Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study of remibrutinib for long-term treatment of adult patients with chronic spontaneous urticaria who completed previous remibrutinib studies

Verified siteRegistered drug
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

This study focuses on patients with Chronic Spontaneous Urticaria, a condition that causes recurring hives and itching without a known trigger. The study will evaluate a medication called remibrutinib (also known as LOU064), which is taken as a film-coated tablet by mouth. Some participants will receive the actual medication, while others will receive a placebo.

The purpose of this research is to assess how well remibrutinib works over an extended period in patients who have already participated in previous studies of this medication. During the study, patients who showed improvement in their symptoms will either continue taking remibrutinib or switch to placebo. The researchers will monitor how long it takes for symptoms to return, if they do.

Throughout the study, participants may also receive other common treatments for their condition, including antihistamines (medications that reduce allergic symptoms) and corticosteroids (medications that reduce inflammation). The study will track any side effects that occur during the treatment period. The total duration of treatment may last up to 160 weeks, depending on the participant's response to the medication.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial medication phase

    You will receive remibrutinib in the form of film-coated tablets for oral use

    The treatment is intended for adults (18 years and older) with chronic spontaneous urticaria (a condition causing recurring itchy hives)

    You need to take the medication as prescribed and attend all scheduled medical visits

  2. Step 2

    Assessment period

    Your response to the treatment will be monitored using the UAS7 score (a measure of hive severity)

    The medical team will evaluate if your score remains below 16 points, which indicates good disease control

  3. Step 3

    Randomized withdrawal phase

    If your condition is well-controlled, you will be randomly assigned to continue either remibrutinib or receive a placebo (inactive tablet)

    This phase lasts up to 24 weeks

    Your symptoms will be closely monitored during this period

  4. Step 4

    Monitoring for events

    The medical team will track any return of symptoms (relapse)

    They will note if you need to stop treatment due to lack of effectiveness

    Any use of other restricted medications will be documented

  5. Step 5

    Safety monitoring

    Throughout the study, any side effects or health changes will be recorded

    Regular health assessments will be conducted during scheduled visits

    The study continues until April 2027

Who can join the trial?

9 criteria

  • You must provide written consent before participating in any study activities
  • You must be an adult aged 18 or older
  • You must have completed one of these previous studies successfully:
    • CLOU064A2301
    • CLOU064A2302
    • CLOU064A1301
    • CLOU064A2305
    • You must be willing and able to:
      • Follow all study procedures
      • Attend all scheduled study visits
      • Both men and women can participate in this study

Who cannot join the trial?

15 criteria

  • Age below 18 years or above 75 years
  • Pregnant or breastfeeding women
  • History of severe allergic reactions to similar medications
  • Current participation in other clinical trials
  • Presence of other skin conditions that could interfere with urticaria (hives) assessment
  • Uncontrolled or severe medical conditions that could affect study participation
  • Use of prohibited medications within specified timeframe before study start
  • UAS7 score (weekly urticaria activity score) of 16 or higher at Week 52 of previous core study
  • Previous discontinuation from the core study due to lack of efficacy
  • Known hypersensitivity to remibrutinib (study medication) or its components
  • Significant liver or kidney dysfunction
  • Active or chronic infections
  • History of malignancy within the past 5 years
  • Mental conditions that could interfere with study compliance
  • Substance abuse or dependence
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Remibrutinib is a medication being studied for treating chronic spontaneous urticaria (hives). It works by blocking specific proteins in the body that are involved in allergic reactions and inflammation. This medication aims to help control symptoms in patients who experience frequent outbreaks of hives with no known trigger. A Placebo is included in this study as a control substance. It looks identical to the active medication but contains no active ingredients. It is used to help determine how effective the real medication is by comparing results between patients who receive the active drug and those who receive the placebo.

What is already known about the treatment

Remibrutinib – An oral BTK (Bruton's tyrosine kinase) inhibitor being investigated for the treatment of Chronic Spontaneous Urticaria (CSU), a condition characterized by recurring hives and itching. This medication works by blocking the BTK enzyme, which plays a crucial role in the immune system's response that leads to allergic reactions and inflammation. Remibrutinib is administered as oral tablets and is currently undergoing Phase 3 clinical trials to evaluate its long-term efficacy and safety in patients with CSU who have shown positive response to initial treatment. The drug represents a novel therapeutic approach in managing chronic urticaria by targeting the underlying molecular mechanisms of the condition rather than just treating symptoms.

Investigated diseases

Chronic Spontaneous Urticaria - A skin condition characterized by the sudden appearance of itchy wheals (hives), angioedema (swelling), or both that recur for 6 weeks or longer. The wheals are temporary and typically resolve within 24 hours, but new ones may appear daily. This condition occurs without any specific external trigger, unlike other forms of urticaria. The itchy welts can appear anywhere on the body, vary in size, and may change shape as the reaction progresses. The condition can significantly affect daily activities and quality of life through persistent itching and discomfort.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-510818-33-00Protocol codeCLOU064A2303BEstimated enrolment696 patientsSponsorNovartis Pharma AG

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.