A Long-term, Single-Arm, Open-label, Multicenter, Follow-on Trial of ARGX-113-2006 to Evaluate Safety of Efgartigimod Administered Intravenously in Children With Generalized Myasthenia Gravis
- Conditions
- Generalized Myasthenia GravisgMG10003816
- Registration Number
- NL-OMON53506
- Lead Sponsor
- Argenx BVBA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 2
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Safety and tolerability of efgartigimod (IV)</p><br>
- Secondary Outcome Measures
Name Time Method <p>Immunogenicity of efgartigimod (IV).</p><br>