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First received: December 16, 2022

Clinical Trial: 24 Weeks Double-blind Randomized Placebo-controlled Trial to Evaluate Efficacy, PK, Safety of LOU064 in Adolescents (12 - <18) With CSU and Inadequate Response to H1-antihistamine Followed by Optional 3 Years Open-label Extension and an Optional 3 Years Safety Long-term Treatment-free Follow-up

Study Status: Completed

Recruit Status: RECRUITING

Condition: Chronic Spontaneous Urticaria

Study Type: INTERVENTIONAL


Official Title: A Double-blind, Randomized, Placebo-controlled Trial to Evaluate the Efficacy, Pharmacokinetics and Safety of Remibrutinib (LOU064) for 24 Weeks in Adolescents From 12 to Less Than 18 Years of Age Wit

Brief Summary: The purpose of this trial is:to assess the efficacy, pharmacokinetics, and safety of remibrutinib vs. placebo in adolescents from 12 to < 18 years of age suffering from chronic spontaneous urticaria inadequately controlled by H1-antihistaminesto collect long-term efficacy, safety and tolerability data on remibrutinib in adolescents after having completed 24 weeks of treatmentto collect safety data in this population for up to three years after the last dose of treatment

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