Recruiting
Phase 3

GSK5784283

Sponsor:

GlaxoSmithKline

Code:

NCT07780656

Conditions

Pulmonary Disease, Chronic Obstructive

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

GSK5784283

Placebo

Standard of care

Study Details

Brief summary:

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Study ID

NCT07780656

Start date

Sep 11, 2026

Status verified date

Sep, 2026

Completion date

Mar 15, 2030

Anticipated

Primary completion date

Jul 20, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

624 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Participants receiving GSK5784283 plus standard of care

placebo comparator: Participants receiving matching placebo plus standard of care

Interventions

GSK5784283

GSK5784283 will be administered.

Placebo

Placebo will be administered.

Standard of care

Standard of care will be administered.

Primary outcome measure

  • Annualized rate of moderate or severe COPD Exacerbations [ Time Frame: Up to Week 78 ]

Central Contacts and Locations

Central contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

+44 (0) 20 89904466GSKClinicalSupportHD@gsk.com

Locations

GSK Investigational Site

Recruiting

Tampa, Florida, United States, 33607

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Sady Alpizar

More Information

Sponsor

GlaxoSmithKline

Last update posted

Sep 25, 2026

Last verified

Sep, 2026

Keywords

  • Chronic obstructive pulmonary disease
  • GSK5784283
  • Eosinophilic phenotype
  • Felcorekibart
  • Monoclonal antibody
  • Thymic Stromal Lymphopoietin

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-26. This information was provided to ClinicalTrials.gov by GlaxoSmithKline on 2026-09-25. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.