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
Universitaetsmedizin Goettingen Goettingen Germany
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Universitaet Leipzig Leipzig Germany
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

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire Rouen Rouen France
Diagnostic-consultative center “Aleksandrovska” EOOD Sofia Bulgaria
Dermafit Centrum s.r.o. Plzen Czechia
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Fakultni Nemocnice Kralovske Vinohrady Prague Czechia
Centre Hospitalier Universitaire De Montpellier Montpellier France
Fakultni Nemocnice U Sv Anny V Brne Brno-Stred Czechia
Hopital Prive D Antony Antony France
Unite De Recherche Clinique HIA Begin Saint-Mande France
Medical Center Research Expert OOD Varna Bulgaria
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Centre Hospitalier Lyon Sud Pierre Benite 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
Hospital Universitario Virgen De Las Nieves Granada Spain
El Hospital Universitario De Gran Canaria Dr. Negrin Las Palmas De Gran Canaria Spain
Specjalistyczna Przychodnia Lekarska Alergo Med Sp. z o.o. Poznan Poland
Tagast 41 Nice France
Studienzentrum an der Hase GbR Bramsche Germany
Praxis Dr. med. Abdou Zarzour Halle (Saale) Germany
MT Medic Specjalistyczna Praktyka Lekarska Tomas Stapiński Krosno Poland
Hbcmurjr Vzxe dkuhtrtl Barcelona Spain
Fpajttxy nnaawbmbs Mlsan a Hgfmncb Prague Czechia
Ponvdkfhw Iuysmqvl Mvqkiutp Mkrvajxxozci Syowx Wnwntbmamcvc I Aqtudfrpwlzww Warsaw Poland
Utqwymthrsauco Cdzscyy Kktiliygo Gdansk Poland
Mubehlyxrmgcgrhqyocjieakpj Hvmbzikurkjfxwrs Halle (Saale) Germany
Hehemien Ufsyxzgnbvrjl Dr Lx Plehfebh Madrid Spain
Clsmuu Hjplcdchkig Rjludupj Dzzvtkbyyegmou Angers France
Cfacnvq Buwds Kfrihfseoet Pnlaonnr Scx z ojtl Gdansk Poland
Tfwncutqzbn ugy Slvrnkmwiik Bcqmgddk Gema Bad Bentheim Germany
Mladvsu Cjivmt Insbq Euif Sofia Bulgaria

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

Trial status

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