Ligelizumab in adolescents with chronic spontaneous urticaria: Results of a dedicated phase 2b randomized clinical trial supported with pharmacometric analysis.
Petra StaubachMontserrat Álvaro-LozanoBulent Enis SekerelMarcus MaurerMoshe Ben-ShoshanMiriam PorterEva HuaYan JiAlis BurciuMarina SavelievaThomas SeverinAnton DrollmannAndrzej BienczakPublished in: Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology (2023)
Ligelizumab exhibited efficacy and safety in adolescent CSU patients, consistent with that in adults. The PK and potency of ligelizumab were not impacted by age, and the same dose of ligelizumab can be used for treating adolescents and adults with CSU. Our study shows how modeling and simulation can complement pediatric drug development.