Tests depemokimab added early to treatment for COPD with type 2 inflammation
Tests depemokimab against placebo in adults with moderate to severe COPD.
Plain-language title generated from the registry record
Registry title: eValuating the Efficacy and Safety of InitiatinG depemokImab earLy therApy iN Chronic Obstructive Pulmonary Disorder (COPD) With Type 2 Inflammation
Key facts
- Where
- Ahrensburg, Bendorf, Berlin, Bonn, Essen, Frankfurt, Frankfurt am Main, Hamburg, Heidelberg, Leipzig, Loewenstein, Mainz, Marburg, München, and Wuppertal, GermanySee the 21 sites
- Phase
- Phase 3
Could this be for you?
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?
Source: NCT07177339, who can take part
Where in Germany
- Velocity Clinical Research Germany GmbHAhrensburg, GermanyTaking people
- KPPK GmbHBendorf, GermanyTaking people
- Charite Universitaetsmedizin Berlin KöRBerlin, GermanyTaking people
- Clinical Studies Pankow Ishak TeberBerlin, GermanyTaking people
- Lungenpraxis Hellersdorf – Jens DriemertBerlin, GermanyTaking people
- Praxis an der OperBerlin, GermanyTaking people
- RCMS/Lungenpraxis HohenzollerndammBerlin, GermanyTaking people
- Universitaetsklinikum Bonn AöRBonn, GermanyTaking people
- Universitaetsklinikum Essen (AoR)Essen, GermanyTaking people
- Studienzentrum Dr. KellerFrankfurt, GermanyTaking people
- IKF Pneumologie GmbH & Co. KGFrankfurt am Main, GermanyTaking people
- Zentrale für die Koordination von Studien und Vorträgen der ElbpneumologieHamburg, GermanyTaking people
- Thoraxklinik Heidelberg gGmbHHeidelberg, GermanyTaking people
- Berufsausuebungsgemeinschaft Bag Prof. Dr. Med Gerhard Hoheisel Dr. Med Andreas Bonitz GbRLeipzig, GermanyTaking people
- POIS Sachsen GmbHLeipzig, GermanyTaking people
- SLK-Kliniken Heilbronn GmbHLoewenstein, GermanyTaking people
- IKF Pneumologie GmbH & Co. KGMainz, GermanyTaking people
- Universitaetsklinikum Giessen und Marburg GmbHMarburg, GermanyTaking people
- Lungenärzte am RundfunkplatzMünchen, GermanyTaking people
- neumologisches Studienzentrum München-WestMünchen, GermanyTaking people
- Petrus-KrankenhausWuppertal, GermanyTaking people
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?
Trial details
- Who runs it
- GlaxoSmithKline
- Trial code
- NCT07177339EU 2025-521108-23-00
- Record updated
- 28 July 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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).
Exclusion: 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.