Recruiting
Phase 3

Depemokimab

Sponsor:

GlaxoSmithKline

Code:

NCT06979323

Conditions

Asthma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Depemokimab

Study Details

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

Study ID

NCT06979323

Start date

Jul 19, 2024

Status verified date

Jun, 2026

Completion date

Feb 11, 2028

Anticipated

Primary completion date

Jan 5, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

150 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Depemokimab

Participants with asthma with type 2 inflammation will receive depemokimab.

Interventions

Depemokimab

Depemokimab will be administered.

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 ]

Central Contacts and Locations

Central contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

+44 (0) 20 89904466GSKClinicalSupportHD@gsk.com

Locations

GSK Investigational Site

Recruiting

Brooksville, Florida, United States, 34613

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Salman Muddassir

GSK Investigational Site

Recruiting

Plantation, Florida, United States, 33324

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Frank Hull

GSK Investigational Site

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Mario Castro

GSK Investigational Site

Recruiting

St Louis, Missouri, United States, 63110

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

James Krings

GSK Investigational Site

Recruiting

New Brunswick, New Jersey, United States, 08901

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Reynold Panettieri

GSK Investigational Site

Recruiting

New York, New York, United States, 10029

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Monica Kraft

GSK Investigational Site

Recruiting

DuBois, Pennsylvania, United States, 15801

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Sandeep Bansal

GSK Investigational Site

Recruiting

Philadelphia, Pennsylvania, United States, 19140-5103

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Kartik Shenoy

GSK Investigational Site

Recruiting

Ajax, Ontario, Canada, L1S 2J5

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

George Philteos

GSK Investigational Site

Recruiting

Hamilton, Ontario, Canada, L8N 3Z5

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Imran Satia

GSK Investigational Site

Recruiting

London, Ontario, Canada, N6A 5A5

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Hana Serajeddini

More Information

Sponsor

GlaxoSmithKline

Last update posted

Jul 2, 2026

Last verified

Jun, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by GlaxoSmithKline on 2026-07-02.