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New treatment option for Pulmonary Disease, Chronic Obstructive
Official title Depemokimab as an Extended treatmeNt Duration Biologic in Adults With Chronic Obstructive Pulmonary Disease (COPD) and Type 2 Inflammation (ENDURA -1)
ClinicalTrials.gov ID: NCT06959095
What this study is testing
What is Depemokimab?
Depemokimab is an investigational medicine, being studied as a potential treatment for pulmonary disease, chronic obstructive.
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
- Depemokimab is being developed as a treatment for individuals with moderate to severe COPD. The aim of this study is to assess the efficacy and safety of depemokimab as an add-on medicine in participants with uncontrolled moderate to severe COPD with type 2 inflammation.
- 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).
- Moderate to severe COPD with frequent exacerbations, defined as:
- 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%...
You likely can't join if
- The following people are excluded:
- 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.
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).
- Moderate to severe COPD with frequent exacerbations, defined as:
- 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.
- The following people are excluded:
- 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 12 hours per day.
- 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's taking place
- Loxahatchee Groves, Florida, United States
- Miami, Florida, United States
- Rock Hill, South Carolina, United States
- Corsicana, Texas, United States
- Changsha, Hunan, China
- Chengdu, Sichuan, China
- Chengdu, China
- Guangzhou, China
- Hangzhou, China
- Jiangmen, China
- Jiangxi, China
- Mianyang, China
- Qingyuan, China
- Zigong, China
- Tokyo, Japan
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 - 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?
Study sites include Loxahatchee Groves, Florida, United States; Miami, Florida, United States; Rock Hill, South Carolina, United States; Corsicana, Texas, United States; Changsha, Hunan, China; Chengdu, Sichuan, China and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.