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
188
Argentina (12)
Investigational Site Number : 0320011
Berazategui , Buenos Aires
Investigational Site Number : 0320004
Buenos Aires
Investigational Site Number : 0320002
Buenos Aires
Investigational Site Number : 0320005
Buenos Aires
Investigational Site Number : 0320006
Buenos Aires
Investigational Site Number : 0320001
Buenos Aires
Investigational Site Number : 0320012
Buenos Aires
Investigational Site Number : 0320003
Buenos Aires
Investigational Site Number : 0320009
Córdoba
Investigational Site Number : 0320007
Mendoza
Investigational Site Number : 0320008
Mendoza
Investigational Site Number : 0320010
Santa Fe
Австралия (4)
Investigational Site Number : 5540004
Dunedin
Investigational Site Number : 0360001
Osborne Park , Western Australia
Investigational Site Number : 0360006
South Brisbane , Queensland
Investigational Site Number : 0360002
Traralgon , Victoria
Бразилия (5)
Santa Casa de Misericordia de Belo Horizonte- Site Number : 0760004
Belo Horizonte , Minas Gerais
Universidade Federal de Goias- Site Number : 0760002
Goiânia , Goiás
WM Pesquisas Clínicas em Doenças Respiratórias- Site Number : 0760003
Porto Alegre , Rio Grande do Sul
Centro Multidisciplinar de Estudos Clínicos- Site Number : 0760001
São Bernardo do Campo , São Paulo
IBCC - Núcleo de Pesquisa e Ensino- Site Number : 0760005
São Paulo
Канада (10)
Investigational Site Number : 1240051
Kelowna , British Columbia
Investigational Site Number : 1240049
Longueuil , Quebec
Investigational Site Number : 1240047
Québec , Quebec
Investigational Site Number : 1240053
Québec , Quebec
Investigational Site Number : 1240050
Saint-Charles-Borromée , Quebec
Investigational Site Number : 1240054
Saint-Charles-Borromée , Quebec
Investigational Site Number : 1240048
Trois-Rivières , Quebec
Investigational Site Number : 1240042
Victoriaville , Quebec
Investigational Site Number : 1240052
West Vancouver , British Columbia
Investigational Site Number : 1240041
Windsor , Ontario
Chile (7)
Investigational Site Number : 1520007
Chillan
Investigational Site Number : 1520004
Recoleta , Reg Metropolitana de Santiago
Investigational Site Number : 1520001
Santiago , Reg Metropolitana de Santiago
Investigational Site Number : 1520002
Santiago , Reg Metropolitana de Santiago
Investigational Site Number : 1520009
Santiago , Reg Metropolitana de Santiago
Investigational Site Number : 1520006
Temuco , La Araucanía
Investigational Site Number : 1520003
Viña del Mar , Valparaiso
Китай (66)
Investigational Site Number : 1560003
Baotou
Investigational Site Number : 1560022
Beijing
Investigational Site Number : 1560001
Beijing
Investigational Site Number : 1560023
Beijing
Investigational Site Number : 1560005
Beijing
Investigational Site Number : 1560090
Changde
Investigational Site Number : 1560057
Changsha
Investigational Site Number : 1560052
Chengdu
Investigational Site Number : 1560032
Chengdu
Investigational Site Number : 1560037
Chongqing
Investigational Site Number : 1560074
Chongqing
Investigational Site Number : 1560051
Foshan
Investigational Site Number : 1560042
Ganzhou
Investigational Site Number : 1560015
Guangzhou
Investigational Site Number : 1560034
Guangzhou
Investigational Site Number : 1560038
Guiyang
Investigational Site Number : 1560016
Haikou
Investigational Site Number : 1560009
Hangzhou
Investigational Site Number : 1560066
Hangzhou
Investigational Site Number : 1560054
Hebei
Investigational Site Number : 1560059
Hefei
Investigational Site Number : 1560007
Hohhot
Investigational Site Number : 1560050
Honghehanizu
Investigational Site Number : 1560046
Huaian City
Investigational Site Number : 1560004
Huizhou
Investigational Site Number : 1560021
Huzhou
Investigational Site Number : 1560065
Jiangyin
Investigational Site Number : 1560081
Jiaxing
