RecruitingPhase 3

Depemokimab as an Extended Treatment Duration Biologic in Adults With Chronic Obstructive Pulmonary Disease (COPD) and Type 2 Inflammation (ENDURA-2)

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study of the Efficacy and Safety of Depemokimab in Adult Participants With COPD 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 80 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 added to usual COPD treatment. It is for adults ages 40 to 80 with uncontrolled moderate to severe COPD, a long-term lung disease, and type 2 inflammation, a type of immune response.

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 compared as an add-on medicine in participants with uncontrolled 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

  • Be 40 to 80 years old when signing the consent form.
  • Have a high blood level of eosinophils, a type of white blood cell.
  • Have COPD documented for at least 1 year. After medicine that opens the airways, breathing tests must show an FEV1/FVC ratio below 0.70 and FEV1 above 30% and no more than 80% of normal.
  • Have had at least 2 moderate COPD flare-ups or 1 severe flare-up in the past 12 months.
  • Have a COPD symptom test (CAT) score of at least 10 at the first visit.
  • Currently smoke or have smoked cigarettes, with at least 10 pack-years—for example, 1 pack a day for 10 years.
  • Have used all 3 required inhaled medicines for at least 6 months: a steroid and two long-acting medicines that open the airways (LAMA and LABA).
  • Have a body mass index (BMI), a measure based on height and weight, of at least 16. Men and women who meet the study rules may join.

Who can't join

  • Have ever been diagnosed with asthma, or have another major lung disease. The study doctor must judge COPD to be the main cause of lung symptoms.
  • Had pneumonia, a COPD flare-up, or a lower airway infection within 4 weeks before the first screening visit.
  • Have had or plan to have surgery to reduce lung size or a procedure to place valves in the lung airways.
  • Were in the early, intensive phase of a lung rehabilitation program within 4 weeks before the first screening visit.
  • Need extra oxygen for more than 16 hours a day to keep resting blood oxygen above 88%.
  • Have right-sided heart failure caused by lung disease, severe high blood pressure in the lungs, unstable heart disease, or an abnormal heart rhythm.
  • Have long-term high carbon dioxide levels that require breathing support through a mask, such as BiPAP or CPAP.
  • Had a known infection caused by parasites within 6 months before the first screening visit.

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

Official eligibility criteria

Inclusion 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 \< 0.70 and a post-bronchodilator FEV1 \>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 multiple inhalers or a single combination inhaler for at least 6 months prior to Screening Visit 1 * Body mass index (BMI) \>=16 kilogram per square meter (kg/m\^2) * Male and eligible female participants Exclusion Criteria: The following subjects 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 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)

Study sites (57)

AL

CO

FL

GA

ID

IL

LA

MA

MD

ME

MI

NC

NJ

NV

NY

PA

SC

TN

TX

WV