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)
Recruiting
Phase 3Interventional Study
Pulmonary Disease, Chronic Obstructive
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
40 – 80
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
624 (estimated)
Sponsor
GlaxoSmithKline · Industry
Who this trial is looking for
This trial is looking for people with moderate to very severe COPD who have frequent flare-ups. Participants will test a new treatment called Felcorekibart to see if it helps reduce these flare-ups better than a placebo.
Are You a Good Fit for This Trial?
Must be takingInhaled corticosteroidLAMALABA
Rules you outCurrent malignancyAsthmaSevere pulmonary hypertension
You may be able to join if
I am between 40 and 80 years old.
I have moderate to very severe COPD.
I have frequent flare-ups of my COPD.
I have elevated levels of certain white blood cells.
I have a high COPD assessment test score.
I am a current or former smoker.
I am already using COPD inhaler treatments.
You may not be able to join if
I have been diagnosed with asthma.
I have other significant lung diseases.
I had pneumonia or a COPD flare-up in the last 4 weeks.
I have had lung surgery planned or performed.
I need oxygen all the time.
I have severe heart problems or high blood pressure in the lungs.
I currently have cancer or had it in the last 5 years.
I have had a heart attack or stroke in the last 6 months.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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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) sco…
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.
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