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RecruitingPhase 3

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)

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-1)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests GSK5784283 (felcorekibart), added to usual treatment, against a placebo (a treatment with no active drug). It checks whether the drug safely reduces moderate and severe flare-ups of COPD, a long-term lung disease. It is for adults ages 40 to 80 with moderate to very severe COPD and frequent flare-ups.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Men or women who meet the study’s requirements.
  • Age 40 to 80.
  • High blood levels of eosinophils, a type of white blood cell.
  • Moderate to very severe COPD with frequent flare-ups.
  • A high score on the COPD Assessment Test, which measures COPD symptoms.
  • Currently smoke cigarettes or smoked them in the past.
  • Use three types of inhaled COPD medicine, including an inhaled steroid, or two types if an inhaled steroid is not suitable.

Who can't join

  • A current or past asthma diagnosis, or another major lung disease.
  • Pneumonia, a COPD flare-up, or a lower airway infection within 4 weeks before the first screening visit.
  • Past or planned surgery to reduce lung size, or a procedure to place valves in the lung airways.
  • Need oxygen for more than 16 hours a day.
  • Right-sided heart failure caused by lung disease with severe high blood pressure in the lungs, or class III or IV heart failure (more severe heart failure).
  • Current cancer or cancer within the past 5 years, except fully treated non-melanoma skin cancer or early cancer limited to the surface of the cervix.
  • Heart attack, unstable angina (heart-related chest pain), or stroke within 6 months before screening, or an unstable heart rhythm.
  • Other major health conditions that could affect safety or study results.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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.

Study sites (2)

FL

LA