Chronic Obstructive Pulmonary Disease (COPD) Clinical Trials

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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

Status: Recruiting
Location: See all (121) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 75
Healthy Volunteers: f
View:

• 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)

Locations
United States
California
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Newport Beach
Colorado
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Lakewood
Florida
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Brandon
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Crystal River
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Doral
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Greenacres City
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Hialeah
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Hollywood
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Miami
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Miami
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Miami
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Miami Lakes
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Orlando
Georgia
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Cordele
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Dunwoody
Idaho
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Boise
Kentucky
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Bowling Green
Louisiana
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Lake Charles
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Shreveport
Maine
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Bangor
Michigan
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Allen Park
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Clarkston
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Dearborn
North Carolina
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Winston-salem
Nevada
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Henderson
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Las Vegas
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Reno
Oklahoma
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Edmond
Pennsylvania
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Dubois
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West Chester
South Carolina
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Greenville
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Rock Hill
Tennessee
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Knoxville
Texas
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Dallas
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Desoto
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Greenville
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Houston
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Houston
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Houston
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Katy
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Mesquite
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Stafford
Other Locations
Australia
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Coffs Harbour
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Spearwood
Bulgaria
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Haskovo
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Montana
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Rousse
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Sofia
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Sofia
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Sofia
Canada
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Kingston
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Windsor
China
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Beijing
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Beijing
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Changchun
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Changchun
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Changsha
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Chengdu
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Chengdu
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Chengdu
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Chongqing
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Dongguan
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Fujian
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Guangzhou
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Guangzhou
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Guangzhou
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Guilin
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Haikou
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Hangzhou
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Harbin
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Hefei
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Hohhot
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Huizhou
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Jiangmen
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Jiangmen
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Jinzhou
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Nanchang
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Nanchang
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Nanjing
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Nanning
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Qinhuangdao
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Shanghai
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Shanghai
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Shapingba
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Shijiazhuang
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Shijiazhuang
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Suining
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Taiyuan
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Taizhou
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Taizhou
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Ürümqi
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Weifang
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Wenzhou
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Xiamen
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Xinxiang
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Yinchuan
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Zunyi
Germany
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Berlin
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Berlin
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Frankfurt
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Frankfurt
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Mainz
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München
Greece
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Ioannina
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Palaió Fáliro
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Thessaloniki
Israel
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Ramat Gan
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Tel Aviv
Japan
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Gifu
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Mie
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Tokyo
New Zealand
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Ebdentown
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Rotorua
Poland
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Bialystok
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Rzeszów
Spain
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Barcelona
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Málaga
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Palma De Mallorca
United Kingdom
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Bedford
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Bradford
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Corby
Contact Information
Primary
US GSK Clinical Trials Call Center
GSKClinicalSupportHD@gsk.com
877-379-3718
Backup
EU GSK Clinical Trials Call Center
GSKClinicalSupportHD@gsk.com
+44 (0) 20 89904466
Time Frame
Start Date: 2025-10-20
Estimated Completion Date: 2029-06-08
Participants
Target number of participants: 1196
Treatments
Experimental: Depemokimab
Participants with Chronic Obstructive Pulmonary Disorder (COPD) with Type 2 inflammation will receive Depemokimab in combination with existing Standard of Care (SoC).
Experimental: Placebo
Participants with COPD with Type 2 inflammation will receive matching Placebo in combination with existing SoC.
Sponsors
Leads: GlaxoSmithKline

This content was sourced from clinicaltrials.gov