Testing Efgartigimod for generalized myasthenia gravis

Exclusion

• −A known hypersensitivity reaction to efgartigimod or any of its excipients.
• −a. Positive serum test at screeningScreeningThe checks done before joining, to see whether a study fits.Read more → for an active viral infection with any of the following conditions: Hepatitis B virus (HBV) that is indicative of an acute or chronic infection; Hepatitis C virus (HCV) based on HCV antibody assay; Positive HIV serology at screening; Positive nasopharyngeal swab polymerase chain reaction (PCR) test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at screening.
• −Participants with MGFA class I, IVb, and V.
• −Has any of the following medical conditions:
• −Clinically significant uncontrolled active or chronic bacterial, viral, or fungal infection at screening.
• −Any other known autoimmune disease that, in the opinion of the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →, would interfere with an accurate assessment of clinical symptoms of myasthenia gravis or put the participant at undue risk.
• −History of malignancy unless deemed cured by adequate treatment with no evidence of recurrence for ≥3 years before the first administration of 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
• −Worsening muscle weakness secondary to concurrent infections or medications (aminoglycosides, fluoro-quinolones, beta-blockers, etc).
• −A documented lack of clinical response to plasma exchange (PLEX).
• −Received a live or live-attenuated vaccine fewer than 28 days before screening. Receiving an inactivated, subunit, polysaccharide, or conjugate vaccine any time before screening is not exclusionary.
• −Received a thymectomy \<3 months before screening or 1 is planned to be performed during the trial period.
• −The following results from these diagnostic assessments will be considered exclusionary:
• −Using the following prior or concomitant therapies: Use of an investigational product within 3 months or 5 half-lives (whichever is longer) before the first dose of IMP, Use of any monoclonal antibody within the 6 months before the first dose of IMP, Use of intravenous immunoglobulin (IVIg), administered subcutaneously or intramuscularly, or PLEX within 4 weeks before screening.
• −Total immunoglobulin (IgG) levels \<6 g/L below the lower limit of normal (LLN) according to the reference ranges of the central laboratory for participant by sex and age at screening.
• −Current participation in another interventionalInterventional studyA study where participants are given something to see what happens.Read more → clinical trial or previous participation in an efgartigimod trial with at least 1 dose of IMP received.
• −History (within 12 months of screening) of current alcohol, drug, or medication abuse as assessed by the investigator.
• −Female adolescents of childbearing potential: Pregnancy or lactation, or the participant intends to become pregnant during the trial or within 90 days after the last dose of IMP.
• −Clinical evidence of other significant serious diseases, or have had a recent major surgery, or who have any other condition that, in the opinion of the investigator, could confound the results of the trial or put the participant at undue risk