A Study to Evaluate the Clinical Outcomes of Efgartigimod PH20 SC in Adults With New-onset Generalized Myasthenia Gravis (gMG)
NCT ID: NCT06909214
Last Updated: 2026-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
30 participants
INTERVENTIONAL
2025-04-17
2027-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Efgartigimod PH20 SC
Participants receiving efgartigimod PH20 SC
Efgartigimod PH20 SC
Subcutaneous injection of efgartigimod PH20 SC
Interventions
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Efgartigimod PH20 SC
Subcutaneous injection of efgartigimod PH20 SC
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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argenx
INDUSTRY
Responsible Party
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Locations
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University of California, San Diego - Altman Clinical and Translational Research Institute (ACTRI)
La Jolla, California, United States
Samir Macwan, M.D., Inc. (S corporation)
Rancho Mirage, California, United States
EZR Research
Boca Raton, Florida, United States
University of Florida Jacksonville
Jacksonville, Florida, United States
University of California Irvine
Orange, Florida, United States
Medsol Clinical Research Center Inc
Port Charlotte, Florida, United States
Baycare Medical Group
St. Petersburg, Florida, United States
Emory Brain Health Center
Atlanta, Georgia, United States
The Queen's Medical Center - West Oahu
Honolulu, Hawaii, United States
Hawaii Pacific Neuroscience
Honolulu, Hawaii, United States
HSHS Medical Group
O'Fallon, Illinois, United States
UMass Memorial Medical Center
Worcester, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
Visionary Investigators Network
Princeton, New Jersey, United States
Cleveland Clinic
Cleveland, Ohio, United States
Erlanger Neuroscience Institute
Chattanooga, Tennessee, United States
Central Texas Neurology Consultants - Elligo
Round Rock, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ARGX-113-2407
Identifier Type: -
Identifier Source: org_study_id
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