RecruitingPhase 3NCT07177339

eValuating the Efficacy and Safety of InitiatinG depemokImab earLy therApy iN Chronic Obstructive Pulmonary Disorder (COPD) With Type 2 Inflammation

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


Sponsor

GlaxoSmithKline

Enrollment

1,196 participants

Start Date

Oct 20, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 40 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study — called VIGILANT — is testing whether starting a biologic drug called depemokimab early improves outcomes for people with COPD (chronic obstructive pulmonary disease) who have a type of airway inflammation driven by immune cells called eosinophils (Type 2 inflammation). Depemokimab targets a protein called IL-5 to reduce these cells. **You may be eligible if...** - You have been diagnosed with moderate to severe COPD for at least 1 year - Your breathing test (spirometry) shows an FEV1/FVC ratio below 0.70 and FEV1 between 30-80% of what is normal for you - You have an elevated eosinophil (a type of immune cell) count in your blood - You have had at least 1 moderate COPD flare-up (exacerbation) in the past 12 months **You may NOT be eligible if...** - You have very severe COPD (FEV1 below 30%) - You do not have the eosinophilic (Type 2) type of COPD - You have not had any recent exacerbations - You have other health conditions that would interfere with the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDepemokimab

Depemokimab will be administered.

DRUGPlacebo

Matching placebo will be administered.


Locations(121)

