Generalized Myasthenia Gravis (gMG)
Conditions
Interventions
Subcutaneous administration of Efgartigimod PH20 SC or intravenous administration of ARGX-113 once a week
Sponsors
Matsuura Yuji
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Must be capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. 2. At least 20 years of age at the time of signing the ICF. 3. Diagnosed with gMG with confirmed documentation and supported by at least 1 of the following: a. History of abnormal neuromuscular transmission demonstrated by single fiber electromyography or repetitive nerve stimulation b. History of positive edrophonium chloride test c. Demonstrated improvement in MG signs upon treatment with oral acetylcholinesterase (AChE) inhibitors as assessed by the treating physician 4. Meeting the clinical criteria as defined by the Myasthenia Gravis Foundation of America (MGFA) class II, III, IVa, or IVb
Exclusion criteria
Exclusion criteria: 1. Are pregnant or lactating, or intend to become pregnant during the study or within 90 days after the last d ose of IMP. 2. Has any of the following medical conditions: a. Clinically significant uncontrolled active or chronic bacterial, viral, or fungal infection at screening b. Any other known autoimmune disease that, in the opinion of the investigator, would interfere with an ac curate assessment of clinical symptoms of myasthenia gravis or put the participant at undue risk c. History of malignancy unless deemed cured by adequate treatment with no evidence of reoccurrence f or >=3 years before the first administration of the IMP. Participants with the following cancers can be included at any time: - adequately treated basal cell or squamous cell skin cancer - carcinoma in situ of the cervix - carcinoma in situ of the breast - incidental histological findings of prostate cancer (TNM Classification of Malignant Tumors stage T1a or T1b). d. Clinical evidence of other significant serious diseases, or the participant has had a recent major surger y, or who have any other condition that, in the opinion of the investigator, could confound the results of the study or put the participant at undue risk.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent reduction from baseline in total IgG levels at day 29, ie, 7 days after the fourth IV or SC administration | — |
Countries
Belgium, Bosnia and Herzegovina, Czech Republic, Georgia, Germany, Hungary, Italy, Japan, Netherlands, Poland, Russia, Serbia, Spain, the UK, the US
Contacts
Public ContactYuji Matsuura
PPD-SNBL K.K.
Outcome results
None listed