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Recruiting NCT06961214

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

Conditions: Pulmonary Disease, Chronic Obstructive

Sex: All
Ages: 40 Years – 80 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 961
Sponsor: GlaxoSmithKline

Location: GSK Investigational Site Sheffield Alabama

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 compared 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 (\30 percent (%) and \=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 and 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 16 hours per day to maintain resting oxygen saturation greater than 88% * 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)

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06961214). StuddyBuddy aggregates publicly available trial information.