Pulmonary Disease, Chronic Obstructive study: Depemokimab
Official title Depemokimab as an Extended Treatment Duration Biologic in Adults With Chronic Obstructive Pulmonary Disease (COPD) and Type 2 Inflammation
ClinicalTrials.gov ID: NCT06959095
What this study is testing
What is Depemokimab (GSK3511294)?
Depemokimab is an investigational sterile liquid formulation being studied as an add‑on treatment for moderate to severe COPD with type 2 inflammation.
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 depemokimab to your usual care can improve breathing and safety for people with uncontrolled moderate to severe COPD and type 2 inflammation.
- Who it's for
- You may be able to join if you are an adult with moderate to severe COPD and type 2 inflammation that is not well controlled by your current treatment.
- What's involved
- You would take depemokimab as an extra medicine along with your regular COPD care. You will have visits to the clinic for check‑ins and tests to see how you are doing.
- Time commitment
- The study lasts several months and requires you to attend scheduled clinic visits for follow‑up and safety checks.
- Phase 3: a large, late-stage study
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
- Participants must be greater than or equal to (\>=) 40 to less than or equal to (\<=) 80 years of age, at the time of signing the informed consent
- Elevated blood eosinophil count (BEC).
- A clinically documented history of COPD as defined by the American Thoracic Society/European Respiratory Society for at least 1 year
- A post-bronchodilator forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) ratio of less than (\ 30 percent (%) and \<= 80%...
- A well-documented history of at least 2 moderate or 1 severe exacerbation in the 12 months prior to screening
You likely can't join if
- Participants with a current or prior physician diagnosis of asthma
- Other clinically significant lung disease: The Investigator must judge that COPD is the primary diagnosis accounting for the clinical manifestations...
- Participants with pneumonia, COPD exacerbation, or lower respiratory tract infection within the 4 weeks prior to Screening Visit 1
- Lung resection: Participants with a history of, or plan for lung volume reduction surgery / endobronchial valve procedure
- Pulmonary rehabilitation: Participants in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Screening Visit 1.
- Continuous oxygen: Participants requiring oxygen supplementation for more than 16 hours per day to maintain resting oxygen saturation greater than 88%
See the full eligibility criteria
- Participants must be greater than or equal to (\>=) 40 to less than or equal to (\<=) 80 years of age, at the time of signing the informed consent
- Elevated blood eosinophil count (BEC).
- A clinically documented history of COPD as defined by the American Thoracic Society/European Respiratory Society for at least 1 year
- A post-bronchodilator forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) ratio of less than (\ 30 percent (%) and \<= 80% predicted normal values
- A well-documented history of at least 2 moderate or 1 severe exacerbation in the 12 months prior to screening
- COPD assessment test (CAT) score \>=10 at Visit 1
- Smoking status: Current or former cigarette smokers with a history of cigarette smoking of \>=10 pack-years.
- Participants should be on optimized inhaler therapy, defined as inhaled corticosteroid (ICS) plus Long-acting muscarinic receptor antagonist (LAMA) plus Long-acting beta2-adrenergic receptor agonist (LABA) either as...
- Body mass index (BMI) \>=16 kilogram per square meter (kg/m\^2).
- Male or eligible female participants
- Participants with a current or prior physician diagnosis of asthma
- Other clinically significant lung disease: The Investigator must judge that COPD is the primary diagnosis accounting for the clinical manifestations of the lung disease
- Participants with pneumonia, COPD exacerbation, or lower respiratory tract infection within the 4 weeks prior to Screening Visit 1
- Lung resection: Participants with a history of, or plan for lung volume reduction surgery / endobronchial valve procedure
- Pulmonary rehabilitation: Participants in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Screening Visit 1.
- Continuous oxygen: Participants requiring oxygen supplementation for more than 16 hours per day to maintain resting oxygen saturation greater than 88%
- Cor pulmonale - resulting in right heart failure, severe pulmonary hypertension
- Chronic hypercapnia requiring Non-invasive positive pressure ventilation (NIPPV) use (including Bi-Level Positive Airway Pressure [BiPAP] or Continuous Positive Airway Pressure [CPAP])
- Unstable cardiovascular disease or arrhythmia.
- Parasitic Infection: Participants with a known, pre-existing parasitic infection within 6 months of Screening (Visit 1)
The study team makes the final eligibility decision.
Where it is enrolling
- Bakersfield, California, United States
- Modesto, California, United States
- Newport Beach, California, United States
- Wilmington, Delaware, United States
- Bradenton, Florida, United States
- Brandon, Florida, United States
- Hialeah, Florida, United States
- Loxahatchee Groves, Florida, United States
- Miami, Florida, United States
- Miami Lakes, Florida, United States
- Orange City, Florida, United States
- Palm Springs, Florida, United States
- Palmetto Bay, Florida, United States
- Pensacola, Florida, United States
- Tamarac, Florida, United States
- Tampa, Florida, United States
- The Villages, Florida, United States
- Riverdale, Georgia, United States
- Stonecrest, Georgia, United States
- Chicago, Illinois, United States
+ 198 more site(s).
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 Bakersfield, California, United States; Modesto, California, United States; Newport Beach, California, United States; Wilmington, Delaware, United States; Bradenton, Florida, United States; Brandon, Florida, United States and 212 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.