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
Status: Recruiting
Location: See all (12) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 4
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• 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
Locations
United States
California
University of California, San Diego - Altman Clinical and Translational Research Institute (ACTRI)