Half-Year 2022 Financial and Clinical Trials Update
Ocrevus (ocrelizumab, RG1594)
Humanized monoclonal antibody selectively targeting CD20+ B cells
Indication
Primary progressive multiple sclerosis
(PPMS)
Relapsing multiple sclerosis (RMS)
PPMS & RMS
Roche
Phase/study
# of patients
Design
Primary endpoint
Phase IIIb
GAVOTTE
N-699
120-week treatment period:
▪ ARM A: Ocrevus 600mg IV every 24 weeks
ARM B: Ocrevus 1200mg if body weight
<75kg or 1800mg if body weight > or equal to
75kg every 24 weeks
▪ Superiority of Ocrevus higher dose versus
approved dose on CCDP
"
Phase Illb
MUSETTE
N-786
120-week treatment period:
ARM A: Ocrevus 600mg IV every 24 weeks
ARM B: Ocrevus 1200mg if body weight <75kg or
1800mg if body weight > or equal to 75kg every 24
weeks
"
ARM A: Ocrevus IV
Phase III
Ocarina II¹
ARM B: Ocrevus SC
N-232
Superiority of Ocrevus higher dose versus
approved dose on CCDP
Serum Ocrevus area under the concentration-time
curve (AUCW1-12) at week 12
Status
CT Identifier
FPI Q4 2020
NCT04548999
1SC with Halozyme's rHuPH20/ Halozyme's human hyaluronidase
CCDP-composite confirmed disability progression; IV-intravenous; SC-Subcutaneous
"
FPI Q4 2020
■ Recruitment completed Q4 2021
NCT04544436
FPI Q2 2022
NCT05232825
108
NeuroscienceView entire presentation