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
NCT02649218 (CQGE031C2201E1)
Chronic spontaneous urticaria / Chronic idiopathic urticaria
Phase 2
Patients
226
Long-term safety; number of participants with treatment-emergent adverse events
NCT03580356 Pearl 2 (CQGE031C2303)
Chronic spontaneous urticarial / Chronic idiopathic urticaria?
Phase 3
1050
Absolute change from baseline in UAS7 (Urticaria Activity Score) at week 12
Primary Outcome
Measures
Arms Intervention
Target Patients
Ligelizumab 240 mg q4wks open label for 52 weeks
Adult patients with chronic spontaneous urticaria inadequately controlled with H1-
antihistamines at approved or increased doses, alone or in combination with H2-
antihistamines or leukotriene receptor antagonists.
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
Read-out Milesstone(s)
2019 (actual)
Publication
82 Investor Relations | Q3 2021 Results
Manuscript: Primary results extension trial (Allergy), H2 2021
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
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