A Phase 2b Study to Assess the Efficacy and Safety of IMVT-1402 in Patients With Graves' Disease

• Research type

  Research Study

• Full title

  A Randomized, Double-Blind, Placebo-Controlled, Phase 2b Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Patients With Graves' Disease

• IRAS ID

  1010982

• Contact name

  Dylan Hernandez

• Contact email

  dylan.hernandez@immunovant.com

• Sponsor organisation

  Immunovant Sciences GmbH

• Clinicaltrials.gov Identifier

  NCT06727604

• Research summary

  The thyroid is a small gland in the neck that helps the body control energy levels and metabolism. Graves’ disease (GD) is an autoimmune condition causing the thyroid to overwork, with symptoms like a fast heartbeat, unexpected weight loss, and anxiety. GD generates harmful antibodies, making the thyroid produce too many hormones. Current medications can control hormone production but not the harmful antibodies.
  This study will test a new treatment, IMVT-1402, and test how well it works for GD compared to a placebo (a look-alike substance that does not have IMVT-1402 in it).

  Researchers will measure:
  • How fast thyroid hormones become normal;
  • How long thyroid hormone levels stay normal after stopping treatment for GD;
  • Changes in harmful antibodies in the body;
  • How many participants can stop using their current medication to treat GD;
  • How participants feel during the study; and
  • Any side effects

  Study parts:
  • Screening: Researchers will check if participants can enter the study.
  • Treatment: Participants will take either IMVT-1402 or placebo alongside with allowed GD medications.
  • Safety Follow-up: Participants will not take any study treatment.

  Participants will be in one of the three study groups:
  • Group 1: Participants will take IMVT-1402 600 mg every week for 52 weeks;
  • Group 2: Participants will take IMVT-1402 600 mg every week for 26 weeks. Researchers will see how well IMVT-1402 treatment worked for each participant. Then, some participants will take IMVT-1402 600 mg
  every week and some will take placebo every week for an additional 26 weeks.
  • Group 3: Participants will receive placebo every week for 52 weeks.
  Participants and researchers will not know who is getting IMVT-1402 or placebo.
  Participants will be in the study for up to 109 weeks total.

• REC name

  North East - Newcastle & North Tyneside 2 Research Ethics Committee

• REC reference

  25/NE/0033

• Date of REC Opinion

  16 Apr 2025

• REC opinion

  Further Information Favourable Opinion