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Study on Omalizumab and Mepolizumab for Patients with Severe Allergic and Eosinophilic Asthma

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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 treatments for severe allergic and eosinophilic asthma, a type of asthma characterized by high levels of certain white blood cells called eosinophils and allergic reactions. The study will compare two medications: omalizumab and mepolizumab. Omalizumab, also known by its code name IGE-025A, is a medication that helps reduce allergic reactions by targeting a specific protein in the body. Mepolizumab, also known as SB240563, works by reducing the number of eosinophils, which are involved in causing inflammation in asthma.

The purpose of the study is to compare how well patients with severe allergic and eosinophilic asthma respond to these two treatments. Participants will receive either omalizumab or mepolizumab through a subcutaneous injection, which means the medication is injected under the skin. The study will last for a period of 22 weeks, during which the response to the treatments will be monitored. This includes observing the rate of severe asthma attacks and other asthma-related outcomes, such as disease control and quality of life.

Throughout the study, researchers will also look at various factors that might predict a better response to either omalizumab or mepolizumab. These factors include age at the onset of severe asthma, the presence of nasal polyps, and certain blood markers. The goal is to understand which treatment might work best for different patients based on these characteristics. This information could help tailor asthma treatments more effectively in the future.

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 visit

    Upon joining the study, you will attend an initial visit. During this visit, you will review and sign the informed consent form, confirming your understanding and agreement to participate in the trial.

    Your eligibility will be confirmed based on criteria such as age, asthma diagnosis, and previous treatments. You must be between 18 and 90 years old and have a documented diagnosis of severe allergic and eosinophilic asthma.

  2. Step 2

    Randomization

    After confirming eligibility, you will be randomly assigned to receive either omalizumab or mepolizumab. This process is random to ensure unbiased results.

  3. Step 3

    Treatment administration

    You will receive your assigned medication through a subcutaneous injection, which means the medication is injected under the skin.

    The dosage and frequency of administration will be determined by the study protocol and your healthcare provider. This will continue for the duration of the trial, which is estimated to last up to one year.

  4. Step 4

    Regular follow-up visits

    Throughout the trial, you will attend regular follow-up visits. These visits are important for monitoring your health and the effectiveness of the treatment.

    During these visits, various assessments will be conducted, including blood tests and questionnaires about your asthma symptoms and quality of life.

  5. Step 5

    End of treatment evaluation

    At the end of the treatment period, a final evaluation will be conducted. This will include a comprehensive assessment of your response to the medication.

    The primary focus will be on the rate of severe asthma exacerbations and other asthma-related outcomes.

Who can join the trial?

5 criteria

  • Signed informed consent form (ICF): You must agree to participate in the study by signing a form that explains the study details.
  • Age: You must be between 18 and 90 years old.
  • Able to comply with the study protocol: You must be able to follow the study instructions and procedures, as judged by the study doctor.
  • Documented physician-diagnosed asthma: You must have a diagnosis of asthma confirmed by a doctor.
  • Eligible to receive omalizumab and mepolizumab: These are specific treatments for asthma. You must be suitable to receive these treatments and have not yet started them.

Who cannot join the trial?

3 criteria

  • Patients who do not have severe allergic and eosinophilic asthma cannot participate. This means the study is only for those with a specific type of asthma that involves severe allergies and a high number of a type of white blood cell called eosinophils.
  • Patients who are not within the specified age range cannot participate. The study is for certain age groups, so if you are outside this range, you cannot join.
  • Patients who are part of a vulnerable population cannot participate. This means people who might need special protection or care are not included in the study.
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Investigated drugs

  • Omalizumab

    is a medication used to treat severe allergic asthma. It works by blocking a substance in the body called immunoglobulin E (IgE), which plays a key role in causing allergic reactions. By reducing the effects of IgE, omalizumab helps to decrease the number of asthma attacks and improve breathing in people with severe asthma that is not well controlled with other treatments.

  • Mepolizumab

    is a medication used for treating severe eosinophilic asthma. It targets and blocks a protein in the body called interleukin-5 (IL-5), which is involved in the growth and activity of eosinophils, a type of white blood cell that can cause inflammation in the lungs. By reducing the number of eosinophils, mepolizumab helps to lower the frequency of asthma attacks and improve overall asthma control in patients with this specific type of asthma.

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 used in medicine to treat severe allergic asthma, and it is well-documented in medical literature. The main therapeutic indication for omalizumab is to reduce the frequency of asthma attacks in patients with severe allergic asthma. At the molecular level, omalizumab works by blocking a protein called IgE, which plays a key role in allergic reactions. It is classified as a monoclonal antibody.

  • Mepolizumab

    Mepolizumab is given as an injection under the skin, usually in a clinical setting. It is recognized in the medical field for its role in managing severe eosinophilic asthma, with substantial support in medical literature. The primary therapeutic use of mepolizumab is to decrease the number of asthma flare-ups in patients with severe eosinophilic asthma. On a molecular level, mepolizumab functions by inhibiting a protein called interleukin-5 (IL-5), which is involved in the growth and activity of eosinophils, a type of white blood cell. It is classified as a monoclonal antibody.

Investigated diseases

Severe allergic and eosinophilic asthma – This is a chronic respiratory condition characterized by inflammation and narrowing of the airways, often triggered by allergens and marked by high levels of eosinophils, a type of white blood cell. The disease progresses with episodes of wheezing, shortness of breath, chest tightness, and coughing, which can vary in frequency and intensity. Over time, these symptoms can become more persistent and severe, leading to frequent asthma attacks or exacerbations. The inflammation in the airways can cause long-term damage if not managed, resulting in decreased lung function. The condition is often associated with other allergic disorders, such as nasal polyps or aspirin sensitivity. Management focuses on controlling symptoms and preventing exacerbations to maintain quality of life.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516783-29-00Protocol code2017/19JUI/325Estimated enrolment340 patientsSponsorCliniques Universitaires Saint-Luc

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