Status:
RECRUITING
A Study to Evaluate the Clinical Outcomes of Efgartigimod PH20 SC in Adults With New-onset Generalized Myasthenia Gravis (gMG)
Lead Sponsor:
argenx
Conditions:
New Onset Generalized Myasthenia Gravis (gMG)
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 efgar...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 17 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06909214
Start Date
April 17 2025
End Date
May 1 2027
Last Update
January 8 2026
Active Locations (17)
Enter a location and click search to find clinical trials sorted by distance.
1
University of California, San Diego - Altman Clinical and Translational Research Institute (ACTRI)
La Jolla, California, United States, 92037
2
Samir Macwan, M.D., Inc. (S corporation)
Rancho Mirage, California, United States, 92270
3
EZR Research
Boca Raton, Florida, United States, 33486
4
University of Florida Jacksonville
Jacksonville, Florida, United States, 32209