Depemokimab Asthma Imaging and Bronchoscopy Sub-Study

July 1, 2026 updated by: GlaxoSmithKline

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

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 type 2 inflammation, characterized by an eosinophilic phenotype.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
      • Mechelen, Belgium, 2800
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Muriel Lins
      • Namur, Belgium, 5101
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Jean-Benoît Martinot
        • Contact:
        • Contact:
  • Canada
    • Ontario
      • Ajax, Ontario, Canada, L1S 2J5
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • George Philteos
        • Contact:
        • Contact:
      • Hamilton, Ontario, Canada, L8N 3Z5
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Imran Satia
      • London, Ontario, Canada, N6A 5A5
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hana Serajeddini
  • China
      • Guangzhou, China, 510163
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ruchong Chen
      • Shanghai, China, 200080
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Min Zhang
      • Tianjin, China, 300052
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jie Cao
  • France
      • Brest, France, 29200
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Raphael Le Mao
        • Contact:
        • Contact:
      • Créteil, France, 94010
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Amel Boudjemaa
      • La Tronche, France, 38700
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Bruno Degano
      • Pessac, France, 33604
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Patrick Berger
      • Reims, France, 51092
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jeanne-Marie Perotin-Collard
  • Germany
      • Bonn, Germany, 53127
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Dirk Skowasch
        • Contact:
        • Contact:
      • Frankfurt, Germany, 60389
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Claus Keller
        • Contact:
        • Contact:
  • Greece
      • Athens, Greece, 106 76
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Paraskevi Katsaounou
        • Contact:
        • Contact:
      • Athens, Greece, 115 21
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nikolaos Zias
      • Heraklion, Greece
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • KATERINA ANTONIOU
      • Ioannina, Greece, 45500
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Konstantinos Kostikas
        • Contact:
        • Contact:
      • Thessaloniki, Greece
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Konstantinos Porpodis
        • Contact:
        • Contact:
  • Italy
      • Catania, Italy
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Carlo Vancheri
      • Genova, Italy, 16132
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Diego Bagnasco
      • Roma, Italy, 00168
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Cristiano Caruso
        • Contact:
        • Contact:
      • Rozzano, Italy, 20089
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Enrico Marco Heffler
  • South Korea
      • Jeonju, South Korea, 54907
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • So Ri Kim
      • Seoul, South Korea, 03080
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Heung-Woo Park
      • Seoul, South Korea, 03722
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Jung-Won Park
        • Contact:
        • Contact:
      • Seoul, South Korea, 06351
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Byung Jae Lee
  • Spain
      • Barcelona, Spain
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ebymar Arismendi Nunez
      • Benalmádena, Spain, 29631
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Gustavo de Luiz Martínez
        • Contact:
        • Contact:
      • Madrid, Spain, 28031
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Ismael Ali Garcia
        • Contact:
        • Contact:
      • Palma de Mallorca, Spain, 070120
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Francisco de Borja García-Cosio Piqueras
      • Santander, Spain, 39008
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Juan Luis Garcia
  • Taiwan
      • Kaohsiung City, Taiwan
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Chau-Chyun Sheu
      • Taichung, Taiwan, 407
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ming-Cheng Chan
      • Taipei, Taiwan, 100
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Pai-Chien Chou
  • United Kingdom
      • Bradford, United Kingdom, BD9 6RJ
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Dinesh Saralaya
        • Contact:
        • Contact:
      • London, United Kingdom, SE1 9RT
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • David Jackson
        • Contact:
        • Contact:
      • London, United Kingdom, W6 8RF
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Salman Siddiqui
      • Southampton, United Kingdom, SO16 6YD
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Hitasha Rupani
        • Contact:
        • Contact:
  • United States
    • Florida
      • Brooksville, Florida, United States, 34613
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Salman Muddassir
      • Plantation, Florida, United States, 33324
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Frank Hull
        • Contact:
        • Contact:
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mario Castro
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • James Krings
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Reynold Panettieri
    • New York
      • New York, New York, United States, 10029
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Monica Kraft
    • Pennsylvania
      • DuBois, Pennsylvania, United States, 15801
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sandeep Bansal
      • Philadelphia, Pennsylvania, United States, 19140-5103
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kartik Shenoy
    • Texas
      • McKinney, Texas, United States, 75069
        • Completed
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Depemokimab
Participants with asthma with type 2 inflammation will receive depemokimab.
Biological: Depemokimab
Depemokimab will be administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From Baseline up to Week 26

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 52 will be assessed.
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 airway wall thickness measured at TLC at Week 26 will be assessed.
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 in total mucus plug volume measured at TLC at Week 52 will be assessed.
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 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.)
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 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.)
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 26 will be assessed.
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
Mean change from baseline in Pre- and Post-BD FEV1 at Week 52 will be assessed.
From Baseline up to Week 52
Number of Participants with Adverse Events (AE)
Time Frame: Up to Week 65 (End of Study)
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.
Up to Week 65 (End of Study)
Number of Participants with Serious Adverse Events (SAE)
Time Frame: Up to Week 65 (End of Study)
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.
Up to Week 65 (End of Study)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Investigators

  • Study Director: GSK Clinical Trials, GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 19, 2024

Primary Completion (Estimated)

January 5, 2028

Study Completion (Estimated)

February 11, 2028

Study Registration Dates

First Submitted

May 16, 2025

First Submitted That Met QC Criteria

May 16, 2025

First Posted (Actual)

May 18, 2025

Study Record Updates

Last Update Posted (Actual)

July 2, 2026

Last Update Submitted That Met QC Criteria

July 1, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 223529
  • 2024-519976-19 (Other Identifier: EU CT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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/

IPD Sharing Time Frame

Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.

IPD Sharing Access Criteria

Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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