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.