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)
Status and phase
Not yet enrolling
Phase 3
Conditions
Pulmonary Disease, Chronic Obstructive
Treatments
Drug: Placebo
Drug: GSK5784283
Drug: Standard of care
Study type
Interventional
Funder types
Industry
Identifiers
Details and patient eligibility
About
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.
Enrollment
624 estimated patients
Sex
All
Ages
40 to 80 years old
Volunteers
No Healthy Volunteers
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.
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Quadruple Blind
624 participants in 2 patient groups, including a placebo group
Participants receiving GSK5784283 plus standard of care
Experimental group
Treatment:
Drug: Standard of care
Drug: GSK5784283
Participants receiving matching placebo plus standard of care
Placebo Comparator group
Treatment:
Drug: Standard of care
Drug: Placebo
Trial contacts and locations
0
Loading...
Central trial contact
EU GSK Clinical Trials Call Center; US GSK Clinical Trials Call Center
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal
© Copyright 2026 Veeva Systems