Last updated: 08/20/2026 04:00:39

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)

GSK study ID
300631
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
2026-526970-17
Trial status
Not yet recruiting
Not yet recruiting
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official 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)
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:

Annualized rate of moderate or severe COPD Exacerbations

Timeframe: Up to Week 78

Secondary outcomes:

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

Timeframe: Baseline (Day 1) and up to Week 52

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

Timeframe: Baseline (Day 1) and at Week 52

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

Timeframe: Up to Week 78

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

Timeframe: Up to Week 78

Time to first moderate or severe COPD exacerbation

Timeframe: Up to Week 78

Interventions:
Drug: GSK5784283
Drug: Placebo
Drug: Standard of care
Enrollment:
624
Observational study model:
Not applicable
Primary completion date:
2029-20-07
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
Not applicable
Collaborators
Not applicable
Study date(s)
August 2026 to March 2030
Type
Interventional
Phase
3

Participation criteria

Sex
Female & Male
Age
40 - 80 Years
Accepts healthy volunteers
No
  • Male or eligible female participants.
  • Participants with >=40 to less than or equal to (<=) 80 years of age.
  • Current or prior physician diagnosis of asthma.
  • Other clinically significant lung disease.
Inclusion and exclusion criteria
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.

Trial location(s)

No location data available.

Study documents

No study documents available.

Results overview

Study Results yet to be posted

Recruitment status
Not yet recruiting
Actual primary completion date
Not applicable
Actual study completion date
Not applicable

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

Additional information
Not applicable
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