Q3 2021 Investor Relations Results
Participants
Company overview
Pharmaceuticals
Oncology
Financial review
Conclusion
Appendix
References
Financial performance
Innovation: Pipeline overview
Innovation: Clinical trials
Neuroscience
Ophthalmology
Respiratory & Allergy
Oncology: Solid Tumors
Hematology
Biosimilars
Global Health
Abbreviations
CRM
IHD
ligelizumab - IgE inhibitor
Study
Indication
Phase
Patients
Primary Outcome
Measures
Arms Intervention
Target Patients
Read-out Milesstone(s)
Publication
NCT03580369 Pearl 1 (CQGE031C2302)
Chronic spontaneous urticaria
Phase 3
1050
Absolute change from baseline in UAS7 (Urticaria Activity Score) at week 12
Ligelizumab dose A q4w for 52 weeks
Ligelizumab dose B q4w for 52 weeks
Omalizumab 300 mg q4w for 52 weeks
Placebo q4w from randomization to wk20, then ligelizumab dose B from wk24 to
wk52
Adolescents and adults with chronic spontaneous urticaria inadequately controlled
with H1-antihistamines
H2-2021 (Q4/2021-Q1/2022 potential COVID impact)
Past publications: Study design presented at UCARE 2018
Congress: primary results EADV 2022 (H2 2022) or AAAAI 2023
Manuscript: primary results, Journal (TBD), 2023
NCT04210843 (CQGE031C2302E1)
Chronic spontaneous urticaria
Phase 3
800
The proportion of subjects with well-controlled disease (UAS7 ? 6) at week 12
Ligelizumab Dose 1 and 3
Ligelizumab Dose 2 and 3
Patients who completed studies CQGE031C2302, CQGE031C2303,
CQGE031C2202 or CQGE031C1301
2026
Study design presented at 2020 EAACI
83 Investor Relations | Q3 2021 Results
1 NOVARTIS | Reimagining MedicineView entire presentation