GSK5784283 added to standard COPD therapy vs placebo in 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 is a Phase 3, randomized, placebo-controlled trial evaluating the safety and efficacy of GSK5784283 as an add-on therapy to standard COPD treatment in adults with moderate to very severe COPD and eosinophilic phenotype. Participants are currently or formerly smokers with elevated CAT scores and a history of frequent exacerbations. The primary goal is to determine if GSK5784283 can lower the annualized rate of moderate and severe exacerbations compared with placebo. Interventions include GSK5784283, placebo, and standard of care, and participants continue their existing inhaled therapies as appropriate. The trial is conducted at three GSK investigational sites in the United States.

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
  Doral, Florida, United States Recruiting
• GSK Investigational Site
  Lake Charles, Louisiana, United States Recruiting
• GSK Investigational Site
  Humble, Texas, United States Recruiting
• GSK Investigational Site
  Huntsville, Texas, United States Recruiting
• GSK Investigational Site
  West Jordan, Utah, United States Recruiting
• GSK Investigational Site
  Fukuoka, Japan Recruiting

Study contacts

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

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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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.