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

Last updated: March 9, 2026
Sponsor: argenx
Overall Status: Active - Recruiting

Phase

4

Condition

Polymyositis (Inflammatory Muscle Disease)

Neuropathy

Sarcopenia

Treatment

Efgartigimod PH20 SC

Clinical Study ID

NCT06909214
ARGX-113-2407
  • Ages > 18
  • All Genders

Study 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

Inclusion

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 monthsbefore screening may be enrolled in the study

  • Has an MG-ADL score ≥5

Exclusion

Exclusion Criteria:

  • gMG diagnosis of MGFA class I or V

  • Underwent a thymectomy prior to screening, except thymectomy for treatment ofnonmalignant thymoma prior to the gMG diagnosis

  • Prior or current use of any of any systemic corticosteroid therapy or nonsteroidalimmunosuppressive therapy for the treatment of gMG

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: Efgartigimod PH20 SC
Phase: 4
Study Start date:
April 17, 2025
Estimated Completion Date:
May 31, 2027

Connect with a study center

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

    La Jolla, California 92037
    United States

    Active - Recruiting

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

    Rancho Mirage, California 92270
    United States

    Active - Recruiting

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

    La Jolla 5363943, California 5332921 92037
    United States

    Site Not Available

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

    Rancho Mirage 5386015, California 5332921 92270
    United States

    Site Not Available

  • EZR Research

    Boca Raton, Florida 33486
    United States

    Active - Recruiting

  • University of Florida Jacksonville

    Jacksonville, Florida 32209
    United States

    Active - Recruiting

  • Visionary Investigators Network

    Miami, Florida 33133
    United States

    Active - Recruiting

  • University of California Irvine

    Orange, Florida 92868
    United States

    Active - Recruiting

  • Medsol Clinical Research Center Inc

    Port Charlotte, Florida 33952
    United States

    Active - Recruiting

  • Baycare Medical Group

    St. Petersburg, Florida 33705
    United States

    Active - Recruiting

  • EZR Research

    Boca Raton 4148411, Florida 4155751 33486
    United States

    Site Not Available

  • University of Florida Jacksonville

    Jacksonville 4160021, Florida 4155751 32209
    United States

    Site Not Available

  • University of California Irvine

    Orange 4167034, Florida 4155751 92868
    United States

    Site Not Available

  • Medsol Clinical Research Center Inc

    Port Charlotte 4169130, Florida 4155751 33952
    United States

    Site Not Available

  • Baycare Medical Group

    St. Petersburg 4171563, Florida 4155751 33705
    United States

    Site Not Available

  • Emory Brain Health Center

    Atlanta, Georgia 30329
    United States

    Active - Recruiting

  • Emory Brain Health Center

    Atlanta 4180439, Georgia 4197000 30329
    United States

    Site Not Available

  • Hawaii Pacific Neuroscience

    Honolulu, Hawaii 96817
    United States

    Active - Recruiting

  • The Queen's Medical Center - West Oahu

    Honolulu, Hawaii 96813
    United States

    Active - Recruiting

  • Hawaii Pacific Neuroscience

    Honolulu 5856195, Hawaii 5855797 96817
    United States

    Active - Recruiting

  • The Queen's Medical Center - West Oahu

    Honolulu 5856195, Hawaii 5855797 96813
    United States

    Site Not Available

  • HSHS Medical Group

    O'Fallon, Illinois 62269
    United States

    Active - Recruiting

  • HSHS Medical Group

    O'Fallon 4245926, Illinois 4896861 62269
    United States

    Site Not Available

  • UMass Memorial Medical Center

    Worcester, Massachusetts 01655
    United States

    Active - Recruiting

  • UMass Memorial Medical Center

    Worcester 4956184, Massachusetts 6254926 01655
    United States

    Site Not Available

  • Henry Ford Health System

    Detroit, Michigan 48202
    United States

    Active - Recruiting

  • Henry Ford Health System

    Detroit 4990729, Michigan 5001836 48202
    United States

    Site Not Available

  • Visionary Investigators Network

    Princeton 5102922, New Jersey 5101760 08540
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • Cleveland Clinic

    Cleveland 5150529, Ohio 5165418 44195
    United States

    Site Not Available

  • Erlanger Neuroscience Institute

    Chattanooga, Tennessee 37403
    United States

    Active - Recruiting

  • Erlanger Neuroscience Institute

    Chattanooga 4612862, Tennessee 4662168 37403
    United States

    Site Not Available

  • Central Texas Neurology Consultants - Elligo

    Round Rock, Texas 78681
    United States

    Active - Recruiting

  • Central Texas Neurology Consultants - Elligo

    Round Rock 4724129, Texas 4736286 78681
    United States

    Site Not Available

  • Center for Neurological Disorders - Greenfield

    Greenfield, Wisconsin 53228-1321
    United States

    Active - Recruiting

  • Center for Neurological Disorders - Greenfield

    Greenfield 5255068, Wisconsin 5279468 53228-1321
    United States

    Site Not Available

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