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Study to Assess the Efficacy and Safety of IMVT-1402 in Participants With Mild to Severe Generalized Myasthenia Gravis
RECRUITINGPhase 3Sponsored by Immunovant Sciences GmbH
Actively Recruiting
PhasePhase 3
SponsorImmunovant Sciences GmbH
Started2025-05-27
Est. completion2027-12
Eligibility
Age18 Years – 80 Years
Healthy vol.Accepted
Locations46 sites
View on ClinicalTrials.gov →
NCT07039916
Summary
The purpose of the study is to assess the efficacy, safety and tolerability of IMVT-1402 in adult participants with mild to severe generalized myasthenia gravis.
Eligibility
Age: 18 Years – 80 YearsHealthy volunteers accepted
Inclusion Criteria: * Participants with the ability to understand the requirements of the trial, provide written informed consent, and comply with the trial protocol procedures. * Have mild to severe gMG by Myasthenia Gravis Foundation of America (MGFA) classification of Class II, III, or IVa at the Screening Visit * Have an MG activities of daily living (MG-ADL) score of ≥ 6 at the Screening Visit and Baseline Visit (Day 1) Additional inclusion criteria are defined in the protocol. Exclusion Criteria: * Have experienced myasthenic crisis within 12 weeks prior to the Screening Visit. * Have had a thymectomy performed \< 6 months prior to the Screening Visit or have a planned thymectomy during the study * Have any active or untreated malignant thymoma Additional exclusion criteria are defined in the protocol.
Conditions2
CancerGeneralized Myasthenia Gravis
Interventions1
Locations46 sites
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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.
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Actively Recruiting
PhasePhase 3
SponsorImmunovant Sciences GmbH
Started2025-05-27
Est. completion2027-12
Eligibility
Age18 Years – 80 Years
Healthy vol.Accepted
Locations46 sites
View on ClinicalTrials.gov →
NCT07039916