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
QGE031 - Anti-IgE
Study
Indication
Phase
NCT03580356 PEARL 2 (CQGE031C2303)
Chronic spontaneous urticaria
Phase 3
Patients
Primary Outcome
1050
Absolute change from baseline in UAS7 (Urticaria Activity Score) at week 12
Measures
Arms Intervention
Ligelizumab dose A q4w for 52 weeks
Ligelizumab dose B q4w for 52 weeks
Target Patients
Read-out Milesstone(s)
Publication
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
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
84 Investor Relations | Q2 2021 Results
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