Investigational Site Number : 1560055
Jinan
Investigational Site Number : 1560028
Jinan
Investigational Site Number : 1560013
Jinan
Investigational Site Number : 1560079
Jingzhou
Investigational Site Number : 1560040
Jining
Investigational Site Number : 1560061
Kunming
Investigational Site Number : 1560077
Luoyang
Investigational Site Number : 1560063
Meihekou
Investigational Site Number : 1560014
Nanchang
Investigational Site Number : 1560047
Nanjing
Investigational Site Number : 1560082
Nanjing
Investigational Site Number : 1560018
Nanyang
Investigational Site Number : 1560073
Panjin
Investigational Site Number : 1560043
Qingyuan
Investigational Site Number : 1560025
Qinhuangdao
Investigational Site Number : 1560031
Qiqihar
Investigational Site Number : 1560045
Quzhou
Investigational Site Number : 1560008
Shanghai
Investigational Site Number : 1560017
Shanghai
Investigational Site Number : 1560072
Shaoyang
Investigational Site Number : 1560035
Shenyang
Investigational Site Number : 1560053
Shijiazhuang
Investigational Site Number : 1560002
Suzhou
Investigational Site Number : 1560024
Taiyuan
Investigational Site Number : 1560075
Ürümqi
Investigational Site Number : 1560033
Weifang
Investigational Site Number : 1560036
Wenzhou
Investigational Site Number : 1560019
Wuhan
Investigational Site Number : 1560071
Wuhan
Investigational Site Number : 1560070
Xi'an
Investigational Site Number : 1560020
Xi'an
Investigational Site Number : 1560083
Xiangyang
Investigational Site Number : 1560006
Xinxiang
Investigational Site Number : 1560089
Yinchuan
Investigational Site Number : 1560076
Yiyang
Investigational Site Number : 1560044
Zhangzhou
Investigational Site Number : 1560084
Zigong
Investigational Site Number : 1560039
Zunyi
Malaysia (1)
Investigational Site Number : 4580007
Sibu
New Zealand (3)
Investigational Site Number : 5540001
Auckland
Investigational Site Number : 5540003
Christchurch , Canterbury
Investigational Site Number : 5540002
Ebdentown , Wellington Region
South Africa (4)
Investigational Site Number : 7100001
Cape Town , Alberta
Investigational Site Number : 7100003
Cape Town
Investigational Site Number : 7100013
Krugersdorp
Investigational Site Number : 7100012
Pretoria
Южна Корея (7)
Investigational Site Number : 4100007
Anyang-si , Gyeonggi-do
Investigational Site Number : 4100005
Daegu , Gyeongsangbuk-do
Investigational Site Number : 4100003
Jeonju , Jeollabuk-do
Investigational Site Number : 4100004
Seoul , Seoul-teukbyeolsi
Investigational Site Number : 4100002
Seoul , Seoul-teukbyeolsi
Investigational Site Number : 4100001
Seoul , Seoul-teukbyeolsi
Investigational Site Number : 4100006
Seoul , Seoul-teukbyeolsi
Taiwan (7)
Investigational Site Number : 1580007
Changhua
Investigational Site Number : 1580006
Guishan
Investigational Site Number : 1580008
Hsinchu
Investigational Site Number : 1580001
Kaohsiung City
Investigational Site Number : 1580005
Taipei
Investigational Site Number : 1580002
Taipei
Investigational Site Number : 1580003
Taipei
Великобритания (10)
Investigational Site Number : 8260013
Chertsey , Surrey
Investigational Site Number : 8260007
London , England
Investigational Site Number : 8260008
London , Hammersmith and Fulham
Investigational Site Number : 8260001
London , London, City of
Investigational Site Number : 8260016
London , London, City of
Investigational Site Number : 8260035
Milton Keynes , Buckinghamshire
Investigational Site Number : 8260005
Reading
Investigational Site Number : 8260017
Rotherham
Investigational Site Number : 8260030
Salford , Manchester
Investigational Site Number : 8260006
Southampton , Hampshire
САЩ (52)
Appalachian Clinical Research- Site Number : 8400060
Adairsville , Georgia
Vitalis Clinical Research Center- Site Number : 8400040
Allen Park , Michigan
Rheumatology & Pulmonary Clinic- Site Number : 8400012
Beckley , West Virginia
