eValuating the Efficacy and Safety of InitiatinG depemokImab earLy therApy iN Chronic Obstructive Pulmonary Disorder (COPD) With Type 2 Inflammation | NCT07177339 | Trialant

eValuating the Efficacy and Safety of InitiatinG depemokImab earLy therApy iN Chronic Obstructive Pulmonary Disorder (COPD) With Type 2 Inflammation | NCT07177339 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: 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

GSK Investigational SiteRecruiting

Newport Beach, California 92663, United States

US GSK Clinical Trials Call CenterContact

GSKClinicalSupportHD@gsk.com877-379-3718

EU GSK Clinical Trials Call CentreContact

GSKClinicalSupportHD@gsk.com+44 (0) 20 8990 4466

Ryan KleinPrincipal Investigator

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Lakewood, Colorado 80228-1813, United States

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Brandon, Florida 33511, United States

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Crystal River, Florida 34429, United States

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Doral, Florida 33172, United States

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Greenacres City, Florida 33467, United States

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Hialeah, Florida 33012, United States

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Hollywood, Florida 33024, United States

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Miami, Florida 33125, United States

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Miami, Florida 33126, United States

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Miami, Florida 33176, United States

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Miami Lakes, Florida 33016, United States

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Orlando, Florida 32825, United States

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Cordele, Georgia 31015, United States

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Dunwoody, Georgia 30350, United States

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Boise, Idaho 83702, United States

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Bowling Green, Kentucky 42101, United States

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Lake Charles, Louisiana 70605, United States

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Shreveport, Louisiana 71105, United States

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Bangor, Maine 04401, United States

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Allen Park, Michigan 48101, United States

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Clarkston, Michigan 48346, United States

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Dearborn, Michigan 48126, United States

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Henderson, Nevada 89052, United States

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Las Vegas, Nevada 89123, United States

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Reno, Nevada 89502, United States

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Winston-Salem, North Carolina 27103, United States

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Edmond, Oklahoma 73013, United States

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DuBois, Pennsylvania 15801, United States

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West Chester, Pennsylvania 19380, United States

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Greenville, South Carolina 29607, United States

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Rock Hill, South Carolina 29732, United States

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Knoxville, Tennessee 37919, United States

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Dallas, Texas 75254, United States

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DeSoto, Texas 75115, United States

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Greenville, Texas 75401, United States

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Houston, Texas 77058, United States

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Houston, Texas 77089, United States

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Houston, Texas 77090, United States

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Katy, Texas 77494, United States

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Mesquite, Texas 75149, United States

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Stafford, Texas 77477, United States

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Coffs Harbour, New South Wales 2450, Australia

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Spearwood, Western Australia 6163, Australia

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Haskovo, 6300, Bulgaria

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Montana, 3400, Bulgaria

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Rousse, 7002, Bulgaria

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Sofia, 1463, Bulgaria

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Sofia, 1510, Bulgaria

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Sofia, 1756, Bulgaria

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Kingston, Ontario K7M 7E4, Canada

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Windsor, Ontario N8X 1T3, Canada

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Shapingba, Chongqing Municipality, China

US GSK Clinical Trials Call CenterContact

GSKClinicalSupportHD@gsk.com877-379-3718

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Nanning, Guangxi 530016, China

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Chengdu, Sichuan 610500, China

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Chengdu, Sichuan, China

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Suining, Sichuan 629018, China

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Beijing, 100020, China

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Beijing, 100034, China

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Changchun, 130021, China

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Changchun, 130041, China

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Changsha, 410013, China

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Chengdu, 610041, China

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Chongqing, 400042, China

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Dongguan, 523326, China

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Fujian, 350001, China

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Guangzhou, 510080, China

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Guangzhou, 510150, China

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Guangzhou, 510180, China

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Guilin, 541002, China

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Haikou, 570001, China

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Hangzhou, 310000, China

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Harbin, 150001, China

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Hefei, 230001, China

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Hohhot, 010050, China

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Huizhou, 516000, China

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Jiangmen, 529100, China

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Jiangmen, 529700, China

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Jinzhou, 121000, China

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Nanchang, 330000, China

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Nanchang, 330006, China

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Nanjing, 210009, China

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Qinhuangdao, 66000, China

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Shanghai, 200032, China

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Shanghai, 201199, China

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Shijiazhuang, 050000, China

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Shijiazhuang, 050051, China

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Taiyuan, 030001, China

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Taizhou, 317000, China

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Taizhou, 318000, China

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Ürümqi, 830054, China

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Weifang, China

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Wenzhou, 325000, China

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Xiamen, 361004, China

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Xinxiang, 453000, China

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Yinchuan, 750001, China

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Zunyi, 563114, China

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Berlin, 10625, Germany

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Berlin, 10717, Germany

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Frankfurt, 60389, Germany

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Frankfurt, 60596, Germany

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Mainz, 60549, Germany

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München, 81241, Germany

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Palaió Fáliro, Anatoliki Attiki 175 62, Greece

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Ioannina, 45500, Greece

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Thessaloniki, Greece

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Ramat Gan, 52621, Israel

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Tel Aviv, 64239, Israel

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Gifu, 509-6134, Japan

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Mie, 515-8544, Japan

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Tokyo, 140-8522, Japan

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Ebdentown, Upper Hutt 5018, New Zealand

US GSK Clinical Trials Call CenterContact

GSKClinicalSupportHD@gsk.com877-379-3718

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Rotorua, 3010, New Zealand

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Bialystok, 15-044, Poland

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Rzeszów, 35-051, Poland

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Barcelona, Spain

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Málaga, 29010, Spain

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Palma de Mallorca, 07010, Spain

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Bedford, MK40 2FG, United Kingdom

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Bradford, BD9 6RJ, United Kingdom

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Corby, NN17 2UR, United Kingdom