Evaluating the Pharmacodynamic Noninferiority of Efgartigimod PH20 SC Administered Subcutaneously as Compared to Efgartigimod Administered Intravenously in Patients With Generalized Myasthenia Gravis
Evaluating the Pharmacodynamic Noninferiority of Efgartigimod PH20 SC Administered Subcutaneously as Compared to Efgartigimod Administered Intravenously in Patients With Generalized Myasthenia Gravis
The purpose of this study is to investigate the Pharmacodynamics (PD), Pharmacokinetics (PK),
 safety, tolerability, immunogenicity, and clinical efficacy of efgartigimod coformulated with
 recombinant human hyaluronidase PH20 (rHuPH20) as compared to efgartigimod IV infused in
 patients with generalized myasthenia gravis (gMG). The study duration is approximately 12
 weeks. After screening, patients will be randomized to receive either efgartigimod infusions
 or efgartigimod PH20 subcutaneously (SC)
Inclusion Criteria:

 Bullet list of each inclusion criterium:

 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 18 years of age at the time of signing the informed consent form.

 3. Diagnosed with generalized Myasthenia Gravis (gMG) with confirmed documentation and
 supported by at least 1 of the following:

 1. History of abnormal neuromuscular transmission demonstrated by single fiber
 electromyography or repetitive nerve stimulation

 2. History of positive edrophonium chloride test

 3. Demonstrated improvement in Myasthenia Gravis (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:

 Bullet list of each exclusion criterium:

 1. Are pregnant or lactating, or intend to become pregnant during the study or within 90
 days after the last dose of Investigational Medicinal Product.

 2. Has any of the following medical conditions:

 1. Clinically significant uncontrolled active or chronic bacterial, viral, or fungal
 infection at screening

 2. Any other known autoimmune disease that, in the opinion of the investigator,
 would interfere with an accurate assessment of clinical symptoms of myasthenia
 gravis or put the participant at undue risk.

 3. History of malignancy unless deemed cured by adequate treatment with no evidence
 of reoccurrence for ≥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).

 4. Clinical evidence of other significant serious diseases, or the participant has
 had a recent major surgery, 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.