Идёт набор NCT07190209

Efficacy, Safety, and Tolerability Study of Lunsekimig Compared With Placebo in Adult Participants With Inadequately Controlled Chronic Obstructive Pulmonary Disease (COPD) Characterized by an Eosinophilic Phenotype

Фаза III С лечением Chronic Obstructive Pulmonary Disease

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Lunsekimig, Placebo.
Кому может быть актуально: Состояния в реестре: Chronic Obstructive Pulmonary Disease. Базовые параметры: 40 лет — 80 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США, Аргентина, Бразилия, Канада, Чили +6
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Phase 2b/Phase 3, Randomized, Double-blind, Placebocontrolled, Multicenter Study, to Investigate the Efficacy and Safety of Lunsekimig in Adult Participants With Inadequately Controlled Chronic Obstructive Pulmonary Disease (COPD) Characterized by an Eosinophilic Phenotype

Обзор

This is a parallel, Phase 2b/Phase 3, 3-arm study to investigate the efficacy, safety, and tolerability of subcutaneous (SC) treatment with lunsekimig compared with placebo in adult participants (aged 40 to 80 years, inclusive) with inadequately controlled Chronic obstructive pulmonary disease (COPD) characterized by an eosinophilic phenotype. Participation to the study consists of 3 periods: * Screening period of up to 4 weeks * Randomized intervention period of approximately 48 weeks * Follow-up period: Approximately 8 weeks The study duration will be up to 60 weeks.

Подробное описание

All eligible participants will undergo subcutaneous administrations of lunsekimig or matching placebo during a 48-weeks treatment period

Вмешательства

Препарат Lunsekimig
Pharmaceutical form: solution for injection in prefilled syringe. Route of administration: Subcutaneous injection
Препарат Placebo
Pharmaceutical form: solution for injection. Route of administration: Subcutaneous injection

Первичные конечные точки

Annualized rate of moderate-to-severe chronic obstructive pulmonary disease (COPD) exacerbations [Срок оценки: From Baseline up to 48 weeks]

Вторичные конечные точки (12)

Change from baseline in post-Bronchodilator Forced Expiratory Volume in 1 second (post-BD FEV1) [Срок оценки: From Baseline up to 48 weeks]
Change from baseline in pre-Bronchodilator Forced Expiratory Volume in 1 second (pre-BD FEV1) [Срок оценки: From Baseline up to 48 weeks]
Change from baseline in the SGRQ-C total score [Срок оценки: From Baseline up to 48 weeks]
SGRQ responder defined as an improvement of ≥4 points in the SGRQ-C total score [Срок оценки: From Baseline up to 48 weeks]
Change from baseline in the Chronic airways assessment Test (CAAT) score [Срок оценки: From Baseline up to 48 weeks]
CAAT responder defined as an improvement of ≥2 points in the CAAT total score [Срок оценки: From Baseline up to 48 weeks]
Change from baseline in the E-RS:COPD total score [Срок оценки: From Baseline up to 48 weeks]
E-RS:COPD responder defined as an improvement of ≥2 points in the E-RS:COPD total score [Срок оценки: From Baseline up to 48 weeks]
Annualized rate of severe COPD exacerbations [Срок оценки: From Baseline up to 48 weeks]
Time to first moderate or severe COPD exacerbation [Срок оценки: From Baseline up to 48 weeks]
Time to first severe COPD exacerbation [Срок оценки: From Baseline up to 48 weeks]
Incidence of participants with TEAEs, including AESIs, and SAEs [Срок оценки: From Baseline up to 56 weeks]

Критерии участия

Критерии включения

Between 40 to 80 years of age
Physician diagnosed chronic obstructive pulmonary disease (COPD) ≥1 year
Post-bronchodilator forced expiratory volume in 1 second (post-BD FEV1) ≥ 20% and ≤ 70% of predicted value and FEV1/FVC (forced expiratory volume in 1 second /forced vital capacity) <0.70
Former or current smokers ≥10 pack-years
Chronic Airways Assessment Test (CAAT) ≥10
≥2 moderate or ≥1 severe COPD exacerbations in the prior year
Triple (ICS+LABA+LAMA) COPD therapy ≥12 consecutive weeks
EOS (blood eosinophil count) ≥ 150 cells/μL
18.0 ≤ Body Mass Index ≤ 40.0 kg/m2

Критерии исключения

Participants are excluded from the study if any of the following criteria apply:

Asthma, including pediatric asthma, or asthma-COPD overlap syndrome (ACOS)
Significant pulmonary disease other than COPD
Long-term oxygen therapy >4.0 L/min or requirement of >2.0 L/min to maintain oxygen saturation >88% at rest
Unstable disorder that can impact participants safety or study outcomes
Active or incompletely treated tuberculosis
Current or past malignancies
Concomitant therapies:

long-term macrolides or phosphodiesterase Type 3 (PDE-3) or PDE-4 inhibitors unless on stable therapy for >6 months
any biologic therapy or systemic immunosuppressant within 4 months or 5 half-lives prior to Screening

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial

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