Half-Year 2022 Financial and Clinical Trials Update
Ocrevus (ocrelizumab, RG1594)
Humanized monoclonal antibody selectively targeting CD20+ B cells
Indication
Relapsing and primary progressive multiple sclerosis (RMS & PPMS)
Primary progressive multiple sclerosis (PPMS)
Phase/study
# of patients
Design
Phase Illb
ENSEMBLE PLUS
Phase IIIb
ORATORIO-HAND
N=1,225
•
• Substudy of ongoing phase IIIb, open-label, single-arm ENSEMBLE study
Shorter two-hour infusion time
120-week treatment period:
☐
ARM A: Ocrevus 600mg IV q24w
☐
ARM B: Placebo
N - 1000
Primary endpoint
Status
.
Safety, measured by the proportion of patients with IRRs following the first
randomised 600 mg infusion (frequency/severity assessed during and 24-
hours post infusion)
• Filed in US and EU Q1 2020
• Approved in EU Q2 2020 and US Q4 2020
• Data published Neurol, Neuroimmunol and Neuroinflamm Sept 2020; 7(5),
e807
Time to upper limb disability progression confirmed for at least 12 weeks
FPI Q3 2019
CT Identifier
IV-intravenous; IRR=Infusion Related Reaction
NCT03085810
NCT04035005
107
Roche
NeuroscienceView entire presentation