RECRUITINGPhase 4INTERVENTIONAL
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
About This Trial
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 May Be Eligible (Plain English)
Who May Qualify:
- 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
Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
BIOLOGICAL
Efgartigimod PH20 SC
Subcutaneous injection of efgartigimod PH20 SC
Locations (18)
University of California, San Diego - Altman Clinical and Translational Research Institute (ACTRI)
La Jolla, California, United States
Samir Macwan, M.D., Inc. (S corporation)
Rancho Mirage, California, United States
EZR Research
Boca Raton, Florida, United States
University of Florida Jacksonville
Jacksonville, Florida, United States
Visionary Investigators Network
Miami, Florida, United States
University of California Irvine
Orange, Florida, United States
Medsol Clinical Research Center Inc
Port Charlotte, Florida, United States
Baycare Medical Group
St. Petersburg, Florida, United States
Emory Brain Health Center
Atlanta, Georgia, United States
The Queen's Medical Center - West Oahu
Honolulu, Hawaii, United States
Hawaii Pacific Neuroscience
Honolulu, Hawaii, United States
HSHS Medical Group
O'Fallon, Illinois, United States
UMass Memorial Medical Center
Worcester, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
Cleveland Clinic
Cleveland, Ohio, United States
Erlanger Neuroscience Institute
Chattanooga, Tennessee, United States
Central Texas Neurology Consultants - Elligo
Round Rock, Texas, United States
Center for Neurological Disorders - Greenfield
Greenfield, Wisconsin, United States