Chronic Obstructive Pulmonary Disease (COPD) Clinical Trials

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A Randomized, Double-Blind, Placebo- Controlled, Parallel-Group, Multicenter Study of the Efficacy and Safety of Depemokimab In Adult Participants With COPD With Type 2 Inflammation

Status: Recruiting
Location: See all (278) locations...
Intervention Type: Biological, Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

Depemokimab is being developed as a treatment for individuals with moderate to severe COPD. The aim of this study is to assess the efficacy and safety of depemokimab as an add-on medicine in participants with uncontrolled moderate to severe COPD with type 2 inflammation.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 80
Healthy Volunteers: f
View:

• Participants must be greater than or equal to (\>=) 40 to less than or equal to (\<=) 80 years of age, at the time of signing the informed consent

• Elevated blood eosinophil count (BEC).

• Moderate to severe COPD with frequent exacerbations, defined as:

‣ A clinically documented history of COPD as defined by the American Thoracic Society/European Respiratory Society for at least 1 year

⁃ A post-bronchodilator forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) ratio of less than (\<) 0.70 and a post- bronchodilator FEV1 \>30 percent (%) and \<= 80% predicted normal values

⁃ A well-documented history of at least 2 moderate or 1 severe exacerbation in the 12 months prior to screening

• COPD assessment test (CAT) score \>=10 at Visit 1

• Smoking status: Current or former cigarette smokers with a history of cigarette smoking of \>=10 pack-years.

• Participants should be on optimized inhaler therapy, defined as inhaled corticosteroid (ICS) plus Long-acting muscarinic receptor antagonist (LAMA) plus Long-acting beta2-adrenergic receptor agonist (LABA) either as multiple inhalers or a single combination inhaler for at least 6 months prior to Screening Visit 1

• Body mass index (BMI) \>=16 kilogram per square meter (kg/m\^2).

• Male or eligible female participants

Locations
United States
California
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Bakersfield
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Modesto
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Newport Beach
Delaware
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Wilmington
Florida
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Bradenton
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Brandon
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Hialeah
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Hialeah
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Loxahatchee Groves
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Miami
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Miami
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Miami Lakes
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Orange City
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Palm Springs
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Palmetto Bay
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Pensacola
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Tamarac
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Tampa
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The Villages
Georgia
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Riverdale
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Stonecrest
Illinois
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Chicago
Maryland
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Baltimore
Michigan
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Clarkston
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Flint
Missouri
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St Louis
North Carolina
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Winston-salem
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Winston-salem
Nevada
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Henderson
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Las Vegas
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Reno
New York
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North Massapequa
South Carolina
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Greenville
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Rock Hill
Tennessee
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Franklin
Texas
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Corsicana
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Dallas
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Houston
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Houston
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Houston
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Mckinney
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Pearland
Other Locations
Argentina
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Buenos Aires
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Buenos Aires
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Buenos Aires
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Buenos Aires
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Buenos Aires
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Ciudad Autonoma De Bueno
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La Plata
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Mendoza
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Mendoza
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Paraná
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Rosario
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San Juan Bautista
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San Miguel De Tucumán
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San Miguel De Tucumán
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San Miguel De Tucumán
Belgium
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Aalst
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Genk
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Kortrijk
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Liège
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Namur
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Sint-niklaas
Canada
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Ajax
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Richmond
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Saint-charles-borromée
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Saskatoon
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Sherbrooke
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Toronto
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Windsor
Chile
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Curicó
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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Changsha
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Chengdu
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Chengdu
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Chongqing
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Dongguan
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Fuyang
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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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Hangzhou
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Hefei
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Hohhot
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Hohhot
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Huizhou
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Huizhou
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Jiangmen
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Jiangmen
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Jiangsu
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Jiangxi
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Jinan
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Kunming
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Kunming
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Lianyungang
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Liuzhou
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Meizhou
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Mianyang
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Nanchang
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Nanchang
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Qingdao
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Qingyuan
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Qinhuangdao
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Shanghai
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Shanghai
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Shanghai
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Shanghai
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Suzhou
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Taiyuan
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Taizhou
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Ürümqi
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Weifang
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Wenzhou
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Wuhan
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Wuxi
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Xi'an
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Xiamen
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Yinchuan
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Zhanjiang
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Zhengzhou
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Zigong
Croatia
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Split
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Zagreb
Denmark
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Aalborg
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Hvidovre
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Roskilde
France
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Amiens
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Blois
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Caen
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La Tronche
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Lyon
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Marseille
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Nice
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Pessac
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Saint-quentin
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Toulouse
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Villeurbanne
Germany
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Ahrensburg
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Berlin
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Berlin
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Bonn
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Donaustauf
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Essen
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Frankfurt Am Main
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Frankfurt Am Main
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Giessen
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Kiel
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Löwenstein
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Mainz
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München
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Peine
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Wiesbaden
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Wuppertal
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Würzburg
Hungary
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Budapest
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Budapest
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Pécs
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Törökbálint
Ireland
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Cork
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Drogheda
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Dublin
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Dublin
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Galway
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Mullingar
Japan
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Chiba
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Chiba
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Chiba
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Fukuoka
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Fukuoka
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Fukuoka
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Fukuoka
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Fukushima
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Gifu
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Hokkaido
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Hyōgo
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Hyōgo
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Hyōgo
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Hyōgo
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Hyōgo
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Ibaraki
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Ishikawa
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Kagawa
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Kanagawa
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Kanagawa
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Kanagawa
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Kitakyushu-shi
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Kyoto
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Mie
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Mie
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Nankoku-shi
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Niigata
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Niigata
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Okayama
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Omuta Shi
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Osaka
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Osaka
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Osaka
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Shizuoka
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Shizuoka
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Shizuoka
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Shizuoka
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Shizuoka
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Tokyo
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Tokyo
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Tokyo
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Tokyo
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Tokyo
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Tokyo
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Tokyo
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Yamaguchi
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Yokohama
Netherlands
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Breda
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Deventer
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Enschede
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Harderwijk
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Hoofddorp
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Nijmegen
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Zutphen
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Zwolle
Norway
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Lørenskog
Poland
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Bialystok
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Bydgoszcz
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Katowice
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Krakow
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Poznan
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Poznan
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Rzeszów
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Rzeszów
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Wroclaw
Portugal
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Almada
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Guarda
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Lisbon
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Lisbon
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Lisbon
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Loures
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Senhora Da Hora
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Setúbal
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Vila Nova De Gaia
Slovakia
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Košice
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Spišská Nová Ves
Spain
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Alzira
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Barcelona
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Benalmádena
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Ferrol
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Galdakaovizcaya
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Madrid
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Madrid
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Málaga
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Marbella
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Marbella
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Palma De Mallorca
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Pozuelo De Alarcón
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Santander
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Seville
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Zaragoza
Sweden
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Lund
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Stockholm
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Stockholm
Switzerland
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Aarau
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Zurich
Taiwan
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Changhua
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Kaohsiung City
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Taichung
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Taichung
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Taipei
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Taipei
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Taipei
Turkey
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Antalya
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Çanakkale
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Denizli
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Izmir
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İzmit
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: 2025-06-20
Estimated Completion Date: 2029-02-14
Participants
Target number of participants: 981
Treatments
Experimental: Depemokimab
Participants will be administered depemokimab along with standard of care (SoC).
Placebo_comparator: Placebo
Participants will be administered placebo along with SoC.
Sponsors
Leads: GlaxoSmithKline

This content was sourced from clinicaltrials.gov