Recruiting NCT06959095
Depemokimab as an Extended treatmeNt Duration Biologic in Adults With Chronic Obstructive Pulmonary Disease (COPD) and Type 2 Inflammation (ENDURA -1)
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, China, Japan
- 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 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. Georges 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 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.
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
Study locations
China · 10 centers
- GSK Investigational Site — Changsha
- GSK Investigational Site — Chengdu
- GSK Investigational Site — Chengdu
- GSK Investigational Site — Guangzhou
- GSK Investigational Site — Hangzhou
- GSK Investigational Site — Jiangmen
- GSK Investigational Site — Jiangxi
- GSK Investigational Site — Mianyang
- … and 2 more centers
United States · 4 centers
- GSK Investigational Site — Loxahatchee Groves
- GSK Investigational Site — Miami
- GSK Investigational Site — Rock Hill
- GSK Investigational Site — Corsicana
Japan · 1 center
- GSK Investigational Site — Tokyo
Identifiers
NCT: NCT06959095 · 222714 · 2024-520418-22