Q3 2023 Results
Company overview
Financial review
Conclusions
Innovation: Pipeline overview
Financial performance
Cardiovascular
Immunology
remibrutinib - BTK inhibitor
Indication
Phase
NCT05147220 REMODEL-1 (CLOU064C12301)
Multiple sclerosis
Phase 3
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
Arms
Intervention
Arm 1: Experimental; Remibrutinib - Core (Remibrutinib tablet and matching
placebo of teriflunomide capsule)
Arm 2: Active Comparator; Teriflunomide - Core (Teriflunomide capsule and
matching placebo remibrutinib tablet)
Appendix
Innovation: Clinical trials
Neuroscience
Oncology
Target
Patients
Readout
Milestone(s)
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
Publication
TBD
64 Investor Relations | Q3 2023 Results
remibrutinib - BTK inhibitor
NCT05156281 REMODEL-2 (CLOU064C12302)
Multiple sclerosis
Phase 3
Indication
Phase
Patients
800
Primary
Outcome
References
Annualized relapse rate (ARR) of confirmed relapses
Abbreviations
Other
Measures
Arms
Intervention
Target
Patients
Arm 1: Experimental; Remibrutinib - Core
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
Readout
Milestone(s)
Publication
TBD
NOVARTIS | Reimagining MedicineView entire presentation