RecruitingPhase 3

eValuating the Efficacy and Safety of InitiatinG depemokImab earLy therApy iN Chronic Obstructive Pulmonary Disorder (COPD) With Type 2 Inflammation

A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Study of the Efficacy and Safety of Early Depemokimab Initiation as add-on Treatment in COPD Patients With Type 2 Inflammation

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years to 75 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well depemokimab works and how safe it is when started early as an added treatment for COPD, a long-term lung disease. It is for people with moderate to severe COPD and type 2 inflammation, a type of immune system response.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Men or women who meet the study’s requirements.
  • A blood test showing the required pattern of eosinophils, a type of white blood cell.
  • COPD documented for at least 1 year, with breathing tests showing moderate to severe disease after salbutamol, a medicine that opens the airways.
  • Exactly 1 moderate COPD flare-up in the past 12 months.
  • Risk factors for future flare-ups, such as shortness of breath, a high COPD symptom score, low breathing test results, or chronic bronchitis (long-term swelling of the airways).
  • Current or former cigarette smoker with at least 10 pack-years of smoking, such as 1 pack a day for 10 years.
  • Use of an approved combination of 2 or 3 inhaled medicines for at least 3 months, as checked by the study doctor.
  • Body mass index (BMI), a measure of weight compared with height, of at least 16.

Who can't join

  • Another lung disease is the main cause of your lung symptoms, or you have another important lung disease.
  • Current or past asthma, unless it ended before age 18 and never returned.
  • More than 1 moderate COPD flare-up, or a severe flare-up, in the past 12 months.
  • Pneumonia, a COPD flare-up, or a lower airway infection within 4 weeks before the first visit.
  • Past or planned surgery to reduce lung size, or a procedure to place valves in the airways.
  • Being in the acute phase of a lung rehabilitation program within 4 weeks before the first visit.
  • Long-term high carbon dioxide levels in the blood that require breathing support through a mask, such as BiPAP or CPAP.
  • Needing extra oxygen for COPD.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion 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 (\<)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 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 investigator for at least 3 months * Body mass index (BMI) \>=16 kilograms per square meter (kg/m\^2) Exclusion Criteria: * 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

Study sites (42)

CA

CO

FL

GA

ID

KY

LA

ME

MI

NC

NV

OK

PA

SC

TN

TX