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A Study to Evaluate the Clinical Outcomes of Efgartigimod PH20 SC in Adults With New-onset Generalized Myasthenia Gravis (gMG)
A Phase 4, Open-Label, Prospective, Single-Group, Multicenter Study to Evaluate the Clinical Outcomes of Efgartigimod PH20 SC in Adult Participants With New-Onset Generalized Myasthenia Gravis
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
About the 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.
What is being tested
- Efgartigimod PH20 SC (biological)
Sponsor: argenx · Participants: 30 · Started: Apr 17, 2025
Contact the study team
- Sabine Coppieters, MD · Phone: 857-350-4834
Official record on ClinicalTrials.gov — NCT06909214
Locations in the U.S.
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.