Evaluating Efgartigimod PH20 SC in Adults with New-onset Generalized Myasthenia Gravis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the clinical outcomes of efgartigimod PH20 SC in adults diagnosed with new-onset generalized myasthenia gravis (gMG), specifically those who have experienced symptoms for less than one year. Participants will undergo a treatment period lasting 51 weeks, with the overall study duration for each individual being approximately 58 weeks. The study focuses on treatment-naive patients or those who have only received AChEI therapy for gMG. The effectiveness of the treatment will be measured through various clinical outcomes.

Why it matters

Who can join: the full rules

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

Where it's running

• University of California, San Diego - Altman Clinical and Translational Research Institute (ACTRI)
  La Jolla, California, United States Recruiting
• Samir Macwan, M.D., Inc. (S corporation)
  Rancho Mirage, California, United States Recruiting
• EZR Research
  Boca Raton, Florida, United States Recruiting
• University of Florida Jacksonville
  Jacksonville, Florida, United States Recruiting
• Visionary Investigators Network
  Miami, Florida, United States Recruiting
• University of California Irvine
  Orange, Florida, United States Recruiting

Study contacts

• Study coordinator: Sabine Coppieters, MD
• Email: clinicaltrials@argenx.com
• Phone: 857-350-4834

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.