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

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

Status

Enrolling by invitation

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07286006

Enrollment

372

Registered

2025-12-16

Start date

2026-01-26

Completion date

2030-03-01

Last updated

2026-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Graves' Disease

Keywords

IMVT-1402, Graves' disease, Immunoglobulin G, Thyroid-Stimulating Hormone Receptor, Antithyroid drug, FcRn, Imeroprubart

Brief summary

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.

Interventions

DRUGIMVT-1402

Dose 1 for up to 52 weeks

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Percentage of Group A Participants who remain euthyroid, Off ATD, and Off IMVT-1402	At Week 52

Secondary

Measure	Time frame
Percentage of Group A Participants who are euthyroid and off ATD	At Week 26
Percentage of Group A Participants who are euthyroid, off ATD, and off IMVT-1402	Up to Week 52
Time to earliest date of euthyroidism, off ATD, and off IMVT-1402 to the earliest date of confirmed relapse in Group A Participants	Up to Week 52
Percentage of Group B Participants who remain euthyroid, off ATD, and off IMVT-1402	Up to Week 52
Time from Week 0 to the earliest date of confirmed relapse in Group B Participants	Up to Week 52
Percentage of Group C Participants who remain euthyroid, off ATD, and off IMVT-1402	Up to Week 52
Time From Week 0 to the earliest date of confirmed relapse in Group C Participants	Up to Week 52
Percentage of Group A Participants who are euthyroid, off ATD, and seronegative for TRAb	At Week 26

Countries

Australia, Bulgaria, Czechia, Latvia, Poland, South Korea, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 28, 2026