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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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 trial?

6 criteria

  • 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 trial?

2 criteria

  • 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.
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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.

What is already known about the treatment

Remibrutinib - Remibrutinib is taken by mouth as a film-coated tablet, so it is swallowed with water. It is an investigational medicine in clinical studies and is also described in medical literature as a newer targeted treatment for allergic skin conditions such as chronic spontaneous urticaria. It is used to help reduce hives, itching, and swelling by blocking Bruton’s tyrosine kinase, a protein that helps immune cells release signals like histamine and other substances that drive allergic reactions. It belongs to the class of Bruton’s tyrosine kinase inhibitors, which are designed to calm overactive immune responses.

Investigated diseases

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-524078-40-00Protocol codeCLOU064A2306BEstimated enrolment279 patientsSponsorNovartis Pharma AG

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

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