Recruiting NCT07177339

eValuating the Efficacy and Safety of InitiatinG depemokImab earLy therApy iN Chronic Obstructive Pulmonary Disorder (COPD) With Type 2 Inflammation

Phase III Interventional Pulmonary Disease, Chronic Obstructive

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Depemokimab, Placebo.
Who it may be relevant to: Registry conditions: Pulmonary Disease, Chronic Obstructive. Basic parameters: 40 years — 75 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Australia, Bulgaria, Canada, China +8
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

Depemokimab is being developed as a treatment for individuals with moderate to severe Chronic Obstructive Pulmonary Disorder (COPD). The aim of this study is to assess the efficacy and safety of early initiation of depemokimab as an add-on medicine in participants with moderate to severe COPD with type 2 inflammation.

Interventions

Drug Depemokimab
Depemokimab will be administered.
Drug Placebo
Matching placebo will be administered.

Primary outcome measures

Annualized Rate of Moderate/Severe Exacerbations [Time frame: From Baseline Up to Week 156]

Secondary outcome measures (3)

Time to First Moderate/Severe Exacerbation [Time frame: From Baseline Up to Week 156]
Change from Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score at Week 52 [Time frame: From Baseline up to Week 52]
Change from Baseline in Evaluating Respiratory Symptoms (E-RS): COPD Total Score at Week 52 [Time frame: From Baseline up to Week 52]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Quadruple blind
Primary purpose: Treatment

Study locations

China · 45 centers

GSK Investigational Site — Shapingba
GSK Investigational Site — Nanning
GSK Investigational Site — Chengdu
GSK Investigational Site — Chengdu
GSK Investigational Site — Suining
GSK Investigational Site — Beijing
GSK Investigational Site — Beijing
GSK Investigational Site — Changchun
… and 37 more centers

United States · 42 centers

GSK Investigational Site — Newport Beach
GSK Investigational Site — Lakewood
GSK Investigational Site — Brandon
GSK Investigational Site — Crystal River
GSK Investigational Site — Doral
GSK Investigational Site — Greenacres City
GSK Investigational Site — Hialeah
GSK Investigational Site — Hollywood
… and 34 more centers

Bulgaria · 6 centers

GSK Investigational Site — Haskovo
GSK Investigational Site — Montana
GSK Investigational Site — Rousse
GSK Investigational Site — Sofia
GSK Investigational Site — Sofia
GSK Investigational Site — Sofia

Germany · 6 centers