AuthorisedTherapeutic confirmatory (Phase III)Interventional

A double-blind, double-dummy, parallel group, multicenter Phase 3 extension study evaluating the long-term safety and efficacy of 2 doses of remibrutinib in adult participants with moderate to severe hidradenitis suppurativa

This research is focused on a skin condition called hidradenitis suppurativa (HS), which causes painful lumps and abscesses. The study is testing a new medication called remibrutinib in adults who have moderate to severe HS. It's designed to be a long-term follow-up for people who have already been in an earlier study. Researchers want to understand the long-term safety of remibrutinib and how well it works over time. They will carefully track any new side effects that happen during the study and see if the medication continues to improve HS symptoms. This information will help doctors understand if remibrutinib is a good long-term treatment option for people living with HS.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Novartis Pharma AG

Enrolment target

307

Start

20 May 2026

Hidradenitis Suppurativa (HS)

What is this study about?

This study is designed to learn more about a medication called remibrutinib for people who have moderate to severe hidradenitis suppurativa, often called HS. HS is a long-term skin condition that causes painful lumps, boils, and abscesses, mostly in areas where skin rubs together, like the armpits or groin. It can be very challenging to live with.

Researchers want to see how safe remibrutinib is when taken for a long time and how well it helps control HS symptoms over many months. This particular study is an 'extension study,' which means it's for people who have already started taking remibrutinib (or a placebo, which is a dummy pill) in a previous study. By continuing to follow these participants, doctors can get a clearer picture of the medication's long-term effects.

The main goal is to keep a close eye on any side effects that might appear while people are taking the medication. They will also look at how much HS symptoms improve, such as how many active lesions people have and how much pain they feel. This study is important because new and effective long-term treatments are needed for people with HS to help them manage their condition and improve their quality of life.

Key takeaways

This study is testing a new HS medicine called remibrutinib long-term.
It's for adults with moderate to severe HS.
It's an extension study for previous participants.
The main goals are to check long-term safety and how well it improves HS.
You'll have regular hospital visits for health checks and symptom assessments.

Who may be eligible?

This study is for adults aged 18 years and older. Both men and women are welcome to participate.

Crucially, this is an extension study, which means it's for people who have already been taking part in an earlier study for hidradenitis suppurativa. If you haven't been in the previous study, you won't be able to join this one.

The doctors will check your medical history to make sure this study is right for you and that taking remibrutinib would be safe.

Quick self-check

Are you 18 years old or older?
Have you previously taken part in an earlier remibrutinib study for HS?
Do you have moderate to severe hidradenitis suppurativa?
Are you able to attend regular clinic visits?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you will continue to take the study medication, remibrutinib, as prescribed. You might have been taking remibrutinib in a previous study, or you might have been taking a placebo (a dummy pill) and will now switch to remibrutinib. You will have regular visits to the clinic where doctors and nurses will check your general health, assess your HS symptoms, and ask about any side effects you might be experiencing. These visits will involve physical examinations, possibly blood tests, and discussions about how you're feeling. The total duration of your participation will depend on the study plan, but it's designed to be a long-term follow-up.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as continued access to a new medication that might help improve your HS symptoms. However, like all medications, remibrutinib might cause side effects, some of which could be serious. The study team will carefully monitor you for any side effects. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (12)

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Portugal
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Greece
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Germany
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Hungary
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France
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Spain
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Bulgaria
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Slovakia
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Poland
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Czechia
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Belgium
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Italy

Common questions

What is hidradenitis suppurativa (HS)?

HS is a chronic skin condition causing painful, recurring lumps and boils, often in body folds like the armpits or groin.

What is remibrutinib?

Remibrutinib is the name of the new medication being tested in this study for HS.

Why is this called an 'extension' study?

It means this study continues to follow people who have already been in an earlier research study for HS and remibrutinib.

What does 'long-term safety' mean?

It means researchers want to see if the medication causes any side effects over a longer period of time, not just for a few weeks or months.

Will I know if I'm taking the active drug or a dummy pill?

Typically, in this kind of study (which is often 'blinded'), neither you nor your study doctor will know if you're getting the active drug or a placebo, to ensure fair results. However, since this is an extension study, participants are usually switched to the active treatment.