RecruitingNew Onset Generalized Myasthenia Gravis (gMG)

A Study to Evaluate the Clinical Outcomes of Efgartigimod PH20 SC in Adults With New-onset Generalized Myasthenia Gravis (gMG)

Eligible age

18+ yrs

Accepts

All genders

Locations

11 states

Healthy volunteers

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About this study

The main purpose of this study is to measure how well adults with new-onset gMG (which means they've had generalized disease signs and/or symptoms for less than 1 year) respond to treatment with efgartigimod PH20 SC. The study consists of a treatment period of 51 weeks. The study duration for each participant will be approximately 58 weeks.

Sponsor: argenx

You may qualify if…

✓ Is at least 18 years when signing the ICF
✓ Has been diagnosed with gMG of MGFA class II, III, or IV
✓ Is seropositive for AChR-Ab
✓ Is treatment-naive for gMG or has been administered AChEI for the treatment of gMG
✓ Had onset of generalized MG signs and/or symptoms within 12 months before screening; candidates who also had onset of ocular MG signs and/or symptoms within 24 months before screening may be enrolled in the study
✓ Has an MG-ADL score ≥5

You may not qualify if…

✕ gMG diagnosis of MGFA class I or V
✕ Underwent a thymectomy prior to screening, except thymectomy for treatment of nonmalignant thymoma prior to the gMG diagnosis
✕ Prior or current use of any of any systemic corticosteroid therapy or nonsteroidal immunosuppressive therapy for the treatment of gMG