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Depemokimab for adults with COPD and eosinophilic (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

PHASE3 · GlaxoSmithKline · NCT06961214

This study will test whether adding depemokimab to usual inhaled therapy can reduce flare-ups and improve outcomes for adults (40–80) with moderate-to-severe COPD and high blood eosinophils.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment960 (estimated)
Ages40 Years to 80 Years
SexAll
SponsorGlaxoSmithKline (industry)
Drugs / interventionsDepemokimab
Locations159 sites (Sheffield, Alabama and 158 other locations)
Trial IDNCT06961214 on ClinicalTrials.gov

What this trial studies

This Phase 3, randomized, placebo-controlled trial compares depemokimab versus placebo as an add-on to optimized inhaled therapy in adults with moderate-to-severe COPD and evidence of type 2 (eosinophilic) inflammation. Eligible participants have elevated blood eosinophil counts, a history of frequent exacerbations, and post-bronchodilator airflow limitation (FEV1/FVC <0.70 and FEV1 >30% to ≤80% predicted). The study will follow participants for efficacy and safety outcomes, with a focus on exacerbation frequency and respiratory function while monitoring adverse events. Sites for enrollment are GSK investigational centers in the United States.

Who should consider this trial

Good fit: Ideal candidates are adults aged 40–80 with moderate-to-severe COPD, elevated blood eosinophil counts, a history of frequent exacerbations, and who are on optimized inhaled therapy including an inhaled corticosteroid and long-acting bronchodilator(s).

Not a fit: Patients without type 2/eosinophilic inflammation or those with very low blood eosinophil counts are unlikely to benefit from this eosinophil-targeting biologic.

Why it matters

Potential benefit: If successful, depemokimab could lower the rate of COPD exacerbations and provide longer-lasting control for patients with eosinophilic COPD when added to standard inhaled therapy.

How similar studies have performed: Other biologics that target eosinophils have shown mixed results in COPD, with some trials reporting modest reductions in exacerbations in eosinophilic subgroups while others were inconclusive.

Eligibility criteria

Show full inclusion / exclusion 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)

Where this trial is running

Sheffield, Alabama and 158 other locations

+109 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

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

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.