RecruitingPhase 3NCT06959095

Depemokimab as an Extended treatmeNt Duration Biologic in Adults With Chronic Obstructive Pulmonary Disease (COPD) and Type 2 Inflammation (ENDURA -1)

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


Sponsor

GlaxoSmithKline

Enrollment

981 participants

Start Date

Jun 20, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 40 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called depemokimab — a long-acting biologic injection given only twice a year — for people with moderate-to-severe COPD who have frequent flare-ups and high levels of a type of immune cell called eosinophils. This drug targets a specific immune pathway (called type 2 inflammation) that may contribute to COPD in certain patients. **You may be eligible if...** - You are between 40 and 80 years old - You have a confirmed diagnosis of COPD for at least 1 year - Your breathing tests show moderate-to-severe airflow limitation - You have had at least 2 moderate or 1 severe COPD flare-up in the past year - Your blood eosinophil count is elevated - You are a current or former smoker **You may NOT be eligible if...** - You have asthma as your primary diagnosis - Your COPD flare-ups are very infrequent - Your eosinophil count is normal or low - You have certain other serious lung or immune conditions - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDepemokimab

Depemokimab as a sterile liquid formulation will be administered.

DRUGPlacebo

Placebo as a sterile 0.9 percent (%) sodium chloride solution will be administered.


Locations(15)

GSK Investigational Site

Loxahatchee Groves, Florida, United States

GSK Investigational Site

Miami, Florida, United States

GSK Investigational Site

Rock Hill, South Carolina, United States

GSK Investigational Site

Corsicana, Texas, United States

GSK Investigational Site

Changsha, Hunan, China

GSK Investigational Site

Chengdu, Sichuan, China

GSK Investigational Site

Chengdu, China

GSK Investigational Site

Guangzhou, China

GSK Investigational Site

Hangzhou, China

GSK Investigational Site

Jiangmen, China

GSK Investigational Site

Jiangxi, China

GSK Investigational Site

Mianyang, China

GSK Investigational Site

Qingyuan, China

GSK Investigational Site

Zigong, China

GSK Investigational Site

Tokyo, Japan

View Full Details on ClinicalTrials.gov

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NCT06959095


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