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Study to Assess the Efficacy and Safety of IMVT-1402 in Participants With Mild to Severe Generalized Myasthenia Gravis
Study to Assess the Efficacy and Safety of IMVT-1402 in Participants With Mild to Severe Generalized Myasthenia Gravis

NCT07039916

RecruitingPhase 3

Sponsor: Immunovant Sciences GmbH

Conditions: Generalized Myasthenia Gravis

Interventions: IMVT-1402, IMVT-1402, Placebo, IMVT-1402

Countries: United States, Argentina, Czechia, Denmark, Georgia, Germany, Greece, Hungary

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 overview

Sex: ALL

Age: 18 Years to 80 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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.
Locations (88)
  • Huntsville, Alabama, United States
  • Mobile, Alabama, United States
  • Phoenix, Arizona, United States
  • Scottsdale, Arizona, United States
  • Tucson, Arizona, United States
  • Carlsbad, California, United States
  • Irvine, California, United States
  • Los Angeles, California, United States
  • Rancho Mirage, California, United States
  • San Francisco, California, United States
  • Fort Collins, Colorado, United States
  • New Haven, Connecticut, United States
  • Washington D.C., District of Columbia, United States
  • Clearwater, Florida, United States
  • Ormond Beach, Florida, United States
  • Port Charlotte, Florida, United States
  • Rockledge, Florida, United States
  • Tampa, Florida, United States
  • Atlanta, Georgia, United States
  • Augusta, Georgia, United States
  • Schaumburg, Illinois, United States
  • Lexington, Kentucky, United States
  • Nicholasville, Kentucky, United States
  • New Orleans, Louisiana, United States
  • Foxborough, Massachusetts, United States
  • Detroit, Michigan, United States
  • East Lansing, Michigan, United States
  • Omaha, Nebraska, United States
  • Totowa, New Jersey, United States
  • New York, New York, United States
  • + 58 more on CT.gov