What this study is
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's being tested
- GSK5784283
Intervention · DRUG
GSK5784283 will be administered.
- Placebo
Intervention · DRUG
Placebo will be administered.
- Standard of care
Intervention · DRUG
Standard of care will be administered.
Study details
- Official title
- 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)
- Sponsor
- GlaxoSmithKline
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Enrolling
- 624 people
- Starts
- 2026-09-11
- Est. completion
- 2030-03-15
- Design
- Quadruple-blind, randomized, parallel groups, Phase 3
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 40 Years – 80 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (8)
8 openContact for every open site
- US GSK Clinical Trials Call Center · Contact877-379-3718GSKClinicalSupportHD@gsk.com
- EU GSK Clinical Trials Call Centre · Contact+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Cape Coral, Florida, United States
- Alfonso Garcia Bello · Principal investigator
RecruitingGSK Investigational Site
Greenacres City, Florida, United States
- Jorge Calle Medina · Principal investigator
RecruitingGSK Investigational Site
Miami, Florida, United States
- David Romero-Fischmann · Principal investigator
RecruitingGSK Investigational Site
Tampa, Florida, United States
- Sady Alpizar · Principal investigator
RecruitingGSK Investigational Site
New York, New York, United States
- Diego Ponieman · Principal investigator
RecruitingGSK Investigational Site
Rapid City, South Dakota, United States
- Richard Beasley · Principal investigator
RecruitingGSK Investigational Site
West Point, Utah, United States
- Kelly Amann · Principal investigator
RecruitingGSK Investigational Site
Spokane, Washington, United States
- Sarah Smiley · Principal investigator
Recruiting
Study team
Sponsor
GlaxoSmithKline
Study ID 300631
Study director
GSK Clinical Trials
GlaxoSmithKline
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.