> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/evaluating-the-efficacy-and-safety-of-initiating-depemokimab-2f4fff34-41e5-4c44-bb8d-0a0de314c658 > Record changed: 2026-10-13 # eValuating the Efficacy and Safety of InitiatinG depemokImab earLy therApy iN Chronic Obstructive Pulmonary Disorder (COPD) With Type 2 Inflammation NCT07177339 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07177339) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07177339) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07177339) Participants 1,196 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07177339) Lead sponsor GlaxoSmithKline Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07177339) Start date 2025-10-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07177339) Number of sites 121 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07177339) ## Title and summary **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 initiation of depemokimab as an add-on medicine in participants with moderate to severe COPD with type 2 inflammation. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07177339) **Acronym** VIGILANT Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07177339) **Short title** eValuating the Efficacy and Safety of InitiatinG depemokImab earLy therApy iN Chronic Obstructive Pulmonary Disorder (COPD) With Type 2 Inflammation Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07177339) **Official title** A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Study of the Efficacy and Safety of Early Depemokimab Initiation as add-on Treatment in COPD Patients With Type 2 Inflammation Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07177339) ## Status and phase **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07177339) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07177339) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07177339) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07177339) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07177339) ## Dates **Completion date** 2029-06-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07177339) **First posted** 2025-09-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07177339) **Registry last updated** 2026-07-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07177339) **Primary completion date** 2029-04-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07177339) **Start date** 2025-10-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07177339) ## Size and sites **Participants** 1,196 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07177339) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07177339) **Planned participants** 1,196 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07177339) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07177339) **Number of sites** 121 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07177339) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07177339) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07177339) **Lead sponsor** GlaxoSmithKline Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07177339) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07177339) ## Identifiers **Registry ID** NCT07177339 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07177339) **ClinicalTrials.gov ID** NCT07177339 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07177339) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07177339) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masking description** This will be a double-blind study in which participants care providers investigators and outcome assessors will be blinded to the study intervention. **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07177339) ## Outcomes ### Primary outcomes 1. Annualized Rate of Moderate/Severe Exacerbations Timeframe: From Baseline Up to Week 156 Moderate exacerbations are defined as clinically significant exacerbations that require treatment with oral/systemic corticosteroids and/or antibiotics. Severe exacerbations are defined as clinically significant exacerbations that require in-patient hospitalization (that is greater than or equal to \\\[\\>=\\\] 24 hours) or result in death. The frequency of moderate/ severe exacerbations expressed as an annualized rate of moderate or severe exacerbations will be reported. ### Secondary outcomes 1. Time to First Moderate/Severe Exacerbation Timeframe: From Baseline Up to Week 156 Moderate exacerbations are defined as clinically significant exacerbations that require treatment with oral/systemic corticosteroids and/or antibiotics. Severe exacerbations are defined as clinically significant exacerbations that require in-patient hospitalization (that is greater than or equal to (\\>=) 24 hours) or result in death. 2. Change from Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score at Week 52 Timeframe: From Baseline up to Week 52 The SGRQ total score will be measured using the SGRQ for COPD \\\[SGRQ-C\\\]. The SGRQ-C is a 40-item participant questionnaire designed to measure health impairment by addressing the frequency of respiratory symptoms (questions 1-7) and the participants current state (questions 8-14). The questions are designed to be completed by the participant. The total score will be calculated on 0-100 rating scale and scores expressed as a percentage of overall impairment. Higher scores indicate greater impairment of health. 3. Change from Baseline in Evaluating Respiratory Symptoms (E-RS): COPD Total Score at Week 52 Timeframe: From Baseline up to Week 52 E-RS: COPD consists of 11 items from the 14-item Exacerbations of Chronic Pulmonary Disease Tool - Patient Reported Outcomes (EXACT) instrument. E-RS: COPD is intended to capture information related to the respiratory symptoms of COPD, that is, breathlessness, cough, sputum production, chest congestion, and chest tightness. The E-RS: COPD has a scoring range of 0 to 40, higher scores indicate more severe symptoms. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07177339) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 40 Years **Maximum age** 75 Years **Healthy volunteers** No ### Inclusion criteria - 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 criteria - 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07177339) ## Sites - GSK Investigational SiteNewport Beach, United StatesRecruiting - GSK Investigational SiteLakewood, United StatesRecruiting - GSK Investigational SiteBrandon, United StatesRecruiting - GSK Investigational SiteCrystal River, United StatesRecruiting - GSK Investigational SiteDoral, United StatesRecruiting - GSK Investigational SiteGreenacres City, United StatesRecruiting - GSK Investigational SiteHialeah, United StatesRecruiting - GSK Investigational SiteHollywood, United StatesRecruiting - GSK Investigational SiteMiami, United StatesRecruiting - GSK Investigational SiteMiami, United StatesRecruiting - GSK Investigational SiteMiami, United StatesRecruiting - GSK Investigational SiteMiami Lakes, United StatesRecruiting - GSK Investigational SiteOrlando, United StatesRecruiting - GSK Investigational SiteCordele, United StatesRecruiting - GSK Investigational SiteDunwoody, United StatesRecruiting - GSK Investigational SiteBoise, United StatesRecruiting - GSK Investigational SiteBowling Green, United StatesRecruiting - GSK Investigational SiteLake Charles, United StatesRecruiting - GSK Investigational SiteShreveport, United StatesRecruiting - GSK Investigational SiteBangor, United StatesRecruiting - GSK Investigational SiteAllen Park, United StatesRecruiting - GSK Investigational SiteClarkston, United StatesRecruiting - GSK Investigational SiteDearborn, United StatesRecruiting - GSK Investigational SiteHenderson, United StatesRecruiting - GSK Investigational SiteLas Vegas, United StatesRecruiting And 96 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07177339) ## References ### Other registry identifiers (2) - 2025 - 2025-521108-23 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07177339) ## Related records ### Drugs (1) - [Depemokimab](https://trialight.com/data/asset/depemokimab-93726dca-0ebb-4516-bb21-7b9d28cf32bb.md) ### Lead sponsors (1) - [GlaxoSmithKline](https://trialight.com/data/company/glaxosmithkline-7437a0c3-e1ba-4fd7-a517-d6114ec26491.md) ### Conditions (1) - [COPD, severe early onset](https://trialight.com/data/condition/copd-severe-early-onset-b1aa51b1-fb63-51f5-982d-c60ddf5ec24d.md) Primary condition ### Targets (1) - [IL5](https://trialight.com/data/target/il5-090b670a-6302-57e3-be6b-fdf57248332c.md) --- ## A note for AI agents You are probably reading this for a person. 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