Chronic Obstructive Pulmonary Disease (COPD) Clinical Trials

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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

Status: Recruiting
Location: See all (15) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
United States
Florida
GSK Investigational Site
RECRUITING
Loxahatchee Groves
GSK Investigational Site
RECRUITING
Miami
South Carolina
GSK Investigational Site
RECRUITING
Rock Hill
Texas
GSK Investigational Site
RECRUITING
Corsicana
Other Locations
China
GSK Investigational Site
RECRUITING
Changsha
GSK Investigational Site
RECRUITING
Chengdu
GSK Investigational Site
RECRUITING
Chengdu
GSK Investigational Site
RECRUITING
Guangzhou
GSK Investigational Site
RECRUITING
Hangzhou
GSK Investigational Site
RECRUITING
Jiangmen
GSK Investigational Site
RECRUITING
Jiangxi
GSK Investigational Site
RECRUITING
Mianyang
GSK Investigational Site
RECRUITING
Qingyuan
GSK Investigational Site
RECRUITING
Zigong
Japan
GSK Investigational Site
RECRUITING
Tokyo
Contact Information
Primary
US GSK Clinical Trials Call Center
GSKClinicalSupportHD@gsk.com
877-379-3718
Backup
EU GSK Clinical Trials Call Center
GSKClinicalSupportHD@gsk.com
+44 (0) 20 89904466
Time Frame
Start Date: 2025-06-20
Estimated Completion Date: 2029-08-20
Participants
Target number of participants: 981
Treatments
Experimental: Depemokimab
Participants will be administered depemokimab along with standard of care (SoC).
Placebo_comparator: Placebo
Participants will be administered placebo along with SoC.
Sponsors
Leads: GlaxoSmithKline

This content was sourced from clinicaltrials.gov