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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
Sponsor: Sanofi
Summary
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.
Official title: A Phase 2b/Phase 3, Randomized, Double-blind, Placebo-controlled, 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
Key Details
Gender
All
Age Range
40 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
942
Start Date
2025-09-17
Completion Date
2030-01-22
Last Updated
2026-03-23
Healthy Volunteers
No
Conditions
Interventions
Lunsekimig
Pharmaceutical form: solution for injection in prefilled syringe. Route of administration: Subcutaneous injection
Placebo
Pharmaceutical form: solution for injection. Route of administration: Subcutaneous injection
Locations (175)
Tucson Clinical Research Institute- Site Number : 8400006
Tucson, Arizona, United States
Ark Clinical Research- Site Number : 8400113
Long Beach, California, United States
Alliance Clinical - West Hills- Site Number : 8400067
Los Angeles, California, United States
California Medical Research Associates - Northridge- Site Number : 8400089
Northridge, California, United States
Alpine Clinical Research Center - Boulder - 47th Street- Site Number : 8400005
Boulder, Colorado, United States
Critical Care Pulmonary & Sleep Associates- Site Number : 8400081
Lakewood, Colorado, United States
Hillcrest Medical Research- Site Number : 8400082
DeLand, Florida, United States
Finlay Medical Research - Greenacres- Site Number : 8400107
Greenacres City, Florida, United States
Direct Helpers Research Center- Site Number : 8400057
Hialeah, Florida, United States
Pulmonary Specialists of the Palm Beaches- Site Number : 8400017
Loxahatchee Groves, Florida, United States
DL Research Solutions- Site Number : 8400140
Miami, Florida, United States
Phoenix Medical Research - Miami - 24th Street- Site Number : 8400027
Miami, Florida, United States
Professional Research Center- Site Number : 8400046
Miami, Florida, United States
Research Institute of South Florida- Site Number : 8400028
Miami, Florida, United States
Innovations Biotech- Site Number : 8400019
Miami, Florida, United States
Heuer M.D. Research- Site Number : 8400018
Orlando, Florida, United States
Florida Institute for Clinical Research- Site Number : 8400001
Orlando, Florida, United States
Avanza Medical Research Center- Site Number : 8400015
Pensacola, Florida, United States
Hull and Hull Medical Specialists- Site Number : 8400002
Plantation, Florida, United States
Appalachian Clinical Research- Site Number : 8400060
Adairsville, Georgia, United States
Christie Clinic in Champaign on University- Site Number : 8400023
Champaign, Illinois, United States
Sneeze Wheeze & Itch Associates- Site Number : 8400020
Normal, Illinois, United States
Asha Clinical Research - Munster- Site Number : 8400115
Hammond, Indiana, United States
Care Access - Shreveport - Youree Drive- Site Number : 8400007
Shreveport, Louisiana, United States
Lucida Clinical Trials- Site Number : 8400101
New Bedford, Massachusetts, United States
Vitalis Clinical Research Center- Site Number : 8400040
Allen Park, Michigan, United States
Bolt Clinical Research- Site Number : 8400086
Brighton, Michigan, United States
Hannibal Regional Healthcare System- Site Number : 8400035
Hannibal, Missouri, United States
Excel Clinical Research - Las Vegas- Site Number : 8400070
Las Vegas, Nevada, United States
AB Clinical Trials- Site Number : 8400075
Las Vegas, Nevada, United States
Bioluminux Clinical Research - Hamilton, New Jersey- Site Number : 8400037
Hamilton, New Jersey, United States
Mid Hudson Medical Research - New Windsor- Site Number : 8400004
New Windsor, New York, United States
East Carolina University- Site Number : 8400102
Greenville, North Carolina, United States
Piedmont Healthcare - Family Medicine- Site Number : 8400022
Statesville, North Carolina, United States
All-Trials Clinical Research- Site Number : 8400008
Winston-Salem, North Carolina, United States
Asthma & Allergy Center - Toledo- Site Number : 8400110
Toledo, Ohio, United States
Layrek Clinical Research- Site Number : 8400066
Tulsa, Oklahoma, United States
The Oregon Clinic, PC- Site Number : 8400065
Portland, Oregon, United States
MedTrial- Site Number : 8400010
Columbia, South Carolina, United States
