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

Phase 2Not Yet RecruitingNCT07286006

Immunovant Sciences GmbH372 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

372

Conditions

Graves' Disease

Interventions

IMVT-1402DRUG

Dose 1 for up to 52 weeks

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: At Week 52

Secondary Outcomes

Percentage of Group A Participants who are euthyroid and off ATD

Time frame: At Week 26

Percentage of Group A Participants who are euthyroid and off ATD

Time frame: Up to Week 52

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

Time frame: 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

Time frame: Up to Week 52

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

Time frame: Up to Week 52

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

Time frame: At Week 52

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

Time frame: Up to Week 52

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

Time frame: Up to Week 52

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

Time frame: At Week 52

Central Contacts

Central Study Contact

CONTACT

18007970414 clinicaltrials@immunovant.com

Data from ClinicalTrials.gov

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