Depemokimab Asthma Imaging and Bronchoscopy Sub-Study

NCT06979323 | Recruiting Phase 3 FDA Drug

• 2 other identifiers: 2235292024-519976-19
• Study Type: interventional
• Target: 150
• Locations: 11 countries
• Sites: 43

Brief 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 type 2 inflammation, characterized by an eosinophilic phenotype.

Conditions

Asthma

Keywords

Depemokimab; Asthma; Type 2 Inflammation; Eosinophilic Phenotype; High Resolution Computed Tomography (HRCT); Bronchoscopy; IMAGINE study

Outcome Measures

Primary Outcomes (1)

• 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.

  From Baseline up to Week 26

Secondary Outcomes (9)

• Mean Change from Baseline in Airway Wall Thickness Measured at TLC at Week 52

  From Baseline up to Week 52

• Mean Change from Baseline in Airway Wall Thickness Measured at TLC at Week 26

  From Baseline up to Week 26

• Mean Change from Baseline in Total Mucus Plug Volume Measured at TLC at Week 52

  From Baseline up to Week 52

• Mean Change from Baseline at Week 26 for Mucus Segment Score

  From Baseline up to Week 26

• Mean Change from Baseline at Week 52 for Mucus Segment Score

  From Baseline up to Week 52

Study Arms (1)

Depemokimab

EXPERIMENTAL

Participants with asthma with type 2 inflammation will receive depemokimab.

Biological: Depemokimab

Interventions

Depemokimab BIOLOGICAL

Depemokimab will be administered.

Depemokimab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (43)

GSK Investigational Site

Brooksville, Florida, 34613, United States

RECRUITING

GSK Investigational Site

Plantation, Florida, 33324, United States

RECRUITING

GSK Investigational Site

Kansas City, Kansas, 66160, United States

RECRUITING

GSK Investigational Site

St Louis, Missouri, 63110, United States

RECRUITING

GSK Investigational Site

New Brunswick, New Jersey, 08901, United States

RECRUITING

GSK Investigational Site

New York, New York, 10029, United States

RECRUITING

GSK Investigational Site

DuBois, Pennsylvania, 15801, United States

RECRUITING

GSK Investigational Site

Philadelphia, Pennsylvania, 19140-5103, United States

RECRUITING

GSK Investigational Site

McKinney, Texas, 75069, United States

RECRUITING

GSK Investigational Site

Mechelen, 2800, Belgium

RECRUITING

GSK Investigational Site

Namur, 5101, Belgium

RECRUITING

GSK Investigational Site

Ajax, Ontario, L1S 2J5, Canada

RECRUITING

GSK Investigational Site

Hamilton, Ontario, L8N 3Z5, Canada

RECRUITING

GSK Investigational Site

London, Ontario, N6A 5A5, Canada

RECRUITING

GSK Investigational Site

Guangzhou, 510163, China

RECRUITING

GSK Investigational Site

Shanghai, 200080, China

RECRUITING

GSK Investigational Site

Tianjin, 300052, China

RECRUITING

GSK Investigational Site

Brest, 29200, France

RECRUITING

GSK Investigational Site

Créteil, 94010, France

RECRUITING

GSK Investigational Site

La Tronche, 38700, France

RECRUITING

GSK Investigational Site

Pessac, 33604, France

RECRUITING

GSK Investigational Site

Reims, 51092, France

RECRUITING

GSK Investigational Site

Bonn, 53127, Germany

RECRUITING

GSK Investigational Site

Frankfurt, 60389, Germany

RECRUITING

GSK Investigational Site

Athens, 106 76, Greece

RECRUITING

GSK Investigational Site

Athens, 115 21, Greece

RECRUITING

GSK Investigational Site

Heraklion, Greece

RECRUITING

GSK Investigational Site

Ioannina, 45500, Greece

RECRUITING

GSK Investigational Site

Thessaloniki, Greece

RECRUITING

GSK Investigational Site

Roma, 00168, Italy

RECRUITING

GSK Investigational Site

Barcelona, Spain

RECRUITING

GSK Investigational Site

Barcelona, Spain

RECRUITING

GSK Investigational Site

Benalmádena, 29631, Spain

RECRUITING

GSK Investigational Site

Madrid, 28031, Spain

RECRUITING

GSK Investigational Site

Palma de Mallorca, 070120, Spain

RECRUITING

GSK Investigational Site

Santander, 39008, Spain

RECRUITING

GSK Investigational Site

Kaohsiung City, Taiwan

RECRUITING

GSK Investigational Site

Taichung, 407, Taiwan

RECRUITING

GSK Investigational Site

Taipei, 100, Taiwan

RECRUITING

GSK Investigational Site

Bradford, BD9 6RJ, United Kingdom

RECRUITING

GSK Investigational Site

London, SE1 9RT, United Kingdom

RECRUITING

GSK Investigational Site

London, W6 8RF, United Kingdom

RECRUITING

GSK Investigational Site

Southampton, SO16 6YD, United Kingdom

RECRUITING

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a single arm study

Study Record Dates

• First Submitted: May 16, 2025
• First Posted: May 18, 2025
• Study Start: June 3, 2025
• Primary Completion (Estimated): December 8, 2027
• Study Completion (Estimated): February 11, 2028
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.
• 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.

Locations

US (9); CN (3); TW (3); ES (6); IT (1); CA (3); BE (2); GB (4); FR (5); GR (5); DE (2)