No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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 – 75
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
1,196 (estimated)
Sponsor
GlaxoSmithKline · Industry
Who this trial is looking for
This trial is looking for individuals with moderate to severe COPD and type 2 inflammation. Participants will receive early treatment with depemokimab in addition to their current COPD medications.
Are You a Good Fit for This Trial?
You may be able to join if
I am a male or eligible female participant.
I have been diagnosed with moderate to severe COPD.
I have a blood test showing eosinophils present.
I have a history of only 1 COPD flare-up in the last year.
I have been on dual or triple inhaler therapy for at least 3 months.
I have a body mass index (BMI) of at least 16.
I am a current or former smoker with at least 10 pack-years of smoking history.
You may not be able to join if
I have a current or past diagnosis of asthma.
I have had more than one moderate or severe COPD flare-up in the past year.
I have had a pneumonia or COPD flare-up in the last 4 weeks.
I have had lung surgery planned or done.
I am in the acute phase of a pulmonary rehabilitation program.
I need oxygen therapy for my COPD.
I require non-invasive positive pressure ventilation for chronic hypercapnia.
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 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.
Trial Locations
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Status
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)/…
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
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