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Study on the Effects of Omalizumab on Carotid Artery Stenosis in Patients Undergoing Carotid Endarterectomy

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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 the effects of a treatment for atherosclerosis, specifically targeting a condition known as carotid artery stenosis. This condition involves the narrowing of the carotid arteries, which are the main blood vessels that supply blood to the brain. The treatment being tested is a medication called omalizumab, also known by its code name IGE-025A. Omalizumab is administered as a solution for injection and is designed to inhibit the activation of certain cells in the body called mast cells, which play a role in inflammation and allergic reactions.

The purpose of the study is to determine if a short course of omalizumab can reduce the activation of mast cells within atherosclerotic plaques, which are fatty deposits that can build up in the arteries. Participants in the study will receive either omalizumab or a placebo, which is a substance with no active medication. The study will involve regular monitoring and assessments to observe the effects of the treatment on the participants' condition.

Throughout the study, various health parameters will be measured to evaluate the impact of omalizumab on inflammation and other related factors. These include the levels of certain immune cells and proteins in the blood and within the plaques themselves. The study aims to provide insights into whether omalizumab can help manage atherosclerosis by targeting mast cell activity, potentially leading to new treatment options for patients with carotid artery stenosis.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed. The patient must be 18 years or older, able to provide consent, and have a carotid artery stenosis of at least 50% where revascularization through carotid endarterectomy is planned.
Step 2
Initial assessment
An initial assessment is conducted to gather baseline data. This includes measuring the percentage of mast cell activation using a technique called flow cytometry.
Step 3
Treatment administration
The patient receives a treatment with an anti-IgE monoclonal antibody called omalizumab. This is administered as an intramuscular injection using a product named Xolair, which is a 150 mg solution for injection in a pre-filled syringe.
Step 4
Monitoring and follow-up
The effects of the treatment are monitored. This includes measuring the level of inflammation and the percentage of various inflammatory cells in the immune cell suspension obtained from the plaque.
The treatment's impact on circulating IgE levels, tryptase levels, and the activation status of basophils is also assessed.
Additional evaluations include examining the plaque phenotype, such as necrotic area and cellular composition, and monitoring circulating white blood cell count and other markers of inflammation.
Step 5
Safety assessment
Safety is assessed by documenting any arterial thromboembolic events that occur during the study.
Step 6
Completion of the study
The study is estimated to conclude by October 2027. At this point, all data collected will be analyzed to determine the effectiveness and safety of the treatment.

Who can join the trial?

4 criteria

The patient must be **18 years or older**.
The patient must be able and willing to give their consent and sign an **informed consent**. This means they understand the study and agree to participate.
The patient must have **carotid artery stenosis**, which is a narrowing of the carotid artery. This narrowing must be at least **50%**. The carotid artery is a major blood vessel in the neck that supplies blood to the brain.
The patient must be scheduled for a **carotid endarterectomy**, which is a surgical procedure to remove the buildup of plaque in the carotid artery.

Who cannot join the trial?

5 criteria

Patients with **carotid artery stenosis** cannot participate. This is a condition where the large blood vessels in the neck that supply blood to the brain become narrowed.
Patients who have had a **carotid endarterectomy** are excluded. This is a surgical procedure to remove plaque buildup from the carotid artery.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Both male and female patients are eligible, but those who do not meet other criteria will be excluded.
Patients who are considered part of a **vulnerable population** are not eligible. This term refers to groups who may be at a higher risk of harm or exploitation.

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Universitair Medisch Centrum Utrecht
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Utrecht, The Netherlands

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Investigated drugs

Omalizumab is a monoclonal antibody used in this clinical trial to investigate its ability to limit mast cell activation within atherosclerotic plaques. The study aims to see if this treatment can reduce the activity of mast cells in the plaques found in the arteries, which are often associated with atherosclerosis.

Omalizumab

What is already known about the treatment

Omalizumab – Omalizumab is administered as an injection under the skin, typically in a healthcare setting. It is currently being studied for its potential to reduce mast cell activation in atherosclerotic plaques, particularly in patients with carotid artery stenosis. The main therapeutic indication being explored is its ability to limit inflammation within these plaques, which could help prevent complications like stroke. At the molecular level, omalizumab works by binding to immunoglobulin E (IgE) antibodies, preventing them from attaching to mast cells and basophils, thereby reducing allergic responses and inflammation. It is classified as a monoclonal antibody used primarily for allergic conditions, but its role in cardiovascular diseases is under investigation.

Investigated diseases

Carotid Artery Stenosis – This condition involves the narrowing of the carotid arteries, which are the major blood vessels in the neck that supply blood to the brain. The narrowing is usually caused by a buildup of plaque, which is a combination of fat, cholesterol, and other substances. As the plaque accumulates, it can restrict blood flow to the brain, potentially leading to serious complications. Over time, the plaque may harden or rupture, which can further impede blood flow or cause a blood clot to form. This process can progress slowly and may not present symptoms until the arteries are significantly narrowed. Regular monitoring and lifestyle changes are often recommended to manage the progression of this condition.