Pulmonary Disease, Chronic Obstructive study: GSK5784283
Official title 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)
ClinicalTrials.gov ID: NCT07780656
What this study is testing
What is GSK5784283?
This is an investigational medicine being studied to see if it can help reduce flare-ups in people with chronic obstructive pulmonary disease (COPD).
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether adding GSK5784283 to your usual care lowers the yearly number of moderate and severe COPD flare‑ups. It also looks at how safe the drug is.
- Who it's for
- You may be able to join if you have moderate to very severe COPD and are already taking your regular medicines.
- What's involved
- You will take the study drug or a pretend treatment at home, and you will have regular check‑ins with the study team to track your health and any side effects.
- Time commitment
- The study lasts about a year, with several visits to the clinic for check‑ins and health assessments.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 80
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Cape Coral, Florida, United States
- Greenacres City, Florida, United States
- Miami, Florida, United States
- Tampa, Florida, United States
- New York, New York, United States
- Rapid City, South Dakota, United States
- West Point, Utah, United States
- Spokane, Washington, United States
- Buenos Aires, Argentina
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Cape Coral, Florida, United States; Greenacres City, Florida, United States; Miami, Florida, United States; Tampa, Florida, United States; New York, New York, United States; Rapid City, South Dakota, United States and 3 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.