Study to Assess the Efficacy and Safety of IMVT-1402 in Participants With Mild to Severe Generalized Myasthenia Gravis
NCT ID: NCT07039916
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
231 participants
INTERVENTIONAL
2025-05-27
2028-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Group 1: IMVT-1402 Dose 1
IMVT-1402
• Dose 1 subcutaneous (SC) once weekly (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)
Group 2: IMVT-1402 Dose 2
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/ IMVT-1402
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)
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
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Immunovant Sciences GmbH
INDUSTRY
Responsible Party
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Locations
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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 - 1022
Lexington, Kentucky, United States
Site Number - 1032
Nicholasville, Kentucky, United States
Site Number - 1005
East Lansing, Michigan, 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 - 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 - 8002
Tbilisi, , Georgia
Site Number - 6504
Goettigen, , Germany
Site Number - 6503
Würzburg, , Germany
Site Number - 7552
Budapest, , Hungary
Site Number - 7553
Budapest, , Hungary
Site Number - 7502
Constanța, , Romania
Site Number - 7501
Târgu Mureş, , Romania
Site Number - 9002
Niš, , Serbia
Countries
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Central Contacts
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Other Identifiers
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2024-515979-35-00
Identifier Type: CTIS
Identifier Source: secondary_id
IMVT-1402-3101
Identifier Type: -
Identifier Source: org_study_id