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A Study to Evaluate the Clinical Outcomes of Efgartigimod PH20 SC in Adults With New-onset Generalized Myasthenia Gravis (gMG)
Sponsor: argenx
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2025-04-17
Completion Date
2027-05
Last Updated
2026-03-10
Healthy Volunteers
No
Interventions
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