AuthorisedTherapeutic confirmatory (Phase III)Interventional

An open-label, multi-center protocol for patients who have completed a previous Novartis sponsored remibrutinib study and are judged by the investigator to benefit from continued treatment with remibrutinib

This study is designed for adults (18 years and older) who live with chronic spontaneous urticaria, a condition that causes itchy hives to appear repeatedly without a clear cause. Participants in this study have already taken a trial medicine called remibrutinib (also known as LOU064) in a previous study run by Novartis. The main reason for this new study is to allow people who have found benefit from remibrutinib to continue taking it. Your doctor will decide if continuing the treatment is right for you. Researchers will keep a close eye on how well the medicine works over a longer period and check for any side effects to understand its safety when used for an extended time. This type of study helps gather more information about new treatments.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Novartis Pharma AG

Enrolment target

154

Start

20 May 2026

Chronic Spontaneous Urticaria

What is this study about?

This study is for people who have chronic spontaneous urticaria, which is a condition where you get itchy red welts or hives on your skin that appear often for months or even years, without an obvious cause. It can be very uncomfortable and affect your daily life.

The medicine being looked at is called remibrutinib (you might also see it called LOU064). This isn't a new medicine in the sense that you haven't taken it before. This study is specifically for individuals who have already participated in an earlier research study focusing on remibrutinib, and whose doctors believe that continuing with this treatment would be beneficial for them.

The main goal of this particular study is to gather more information about the long-term safety and effectiveness of remibrutinib. By allowing participants to continue taking the medicine, researchers can observe how the treatment works over an extended period. They will pay close attention to any side effects that might occur and see if the medicine continues to help manage chronic spontaneous urticaria symptoms.

Key takeaways

This study is for adults with ongoing hives who are already taking a specific trial medicine.
It allows you to continue remibrutinib (LOU064) if your doctor thinks it's helping your chronic spontaneous urticaria.
The primary goal is to check the long-term safety and effectiveness of the medicine.
You'll have regular medical checks and receive the study medicine at no cost.
You can stop participating at any point without affecting your routine medical care.

Who may be eligible?

To be considered for this study, you must meet certain requirements. The most important thing is that you must have already taken part in a previous study sponsored by Novartis where you received remibrutinib (or LOU064).

Your study doctor must also believe that you are benefiting from the remibrutinib treatment and that it would be a good idea for you to continue taking it.

Finally, this study is open to both men and women who are 18 years old or older. If you meet these main points, your doctor can discuss with you if this study is an option.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have chronic spontaneous urticaria (ongoing hives)?
Have you previously taken part in a Novartis-sponsored study where you received remibrutinib (LOU064)?
Does your study doctor believe you are benefiting from remibrutinib and should continue taking it?

Answer every question to see your result.

What does participation involve?

If you join this study, you will continue to receive the study medicine, remibrutinib (LOU064). You'll have regular visits with the study team, likely at a clinic, where they will monitor your health closely. These visits will involve checks to see if the medicine is still working for your hives and itching, and to check for any possible side effects. You might have physical examinations, blood tests, and answer questions about your symptoms and how you're feeling.

The specific number and frequency of visits will be explained by the study team, as will the total duration for which you might continue the treatment as part of this study. You will receive the study medicine at no cost, and your overall health will be carefully watched throughout your time in the study.

Potential risks and benefits

Participating in this study might offer you the benefit of continuing a treatment that your doctor believes is helping your chronic spontaneous urticaria. This might mean continued relief from your symptoms. As with any medication, there's always a possibility of experiencing side effects, including serious ones. The study team will explain all known potential risks associated with remibrutinib based on previous studies. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (6)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Germany
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Unverified
Spain
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Unverified
France
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Unverified
Poland
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Unverified
Bulgaria
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Unverified
Czechia

Common questions

What is chronic spontaneous urticaria?

It's a skin condition where you get itchy hives or welts that appear regularly for more than six weeks, without a clear reason, and can be quite bothersome.

What is remibrutinib?

Remibrutinib (also called LOU064) is the name of the medicine being studied. It's a treatment that was given in a previous clinical trial for chronic spontaneous urticaria.

Why is this study happening?

This study allows people who previously took remibrutinib and are benefiting from it to keep taking the medicine. It helps researchers gather more information on its long-term safety and how well it works over time.

Will I get a placebo (dummy medicine) in this study?

No, this study is 'open-label,' meaning both you and your study doctor will know you are receiving remibrutinib, not a placebo, unlike some earlier studies.

Can I stop participating in the study if I change my mind?

Yes, you are free to withdraw from the study at any time, for any reason, without needing to explain why, and it will not affect your standard medical care.