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

Официальное название

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Dupilumab on Airway Inflammation Through Assessments of Mucus Plugging and Other Lung Imaging Parameters in Patients With Chronic Obstructive Pulmonary Disease.

Обзор

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.

Вмешательства

• Препарат Dupilumab
  Pharmaceutical form:Solution for injection-Route of administration:SC injection
• Препарат Placebo
  Pharmaceutical form:Solution for injection-Route of administration:SC injection

Первичные конечные точки

• Change from baseline to Week 24 in global lung mucus score (UCSF mucus scoring) [Срок оценки: Baseline to Week 24]

Вторичные конечные точки (5)

• Change from baseline to Week 24 in mucus volume for global lung by High-resolution Computed Tomography (HRCT) [Срок оценки: Baseline to Week 24]
• Change from baseline to Week 24 in trimmed distal airway wall thickness at TLC by HRCT [Срок оценки: Baseline to Week 24]
• Change from baseline to Week 24 in airway resistance from R5 to R20 measured by Forced Oscillation Technique (FOT) [Срок оценки: Baseline to Week 24]
• Change from baseline to Week 24 in Reactance area (AX) measured by FOT [Срок оценки: Baseline to Week 24]
• Incidence of Treatment-Emergent Adverse Event (TEAE), Serious Adverse Event (SAE), and Adverse Event of Special Interest (AESI) including potentially clinically significant abnormalities [Срок оценки: Baseline to Week 36]

Критерии участия

Критерии включения

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

Критерии исключения

• 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.

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

США · 10 центров

• University of Alabama at Birmingham - School of Medicine- Site Number : 8400003 — Birmingham
• Finlay Medical Research- Site Number : 8400010 — Miami
• Private Practice - Dr. David Kavtaradze- Site Number : 8400017 — Cordele
• University of Kansas Medical Center- Site Number : 8400005 — Kansas City
• Johns Hopkins Bayview Medical Center- Site Number : 8400009 — Baltimore
• Brigham & Women's Hospital- Site Number : 8400014 — Boston
• American Health Research - Charlotte- Site Number : 8400013 — Charlotte
• Atrium Health Wake Forest Baptist Pulmonary, Sleep And Allergy- Site Number : 8400004 — Winston-Salem
• … и ещё 2 центра

Франция · 7 центров

• 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

Бразилия · 5 центров

• Hospital Dom Pedro De Alcantara- Site Number : 0760009 — Feira de Santana
• Associacao Proar- Site Number : 0760005 — Salvador
• Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760002 — Porto Alegre
• Hospital Beneficência Portuguesa de São Paulo- Site Number : 0760006 — São Paulo
• Incor - Instituto do Coracao- Site Number : 0760001 — São Paulo

South Korea · 5 центров

• Investigational Site Number : 4100005 — Anyang-si
• Investigational Site Number : 4100001 — Seoul
• Investigational Site Number : 4100004 — Seoul
• Investigational Site Number : 4100002 — Seoul
• Investigational Site Number : 4100003 — Seoul

Испания · 5 центров

• Investigational Site Number : 7240001 — Barcelona
• Investigational Site Number : 7240005 — Santander
• Investigational Site Number : 7240002 — Pozuelo de Alarcón
• Investigational Site Number : 7240004 — Oviedo
• Investigational Site Number : 7240003 — Madrid

Китай · 4 центра

• Investigational Site Number : 1560005 — Чэнду
• Investigational Site Number : 1560001 — Гуанчжоу
• Investigational Site Number : 1560004 — Ханчжоу
• Investigational Site Number : 1560009 — Xiamen

Нидерланды · 4 центра

• Investigational Site Number : 5280001 — Groningen
• Investigational Site Number : 5280003 — Hoofddorp
• Investigational Site Number : 5280006 — Nijmegen
• Investigational Site Number : 5280002 — Rotterdam

Великобритания · 4 центра

• Investigational Site Number : 8260006 — Newcastle upon Tyne
• Investigational Site Number : 8260008 — Southampton
• Investigational Site Number : 8260003 — Leicester
• Investigational Site Number : 8260001 — Bradford

Аргентина · 3 центра

• Investigational Site Number : 0320001 — San Miguel de Tucumán
• Investigational Site Number : 0320002 — Buenos Aires
• Investigational Site Number : 0320003 — Buenos Aires

Венгрия · 3 центра

• Investigational Site Number : 3480003 — Debrecen
• Investigational Site Number : 3480001 — Hajdúnánás
• Investigational Site Number : 3480002 — Pécs

Польша · 3 центра

• Investigational Site Number : 6160001 — Poznan
• Investigational Site Number : 6160003 — Bialystok
• Investigational Site Number : 6160002 — Ostrowiec Świętokrzyski

Швейцария · 3 центра

• Investigational Site Number : 7560004 — Basel
• Investigational Site Number : 7560002 — Geneva
• Investigational Site Number : 7560003 — Sion

Дания · 2 центра

• Investigational Site Number : 2080003 — Aalborg
• Investigational Site Number : 2080002 — Vejle

Италия · 2 центра

• Investigational Site Number : 3800001 — Cona
• Investigational Site Number : 3800004 — Siena

Сингапур · 2 центра

• Investigational Site Number : 7020002 — Singapore
• Investigational Site Number : 7020001 — Singapore

Швеция · 2 центра

• Investigational Site Number : 7520002 — Gothenburg
• Investigational Site Number : 7520003 — Lund

Тайвань · 2 центра

• Investigational Site Number : 1580001 — Kaohsiung City
• Investigational Site Number : 1580002 — Taipei

Канада · 1 центр

• Investigational Site Number : 1240002 — London

Саудовская Аравия · 1 центр

• Investigational Site Number : 6820003 — Riyadh

Идентификаторы

NCT: NCT07053423 · LPS18583 · 2025-521268-37 · U1111-1314-5262

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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