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ELRISE MFNCT07623161

A Study to Compare Elritercept to Placebo in Adults With Myelofibrosis and Anemia Who Are Taking Ruxolitinib

StatusRecruiting
PhasePhase 3
SponsorTakeda
Primary completion (estimated)
Track this trial

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Record History

All 6 versions: 6 with changes below. See every version on ClinicalTrials.gov ↗

  1. Trial sites expanded: 195 → 214 locations
  2. Eligibility criteria expanded, about 44 words
    • Start date changed from estimate of Sep 2, 2026 to Sep 10, 2026
    • Secondary endpoints: details revised at 19 of 30 entries
    • Site details revised at 11 of 195 sites
  3. Study sites: 194 to 195
    • Start date: Aug 25, 2026 to Sep 2, 2026
    v4
  4. Trial sites reduced: 207 → 194 locationsv3
  5. Recruitment opened
    • Trial sites expanded: 0 → 207 locations
    v2
  6. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Proportion of Participants Who Are Red Blood Cell-Transfusion Independent (RBC-TI) for Any Consecutive Greater Than or Equal to (≥) 12-Week Period During the 36-Week Double-Blinded Treatment Period
Timeframe: From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)

Secondary (30)

Proportion of Participants Who Achieve ≥50 Percent (%) Reduction in RBC Transfusion Burden From Baseline Over Any Consecutive 12-Week Period
Proportion of Participants Who Are RBC-TI for Any Consecutive ≥16-Week Period
Proportion of Participants Who Are RBC-TI for Any Consecutive ≥12-Week Period With Concurrent Mean Hemoglobin (Hgb) Increase ≥1.5 Grams per Deciliter (g/dL) From Baseline
Proportion of Participants Who Are RBC-TI for Any Consecutive ≥24-Week Period
Proportion of Participants Who Are RBC-TI for Any Consecutive ≥12-Week Period With Concurrent Mean Hgb Increase of ≥1.0 g/dL and ≥2.0 g/dL From Baseline
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Proportion of Participants Who Are RBC-TI for Any Consecutive 16- or 24-Week Period With a Concurrent Mean Hgb Increase of ≥1.0 g/dL, ≥1.5 g/dL, and ≥2.0 g/dL From Baseline
Maximum Duration of RBC-TI for Participants Who Achieved RBC-TI for a Consecutive ≥12 Weeks
Maximum Duration of RBC-TI With Concurrent Mean Hgb Increase of ≥1.5 g/dL for Participants Who Achieved Consecutive ≥12 Weeks RBC-TI With Concurrent Mean Hgb Increase of ≥1.5 g/dL
Time to Onset of Anemia Response
Mean Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 - Fatigue 7a T-Score at Week 36
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Fatigue Scale Score at Week 36
Proportion of Participants With Meaningful Improvement and Meaningful Deterioration in PROMIS Short Form v1.0 - Fatigue 7a T-score
Time to Meaningful Improvement and Meaningful Deterioration in PROMIS Short Form v1.0 - Fatigue 7a T-Score From Baseline
Proportion of Participants With Meaningful Improvement and Meaningful Deterioration in EORTC QLQ-C30 Fatigue Scale Score
Time to Meaningful Improvement and Meaningful Deterioration in EORTC QLQ-C30 Fatigue Scale Score From Baseline
Mean Changes From Baseline in Myelofibrosis Symptom Assessment Form (MFSAF) v4.0 7-Item Total Symptom Score at Week 36
Proportion of Participants Achieving Confirmed 50% Reduction in MFSAF v4.0 Total Symptom Score (TSS50)
Time to Symptom Response in MFSAF TSS50 From Baseline
Mean Change From Baseline EORTC QLQ-C30 Physical Functioning Scale Score at Week 36
Proportion of Participants With Meaningful Improvement and Meaningful Deterioration in EORTC QLQ-C30 Physical Functioning Scale Score
Time to Meaningful Improvement and Meaningful Deterioration in EORTC QLQ-C30 Physical Functioning Scale Score From Baseline
Proportion of Participants With Platelet Response During the 36-Week Double-Blinded Treatment Period
Proportion of Participants Achieving Spleen Volume Reduction (SVR) From Baseline as Measured by Computed Tomography/Magnetic Resonance Imaging (CT/MRI) During the 36-Week Double-Blinded Treatment Period
Proportion of Participants Who Develop Accelerated Phase (AP) MF
Time to Progression in Participants Who Develop AP MF
Proportion of Participants Who Develop Blast Phase (BP) MF
Time to Progression in Participants Who Develop BP MF
Plasma Concentration-Time Data for Participants Treated With Elritercept
Proportion of Participants Treated With Elritercept who Have Antidrug Antibodies
Overall Survival (OS)

Arms and interventions

ElriterceptExperimental

Participants will receive elritercept at a starting dose of 3.75 milligrams per kilogram (mg/kg) subcutaneously (SC) once every 4 weeks (Q4W) on Day 1 of each 28-day cycle for approximately 36 weeks during the double-blinded treatment period, with possible up-titration to 5.0 mg/kg from Cycle 3 Day 1 based on response and safety/tolerability. Participants may continue to receive elritercept during the extended open-label treatment period.

PlaceboPlacebo comparator

Participants will receive elritercept-matching placebo with equivalent volume to elritercept SC Q4W on Day 1 of each 28-day cycle for approximately 36 weeks during the double-blinded treatment period. Eligible participants may initiate elritercept at a starting dose of 3.75 mg/kg SC Q4W on Day 1 of each 28-day cycle during the extended open-label treatment period, with possible up-titration to 5.0 mg/kg after 2 cycles, based on response and safety/tolerability.

Drugs: Placebo, Elritercept

Sites

214 sites in 31 countries

United States 35, Italy 12, India 10, Brazil 9, France 9, Germany 9, Spain 9, Japan 8, Australia 7, Canada 7, Greece 7, Poland 7, South Korea 7, United Kingdom 7, Argentina 6, Chile 6, Belgium 5, Bulgaria 5, Israel 5, Taiwan 5, Austria 4, Colombia 4, Czechia 4, Ireland 4, Malaysia 4, Romania 4, Turkey (Türkiye) 4, Mexico 3, Saudi Arabia 3, Sweden 3, Hungary 2