Q4 2022 Results
Company overview
Innovation: Pipeline overview
Cardiovascular
Financial review
Immunology
remibrutinib - BTK inhibitor
2023 priorities
Innovation: Clinical trials
Neuroscience
Oncology
remibrutinib - BTK inhibitor
Appendix
Abbreviations
Other
NCT05147220 REMODEL-1 (CLOU064C12301)
Indication
Multiple sclerosis
Indication
NCT05156281 REMODEL-2 (CLOU064C12302)
Multiple sclerosis
Phase
Phase 3
Phase
Phase 3
Patients
800
Patients
800
Primary
Outcome
Measures
Annualized relapse rate (ARR) of confirmed relapses [Core Part]. ARR is the
average number of confirmed MS relapses in a year
Primary
Annualized relapse rate (ARR) of confirmed relapses
Outcome
Measures
Arms
Intervention
Arm 1: Experimental; Remibrutinib - Core (Remibrutinib tablet and matching
placebo of teriflunomide capsule)
Arms
Arm 1: Experimental; Remibrutinib - Core
Intervention
Arm 2: Active Comparator; Teriflunomide - Core (Teriflunomide capsule and
matching placebo remibrutinib tablet)
Target
Patients
Arm 3: Experimental; Remibrutinib - Extension (Participants on remibrutinib in
Core will continue on remibrutinib tablet)
Arm 4: Experimental; Remibrutinib - Extension (on teriflunomide in Core)
(Participants on teriflunomide in Core will switch to remibrutinib tablet)
Patients with relapsing Multiple Sclerosis
Estimated primary completion 2026
Readout
Milestone(s)
Publication
TBD
79 Investor Relations | Q4 2022 Results
Remibrutinib tablet and matching placebo of teriflunomide capsule
Arm 2: Active Comparator; Teriflunomide - Core
Teriflunomide capsule and matching placebo remibrutinib tablet
Arm 3: Experimental: Remibrutinib - Extension
Participants on remibrutinib in Core will continue on remibrutinib tablet
Arm 4: Experimental: Remibrutinib - Extension (on teriflunomide in Core)
Participants on teriflunomide in Core will switch to remibrutinib tablet
Patients with relapsing Multiple Sclerosis
Estimated primary completion 2026
Target
Patients
Readout
Milestone(s)
Publication
TBD
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