Study population and study design
MYASTHENIA GRAVIS
This analysis was based on pharmacokinetic, pharmacodynamic, and immunogenicity data from the double-blind RCP of the phase 3, multinational CHAMPION MG study of ravulizumab in adults with AChR Ab+ gMG (ClinicalTrials.gov ID: NCT03920293). Details of the study design and clinical efficacy and safety results have been reported elsewhere [In brief, the CHAMPION MG study enrolled 175 patients aged ≥ 18 years who had a diagnosis of AChR Ab+ MG ≥ 6 months before screening, a Myasthenia Gravis–Activities of Daily Living (MG-ADL) total score of ≥ 6 at screening and randomization, and no previous treatment with a complement inhibitor. A total of 86 patients received ravulizumab for 26 weeks and 89 patients received placebo. Intravenous dosing of ravulizumab was based on the patient’s body weight [The current analysis of pharmacokinetic/pharmacodynamic data was performed on the 86 patients who received ravulizumab in the RCP of the CHAMPION MG study.