MEZA ITP Study

  • Research type

    Research Study

  • Full title

    A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Safety of Mezagitamab Subcutaneous Injection in Participants with Chronic Primary Immune Thrombocytopenia

  • IRAS ID

    1010936

  • Contact name

    Parth Patwari

  • Contact email

    parth.patwari@takeda.com

  • Sponsor organisation

    Takeda Development Center Americas Inc.

  • Eudract number

    2024-514401-54

  • Research summary

    ITP is an autoimmune bleeding disorder that results in a decreased platelet count and may lead to bleeding events, some of which can be severe or life-threatening. Approximately 20% of patients with ITP do not respond to currently available treatments, or experience a loss of response or intolerance, resulting in increased bleeding-related morbidity and diminished quality of life. The purpose of this trial is to evaluate efficacy and safety of mezagitamab as a new treatment option that can provide a sustained platelet response, prevent bleeding, and improve the quality of life for patients with primary ITP who have had an insufficient response or intolerance to prior therapy.

  • REC name

    London - Chelsea Research Ethics Committee

  • REC reference

    25/LO/0035

  • Date of REC Opinion

    31 Jan 2025

  • REC opinion

    Further Information Favourable Opinion