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

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified May 2026 by Immunovant Sciences GmbH
Sponsor
Immunovant Sciences GmbH
Information Provided by (Responsible Party)
Immunovant Sciences GmbH
Clinicaltrials.gov Identifier
NCT07039916
Other Study ID Numbers:
IMVT-1402-3101
First Submitted
June 17, 2025
First Posted
June 25, 2025
Last Update Posted
June 14, 2026
Last Verified
May 2026

ClinicalTrials.gov processed this data on June 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Generalized Myasthenia Gravis
Drug: IMVT-1402Drug: IMVT-1402Drug: Placebo

Study Design

Study TypeInterventional
Actual Enrollment231 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingTriple
Primary PurposeTreatment
Official TitleA 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
Study Start DateMay 26, 2025
Actual Primary Completion Date1yr 4mos from now
Actual Study Completion Date2yrs 4mos from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Group 1: IMVT-1402 Dose 1
Drug: IMVT-1402
• Dose 1 subcutaneous (SC) once weekly (QW) for 12 weeks (Period 1)
Group 2: IMVT-1402 Dose 2
Drug: IMVT-1402
• Dose 1 subcutaneous (SC) once weekly (QW) for 12 weeks (Period 1)
Placebo/ IMVT-1402
Drug: Placebo
• Placebo SC QW for 12 weeks (Period 1)

Outcome Measures

Primary Outcome Measures
  1. Change from Baseline in MG-ADL Score for Antibody-positive Participants
Secondary Outcome Measures
  1. Change from Baseline in Quantitative Myasthenia Gravis (QMG) Score for Antibody-positive Participants
  2. Percentage of Antibody-positive Participants Achieving MG-ADL Score of 0 or 1
  3. Percentage of Antibody-positive Participants with ≥50% Improvement in MG-ADL Score

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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.

Contacts and Locations

Sponsors and CollaboratorsImmunovant Sciences GmbH
Locations
Site Number - 1056 | Huntsville Alabama, United States, 35801Site Number - 1041 | Mobile Alabama, United States, 36604Site Number - 1017 | Phoenix Arizona, United States, 85028Site Number - 1025 | Scottsdale Arizona, United States, 85251Site Number - 1042 | Tucson Arizona, United States, 85718Site Number - 1010 | Carlsbad California, United States, 92011Site Number - 1028 | Irvine California, United States, 92697Site Number - 1023 | Los Angeles California, United States, 90033Site Number - 1029 | Rancho Mirage California, United States, 92270Site Number - 1004 | San Francisco California, United States, 94143Site Number - 1027 | Fort Collins Colorado, United States, 80528Site Number - 1001 | New Haven Connecticut, United States, 06510Site Number - 1024 | Washington D.C. District of Columbia, United States, 20010Site Number - 1006 | Clearwater Florida, United States, 33761Site Number - 1037 | Ormond Beach Florida, United States, 32174Site Number - 1002 | Port Charlotte Florida, United States, 33952Site Number - 1050 | Rockledge Florida, United States, 32955Site Number - 1007 | Tampa Florida, United States, 33612Site Number - 1014 | Atlanta Georgia, United States, 30329Site Number - 1043 | Augusta Georgia, United States, 30912Site Number - 1054 | Schaumburg Illinois, United States, 60173Site Number - 1022 | Lexington Kentucky, United States, 40536-0284Site Number - 1032 | Nicholasville Kentucky, United States, 40356Site Number - 1046 | New Orleans Louisiana, United States, 70121Site Number - 1049 | Foxborough Massachusetts, United States, 02035Site Number - 1026 | Detroit Michigan, United States, 48201Site Number - 1005 | East Lansing Michigan, United States, 48824Site Number - 1018 | Omaha Nebraska, United States, 68198Site Number - 1019 | Totowa New Jersey, United States, 07512Site Number - 1036 | New York New York, United States, 10021Site Number - 1034 | New York New York, United States, 10065Site Number - 1020 | Chapel Hill North Carolina, United States, 27599Site Number - 1013 | Durham North Carolina, United States, 27710Site Number - 1044 | Raleigh North Carolina, United States, 27607Site Number - 1038 | Cincinnati Ohio, United States, 45221Site Number - 1045 | Oklahoma City Oklahoma, United States, 73104Site Number - 1011 | Yukon Oklahoma, United States, 73099Site Number - 1031 | Eugene Oregon, United States, 97477Site Number - 1030 | Charleston South Carolina, United States, 29425Site Number - 1015 | Charleston South Carolina, United States, 29486Site Number - 1021 | Memphis Tennessee, United States, 38120Site Number - 1003 | Dallas Texas, United States, 75206Site Number - 1047 | Denton Texas, United States, 76208Site Number - 1048 | Lubbock Texas, United States, 79414Site Number - 1009 | Charlottesville Virginia, United States, 22903Site Number - 1040 | Richmond Virginia, United States, 23298Site Number - 1035 | Greenfield Wisconsin, United States, 53228Site Number - 5002 | Rosario , Argentina, S2000Site Number - 3201 | Brno , Czechia, 60300Site Number - 3601 | Copenhagen , Denmark, 2177Site Number - 8002 | Tbilisi , Georgia, 0114Site Number - 8003 | Tbilisi , Georgia, 114Site Number - 8001 | Tbilisi , Georgia, 159Site Number - 6502 | Bochum , Germany, 44791Site Number - 6504 | Goettigen , Germany, 37075Site Number - 6505 | Magdeburg , Germany, 39120Site Number - 6503 | Würzburg , Germany, 97070Site Number - 3903 | Athens , Greece, 11528Site Number - 3902 | Athens , Greece, 12462Site Number - 3901 | Pátrai , Greece, 26504Site Number - 3904 | Thessaloniki , Greece, 54642Site Number - 7552 | Budapest , Hungary, 1085Site Number - 7553 | Budapest , Hungary, 1204Site Number - 7551 | Kistarcsa , Hungary, 2143Site Number - 6003 | Bergamo , Italy, 24127Site Number - 6002 | Milan , Italy, 20133Site Number - 6001 | Naples , Italy, 80131Site Number - 6004 | Rome , Italy, 136Site Number - 3005 | Gdansk , Poland, 80-214Site Number - 3001 | Katowice , Poland, 40-689Site Number - 3006 | Krakow , Poland, 31-324Site Number - 3002 | Krakow , Poland, 31-503Site Number - 3003 | Krakow , Poland, 31-505Site Number - 3004 | Lublin , Poland, 20-701Site Number - 3007 | Warsaw , Poland, 01-684Site Number - 7502 | Constanța , Romania, 900348Site Number - 7501 | Târgu Mureş , Romania, 540136Site Number - 9001 | Belgrade , Serbia, 11000Site Number - 9002 | Niš , Serbia, 18000Site Number - 7103 | Barcelona , Spain, 8195Site Number - 7101 | Córdoba , Spain, 14011Site Number - 7104 | Madrid , Spain, 28034Site Number - 7002 | Glasgow , United Kingdom, G51 4TFSite Number - 7004 | London , United Kingdom, WC1N 3BG