Half-Year 2022 Financial and Clinical Trials Update
Actemra/RoActemra (tocilizumab, RG-1569)
Interleukin 6 receptor inhibitor
Indication
Phase/study
# of patients
Design
Phase III
COVACTA¹
N=450
ARM A: Actemra plus standard of care
◉
ARM B: Placebo plus standard of care
Adult hospitalised with severe COVID-19 pneumonia
Phase III
REMDACTA²
ARM A: Remdesivir plus Actemra
ARM B: Remdesivir plus placebo
N=650
Primary endpoint
◉
-
Clinical status assessed using 7-Category Ordinal Scale (Day 28)
FPI Q1 2020
Recruitment completed Q2 2020
Primary endpoint not met Q3 2020
Status
☐
Published in NEJM 2021; 384:1503-1516
Time to hospital discharge or ready for discharge
■ FPI Q2 2020
Recruitment completed Q1 2021
Primary endpoint not met Q1 2021
Published in Intensive Care Med 2021 doi: 10.1007/s00134-021-06507-x
CT Identifier
NCT04320615
Filed in EU Q3 2021
Approved in EU Q4 2021
In collaboration with US Biomedical Advanced Research and Development Authority (BARDA); 2In collaboration with Gilead Sciences, Inc.
NEJM-New England Journal of Medicine
NCT04409262
115
Roche
ImmunologyView entire presentation