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
NCT05030311 REMIX-1 (CLOU064A2301)
Chronic spontaneous urticaria
Indication
Phase
Phase 3
Patients
470
Primary
Outcome
Measures
Arms
Intervention
Target Patients
Change from baseline in UAS7 (Scenario 1 with UAS7 as primary efficacy
endpoint)
Arm 1: LOU064 (blinded)
LOU064 (blinded) taken orally for 24 weeks, followed by LOU064 (open-label)
taken orally open label for 28 weeks. Randomized in a 2:1 ratio (arm 1:arm 2)
Arm 2: LOU064 placebo (blinded)
LOU064 placebo (blinded) taken orally for 24 weeks, followed by LOU064 (open-
label) taken orally for 28 weeks. Randomized in a 2:1 ratio (arm 1:arm 2)
Adult Chronic Spontaneous Urticaria (CSU) patients inadequately controlled by
H1-antihistamines
Readout
Milestone(s)
2024 (Final)
Publication
TBD
□ NOVARTIS Reimagining Medicine
remibrutinib - BTK inhibitor
NCT05032157 REMIX-2 (CLOU064A2302)
Indication
Phase
Chronic spontaneous urticaria
Phase 3
Patients
455
Primary
Outcome
Measures
Arms
Intervention
Target Patients
Readout
Milestone(s)
1. Change from baseline in UAS7 (Scenario 1 with UAS7 as primary efficacy
endpoint)
2. Absolute change in ISS7 an absolute change in HSS7 (Scenario 2 with ISS7
and HSS7 as co-primary efficacy endpoints)
Arm 1: LOU064 (blinded)
LOU064A (blinded) taken orally b.i.d. for 24 weeks, followed by LOU064
(open-label) taken orally open label for 28 weeks
Arm 2: LOU064 placebo (blinded)
LOU064A placebo (blinded) taken orally for 24 weeks, followed by LOU064 (open-
label) taken orally open label for 28 weeks
Eligible participants randomized to the treatment arms in a 2:1 ratio (arm 1: arm 2)
Adult participants suffering from chronic spontaneous urticaria (CSU) inadequately
controlled by H1-antihistamines in comparison to placebo
2024 (Final)
Publication
TBD
Novartis Q4 Results | January 31, 2024
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