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)
Key facts
- Where
- Fukuoka és Tokyo, JapánSee the 2 sites
- Phase
- 3. fázis
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 40 and 80 years old?
Forrás: NCT07780669: ki vehet részt
Where in Japán
- FukuokaFukuoka, JapánTaking people
- TokyoTokyo, JapánTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- GlaxoSmithKline
- Trial code
- NCT07780669
- Record updated
- 2026. november 5.
- Original description
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.Read full original descriptionShow less
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-1)
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.
Inclusion: 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: Current or prior physician diagnosis of asthma; Pneumonia, COPD exacerbation, or lower respiratory tract infection within the 4 weeks prior to Screening Visit 1; Continuous oxygen therapy (more than 16 hours/ day); Other clinically significant lung disease; Participants with a history of, or plan for lung volume reduction surgery / endobronchial valve procedure; 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.