Q1 2022 Results slide image

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 NOVARTIS | Reimagining Medicine
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