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NCT06909214PHASE4Recruiting

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

argenx

Start Date

4/17/2025

Completion Date

5/1/2027

Summary

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

BIOLOGICAL

Efgartigimod PH20 SC

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Conditions

New Onset Generalized Myasthenia Gravis (gMG)

Locations

University of California, San Diego - Altman Clinical and Translational Research Institute (ACTRI)

La Jolla, California 92037

United States

Samir Macwan, M.D., Inc. (S corporation)

Rancho Mirage, California 92270

United States

EZR Research

Boca Raton, Florida 33486

United States

University of Florida Jacksonville

Jacksonville, Florida 32209

United States

Visionary Investigators Network

Miami, Florida 33133

United States

University of California Irvine

Orange, Florida 92868

United States

Medsol Clinical Research Center Inc

Port Charlotte, Florida 33952

United States

Baycare Medical Group

St. Petersburg, Florida 33705

United States

Emory Brain Health Center

Atlanta, Georgia 30329

United States

The Queen's Medical Center - West Oahu

Honolulu, Hawaii 96813

United States

Hawaii Pacific Neuroscience

Honolulu, Hawaii 96817

United States

HSHS Medical Group

O'Fallon, Illinois 62269

United States

UMass Memorial Medical Center

Worcester, Massachusetts 01655

United States

Henry Ford Health System

Detroit, Michigan 48202

United States

Cleveland Clinic

Cleveland, Ohio 44195

United States

Erlanger Neuroscience Institute

Chattanooga, Tennessee 37403

United States

Central Texas Neurology Consultants - Elligo

Round Rock, Texas 78681

United States

Center for Neurological Disorders - Greenfield

Greenfield, Wisconsin 53228-1321

United States