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

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Annualized Rate of Moderate/Severe Exacerbations [Срок оценки: From Baseline up to Week 104]

Вторичные конечные точки (5)

• Time to First Moderate/Severe Exacerbation [Срок оценки: From Baseline up to Week 104]
• Change From Baseline in St. Georges Respiratory Questionnaire (SGRQ) Total Score at Week 52 [Срок оценки: 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 [Срок оценки: From Baseline up to Week 52]
• Annualized Rate of Exacerbations Requiring Emergency Department (ED) Visit or Hospitalization [Срок оценки: From Baseline up to Week 104]
• Annualized Rate of Severe Exacerbations [Срок оценки: From Baseline up to Week 104]

Критерии участия

Критерии включения

• 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.

Критерии исключения

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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 10 центров

• GSK Investigational Site — Чанша
• GSK Investigational Site — Чэнду
• GSK Investigational Site — Чэнду
• GSK Investigational Site — Гуанчжоу
• GSK Investigational Site — Ханчжоу
• GSK Investigational Site — Jiangmen
• GSK Investigational Site — Jiangxi
• GSK Investigational Site — Mianyang
• … и ещё 2 центра

США · 4 центра

• GSK Investigational Site — Loxahatchee Groves
• GSK Investigational Site — Miami
• GSK Investigational Site — Rock Hill
• GSK Investigational Site — Corsicana

Япония · 1 центр

• GSK Investigational Site — Tokyo

Идентификаторы

NCT: NCT06959095 · 222714 · 2024-520418-22

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