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
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.
Описание
All eligible participants will undergo subcutaneous administrations of lunsekimig or matching placebo during a 48-weeks treatment period
Кой може да участва
Inclusion Criteria:
* 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
Exclusion Criteria:
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
Интервенции
Lunsekimig
DRUG
Placebo
DRUG
Места на провеждане
166
Argentina (12)
Investigational Site Number : 0320011
Buenos Aires
Investigational Site Number : 0320005
Buenos Aires
Investigational Site Number : 0320010
Buenos Aires
Investigational Site Number : 0320001
Buenos Aires
Investigational Site Number : 0320002
Buenos Aires
Investigational Site Number : 0320009
Buenos Aires
Investigational Site Number : 0320007
La Plata , Buenos Aires
Investigational Site Number : 0320008
Lobos , Buenos Aires
Investigational Site Number : 0320004
Rosario , Santa Fe Province
Investigational Site Number : 0320012
Rosario , Santa Fe Province
Investigational Site Number : 0320006
San Miguel de Tucumán , Tucumán Province
Investigational Site Number : 0320003
San Miguel de Tucumán , Tucumán Province
Бразилия (9)
Chronos Pesquisa Clínica- Site Number : 0760012
Brasília , Federal District
Centro de Estudos em Terapias Inovadoras- Site Number : 0760013
Curitiba , Paraná
Hospital Universitário Onofre Lopes- Site Number : 0760016
Natal , Rio Grande do Norte
LMK Servicos Medicos- Site Number : 0760018
Porto Alegre , Rio Grande do Sul
Instituto Ceos- Site Number : 0760005
Porto Alegre , Rio Grande do Sul
Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760001
Porto Alegre , Rio Grande do Sul
Fundação Faculdade Regional de Medicina de São José do Rio Preto- Site Number : 0760011
São José do Rio Preto , São Paulo
Centro Internacional de Pesquisa Clínica (CIPES)- Site Number : 0760008
São José dos Campos , São Paulo
Hospital Beneficência Portuguesa de São Paulo- Site Number : 0760010
São Paulo
Канада (5)
Investigational Site Number : 1240010
Ajax , Ontario
Investigational Site Number : 1240004
Guelph , Ontario
Investigational Site Number : 1240012
Ottawa , Ontario
Investigational Site Number : 1240009
Stoney Creek , Ontario
Investigational Site Number : 1240001
Toronto , Ontario
Chile (7)
Investigational Site Number : 1520004
Santiago , Reg Metropolitana de Santiago
Investigational Site Number : 1520001
Santiago , Reg Metropolitana de Santiago
Investigational Site Number : 1520003
Santiago , Reg Metropolitana de Santiago
Investigational Site Number : 1520007
Santiago , Reg Metropolitana de Santiago
Investigational Site Number : 1520006
Talca , Maule Region
Investigational Site Number : 1520002
Valdivia , Los Ríos Region
Investigational Site Number : 1520005
Viña del Mar , Valparaiso
Китай (47)
Investigational Site Number : 1560035
Beijing
Investigational Site Number : 1560054
Changchun
Investigational Site Number : 1560010
Changsha
Investigational Site Number : 1560032
Changsha
Investigational Site Number : 1560018
Chengdu
Investigational Site Number : 1560004
Chengdu
Investigational Site Number : 1560005
Chengdu
Investigational Site Number : 1560062
Foshan
Investigational Site Number : 1560021
Guangzhou
Investigational Site Number : 1560001
Guangzhou
Investigational Site Number : 1560030
Hangzhou
Investigational Site Number : 1560024
Harbin
Investigational Site Number : 1560012
Hefei
Investigational Site Number : 1560046
Hefei
Investigational Site Number : 1560044
Huizhou
Investigational Site Number : 1560026
Jiaozuo
Investigational Site Number : 1560039
