Depemokimab as an Extended treatmeNt Duration Biologic in Adults With Chronic Obstructive Pulmonary Disease (COPD) and Type 2 Inflammation (ENDURA -1)

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Pulmonary Disease, Chronic Obstructive

In brief

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.

Key facts

Study ID: NCT06959095
Run by: GlaxoSmithKline
People needed: 981
Starts: 2025-06-20
Expected to finish: 2029-08-20
Last updated by the study team: 2025-10-08

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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).

Where it is running

GSK Investigational Site — Loxahatchee Groves, Florida, United States (enrolling)
GSK Investigational Site — Miami, Florida, United States (enrolling)
GSK Investigational Site — Rock Hill, South Carolina, United States (enrolling)
GSK Investigational Site — Corsicana, Texas, United States (enrolling)
GSK Investigational Site — Changsha, Hunan, China (enrolling)
GSK Investigational Site — Chengdu, Sichuan, China (enrolling)
GSK Investigational Site — Chengdu, China (enrolling)
GSK Investigational Site — Guangzhou, China (enrolling)
GSK Investigational Site — Hangzhou, China (enrolling)
GSK Investigational Site — Jiangmen, China (enrolling)
GSK Investigational Site — Jiangxi, China (enrolling)
GSK Investigational Site — Mianyang, China (enrolling)
GSK Investigational Site — Qingyuan, China (enrolling)
GSK Investigational Site — Zigong, China (enrolling)
GSK Investigational Site — Tokyo, Japan (enrolling)

Full record on ClinicalTrials.gov

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