Actively Recruiting
A Multicenter, Randomized, Double-blind, Placebo-controlled Study of Early Depemokimab Treatment in COPD Patients With Type 2 Inflammation
Led by GlaxoSmithKline · Updated on 2025-11-25
1196
Participants Needed
6
Research Sites
6 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating depemokimab as a treatment for people with moderate to severe Chronic Obstructive Pulmonary Disease (COPD) who have type 2 inflammation. The study aims to assess the effectiveness and safety of starting depemokimab early as an add-on treatment alongside standard care. This Phase 3 trial is randomized, double-blind, and placebo-controlled to provide reliable results. Participants will be randomly assigned to receive either depemokimab combined with their existing standard treatments or a matching placebo with standard care. The study will compare these two groups over time to evaluate the impact on COPD symptoms and exacerbations. Treatment is given as part of their regular inhaler therapy, which must have been stable for at least 3 months before joining the study. During the trial, participants will be monitored for up to 156 weeks (about 3 years) to track the number of moderate to severe COPD flare-ups. They will also complete questionnaires like the St. George's Respiratory Questionnaire and Evaluating Respiratory Symptoms (E-RS) to measure quality of life and respiratory symptoms. Safety and lung function will be regularly assessed to ensure participant well-being throughout the study period.
CONDITIONS
Brief 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 diagnosed for at least 1 year
- Post-salbutamol FEV1/FVC ratio less than 0.70
- Post-salbutamol FEV1 greater than 30% and less than 80% predicted
- History of 1 moderate COPD exacerbation in the past 12 months
- Presence of risk factors such as mMRC dyspnea score ≥ 2, CAT score ≥ 15, post-bronchodilator FEV1 < 50%, or chronic bronchitis
- Current or former smokers with ≥10 pack-years
- On 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 lung disease diagnosis
- Current or prior asthma diagnosis (except resolved childhood asthma)
- Other significant lung diseases
- More than one moderate or any severe COPD exacerbation in past 12 months
- Pneumonia, COPD exacerbation, or lower respiratory infection within 4 weeks prior to visit
- History or planned lung volume reduction surgery/endobronchial valve procedure
- In acute phase of pulmonary rehabilitation within 4 weeks prior to visit
- Chronic hypercapnia requiring non-invasive ventilation (BiPAP or CPAP)
- Continuous oxygen therapy requirement for COPD
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 156 weeks
Participants receive depemokimab or placebo in combination with their existing standard of care inhaler therapy.
Regular visits during treatment period
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
E
EU GSK Clinical Trials Call Center
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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