New drug aims to cut dangerous COPD attacks in half
NCT ID NCT06959095
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests an experimental drug called depemokimab for people with moderate to severe COPD who also have type 2 inflammation. The goal is to see if adding this medicine to standard treatment can reduce the number of serious flare-ups that require steroids, antibiotics, or hospital stays. About 981 adults aged 40 to 80 with high eosinophil levels and frequent exacerbations will take part.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 981 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2025
- Expected to finish
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Aug 2029
An estimate. End dates often move.
- Lead sponsor
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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
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40 to 80 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Participants must be greater than or equal to (\>=) 40 to less than or equal to (\<=) 80 years of age, at the time of signing the informed consent. * Elevated blood eosinophil count (BEC). * Moderate to severe COPD with frequent exacerbations, defined as: * A clinically documented history of COPD as defined by the American Thoracic Society/European Respiratory Society for at least 1 year * A post-bronchodilator forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) ratio of less than (\<) 0.70 and a post- bronchodilator FEV1 \>30 percent (%) and \<= 80% predicted normal values * A well-documented history of at least 2 moderate or 1 severe exacerbation in the 12 months prior to screening * COPD assessment test (CAT) score \>=10 at Visit 1. * Smoking status: Current or former cigarette smokers with a history of cigarette smoking of \>=10 pack-years. * Participants should be on optimized inhaler therapy, defined as inhaled corticosteroid (ICS) plus Long-acting muscarinic receptor antagonist (LAMA) plus Long-acting beta2-adrenergic receptor agonist (LABA) either as multiple inhalers or a single combination inhaler for at least 6 months prior to Screening Visit 1. * Body mass index (BMI) \>=16 kilogram per square meter (kg/m\^2). * Male or eligible female participants. Exclusion Criteria: The following subjects are excluded: * Participants with a current or prior physician diagnosis of asthma. * Other clinically significant lung disease: The Investigator must judge that COPD is the primary diagnosis accounting for the clinical manifestations of the lung disease. * Participants with pneumonia, COPD exacerbation, or lower respiratory tract infection within the 4 weeks prior to Screening Visit 1. * Lung resection: Participants with a history of, or plan for lung volume reduction surgery / endobronchial valve procedure. * Pulmonary rehabilitation: Participants in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Screening Visit 1. * Continuous oxygen: Participants requiring oxygen supplementation for more than 12 hours per day. * Cor pulmonale - resulting in right heart failure, severe pulmonary hypertension * Chronic hypercapnia requiring Non-invasive positive pressure ventilation (NIPPV) use (including Bi-Level Positive Airway Pressure \[BiPAP\] or Continuous Positive Airway Pressure \[CPAP\]). * Unstable cardiovascular disease or arrhythmia. * Parasitic Infection: Participants with a known, pre-existing parasitic infection within 6 months of Screening (Visit 1).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
15 sites in 3 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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GSK Investigational Site
RECRUITINGLoxahatchee Groves, Florida, 33470, United States
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GSK Investigational Site
RECRUITINGMiami, Florida, 33155, United States
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GSK Investigational Site
RECRUITINGRock Hill, South Carolina, 29732, United States
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GSK Investigational Site
RECRUITINGCorsicana, Texas, 75110, United States
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GSK Investigational Site
RECRUITINGChangsha, Hunan, 410015, China
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GSK Investigational Site
RECRUITINGChengdu, Sichuan, China
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GSK Investigational Site
RECRUITINGChengdu, 610041, China
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GSK Investigational Site
RECRUITINGGuangzhou, 510150, China
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GSK Investigational Site
RECRUITINGHangzhou, 310000, China
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GSK Investigational Site
RECRUITINGJiangmen, 529000, China
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GSK Investigational Site
RECRUITINGJiangxi, China
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GSK Investigational Site
RECRUITINGMianyang, China
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GSK Investigational Site
RECRUITINGQingyuan, 511500, China
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GSK Investigational Site
RECRUITINGZigong, 643036, China
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GSK Investigational Site
RECRUITINGTokyo, 140-8522, Japan
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