What do we already know about this topic?

• Chronic spontaneous urticaria (CSU) is a chronic skin disease with itchy hives, angioedema, or both, lasting for >6 weeks.
• Ligelizumab is a next-generation anti-IgE antibody.
• Ligelizumab improved urticaria symptom control in patients with H1-antihistamine (H1-AH) refractory CSU in the previously published Phase 2b study.

How was this study conducted?

• PEARL-1 and -2: randomized, double-blind, active-and placebo-controlled, parallel-group studies.
• 52-week treatment period and 12-week follow-up.
• Patients >12 with CSU refractory to H1-AH randomized to ligelizumab 72 or 120 mg, omalizumab 300 mg, or placebo subcutaneously Q4W.
• Patients on placebo transitioned to ligelizumab 120 mg at Week 24.
• Primary endpoint: mean change from baseline in weekly Urticaria Activity Score (UAS7) at Week 12.
• Safety was assessed throughout for both adults and adolescents.