Q4 2021 Results
Participants
Company overview
Pharmaceuticals
Oncology
Financial review
Conclusion
Appendix
Financial performance
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
NCT05024058 PEARL-PROVOKE (CQGE031E12301)
CINDU
Phase 3
438
1. Change from baseline in Total Fric Score in participants with symptomatic
dermographism
Arm 1: Experimental Ligelizumab low dose, symptomatic dermographism group
Arm 2: Experimental Ligelizumab high dose, symptomatic dermographism
Arm 3: Placebo Comparator. Placebo SC q4W, symptomatic dermographism
Arm 4: Experimental Ligelizumab low dose, cold urticaria
Arm 5: Experimental Ligelizumab high dose, cold urticaria
Arm 6: Placebo Comparator: Placebo SC q4w, cold urticaria
Arm 7: Experimental Ligelizumab high dose, cholinergic urticaria
Arm 8: Placebo Comparator: Placebo SC q4w, cholinergic urticaria
Adolescents and adults with chronic inducible urticaria who remain symptomatic
despite treatment with H1- Antihistamines
Target Patients
Read-out Milestone(s)
Publication
2024
TBD
NCT04984876 PEANUT (CQGE031G12301)
Food allergy
Phase 3
486
1. Proportion of participants who can tolerate a single dose of ≥ 600 mg (1044 mg
cumulative tolerated dose) of peanut protein without dose-limiting symptoms at
Week 12
Arm 1: Experimental igelizumab 240 mg subcutaneous injection for 52 weeks
Arm 2: Experimental ligelizumab 120 mg subcutaneous injection for 52 weeks
Arm 3: Experimental Placebo 8 weeks and ligelizumab 120 mg
Arm 4: Placebo subcutaneous injection for first 8 weeks and ligelizumab 120 mg
subcutaneous injection for 44 weeks
Arm 5: Experimental Placebo 16 weeks and ligelizumab 120 mg/240 mg
subcutaneous injection for 36 weeks
Arm 6: Experimental Placebo 8 weeks and ligelizumab 240 mg subcutaneous
injection for 44 weeks
Participants with a medically confirmed diagnosis of IgE-mediated peanut allergy
2025
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