Clinical trial NCT06961214: Depemokimab as an Extended treatmeNt Duration Biologic in Adults With Chronic Obstructive Pulmonary Disease (COPD) and Type 2 Inflammation (ENDURA-2)
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Depemokimab
GSK3511294
Eosinophilic phenotype
Chronic obstructive pulmonary disease
COPD
Moderate COPD
Severe COPD
Uncontrolled Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Exacerbations
Placebo
Type 2 inflammation
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2025-05-07
Enrollment: 960
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Click here to enter text.

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 12 hours per day
* 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)

Primary outcomes:
measure: Annualized Rate of Moderate/Severe Exacerbations
timeFrame: From Baseline up to Week 104
Secondary outcomes:
measure: Time to First Moderate/Severe Exacerbation
timeFrame: From Baseline up to Week 104
measure: Change from Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score at Week 52
timeFrame: From Baseline up to Week 52
measure: Change from Baseline in Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary Disease (E-RS: COPD) Total Score at Week 52
timeFrame: From Baseline up to Week 52
measure: Annualized Rate of Exacerbations Requiring Emergency Department (ED) Visit or Hospitalization
timeFrame: From Baseline up to Week 104
measure: Annualized Rate of Severe Exacerbations
timeFrame: From Baseline up to Week 104
Other outcomes:
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