A Phase 2b Study of IMVT-1402 in CIDP

  • Research type

    Research Study

  • Full title

    A Phase 2b, Multi-center, Randomized, Double-blind, Placebo-controlled Study of IMVT-1402 Treatment in Adult Participants with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

  • IRAS ID

    1011913

  • Contact name

    Dylan Hernandez

  • Contact email

    dylan.hernandez@immunovant.com

  • Sponsor organisation

    Immunovant Sciences GmbH

  • Clinicaltrials.gov Identifier

    NCT07032662

  • Research summary

    In CIDP, the body produces abnormal antibodies against its own nerves and attacks them. As a result, muscles are weaker and get tired more quickly than normal.
    This study will test a new treatment for CIDP, called IMVT-1402, that works by reducing the level of antibodies, including these abnormal antibodies. This treatment might keep CIDP under control better than current treatments (like immunoglobulin [Ig] or corticosteroids).
    This study will test how well IMVT-1402 treatment works for CIDP. The study will compare IMVT-1402 to a placebo.
    Researchers will do checkups to see how well the study treatment works. This study has 4 parts:
    Screening period
    Period 1: A 24-week main treatment period in which participants will either take 600mg of IMVT-1402 or placebo once a week
    Period 2: An optional 52-week treatment period in which all participants will take 600m of IMVT-1402 once a week
    Safety follow-up: Participants will not take any study treatment
    Potential participants can enter the study if they meet certain eligibility criteria.

  • REC name

    North East - Newcastle & North Tyneside 2 Research Ethics Committee

  • REC reference

    25/NE/0129

  • Date of REC Opinion

    14 Aug 2025

  • REC opinion

    Further Information Favourable Opinion