A Study to Evaluate the Clinical Outcomes of Efgartigimod PH20 SC in Adults With New-onset Generalized Myasthenia Gravis (gMG)
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
Sponsorargenx
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Efgartigimod PH20 SC
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov