A Study to Investigate the Efficacy and Safety of GSK5784283 (Felcorekibart) Compared With Placebo in Participants With Moderate to Very Severe COPD (PERSIST COPD-1)

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age40-80
SponsorGlaxoSmithKline

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • GSK5784283

    Drug

    GSK5784283 will be administered.

  • Placebo

    Drug

    Placebo will be administered.

  • Standard of care

    Drug

    Standard of care will be administered.

Treatment groups

624 Participants
are divided into 2 treatment groups
Group A: Participants receiving GSK5784283 plus standard of careExperimental treatment 2 interventions
Group B: Participants receiving matching placebo plus standard of carePlacebo comparator 2 interventions

Trial outcomes

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.

Time frame
Up to Week 78

Secondary outcomes

1

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

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.

Time frame
Baseline (Day 1) and up to Week 52
2

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

FEV1 is defined as the volume of air exhaled from the lungs in the first second of a forced expiration as measured by spirometry.

Time frame
Baseline (Day 1) and at Week 52
3

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

Annualized rate of COPD exacerbations requiring ED visit or hospitalization (For pooled analysis across studies 300629 and 300631) will be assessed.

Time frame
Up to Week 78
4

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

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 frame
Up to Week 78

Other outcomes

Sponsors and contacts

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