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

NCT ID: NCT07286006

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

372 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-28

Study Completion Date

2030-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Graves' Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A

Group Type EXPERIMENTAL

IMVT-1402

Intervention Type DRUG

Dose 1 for up to 52 weeks

Group B

Group Type NO_INTERVENTION

No interventions assigned to this group

Group C

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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IMVT-1402

Dose 1 for up to 52 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Participants who completed Study IMVT-1402-2502 or Study IMVT-1402-2503.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Immunovant Sciences GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Central Study Contact

Role: CONTACT

[email protected]
18007970414

Other Identifiers

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IMVT-1402-2505

Identifier Type: -

Identifier Source: org_study_id