Phase 4 Study to Assess Efgartigimod PH20 SC Treatment in Adults with New-Onset Generalized Myasthenia Gravis

What this Trial Is About

Researchers are evaluating how well adults with new-onset generalized myasthenia gravis gMG respond to treatment with efgartigimod PH20 SC. This study focuses on adults who have had generalized disease signs or symptoms for less than one year and aims to assess clinical outcomes during a phase 4, open-label, single-group trial. Participants will receive subcutaneous injections of efgartigimod PH20 SC during a treatment period lasting 51 weeks. The study follows each participant for approximately 58 weeks to monitor their response to the treatment and any changes in their condition over time. During the study, participants will be regularly evaluated using measures like the proportion who achieve minimal symptom expression MSE within the first 16 weeks, changes in MG-ADL and MG-QOL-15r scores over time, and use of systemic corticosteroids as add-on therapy. Researchers will also monitor the incidence of adverse events throughout the study period to assess safety and tolerability.

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