BACKGROUND: B cells may be involved in the pathophysiology of multiple sclerosis 
(MS). Inebilizumab (formerly MEDI-551) binds to and depletes CD19+ B cells.
OBJECTIVES: To assess safety, tolerability, pharmacokinetics, pharmacodynamics 
and immunogenicity of inebilizumab in adults with relapsing MS.
METHODS: This phase 1 trial randomised 28 patients 3:1 (21, inebilizumab; 7, 
placebo) to inebilizumab (2 intravenous (IV) doses, days 1 and 15: 30, 100 or 
600 mg; or single subcutaneous (SC) dose on day 1: 60 or 300 mg) or matching 
placebo, with follow-up until at least week 24 or return of CD19+ B-cell count 
to ⩾80 cells/µL.
RESULTS: Complete B-cell depletion was observed across all doses. 
Infusion/injection (grade 1/2) reactions occurred in 6/15 patients receiving 
inebilizumab IV, 2/5 placebo IV and 1/6 inebilizumab SC. Serious adverse events 
occurred in three patients receiving inebilizumab: pyrexia, mixed-drug 
intoxication (unrelated to inebilizumab; resulted in death) and urinary tract 
infection. Mean number of cumulative new gadolinium-enhancing lesions over 
24 weeks was 0.1 with inebilizumab versus 1.3 with placebo; mean numbers of 
new/newly enlarging T2 lesions were 0.4 and 2.4, respectively.
CONCLUSION: Inebilizumab had an acceptable safety profile in relapsing MS 
patients and showed a trend in reductions in new/newly enlarging and 
gadolinium-enhancing lesions.