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Study on the Effectiveness and Safety of Remibrutinib Compared to Placebo and Omalizumab in Adults with Chronic Spontaneous Urticaria Uncontrolled by 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 Spontaneous Urticaria (CSU), which is characterized by the sudden appearance of hives and itching without a known cause. The study aims to evaluate the effectiveness, safety, and tolerability of a medication called remibrutinib, which is taken as a 25 mg film-coated tablet. Remibrutinib works by inhibiting a specific enzyme in the body that is involved in the immune response. The study will compare remibrutinib to a placebo and to another medication called omalizumab, which is given as an injection every four weeks. Omalizumab is already used as a treatment for CSU and will serve as an active control in this study.

The purpose of the study is to determine if remibrutinib is more effective than a placebo in reducing the symptoms of CSU, such as itching and hives, over a period of 52 weeks. Participants in the study will be randomly assigned to receive either remibrutinib, a placebo, or omalizumab. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving which treatment, to ensure unbiased results. Throughout the study, participants will be monitored for any changes in their symptoms and any side effects they may experience.

This trial is important for understanding how well remibrutinib works in treating CSU, especially in patients who have not responded well to other treatments like second-generation H1-antihistamines. The study will help determine if remibrutinib can provide a new option for managing this challenging condition. Participants will be required to keep a daily diary of their symptoms to help researchers assess the effectiveness of the treatment. The study will last for a total of 52 weeks, with regular check-ins to monitor progress and any potential side effects.

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

    Randomization and initial assessment

    Upon joining the study, participants are randomly assigned to one of the treatment groups. This process is called randomization and ensures that each participant has an equal chance of receiving any of the treatments being tested.

    An initial assessment is conducted to establish baseline measurements. This includes evaluating the severity of chronic spontaneous urticaria (CSU) using scores such as UAS7, ISS7, and HSS7.

  2. Step 2

    Treatment phase

    Participants receive either remibrutinib 25 mg twice daily or a placebo. The placebo is a substance with no active medication, used to compare the effects of the actual drug.

    In addition, omalizumab 300 mg is administered every 4 weeks as an active control. This means it is used to compare the effects of remibrutinib against a known treatment.

    The treatment phase lasts for 52 weeks, during which participants continue to take their assigned medication and attend regular study visits for monitoring.

  3. Step 3

    Monitoring and assessments

    Throughout the study, participants are monitored for any changes in their condition and for any side effects. This includes regular assessments of the severity of itch and hives using the UAS7, ISS7, and HSS7 scores.

    Participants are required to complete a daily diary to record their symptoms and any side effects experienced. This helps in tracking the progress and effectiveness of the treatment.

  4. Step 4

    Final evaluation

    At the end of the 52-week treatment period, a final evaluation is conducted. This includes a comprehensive assessment of the participant's condition and any changes from the baseline measurements.

    The primary goal is to determine the absolute change in UAS7, ISS7, and HSS7 scores from the start of the study to Week 12, as well as any improvements in the severity of itch and hives.

Who can join the trial?

7 criteria

  • Participants must be **adults**, meaning they are **18 years or older** at the time they agree to join the study.
  • Participants must have had **Chronic Spontaneous Urticaria (CSU)** for at least **6 months** before the study begins. CSU is a condition where hives appear without a known cause.
  • Participants must have CSU that is not well controlled by **second-generation H1-AH**. This means they still have itching and hives for at least **6 weeks** before the study, even while using these medications. **H1-AH** are a type of medicine used to treat allergies.
  • Participants must have certain scores on tests that measure their symptoms, such as the **UAS7 score** of 16 or more, **ISS7 score** of 6 or more, and **HSS7 score** of 6 or more, in the week before they start the study. These scores help measure the severity of hives and itching.
  • Participants must have a record of having hives within the **three months** before starting the study.
  • Participants must be willing and able to fill out a **Urticaria Patient Daily Diary (UPDD)** every day during the study. This diary helps track their symptoms and how they feel.
  • Participants must not have missed more than one entry in their UPDD in the week before starting the study. This means they should have filled out the diary almost every day.

Who cannot join the trial?

10 criteria

  • Patients who have a history of severe allergic reactions to the study medication.
  • Patients who are currently participating in another clinical trial.
  • Patients who have a serious medical condition that could interfere with the study, such as uncontrolled diabetes or heart disease.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who have had a recent infection that required treatment with antibiotics.
  • Patients who have a history of cancer, except for certain types of skin cancer.
  • Patients who have a known infection with HIV, hepatitis B, or hepatitis C.
  • Patients who have received certain medications that could affect the study results.
  • Patients who have a history of mental health disorders that are not well controlled.
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Investigated drugs

  • Remibrutinib

    is a medication being studied for its effectiveness in treating chronic spontaneous urticaria, a condition characterized by persistent hives. The trial aims to see if remibrutinib can reduce the severity and frequency of hives in patients who have not responded well to standard antihistamine treatments.

  • Omalizumab

    is an active control medication used in this trial. It is typically administered every four weeks and is known to help manage symptoms of chronic spontaneous urticaria by targeting and reducing the activity of certain immune system components that contribute to the condition.

What is already known about the treatment

  • Remibrutinib

    Remibrutinib is administered orally in tablet form, taken twice daily. It is currently being studied in clinical trials for its effectiveness in treating chronic spontaneous urticaria, a condition characterized by persistent hives. The medication works by inhibiting Bruton's tyrosine kinase, which plays a role in the immune response that leads to inflammation and symptoms of urticaria. Remibrutinib is classified as a kinase inhibitor and is being compared to placebo and omalizumab in ongoing research to assess its safety and efficacy.

  • Omalizumab

    Omalizumab is administered via subcutaneous injection, typically given every four weeks. It is an established medication used to treat chronic spontaneous urticaria, especially in cases not adequately controlled by antihistamines. Omalizumab works by binding to immunoglobulin E (IgE), preventing it from attaching to receptors on immune cells, thereby reducing allergic reactions and inflammation. It is classified as a monoclonal antibody and is used as an active control in clinical trials to evaluate new treatments for urticaria.

Investigated diseases

Chronic Spontaneous Urticaria – This is a skin condition characterized by the sudden appearance of hives, which are red, itchy welts on the skin. These hives can appear anywhere on the body and may vary in size and shape. The condition is termed "spontaneous" because the hives occur without a known trigger. It is considered "chronic" when the hives persist for six weeks or longer. The severity of the symptoms can fluctuate, with periods of more intense itching and swelling. The exact cause of chronic spontaneous urticaria is often unknown, but it involves the immune system reacting inappropriately.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-502161-19-00Protocol codeCLOU064A2304Estimated enrolment505 patientsSponsorNovartis Pharma AG

sourced from the EU Clinical Trials Register and site verification

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