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NCT Number: NCT07780656

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)

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.

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Key information

Conditions

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

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GSK5784283

Drug

GSK5784283 will be administered.

Placebo

Drug

Placebo will be administered.

Standard of care

Drug

Standard of care will be administered.

Primary outcomes

  1. Annualized rate of moderate or severe COPD Exacerbations

    Time frame: 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 outcomes

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

    Time frame: 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

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

  5. Time to first moderate or severe COPD exacerbation

    Time frame: Up to Week 78

    Time to first moderate or severe exacerbation (For pooled analysis across studies 300629 and 300631) will be assessed.

Study contacts

Contact information is provided by the study sponsor or research team.

EU GSK Clinical Trials Call Center

CONTACT

[email protected]

+44 (0) 20 89904466

US GSK Clinical Trials Call Center

CONTACT

[email protected]

877-379-3718

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study of the Efficacy and Safety of GSK5784283 (Felcorekibart) in Participants 40 to 80 Years of Age With Moderate to Very Severe COPD (PERSIST COPD-2)

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Aug 21, 2026
Registry last updated
Aug 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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