Study of Remibrutinib (LOU064) Efficacy and Safety and Exploration of Its Mechanism of Action in Participants With Chronic Urticaria

To be part of this study, you need to be an adult aged 18 or over. You must have chronic hives that haven't fully cleared up even after taking antihistamines. If you have Chronic Inducible Urticaria, your hives must have been present for at least four months and be bothersome. If you have Chronic Spontaneous Urticaria, you must have had it for at least six months and your symptoms must be quite active, as shown by specific symptom scores.

There are also some reasons why you might not be able to join. For example, if your hives are part of a very rare genetic condition, or if they are caused by other specific medical conditions like certain types of vasculitis, severe allergies to food that you eat regularly, or specific inherited swelling conditions. We also need to make sure that for people with Chronic Inducible Urticaria, the main problem is truly the inducible hives and not other types of hives mixed in.

If you decide to take part, your first step will be a screening period lasting up to four weeks. During this time, doctors will do some checks to make sure the study is a good fit for you. Once enrolled, you'll either receive the study medicine, remibrutinib, or a placebo (a treatment with no active drug) for 12 weeks. You won't know which one you're getting, and neither will the study staff, which helps keep the results fair. Throughout this time, you'll have appointments to assess how you're feeling and how your hives are. After your last dose of medication, you'll have a final visit about 7 days later. About a month after your last dose, there will be a safety follow-up phone call to check in on you. The total study duration, including screening, treatment, and follow-up, will be around 17-18 weeks.