Depemokimab for Asthma Imaging and Bronchoscopy
This study is looking at how a medicine called depemokimab affects the lungs of people with asthma. Depemokimab is a monoclonal antibody, a type of medicine that targets specific cells or proteins in the body. The study wants to see if depemokimab can reduce the amount of mucus plugs in your lungs, which can make breathing difficult. To join, you need to be at least 18 years old and have had asthma for at least two years, as diagnosed by standard medical guidelines. The main goal is to measure changes in mucus plug volume after 26 weeks. The current status of this study is unclear, but it plans to enroll about 150 participants.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It aims to enroll 150 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint is measured up to Week 26, which gives an idea of the study duration for this measurement.
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NCT06979323
Depemokimab Asthma Imaging and Bronchoscopy Sub-Study
Recruiting
PHASE3Ages 18+InterventionalTreatmentGlaxoSmithKline
~150 participants
Updated 2026-07-02 on ClinicalTrials.gov
What's tested:Depemokimab
At a glance
Recruiting sites
49 of 50 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Mean Change from Baseline in Total Mucus Plug Volume Measured at Total Lung Capacity (TLC) at Week 26
Measured over From Baseline up to Week 26
Conditions
Where it's being run
50 sites across 18 statesSpain6
France5
Greece5
Italy4
South Korea4
United Kingdom4
Ontario3
China3
Study leadership
- GSK Clinical Trials · STUDY_DIRECTOR · GlaxoSmithKline
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Documented clinical diagnosis of asthma for greater than or equal to (\>=) 2 years as per the National Heart, Lung, and Blood Institute guidelines (NHLBI, 2020) or GINA guidelines (GINA, 2024), or joint guidance from the British Thoracic Society, National Institute for Health and Care Excellence, and Scottish Intercollegiate Guidelines Network \[NICE, 2024\] along with the following: an eosinophilic phenotype as evidenced by a blood eosinophil count of \>=300 cells/microliters (mcL) at screening or a documented history of blood eosinophil count \>=300 cells/mcL within 3 months prior to screening; Exhaled nitric oxide (FeNO) measure of \>=25 parts per billion (ppb) recorded at screening; and a previously confirmed history of \>= 2 exacerbations requiring treatment with systemic corticosteroid (SCS; intramuscular \[IM\], intravenous \[IV\], or oral), in the 12 months prior to screening, despite the use of medium to high dose Inhaled corticosteroids (ICS)
Uncontrolled asthma indicated by Astha Control Questionnaire-5 (ACQ-5) greater than (\>) 1.5 recorded at screening
Persistent airflow obstruction as indicated by pre-bronchodilator Forced Expiration Volume in 1 second (FEV1) less than (\<) 80 percentage (%) predicted (GLI 2012) and recorded at screening
A well-documented requirement for regular treatment with medium or high dose ICS (in the 12 months prior to screening with or without maintenance oral corticosteroids \[OCS\])
Current treatment with at least one additional asthma controller medication, besides ICS, for at least 3 months \[for example, Long-acting Beta 2 agonists \[LABA\], Long-acting muscarinic antagonists \[LAMA\], leukotriene receptor antagonist (LTRA), or theophylline\]
Male Participants: No additional requirements for male participants
A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: is a participant of non-childbearing potential (PONCBP) or is a participant of childbearing potential (POCBP) and using a contraceptive method that is highly effective (with a failure rate of \<1% per year), with low user dependency,
A POCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 24 hours before the first dose of study intervention
Capable of giving written informed consent,
For the bronchoscopy sub study participants who sign the Informed Consent for the biopsy sub study, the following additional eligibility criteria will apply:
Participants not on maintenance OCS (oral corticosteroids) at the time of screening.
