Clinical trial NCT06959095: Depemokimab as an Extended treatmeNt Duration Biologic in Adults With Chronic Obstructive Pulmonary Disease (COPD) and Type 2 Inflammation (ENDURA -1)
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
Exacerbations
Placebo
Type 2 inflammation
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2025-05-06
Enrollment: 981
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a placebo-controlled, multicenter trial
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 as an add-on medicine in participants with uncontrolled moderate to severe COPD with type 2 inflammation.


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 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 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. Georges 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:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: