Summary

Eligibility
for people ages 40-80 (full criteria)
Location
at UC Irvine
Dates
study started
study ends around
Principal Investigator
by Lillian Chow (uci)

Description

Summary

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.

Official Title

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

Keywords

Pulmonary Disease, Chronic Obstructive, Depemokimab, GSK3511294, Eosinophilic phenotype, Chronic obstructive pulmonary disease, (COPD), Moderate COPD, Severe COPD, Uncontrolled Moderate to Severe Chronic Obstructive Pulmonary Disease, Exacerbations, Placebo, Type 2 inflammation

Eligibility

You can join if…

Open to people ages 40-80

  • 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/m2).
  • Male or eligible female participants

You CAN'T join 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 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)

Locations

  • GSK Investigational Site accepting new patients
    Newport Beach California 92663 United States
  • GSK Investigational Site accepting new patients
    Modesto California 95355-4046 United States

Lead Scientist at University of California Health

  • Lillian Chow (uci)
    Associate Clinical Professor, Medicine, School of Medicine

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
GlaxoSmithKline
ID
NCT06959095
Phase
Phase 3 Chronic Obstructive Pulmonary Disease Research Study
Study Type
Interventional
Participants
Expecting 981 study participants
Last Updated