A Multi-center, Randomized, Double-blind, Active and Placebo-controlled Study to Investigate the Efficacy and Safety of Ligelizumab (QGE031) in the Treatment of Chronic Spontaneous Urticaria (CSU) in Adolescents and Adults Inadequately Controlled With H1-antihistamines
Latest Information Update: 09 Jan 2025
At a glance
- Drugs Ligelizumab (Primary) ; Omalizumab
- Indications Chronic urticaria
- Focus Registrational; Therapeutic Use
- Acronyms Pearl 2
- Sponsors Novartis; Novartis Healthcare; Novartis Pharma KK; Novartis Pharmaceuticals
Most Recent Events
- 23 Nov 2023 Primary endpoint has not been met. (Absolute change from baseline in UAS7 at Week 12 (Ligelizumab 72 mg Vs Omalizumab 300 mg))
- 23 Nov 2023 Primary endpoint has been met. (Absolute change from baseline in UAS7 at Week 12 ligelizumab 72mg, 120mg vs Placebo)
- 23 Nov 2023 Results assessing efficacy and safety of ligelizumab in adults and adolescents with chronic spontaneous urticaria in two phase III trials PEARL-1 and PEARL-2 published in the Lancet.