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Study to Assess the Efficacy and Safety of IMVT-1402 in Participants With Mild to Severe Generalized Myasthenia Gravis
Sponsor: Immunovant Sciences GmbH
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.
Official title: A Phase 3, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of IMVT-1402 in Patients With Mild to Severe Generalized Myasthenia Gravis
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
231
Start Date
2025-05-27
Completion Date
2028-12
Last Updated
2026-03-06
Healthy Volunteers
No
Conditions
Interventions
IMVT-1402
• Dose 1 subcutaneous (SC) once weekly (QW) for 12 weeks (Period 1)
IMVT-1402
* Dose 2 SC QW for 12 weeks (Period 1) * Dose 2 SC QW for 14 weeks (Period 2) * Dose 2 SC QW for 52 weeks (Period 3)
Placebo
• Placebo SC QW for 12 weeks (Period 1)
IMVT-1402
* Dose 1 SC QW for 14 weeks (Period 2) * Dose 1 SC QW for 52 weeks (Period 3)
Locations (75)
Site Number - 1041
Mobile, Alabama, United States
Site Number - 1017
Phoenix, Arizona, United States
Site Number - 1025
Scottsdale, Arizona, United States
Site Number - 1042
Tucson, Arizona, United States
Site Number - 1010
Carlsbad, California, United States
Site Number - 1028
Irvine, California, United States
Site Number - 1023
Los Angeles, California, United States
Site Number - 1029
Rancho Mirage, California, United States
Site Number - 1004
San Francisco, California, United States
Site Number - 1027
Fort Collins, Colorado, United States
Site Number - 1001
New Haven, Connecticut, United States
Site Number - 1024
Washington D.C., District of Columbia, United States
Site Number - 1006
Clearwater, Florida, United States
Site Number - 1037
Ormond Beach, Florida, United States
Site Number - 1002
Port Charlotte, Florida, United States
Site Number - 1050
Rockledge, Florida, United States
Site Number - 1007
Tampa, Florida, United States
Site Number - 1014
Atlanta, Georgia, United States
Site Number - 1043
Augusta, Georgia, United States
Site Number - 1022
Lexington, Kentucky, United States
Site Number - 1032
Nicholasville, Kentucky, United States
Site Number - 1046
New Orleans, Louisiana, United States
Site Number - 1049
Foxborough, Massachusetts, United States
Site Number - 1026
Detroit, Michigan, United States
Site Number - 1005
East Lansing, Michigan, United States
Site Number - 1018
Omaha, Nebraska, United States
Site Number - 1019
Totowa, New Jersey, United States
Site Number - 1036
New York, New York, United States
Site Number - 1034
New York, New York, United States
Site Number - 1020
Chapel Hill, North Carolina, United States
Site Number - 1013
Durham, North Carolina, United States
Site Number - 1044
Raleigh, North Carolina, United States
Site Number - 1038
Cincinnati, Ohio, United States
Site Number - 1011
Yukon, Oklahoma, United States
Site Number - 1031
Eugene, Oregon, United States
Site Number - 1030
Charleston, South Carolina, United States
Site Number - 1015
Charleston, South Carolina, United States
Site Number - 1021
Memphis, Tennessee, United States
Site Number - 1003
Dallas, Texas, United States
Site Number - 1047
Denton, Texas, United States
Site Number - 1048
Lubbock, Texas, United States
Site Number - 1009
Charlottesville, Virginia, United States
Site Number - 1040
Richmond, Virginia, United States
Site Number - 1035
Greenfield, Wisconsin, United States
Site Number - 3201
Brno, Czechia
Site Number - 3601
Copenhagen, Denmark
Site Number - 8002
Tbilisi, Georgia
Site Number - 8003
Tbilisi, Georgia
Site Number - 8001
Tbilisi, Georgia
Site Number - 6502
Bochum, Germany
Site Number - 6504
Goettigen, Germany
Site Number - 6503
Würzburg, Germany
Site Number - 3902
Athens, Greece
Site Number - 3901
Pátrai, Greece
Site Number - 3904
Thessaloniki, Greece
Site Number - 7552
Budapest, Hungary
Site Number - 7553
Budapest, Hungary
Site Number - 7551
Kistarcsa, Hungary
Site Number - 6003
Bergamo, Italy
Site Number - 6002
Milan, Italy
Site Number - 6001
Naples, Italy
Site Number - 6004
Rome, Italy
Site Number - 3001
Katowice, Poland
Site Number - 3006
Krakow, Poland
Site Number - 3002
Krakow, Poland
Site Number - 3003
Krakow, Poland
Site Number - 3004
Lublin, Poland
Site Number - 7502
Constanța, Romania
Site Number - 7501
Târgu Mureş, Romania
Site Number - 9001
Belgrade, Serbia
Site Number - 9002
Niš, Serbia
Site Number - 7103
Barcelona, Spain
Site Number - 7101
Córdoba, Spain
Site Number - 7104
Madrid, Spain
Site Number - 7002
Glasgow, United Kingdom