GSK5784283 added to standard COPD care versus placebo in adults with moderate to very severe COPD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 trial compares the monoclonal antibody GSK5784283 (Felcorekibart) plus standard COPD care to placebo plus standard care in adults with moderate to very severe COPD who have an eosinophilic phenotype and frequent exacerbations. Participants continue their existing inhaled therapies (ICS/LAMA/LABA or dual therapy) as appropriate. The primary goal is to see if the add-on therapy lowers the annual rate of moderate to severe COPD exacerbations. Safety and tolerability are also assessed over the study period. The study is conducted at GSK investigational sites in Florida, enrolling adults aged 40 to 80.

Why it matters

Who can join: the full rules

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.

Where it's running

• GSK Investigational Site
  Cape Coral, Florida, United States Recruiting
• GSK Investigational Site
  Greenacres City, Florida, United States Recruiting
• GSK Investigational Site
  Miami, Florida, United States Recruiting
• GSK Investigational Site
  Tampa, Florida, United States Recruiting
• GSK Investigational Site
  New York, New York, United States Recruiting
• GSK Investigational Site
  Rapid City, South Dakota, United States Recruiting

Study contacts

• Study coordinator: US GSK Clinical Trials Call Center
• Email: GSKClinicalSupportHD@gsk.com
• Phone: 877-379-3718

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.