Procedures
6‐week, ®
The study included a screening period of 3 weeks to evaluate eligibility, a 6‐week double‐blind, placebo‐controlled treatment period, an OLE treatment period of 6 weeks, and a follow‐up period of 6 weeks (Fig. Anti‐AChR antibody levels were quantitated from serum samples. Specific assays that were used were the Acetylcholine Receptor Autoantibody (AChRAb) RIA Assay Kit (KRONUS, Star, ID, USA) for AChR antibodies, and the Optilite® immunoturbidimetric assay for IgG subclasses (The Binding Site Group Ltd., Birmingham, United Kingdom), both at Quest Diagnostics, San Juan Capistrano, CA, USA. The immunoturbidimetric immunoglobulin assay (F. Hoffmann‐La Roche Ltd., Basel, Switzerland) at Eurofins Central Lab, Lancaster, PA, USA was used for total IgG quantification.Serum compound concentration–time data were analyzed via noncompartmental methods using Phoenix WinNonlin version 8.1 (Certera, Princeton, NJ, USA). PK parameters for batoclimab assessed in the study included area under the serum concentration−time curve (AUCPD assessments included serum IgG, IgG subclasses (1–4), and anti‐AChR concentrations, summarized as both raw values and percentage change from baseline (intra‐patient assessment). Clinical efficacy was assessed using the MG Activities of Daily Living (MG‐ADL) score (range 0–24),