A Study to Evaluate the Clinical Outcomes of Efgartigimod PH20 SC in Adults With New-onset Generalized Myasthenia Gravis (gMG)
Purpose
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.
Condition
- New Onset Generalized Myasthenia Gravis (gMG)
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 4
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Efgartigimod PH20 SC |
Participants receiving efgartigimod PH20 SC |
|
Recruiting Locations
University of California, San Diego - Altman Clinical and Translational Research Institute (ACTRI)
La Jolla 5363943, California 5332921 92037
La Jolla 5363943, California 5332921 92037
Samir Macwan, M.D., Inc. (S corporation)
Rancho Mirage 5386015, California 5332921 92270
Rancho Mirage 5386015, California 5332921 92270
EZR Research
Boca Raton 4148411, Florida 4155751 33486
Boca Raton 4148411, Florida 4155751 33486
University of Florida Jacksonville
Jacksonville 4160021, Florida 4155751 32209
Jacksonville 4160021, Florida 4155751 32209
University of California Irvine
Orange 4167034, Florida 4155751 92868
Orange 4167034, Florida 4155751 92868
Medsol Clinical Research Center Inc
Port Charlotte 4169130, Florida 4155751 33952
Port Charlotte 4169130, Florida 4155751 33952
Baycare Medical Group
St. Petersburg 4171563, Florida 4155751 33705
St. Petersburg 4171563, Florida 4155751 33705
Emory Brain Health Center
Atlanta 4180439, Georgia 4197000 30329
Atlanta 4180439, Georgia 4197000 30329
Hawaii Pacific Neuroscience
Honolulu 5856195, Hawaii 5855797 96817
Honolulu 5856195, Hawaii 5855797 96817
HSHS Medical Group
O'Fallon 4245926, Illinois 4896861 62269
O'Fallon 4245926, Illinois 4896861 62269
UMass Memorial Medical Center
Worcester 4956184, Massachusetts 6254926 01655
Worcester 4956184, Massachusetts 6254926 01655
Henry Ford Health System
Detroit 4990729, Michigan 5001836 48202
Detroit 4990729, Michigan 5001836 48202
Visionary Investigators Network
Princeton 5102922, New Jersey 5101760 08540
Princeton 5102922, New Jersey 5101760 08540
Cleveland Clinic
Cleveland 5150529, Ohio 5165418 44195
Cleveland 5150529, Ohio 5165418 44195
Erlanger Neuroscience Institute
Chattanooga 4612862, Tennessee 4662168 37403
Chattanooga 4612862, Tennessee 4662168 37403
Central Texas Neurology Consultants - Elligo
Round Rock 4724129, Texas 4736286 78681
Round Rock 4724129, Texas 4736286 78681
More Details
- Status
- Recruiting
- Sponsor
- argenx