Chattanooga Research and Medicine- Site Number : 8400026
Chattanooga, Tennessee, United States
IntraCare- Site Number : 8400034
Dallas, Texas, United States
Premier Pulmonary Critical Care and Sleep- Site Number : 8400111
Denison, Texas, United States
El Paso Pulmonary Association- Site Number : 8400033
El Paso, Texas, United States
Axsendo Clinical Research - Houston- Site Number : 8400054
Houston, Texas, United States
SE Houston- Site Number : 8400120
Houston, Texas, United States
Synergy Group US - Missouri City- Site Number : 8400119
Missouri City, Texas, United States
Synergy Group US - Missouri City- Site Number : 8400133
Missouri City, Texas, United States
Elligo Health Care, Hillcroft Medical Clinic Association- Site Number : 8400053
Sugar Land, Texas, United States
Medrasa Clinical Research - Wylie- Site Number : 8400124
Wylie, Texas, United States
Dominion Medical Associates - Richmond - East Leigh Street- Site Number : 8400154
Richmond, Virginia, United States
Rheumatology & Pulmonary Clinic- Site Number : 8400012
Beckley, West Virginia, United States
Investigational Site Number : 0320011
Berazategui, Buenos Aires, Argentina
Investigational Site Number : 0320004
Buenos Aires, Argentina
Investigational Site Number : 0320002
Buenos Aires, Argentina
Investigational Site Number : 0320005
Buenos Aires, Argentina
Investigational Site Number : 0320006
Buenos Aires, Argentina
Investigational Site Number : 0320001
Buenos Aires, Argentina
Investigational Site Number : 0320012
Buenos Aires, Argentina
Investigational Site Number : 0320003
Buenos Aires, Argentina
Investigational Site Number : 0320009
Córdoba, Argentina
Investigational Site Number : 0320007
Mendoza, Argentina
Investigational Site Number : 0320008
Mendoza, Argentina
Investigational Site Number : 0320010
Santa Fe, Argentina
Investigational Site Number : 0360006
South Brisbane, Queensland, Australia
Investigational Site Number : 0360002
Traralgon, Victoria, Australia
Investigational Site Number : 0360001
Osborne Park, Western Australia, Australia
Investigational Site Number : 5540004
Dunedin, Australia
Universidade Federal de Goias- Site Number : 0760002
Goiânia, Goiás, Brazil
Santa Casa de Misericordia de Belo Horizonte- Site Number : 0760004
Belo Horizonte, Minas Gerais, Brazil
WM Pesquisas Clínicas em Doenças Respiratórias- Site Number : 0760003
Porto Alegre, Rio Grande do Sul, Brazil
Centro Multidisciplinar de Estudos Clínicos- Site Number : 0760001
São Bernardo do Campo, São Paulo, Brazil
IBCC - Núcleo de Pesquisa e Ensino- Site Number : 0760005
São Paulo, Brazil
Investigational Site Number : 1240051
Kelowna, British Columbia, Canada
Investigational Site Number : 1240052
West Vancouver, British Columbia, Canada
Investigational Site Number : 1240041
Windsor, Ontario, Canada
Investigational Site Number : 1240049
Longueuil, Quebec, Canada
Investigational Site Number : 1240047
Québec, Quebec, Canada
Investigational Site Number : 1240053
Québec, Quebec, Canada
Investigational Site Number : 1240050
Saint-Charles-Borromée, Quebec, Canada
Investigational Site Number : 1240054
Saint-Charles-Borromée, Quebec, Canada
Investigational Site Number : 1240048
Trois-Rivières, Quebec, Canada
Investigational Site Number : 1240042
Victoriaville, Quebec, Canada
Investigational Site Number : 1520006
Temuco, La Araucanía, Chile
Investigational Site Number : 1520004
Recoleta, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520001
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520002
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520009
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520003
Viña del Mar, Región de Valparaíso, Chile
Investigational Site Number : 1520007
Chillán, Chile
Investigational Site Number : 1560003
Baotou, China
Investigational Site Number : 1560022
Beijing, China
Investigational Site Number : 1560001
Beijing, China
Investigational Site Number : 1560023
Beijing, China
Investigational Site Number : 1560005
Beijing, China
Investigational Site Number : 1560090
Changde, China
Investigational Site Number : 1560057
Changsha, China
Investigational Site Number : 1560052
Chengdu, China
Investigational Site Number : 1560032
Chengdu, China
Investigational Site Number : 1560037
Chongqing, China
Investigational Site Number : 1560074
Chongqing, China
Investigational Site Number : 1560051
