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Study on Remibrutinib for Adults with Chronic Inducible Urticaria Uncontrolled by H1-Antihistamines

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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 focused on studying a condition known as Chronic Inducible Urticaria (CINDU), which includes types like symptomatic dermographism, cold urticaria, and cholinergic urticaria. These are conditions where the skin reacts with hives or welts due to specific triggers such as scratching, cold temperatures, or physical activity. The study is testing a new treatment called remibrutinib (LOU064), which is a low molecular weight compound that works by inhibiting a specific enzyme in the body. This treatment is being compared to a placebo to see how effective it is in helping people with CINDU who have not had success with standard treatments like H1-antihistamines, which are medications that block the effects of histamine, a substance in the body that causes allergy symptoms.

The purpose of the study is to determine if remibrutinib can help more people achieve a complete response, meaning their symptoms are fully controlled, compared to those taking a placebo. Participants in the study will take the medication orally, in the form of a film-coated tablet, over a period of 52 weeks. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication and who is receiving the placebo, to ensure unbiased results. There is also an open-label extension, which means that after the initial study period, all participants may have the opportunity to receive the actual medication.

Throughout the study, participants will be monitored for any changes in their symptoms and any side effects they may experience. The study aims to provide valuable information on the safety, effectiveness, and tolerability of remibrutinib for people with CINDU. This research could potentially lead to a new treatment option for those who struggle with this challenging condition.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomization

    Upon joining the study, participants are randomly assigned to receive either the active medication, remibrutinib, or a placebo. This process is double-blind, meaning neither the participant nor the study team knows which treatment is being administered.

  2. Step 2

    Medication administration

    Participants take the assigned medication orally. The active medication, remibrutinib, is administered in the form of a 25 mg film-coated tablet. The dosage is taken twice daily (b.i.d), which means once in the morning and once in the evening.

  3. Step 3

    Initial assessment

    At Week 2, participants undergo assessments to evaluate their response to the treatment. This includes measuring changes in symptoms such as itch and hives using specific tests designed for each subtype of Chronic Inducible Urticaria (CINDU).

  4. Step 4

    Mid-study evaluation

    At Week 12, a comprehensive evaluation is conducted to assess the efficacy of the treatment. The primary goal is to determine the proportion of participants who achieve a complete response, meaning significant improvement or resolution of symptoms.

  5. Step 5

    Ongoing monitoring

    Throughout the 52-week study period, participants continue to take the medication and attend regular follow-up visits. These visits are crucial for monitoring safety and any potential side effects.

  6. Step 6

    Open-label extension

    After the initial 52-week period, participants may enter an open-label extension phase. In this phase, all participants receive the active medication, remibrutinib, regardless of their initial group assignment.

  7. Step 7

    Final assessment

    At the end of the study, a final assessment is conducted to evaluate the long-term effects and safety of the treatment. This includes a detailed analysis of symptom changes and any adverse events experienced during the trial.

Who can join the trial?

7 criteria

  • Participants must be **male or female** and at least **18 years old** at the time of signing the consent form.
  • Participants must have a **confirmed diagnosis** of **Chronic Inducible Urticaria (CINDU)**, which includes conditions like **symptomatic dermographism**, **cold urticaria**, or **cholinergic urticaria** for at least **4 months**. This means they should have medical records or other proof of the condition.
  • The condition must not be well controlled with **H1-AH**, which are medications typically used to treat allergies, at the approved doses.
  • Participants must show a specific response to a **provocation test** for each type of urticaria at the start of the study:
  • For **Symptomatic Dermographism**: A **Total Fric Score** of 3 or more using a special test called **FricTest® 4.0** and a score of 5 or more for itchiness after the test.
  • For **Cold Urticaria**: A **Critical Threshold Temperature** of 15°C or higher using a test called **TempTest® 4.0** and a score of 5 or more for itchiness after the test.
  • For **Cholinergic Urticaria**: A doctor's assessment of the severity of hives with a score of 2 or more using a test called **Pulse-controlled ergometry test** and a score of 5 or more for itchiness after the test.

Who cannot join the trial?

10 criteria

  • Participants with any other skin condition that might interfere with the study results.
  • Individuals who have had a severe allergic reaction to similar medications in the past.
  • People currently taking medications that could affect the study outcomes.
  • Participants with a history of certain heart conditions.
  • Individuals with uncontrolled high blood pressure.
  • People with a history of certain types of cancer.
  • Participants who are pregnant or breastfeeding.
  • Individuals with a history of drug or alcohol abuse.
  • People with certain infections that are not well controlled.
  • Participants who have been part of another clinical trial recently.
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Investigated drugs

Remibrutinib (LOU064) is a medication being studied for its effectiveness, safety, and tolerability in treating Chronic Inducible Urticaria (CINDU) in adults. This condition includes symptoms like dermographism, cold urticaria, and cholinergic urticaria, which are types of skin reactions. The trial aims to see if remibrutinib can help achieve a complete response in patients who have not been adequately controlled by H1-antihistamines.

What is already known about the treatment

Remibrutinib – Remibrutinib is administered orally in tablet form, typically taken twice daily. It is currently being studied in clinical trials for its effectiveness in treating Chronic Inducible Urticaria (CINDU), a condition characterized by hives triggered by specific stimuli. The medication works by inhibiting Bruton's tyrosine kinase (BTK), a protein involved in the activation of immune cells that contribute to inflammation and allergic responses. Remibrutinib is classified as a kinase inhibitor, and its development is focused on providing relief for patients whose symptoms are not adequately controlled by standard antihistamine treatments.

Investigated diseases

Chronic Inducible Urticaria (CINDU) – This is a condition where hives or welts appear on the skin in response to specific triggers. It includes subtypes such as symptomatic dermographism, cold urticaria, and cholinergic urticaria. In symptomatic dermographism, the skin reacts to physical pressure or scratching. Cold urticaria is triggered by exposure to cold temperatures, leading to itchy welts. Cholinergic urticaria occurs due to an increase in body temperature, often from exercise or hot showers, causing small, itchy bumps. The symptoms can vary in intensity and duration, often appearing shortly after exposure to the trigger.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505739-12-01Protocol codeCLOU064M12301Estimated enrolment353 patientsSponsorNovartis Pharma AG

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