Tests depemokimab added early to treatment for COPD with type 2 inflammation
Tests depemokimab against placebo in adults with moderate to severe COPD.
Key facts
- Who runs it
- GlaxoSmithKline
- Where
- Bedford, Bradford, and Corby, United KingdomSee the 3 sitesAlso in 19 other countries, 168 sites
- Trial code
- Registry title
- eValuating the Efficacy and Safety of InitiatinG depemokImab earLy therApy iN Chronic Obstructive Pulmonary Disorder (COPD) With Type 2 Inflammation
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 1,196 people, planned
- Started
- 20 Oct 2025
- Expected to end
- 8 Jun 2029
- Type of study
- Interventional, 2 groups
- Treatments tested
- Depemokimab
- Placebo
- Record updated
- 28 July 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with moderate to severe COPD and type 2 inflammation (high blood eosinophils). They have had only 1 moderate flare-up in the past year.
- Age
- 40 to 75 years
- Sex
- Men and women can join.
- Disease stage
- Moderate to severe COPD, documented for at least 1 year, with an FEV1/FVC ratio below 0.70 and FEV1 above 30% and below 80% of predicted. Only 1 moderate flare-up in the past 12 months, plus at least one risk factor (mMRC dyspnea score 2 or more, CAT 15 or more, FEV1 below 50% predicted, or chronic bronchitis).
- Earlier treatment
- Must have used a dual inhaler (ICS+LABA or LABA+LAMA) or a triple inhaler (ICS+LABA+LAMA) for at least 3 months.
- Biomarker or test result
- Eosinophilic type, shown by the blood eosinophil count.
Main reasons for not taking part
- Current or past asthma diagnosis (childhood asthma that resolved before age 18 is allowed)
- More than one moderate flare-up, or any severe flare-up, in the past 12 months
- Pneumonia, COPD flare-up or lower respiratory tract infection in the past 4 weeks
- Lung volume reduction surgery or endobronchial valve procedure, done or planned
- Needs continuous oxygen for COPD, or needs BiPAP or CPAP for chronic hypercapnia
The registry criteria, word for word
Show all 15 criteriaShow less
Who can take part
- Male or eligible female participants
- Eosinophilic phenotype measured using Blood Eosinophil Count (BEC)
- Moderate to severe COPD, defined as; A clinically documented history of COPD for at least 1 year; A post-salbutamol Forced expiratory volume in one second (FEV1)/Forced vital capacity (FVC) ratio of less than (<)0.70 and a post-salbutamol FEV1 greater than (>)30 percent (%) and <80% predicted normal values
- Elevated risk for exacerbations, defined as; A well-documented history of only 1 moderate COPD exacerbation in the prior 12 months and; The presence of risk factors for future exacerbations/deterioration such as:; Modified Medical Research Council (mMRC) dyspnea score >= 2; COPD Assessment Test (CAT) >= 15; Post-bronchodilator FEV1 < 50% predicted; Chronic bronchitis
- Smoking status: Current or former cigarette smokers with a history of cigarette smoking of >=10 pack-years at Screening
- Dual (Inhaled corticosteroid (ICS)+ Long-acting beta2-adrenergic receptor agonist [LABA] or LABA+ Long-acting muscarinic receptor antagonist [LAMA]) or triple (ICS+LABA+LAMA) inhaler therapy as assessed by the investigator for at least 3 months
- Body mass index (BMI) >=16 kilograms per square meter (kg/m\^2)
Who cannot take part
- The Investigator must judge that COPD is the primary diagnosis accounting for the clinical manifestations of lung disease, and clinical manifestations of lung disease where primary diagnosis is not COPD are excluded; Participants with a current or prior physician diagnosis of asthma; Participants with childhood asthma are permitted, provided that childhood asthma has resolved before 18 years of age and has not recurred
- COPD severity: Participants with more than one moderate exacerbation or severe exacerbation in the past 12 months prior to Visit 1
- COPD stability: Participants with pneumonia, COPD exacerbation, or lower respiratory tract infection within the 4 weeks prior to Visit 1
- Pulmonary rehabilitation: Participants in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Visit 1
- Other clinically significant lung disease: The Investigator must judge that COPD is the primary diagnosis accounting for the clinical manifestations of the lung disease
- Lung resection: Participants with a history of, or plan for lung volume reduction surgery/endobronchial valve procedure
- Chronic hypercapnia requiring non-invasive positive pressure ventilation (NIPPV) use including Bi-Level Positive Airway Pressure (BiPAP) or Continuous Positive Airway Pressure (CPAP) are excluded
- Continuous oxygen: Participants requiring oxygen supplementation for COPD
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 40 and 75 years old?
Where in United Kingdom
Also in 19 other countries, 168 sites
- BedfordHospital not named in the registryContact: Peter Adura (principal investigator)Taking people
- BradfordHospital not named in the registryContact: Dinesh Saralaya (principal investigator)Taking people
- CorbyHospital not named in the registryContact: Amardeep Heer (principal investigator)Taking people
About the trial
What the trial wants to find out
Depemokimab is being developed as a treatment for individuals with moderate to severe Chronic Obstructive Pulmonary Disorder (COPD). The aim of this study is to assess the efficacy and safety of early initiation of depemokimab as an add-on medicine in participants with moderate to severe COPD with type 2 inflammation.
The 2 groups in the trial
- DepemokimabTreatment being tested
Participants with Chronic Obstructive Pulmonary Disorder (COPD) with Type 2 inflammation will receive Depemokimab in combination with existing Standard of Care (SoC).
- PlaceboTreatment being tested
Participants with COPD with Type 2 inflammation will receive matching Placebo in combination with existing SoC.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Study of the Efficacy and Safety of Early Depemokimab Initiation as add-on Treatment in COPD Patients With Type 2 Inflammation
- Plain-language title
- Tests depemokimab added early to treatment for COPD with type 2 inflammationGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT07177339, who can take part
- Record updated
- 28 July 2026