Participants with post bronchodilator FEV1 \>= 50% predicted
Participants with no known increased risk for bleeding or clotting abnormalities including: No history of easy bleeding, bruising or known bleeding diathesis; No current anticoagulant and antiplatelet therapy; No acetylsalicylic acid use within 2 weeks of the planned procedure; Normal screening platelet count
Participants with no specific contraindication to bronchoscopy with endobronchial biopsy in the opinion of the investigator
No history of allergic reaction to local anesthesia or general anesthetic agent, whichever is relevant to the procedure being performed
Exclusion
Presence of a known pre-existing, clinically important lung condition other than asthma. This includes (but is not limited to) current infection, bronchiectasis, pulmonary fibrosis, bronchopulmonary aspergillosis, or a history of lung cancer. Participants with current diagnoses of emphysema or chronic bronchitis (Chronic obstructive pulmonary disease \[COPD\] other than asthma) are excluded
Participants with other conditions that could lead to elevated eosinophils such as hyper eosinophilic syndromes including (but not limited to) Eosinophilic Granulomatosis with Polyangiitis (EGPA, formerly known as Churg-Strauss Syndrome) or eosinophilic esophagitis
Participants who developed an exacerbation within 4 weeks before screening
Participants with a known, pre-existing parasitic infestation within 6 months prior to screening unless treated and evidenced to have been resolved
A known immunodeficiency (e.g. human immunodeficiency virus HIV), other than that explained by the use of corticosteroids (CSs) taken as therapy for asthma
A current malignancy or previous history of cancer in remission for less than 12 months prior to screening
Participants who have known, pre-existing, clinically significant cardiac, endocrine, autoimmune, metabolic, neurological, psychiatric, renal, gastrointestinal, hepatic, hematologic abnormalities or any other system abnormalities that are uncontrolled with standard treatment
Participants with current diagnosis of vasculitis
Participants who have a previous documented failure with anti-IL-5/5R therapy
Participants who have received monoclonal antibody (mAb) therapy targeting IL 5/5R, IL 4R/IL 13, IL 33, IgE, or Thymic Stromal Lymphpoietin (TSLP) within 12 months or 5 terminal phase half-lives of the drug, whichever is longer prior to the screening. Authorized treatments for Coronavirus disease-2019 (COVID-19) are permitted
Participants who have received treatment with an investigational drug within the past 30 days or 5 terminal phase half-lives of the drug whichever is longer, prior to the first dose of study intervention (this also includes investigational formulations of marketed products)
Previously participated in any clinical study with biologic treatments for asthma (for example, omalizumab, mepolizumab, dupilumab, reslizumab, benralizumab, other mAbs (including Tezepelumab) or depemokimab and received study intervention (including placebo) within 12 months prior to the first dose of study intervention
A history (or suspected history) of alcohol misuse or substance abuse within 2 years prior to the first dose of study intervention
Current smokers or former smokers with a smoking history \>=20 pack years (number of pack years = \[number of cigarettes per day/20\] x number of years smoked) and vapers
Participants with allergy/intolerance to a mAb or biologic or any of the excipients of depemokimab
Participants who are pregnant or breastfeeding
Participants who have known evidence of lack of adherence to controller medications and/or ability to follow physician's recommendations
Participants who have occupational ionizing-radiation exposure exceeding 10 Millisievert (mSV) over 3 years as documented with a dosimeter; have been exposed to elevated ionizing radiation from research imaging studies, for example, Participation in a research study with a single positron emission tomography scan in the past 3 years, and Participation in a research study with 2 or more computed tomography (CT) scans in the past 3 years in the following anatomical regions: chest, abdomen, cardiac, or spine
Presence of metal objects that may interfere with chest CT quantification including presence of a cardiac pacemaker, defibrillator, metal prosthetic heart valve, metal projectile or metal weapon fragment (bullet, shrapnel, shotgun shot) or metal shoulder prosthesis
Evidence of clinically significant abnormality in the hematological, biochemical or urinalysis screen at screening (Visit 0), as judged by the investigator
What this trial measures
- Mean Change from Baseline in Total Mucus Plug Volume Measured at Total Lung Capacity (TLC) at Week 26From Baseline up to Week 26
Mean change from baseline in total mucus plug volume measured at TLC at Week 26 will be assessed.