Depemokimab as an Extended treatmeNt Duration Biologic in Adults With Chronic Obstructive Pulmonary Disease (COPD) and Type 2 Inflammation (ENDURA -1)
NCT ID: NCT06959095
Last Updated: 2025-10-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
981 participants
INTERVENTIONAL
2025-06-20
2029-08-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Depemokimab
Participants will be administered depemokimab along with standard of care (SoC).
Depemokimab
Depemokimab as a sterile liquid formulation will be administered.
Placebo
Participants will be administered placebo along with SoC.
Placebo
Placebo as a sterile 0.9 percent (%) sodium chloride solution will be administered.
Interventions
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Depemokimab
Depemokimab as a sterile liquid formulation will be administered.
Placebo
Placebo as a sterile 0.9 percent (%) sodium chloride solution will be administered.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
40 Years
80 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Loxahatchee Groves, Florida, United States
GSK Investigational Site
Miami, Florida, United States
GSK Investigational Site
Rock Hill, South Carolina, United States
GSK Investigational Site
Corsicana, Texas, United States
GSK Investigational Site
Changsha, Hunan, China
GSK Investigational Site
Chengdu, Sichuan, China
GSK Investigational Site
Chengdu, , China
GSK Investigational Site
Guangzhou, , China
GSK Investigational Site
Hangzhou, , China
GSK Investigational Site
Jiangmen, , China
GSK Investigational Site
Jiangxi, , China
GSK Investigational Site
Mianyang, , China
GSK Investigational Site
Qingyuan, , China
GSK Investigational Site
Zigong, , China
GSK Investigational Site
Tokyo, , Japan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024-520418-22
Identifier Type: OTHER
Identifier Source: secondary_id
222714
Identifier Type: -
Identifier Source: org_study_id
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