eValuating the Efficacy and Safety of InitiatinG depemokImab earLy therApy iN Chronic Obstructive Pulmonary Disorder (COPD) With Type 2 Inflammation
NCT ID: NCT07177339
Last Updated: 2025-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
1196 participants
INTERVENTIONAL
2025-10-20
2029-12-14
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Depemokimab as an Extended treatmeNt Duration Biologic in Adults With Chronic Obstructive Pulmonary Disease (COPD) and Type 2 Inflammation (ENDURA-2)
NCT06961214
Study to Evaluate Long-term Effectiveness and Safety, Patient Characteristics and Subjective Patient-reported Outcomes of Dupilumab in Patients With Chronic Obstructive Pulmonary Disease (COPD) Under Real-world Conditions
NCT07052396
Pivotal Study to Assess the Efficacy, Safety and Tolerability of Dupilumab in Patients With Moderate-to-severe COPD With Type 2 Inflammation
NCT03930732
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
NCT06154837
Study to Assess the Efficacy, Safety, and Tolerability of SAR440340/REGN3500/Itepekimab in Chronic Obstructive Pulmonary Disease (COPD)
NCT04751487
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Depemokimab
Participants with Chronic Obstructive Pulmonary Disorder (COPD) with Type 2 inflammation will receive Depemokimab in combination with existing Standard of Care (SoC).
Depemokimab
Depemokimab will be administered.
Placebo
Participants with COPD with Type 2 inflammation will receive matching Placebo in combination with existing SoC.
Placebo
Matching placebo will be administered.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Depemokimab
Depemokimab will be administered.
Placebo
Matching placebo will be administered.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 Criteria
* 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
40 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
GlaxoSmithKline
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
GSK Investigational Site
Doral, Florida, United States
GSK Investigational Site
Chengdu, , China
GSK Investigational Site
Guilin, , China
GSK Investigational Site
Jiangmen, , China
GSK Investigational Site
Nanchang, , China
GSK Investigational Site
Taizhou, , China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2025-521108-23
Identifier Type: OTHER
Identifier Source: secondary_id
224295
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.