Q1 2022 Results
Company overview
Financial performance
CRM
Financial review
Immunology
Neuroscience
2022 priorities
Innovation: Pipeline overview
Ophthalmology
Appendix
References
Innovation: Clinical trials
Abbreviations
Respiratory & Allergy
Oncology: Solid Tumors
Hematology
Biosimilars
Global Health
remibrutinib - BTK inhibitor
Study
Indication
Phase
Patients
Primary Outcome
Measures
Arms Intervention
NCT05030311 REMIX-1 (CLOU064A2301)
Chronic spontaneous urticaria (CSU)
Phase 3
450
1. Change from baseline in UAS7 (Scenario 1 with UAS7 as primary efficacy
endpoint)
2. Absolute change in ISS7 and absolute change in HSS7 (Scenario 2 with ISS7 and
HSS7 as co-primary efficacy endpoints)
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 participants suffering from chronic spontaneous urticaria (CSU) inadequately
controlled by H1-antihistamines in comparison to placebo
Target Patients
Read-out Milestone(s)
Publication
2024
TBD
NCT05032157 REMIX-2 (CLOU064A2302)
Chronic spontaneous urticaria (CSU)
Phase 3
450
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. Randomised in 2:1 ratio (active vs
placebo)
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. Randomised in 2:1 ratio (active vs
placebo)
Adult participants suffering from chronic spontaneous urticaria (CSU) inadequately
controlled by H1-antihistamines in comparison to placebo
2024
TBD
67 Investor Relations | Q1 2022 Results
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