A Study to Evaluate the Clinical Outcomes of Efgartigimod PH20 SC in Adults With New-onset Generalized Myasthenia Gravis (gMG)
argenx · NCT06909214
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18+ · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 4
- Target enrollment
- 30
- US sites recruiting
- 18
- Study start
- April 17, 2025
- Record last updated
- March 10, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study 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.
Being studied: Efgartigimod PH20 SC
Conditions: New Onset Generalized Myasthenia Gravis (gMG)
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
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
Recruiting US locations
University of California, San Diego - Altman Clinical and Translational Research Institute (ACTRI)
La Jolla, CA 92037
Site contact: Wali Qayoumi, MD · 857-350-4834 · clinicaltrials@argenx.com
Samir Macwan, M.D., Inc. (S corporation)
Rancho Mirage, CA 92270
Site contact: Samir Macwan, MD · 857-350-4834 · clinicaltrials@argenx.com
EZR Research
Boca Raton, FL 33486
Site contact: Patricio Espinosa Prado, MD · 857-350-4834 · clinicaltrials@argenx.com
University of Florida Jacksonville
Jacksonville, FL 32209
Site contact: Michael Pulley, MD · 857-350-4834 · clinicaltrials@argenx.com
Visionary Investigators Network
Miami, FL 33133
Site contact: Andrew Lerman, MD · 857-350-4834 · clinicaltrials@argenx.com
University of California Irvine
Orange, FL 92868
Site contact: Ali Habib, MD · 857-350-4834 · clinicaltrials@argenx.com
Medsol Clinical Research Center Inc
Port Charlotte, FL 33952
Site contact: George Li, MD · 857-350-4834 · clinicaltrials@argenx.com
Baycare Medical Group
St. Petersburg, FL 33705
Site contact: Michael Rosario-Prieto, MD · 857-350-4834 · clinicaltrials@argenx.com
Emory Brain Health Center
Atlanta, GA 30329
Site contact: Vita Kesner, MD · 857-350-4834 · clinicaltrials@argenx.com
The Queen's Medical Center - West Oahu
Honolulu, HI 96813
Site contact: Jeffrey Miles, MD · 857-350-4834 · clinicaltrials@argenx.com
Hawaii Pacific Neuroscience
Honolulu, HI 96817
Site contact: Natalia Gonzalez Caldito, MD · 857-350-4834 · clinicaltrials@argenx.com
HSHS Medical Group
O'Fallon, IL 62269
Site contact: Raghav Govindarajan, MD · 857-350-4834 · clinicaltrials@argenx.com
UMass Memorial Medical Center
Worcester, MA 01655
Site contact: Shivkumar Bhadola, MD · 857-350-4834 · clinicaltrials@argenx.com
Henry Ford Health System
Detroit, MI 48202
Site contact: Kavita Grover, MD · 857-350-4834 · clinicaltrials@argenx.com
Cleveland Clinic
Cleveland, OH 44195
Site contact: Yuebing Li, MD · 857-350-4834 · clinicaltrials@argenx.com
Erlanger Neuroscience Institute
Chattanooga, TN 37403
Site contact: Joshua Alpers, MD · 857-350-4834 · clinicaltrials@argenx.com
Central Texas Neurology Consultants - Elligo
Round Rock, TX 78681
Site contact: Adam Horvit, MD · 857-350-4834 · clinicaltrials@argenx.com
Center for Neurological Disorders - Greenfield
Greenfield, WI 53228-1321
Site contact: Bhupendra Khatri, MD · 857-350-4834 · clinicaltrials@argenx.com
Study contacts (from the official record)
- Sabine Coppieters, MD · 857-350-4834 · clinicaltrials@argenx.com