A Study to Evaluate the Clinical Outcomes of Efgartigimod PH20 SC in Adults With New-onset Generalized Myasthenia Gravis (gMG)

Recruiting now · Phase 4

Conditions studied: New Onset Generalized Myasthenia Gravis (gMG)

In brief

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.

Key facts

Study ID

NCT06909214

Run by

argenx

People needed

30

Starts

2025-04-17

Expected to finish

2027-05-01

Last updated by the study team

2026-03-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of California, San Diego - Altman Clinical and Translational Research Institute (ACTRI) — La Jolla, California, United States (enrolling)
• Samir Macwan, M.D., Inc. (S corporation) — Rancho Mirage, California, United States (enrolling)
• EZR Research — Boca Raton, Florida, United States (enrolling)
• University of Florida Jacksonville — Jacksonville, Florida, United States (enrolling)
• Visionary Investigators Network — Miami, Florida, United States (enrolling)
• University of California Irvine — Orange, Florida, United States (enrolling)
• Medsol Clinical Research Center Inc — Port Charlotte, Florida, United States (enrolling)
• Baycare Medical Group — St. Petersburg, Florida, United States (enrolling)
• Emory Brain Health Center — Atlanta, Georgia, United States (enrolling)
• The Queen's Medical Center - West Oahu — Honolulu, Hawaii, United States (enrolling)
• Hawaii Pacific Neuroscience — Honolulu, Hawaii, United States (enrolling)
• HSHS Medical Group — O'Fallon, Illinois, United States (enrolling)
• UMass Memorial Medical Center — Worcester, Massachusetts, United States (enrolling)
• Henry Ford Health System — Detroit, Michigan, United States (enrolling)
• Cleveland Clinic — Cleveland, Ohio, United States (enrolling)
• Erlanger Neuroscience Institute — Chattanooga, Tennessee, United States (enrolling)
• Central Texas Neurology Consultants - Elligo — Round Rock, Texas, United States (enrolling)
• Center for Neurological Disorders - Greenfield — Greenfield, Wisconsin, United States (enrolling)

Full record on ClinicalTrials.gov

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