Actively Recruiting
A Study to Evaluate the Clinical Outcomes of Efgartigimod PH20 SC in Adults With New-onset Generalized Myasthenia Gravis (gMG)
Led by argenx · Updated on 2026-03-10
30
Participants Needed
18
Research Sites
106 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Evaluate the Clinical Outcomes of Efgartigimod PH20 SC in Adults With New-onset Generalized Myasthenia Gravis (gMG)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years old when signing the informed consent form
- Diagnosed with generalized myasthenia gravis (gMG) of MGFA class II, III, or IV
- Seropositive for acetylcholine receptor antibodies (AChR-Ab)
- Treatment-naive for gMG or previously treated only with acetylcholinesterase inhibitors (AChEI)
- Onset of generalized MG symptoms within 12 months before screening; onset of ocular MG symptoms within 24 months before screening allowed
- MG-ADL score of 5 or higher
You will not qualify if you...
- Diagnosed with gMG of MGFA class I or V
- Had thymectomy before screening, except if performed for nonmalignant thymoma before gMG diagnosis
- Prior or current use of systemic corticosteroids or nonsteroidal immunosuppressive therapy for gMG
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 18 locations
1
University of California, San Diego - Altman Clinical and Translational Research Institute (ACTRI)
La Jolla, California, United States, 92037
Actively Recruiting
2
Samir Macwan, M.D., Inc. (S corporation)
Rancho Mirage, California, United States, 92270
Actively Recruiting
3
EZR Research
Boca Raton, Florida, United States, 33486
Actively Recruiting
4
University of Florida Jacksonville
Jacksonville, Florida, United States, 32209
Actively Recruiting
5
Visionary Investigators Network
Miami, Florida, United States, 33133
Actively Recruiting
6
University of California Irvine
Orange, Florida, United States, 92868
Actively Recruiting
7
Medsol Clinical Research Center Inc
Port Charlotte, Florida, United States, 33952
Actively Recruiting
8
Baycare Medical Group
St. Petersburg, Florida, United States, 33705
Actively Recruiting
9
Emory Brain Health Center
Atlanta, Georgia, United States, 30329
Actively Recruiting
10
The Queen's Medical Center - West Oahu
Honolulu, Hawaii, United States, 96813
Actively Recruiting
11
Hawaii Pacific Neuroscience
Honolulu, Hawaii, United States, 96817
Actively Recruiting
12
HSHS Medical Group
O'Fallon, Illinois, United States, 62269
Actively Recruiting
13
UMass Memorial Medical Center
Worcester, Massachusetts, United States, 01655
Actively Recruiting
14
Henry Ford Health System
Detroit, Michigan, United States, 48202
Actively Recruiting
15
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
16
Erlanger Neuroscience Institute
Chattanooga, Tennessee, United States, 37403
Actively Recruiting
17
Central Texas Neurology Consultants - Elligo
Round Rock, Texas, United States, 78681
Actively Recruiting
18
Center for Neurological Disorders - Greenfield
Greenfield, Wisconsin, United States, 53228-1321
Actively Recruiting
Research Team
S
Sabine Coppieters, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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