Depemokimab for adults with COPD and eosinophilic (type 2) inflammation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 16 hours per day to maintain resting oxygen saturation greater than 88%
* 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's running

• GSK Investigational Site
  Sheffield, Alabama, United States Recruiting
• GSK Investigational Site
  Aurora, Colorado, United States Recruiting
• GSK Investigational Site
  Brooksville, Florida, United States Recruiting
• GSK Investigational Site
  Doral, Florida, United States Recruiting
• GSK Investigational Site
  Fort Lauderdale, Florida, United States Recruiting
• GSK Investigational Site
  Miami, Florida, United States Recruiting

+143 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: US GSK Clinical Trials Call Center
• Email: GSKClinicalSupportHD@gsk.com
• Phone: 877-379-3718

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• GSK5784283 added to standard COPD therapy vs placebo in moderate to very severe COPD

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• GSK5784283 added to standard COPD care versus placebo in adults with moderate to very severe COPD

  This study tests whether adding GSK5784283 to a patient’s current COPD treatment helps reduce COPD flare-ups compared with a placebo in adults with eosinophilic COPD and a history of frequent exacerbations.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.