Recruiting NCT06961214

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

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 — 80 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, Argentina, Australia, Austria, Bulgaria +10
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 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

Overview

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 compared as an add-on medicine in participants with uncontrolled moderate to severe COPD with type 2 inflammation.

Interventions

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

Primary outcome measures

Annualized Rate of Moderate/Severe Exacerbations [Time frame: From Baseline up to Week 104]

Secondary outcome measures (5)

Time to First Moderate/Severe Exacerbation [Time frame: From Baseline up to Week 104]
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 in Chronic Obstructive Pulmonary Disease (E-RS: COPD) Total Score at Week 52 [Time frame: From Baseline up to Week 52]
Annualized Rate of Exacerbations Requiring Emergency Department (ED) Visit or Hospitalization [Time frame: From Baseline up to Week 104]
Annualized Rate of Severe Exacerbations [Time frame: From Baseline up to Week 104]

Eligibility criteria

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 12 hours per day
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)

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