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eValuating the efficacy and safety of InitiatinG depemokImab earLy therApy iN COPD with Type 2 inflammation (VIGILANT)
EU CTIS ID: 2025-521108-23-00
What this study is testing
To evaluate the efficacy of depemokimab compared with placebo
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
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 (<)0.70 and a post-salbutamol FEV1 greater 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 : ▪ 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 investigator for at least 3 months
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 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
See the full eligibility criteria
Who can join
- 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 (<)0.70 and a post-salbutamol FEV1 greater 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 : ▪ 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 investigator for at least 3 months
- Body mass index (BMI) >=16 kilograms per square meter (kg/m^2)
What rules you out
- 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
- Brazil
- Australia
- Mexico
- Japan
- New Zealand
- United States
- Argentina
- Israel
- Korea, Republic of
- United Kingdom
- Canada
- Chile
- Taiwan
- China
- Colombia
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brazil; Australia; Mexico; Japan; New Zealand; United States 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 EU CTIS; the study team decides eligibility.