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

Launched by ARGENX · Mar 27, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called efgartigimod PH20 SC for adults who have recently been diagnosed with generalized myasthenia gravis (gMG), a condition that affects the muscles and can cause weakness. The main goal is to see how well this treatment works over a period of 51 weeks. Participants in the trial will be involved for about 58 weeks in total.

To be eligible for the study, participants must be at least 18 years old and have been diagnosed with gMG within the last year. They also need to have specific antibodies (AChR-Ab) in their blood and have a certain level of muscle weakness, as measured by a score. However, people with certain types of gMG or those who have had specific surgeries or treatments for the condition before may not qualify. This trial is not yet recruiting participants, so it’s still in the early planning stages. If you or someone you know might fit these criteria, it could be a potential opportunity to help advance treatment for gMG.

Gender

ALL

Eligibility 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