A Study to Investigate the Efficacy and Safety of GSK5784283 (Felcorekibart) Compared With Placebo in Participants With Moderate to Very Severe COPD (PERSIST COPD-2)

NCT07780656 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: 3006312026-526970-17
• Study Type: interventional
• Target: 624
• Locations: 0 countries
• Sites: N/A

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Annualized rate of moderate or severe COPD Exacerbations

  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.

  Up to Week 78

Secondary Outcomes (5)

• Change from Baseline in St. George's respiratory questionnaire (SGRQ) total score

  Baseline (Day 1) and up to Week 52

• Change from Baseline in pre-Bronchodilator Forced expiratory volume in 1 second (FEV1)

  Baseline (Day 1) and at Week 52

• Annualized rate of COPD exacerbations requiring emergency department (ED) visit or hospitalization

  Up to Week 78

• Annualized rate of moderate/severe COPD exacerbations among participants with elevated screening blood eosinophil counts (BEC)

  Up to Week 78

• Time to first moderate or severe COPD exacerbation

  Up to Week 78

Study Arms (2)

Participants receiving GSK5784283 plus standard of care

EXPERIMENTAL

Drug: GSK5784283; Drug: Standard of care

Participants receiving matching placebo plus standard of care

PLACEBO COMPARATOR

Drug: Placebo; Drug: Standard of care

Interventions

GSK5784283 DRUG

GSK5784283 will be administered.

Participants receiving GSK5784283 plus standard of care

Placebo DRUG

Placebo will be administered.

Participants receiving matching placebo plus standard of care

Standard of care DRUG

Standard of care will be administered.

Participants receiving GSK5784283 plus standard of care; Participants receiving matching placebo plus standard of care

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Central Study Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718; GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a double-blind study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2026
• First Posted: August 21, 2026
• Study Start: August 31, 2026
• Primary Completion (Estimated): July 20, 2029
• Study Completion (Estimated): March 15, 2030
• Last Updated: August 21, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.