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Depemokimab as an Extended treatmeNt Duration Biologic in Adults With Chronic Obstructive Pulmonary Disease (COPD) and Type 2 Inflammation (ENDURA -1)

NCT06959095 · GlaxoSmithKline
In plain English

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Official title
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
About this study
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 criteria
Inclusion Criteria: * 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. Exclusion Criteria: The following subjects are excluded: * Participants with a current or prior physician diagnosis of asthma. * Other clinically significant lung disease: The Investigator must judge that COPD is the primary diagnosis accounting for the clinical manifestations of the lung disease. * Participants with pneumonia, COPD exacerbation, or lower respiratory tract infection within the 4 weeks prior to Screening 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 Screening Visit 1. * Continuous oxygen: Participants requiring oxygen supplementation for more than 12 hours per day. * Cor pulmonale - resulting in right heart failure, severe pulmonary hypertension * Chronic hypercapnia requiring Non-invasive positive pressure ventilation (NIPPV) use (including Bi-Level Positive Airway Pressure \[BiPAP\] or Continuous Positive Airway Pressure \[CPAP\]). * Unstable cardiovascular disease or arrhythmia. * Parasitic Infection: Participants with a known, pre-existing parasitic infection within 6 months of Screening (Visit 1).
Study design
Enrollment target: 981 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2025-06-20
Estimated completion: 2029-08-20
Last updated: 2025-10-08
Interventions
Drug: DepemokimabDrug: Placebo
Primary outcomes
  • Annualized Rate of Moderate/Severe Exacerbations (From Baseline up to Week 104)
Sponsor
GlaxoSmithKline · industry
Contacts & investigators
ContactUS GSK Clinical Trials Call Center · contact · GSKClinicalSupportHD@gsk.com · 877-379-3718
ContactEU GSK Clinical Trials Call Center · contact · GSKClinicalSupportHD@gsk.com · +44 (0) 20 89904466
InvestigatorGSK Clinical Trials · study_director, GlaxoSmithKline
All locations (15)
GSK Investigational SiteRecruiting
Loxahatchee Groves, Florida, United States
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Miami, Florida, United States
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Rock Hill, South Carolina, United States
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Corsicana, Texas, United States
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Changsha, Hunan, China
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Chengdu, Sichuan, China
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Chengdu, China
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Guangzhou, China
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Hangzhou, China
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Jiangmen, China
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Jiangxi, China
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Mianyang, China
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Qingyuan, China
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Zigong, China
GSK Investigational SiteRecruiting
Tokyo, Japan
Depemokimab as an Extended treatmeNt Duration Biologic in Adults With Chronic Obstructive Pulmonary Disease (COPD) and Type 2 Inflammation (ENDURA -1) · TrialPath