A Study to Investigate the Efficacy and Safety of GSK5784283 (Felcorekibart) Compared With Placebo in Participants With Moderate to Very Severe COPD (PERSIST COPD-2)
RecruitingPhase 3
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study of the Efficacy and Safety of GSK5784283 (Felcorekibart) in Participants 40 to 80 Years of Age With Moderate to Very Severe COPD (PERSIST COPD-2)
Who can join
Ages 40 to 80 · All sexes
Full eligibility criteria
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.
About the study
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.
What is being tested
- GSK5784283 (drug)
- Placebo (drug)
- Standard of care (drug)
Sponsor: GlaxoSmithKline · Participants: 624 · Started: Sep 11, 2026
Contact the study team
- US GSK Clinical Trials Call Center · Phone: 877-379-3718
- EU GSK Clinical Trials Call Center · Phone: +44 (0) 20 89904466
Official record on ClinicalTrials.gov — NCT07780656
Locations in the U.S.
| Florida | GSK Investigational Site, Miami (Not yet recruiting) GSK Investigational Site, Tampa |
| South Dakota | GSK Investigational Site, Rapid City (Not yet recruiting) |
| Utah | GSK Investigational Site, West Point (Not yet recruiting) |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.