A Study to Evaluate the Clinical Outcomes of Efgartigimod PH20 SC in Adults With New-onset
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 a
| Condition(s) | New Onset Generalized Myasthenia Gravis (gMG) |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional |
| Summary | 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. |
| Who can participate | 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 |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | argenx |
| Locations | La Jolla, California, United States; Rancho Mirage, California, United States; Boca Raton, Florida, United States; Jacksonville, Florida, United States; Miami, Florida, United States; Orange, Florida, United States (+12 more sites) |
| Start date | 2025-04-17 |
| NCT ID | NCT06909214 |
| Official listing | https://clinicaltrials.gov/study/NCT06909214 |