A Study to Evaluate the Efficacy and Safety of IGIV-C in Symptomatic Subjects With Generalized Myasthenia Gravis
A Study to Evaluate the Efficacy and Safety of IGIV-C in Symptomatic Subjects With Generalized Myasthenia Gravis
The primary objective is to evaluate whether IGIV-C improves MG symptoms as compared to
 placebo in subjects with MG.
The primary objective is to evaluate the efficacy of IGIV-C in subjects with generalized
 myasthenia gravis (MG) on standard of care treatment at study entry in terms of improvement
 in MG symptoms as measured by the mean change in Quantitative Myasthenia Gravis (QMG) score
 from Baseline (Week 0) to Week 24 as compared to placebo.

 The safety objective of this study is to evaluate the safety and tolerability of IGIV-C
 loading dose of 2 g/kg followed by 7 maintenance dosages of 1 g/kg every 3 weeks through Week
 21 in subjects with MG.
Inclusion Criteria:

 -  Anti-acetylcholine receptor (AChR) antibody positive

 -  Confirmed diagnosis of generalized myasthenia gravis (MG).

 -  Myasthenia Gravis Foundation of America (MGFA) classification of Class II, III, or IVa
 inclusive at Screening.

 -  QMG >= 10 at Screening. Note: Subjects who only have a history of ocular MG may not
 enroll.

 -  Receiving standard of care MG treatment at a stable dose consisting of any one of the
 following for the time intervals delineated below (time intervals apply to medications
 and maintenance of stable dose level):

 1. Cholinesterase inhibitor (pyridostigmine or equivalent) for at least 2 weeks
 prior to Screening and no immunosuppressants

 2. Cholinesterase inhibitor (pyridostigmine or equivalent) for at least 2 weeks
 prior to Screening AND/OR only one of the following:

 1. Prednisone (up to 60 mg/day or equivalent) for at least 2 months prior to
 Screening, OR

 2. Azathioprine for at least 6 months prior to Screening, OR

 3. Mycophenolate mofetil for at least 6 months prior to Screening, OR

 4. Methotrexate for at least 6 months prior to Screening, OR

 5. Cyclosporine or tacrolimus for at least 3 months prior to Screening

 3. Cholinesterase inhibitor (pyridostigmine or equivalent) for at least 2 weeks
 prior to Screening AND/OR prednisone (up to 60 mg/day or equivalent) for at least
 one month prior to Screening and only one of the following:

 1. Azathioprine for at least 6 months prior to Screening, OR

 2. Mycophenolate mofetil for at least 6 months prior to Screening, OR

 3. Methotrexate for at least 6 months prior to Screening, OR

 4. Cyclosporine or tacrolimus for at least 3 months prior to Screening

 Exclusion Criteria:

 -  Have received cyclophosphamide or any other immunosuppressive agent apart from the
 ones allowed per inclusion criteria within the past 6 months

 -  Any change in MG treatment regimen between Screening (Week -3, Visit 0) and Baseline
 (Week 0, Visit 1)

 -  Greater than two point change in QMG score, increased or decreased, between Screening
 (Week -3, Visit 0) and Baseline (Week 0, Visit 1)

 -  Any episode of myasthenic crisis in the one month prior to Screening

 -  Evidence of malignancy within the past 5 years (non-melanoma skin cancer, carcinoma in
 situ of cervix is allowed) or thymoma potentially requiring surgical intervention
 during the course of the trial (intent to perform thymectomy)

 -  Thymectomy within the preceding 6 months

 -  Rituximab, belimumab, eculizumab or any monoclonal antibody used for immunomodulation
 within the past 12 months

 -  Have received immune globulin (Ig) treatment given by intravenous (IV), subcutaneous,
 or intramuscular route within the last 3 months

 -  Current known hyperviscosity or hypercoagulable state

 -  Currently receiving anti-coagulation therapy (vitamin K antagonists, nonvitamin K
 antagonist oral anticoagulants [e.g., dabigatran etexilate, rivaroxaban, edoxaban, and
 apixaban], parenteral anticoagulants [e.g., fondaparinux]). Note that oral
 anti-platelet agents are allowed (e.g., aspirin, clopidogrel, ticlodipine)

 -  Documented diagnosis of thrombotic complications to polyclonal intravenous
 immunoglobulin (IVIg) therapy in the past

 -  History of recent (within the last year) myocardial infarction or stroke

 -  Uncontrolled congestive heart failure; embolism; or historically documented (within
 the last year) electrocardiogram (ECG) changes indicative of myocardial ischemia or
 atrial fibrillation

 -  History of chronic alcoholism or illicit drug abuse (addiction) in the 12 months
 preceding the Screening/Week -3 (Visit 0)

 -  Plasma exchange (PLEX) performed within the last 3 months

 -  Renal impairment (i.e., serum creatinine exceeds more than 1.5 times the upper limit
 of normal [ULN] for the expected normal range for the testing laboratory).

 -  Hemoglobin levels less than 9 g per dL