Evaluating the Pharmacodynamic Noninferiority of Efgartigimod PH20 SC Administered Subcutaneously as Compared to Efgartigimod Administered Intravenously in Patients With Generalized Myasthenia Gravis
Condition: Generalized Myasthenia Gravis
MeSH terms: Myasthenia Gravis; Muscle Weakness
Intervention: efgartigimod PH20 SC; efgartigimod IV
Intervention description: Subcutaneous injection with efgartigimod PH20 SC; Intravenous infusion of efgartigimod
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 110.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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)
    

Eligibility criteria:

        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.