A Phase 3 Study to Evaluate the Efficacy and Safety of Efgartigimod IV in Patients With Acetylcholine Receptor Binding Antibody Seronegative Generalized Myasthenia Gravis
Condition(s) studied
Investigational drug(s) / intervention(s)
Efgartigimod IV: Intravenous infusion of efgartigimod
Placebo IV: Intravenous infusion of placebo
Study summary
The primary purpose of this study is to measure the efficacy and safety of efgartigimod IV compared to placebo in participants with Acetylcholine Receptor Binding Antibody (AChR-Ab) seronegative Generalized Myasthenia Gravis (gMG). The study consists of a Part A where participants will be randomized to receive either efgartigimod IV or placebo IV and a Part B where participants completing part A will receive open-label efgartigimod IV. Participants will be in the study for up to (approximately) 3.5 years.
Eligibility
Primary outcome measure(s)
- MG-ADL Total Score Change From Baseline — Up to 29 days in part A
The Myasthenia Gravis Activities of Daily Living (MG-ADL) scale is an 8-item instrument used to assess MG symptoms and their effects on daily activities. The total score ranges from 0 (no symptoms) to 24 (most severe symptoms).
Trial sites (91)
| Facility | City | Region | Status |
|---|---|---|---|
| HonorHealth Neurology - Bob Bove Neuroscience Institute | Scottsdale | Arizona | |
| Loma Linda University Health | Fresno | California | |
| First Choice Neurology Boca Raton | Boca Raton | Florida | |
| SFM Clinical Research LLC | Boca Raton | Florida | |
| The Neurology Institute / Healthcare Innovations Institute - Coral Springs | Coral Springs | Florida | |
| Neurology Associates PA | Maitland | Florida | |
| Desai Sethi Medical Center | Miami | Florida | |
| Medsol Clinical Research Center Inc | Port Charlotte | Florida | |
| BayCare - St. Anthony's Hospital | St. Petersburg | Florida | |
| University of South Florida (USF) Health - Morsani Center for Advanced Healthcare | Tampa | Florida | |
| Wellstar - Augusta University Medical Center | Augusta | Georgia | |
| Kansas University Medical Center - Kansas City | Fairway | Kansas | |
| Rutgers-Robert Wood Johnson Medical School | New Brunswick | New Jersey | |
| University of North Carolina - Chapel Hill | Chapel Hill | North Carolina | |
| Duke University School of Medicine - Duke Early Phase Clinical Research Unit | Durham | North Carolina | |
| Cleveland Clinic | Cleveland | Ohio | |
| Erlanger Neuroscience Institute | Chattanooga | Tennessee | |
| National Neuromuscular Research Institute | Austin | Texas | |
| University of Washington Medical Center - Montlake | Seattle | Washington | |
| Hôpital Erasme | Anderlecht | Belgium | |
| Cliniques Universitaires Saint-Luc | Brussels | Belgium | |
| AZ Sint-Lucas Gent | Ghent | Belgium | |
| UZ Leuven | Leuven | Belgium | |
| Heritage Medical Research Clinic | Calgary | Canada | |
| Genge Partners Inc. | Montreal | Canada | |
| Ottawa Hospital - Civic Campus | Ottawa | Canada | |
| Xuanwu Hospital Capital Medical University | Beijing | China | |
| The First Hospital of Jilin University | Changchun | China | |
| Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital | Chongqing | China | |
| The First Affiliated Hospital of Chongqing Medical University | Chongqing | China | |
| Fujian Medical University Union Hospital | Fuzhou | China | |
| The First Affiliated Hospital of Guangxi Medical University | Guangxi | China | |
| The First Affiliated Hospital of Guangzhou University Chinese Medicine | Guangzhou | China | |
| Guangdong Province Traditional Chinese Medical Hospital | Guangzhou | China | |
| The Affiliated Hospital of Guizhou Medical University | Guiyang | China | |
| Ningbo Medical Center Lihuili Hospital | Ningbo | China | |
| Qilu Hospital of Shandong University | Qingdao | China | |
| Huashan Hospital Fudan University | Shanghai | China | |
| First Hospital of Shanxi Medical University | Taiyuan | China | |
| Tongji Hospital Tongji Medical College Huazhong University of Science and Technology | Wuhan | China |
+ 51 more sites — see the full list on the official registry below.
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Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06298552 on ClinicalTrials.gov ↗ ← All trials in Poland