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Tests treatment safety and results for Pulmonary Disease, Chronic Obstructive
Official title eValuating the Efficacy and Safety of InitiatinG depemokImab earLy therApy iN Chronic Obstructive Pulmonary Disorder (COPD) With Type 2 Inflammation
ClinicalTrials.gov ID: NCT07177339
What this study is testing
What is Depemokimab?
Depemokimab is an investigational medicine, being studied as a potential treatment for pulmonary disease, chronic obstructive.
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 Chronic Obstructive Pulmonary Disorder (COPD). The aim of this study is to assess the efficacy and safety of early initiation of depemokimab as an add-on medicine in participants with 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 75
You may be able to join if
- Male or eligible female participants
- Eosinophilic phenotype measured using Blood Eosinophil Count (BEC)
- Moderate to severe COPD, defined as
- A clinically documented history of COPD for at least 1 year
- A post-salbutamol Forced expiratory volume in one second (FEV1)/Forced vital capacity (FVC) ratio of less than (\ )30 percent (%) and \<80% predicted...
You likely can't join if
- The Investigator must judge that COPD is the primary diagnosis accounting for the clinical manifestations of lung disease, and clinical...
- Participants with a current or prior physician diagnosis of asthma
- Participants with childhood asthma are permitted, provided that childhood asthma has resolved before 18 years of age and has not recurred
- Other clinically significant lung disease: The Investigator must judge that COPD is the primary diagnosis accounting for the clinical manifestations...
- COPD severity: Participants with more than one moderate exacerbation or severe exacerbation in the past 12 months prior to Visit 1
- COPD stability: Participants with pneumonia, COPD exacerbation, or lower respiratory tract infection within the 4 weeks prior to Visit 1
See the full eligibility criteria
- Male or eligible female participants
- Eosinophilic phenotype measured using Blood Eosinophil Count (BEC)
- Moderate to severe COPD, defined as
- A clinically documented history of COPD for at least 1 year
- A post-salbutamol Forced expiratory volume in one second (FEV1)/Forced vital capacity (FVC) ratio of less than (\ )30 percent (%) and \<80% predicted normal values
- Elevated risk for exacerbations, defined as
- A well-documented history of only 1 moderate COPD exacerbation in the prior 12 months and
- The presence of risk factors for future exacerbations/deterioration such as:
- Modified Medical Research Council (mMRC) dyspnea score \>= 2
- COPD Assessment Test (CAT) \>= 15
- Post-bronchodilator FEV1 \< 50% predicted
- Chronic bronchitis
- Smoking status: Current or former cigarette smokers with a history of cigarette smoking of \>=10 pack-years at Screening.
- Dual (Inhaled corticosteroid (ICS)+ Long-acting beta2-adrenergic receptor agonist [LABA] or LABA+ Long-acting muscarinic receptor antagonist [LAMA]) or triple (ICS+LABA+LAMA) inhaler therapy as assessed by the...
- Body mass index (BMI) \>=16 kilograms per square meter (kg/m\^2)
- The Investigator must judge that COPD is the primary diagnosis accounting for the clinical manifestations of lung disease, and clinical manifestations of lung disease where primary diagnosis is not COPD are excluded
- Participants with a current or prior physician diagnosis of asthma
- Participants with childhood asthma are permitted, provided that childhood asthma has resolved before 18 years of age and has not recurred
- Other clinically significant lung disease: The Investigator must judge that COPD is the primary diagnosis accounting for the clinical manifestations of the lung disease.
- COPD severity: Participants with more than one moderate exacerbation or severe exacerbation in the past 12 months prior to Visit 1
- COPD stability: Participants with pneumonia, COPD exacerbation, or lower respiratory tract infection within the 4 weeks prior to 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 Visit 1
- Chronic hypercapnia requiring non-invasive positive pressure ventilation (NIPPV) use including Bi-Level Positive Airway Pressure (BiPAP) or Continuous Positive Airway Pressure (CPAP) are excluded
- Continuous oxygen: Participants requiring oxygen supplementation for COPD
The study team makes the final eligibility decision.
Where it's taking place
- Doral, Florida, United States
- Chengdu, China
- Guilin, China
- Jiangmen, China
- Nanchang, China
- Taizhou, China
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 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Doral, Florida, United States; Chengdu, China; Guilin, China; Jiangmen, China; Nanchang, China; Taizhou, China. 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.