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)
Purpose
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.
Condition
- Pulmonary Disease, Chronic Obstructive
Eligibility
- Eligible Ages
- Between 40 Years and 80 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Masking Description
- This is a double-blind study
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Participants receiving GSK5784283 plus standard of care |
|
|
|
Placebo Comparator Participants receiving matching placebo plus standard of care |
|
Recruiting Locations
GSK Investigational Site
Doral, Florida 33172
Doral, Florida 33172
GSK Investigational Site
Lake Charles, Louisiana 70605
Lake Charles, Louisiana 70605
More Details
- Status
- Recruiting
- Sponsor
- GlaxoSmithKline