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Study of depemokimab to improve airway function in patients with type 2 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 study focuses on people with Type 2 asthma characterized by an eosinophilic phenotype, which is a form of asthma associated with increased levels of specific inflammatory cells called eosinophils in the blood. The study will test a medication called depemokimab, which is given as an injection under the skin (subcutaneous injection).

The purpose of this research is to understand how depemokimab affects the structure and function of airways in people with this type of asthma. The study will specifically look at changes in the amount of mucus in the lungs and the thickness of airway walls. The treatment period will last 52 weeks, with participants receiving regular doses of the study medication.

During the study, participants will undergo various tests including high-resolution CT scans of their lungs. Some participants may also take part in an optional procedure called a bronchoscopy, which involves inserting a thin tube with a camera into the airways to collect small tissue samples. The study will measure how the airways change over time while participants are receiving the study medication.

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 assessment

    Your asthma condition will be evaluated through specific tests including lung function measurements and blood tests to check eosinophil levels

    A breathing test will measure your exhaled nitric oxide (FeNO) levels

    You will complete an asthma control questionnaire to assess your current symptoms

  2. Step 2

    Treatment initiation

    You will receive depemokimab through an injection under the skin (subcutaneous injection)

    The treatment will continue while maintaining your current asthma medications including inhaled corticosteroids and other controller medications

  3. Step 3

    Week 26 evaluation

    A high-resolution CT scan will be performed to measure mucus in your airways

    Your lung function will be reassessed

    The medical team will evaluate your response to the treatment

  4. Step 4

    Week 52 evaluation

    Another high-resolution CT scan will be performed to measure your airway wall thickness

    Final assessment of your lung function and overall response to treatment will be conducted

  5. Step 5

    Optional bronchoscopy sub-study

    If you agreed to participate in the sub-study, a bronchoscopy procedure will be performed to collect tissue samples from your airways

    This procedure requires separate consent and additional safety assessments

Who can join the trial?

12 criteria

  • Must be 18 years or older
  • Must have been diagnosed with asthma for at least 2 years and have: - Blood test showing 300 or more eosinophils (type of white blood cells) per microliter - Exhaled nitric oxide level of 25 parts per billion or higher - At least 2 severe asthma attacks requiring steroid treatment in the past 12 months
  • Must have uncontrolled asthma with an ACQ-5 score higher than 1.5 (a questionnaire measuring asthma control)
  • Must have reduced lung function with FEV1 less than 80% of predicted value (FEV1 measures how much air you can exhale in one second)
  • Must be using medium or high dose inhaled corticosteroids for at least 12 months
  • Must be using at least one additional asthma control medication for 3 months or more
  • Can be male or female
  • Female participants must either: - Be unable to become pregnant, or - Use highly effective birth control during the study and for 35 weeks after
  • Must have normal blood clotting and no history of easy bleeding
  • Must not be taking blood-thinning medications
  • Must not have had any allergic reactions to anesthesia
  • Must have lung function (FEV1) that is 50% or higher than predicted after using bronchodilator

Who cannot join the trial?

13 criteria

  • History of life-threatening asthma requiring mechanical ventilation or intensive care unit admission in the past 12 months
  • Current active lung infections or diseases other than asthma
  • Severe allergic reactions or history of anaphylaxis to biological treatments
  • Pregnant women or those planning pregnancy during the study period
  • Current participation in other clinical trials or use of investigational drugs within 30 days
  • Significant heart, liver, or kidney disease that could interfere with the study
  • Current smokers or those who quit smoking less than 6 months ago
  • History of cancer within the past 5 years (except for successfully treated non-melanoma skin cancer)
  • Uncontrolled systemic diseases that could affect the study results
  • Known immune system disorders or conditions that affect the immune system
  • Major surgery planned during the study period
  • Unable to perform required breathing tests or use inhalers properly
  • History of poor compliance with medical treatments
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Investigated drugs

Depemokimab is a medication being studied for treating asthma in patients who have Type 2 inflammation with an eosinophilic phenotype. It works by targeting specific inflammatory pathways in the airways. This medication is designed to help reduce mucus plugging in the lungs and improve airway function in people with asthma. The medication is administered to patients while their lungs are at total lung capacity to evaluate its effects on mucus volume and overall lung structure.

What is already known about the treatment

Depemokimab - A novel biological medication administered through subcutaneous injection, specifically developed for treating severe asthma with type 2 inflammation characterized by eosinophilic phenotype. This investigational drug works by targeting and inhibiting specific inflammatory pathways involved in eosinophilic asthma, helping to reduce airway inflammation and mucus production in the lungs. As an experimental monoclonal antibody currently in Phase 3b clinical trials, depemokimab is being studied for its potential effects on airway structure and function, with particular focus on its ability to reduce mucus plug volume in the airways of asthma patients. The medication belongs to the class of biological asthma treatments and represents a potential new option for patients with severe eosinophilic asthma who may not respond adequately to existing treatments.

Investigated diseases

Asthma with type 2 inflammation - A specific form of asthma characterized by inflammation in the airways with high levels of eosinophils, a type of white blood cell. The condition causes the airways to become narrow and swollen, leading to breathing difficulties, coughing, and chest tightness. In this form of asthma, patients typically experience excess mucus production that can form plugs in the airways. The inflammation causes thickening of the airway walls, further restricting airflow. This type of asthma is associated with allergic responses and tends to be persistent.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-519976-19-00Protocol code223529Estimated enrolment106 patientsSponsorGlaxosmithkline Research & Development Limited

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