Status:
RECRUITING
eValuating the Efficacy and Safety of InitiatinG depemokImab earLy therApy iN Chronic Obstructive Pulmonary Disorder (COPD) With Type 2 Inflammation
Lead Sponsor:
GlaxoSmithKline
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
40-75 years
Phase:
PHASE3
Brief Summary
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...
Eligibility Criteria
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
- Other clinically significant lung disease: The Investigator must judge that COPD is the primary diagnosis accounting for the clinical manifestations of the lung disease.
- 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
- 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 Visit 1
- 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
Key Trial Info
Start Date :
October 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 14 2029
Estimated Enrollment :
1196 Patients enrolled
Trial Details
Trial ID
NCT07177339
Start Date
October 20 2025
End Date
December 14 2029
Last Update
November 25 2025
Active Locations (6)
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1
GSK Investigational Site
Doral, Florida, United States, 33172
2
GSK Investigational Site
Chengdu, China, 610041
3
GSK Investigational Site
Guilin, China, 541002
4
GSK Investigational Site
Jiangmen, China, 529100