Actively Recruiting
eValuating the Efficacy and Safety of InitiatinG depemokImab earLy therApy iN Chronic Obstructive Pulmonary Disorder (COPD) With Type 2 Inflammation
Led by GlaxoSmithKline · Updated on 2025-11-25
1196
Participants Needed
6
Research Sites
216 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
eValuating the Efficacy and Safety of InitiatinG depemokImab earLy therApy iN Chronic Obstructive Pulmonary Disorder (COPD) With Type 2 Inflammation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or eligible female participants
- Eosinophilic phenotype measured using Blood Eosinophil Count (BEC)
- Moderate to severe COPD with a history of COPD for at least 1 year
- Post-salbutamol FEV1/FVC ratio less than 0.70 and post-salbutamol FEV1 greater than 30% and less than 80% predicted normal values
- Elevated risk for exacerbations defined by one moderate COPD exacerbation in prior 12 months and risk factors such as mMRC dyspnea score >= 2, CAT >= 15, post-bronchodilator FEV1 < 50% predicted, or chronic bronchitis
- Current or former smokers with at least 10 pack-years of cigarette smoking
- Use of dual (ICS+LABA or LABA+LAMA) or triple (ICS+LABA+LAMA) inhaler therapy for at least 3 months
- Body mass index (BMI) >= 16 kg/m2
You will not qualify if you...
- COPD not the primary diagnosis for lung disease symptoms
- Current or prior physician diagnosis of asthma (except childhood asthma resolved before age 18 with no recurrence)
- Other clinically significant lung diseases
- More than one moderate or any severe COPD exacerbation in past 12 months
- Pneumonia, COPD exacerbation, or lower respiratory tract infection within 4 weeks prior to Visit 1
- History or planned lung volume reduction surgery or endobronchial valve procedure
- In acute phase of pulmonary rehabilitation within 4 weeks prior to Visit 1
- Chronic hypercapnia requiring non-invasive positive pressure ventilation (NIPPV) including BiPAP or CPAP
- Need for continuous oxygen supplementation for COPD
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
GSK Investigational Site
Doral, Florida, United States, 33172
Actively Recruiting
2
GSK Investigational Site
Chengdu, China, 610041
Actively Recruiting
3
GSK Investigational Site
Guilin, China, 541002
Actively Recruiting
4
GSK Investigational Site
Jiangmen, China, 529100
Actively Recruiting
5
GSK Investigational Site
Nanchang, China, 330000
Actively Recruiting
6
GSK Investigational Site
Taizhou, China, 317000
Actively Recruiting
Research Team
U
US GSK Clinical Trials Call Center
CONTACT
E
EU GSK Clinical Trials Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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