Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT07286006

A Long-Term Extension Study of IMVT-1402 in Adult Participants With Graves' Disease (GD)

This is a long-term extension study that will rollover participants completing feeder studies IMVT-1402-2502 (NCT06727604) or IMVT-1402-2503 (NCT07018323) to evaluate the efficacy and safety of IMVT-1402 in adult participants with GD. Eligible participants will be assigned to 1 of 3 study groups (Groups A, B and C) based on their GD status at the completion of their respective feeder study.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Graves' Disease Autoimmune Diseases Endocrine System Diseases Exophthalmos Eye Diseases Goiter Graves Disease Hyperthyroidism Immune System Diseases Orbital Diseases Thyroid Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Site Number - 5152, South Brisbane, Queensland, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants who completed Study IMVT-1402-2502 or Study IMVT-1402-2503.
  • Other, more specific inclusion criteria are defined in the protocol.

Exclusion criteria

  • Have permanently discontinued IMP during the treatment period in the feeder study or have met study stopping criteria at any point up until the end of participation in the feeder study.

Treatment and study plan

IMVT-1402

Drug

Dose 1 for up to 52 weeks

Primary outcomes

  1. Percentage of Group A Participants who remain euthyroid, Off ATD, and Off IMVT-1402

    Time frame: At Week 52

Secondary outcomes

  1. Percentage of Group A Participants who are euthyroid and off ATD

    Time frame: At Week 26

  2. Percentage of Group A Participants who are euthyroid and off ATD

    Time frame: Up to Week 52

  3. Percentage of Group A Participants who are euthyroid, off ATD, and off IMVT-1402

    Time frame: Up to Week 52

  4. Time to earliest date of euthyroidism, off ATD, and off IMVT-1402 to the earliest date of confirmed relapse in Group A Participants

    Time frame: Up to Week 52

  5. Percentage of Group B Participants who remain euthyroid, off ATD, and off IMVT-1402

    Time frame: Up to Week 52

  6. Percentage of Group B Participants who remain euthyroid, off ATD, and off IMVT-1402

    Time frame: At Week 52

  7. Time from Week 0 to the earliest date of confirmed relapse in Group B Participants

    Time frame: Up to Week 52

  8. Percentage of Group C Participants who remain euthyroid, off ATD, and off IMVT-1402

    Time frame: Up to Week 52

  9. Percentage of Group C Participants who remain euthyroid, off ATD, and off IMVT-1402

    Time frame: At Week 52

  10. Time From Week 0 to the earliest date of confirmed relapse in Group C Participants

    Time frame: Up to Week 52

  11. Percentage of Group A Participants who are euthyroid, off ATD, and seronegative for TRAb

    Time frame: At Week 26

  12. Percentage of Group A Participants who are euthyroid, off ATD, and seronegative for TRAb

    Time frame: Up to Week 52

Sponsors and collaborators

Lead sponsor

Immunovant Sciences GmbH

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Dec 16, 2025
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.