GSK Investigational Site

Newport Beach, California, United States

GSK Investigational Site

Lakewood, Colorado, United States

GSK Investigational Site

Brandon, Florida, United States

GSK Investigational Site

Crystal River, Florida, United States

GSK Investigational Site

Doral, Florida, United States

GSK Investigational Site

Greenacres City, Florida, United States

GSK Investigational Site

Hialeah, Florida, United States

GSK Investigational Site

Hollywood, Florida, United States

GSK Investigational Site

Miami, Florida, United States

GSK Investigational Site

Miami, Florida, United States

GSK Investigational Site

Miami, Florida, United States

GSK Investigational Site

Miami Lakes, Florida, United States

GSK Investigational Site

Orlando, Florida, United States

GSK Investigational Site

Cordele, Georgia, United States

GSK Investigational Site

Dunwoody, Georgia, United States

GSK Investigational Site

Boise, Idaho, United States

GSK Investigational Site

Bowling Green, Kentucky, United States

GSK Investigational Site

Lake Charles, Louisiana, United States

GSK Investigational Site

Shreveport, Louisiana, United States

GSK Investigational Site

Bangor, Maine, United States

GSK Investigational Site

Allen Park, Michigan, United States

GSK Investigational Site

Clarkston, Michigan, United States

GSK Investigational Site

Dearborn, Michigan, United States

GSK Investigational Site

Henderson, Nevada, United States

GSK Investigational Site

Las Vegas, Nevada, United States

GSK Investigational Site

Reno, Nevada, United States

GSK Investigational Site

Winston-Salem, North Carolina, United States

GSK Investigational Site

Edmond, Oklahoma, United States

GSK Investigational Site

DuBois, Pennsylvania, United States

GSK Investigational Site

West Chester, Pennsylvania, United States

GSK Investigational Site

Greenville, South Carolina, United States

GSK Investigational Site

Rock Hill, South Carolina, United States

GSK Investigational Site

Knoxville, Tennessee, United States

GSK Investigational Site

Dallas, Texas, United States

GSK Investigational Site

DeSoto, Texas, United States

GSK Investigational Site

Greenville, Texas, United States

GSK Investigational Site

Houston, Texas, United States

GSK Investigational Site

Houston, Texas, United States

GSK Investigational Site

Houston, Texas, United States

GSK Investigational Site

Katy, Texas, United States

GSK Investigational Site

Mesquite, Texas, United States

GSK Investigational Site

Stafford, Texas, United States

GSK Investigational Site

Coffs Harbour, New South Wales, Australia

GSK Investigational Site

Spearwood, Western Australia, Australia

GSK Investigational Site

Haskovo, Bulgaria

GSK Investigational Site

Montana, Bulgaria

GSK Investigational Site

Rousse, Bulgaria

GSK Investigational Site

Sofia, Bulgaria

GSK Investigational Site

Sofia, Bulgaria

GSK Investigational Site

Sofia, Bulgaria

GSK Investigational Site

Kingston, Ontario, Canada

GSK Investigational Site

Windsor, Ontario, Canada

GSK Investigational Site

Shapingba, Chongqing Municipality, China

GSK Investigational Site

Nanning, Guangxi, China

GSK Investigational Site

Chengdu, Sichuan, China

GSK Investigational Site

Chengdu, Sichuan, China

GSK Investigational Site

Suining, Sichuan, China

GSK Investigational Site

Beijing, China

GSK Investigational Site

Beijing, China

GSK Investigational Site

Changchun, China

GSK Investigational Site

Changchun, China

GSK Investigational Site

Changsha, China

GSK Investigational Site

Chengdu, China

GSK Investigational Site

Chongqing, China

GSK Investigational Site

Dongguan, China

GSK Investigational Site

Fujian, China

GSK Investigational Site

Guangzhou, China

GSK Investigational Site

Guangzhou, China

GSK Investigational Site

Guangzhou, China

GSK Investigational Site

Guilin, China

GSK Investigational Site

Haikou, China

GSK Investigational Site

Hangzhou, China

GSK Investigational Site

Harbin, China

GSK Investigational Site

Hefei, China

GSK Investigational Site

Hohhot, China

GSK Investigational Site

Huizhou, China

GSK Investigational Site

Jiangmen, China

GSK Investigational Site

Jiangmen, China

GSK Investigational Site

Jinzhou, China

GSK Investigational Site

Nanchang, China

GSK Investigational Site

Nanchang, China

GSK Investigational Site

Nanjing, China

GSK Investigational Site

Qinhuangdao, China

GSK Investigational Site

Shanghai, China

GSK Investigational Site

Shanghai, China

GSK Investigational Site

Shijiazhuang, China

GSK Investigational Site

Shijiazhuang, China

GSK Investigational Site

Taiyuan, China

GSK Investigational Site

Taizhou, China

GSK Investigational Site

Taizhou, China

GSK Investigational Site

Ürümqi, China

GSK Investigational Site

Weifang, China

GSK Investigational Site

Wenzhou, China

GSK Investigational Site

Xiamen, China

GSK Investigational Site

Xinxiang, China

GSK Investigational Site

Yinchuan, China

GSK Investigational Site

Zunyi, China

GSK Investigational Site

Berlin, Germany

GSK Investigational Site

Berlin, Germany

GSK Investigational Site

Frankfurt, Germany

GSK Investigational Site

Frankfurt, Germany

GSK Investigational Site

Mainz, Germany

GSK Investigational Site

München, Germany

GSK Investigational Site

Palaió Fáliro, Anatoliki Attiki, Greece

GSK Investigational Site

Ioannina, Greece

GSK Investigational Site

Thessaloniki, Greece

GSK Investigational Site

Ramat Gan, Israel

GSK Investigational Site

Tel Aviv, Israel

GSK Investigational Site

Gifu, Japan

GSK Investigational Site

Mie, Japan

GSK Investigational Site

Tokyo, Japan

GSK Investigational Site

Ebdentown, Upper Hutt, New Zealand

GSK Investigational Site

Rotorua, New Zealand

GSK Investigational Site

Bialystok, Poland

GSK Investigational Site

Rzeszów, Poland

GSK Investigational Site

Barcelona, Spain

GSK Investigational Site

Málaga, Spain

GSK Investigational Site

Palma de Mallorca, Spain

GSK Investigational Site

Bedford, United Kingdom

GSK Investigational Site

Bradford, United Kingdom

GSK Investigational Site

Corby, United Kingdom

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NCT07177339


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