Tests depemokimab as add-on treatment for COPD with type 2 inflammation
Tests depemokimab, added to usual care, in adults with uncontrolled COPD and type 2 inflammation.
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 (ENDURA-2)
Key facts
- Where
- Bari, Catania, Ferrara, Foggia, Genoa, Rome, Rozzano, and Telese Terme, ItalySee the 10 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: NCT06961214, who can take part
Where in Italy
- Azienda Universitaria Ospedaliera Consorziale Policlinico BariBari, ItalyTaking people
- Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di CataniaCatania, ItalyTaking people
- University Hospital Of FerraraFerrara, ItalyTaking people
- Azienda Ospedaliero Universitaria Ospedali RiunitiFoggia, ItalyTaking people
- IRCCS Ospedale Policlinico San MartinoGenoa, ItalyTaking people
- Azienda Ospedaliera Policlinico Universitario Tor VergataRome, ItalyTaking people
- Azienda Ospedaliero-Universitaria Policlinico Umberto IRome, ItalyTaking people
- Università Campus Bio-Medico di RomaRome, ItalyTaking people
- Humanitas Mirasole S.p.A.Rozzano, ItalyTaking people
- Istituti Clinici Scientifici Maugeri S.p.A. Societa' Benefit In Forma Abbreviata Istituti Clinici Scientifici Maugeri S.p.A. Sb O Anche Ics Maugeri S.p.A. Sb O Maugeri S.p.A. SbTelese Terme, ItalyTaking 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
- NCT06961214EU 2024-520417-41-00
- 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 compared 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 compared 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 < 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 and 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]).