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A Study to Investigate the Efficacy and Safety of GSK5784283 (Felcorekibart) Compared With Placebo in Participants With Moderate to Very Severe COPD (PERSIST COPD-1)
RECRUITINGPhase 3Sponsored by GlaxoSmithKline
Actively Recruiting
PhasePhase 3
SponsorGlaxoSmithKline
Started2026-08-27
Est. completion2029-07-20
Eligibility
Age40 Years – 80 Years
Healthy vol.Accepted
Locations2 sites
View on ClinicalTrials.gov →
NCT07780669
Summary
The study primarily aims to demonstrate the superiority of GSK5784283 as an add-on therapy compared to placebo in reducing the annualized rate of moderate and severe chronic obstructive pulmonary disease (COPD) exacerbations.
Eligibility
Age: 40 Years – 80 YearsHealthy volunteers accepted
Inclusion Criteria: * Male or eligible female participants * Participants with \>=40 to less than or equal to (\<=) 80 years of age. * An eosinophilic phenotype with elevated BEC. * Moderate to very severe COPD with frequent exacerbations. * Participants with elevated COPD assessment test (CAT) score. * Current or former cigarette smokers. * On triple (Inhaled corticosteroid \[ICS\]+ Long-acting muscarinic antagonist \[LAMA\]+ Long-acting beta-agonist \[LABA\]) or dual inhaled COPD therapy, if ICS is considered not appropriate. Exclusion Criteria: * Current or prior physician diagnosis of asthma * Other clinically significant lung disease. * Pneumonia, COPD exacerbation, or lower respiratory tract infection within the 4 weeks prior to Screening Visit 1. * Participants with a history of, or plan for lung volume reduction surgery / endobronchial valve procedure. * Continuous oxygen therapy (more than 16 hours/ day). * Cor pulmonale resulting in right heart failure and severe pulmonary hypertension. * A current malignancy or history of malignant neoplasm within the last 5 years (except definitively treated non-melanoma skin cancer or carcinoma in situ of the uterine cervix). * Myocardial infarction, unstable angina or stroke within 6 months of screening, unstable arrhythmia. * New York Heart Association class III or IV heart failure. * Other significant medical conditions that could impact participants' safety or study outcomes.
Conditions2
COPDPulmonary Disease, Chronic Obstructive
Interventions1
Locations2 sites
Florida
1 siteGSK Investigational Site
Louisiana
1 siteGSK Investigational Site
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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.
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Actively Recruiting
PhasePhase 3
SponsorGlaxoSmithKline
Started2026-08-27
Est. completion2029-07-20
Eligibility
Age40 Years – 80 Years
Healthy vol.Accepted
Locations2 sites
View on ClinicalTrials.gov →
NCT07780669