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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)

NCT07780669

RecruitingPhase 3

Sponsor: GlaxoSmithKline

Conditions: Pulmonary Disease, Chronic Obstructive

Interventions: GSK5784283, Placebo, Standard of care

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 40 Years to 80 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (2)

Doral, Florida, United States
Lake Charles, Louisiana, United States