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

RecruitingPhase 4Ages 18 Years - anyAllargenx
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ5 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
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What it tests

  • Efgartigimod PH20 SC
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Where

18 sites
University of California, San Diego - Altman Clinical and Translational Research Institute (ACTRI)
La Jolla, United States
Samir Macwan, M.D., Inc. (S corporation)
Rancho Mirage, United States
EZR Research
Boca Raton, United States
University of Florida Jacksonville
Jacksonville, United States
Visionary Investigators Network
Miami, United States
University of California Irvine
Orange, United States
Medsol Clinical Research Center Inc
Port Charlotte, United States
Baycare Medical Group
St. Petersburg, United States

โ€ฆand 10 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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