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

NCT07623161 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: TAK-226-30022026-525660-17-00
• Study Type: interventional
• Target: 324
• Locations: 0 countries
• Sites: N/A

Brief Summary

The main aim of this study is to find out how well elritercept works to improve anemia in participants with myelofibrosis (MF) who are taking ruxolitinib when compared to placebo. Other aims are to learn how elritercept improves anemia compared to placebo; to learn if elritercept reduces tiredness, improves symptoms related to MF, and helps participants do physical activities more easily. The study also aims to find out how elritercept affects the bone marrow, the spleen, and whether participants develop antibodies to the study drug. The study will also check how safe elritercept is compared to placebo, and if elritercept stays safe over a long period of time. Participants will receive study treatment for at least 9 months (36 weeks). After this period, participants who received placebo will have the option to switch to elritercept.

Conditions

Anemia; Myelofibrosis

Keywords

TAK-226; Drug therapy

Outcome Measures

Primary Outcomes (1)

• 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

  RBC-TI is defined as no RBC transfusions administered for the specified time period during study treatment.

  From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)

Secondary Outcomes (30)

• Proportion of Participants Who Achieve ≥50 Percent (%) Reduction in RBC Transfusion Burden From Baseline Over Any Consecutive 12-Week Period

  From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)

• Proportion of Participants Who Are RBC-TI for Any Consecutive ≥16-Week Period

  From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)

• 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

  From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)

• Proportion of Participants Who Are RBC-TI for Any Consecutive ≥24-Week Period

  From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)

• 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

  From Cycle 1 Day 1 through Week 36 (each cycle is 28 days)

Study Arms (2)

Elritercept

EXPERIMENTAL

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.

Drug: Elritercept

Placebo

PLACEBO 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.

Drug: Placebo; Drug: Elritercept

Interventions

Placebo DRUG

Elritercept-matching placebo

Placebo

Elritercept DRUG

Elritercept, SC, injection

Also known as: TAK-226

Elritercept; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged ≥18 years at the time of signing the informed consent form (ICF).
• Able to understand the purpose and risks of the trial and voluntarily sign an ICF.
• Diagnosed with primary myelofibrosis (PMF), post-essential thrombocythemia (post-ET MF) or post-polycythemia vera (post-PV MF) according to the 2022 WHO criteria (WHO Classification of Tumours Editorial Board 2024), confirmed by local pathology report.
• Transfusion status as assessed in the 12 weeks immediately preceding randomization classified as Transfusion Dependent: 3 to 8 RBC units over 12 weeks.
• Receiving ruxolitinib (as approved in the country of the trial site) as the standard of care treatment for MF for at least 12 consecutive weeks, and on a stable daily dose for at least the 8 weeks immediately preceding the date of randomization.
• Eastern Cooperative Oncology Group score less than or equal to (≤) 2.

You may not qualify if:

• Prior treatment with luspatercept, sotatercept, or other transforming growth factor beta inhibitors or activin receptor ligand traps.
• Systemic treatment within 28 days before randomization with any of the following:
• Androgens (including danazol). Participants on stable androgen dosing for hypogonadism for ≥8 weeks are allowed.
• erythropoiesis-stimulating agents.
• granulocyte colony stimulating factor or granulocyte-macrophage colony stimulating factor.
• High dose corticosteroids. Participants on stable chronic steroid doses of prednisone ≤10 mg/day or corticosteroid equivalent for ≥4 weeks are allowed. Other treatments for autoimmune diseases may be allowed upon medical monitor review.
• Hydroxyurea.
• Immunomodulatory drugs (for example, thalidomide, pomalidomide, or lenalidomide).
• Interferon.
• Thrombopoietin receptor agonists.
• Initiation of new iron chelation therapy or dose adjustments to existing iron chelation therapy ≤8 weeks prior to randomization. Participants on stable doses of iron chelation therapy for ≥8 weeks are allowed.
• Clinically significant anemia that is due to causes other than MF or Janus kinase (JAK) inhibitor therapy (for example, thalassemia, iron deficiency, vitamin B12 and/or folate deficiencies, autoimmune or hemolytic anemia, infections, or any active clinically significant bleeding or sequestration).
• Receipt of RBC transfusion for any reason(s) other than underlying MF within 12 weeks before randomization.
• Life expectancy \<12 months per investigator's judgment.
• Clinically significant cardiovascular disease, defined as:

Sponsors & Collaborators

• Takeda: lead

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MeSH Terms

Conditions

Primary Myelofibrosis; Anemia

Condition Hierarchy (Ancestors)

Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Central Study Contacts

Takeda Contact

CONTACT

+1-877-825-3327; medinfoUS@takeda.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2026
• First Posted: June 3, 2026
• Study Start (Estimated): August 25, 2026
• Primary Completion (Estimated): December 7, 2029
• Study Completion (Estimated): March 30, 2034
• Last Updated: June 3, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.