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Study on the Effectiveness and Safety of Remibrutinib for Teens with Chronic Spontaneous Urticaria Not Controlled 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 Spontaneous Urticaria (CSU), which is a type of hives that occurs without a known cause and lasts for more than six weeks. The study is testing a new treatment called remibrutinib (also known by its code name LOU064), which is a medication that works by blocking a specific protein in the body that may be involved in causing the symptoms of CSU. The trial will also involve the use of a placebo, which is a substance with no active medication, to compare the effects of remibrutinib.

The purpose of the study is to evaluate how effective remibrutinib is in treating CSU in adolescents aged 12 to less than 18 years who have not responded well to standard treatments known as H1-antihistamines. These are medications that help reduce allergy symptoms by blocking the action of histamine, a substance in the body that causes allergic reactions. Participants in the study will take the medication or placebo for 24 weeks, and their symptoms will be monitored to see if there is an improvement. After this period, there is an option for participants to continue in an open-label extension, where they will receive remibrutinib for up to three more years, and a long-term follow-up period for safety monitoring.

Throughout the study, researchers will assess changes in the severity of the hives and itching, as well as monitor any side effects or changes in health. The study aims to provide valuable information on the safety and effectiveness of remibrutinib for treating CSU in young people, potentially offering a new option for those who do not find relief with current treatments.

The research process

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

Step 1
Initial treatment phase
The trial begins with a 24-week period where participants receive either the medication remibrutinib or a placebo. The medication is administered in the form of a film-coated tablet taken orally.
Participants are randomly assigned to receive either remibrutinib or a placebo. The dosage of remibrutinib is either 25 mg or 10 mg, depending on the group assignment.
The primary goal during this phase is to evaluate the effectiveness of remibrutinib in reducing symptoms of chronic spontaneous urticaria, such as itch and hives, compared to the placebo.
Step 2
Evaluation at week 12
At week 12, the trial assesses the change in symptoms from the start of the trial. This includes measuring the severity of itch and hives using specific scores: UAS7, ISS7, and HSS7.
The concentration of remibrutinib in the body is also measured to understand how the medication is processed.
Step 3
Optional open-label extension
After the initial 24-week period, participants have the option to continue in an open-label extension for up to 3 years. In this phase, all participants receive remibrutinib, and there is no placebo group.
The purpose of this phase is to gather additional data on the long-term safety and effectiveness of remibrutinib.
Step 4
Optional long-term follow-up
Following the open-label extension, there is an optional long-term follow-up period lasting up to 3 years. During this time, participants do not receive any medication.
This phase aims to monitor the long-term safety of participants after stopping the medication.

Who can join the trial?

8 criteria

Participants must be **male or female adolescents** aged **12 to less than 18 years** at the time of signing the informed consent.
Participants must have had **Chronic Spontaneous Urticaria (CSU)** for **6 months or more** before the screening. CSU is a condition where hives appear without a known cause.
Participants must have a **diagnosis of CSU** that is not well controlled by **second-generation H1-AH**. H1-AH refers to a type of medication used to treat allergies.
Participants must have experienced **itch and hives for 6 consecutive weeks** before the screening, even while using second-generation H1-AH as per local treatment guidelines.
Participants must have a **UAS7 score of 16 or more**. UAS7 is a tool used to measure the severity of hives over a week, with scores ranging from 0 to 42.
Participants must have an **ISS7 score of 6 or more**. ISS7 measures the severity of itch over a week, with scores ranging from 0 to 21.
Participants must have an **HSS7 score of 6 or more**. HSS7 measures the severity of hives over a week, with scores ranging from 0 to 21.
Participants must have **documentation of hives** within three months before randomization, which can be recorded at screening, at randomization, or in their medical history.

Who cannot join the trial?

12 criteria

Patients who have a history of severe allergic reactions to the study medication.
Patients who are currently participating in another clinical trial.
Patients with a history of certain heart conditions, such as heart failure or irregular heartbeat.
Patients with uncontrolled high blood pressure.
Patients with active infections that require treatment.
Patients who are pregnant or breastfeeding.
Patients with a history of cancer within the last five years, except for certain skin cancers.
Patients with liver disease or abnormal liver function tests.
Patients with kidney disease or abnormal kidney function tests.
Patients who have used certain medications that might interfere with the study.
Patients with a history of drug or alcohol abuse within the last year.
Patients with any other medical condition that the study doctors believe would make it unsafe to participate.

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Verified sites

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Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
Verified
Naples, Italy
Azienda Ospedaliero Universitaria Parma
Responsive
Parma, Italy
Universitair Medisch Centrum Utrecht
Responsive
Utrecht, The Netherlands

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Investigated drugs

Remibrutinib (LOU064) is a medication being studied for its effectiveness in treating chronic spontaneous urticaria, a condition characterized by persistent hives, in adolescents aged 12 to less than 18 years. This trial aims to determine how well remibrutinib works in reducing the symptoms of urticaria that are not adequately controlled by standard H1-antihistamines. The study will also evaluate the safety and how the body processes the medication over a 24-week period, with an option for participants to continue in an open-label extension for up to three additional years.

What is already known about the treatment

Remibrutinib – Remibrutinib is administered orally and is currently being studied in clinical trials for its effectiveness in treating chronic spontaneous urticaria, particularly in adolescents aged 12 to less than 18 years who do not respond adequately to H1-antihistamines. The medication is in the investigational stage, with ongoing research to evaluate its safety and efficacy. It is primarily indicated for chronic spontaneous urticaria, a condition characterized by persistent hives and itching. Remibrutinib works by inhibiting Bruton's tyrosine kinase, a protein involved in the signaling pathways that lead to inflammation and allergic responses. It is classified as a kinase inhibitor, targeting specific molecular pathways to reduce symptoms associated with the condition.

Investigated diseases

Chronic Spontaneous Urticaria – This is a skin condition characterized by the sudden appearance of itchy hives or welts on the skin, which can occur without an obvious trigger. The hives can vary in size and may appear and disappear over a period of time. The condition is considered chronic when it persists for six weeks or longer. It can also be accompanied by swelling, known as angioedema, particularly around the eyes, lips, and sometimes the throat. The exact cause is often unknown, but it may involve the immune system reacting inappropriately. Symptoms can fluctuate in intensity and may be influenced by factors such as stress, heat, or pressure on the skin.