Alpine Clinical Research Center - Boulder - 47th Street- Site Number : 8400005
Boulder , Colorado
Bolt Clinical Research- Site Number : 8400086
Brighton , Michigan
Christie Clinic in Champaign on University- Site Number : 8400023
Champaign , Illinois
Chattanooga Research and Medicine- Site Number : 8400026
Chattanooga , Tennessee
MedTrial- Site Number : 8400010
Columbia , South Carolina
IntraCare- Site Number : 8400034
Dallas , Texas
Premier Pulmonary Critical Care and Sleep- Site Number : 8400111
Denison , Texas
El Paso Pulmonary Association- Site Number : 8400033
El Paso , Texas
Finlay Medical Research - Greenacres- Site Number : 8400107
Greenacres City , Florida
East Carolina University- Site Number : 8400102
Greenville , North Carolina
Bioluminux Clinical Research - Hamilton, New Jersey- Site Number : 8400037
Hamilton , New Jersey
Asha Clinical Research - Munster- Site Number : 8400115
Hammond , Indiana
Hannibal Regional Healthcare System- Site Number : 8400035
Hannibal , Missouri
Direct Helpers Research Center- Site Number : 8400057
Hialeah , Florida
Axsendo Clinical Research - Houston- Site Number : 8400054
Houston , Texas
SE Houston- Site Number : 8400120
Houston , Texas
Inglewood Clinical- Site Number : 8400074
Inglewood , California
Critical Care Pulmonary & Sleep Associates- Site Number : 8400081
Lakewood , Colorado
Excel Clinical Research - Las Vegas- Site Number : 8400070
Las Vegas , Nevada
AB Clinical Trials- Site Number : 8400075
Las Vegas , Nevada
COMPLETED
Ark Clinical Research- Site Number : 8400113
Long Beach , California
Alliance Clinical - West Hills- Site Number : 8400067
Los Angeles , California
Pulmonary Specialists of the Palm Beaches- Site Number : 8400017
Loxahatchee Groves , Florida
DL Research Solutions- Site Number : 8400140
Miami , Florida
Phoenix Medical Research - Miami - 24th Street- Site Number : 8400027
Miami , Florida
Professional Research Center- Site Number : 8400046
Miami , Florida
Research Institute of South Florida- Site Number : 8400028
Miami , Florida
Innovations Biotech- Site Number : 8400019
Miami , Florida
Synergy Group US - Missouri City- Site Number : 8400119
Missouri City , Texas
Synergy Group US - Missouri City- Site Number : 8400133
Missouri City , Texas
Lucida Clinical Trials- Site Number : 8400101
New Bedford , Massachusetts
Mid Hudson Medical Research - New Windsor- Site Number : 8400004
New Windsor , New York
Sneeze Wheeze & Itch Associates- Site Number : 8400020
Normal , Illinois
California Medical Research Associates - Northridge- Site Number : 8400089
Northridge , California
Florida Institute for Clinical Research- Site Number : 8400001
Orlando , Florida
Avanza Medical Research Center- Site Number : 8400015
Pensacola , Florida
Peoria Pulmonary Associates Ltd- Site Number : 8400095
Peoria , Illinois
Hull and Hull Medical Specialists- Site Number : 8400002
Plantation , Florida
The Oregon Clinic, PC- Site Number : 8400065
Portland , Oregon
Dominion Medical Associates - Richmond - East Leigh Street- Site Number : 8400154
Richmond , Virginia
ACTIVE_NOT_RECRUITING
Windom Allergy, Asthma and Sinus Specialists- Site Number : 8400041
Sarasota , Florida
Care Access - Shreveport - Youree Drive- Site Number : 8400007
Shreveport , Louisiana
Piedmont Healthcare - Family Medicine- Site Number : 8400022
Statesville , North Carolina
Elligo Health Care, Hillcroft Medical Clinic Association- Site Number : 8400053
Sugar Land , Texas
Asthma & Allergy Center - Toledo- Site Number : 8400110
Toledo , Ohio
Tucson Clinical Research Institute- Site Number : 8400006
Tucson , Arizona
Layrek Clinical Research- Site Number : 8400066
Tulsa , Oklahoma
All-Trials Clinical Research- Site Number : 8400008
Winston-Salem , North Carolina
Medrasa Clinical Research - Wylie- Site Number : 8400124
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