Q1 2023 Results
Company overview
Innovation: Pipeline overview
Cardiovascular
Financial review
Conclusions
Financial performance
Immunology
remibrutinib - BTK inhibitor
Appendix
Innovation: Clinical trials
Neuroscience
Oncology
remibrutinib - BTK inhibitor
Indication
NCT05030311 REMIX-1 (CLOU064A2301)
Chronic spontaneous urticaria
Indication
NCT05032157 REMIX-2 (CLOU064A2302)
Chronic spontaneous urticaria
Phase
Phase 3
Phase
Phase 3
Patients
450
Patients
450
Primary
Outcome
Change from baseline in UAS7 (Scenario 1 with UAS7 as primary efficacy
endpoint)
Measures
Primary
Outcome
Measures
Arms
Intervention
Target
Patients
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
62 Investor Relations | Q1 2023 Results
Arms
Intervention
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
2024 (Final)
Target
Patients
Readout
Milestone(s)
Publication
TBD
1 NOVARTIS | Reimagining MedicineView entire presentation