagnosis of Acute Myeloid Leukemia (AML)
Time From Randomization to the Death of a Participant From any Cause

Arms and interventions

ElriterceptExperimental

Participants will receive elritercept at a starting dose of 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.

Epoetin AlfaActive 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).

Drugs: Elritercept, Epoetin Alfa

Sites

166 sites in 28 countries

United States 35, Italy 11, Australia 10, Brazil 8, Japan 8, India 7, Spain 7, Greece 6, South Korea 6, Taiwan 6, United Kingdom 6, France 5, Germany 5, Poland 5, Turkey (Türkiye) 5, Argentina 4, Ireland 4, Mexico 4, Belgium 3, Malaysia 3, Norway 3, Switzerland 3, Thailand 3, Bulgaria 2, Hungary 2, Lithuania 2, Romania 2, Netherlands 1