Generalized Myasthenia Gravis MedDRA version: 21.1 Level: PT Classification code 10028417 Term: Myasthenia gravis System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Name: efgartigimod
Product Code: [argx-113]
Pharmaceutical Form: Concentrate for solution for injection/infusion
INN or Proposed INN: EFGARTIGIMOD ALFA
CAS Number: 1821402-21-4
Current Sponsor
Sponsors
ARGENX BV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The participant completed ARGX-113-2006, defined as: a. The participant reached EoT 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 IP visits within the ARGX-113-2006 trial's timeframe (ie, between TPnV1 to IPnV4). 2. Either the participant or the participant's legally acceptable representative (LAR) can understand the requirements of the trial and provide written informed consent/assent (including consent/assent for the use and disclosure of research-related health information), and demonstrates a willingness and ability to comply with the trial protocol procedures (including attending the required trial visits). 3. Contraceptive use by males and females must be consistent with local regulations for those participating in clinical trials and: a. Male participants agree not to donate sperm from the time the informed consent form (ICF) is signed until the end of the trial. b. Female adolescents of childbearing potential (FAOCBP; defined in Section 10.4.1.1 of the protocol ) must have a negative urine pregnancy test at trial entry (TP1V1 or IP0V1). The contraceptive requirements for male participants are described in Section 10.4.2.2. The contraceptive requirements for FAOCBP are described in Section 10.4.2.1. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Participants are excluded from the trial if any of the following criteria apply: 1. FAOCBP: 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: a. 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 |
|---|---|
| Main Objective: To evaluate the safety and tolerability of efgartigimod e.v.;Secondary Objective: To evaluate the immunogenicity of efgartigimod IV;Primary end point(s): - Incidence and severity of adverse events (AEs) - Incidence and severity of serious adverse events (SAEs) - Incidence and severity of adverse events of special interest (AESIs) - Changes in laboratory test results, vital signs, height and weight, and electrocardiogram (ECG) results;Timepoint(s) of evaluation of this end point: Once a month | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Incidence and prevalence of antidrug antibodies (ADAs) against efgartigimod;Timepoint(s) of evaluation of this end point: No specific timepoints, during the entire study | — |
Countries
Austria, Belgium, Canada, France, Georgia, Germany, Italy, Netherlands, Poland, Spain, United Kingdom, United States
Contacts
Public ContactRegulatory
argenx BV
Outcome results
None listed