Depemokimab — a long‑acting biologic for adults with COPD and type 2 inflammation.

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

This trial will test whether adding depemokimab, a long‑acting injectable biologic, reduces flare-ups and improves symptoms in adults with uncontrolled moderate-to-severe COPD who have type 2 inflammation.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 981 (estimated)
• Ages: 40 Years to 80 Years
• Sex: All
• Sponsor: GlaxoSmithKline (Industry-sponsored)
• Drugs / interventions: Depemokimab
• Locations: 15 sites (Loxahatchee Groves, Florida and 14 other locations)
• Trial ID: NCT06959095 on ClinicalTrials.gov

What this trial studies

ENDURA‑1 is a Phase 3, randomized, double‑blind, placebo‑controlled trial testing depemokimab as an add‑on extended‑duration biologic for adults 40–80 with moderate-to-severe COPD and elevated blood eosinophils. Eligible participants have a history of frequent exacerbations despite optimized inhaled therapy and will be randomized to receive depemokimab or placebo with regular clinic visits for dosing, lung function testing, symptom monitoring, and safety assessments. Key outcomes include exacerbation rate, COPD symptoms (e.g., CAT score), lung function (FEV1), and adverse events over the treatment period. Study conduct is at GSK investigational sites with in-person dosing and follow-up visits.

Who should consider this trial

Good fit: Adults aged 40–80 with moderate-to-severe COPD, elevated blood eosinophils (type 2 inflammation), a history of frequent exacerbations despite optimized inhaled therapy, and a ≥10 pack‑year smoking history are the intended candidates.

Not a fit: People with mild COPD, no evidence of type 2 inflammation (low eosinophil counts), never-smokers, or those whose symptoms are well controlled on current therapy are unlikely to benefit from this treatment.

Why it matters

Potential benefit: If successful, depemokimab could reduce COPD exacerbations and improve symptoms with less frequent dosing because it is designed as an extended‑duration biologic.

How similar studies have performed: IL‑5–targeting biologics have shown clear benefit in eosinophilic asthma, while prior COPD studies of similar approaches have yielded mixed results, so the approach is partially supported but not yet proven in COPD.

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).

Where this trial is running

Loxahatchee Groves, Florida and 14 other locations

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

Study contacts

• Study coordinator: US GSK Clinical Trials Call Center

Conditions Pulmonary Disease, Chronic Obstructive; Depemokimab; GSK3511294; Eosinophilic phenotype; Chronic obstructive pulmonary disease; Moderate COPD; Severe COPD; Uncontrolled Moderate to Severe Chronic Obstructive Pulmonary Disease