Q3 2022 Results
Company overview
Financial performance
Cardiovascular
Financial review
2022 priorities
Appendix
Innovation: Pipeline overview
Innovation: Clinical trials
Immunology
Neuroscience
Oncology
remibrutinib - BTK inhibitor
NCT05030311 REMIX-1 (CLOU064A2301)
Chronic spontaneous urticaria
Phase 3
Indication
Phase
Patients
450
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
2024
Read-out
Milestone(s)
Publication
TBD
58 Investor Relations | Q3 2022 Results
remibrutinib - BTK inhibitor
NCT05032157 REMIX-2 (CLOU064A2302)
Chronic spontaneous urticaria
Phase 3
Indication
Phase
Patients
450
Primary
Outcome
Measures
Arms
Intervention
Target Patients
References
Abbreviations
Other
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
Read-out
Milestone(s)
Publication
2024
Primary 2025
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