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MyelofibrosisCancerDrugPhase 3

What this study is

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.

What's being tested

  • Placebo

    Intervention · DRUG

    Elritercept-matching placebo

  • Elritercept

    Intervention · DRUG

    Elritercept, SC, injection

Study details

Official title
A Phase 3, Double-Blind, Randomized Trial Evaluating the Efficacy and Safety of Elritercept (TAK-226) Compared to Placebo in Participants With Myelofibrosis and Anemia on Concurrent Ruxolitinib Therapy
Sponsor
Takeda
Conditions
Myelofibrosis · Anemia
Enrolling
324 people
Starts
2026-09-10
Est. completion
2034-03-30
Design
Triple-blind, randomized, parallel groups, Phase 3
Record
View on ClinicalTrials.gov ↗