Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Eculizumab in Chinese Adults With gMG

Inclusion Criteria

• •Diagnosis of MG must be made by the following tests:
• •1. Positive serologic test for anti-AChR Abs as confirmed at Screening, and
• •2. One of the following:
• •1. Abnormal neuromuscular transmission demonstrated by repetitive nerve stimulation, or
• •2. History of positive anticholinesterase test, eg, neostigmine test, or
• •3. Participant has demonstrated improvement in MG signs on oral cholinesterase inhibitors as assessed by the treating physician
• •MGFA Clinical Classification Class II to IV at Screening
• •MG-ADL total score must be ≥ 6 at Screening and Day 1
• •Participants who have:
• •1. Failed treatment with 2 or more ISTs over one year (either in combination or as monotherapy), ie, continue to have impairment ADLs (persistent weakness, experience crisis, or unable to tolerate IST) despite ISTs or,
• •2. Failed at least one IST and require chronic PE or IVIg to control symptoms, ie, participants who require PE or IVIg on a regular basis for the management of muscle weakness at least 2 cycles over last 12 months
• •1. Treatment completed \> 5 years prior to the Screening Visit
• •2. No recurrence within the 5 years prior to the Screening Visit
• •3. No radiological indication of recurrence in a computed tomography (CT) or magnetic resonance imaging (MRI) scan, including administration of intravenous (IV) contrast, performed within 6 months of first dose on Day 1
• •Weakness only affecting ocular or peri-ocular muscles (MGFA Class I)
• •MG crisis at Screening (MGFA Class V). However, such participants may be rescreened with Alexion approval once they are treated and medically stable, in the opinion of the Investigator
• •History of N meningitidis infection or unresolved meningococcal disease