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RecruitingPhase 2NCT07018323

A Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Participants With Graves' Disease

Trial Parameters

ConditionGraves' Disease
SponsorImmunovant Sciences GmbH
Study TypeINTERVENTIONAL
PhasePhase 2
Enrollment210
SexALL
Min Age18 Years
Max Age75 Years
Start Date2025-06-19
Completion2027-05
Interventions
IMVT-1402IMVT-1402Placebo

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Brief Summary

This is a multi-center, global, randomized, double-blind, placebo-controlled Phase 2b study to assess the efficacy, safety, and tolerability of IMVT-1402 in adult participants with Graves' disease (GD) who are hyperthyroid despite antithyroid drug (ATD) treatment.

Eligibility Criteria

Inclusion Criteria: * Participants with the ability to understand the requirements of the trial, provide written informed consent, and comply with the trial protocol procedures. * Male or female participants aged ≥ 18 years. * Participants with diagnosis of GD who are hyperthyroid despite ATD treatment. * Other, more specific inclusion criteria are defined in the protocol. Exclusion Criteria: * Have previously been successfully treated with radioactive iodine (RAI) therapy or have undergone total thyroidectomy. * Have an autoimmune disease other than GD requiring treatment that, in the Investigator's judgment, puts the participant at undue risk. * Have moderate-to-severe active thyroid eye disease (TED) and are expected to require immediate surgical intervention and/or are planning corrective surgery/irradiation or medical therapy for TED during study participation. * Additional exclusion criteria are defined in the protocol.

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