A Study to Investigate Efficacy, Safety, and Tolerability of Remibrutinib Compared With Placebo in Adults With CINDU Inadequately Controlled by H1-antihistamines

To be considered for this study, you need to be an adult aged 18 or older and have a confirmed diagnosis of Chronic Inducible Urticaria (CINDU) for at least four months. This means your hives are triggered by things like cold, pressure, or heat (cholinergic urticaria), and your current antihistamine tablets aren't fully controlling your symptoms. When you're assessed for the study, doctors will perform specific tests to confirm your type of CINDU and how severe it is; for example, they might use special tools to check your reaction to cold or pressure, or monitor your reaction during exercise.

There are also some reasons why you wouldn't be able to join the study. For instance, if you've previously taken remibrutinib or similar types of medication called BTK inhibitors, or if you have a different kind of long-lasting hives called chronic spontaneous urticaria (unless it has now resolved). You also wouldn't be eligible if your CINDU is a rare, inherited (familial) form, or if you have a condition where you don't sweat (anhidrosis) if you have cholinergic urticaria. The study team will carefully review all your medical information to see if this study is suitable for you.

If you complete the main part of the study, you might then be able to join an optional longer-term part of the study. This part is designed to continue gathering information about how remibrutinib works and its safety over a longer time.

Taking part in this study involves several stages. First, there's a screening period, which lasts up to 4 weeks, where doctors will check if you're suitable for the study. If you are, you'll then enter the main 'core' part of the study, which lasts about 52 weeks (just under a year).

During the first 24 weeks of the core study, you'll receive either remibrutinib or a dummy treatment (placebo) as a tablet, but neither you nor your doctor will know which one. After these 24 weeks, you'll switch to receiving remibrutinib as an open-label treatment for another 28 weeks, meaning both you and your doctor will know what you're taking. Throughout this period, you'll have regular visits to the clinic for assessments, which will include checks on your symptoms, safety monitoring, and possibly some blood tests.

After the 52-week core treatment period, there will be a 4-week follow-up period without any study medication. Following this, you might have the option to join a longer-term 'Open-label Extension' period, which could last for up to 3 years. In this extension, you would receive remibrutinib if your symptoms return or continue. Throughout the entire study, the total duration for you could be up to 4 years, including regular clinic visits and medication as directed by the study team.