Generalized Myasthenia Gravis gMG
Conditions
Interventions
Intravenous infusion with efgartigimod. This consists of 4 weekly infusions per
Treatment period.
Sponsors
Argenx BVBA
Eligibility
Age
2 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. The participant completed ARGX-113-2006, defined as: a. The participant reached EoT (End of Trial) in trial ARGX-113-2006 and agreed to participate in the ARGX-113-2008 trial. b. The participant qualifies for retreatment in trial ARGX-113-2006, but cannot complete a Treatment Period (TP) and the required Intertreatment Period visits within the ARGX-113-2006 trial's timeframe
Exclusion criteria
Exclusion criteria: 1. Female Adolescents Of Child Bearing Potential: Pregnancy or lactation, or the participant intends to become pregnant during the trial or within 90 days after the last dose of investigational medicinal product (IMP) 2. Discontinued early from ARGX-113-2006 treatment due to: pregnancy, receiving prohibited medication, participating in another trial with an investigational product, or the occurrence of a life-threatening or an investigational medicinal product-related AE, as assessed by the investigator 3. A known hypersensitivity reaction to efgartigimod or any of its excipients 4. Received a live-attenuated vaccine fewer than 4 weeks before trial entry. 5. Any of the following medical conditions: Clinically significant uncontrolled chronic bacterial, viral, or fungal infection at trial entry b. Any other known autoimmune disease that, in the opinion of the investigator, would interfere with accurate assessment of clinical symptoms of gMG or put the participant at undue risk
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability of efgartigimod (IV) | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunogenicity of efgartigimod (IV). | — |
Countries
Netherlands
Outcome results
None listed