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Study on Long-Term Safety of Depemokimab for Adults and Adolescents with Severe Eosinophilic Asthma

Verified siteInvestigationalNo placebo
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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 long-term safety of a treatment called GSK3511294, also known as Depemokimab, for individuals with severe asthma that has a specific characteristic known as an eosinophilic phenotype. Asthma is a condition that affects the airways in the lungs, making it difficult to breathe. The eosinophilic phenotype refers to a type of asthma where there is a higher number of a certain type of white blood cell called eosinophils, which can cause inflammation and worsen asthma symptoms.

The purpose of this study is to observe how safe Depemokimab is when used over a long period. Participants in this study will receive Depemokimab as a solution for injection under the skin every 26 weeks, in addition to their existing asthma treatments. The study will last for about 12 months, during which the participants' health will be monitored to identify any side effects or reactions to the treatment.

This study is an open-label extension, meaning that all participants will know they are receiving Depemokimab, and it is designed for those who have already completed previous related studies. The study aims to gather information on any adverse events, which are unexpected medical problems, and to check for any immune responses to the drug, such as the development of antibodies against it. Participants' asthma control and lung function will also be assessed at various points during the study to understand the treatment's impact on their condition.

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

    Participants who completed the previous study intervention treatment during Study 206713 or Study 213744 are eligible to join this study.

    Participants must be adults or adolescents aged 12 years or older. In Germany and the UK, only adults aged 18 years or older are eligible.

    Female participants must not be pregnant or breastfeeding and must use a highly effective contraceptive method if they are of childbearing potential.

  2. Step 2

    Initial assessment

    A highly sensitive urine pregnancy test is required for women of childbearing potential before receiving the first dose.

    Participants must provide signed informed consent, agreeing to comply with the study requirements.

  3. Step 3

    Treatment administration

    The study involves the administration of GSK3511294 (Depemokimab) at a dose of 100 mg.

    The medication is given as a solution for injection under the skin (subcutaneous use) every 26 weeks.

    This treatment is in addition to existing asthma therapy.

  4. Step 4

    Monitoring and follow-up

    The study aims to evaluate the long-term safety of the medication over a 12-month period.

    Participants will be monitored for any adverse events or serious adverse events over 52 weeks.

    The presence of anti-drug antibodies will be measured to assess immunogenicity.

  5. Step 5

    Evaluation of asthma control

    The study will track the annualized rate of clinically significant asthma exacerbations over 52 weeks.

    Changes in asthma control will be assessed using the Asthma Control Questionnaire-5 (ACQ-5) at specific time points.

    Participants' respiratory health will be evaluated using the St. George's Respiratory Questionnaire (SGRQ) at Week 26 and Week 52.

    Lung function will be measured by changes in prebronchodilator FEV1 at Week 26 and Week 52.

Who can join the trial?

6 criteria

  • Participants must have completed the treatment in a previous study, either Study 206713 or Study 213744.
  • Participants must be adults or adolescents who are at least 12 years old at the time of signing the consent form. In some countries, only adults 18 years or older can participate.
  • Both males and females can participate. For females, they must not be pregnant or breastfeeding. If they can have children, they need to use a very reliable method of birth control during the study and for a period after the study ends.
  • Females who can have children must have a negative pregnancy test before starting the study.
  • Participants must be able to understand and sign a consent form, agreeing to follow the study's rules and requirements.
  • In France, participants must be part of a social security system to join the study.

Who cannot join the trial?

7 criteria

  • Participants with any other type of asthma that is not classified as severe asthma with an eosinophilic phenotype. This means the asthma must be severe and related to a high number of a specific type of white blood cell called eosinophils.
  • Participants who are not able to follow the study procedures or attend the required visits.
  • Participants who have any other medical condition that might interfere with the study or make it unsafe for them to participate.
  • Participants who are currently taking part in another clinical trial or have recently participated in one.
  • Participants who have a known allergy or sensitivity to the study medication or any of its ingredients.
  • Participants who are pregnant or breastfeeding, as the effects of the study medication on unborn babies or infants are not known.
  • Participants who have a history of drug or alcohol abuse that might affect their ability to participate in the study.
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Investigated drugs

GSK3511294 (Depemokimab) is a medication being studied for its long-term safety in people with severe asthma who have an eosinophilic phenotype. This medication is given as an injection under the skin every 26 weeks. It is used in addition to the asthma treatments that participants are already receiving. The study aims to understand how safe this medication is when used over a longer period.

What is already known about the treatment

Depemokimab – This medication is administered as a subcutaneous injection, typically given every 26 weeks. It is currently being studied in clinical trials to assess its long-term safety for treating severe asthma with an eosinophilic phenotype. The main therapeutic indication is for patients with this specific type of asthma, which is characterized by high levels of eosinophils, a type of white blood cell. Depemokimab works by targeting and inhibiting interleukin-5 (IL-5), a protein that plays a key role in the growth and activation of eosinophils. It is classified as a monoclonal antibody, which is a type of biologic drug designed to target specific molecules in the body.

Investigated diseases

Severe asthma with an eosinophilic phenotype – This form of asthma is characterized by high levels of eosinophils, a type of white blood cell, in the airways. It often leads to more frequent and severe asthma attacks compared to other types of asthma. Individuals with this condition may experience symptoms such as wheezing, shortness of breath, chest tightness, and coughing. The disease can be persistent and may not respond well to standard asthma treatments. Over time, the inflammation caused by eosinophils can lead to airway remodeling, which may worsen lung function. Managing this condition often requires specialized treatments to control the eosinophilic inflammation.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505203-23-01Protocol code212895Estimated enrolment750 patientsSponsorGlaxosmithkline Research & Development Limited

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