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NCT07039916
Study to Assess the Efficacy and Safety of IMVT-1402 in Participants With Mild to Severe Generalized Myasthenia Gravis
Conditions: Generalized Myasthenia Gravis
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 231
Sponsor: Immunovant Sciences GmbH
Location: Site Number - 1056 Huntsville Alabama
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 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.
* 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.
Source: ClinicalTrials.gov (NCT07039916). StuddyBuddy aggregates publicly available trial information.