A Long-Term Extension Study of IMVT-1402 in Adult Patients With Graves' Disease

• Research type

  Research Study

• Full title

  A Long-Term Extension Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 in Adult Patients With Graves' Disease

• IRAS ID

  1013261

• Contact name

  Sarah York

• Contact email

  sarah.york@immunovant.com

• Sponsor organisation

  Immunovant Sciences GmbH

• Eudract number

  2025-524001-33

• Clinicaltrials.gov Identifier

  NCT07286006

• Research summary

  Graves’ disease (GD) is an autoimmune thyroid condition that causes the body to make harmful antibodies. These harmful antibodies cause the thyroid gland to make too much thyroid hormone. When a patient has too much thyroid hormone, their symptoms can include fast heartbeat, unexpected weight loss, and anxiety. Although current medications can stop the thyroid from making too much thyroid hormone, they do not help to remove the harmful antibodies.
  This study is an extension of previous GD studies for IMVT-1402. Participants in this study have completed one of the previous studies (IMVT-1402-2502 or IMVT-1402-2503). This study will continue to test a new treatment called IMVT-1402.
  The purpose of this study is to assess the effectiveness of IMVT-1402 in people with GD, and its safety.
  Eligibility will be assessed using key criteria: inclusion—completion of one of prior studies with IMVT-1402; exclusion—permanent treatment discontinuation. Other requirements apply.
  Participants will be in 1 of the following 3 groups:
  • Group A: Participants will receive IMVT-1402 weekly. After IMVT-1402 treatment ends, participants will be monitored.
  • Group B and C: Participants will not take any study treatment.
  Group assignments are based on how participants responded to study treatment (placebo or IMVT-1402) in their previous study, as well as their GD status. Participants will know if they are getting IMVT-1402 or not in this study.
  Participants in Group A will be in this study for up to 104 weeks total. Participants in Groups B or C will be in this study for up to 52 weeks total. This study has 2 parts:
  • Treatment (Group A only): Participants will receive IMVT-1402 weekly. Participants will continue to take their GD medications that are allowed in the study, if needed.
  • Off-Treatment Observation (Groups A, B, and C): Participants will not receive treatment during this part of the study

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  26/LO/0127

• Date of REC Opinion

  30 Mar 2026

• REC opinion

  Further Information Favourable Opinion