Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
40 – 80
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
981 (estimated)
Sponsor
GlaxoSmithKline · Industry
Who this trial is looking for
This trial is looking for adults aged 40 to 80 with moderate to severe COPD and type 2 inflammation. Participants will take a new medicine called depemokimab to see how it helps manage their condition.
Are You a Good Fit for This Trial?
Must be takingInhaled corticosteroidLong-acting muscarinic receptor antagonistLong-acting beta2-adrenergic receptor agonist
Rules you outCor pulmonaleChronic hypercapnia
You may be able to join if
I am between 40 and 80 years old.
I have been diagnosed with moderate to severe COPD.
I have frequent COPD flare-ups.
I have an elevated blood eosinophil count.
I have a COPD assessment test score of 10 or more.
I am a current or former smoker with a history of cigarette smoking.
I have been using optimized inhaler therapy for at least 6 months.
My body mass index is 16 or higher.
You may not be able to join if
I have a current or past diagnosis of asthma.
I have other serious lung diseases.
I had pneumonia or a COPD flare-up in the last 4 weeks.
I have had any lung surgery planned or performed.
I am in the acute phase of a pulmonary rehabilitation program.
I need oxygen for more than 12 hours a day.
I have unstable heart conditions.
I have a known parasitic infection in the last 6 months.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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Status
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 docu…
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 less than (\<) 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 or 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)
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