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efgartigimod administration

Phase 3

Myasthaenia Gravis | Small molecule | Other |argenx SE|Last Updated: Jul 29, 2025

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
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment30
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06765161Efgartigimod in IVIG Dependent Myasthenia Gravis PatientsPHASE3 RECRUITING 30 — — Feb 6, 2025Jan 6, 2027Jul 29, 20251 Canada
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Study Endpoints
Primary Endpoints
MG-ADL
a sustained decrease persistent for at least 4 consecutive weeks over the 26 week period

The percentage of patients who do not experience, at any time during the study, a 2 or more-point deterioration from their averaged baseline MG-ADL score that is sustained for a period of 4 or more consecutive weeks. (stable or improved patients)

Secondary Endpoints
QMG
those who experience a sustained decrease for 4 consecutive weeks during the 26 week period
MGQOL
during the whole study period of 26 weeks
incidence of patients who are still receiving efgartigimod by the end of the 26 weeks
for the duration of the 26 week study
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
treatmentEXPERIMENTALEfgartigimod infusion
Interventions
NameTypeDescription
efgartigimod administrationDRUGefgartigimod infusion
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Eligibility Criteria
Age Range18 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * 1\. Signed informed consent. 2. Age 18-80 years 3. Acetylcholine receptor antibody positive, myasthenia gravis patients, with stable disease for the past four or more months. Stable disease is defined as no change in dosage or interval in IVIG treatments and without any signif...

Countries:Canada
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT06765161studyFirstPostDate: changed