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Набира участници Фаза 4 NCT07053423

A Study to Investigate Airway Inflammation With Dupilumab Subcutaneously in Participants Aged ≥40 to ≤85 Years With Chronic Obstructive Pulmonary Disease.

Фаза 4 – наблюдение след одобрението на пазара
Заболявания: Chronic Obstructive Pulmonary Disease

Спонсор: Sanofi

Налично на: БГ
Обобщение
LPS18583 is a multinational, randomized, double-blind, placebo-controlled, parallel-group, Phase 4 study with 2 treatment groups. The purpose of this study is to assess the effect of dupilumab compared with placebo on airway inflammation, resistance, and remodeling including mucus plugging and its association with improvement on lung function, exacerbations, and quality of life improvement in participants aged 40 years of age up to 85 years of age (inclusive). Study details include: The study duration will be up to 40 weeks. The treatment duration will be up to 24 weeks. The number of visits will be 9.
Кой може да участва
Inclusion Criteria: Participants with a physician diagnosis of Chronic Obstructive Pulmonary Disease (COPD) who meet the following criteria at screening: * Current or former smokers with a smoking history of ≥10 pack-years * Moderate-to-severe COPD (post-BD FEV1/FVC ratio \<0.70 and post-BD FEV1 % predicted \>30% and ≤70%) * Medical Research Council Dyspnea Scale grade ≥2 or COPD assessment test (CAT) score ≥10 * Global Initiative for Chronic Obstructive Lung Disease (GOLD) category E , Frequent or severe exacerbations * Background triple therapy (ICS + LABA + LAMA) for 3 months before randomization with a stable dose of medication for ≥1 month before Visit 1; dual therapy (LABA + LAMA) allowed if ICS is contraindicated * Evidence of Type 2 inflammation: Participants with blood eosinophils ≥300 cells/μL at screening or with blood eosinophils ≥150 cells/μL at Visit 1 (screening) and with a history of blood eosinophils ≥300 cells/μL within the past year during stable state (non-exacerbation). * Mucus score cutoff of ≥3 Exclusion Criteria: * A current diagnosis of asthma according to the Global Initiative for Asthma diagnostic (GINA) guidelines, or documented history of asthma * Significant pulmonary disease other than COPD (eg, lung fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension, bronchiectasis, Churg-Strauss Syndrome) or another diagnosed pulmonary or systemic disease associated with elevated peripheral eosinophil counts * Treatment with oxygen \>4.0 L/min for ≥8 hours/day Respiratory tract infection within 4 weeks before screening, or during the screening period * Diagnosis of α-1 anti-trypsin deficiency * Any biologic therapy (including experimental treatments and dupilumab) * Participants on treatment with mucolytics unless on stable therapy for \>6 months The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Интервенции
Dupilumab
DRUG
Placebo
DRUG
Места на провеждане 58
Argentina (3)
Investigational Site Number : 0320002
Buenos Aires
Investigational Site Number : 0320003
Buenos Aires
Investigational Site Number : 0320001
San Miguel de Tucumán , Tucumán Province
Бразилия (4)
Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760002
Porto Alegre , Rio Grande do Sul
Associacao Proar- Site Number : 0760005
Salvador , Estado de Bahia
Hospital Beneficência Portuguesa de São Paulo- Site Number : 0760006
São Paulo
Incor - Instituto do Coracao- Site Number : 0760001
São Paulo
Канада (1)
Investigational Site Number : 1240002
London , Ontario
Китай (3)
Investigational Site Number : 1560005
Chengdu
Investigational Site Number : 1560001
Guangzhou
Investigational Site Number : 1560004
Hangzhou
Дания (2)
Investigational Site Number : 2080003
Aalborg
Investigational Site Number : 2080002
Vejle
Франция (7)
Investigational Site Number : 2500008
La Tronche
Investigational Site Number : 2500001
Lille
Investigational Site Number : 2500005
Lyon
Investigational Site Number : 2500006
Marseille
Investigational Site Number : 2500002
Montpellier
Investigational Site Number : 2500003
Pessac
Investigational Site Number : 2500004
Reims
Унгария (3)
Investigational Site Number : 3480003
Debrecen
Investigational Site Number : 3480001
Hajdúnánás
Investigational Site Number : 3480002
Pécs
Италия (2)
Investigational Site Number : 3800001
Cona , Ferrara
Investigational Site Number : 3800004
Siena
Нидерландия (3)
Investigational Site Number : 5280001
Groningen
Investigational Site Number : 5280003
Hoofddorp
Investigational Site Number : 5280006
Nijmegen
Полша (3)
Investigational Site Number : 6160003
Bialystok , Podlaskie Voivodeship
Investigational Site Number : 6160002
Ostrowiec Świętokrzyski , Świętokrzyskie Voivodeship
Investigational Site Number : 6160001
Poznan , Greater Poland Voivodeship
Сингапур (2)
Investigational Site Number : 7020002
Singapore
Investigational Site Number : 7020001
Singapore
Южна Корея (5)
Investigational Site Number : 4100005
Anyang-si , Gyeonggi-do
Investigational Site Number : 4100001
Seoul , Seoul-teukbyeolsi
Investigational Site Number : 4100004
Seoul , Seoul-teukbyeolsi
Investigational Site Number : 4100002
Seoul , Seoul-teukbyeolsi
Investigational Site Number : 4100003
Seoul , Seoul-teukbyeolsi
Испания (5)
Investigational Site Number : 7240001
Barcelona , Barcelona [Barcelona]
Investigational Site Number : 7240003
Madrid
Investigational Site Number : 7240004
Oviedo , Principality of Asturias
Investigational Site Number : 7240002
Pozuelo de Alarcón , Madrid
Investigational Site Number : 7240005
Santander , Cantabria
Швеция (2)
Investigational Site Number : 7520002
Gothenburg
Investigational Site Number : 7520003
Lund
Taiwan (2)
Investigational Site Number : 1580001
Kaohsiung City
Investigational Site Number : 1580002
Taipei
Великобритания (4)
Investigational Site Number : 8260001
Bradford
Investigational Site Number : 8260003
Leicester , Leicestershire
Investigational Site Number : 8260006
Newcastle upon Tyne , England
Investigational Site Number : 8260008
Southampton , Hampshire
САЩ (7)
Johns Hopkins Bayview Medical Center- Site Number : 8400009
Baltimore , Maryland
REX Clinical Trials - Beaumont- Site Number : 8400011
Beaumont , Texas
University of Alabama at Birmingham - School of Medicine- Site Number : 8400003
Birmingham , Alabama
American Health Research - Charlotte- Site Number : 8400013
Charlotte , North Carolina
Clinical Research Associates of Central PA- Site Number : 8400002
DuBois , Pennsylvania
Finlay Medical Research- Site Number : 8400010
Miami , Florida
Atrium Health Wake Forest Baptist Pulmonary, Sleep And Allergy- Site Number : 8400004
Winston-Salem , North Carolina
Технически детайли
Статус
Набира участници
Фаза
Фаза 4
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
40 Years
Максимална възраст
85 Years
Здрави доброволци
Не
Начална дата
22.09.2025
Крайна дата
04.04.2029
Регистрационен номер
NCT07053423
Източник
clinicaltrials.gov
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