Ligelizumab in adolescents with chronic spontaneous urticaria: Results of a dedicated phase 2b randomized clinical trial supported with pharmacometric analysis
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P Staubach, M Alvaro‐Lozano…
Pediatric Allergy and …, 2023
Wiley Online Library
Background Chronic spontaneous urticaria (CSU), a long‐lasting disease in children, impacts their quality of life. We report the results of a phase 2b dose‐finding trial of ligelizumab (NCT03437278) and a high‐affinity humanized monoclonal anti‐IgE antibody, in adolescents with CSU, supported by modeling and simulation analyses, mitigating challenges in pediatric drug development. Methods This multicenter, double‐blind, placebo‐controlled trial, randomized H1‐antihistamine‐refractory adolescent CSU patients (12–18 …