Jinan
Investigational Site Number : 1560049
Jinhua
Investigational Site Number : 1560056
Jining
Investigational Site Number : 1560023
Langfang
Investigational Site Number : 1560033
Linhai
Investigational Site Number : 1560002
Nanchang
Investigational Site Number : 1560003
Nanchang
Investigational Site Number : 1560051
Nanning
Investigational Site Number : 1560017
Ningbo
Investigational Site Number : 1560031
Pingxiang
Investigational Site Number : 1560007
Shanghai
Investigational Site Number : 1560037
Shenzhen
Investigational Site Number : 1560027
Shihezi
Investigational Site Number : 1560015
Suining
Investigational Site Number : 1560022
Taiyuan
Investigational Site Number : 1560034
Taizhou
Investigational Site Number : 1560016
Ürümqi
Investigational Site Number : 1560029
Wenzhou
Investigational Site Number : 1560025
Wuhan
Investigational Site Number : 1560050
Wuxi
Investigational Site Number : 1560052
Xi'an
Investigational Site Number : 1560020
Xiamen
Investigational Site Number : 1560011
Xiangtan
Investigational Site Number : 1560055
Xianyang
Investigational Site Number : 1560058
Xinxiang
Investigational Site Number : 1560040
Xuzhou
Investigational Site Number : 1560041
Yangzhou
Investigational Site Number : 1560060
Yichang
Investigational Site Number : 1560059
Zhanjiang
Investigational Site Number : 1560057
Zhengzhou
Investigational Site Number : 1560048
Zunyi
Япония (21)
Investigational Site Number : 3920021
Chiba
Investigational Site Number : 3920026
Fukuoka
Investigational Site Number : 3920033
Hachiōji , Tokyo
Investigational Site Number : 3920029
Hiroshima
Investigational Site Number : 3920039
Kagoshima
Investigational Site Number : 3920040
Kamakura , Kanagawa
Investigational Site Number : 3920008
Kita , Kagawa-ken
Investigational Site Number : 3920009
Kobe , Hyōgo
Investigational Site Number : 3920042
Kōnan , Aichi-ken
Investigational Site Number : 3920018
Kumamoto
Investigational Site Number : 3920032
Nagoya , Aichi-ken
Investigational Site Number : 3920012
Okayama , Okayama-ken
Investigational Site Number : 3920004
Osaka
Investigational Site Number : 3920007
Saga
Investigational Site Number : 3920043
Sakai , Osaka
Investigational Site Number : 3920030
Sakaidechō , Kagawa-ken
Investigational Site Number : 3920028
Tokyo
Investigational Site Number : 3920003
Ube , Yamaguchi
Investigational Site Number : 3920020
Ureshino , Saga-ken
Investigational Site Number : 3920035
Yokohama , Kanagawa
Investigational Site Number : 3920015
Yokohama , Kanagawa
Турция (7)
Investigational Site Number : 7920002
Adana
Investigational Site Number : 7920006
Ankara
Investigational Site Number : 7920003
Ankara
Investigational Site Number : 7920004
Gaziantep
Investigational Site Number : 7920005
Istanbul
Investigational Site Number : 7920007
Izmir
Investigational Site Number : 7920001
Mersin
Великобритания (8)
Investigational Site Number : 8260002
Bradford
Investigational Site Number : 8260014
Bristol , Bristol, City of
Investigational Site Number : 8260009
Harrow , London, City of
Investigational Site Number : 8260003
Leicester , Leicestershire
Investigational Site Number : 8260015
London , Hammersmith and Fulham
Investigational Site Number : 8260031
London , London, City of
Investigational Site Number : 8260034
Oxford , Oxfordshire
Investigational Site Number : 8260032
Worthing , West Sussex
САЩ (50)
AnMed Oglesby Center- Site Number : 8400074
Anderson , South Carolina
REX Clinical Trials - Beaumont- Site Number : 8400014
Beaumont , Texas
South Texas Medical Research Institute - TTS Research- Site Number : 8400018
Boerne , Texas
Helix Biomedics- Site Number : 8400065