Foshan, China
Investigational Site Number : 1560042
Ganzhou, China
Investigational Site Number : 1560015
Guangzhou, China
Investigational Site Number : 1560034
Guangzhou, China
Investigational Site Number : 1560038
Guiyang, China
Investigational Site Number : 1560016
Haikou, China
Investigational Site Number : 1560009
Hangzhou, China
Investigational Site Number : 1560066
Hangzhou, China
Investigational Site Number : 1560054
Hebei, China
Investigational Site Number : 1560059
Hefei, China
Investigational Site Number : 1560007
Hohhot, China
Investigational Site Number : 1560050
Honghehanizu, China
Investigational Site Number : 1560046
Huaian City, China
Investigational Site Number : 1560004
Huizhou, China
Investigational Site Number : 1560021
Huzhou, China
Investigational Site Number : 1560065
Jiangyin, China
Investigational Site Number : 1560055
Jinan, China
Investigational Site Number : 1560028
Jinan, China
Investigational Site Number : 1560013
Jinan, China
Investigational Site Number : 1560079
Jingzhou, China
Investigational Site Number : 1560040
Jining, China
Investigational Site Number : 1560061
Kunming, China
Investigational Site Number : 1560077
Luoyang, China
Investigational Site Number : 1560063
Meihekou, China
Investigational Site Number : 1560014
Nanchang, China
Investigational Site Number : 1560047
Nanjing, China
Investigational Site Number : 1560082
Nanjing, China
Investigational Site Number : 1560018
Nanyang, China
Investigational Site Number : 1560073
Panjin, China
Investigational Site Number : 1560031
Qiqihar, China
Investigational Site Number : 1560045
Quzhou, China
Investigational Site Number : 1560008
Shanghai, China
Investigational Site Number : 1560017
Shanghai, China
Investigational Site Number : 1560072
Shaoyang, China
Investigational Site Number : 1560035
Shenyang, China
Investigational Site Number : 1560053
Shijiazhuang, China
Investigational Site Number : 1560002
Suzhou, China
Investigational Site Number : 1560024
Taiyuan, China
Investigational Site Number : 1560075
Ürümqi, China
Investigational Site Number : 1560033
Weifang, China
Investigational Site Number : 1560036
Wenzhou, China
Investigational Site Number : 1560019
Wuhan, China
Investigational Site Number : 1560071
Wuhan, China
Investigational Site Number : 1560020
Xi'an, China
Investigational Site Number : 1560006
Xinxiang, China
Investigational Site Number : 1560089
Yinchuan, China
Investigational Site Number : 1560076
Yiyang, China
Investigational Site Number : 1560044
Zhangzhou, China
Investigational Site Number : 1560084
Zigong, China
Investigational Site Number : 1560039
Zunyi, China
Investigational Site Number : 5540003
Christchurch, Canterbury, New Zealand
Investigational Site Number : 5540002
Ebdentown, Wellington Region, New Zealand
Investigational Site Number : 5540001
Auckland, New Zealand
Investigational Site Number : 7100014
Durban, South Africa
Investigational Site Number : 4100007
Anyang-si, Gyeonggi-do, South Korea
Investigational Site Number : 4100005
Daegu, Gyeongsangbuk-do, South Korea
Investigational Site Number : 4100003
Jeonju, Jeollabuk-do, South Korea
Investigational Site Number : 4100004
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 4100002
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 4100001
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 4100006
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 1580008
Hsinchu, Taiwan
Investigational Site Number : 1580001
Kaohsiung City, Taiwan
Investigational Site Number : 1580005
Taipei, Taiwan
Investigational Site Number : 1580002
Taipei, Taiwan
Investigational Site Number : 1580003
Taipei, Taiwan
Investigational Site Number : 8260035
Milton Keynes, Buckinghamshire, United Kingdom
Investigational Site Number : 8260007
London, England, United Kingdom
Investigational Site Number : 8260008
London, Hammersmith and Fulham, United Kingdom
Investigational Site Number : 8260006
Southampton, Hampshire, United Kingdom
Investigational Site Number : 8260016
London, London, City of, United Kingdom
Investigational Site Number : 8260030
Salford, Manchester, United Kingdom
Investigational Site Number : 8260013
Chertsey, Surrey, United Kingdom
Investigational Site Number : 8260005
Reading, United Kingdom
Investigational Site Number : 8260017
Rotherham, United Kingdom