IMG-7289-CTP-201 Phase 2 Essential Thrombocythaemia Study

  • Research type

    Research Study

  • Full title

    A Phase 2 Multi-Center, Open Label Study to Assess the Safety, Efficacy and Pharmacodynamics of IMG-7289 in Patients with Essential Thrombocythemia

  • IRAS ID

    278520

  • Contact name

    Claire Harrison

  • Contact email

    Claire.Harrison@gstt.nhs.uk

  • Sponsor organisation

    Imago BioSciences Inc.

  • Eudract number

    2019-003659-13

  • Duration of Study in the UK

    1 years, 4 months, 31 days

  • Research summary

    This is a clinical study of IMG-7289, a new drug that blocks the activity of an enzyme called LSD1. The study is being
    conducted in patients with Essential Thrombocythemia (ET). LSD1 is essential for some blood cells to develop.
    Blocking LSD1 is expected to be a useful treatment for patients with ET, which is a chronic myeloproliferative
    neoplasm (MPN) most commonly associated with an increased number of platelets (cells that help your blood clot) in
    the blood. This study will enrol 40 participants over the age of 18 who have failed at least one standard treatment for
    their ET. The purpose of the study is to see how well IMG-7289 controls platelets and to see how safe the drug is in
    participants with ET. The dose of IMG-7289 will be adjusted depending on how the participant’s platelet count
    responds to treatment. The goal of the 24 weeks of treatment is to see how many participants’ platelet counts can be
    brought under 400 x 109/L . In the first 24 weeks, the Initial Treatment Period, participants will be seen in clinic every 2
    weeks for 12 weeks and then every 4 weeks for another 12 weeks. If, after 24 weeks of treatment, participants have
    had benefit from treatment with IMG-7289, they can continue to receive IMG-7289 in Additional Treatment Periods of 24
    weeks.

  • REC name

    East Midlands - Leicester South Research Ethics Committee

  • REC reference

    20/EM/0036

  • Date of REC Opinion

    25 Mar 2020

  • REC opinion

    Further Information Favourable Opinion