Pulmonary Disease, Chronic Obstructive
Conditions
Keywords
Chronic obstructive pulmonary disease, GSK5784283, Eosinophilic phenotype, Felcorekibart, Monoclonal antibody, Thymic Stromal Lymphopoietin
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.
Interventions
DRUGGSK5784283
GSK5784283 will be administered.
DRUGPlacebo
Placebo will be administered.
DRUGStandard of care
Standard of care will be administered.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
This is a double-blind study
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Annualized rate of moderate or severe COPD Exacerbations | Up to Week 78 | Moderate exacerbations are defined as clinically significant exacerbations that require treatment with oral/systemic corticosteroids and/or antibiotics. Severe exacerbations are defined as clinically significant exacerbations that require in-patient hospitalization (that is greater than or equal to \[\>=\] 24 hours) or result in death. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in St. George's respiratory questionnaire (SGRQ) total score | Baseline (Day 1) and up to Week 52 | SGRQ total score will be measured using the SGRQ for COPD (SGRQ-C). The SGRQ-C is a 14-item participant questionnaire, designed to measure health impairment by addressing the frequency of respiratory symptoms (questions 1-7) and the participant's current state (questions 8-14). The total score will be calculated on 0-100 rating scale and scores expressed as a percentage of overall impairment. Higher scores indicate greater impairment of health |
| Change from Baseline in pre-Bronchodilator Forced expiratory volume in 1 second (FEV1) | Baseline (Day 1) and at Week 52 | FEV1 is defined as the volume of air exhaled from the lungs in the first second of a forced expiration as measured by spirometry. |
| Annualized rate of COPD exacerbations requiring emergency department (ED) visit or hospitalization | Up to Week 78 | Annualized rate of COPD exacerbations requiring ED visit or hospitalization (For pooled analysis across studies 300629 and 300631) will be assessed. |
| Annualized rate of moderate/severe COPD exacerbations among participants with elevated screening blood eosinophil counts (BEC) | Up to Week 78 | Annualized rate of moderate/severe COPD exacerbations among participants with elevated screening BEC (For pooled analysis across studies 300629 and 300631) will be assessed. |
| Time to first moderate or severe COPD exacerbation | Up to Week 78 | Time to first moderate or severe exacerbation (For pooled analysis across studies 300629 and 300631) will be assessed. |
Contacts
CONTACTUS GSK Clinical Trials Call Center
CONTACTEU GSK Clinical Trials Call Center
STUDY_DIRECTORGSK Clinical Trials
GlaxoSmithKline
Outcome results
None listed