Remibrutinib in Chronic Spontaneous Urticaria for Patients Who Benefited from a Previous Remibrutinib Trial

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What is this study about?

This clinical trial is being done in Chronic Spontaneous Urticaria, a condition that causes hives and itching without a clear trigger. The treatment used in the study is remibrutinib (LOU064), taken by mouth as a film-coated tablet at a dose of 50 mg. The purpose of the study is to look at the long-term safety of remibrutinib.

The study is open label, which means the treatment is known and no hidden treatment is used. It is designed for people who finished a previous remibrutinib study and were thought to be doing well enough to continue treatment. During the trial, remibrutinib is taken over a longer period of time, and health is watched for any side effects, including common adverse events and more serious serious adverse events.

1 <b>start of the trial</b>

You enter the study only after you have completed a previous Novartis-sponsored remibrutinib study and the investigator judges that you may benefit from continued treatment with remibrutinib.

The trial is open-label, which means that the treatment is not hidden and the study drug is known.

The study is for people with chronic spontaneous urticaria, a long-lasting condition that causes hives without a clear trigger.

2 <b>study treatment</b>

You take remibrutinib by mouth as a 50 mg film-coated tablet.

The tablet is taken orally, which means swallowed rather than injected or infused.

The trial description does not specify the exact number of doses per day or the exact treatment duration. It only states that the study is for continued treatment with remibrutinib.

3 <b>during the trial</b>

You remain on treatment while the study team checks your safety over time.

The main purpose of the trial is to look at long-term safety.

Safety is measured by watching for adverse events and serious adverse events. An adverse event is any unwanted medical problem that happens during the study. A serious adverse event is a more severe medical problem.

4 <b>end of the trial period</b>

Your participation continues until the study period ends or until your treatment is stopped according to the study plan.

The trial is planned to run from 2026-05-20 to 2034-01-09.

Who Can Join the Study?

  • The person has completed treatment as planned in a previous Novartis study of remibrutinib, unless the parent study allowed something different.
  • If the previous study ended early because Novartis stopped it for technical or administrative reasons, the person may still qualify if they were benefiting from remibrutinib and the study did not stop because of safety problems or because the treatment did not work.
  • If the person had a relapse during the treatment-free follow-up period, meaning their symptoms came back after stopping treatment, they can enter this study right away.
  • The investigator believes the person is still benefiting from remibrutinib, meaning the treatment is helping them.
  • The investigator also believes the benefit is greater than the risk, meaning the expected help from the treatment is more important than the possible harms.
  • The person is unable to get access to the approved, marketed form of remibrutinib through local rules for post-study drug supply, prescription, or payment coverage.

Who Cannot Join the Study?

  • Having stopped the study treatment early in the main study before it was planned to end.
  • Using medications that are not allowed in the study. These are medicines listed in the study rules as prohibited, meaning they cannot be taken while taking part.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centre Hospitalier Regional Et Universitaire De Brest Brest France
Oncopole Claudius Regaud Toulouse France
Technische Universitaet Dresden Dresden Germany
Medizinische Hochschule Hannover Hanover Germany
Hospital Universitario Y Politecnico La Fe Valencia Spain
Hospital Universitario De Navarra Pamplona Spain
CHU Grenoble Alpes La Tronche France
Universitaetsmedizin Goettingen Goettingen Germany
Centre Hospitalier Universitaire De Bordeaux Bordeaux France

