Q2 2021 Results - Reimagining Medicine
Participants
Company overview
Pharmaceuticals
Oncology
Financial review
Conclusion
Appendix
References
Financial performance
Innovation: Pipeline overview
Innovation: Clinical trials
CRM
IHD
Neuroscience
Oncology
Ophthalmology
Respiratory
Sandoz Biopharmaceuticals
Global Health
Abbreviations
LOU064 - Bruton's tyrosine kinase (BTK) inhibitor
Study
Indication
Phase
Patients
Primary Outcome
Measures
Arms Intervention
NCT03926611 (CLOU064A2201)
Chronic spontaneous urticaria (CSU)
Phase 2
308
Change from baseline in weekly Urticaria Activity Score (UAS7) at Week 4
Arm 1 Low dose of LOU064 orally in the morning (once daily) and matching placebo
in the evening from Day 1 to 85
Arm 2 Medium dose of LOU064 orally in the morning (once daily) and matching
placebo in the evening from Day 1 to 85
Arm 3 High dose of LOU064 orally in the morning (once daily) and matching
placebo in the evening from Day 1 to 85
Arm 4 Low dose of LOU064 orally, twice daily from Day 1 to 85
Arm 5 Medium dose of LOU064 orally, twice daily from Day 1 to 85
Arm 6 High dose of LOU064 orally, twice daily from Day 1 to 85
Placebo arm Matching placebo, orally, twice daily from Day 1 to 85
Adults with CSU inadequately controlled by H1-antihistamines
H2-2021
Target Patients
Read-out Milesstone(s)
Publication
H2-2021
NCT04109313 (CLOU064A2201E1)
Chronic spontaneous urticaria (CSU)
Phase 2
250
Long-term safety and tolerability
Selected dose of LOU064 taken orally twice a day (morning and evening) from day
1 to week 52
Patients with CSU who have participated in preceding studies with LOU064
2022
TBD
82 Investor Relations | Q2 2021 Results
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