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

A Phase 4, Open-Label, Prospective, Single-Group, Multicenter Study to Evaluate the Clinical Outcomes of Efgartigimod PH20 SC in Adult Participants With New-Onset Generalized Myasthenia Gravis

Phase 4 Interventional argenx · NCT06909214

This study is testing a new treatment called efgartigimod PH20 SC to see if it helps adults who have recently been diagnosed with generalized myasthenia gravis feel better.

Quick facts

PhasePhase 4
Study typeInterventional
Enrollment30 (estimated)
Ages18 Years and up
SexAll
Sponsorargenx Industry-sponsored
Locations18 sites (La Jolla, California and 17 other locations)
Trial IDNCT06909214 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have been diagnosed with gMG of MGFA class II, III, or IV and are seropositive for AChR-Ab.

Not a fit: Patients with a diagnosis of MGFA class I or V, those who have undergone thymectomy prior to screening, or those who have used systemic corticosteroids or immunosuppressive therapy for gMG will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the management and outcomes for patients with new-onset generalized myasthenia gravis.

How similar studies have performed: While this specific approach may be novel, similar studies evaluating treatments for generalized myasthenia gravis have shown promising results.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

La Jolla, California and 17 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions New Onset Generalized Myasthenia Gravis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.