Q4 2021 Results
Participants
Financial performance
Company overview
Pharmaceuticals
Oncology
Financial review
Conclusion
Appendix
Innovation: Pipeline overview
Innovation: Clinical trials
CRM
IHD
Neuroscience
Ophthalmology
Respiratory & Allergy
Oncology: Solid Tumors
Hematology
Biosimilars
Global Health
Abbreviations
ligelizumab
-
IgE inhibitor
Study
Indication
Phase
Patients
Primary Outcome
Measures
Arms Intervention
Target Patients
Read-out Milestone(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 (actual)
Past publications: Study design presented at UCARE 2018
Manuscripts
- Primary results. PEARL 1/2 pooled data. NEJM or Lancet. H2-2022 - H1-2023 (Dec 2022
or Jan 2023)
Congress publications
- EADV 2022: Late breaking abstract on primary results (efficacy, safety). H2-2022 as a
first publication in Europe
- ACAAI 2022: Primary results (efficacy, safety). H2-2022 as a first publication in the USA
- AAAAI 2023: secondary results. H1-2023
- AAD 2023: secondary results. H1-2023
NCT03580356 Pearl 2 (CQGE031C2303)
Chronic spontaneous urticarial / Chronic idiopathic urticaria?
Phase 3
1079
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 (actual)
Past publications: Study design presented at UCARE 2018
Manuscripts
- Primary results. PEARL 1/2 pooled data. NEJM or Lancet. H2-2022 - H1-2023 (Dec 2022
or Jan 2023)
Congress publications
- EADV 2022: Late breaking abstract on primary results (efficacy, safety). H2-2022 as a
first publication in Europe
- ACAAI 2022: Primary results (efficacy, safety). H2-2022 as a first publication in the USA
- AAAAI 2023: secondary results. H1-2023
- AAD 2023: secondary results. H1-2023
88 Investor Relations | Q4 2021 Results
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