Study to Assess the Efficacy and Safety of IMVT-1402 in Participants With Mild to Severe Generalized Myasthenia Gravis
Phase 3 – large-scale trial before approval
Conditions:
Generalized Myasthenia Gravis
Sponsor: Immunovant Sciences GmbH
trial.available_in:
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Overview
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.
Who can participate
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.
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