Boynton Beach , Florida
Ten20 Clinical Research- Site Number : 8400141
Carrollton , Texas
Chandler Clinical Research Trials- Site Number : 8400025
Chandler , Arizona
Avicenna Clinical Research- Site Number : 8400126
Chicago Ridge , Illinois
Epic Medical Research - Chickasha- Site Number : 8400097
Chickasha , Oklahoma
Private Practice - Dr. David Kavtaradze- Site Number : 8400006
Cordele , Georgia
Beautiful Minds Clinical Research Center- Site Number : 8400017
Cutler Bay , Florida
Texas Health Presbyterian Hospital Dallas- Site Number : 8400032
Dallas , Texas
Dayton Clinical Research- Site Number : 8400124
Dayton , Ohio
Epic Medical Research - De Soto- Site Number : 8400095
DeSoto , Texas
Primeway Clinical Research- Site Number : 8400121
Fayetteville , Georgia
New York Hospital Queens- Site Number : 8400058
Flushing , New York
Eastern Medical Group Research- Site Number : 8400020
Fort Myers , Florida
Henderson Clinical Trials- Site Number : 8400026
Henderson , Nevada
Advanced Respiratory and Sleep Medicine - Hickory- Site Number : 8400013
Hickory , North Carolina
Trio Clinical Trials- Site Number : 8400106
Houston , Texas
HDH Research- Site Number : 8400104
Houston , Texas
Gulf Coast Clinical Research - Houston- Site Number : 8400049
Houston , Texas
Indy Clinical Research- Site Number : 8400071
Indianapolis , Indiana
University of Kansas Medical Center- Site Number : 8400054
Kansas City , Kansas
Lumi Research - Kingwood- Site Number : 8400120
Kingwood , Texas
IMAX Clinical Trials- Site Number : 8400109
La Palma , California
Premier Medical Associates- Site Number : 8400012
Lady Lake , Florida
Radiance Clinical Research - Lampasas - West Avenue East- Site Number : 8400063
Lampasas , Texas
Sierra Clinical Research - Las Vegas- Site Number : 8400028
Las Vegas , Nevada
Long Beach Research Institute- Site Number : 8400027
Long Beach , California
Downtown L.A. Research Center- Site Number : 8400009
Los Angeles , California
MCR Research- Site Number : 8400004
Miami , Florida
Nuren Medical & Research Center- Site Number : 8400030
Miami , Florida
Deluxe Health Center- Site Number : 8400010
Miami Lakes , Florida
Newport Native MD- Site Number : 8400003
Newport Beach , California
Omega Research Consultants - Orlando - Forest City- Site Number : 8400015
Orlando , Florida
Broward Research Center - Pembroke Pines- Site Number : 8400053
Pembroke Pines , Florida
Temple University Hospital - Main Campus- Site Number : 8400059
Philadelphia , Pennsylvania
Pulmonary Associates - Phoenix - East Bell Road- Site Number : 8400114
Phoenix , Arizona
Preferred Primary Care Physicians - Pleasant Hills- Site Number : 8400092
Pittsburgh , Pennsylvania
Paradigm Research - Redding- Site Number : 8400108
Redding , California
Discovery Clinical Trials - San Antonio- Site Number : 8400031
San Antonio , Texas
Bandera Family Health Care - San Antonio- Site Number : 8400021
San Antonio , Texas
Epic Medical Research - Surprise- Site Number : 8400096
Surprise , Arizona
Clinical Research Trials of Florida- Site Number : 8400011
Tampa , Florida
Deluxe Health Center-Tampa- Site Number : 8400056
Tampa , Florida
Amicis Research Center - Valencia- Site Number : 8400119
Valencia , California
Pulmonary and Medicine Associates- Site Number : 8400007
Warren , Michigan
TPMG Clinical Research Division - Williamsburg- Site Number : 8400081
Williamsburg , Virginia
Atrium Health Wake Forest Baptist Pulmonary, Sleep And Allergy- Site Number : 8400048
Winston-Salem , North Carolina
Southern Clinical Research - Zachary- Site Number : 8400113
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