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New asthma drug aims to clear mucus and protect airways

NCT ID NCT06979323

Disease control Sponsor: GlaxoSmithKline Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 02, 2026 · Updated 1 time

Summary

This study tests a drug called depemokimab in 150 adults with severe asthma caused by a specific type of inflammation. The goal is to see if the drug can reduce mucus plugs and airway thickening in the lungs. Participants will receive the drug and have lung scans and breathing tests over 52 weeks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2024

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

asthma T2-high asthma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Asthma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    49 sites in 12 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • GSK Investigational Site

    RECRUITING

    Brooksville, Florida, 34613, United States

  • GSK Investigational Site

    RECRUITING

    Plantation, Florida, 33324, United States

  • GSK Investigational Site

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • GSK Investigational Site

    RECRUITING

    St Louis, Missouri, 63110, United States

  • GSK Investigational Site

    RECRUITING

    New Brunswick, New Jersey, 08901, United States

  • GSK Investigational Site

    RECRUITING

    New York, New York, 10029, United States

  • GSK Investigational Site

    RECRUITING

    DuBois, Pennsylvania, 15801, United States

  • GSK Investigational Site

    RECRUITING

    Philadelphia, Pennsylvania, 19140-5103, United States

  • GSK Investigational Site

    COMPLETED

    McKinney, Texas, 75069, United States

  • GSK Investigational Site

    RECRUITING

    Mechelen, 2800, Belgium

  • GSK Investigational Site

    RECRUITING

    Namur, 5101, Belgium

  • GSK Investigational Site

    RECRUITING

    Ajax, Ontario, L1S 2J5, Canada

  • GSK Investigational Site

    RECRUITING

    Hamilton, Ontario, L8N 3Z5, Canada

  • GSK Investigational Site

    RECRUITING

    London, Ontario, N6A 5A5, Canada

  • GSK Investigational Site

    RECRUITING

    Guangzhou, 510163, China

  • GSK Investigational Site

    RECRUITING

    Shanghai, 200080, China

  • GSK Investigational Site

    RECRUITING

    Tianjin, 300052, China

  • GSK Investigational Site

    RECRUITING

    Brest, 29200, France

  • GSK Investigational Site

    RECRUITING

    Créteil, 94010, France

  • GSK Investigational Site

    RECRUITING

    La Tronche, 38700, France

  • GSK Investigational Site

    RECRUITING

    Pessac, 33604, France

  • GSK Investigational Site

    RECRUITING

    Reims, 51092, France

  • GSK Investigational Site

    RECRUITING

    Bonn, 53127, Germany

  • GSK Investigational Site

    RECRUITING

    Frankfurt, 60389, Germany

  • GSK Investigational Site

    RECRUITING

    Athens, 106 76, Greece

  • GSK Investigational Site

    RECRUITING

    Athens, 115 21, Greece

  • GSK Investigational Site

    RECRUITING

    Heraklion, Greece

  • GSK Investigational Site

    RECRUITING

    Ioannina, 45500, Greece

  • GSK Investigational Site

    RECRUITING

    Thessaloniki, Greece

  • GSK Investigational Site

    RECRUITING

    Catania, Italy

  • GSK Investigational Site

    RECRUITING

    Genova, 16132, Italy

  • GSK Investigational Site

    RECRUITING

    Roma, 00168, Italy

  • GSK Investigational Site

    RECRUITING

    Rozzano, 20089, Italy

  • GSK Investigational Site

    RECRUITING

    Jeonju, 54907, South Korea

  • GSK Investigational Site

    RECRUITING

    Seoul, 03080, South Korea

  • GSK Investigational Site

    RECRUITING

    Seoul, 03722, South Korea

  • GSK Investigational Site

    RECRUITING

    Seoul, 06351, South Korea

  • GSK Investigational Site

    RECRUITING

    Barcelona, Spain

  • GSK Investigational Site

    RECRUITING

    Barcelona, Spain

  • GSK Investigational Site

    RECRUITING

    Benalmádena, 29631, Spain

  • GSK Investigational Site

    RECRUITING

    Madrid, 28031, Spain

  • GSK Investigational Site

    RECRUITING

    Palma de Mallorca, 070120, Spain

  • GSK Investigational Site

    RECRUITING

    Santander, 39008, Spain

  • GSK Investigational Site

    RECRUITING

    Kaohsiung City, Taiwan

  • GSK Investigational Site

    RECRUITING

    Taichung, 407, Taiwan

  • GSK Investigational Site

    RECRUITING

    Taipei, 100, Taiwan

  • GSK Investigational Site

    RECRUITING

    Bradford, BD9 6RJ, United Kingdom

  • GSK Investigational Site

    RECRUITING

    London, SE1 9RT, United Kingdom

  • GSK Investigational Site

    RECRUITING

    London, W6 8RF, United Kingdom

  • GSK Investigational Site

    RECRUITING

    Southampton, SO16 6YD, United Kingdom

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