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Study on the Effects of Mepolizumab for Achieving Clinical Remission in Patients with Severe 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 the effects of a medication called Nucala on individuals with severe asthma. Severe asthma is a type of asthma that is difficult to control and often requires more intensive treatment. The medication being tested, Nucala, contains an active substance known as mepolizumab, which is administered as a solution for injection. Mepolizumab is a type of protein that helps reduce inflammation in the airways, potentially improving asthma symptoms.

The purpose of this study is to evaluate how well Nucala can help patients with severe asthma achieve what is known as clinical remission, which means a significant reduction or absence of asthma symptoms. Participants in the study will receive Nucala through subcutaneous injections, which means the medication is injected under the skin. The study will follow participants over a period of 24 months to observe the effects of the treatment. Some participants may receive a placebo, which is a substance with no active medication, to compare the results.

Throughout the study, researchers will monitor the participants' asthma symptoms and overall health to determine the effectiveness of Nucala in achieving clinical remission. The study aims to provide valuable insights into the potential benefits of Nucala for individuals with severe asthma, helping to improve treatment options for this challenging condition. Participants will be closely observed to ensure their safety and well-being during the trial period.

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

    Joining the study

    Upon joining the study, the participant must be an adult aged 18 years or over with a confirmed diagnosis of severe asthma.

    The participant must have a physician's decision to start treatment with Nucala and meet specific lung function criteria.

    Written informed consent is required to participate in the study.

  2. Step 2

    Treatment initiation

    The participant will begin treatment with Nucala, which is a 100 mg solution for injection.

    The medication is administered through a subcutaneous injection, which means it is injected under the skin.

    The treatment is provided using either a pre-filled syringe or a pre-filled pen.

  3. Step 3

    Treatment duration

    The treatment with Nucala is expected to continue for a duration of 12 months.

    During this period, the participant's response to the treatment will be monitored to evaluate the achievement of clinical remission.

  4. Step 4

    Evaluation of outcomes

    The primary goal is to assess the proportion of participants achieving clinical remission at 12 months.

    Secondary outcomes include the reduction of asthma exacerbations and the ability to reduce oral corticosteroid use.

    Changes in the participant's quality of life will also be measured using a specific questionnaire.

  5. Step 5

    Completion of the study

    The study is estimated to conclude by July 31, 2026.

    Upon completion, the data collected will be analyzed to determine the effectiveness of Nucala in achieving clinical remission in severe asthma.

Who can join the trial?

6 criteria

  • Adults aged 18 years or older can participate.
  • The participant must have a confirmed diagnosis of **asthma**. This means a doctor has determined that the person has asthma.
  • The doctor must have decided to start treatment with **NUCALA**, which is a medication used for asthma.
  • The participant should have a **predicted FEV1** of 60% or more. **FEV1** stands for "Forced Expiratory Volume in one second," which is a measure of how much air a person can forcefully exhale in one second. It helps to assess lung function.
  • The participant should have 4 or fewer **exacerbations** per year. An **exacerbation** is a worsening or flare-up of asthma symptoms.
  • The participant must provide **written informed consent**. This means they agree to participate in the study after being informed about what it involves.

Who cannot join the trial?

4 criteria

  • Patients with **severe asthma** cannot participate. Severe asthma is a type of asthma that is difficult to control and may require high doses of medication.
  • Patients who are not able to follow the treatment plan with **NUCALA** are excluded. NUCALA is a medication used to treat certain types of asthma.
  • Patients who are not in the age range specified for the study cannot participate. The study is for certain age groups only.
  • Patients who are part of a vulnerable population may not be eligible. Vulnerable populations include groups that may need special protection or care.
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Investigated drugs

Mepolizumab is a medication used in this clinical trial to help people with severe asthma. It works by reducing inflammation in the airways, which can help improve breathing and decrease asthma attacks. The study aims to see how effective mepolizumab is in helping patients achieve clinical remission, meaning their asthma symptoms are significantly reduced or gone.

What is already known about the treatment

Mepolizumab – Mepolizumab is administered as an injection under the skin, typically in a healthcare setting. It is currently recognized in medical literature as a treatment for severe asthma, particularly in patients who do not respond well to standard therapies. The main therapeutic indication for mepolizumab is to help control severe asthma by reducing the frequency of asthma attacks. At the molecular level, mepolizumab works by targeting and inhibiting interleukin-5 (IL-5), a protein that plays a key role in the growth and activation of eosinophils, which are inflammatory cells involved in asthma. It is classified pharmacologically as a monoclonal antibody.

Investigated diseases

Severe Asthma – Severe asthma is a chronic lung condition characterized by frequent and intense symptoms such as wheezing, shortness of breath, chest tightness, and coughing. Unlike mild or moderate asthma, severe asthma does not respond well to standard treatments and can significantly impact daily life. The disease involves inflammation and narrowing of the airways, leading to difficulty in breathing. It often requires specialized management and can be associated with frequent asthma attacks or exacerbations. These exacerbations can lead to increased use of healthcare resources, such as emergency room visits or hospitalizations. The condition may also require the use of high-dose medications to control symptoms and prevent attacks.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509026-21-00Protocol code219871Estimated enrolment336 patientsSponsorGlaxosmithkline Research & Development Limited

sourced from the EU Clinical Trials Register and site verification

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