Early depemokimab treatment for COPD with type 2 (eosinophilic) inflammation

A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Study of the Efficacy and Safety of Early Depemokimab Initiation as add-on Treatment in COPD Patients With Type 2 Inflammation

This trial will test whether adding depemokimab early to standard care helps adults with moderate-to-severe COPD who have type 2 (eosinophilic) inflammation.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1196 (estimated)
• Ages: 40 Years to 75 Years
• Sex: All
• Sponsor: GlaxoSmithKline (Industry-sponsored)
• Drugs / interventions: Depemokimab
• Locations: 6 sites (Doral, Florida and 5 other locations)
• Trial ID: NCT07177339 on ClinicalTrials.gov

What this trial studies

This is a Phase 3, randomized, placebo-controlled trial testing depemokimab as an add-on therapy in adults with moderate-to-severe COPD and evidence of type 2 (eosinophilic) inflammation. Eligible participants have a documented COPD history of at least one year, post-bronchodilator FEV1/FVC < 0.70 with FEV1 between >30% and <80% predicted, and elevated exacerbation risk or symptom burden (for example mMRC ≥2 or CAT ≥15). Current or former smokers with ≥10 pack-years are included, and blood eosinophil counts are used to identify the eosinophilic phenotype. The study compares depemokimab versus placebo on clinical outcomes including exacerbation rates, lung function, symptoms, and safety.

Who should consider this trial

Good fit: Adults with moderate-to-severe COPD who have a blood eosinophil (type 2) inflammatory profile, objective airflow obstruction, elevated exacerbation risk, and a history of smoking (≥10 pack-years) are ideal candidates.

Not a fit: Patients without type 2/eosinophilic inflammation, those with only mild COPD, or individuals without a significant smoking history are unlikely to receive benefit from this approach.

Why it matters

Potential benefit: If successful, depemokimab could reduce COPD exacerbations and improve symptoms for patients with eosinophilic/type 2 COPD when started early as an add-on therapy.

How similar studies have performed: Biologic therapies targeting type 2 inflammation have shown strong benefits in eosinophilic asthma, but prior anti-eosinophil trials in COPD have had mixed results.

Eligibility criteria

Inclusion Criteria:

* Male or eligible female participants
* Eosinophilic phenotype measured using Blood Eosinophil Count (BEC)
* Moderate to severe COPD, defined as

  * A clinically documented history of COPD for at least 1 year
  * A post-salbutamol Forced expiratory volume in one second (FEV1)/Forced vital capacity (FVC) ratio of less than (\<)0.70 and a post-salbutamol FEV1 greater than (\>)30 percent (%) and \<80% predicted normal values
* Elevated risk for exacerbations, defined as

  * A well-documented history of only 1 moderate COPD exacerbation in the prior 12 months and
  * The presence of risk factors for future exacerbations/deterioration such as:
  * Modified Medical Research Council (mMRC) dyspnea score \>= 2
  * COPD Assessment Test (CAT) \>= 15
  * Post-bronchodilator FEV1 \< 50% predicted
  * Chronic bronchitis
* Smoking status: Current or former cigarette smokers with a history of cigarette smoking of \>=10 pack-years at Screening.
* Dual (Inhaled corticosteroid (ICS)+ Long-acting beta2-adrenergic receptor agonist \[LABA\] or LABA+ Long-acting muscarinic receptor antagonist \[LAMA\]) or triple (ICS+LABA+LAMA) inhaler therapy as assessed by the investigator for at least 3 months
* Body mass index (BMI) \>=16 kilograms per square meter (kg/m\^2)

Exclusion Criteria:

* The Investigator must judge that COPD is the primary diagnosis accounting for the clinical manifestations of lung disease, and clinical manifestations of lung disease where primary diagnosis is not COPD are excluded

  * Participants with a current or prior physician diagnosis of asthma
  * Participants with childhood asthma are permitted, provided that childhood asthma has resolved before 18 years of age and has not recurred
* Other clinically significant lung disease: The Investigator must judge that COPD is the primary diagnosis accounting for the clinical manifestations of the lung disease.
* COPD severity: Participants with more than one moderate exacerbation or severe exacerbation in the past 12 months prior to Visit 1
* COPD stability: Participants with pneumonia, COPD exacerbation, or lower respiratory tract infection within the 4 weeks prior to 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 Visit 1
* Chronic hypercapnia requiring non-invasive positive pressure ventilation (NIPPV) use including Bi-Level Positive Airway Pressure (BiPAP) or Continuous Positive Airway Pressure (CPAP) are excluded
* Continuous oxygen: Participants requiring oxygen supplementation for COPD

Where this trial is running

Doral, Florida and 5 other locations

• GSK Investigational Site — Doral, Florida, United States (Recruiting)
• GSK Investigational Site — Chengdu, China (Recruiting)
• GSK Investigational Site — Guilin, China (Recruiting)
• GSK Investigational Site — Jiangmen, China (Recruiting)
• GSK Investigational Site — Nanchang, China (Recruiting)
• GSK Investigational Site — Taizhou, China (Recruiting)

Study contacts

• Study coordinator: US GSK Clinical Trials Call Center

Conditions Pulmonary Disease, Chronic Obstructive; Depemokimab; Chronic Obstructive Pulmonary Disorder; COPD; Type 2 inflammation; Eosinophilic phenotype; Exacerbation