Study of depemokimab to improve airway function in patients with type 2 eosinophilic asthma

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Evangelismos S.A. Athens Greece
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Catania Italy
University General Hospital Of Ioannina Ioannina Greece
Hospital Clinic De Barcelona Barcelona Spain
IRCCS Ospedale Policlinico San Martino Genoa Italy
Centre Hospitalier Universitaire De Montpellier Montpellier France
General University Hospital Of Patras Patras Greece
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Hospital Vithas Xanit Internacional Benalmadena Spain
Thoraxklinik Heidelberg gGmbH Heidelberg Germany
Centre Hospitalier Regional De La Citadelle Liege Belgium
Geniko Nosokomeio Thessalonikis George Papanikolaou Thessaloniki Greece
Algemeen Ziekenhuis Groeninge Kortrijk Belgium
Hospital Universitario Infanta Leonor Madrid Spain
University General Hospital Of Heraklion Heraklion Greece
Hospital Universitario Dr Peset Aleixandre Valencia Spain
Athens Naval Hospital Athens Greece
Pneumocare Namur Belgium
IKF Pneumologie GmbH & Co. KG Frankfurt Germany
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Servei De Salut De Les Illes Balears Palma Spain
Cjmhkq Hrhqxuriamb Usdiyroftvnks Rwheb Reims France
Hcnrifyy Ujoadihgweamj Mjiknsu Dp Vtkoifzwwh Santander Spain
Eyerfgc Mechelen Belgium
Uupjhsbldp Oh Ahtdgnt Edegem Belgium
Lsdox Gunncst Hcykixde Of Abfmah Athens Greece
Sgighdppeadybk Dqb Kqusys Frankfurt Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
01.11.2025
France France
Recruiting
01.11.2025
Germany Germany
Recruiting
01.11.2025
Greece Greece
Recruiting
01.11.2025
Italy Italy
Recruiting
01.11.2025
Spain Spain
Recruiting
01.11.2025

Trial locations

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.

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 ID:
2024-519976-19-00
Protocol code:
223529
NCT ID:
NCT06979323
Trial Phase:
Therapeutic confirmatory (Phase III)

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