Subjects
In a randomized, double-blind, placebo-controlled Phase 2/3 trial (N-MOmentum), 56 subjects with NMOSD received intravenous infusions of placebo and 174 subjects received inebilizumab (300 mg) on study Day 1 and 15 in the randomized controlled period (RCP, Figure 1). To aid the pharmacodynamic evaluation, peripheral CD20+ B cell count data from two dosing-ranging Phase 1 studies in inebilizumab-treated subjects with Systemic Sclerosis (n=24) or Multiple Sclerosis (n=15) were pooled with that in subjects with NMOSD for population PD modeling. Overview of studies and descriptive statistics of baseline demographics of these subjects are summarized in Tables 1 and 2, respectively.