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 (ENDURA-2)
ClinicalTrials.gov ID: NCT06961214
What this study is testing
What is Depemokimab?
This is an investigational injectable medicine being studied as a potential add-on treatment for moderate to severe COPD. It is designed to target type 2 inflammation in the lungs.
Also referred to as GSK3511294.
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 depemokimab works well and is safe. It checks how it compares to other treatments for uncontrolled COPD.
- Who it's for
- You may be able to join if you have moderate to severe COPD that is not well controlled. You must also have a specific type of lung inflammation.
- What's involved
- You would take depemokimab as an extra medicine. You would also get regular check-ups and tests to see how you are doing.
- Time commitment
- The source text does not say how long the study lasts or how many visits are needed.
- 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 \ 30 percent (%) and \<= 80% predicted...
- 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 \ 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 and 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
- Sheffield, Alabama, United States
- Aurora, Colorado, United States
- Brooksville, Florida, United States
- Doral, Florida, United States
- Fort Lauderdale, Florida, United States
- Miami, Florida, United States
- Miami Lakes, Florida, United States
- Naples, Florida, United States
- New Port Richey, Florida, United States
- Ocala, Florida, United States
- Orlando, Florida, United States
- Ormond Beach, Florida, United States
- Palmetto Bay, Florida, United States
- Pembroke Pines, Florida, United States
- St. Petersburg, Florida, United States
- Adairsville, Georgia, United States
- Atlanta, Georgia, United States
- Cordele, Georgia, United States
- Morrow, Georgia, United States
- Boise, Idaho, United States
+ 132 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 Sheffield, Alabama, United States; Aurora, Colorado, United States; Brooksville, Florida, United States; Doral, Florida, United States; Fort Lauderdale, Florida, United States; Miami, Florida, United States and 146 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.