Patients and trial designs
The peripheral B cell count data were obtained from two randomized, double-blind, placebo-controlled Phase 1 studies (MI-CP200 [Study CP200] and CD-IA-MEDI-551-1102 [Study 1102]) and one multicenter, double‑blind, randomized, placebo‑controlled Phase 2/3 study (N-MOmentum). Summary of all clinical studies and the descriptive statistics of baseline categorical and continuous covariates are listed in Table 2 and Table 3, respectively.
Each Phase 1 study involved with 28 adult subjects with either Systemic Sclerosis who had at least moderate skin thickening in an area suitable for repeat biopsy (Study CP200) or with relapsing forms of Multiple Sclerosis (Study 1102). Subjects with Systemic Sclerosis were administered with single intravenous dose (0.1, 0.3, 1.0, 3.0, and 10.0 mg kg -1) of inebilizumab or placebo; subjects with relapsing Multiple Sclerosis were either administered with two doses of inebilizumab (30, 100, or 600 mg) or placebo on Day 1 and 15 intravenously or administered a single dose of inebilizumab (60 or 300 mg) or placebo subcutaneously.
In a Phase 2/3 study (N-MOmentum), comprised of a randomized controlled period (RCP) with an open-label extension period (OLP), a total of 230 adult subjects with NMOSD were intravenously administered inebilizumab (300 mg) or placebo on study Day 1 and 15 in the RCP. Subjects who experienced an Adjudication Committee (AC) determined attack in the RCP, or who completed the Day 197 visit without an attack, exited the RCP and had the option to enroll into the OLP, and initiate or continue treatment with inebilizumab. The trial design schematic is shown in Figure 1.