Sanofi and Regeneron Pharmaceuticals have announced the commencement of patient enrollment in two Phase 3 rheumatoid arthritis (RA) trials, the COMPARE and ASCERTAIN trials, with Sarilumab.
The first fully human monoclonal antibody Sarilumab is directed against the IL-6 receptor and delivered by subcutaneous injection every other week.
Regeneron Laboratories president and Regeneron chief scientific officer George Yancopoulos said, "The COMPARE trial will explore whether these patients would be better served by switching to a different mechanism of action, IL-6 inhibition, rather than administering another TNF-alpha inhibitor."
The SARIL-RA clinical development programme is comprised of the following five trials SARIL-RA MOBILITY, SARIL-RA TARGET, SARIL-RA COMPARE, SARIL-RA ASCERTAIN, and an open-label extension trial, SARIL-RA EXTEND.
SARIL-RA programme is focused on adult populations with moderate-to-severe RA who inadequately respond to either methotrexate (MTX) or tumour necrosis factor alpha (TNF-alpha) inhibitor therapy in approximately 2,600 patients.
The multi-centre, randomised SARIL-RA ASCERTAIN trial will evaluate the safety and tolerability of sarilumab and tocilizumab, both in combination with MTX.
The double-blind, active-control SARIL-RA COMPARE trial will assess the safety and efficacy of sarilumab plus MTX compared to etanercept (a TNF-alpha inhibitor) plus MTX
The primary endpoint of the ASCERTAIN study is safety while Disease Activity Score 28 based on C-reactive protein (DAS28-CRP) at 24 weeks is the primary endpoint of COMPARE trial.
