AsthmaPhase 3NCT06979323

Depemokimab Asthma Imaging and Bronchoscopy Sub-Study

A Phase 3 study testing Depemokimab in people with Asthma, run by GlaxoSmithKline at 50 sites in 12 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Trial summary

Asthma is a chronic condition marked by narrowed and swollen airways due to inflammation leading to recurring symptoms that can vary and worsen unpredictably.\xa0The purpose of this study is to assess how depemokimab, a monoclonal antibody, affects the structure and function of the lungs in asthmatic participants with… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Asthma
What is being tested?: Depemokimab
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 150 participants
Where: 50 sitesin 12 countries
Study dates: 19 Jul 2024to 11 Feb 2028
Phase: Phase 3
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

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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

Who cannot join

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

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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

Trial locations and contacts

50 sites in 12 countries. Contact the study team or a site near you to ask about taking part.

US GSK Clinical Trials Call Center contact

877-379-3718

GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center contact

+44 (0) 20 89904466

GSKClinicalSupportHD@gsk.com

Country

City, postcode or hospital

Sites recruiting now only

50 sites in 12 countries

United States9 sites, 8 recruiting

GSK Investigational Site
Brooksville, Florida, 34613
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
DuBois, Pennsylvania, 15801
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Kansas City, Kansas, 66160
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
McKinney, Texas, 75069
Completed
GSK Investigational Site
New Brunswick, New Jersey, 08901
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
New York, New York, 10029
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Philadelphia, Pennsylvania, 19140-5103
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Plantation, Florida, 33324
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
St Louis, Missouri, 63110
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting

Other trials in United States

Spain6 sites, 6 recruiting

GSK Investigational Site
Barcelona
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Barcelona
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Benalmádena, 29631
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Madrid, 28031
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Palma de Mallorca, 070120
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Santander, 39008
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting

Other trials in Spain

France5 sites, 5 recruiting

GSK Investigational Site
Brest, 29200
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Créteil, 94010
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
La Tronche, 38700
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Pessac, 33604
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Reims, 51092
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting

Other trials in France

Greece5 sites, 5 recruiting

GSK Investigational Site
Athens, 106 76
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Athens, 115 21
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Heraklion
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Ioannina, 45500
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Thessaloniki
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting

Other trials in Greece

Italy4 sites, 4 recruiting

GSK Investigational Site
Catania
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Genova, 16132
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Roma, 00168
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Rozzano, 20089
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting

Other trials in Italy

South Korea4 sites, 4 recruiting

GSK Investigational Site
Jeonju, 54907
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Seoul, 03080
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Seoul, 03722
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Seoul, 06351
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting

Other trials in South Korea

United Kingdom4 sites, 4 recruiting

GSK Investigational Site
Bradford, BD9 6RJ
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
London, SE1 9RT
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
London, W6 8RF
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Southampton, SO16 6YD
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting

Other trials in United Kingdom

Canada3 sites, 3 recruiting

GSK Investigational Site
Ajax, Ontario, L1S 2J5
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Hamilton, Ontario, L8N 3Z5
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
London, Ontario, N6A 5A5
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting

Other trials in Canada

China3 sites, 3 recruiting

GSK Investigational Site
Guangzhou, 510163
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Shanghai, 200080
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Tianjin, 300052
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting

Other trials in China

Taiwan3 sites, 3 recruiting

GSK Investigational Site
Kaohsiung City
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Taichung, 407
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Taipei, 100
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting

Other trials in Taiwan

Belgium2 sites, 2 recruiting

GSK Investigational Site
Mechelen, 2800
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Namur, 5101
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting

Other trials in Belgium

Germany2 sites, 2 recruiting

GSK Investigational Site
Bonn, 53127
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Frankfurt, 60389
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting

Other trials in Germany

About this study

Official title: The IMAGINE Study: A Phase 3b Open Label, Single Arm Study to Assess the Effect of Depemokimab on Airway Structure and Function in Asthma With Type 2 Inflammation Characterized by an Eosinophilic Phenotype Utilizing Quantitative High-resolution CT and Bronchoscopic Airway Sampling in a Sub Study

Conditions: Asthma
Being tested: Depemokimab
Keywords: Depemokimab, Asthma, Type 2 Inflammation, Eosinophilic Phenotype, High Resolution Computed Tomography (HRCT), Bronchoscopy, IMAGINE study
Medical subject headings: Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DepemokimabBiological
Depemokimab will be administered.

Study groups in NCT06979323
Study group	Role	What they receive
Depemokimab	Experimental	Participants with asthma with type 2 inflammation will receive depemokimab. Receives: Biological: Depemokimab

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Change from Baseline in Total Mucus Plug Volume Measured at Total Lung Capacity (TLC) at Week 26
Mean change from baseline in total mucus plug volume measured at TLC at Week 26 will be assessed.
Measured: From Baseline up to Week 26

Secondary outcomes (9)

