This clinical trial is focused on studying a condition known as Chronic Inducible Urticaria (CINDU), which includes types like symptomatic dermographism, cold urticaria, and cholinergic urticaria. These are conditions where the skin reacts with hives or welts due to specific triggers such as scratching, cold temperatures, or physical activity. The study is testing a new treatment called remibrutinib (LOU064), which is a low molecular weight compound that works by inhibiting a specific enzyme in the body. This treatment is being compared to a placebo to see how effective it is in helping people with CINDU who have not had success with standard treatments like H1-antihistamines, which are medications that block the effects of histamine, a substance in the body that causes allergy symptoms.
The purpose of the study is to determine if remibrutinib can help more people achieve a complete response, meaning their symptoms are fully controlled, compared to those taking a placebo. Participants in the study will take the medication orally, in the form of a film-coated tablet, over a period of 52 weeks. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication and who is receiving the placebo, to ensure unbiased results. There is also an open-label extension, which means that after the initial study period, all participants may have the opportunity to receive the actual medication.
Throughout the study, participants will be monitored for any changes in their symptoms and any side effects they may experience. The study aims to provide valuable information on the safety, effectiveness, and tolerability of remibrutinib for people with CINDU. This research could potentially lead to a new treatment option for those who struggle with this challenging condition.



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