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IMVT-1402

Phase 3

Generalized Myasthenia Gravis | Small molecule | Neurology |Immunovant, Inc.|Last Updated: May 22, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment231
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07039916Study to Assess the Efficacy and Safety of IMVT-1402 in Participants With Mild to Severe Generalized Myasthenia GravisPHASE3 RECRUITING 231May 27, 2025Dec 1, 2028May 22, 202683 United States, Argentina +12
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Study Endpoints
Primary Endpoints
Change from Baseline in MG-ADL Score for Antibody-positive Participants
Baseline to Week 12
Secondary Endpoints
Change from Baseline in Quantitative Myasthenia Gravis (QMG) Score for Antibody-positive Participants
Baseline to Week 12
Percentage of Antibody-positive Participants Achieving MG-ADL Score of 0 or 1
Week 12
Percentage of Antibody-positive Participants with ≥50% Improvement in MG-ADL Score
Baseline to Week 12
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Group 1: IMVT-1402 Dose 1EXPERIMENTAL -
Group 2: IMVT-1402 Dose 2EXPERIMENTAL -
Placebo/ IMVT-1402PLACEBO_COMPARATOR -
Interventions
NameTypeDescription
IMVT-1402DRUG• Dose 1 subcutaneous (SC) once weekly (QW) for 12 weeks (Period 1)
PlaceboDRUG• Placebo SC QW for 12 weeks (Period 1)
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Eligibility Criteria
Age Range18 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites83

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 th...

Countries:United StatesArgentinaCzechiaDenmarkGeorgiaGermanyGreeceHungaryItalyPolandRomaniaSerbiaSpainUnited Kingdom
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07039916primaryCompletionDate: changed
LOWMay 24, 2026NCT07039916studyFirstPostDate: changed