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efgartigimod administration

Phase 3

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

Target and mechanism

Molecular targetFCGRT
Target classAntagonist
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

efgartigimod administration · 1 trial · 1 indication

Phase 3 1
NCT06765161Efgartigimod in IVIG Dependent Myasthenia Gravis PatientsMyasthaenia Gravis
RECRUITING30 Analytics
PHASE3RECRUITING
Efgartigimod in IVIG Dependent Myasthenia Gravis Patients
Myasthaenia GravisUnlock trial analytics

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 to 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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Frequently asked questions about efgartigimod administration

What is efgartigimod used for in Myasthenia Gravis?

Efgartigimod is being studied for the treatment of Myasthenia Gravis, specifically in patients who are dependent on intravenous immunoglobulin (IVIG) therapy. It is an investigational therapy currently in Phase 3 clinical development for this condition.

Who is developing efgartigimod?

Efgartigimod is being developed by argenx SE, a biopharmaceutical company traded on the NASDAQ under the ticker symbol ARGX. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Myasthenia Gravis.

What phase is efgartigimod in?

Efgartigimod is currently in Phase 3 clinical development for Myasthenia Gravis. It is an investigational drug and has not yet been approved by regulatory authorities. The ongoing Phase 3 trial is actively recruiting participants.

What clinical trials is efgartigimod in?

Efgartigimod is being evaluated in a Phase 3 clinical trial with the identifier NCT06765161. This trial, titled 'Efgartigimod in IVIG Dependent Myasthenia Gravis Patients,' is recruiting participants in Canada and aims to enroll 30 patients aged 18 years and older.

Is efgartigimod the same as efgartigimod alfa?

Efgartigimod is the drug name used in the clinical trial for IVIG-dependent Myasthenia Gravis patients. The trial does not specify alternative names, so it is not confirmed whether efgartigimod is the same as efgartigimod alfa.