Novartis Q4 Results
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remibrutinib - BTK inhibitor
Company overview
Financial review
Conclusions
Appendix
Innovation: Pipeline overview
Financial performance
Innovation: Clinical trials
Cardiovascular, Renal
and Metabolic
Immunology
> Neuroscience
Oncology
Other
Global Health
Abbreviations
References
remibrutinib - BTK inhibitor
NCT05147220 REMODEL-1 (CLOU064C12301)
Multiple sclerosis
Indication
Phase
Phase 3
Patients
800
Primary
Outcome
Measures
Arms
Intervention
Target Patients
Annualized relapse rate (ARR) of confirmed relapses [Core Part]. ARR is the
average number of confirmed MS relapses in a year
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
NCT05156281 REMODEL-2 (CLOU064C12302)
Indication
Multiple sclerosis
Phase
Phase 3
Patients
800
Primary
Outcome
Measures
Arms
Intervention
Annualized relapse rate (ARR) of confirmed relapses
Target Patients
Readout
Milestone(s)
Publication
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
TBD
□ NOVARTIS Reimagining Medicine
Novartis Q4 Results | January 31, 2024
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