Mean Change from Baseline in Airway Wall Thickness Measured at TLC at Week 52
Mean change from baseline in airway wall thickness measured at TLC at Week 52 will be assessed.
Measured: From Baseline up to Week 52
Mean Change from Baseline in Airway Wall Thickness Measured at TLC at Week 26
Mean change from baseline in airway wall thickness measured at TLC at Week 26 will be assessed.
Measured: From Baseline up to Week 26
Mean Change from Baseline in Total Mucus Plug Volume Measured at TLC at Week 52
Mean change from baseline in total mucus plug volume measured at TLC at Week 52 will be assessed.
Measured: From Baseline up to Week 52
Mean Change from Baseline at Week 26 for Mucus Segment Score
Mean change from baseline at Week 26 for mucus segment score will be assessed. The airway is divided into segments and each segment is given a score depending on the presence and severity of mucus. The segments are scored individually and then these scores are summed to give a total mucus score. (A mucus segment score between 0 - 4 indicates low levels of mucus production and a mucus segment score of 5 indicates higher levels of mucus production.)
Measured: From Baseline up to Week 26
Mean Change from Baseline at Week 52 for Mucus Segment Score
Mean change from baseline at Week 52 for mucus segment score will be assessed. The airway is divided into segments and each segment is given a score depending on the presence and severity of mucus. The segments are scored individually and then these scores are summed to give a total mucus score. (A mucus segment score between 0 - 4 indicates low levels of mucus production and a mucus segment score of 5 indicates higher levels of mucus production.)
Measured: From Baseline up to Week 52
Mean Change from Baseline in Pre- and Post- Bronchodilator Forced Expiration Volume in 1 second (BD FEV1) at Week 26
Mean change from baseline in Pre- and Post- BD FEV1 at Week 26 will be assessed.
Measured: From Baseline up to Week 26
Mean Change from Baseline in Pre- and Post-BD FEV1 at Week 52
Mean change from baseline in Pre- and Post-BD FEV1 at Week 52 will be assessed.
Measured: From Baseline up to Week 52
Number of Participants with Adverse Events (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention.
Measured: Up to Week 65 (End of Study)
Number of Participants with Serious Adverse Events (SAE)
Any untoward medical occurrence resulting in death, life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect, possible drug-induced liver injury or any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent serious outcomes were categorized as SAE. Number of participants who had at least one SAE or non-SAE are presented.
Measured: Up to Week 65 (End of Study)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Jul 202411 Feb 2028

First posted18 May 2025
Study start19 Jul 2024
Primary completion5 Jan 2028 (estimated)
Study completion11 Feb 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for AsthmaStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: This is a single arm study
Masking: None (open label)
Enrolment: 150 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06979323
Sponsor's protocol ID: 223529
Other IDs: 2024-519976-19
Status last verified: Jun 2026
First submitted: 16 May 2025
Last updated: 2 Jul 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

Interested in taking part?

US GSK Clinical Trials Call Center

877-379-3718

GSKClinicalSupportHD@gsk.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Study at a glance

From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The IMAGINE Study: A Phase 3b Open Label, Single Arm Study to Assess the Effect of Depemokimab on Airway Structure and Function in Asthma With Type 2 Inflammation Characterized by an Eosinophilic Phenotype Utilizing Quantitative High-resolution CT and Bronchoscopic Airway Sampling in a Sub Study
ClinicalTrials.gov ID: NCT06979323
Acronym / sponsor ID: 223529
Conditions: Asthma
Keywords: Depemokimab, Asthma, Type 2 Inflammation, Eosinophilic Phenotype, High Resolution Computed Tomography (HRCT), Bronchoscopy, IMAGINE study
Phase: Phase 3
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 150 participants (estimated)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 19 Jul 2024 (actual)
Primary completion: 5 Jan 2028 (estimated)
Study completion: 11 Feb 2028 (estimated)
First posted: 18 May 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: This is a single arm study

Arm	Type	Receives
Depemokimab	Experimental	Biological: DepemokimabParticipants with asthma with type 2 inflammation will receive depemokimab.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (15 listed)

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]

Key exclusion criteria (20 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DepemokimabDepemokimab will be administered.	Biological	Depemokimab

Primary outcome

Mean Change from Baseline in Total Mucus Plug Volume Measured at Total Lung Capacity (TLC) at Week 26
Time frame: From Baseline up to Week 26
Mean change from baseline in total mucus plug volume measured at TLC at Week 26 will be assessed.

9 secondary outcomes

Mean Change from Baseline in Airway Wall Thickness Measured at TLC at Week 52
Time frame: From Baseline up to Week 52
Mean Change from Baseline in Airway Wall Thickness Measured at TLC at Week 26
Time frame: From Baseline up to Week 26
Mean Change from Baseline in Total Mucus Plug Volume Measured at TLC at Week 52
Time frame: From Baseline up to Week 52
Mean Change from Baseline at Week 26 for Mucus Segment Score
Time frame: From Baseline up to Week 26
Mean Change from Baseline at Week 52 for Mucus Segment Score
Time frame: From Baseline up to Week 52
Mean Change from Baseline in Pre- and Post- Bronchodilator Forced Expiration Volume in 1 second (BD FEV1) at Week 26
Time frame: From Baseline up to Week 26
Mean Change from Baseline in Pre- and Post-BD FEV1 at Week 52
Time frame: From Baseline up to Week 52
Number of Participants with Adverse Events (AE)
Time frame: Up to Week 65 (End of Study)
Number of Participants with Serious Adverse Events (SAE)
Time frame: Up to Week 65 (End of Study)

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
Individual participant dataSharing planned: Yes. Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

US GSK Clinical Trials Call Center contact

877-379-3718

GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center contact

+44 (0) 20 89904466

GSKClinicalSupportHD@gsk.com

GSK Clinical Trials study director

GlaxoSmithKline

50 sites in 12 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Depemokimab in people with Asthma, run by GlaxoSmithKline at 50 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 sites in United States, Spain, France, Greece, Italy and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact US GSK Clinical Trials Call Center (877-379-3718, GSKClinicalSupportHD@gsk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change from Baseline in Total Mucus Plug Volume Measured at Total Lung Capacity (TLC) at Week 26 (time frame: From Baseline up to Week 26). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06979323.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.