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Evaluation of remibrutinib (LOU064) effectiveness and safety in adult patients with chronic urticaria: A 12-week placebo-controlled study

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What is this trial about?

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

This clinical trial focuses on studying Chronic Inducible Urticaria and Chronic Spontaneous Urticaria, conditions that cause recurring hives and skin reactions. The study will test a new medication called remibrutinib (also known as LOU064), which is taken as a film-coated tablet. Some participants will receive placebo instead of the active medication.

The study aims to determine how well remibrutinib works in controlling urticaria symptoms compared to placebo. During the treatment, participants will also take standard medications including corticosteroids (anti-inflammatory medicines) and antihistamines (medications that help reduce allergic reactions). The study will last for 12 weeks, during which participants will need to regularly record their symptoms.

Throughout the study, doctors will monitor how well the treatment controls urticaria symptoms, particularly focusing on the most bothersome symptoms such as itching, pain, and burning sensations. They will also assess how the treatment affects participants' quality of life and track any side effects that may occur. Neither the participants nor the doctors conducting the study will know who is receiving the actual medication and who is receiving placebo.

The research process

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

Step 1
Initial screening and baseline assessment
Your eligibility for the study will be evaluated if you are 18 years or older and have been diagnosed with chronic urticaria (hives).
The condition must have been present for at least 4 months for induced urticaria or 6 months for spontaneous urticaria.
Your symptoms must not be adequately controlled with standard antihistamine treatment.
Step 2
Randomization and treatment assignment
You will be randomly assigned to receive either remibrutinib (LOU064) or a placebo (inactive tablet).
Neither you nor your doctor will know which treatment you are receiving during the study.
The medication will be in the form of film-coated tablets taken by mouth.
Step 3
Treatment period
The study will last for 12 weeks.
You will need to take the assigned medication as prescribed.
You will be asked to complete a daily diary called the Urticaria Symptom Daily Diary (USDD) to record your symptoms.
Your most bothersome symptom will be evaluated using a rating scale from 0 to 10.
Step 4
Follow-up assessments
Your symptoms will be evaluated at weeks 2, 6, and 12.
The evaluation will include assessment of urticaria control and impact on quality of life.
Your safety will be monitored throughout the study through assessment of any side effects or adverse events.
Step 5
Study completion
The study will conclude after the 12-week treatment period.
Final assessments will measure the changes in your symptoms and overall condition compared to the start of the study.

Who can join the trial?

11 criteria

You must sign an informed consent form before participating in the study
You must be 18 years or older
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For patients with Chronic Inducible Urticaria (CINDU):
- You must have had symptoms for at least 4 months
- Your condition must not be adequately controlled with standard antihistamine treatment
- You must show specific responses to trigger tests depending on your type of urticaria (such as response to cold, heat, pressure, or water)
- Your most bothersome symptom must score at least 3 on a numerical rating scale
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  For patients with Chronic Spontaneous Urticaria (CSU):
  - You must have had symptoms for at least 6 months
  - Your condition must not be adequately controlled with standard antihistamine treatment for at least 4 weeks
  - You must have a UAS7 score (weekly urticaria activity score) of 16 or higher
  - You must have an HSS7 score (weekly hives severity score) of 8 or higher
  - You must be willing and able to attend all required study visits and procedures

Who cannot join the trial?

14 criteria

History of severe allergic reactions or anaphylaxis (a serious, life-threatening allergic reaction)
Active or chronic infections, including hepatitis B, hepatitis C, or HIV
Current diagnosis of cancer or ongoing cancer treatment
Severe liver problems or abnormal liver function tests
Severe kidney disease or significantly reduced kidney function
Pregnancy or breastfeeding
Use of other investigational drugs within 30 days before starting the study
Major surgery within 8 weeks before starting the study
Uncontrolled high blood pressure
History of serious heart conditions or recent heart problems
Mental health conditions that could interfere with study participation
Drug or alcohol abuse within the past 12 months
Taking medications that could interact with the study drug
Any condition that, in the opinion of the study doctor, makes participation unsafe

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Verified sites

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

Verified
CHU Grenoble Alpes
La Tronche, France
Verified
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz
Mainz, Germany
Responsive
Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie
Rzeszow, Poland

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Investigated drugs

Remibrutinib (LOU064)
is a medication being studied for treating chronic urticaria, a skin condition that causes itchy hives or welts. It works by blocking specific proteins in the body that are involved in triggering allergic reactions and inflammation. This medication aims to help control urticaria symptoms and reduce the discomfort associated with this condition.
Placebo
is an inactive substance that contains no medication. It is used as a comparison to measure how effective the actual medication (remibrutinib) is in treating chronic urticaria symptoms.

Remibrutinib

What is already known about the treatment

Remibrutinib (LOU064) - An investigational oral medication being studied for the treatment of Chronic Inducible Urticaria and Chronic Spontaneous Urticaria, conditions characterized by recurring hives and itching. The drug belongs to the class of Bruton's tyrosine kinase (BTK) inhibitors and works by blocking specific cellular signals that trigger allergic reactions and inflammation in the body. Currently undergoing clinical trials to evaluate its efficacy and safety, remibrutinib is administered in tablet form and represents a potential new treatment option for patients with chronic urticaria who may not respond adequately to existing therapies.

Investigated diseases

Chronic Inducible Urticaria
A skin condition where specific triggers cause temporary red, itchy welts (hives) to appear on the skin. These triggers can include physical factors such as pressure, cold, heat, exercise, or sunlight. The hives typically develop within minutes of exposure to the trigger and can last for several hours. The condition is persistent and occurs repeatedly when exposed to the same trigger.
Chronic Spontaneous Urticaria
A condition characterized by the recurring appearance of itchy wheals (hives), angioedema (swelling), or both for six weeks or longer without any specific external trigger. The hives can appear anywhere on the body, change location within hours, and each individual wheal typically lasts less than 24 hours. The condition can fluctuate in severity, with periods of more frequent outbreaks alternating with periods of fewer symptoms.