Depemokimab Tested in Adults With COPD and Type 2 Inflammation
Tests depemokimab added to usual care in adults with moderate to severe COPD.
Plain-language title generated from the registry record
Registry title: Depemokimab as an Extended Treatment Duration Biologic in Adults With Chronic Obstructive Pulmonary Disease (COPD) and Type 2 Inflammation
Key facts
- Where
- Ahrensburg, Bad Berka, Berlin, Bonn, Cologne, Donaustauf, Essen, Frankfurt, Frankfurt am Main, Giessen, Kiel, Loewenstein, Mainz, München, Peine, Wiesbaden, Wuerzburg, and Wuppertal, GermanySee the 19 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 80 years old?
Source: NCT06959095, who can take part
Where in Germany
- Velocity Clinical Research Germany GmbHAhrensburg, GermanyTaking people
- Zentralklinik Bad Berka GmbHBad Berka, GermanyTaking people
- Pneumologische Praxis am Schloss CharlottenburgBerlin, GermanyTaking people
- Policum Berlin Studien GmbHBerlin, GermanyTaking people
- Universitaetsklinikum Bonn AöRBonn, GermanyTaking people
- Kliniken der Stadt Koeln gGmbHCologne, GermanyTaking people
- Caritas-Krankenhaus St. Maria gGmbHDonaustauf, GermanyTaking people
- Universitaetsklinikum Essen (AoR)Essen, GermanyTaking people
- Studienzentrum Dr. KellerFrankfurt, GermanyTaking people
- IKF Pneumologie GmbH & Co. KGFrankfurt am Main, GermanyTaking people
- Universitaetsklinikum Giessen und Marburg GmbHGiessen, GermanyTaking people
- Universitaetsklinikum Schleswig-Holstein AöRKiel, GermanyTaking people
- SLK-Kliniken Heilbronn GmbHLoewenstein, GermanyTaking people
- IKF Pneumologie GmbH & Co. KGMainz, GermanyTaking people
- Pneumologisches Studienzentrum München-WestMünchen, GermanyTaking people
- Studienzentrum Dr. med. C. SchlenskaPeine, GermanyTaking people
- Lungenfacharztzentrum Wiesbaden BAGWiesbaden, GermanyTaking people
- Klinikum Wuerzburg Mitte gGmbHWuerzburg, 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
- NCT06959095EU 2024-520418-22-00
- Record updated
- 5 October 2026
- Original description
Depemokimab is being developed as a treatment for individuals with moderate to severe COPD. The aim of this study is to assess the efficacy and safety of depemokimab as an add-on medicine in participants with uncontrolled moderate to severe COPD with type 2 inflammation.Read full original descriptionShow less
A Randomized, Double-Blind, Placebo- Controlled, Parallel-Group, Multicenter Study of the Efficacy and Safety of Depemokimab In Adult Participants With COPD With Type 2 Inflammation
Depemokimab is being developed as a treatment for individuals with moderate to severe COPD. The aim of this study is to assess the efficacy and safety of depemokimab as an add-on medicine in participants with uncontrolled moderate to severe COPD with type 2 inflammation.
Inclusion: 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: Participants with a current or prior physician diagnosis of asthma; Participants with pneumonia, COPD exacerbation, or lower respiratory tract infection within the 4 weeks prior to Screening Visit 1; Pulmonary rehabilitation: Participants in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Screening 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; Cor pulmonale - resulting in right heart failure, severe pulmonary hypertension; Unstable cardiovascular disease or arrhythmia; Parasitic Infection: Participants with a known, pre-existing parasitic infection within 6 months of Screening (Visit 1); The following subjects are excluded:; Continuous oxygen: Participants requiring oxygen supplementation for more than 16 hours per day to maintain resting oxygen saturation greater than 88%; Chronic hypercapnia requiring Non-invasive positive pressure ventilation (NIPPV) use (including Bi-Level Positive Airway Pressure [BiPAP] or Continuous Positive Airway Pressure [CPAP]).