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire Rouen Rouen France
Hopital Beaujon Clichy France
Hospital Del Mar Barcelona Spain
Alergologia Plus Sp. z o.o. Poznan Poland
Centre Hospitalier Groupe Hospitalier De La Rochelle Re Aunis La Rochelle France
MT Medic Specjalistyczna Praktyka Lekarska Tomas Stapiński Krosno Poland
Hiqhuobn Vxvc dfiueveg Barcelona Spain
Dpbldyljafbrjqtexcqxqtt cjxgcn “kaixavrhtrqzkzf Eguq Sofia Bulgaria
Fajaqplo nphljuavv Mdxla a Hpvargv Prague Czechia
Ciffpcs Utnphubhkieuepiglpku Bdhyib Kbd Berlin Germany
Ftengtxj Nzhpwtcne Kqeyrziae Vbpvyporx Prague Czechia
Cytuhd Hhtqfsxzluu Uesiflahlsrdg Dq Mrawmqeenff Montpellier France
Hjbrmua Pgawo D Awkmhv Antony France
Ujvhrbhqbumo Layuyou Leipzig Germany
Uawwxghqsvgxda Cgqffcv Kkjodesyj Gdansk Poland
Krtualal dnp Tvngcxzgxfb Uuvrruzmymud Mlknwobx (rci Kpfotzelk Munich Germany
Ueukfwqgijkfztzvtybjt Sstnggoahlzjkzxxzh Axn Kiel Germany
Czppuy Hzurircdxuj Lwum Sko Pierre Benite France
Hnizlpwr Uapzoetmsufzg Dt La Pefsvvrx Madrid Spain
Cldhgh Hqktyuhiain Rbjvcmdw Dyazpjewgdbchk Angers France
Cihletd Bbmcw Koptkudodta Pcgllcck Stb z ophw Gdansk Poland
Hqihfnsn Ujzcjmyqzasgb Vozyad Dy Ldd Nvudhi Granada Spain
Dchhchvi Czhkmfg sxpmny Plzen Czechia
Mzyiujt Cutkje Iufzy Ewmq Sofia Bulgaria
Fkxgrojr Njqrctseg U Sp Aeyy V Brvq Brno-Stred Czechia
Pueatwfoh Ivficbde Mowuvyfn Mwaevzqfqzwe Sgnmc Wdcawtqszsxl I Aqbqxrlsisquk Warsaw Poland
Ulkho Dm Rgqxetstl Cxdajyxc Hdw Bpdgf Saint-Mande France
Mvqanvi Ciqkfp Rsnswpsx Eytxjo Oww Varna Bulgaria
Mfzenjshgqdneyxqjyhyuhujmy Hfdxacowzwvlifpb Halle (Saale) Germany
Tsdkrakrafd urb Spoplkvrowr Bpnlliym Gtha Bad Bentheim Germany
Em Hocrgfbq Uxejtgqdmadcj Dw Gcjl Cqsxnxg Dam Ndkcvo Las Palmas De Gran Canaria Spain
Svrsjbqhxslhrls Pkfylpiscrp Layccsty Agbkgq Mbt Soi z ohhu Poznan Poland
Tjtxrv 4o Nice France
Sdqzxwnkffikou am dza Hceq Gka Bramsche Germany
Pcrkcc Dil mmbb Asrbr Zdbtorf Halle (Saale) Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Recruiting
20.05.2026
Czechia Czechia
Recruiting
20.05.2026
France France
Recruiting
20.05.2026
Germany Germany
Not yet recruiting
20.05.2026
Poland Poland
Recruiting
20.05.2026
Spain Spain
Recruiting
20.05.2026

Trial locations

Investigated Drugs:

remibrutinib is the study medicine being tested in this trial. It is taken by mouth as a tablet and is being given to people who already took part in an earlier study. The goal is to keep treating patients who may still benefit from it while the researchers check its long-term safety and watch for side effects or serious side effects.

Chronic Spontaneous Urticaria – A long-lasting skin condition marked by repeated outbreaks of itchy hives that appear without a clear trigger. The wheals usually come and go, often changing shape and location over time. Some people also develop swelling under the skin, especially around the eyes, lips, hands, or feet. The condition tends to fluctuate, with periods of more active symptoms and periods of fewer or no symptoms.

Trial ID:
2025-524078-40-00
Protocol code:
CLOU064A2306B
Trial Phase:
Therapeutic confirmatory (Phase III)

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