A Phase 3 Study to Assess Efficacy Safety and Tolerability of Remibrutinib in Adult and Adolescent Patients With Moderate to Severe Hidradenitis Suppurativa

To join this study, you must be at least 12 years old. You need to have been diagnosed with hidradenitis suppurativa (HS) for at least 6 months and have a moderate to severe form of the condition. This means you should have at least 5 active lumps (abscesses or inflamed nodules) and these should affect at least two different areas of your body, for example, both armpits.

There are also some reasons why you might not be able to join. For example, if you have more than 20 tunnels or channels (fistulas) on your skin, or if you have other serious skin conditions that would make it hard to assess your HS. You also can't have taken remibrutinib or similar medicines before. If you're currently taking other experimental drugs or certain blood thinners, that might also make you ineligible.

The study also can't accept you if you have certain medical conditions like severe liver problems, a high risk of bleeding, specific heart, kidney, or lung conditions, or known allergies to any of the study drug ingredients. Your study doctor will review all your health information carefully to make sure the study is safe for you.

If you decide to take part in this study, the total commitment will be about 76 weeks, or roughly a year and a half. This time includes several stages.

First, there's a screening period of up to 4 weeks, where doctors check if you're suitable for the study. After that, you'll enter Treatment Period 1, which lasts 16 weeks. During this time, you will be given either remibrutinib (one of two different doses) or a placebo (a dummy pill). Neither you nor your study doctor will know which one you are receiving – this is called 'double-blind'.

Following this, there's Treatment Period 2, lasting 52 weeks, where you will continue to receive remibrutinib. Throughout these treatment periods, you'll have regular visits to the clinic so the study team can monitor your health, check how your HS is reacting to the treatment, and manage any side effects. These visits will involve physical examinations, blood tests, and discussions about your symptoms.

Finally, after you stop taking the study medicine, there's a 4-week Safety Follow-Up period. This is to ensure you're doing well and to check for any lasting effects. You are encouraged to stay in the study even if you stop taking the treatment early, but if you don't want to, you would still complete this 4-week safety check.