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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, Placebocontrolled, 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
2025-09-16
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 (153)
Chandler Clinical Research Trials- Site Number : 8400025
Chandler, Arizona, United States
Pulmonary Associates - Phoenix - East Bell Road- Site Number : 8400114
Phoenix, Arizona, United States
Epic Medical Research - Surprise- Site Number : 8400096
Surprise, Arizona, United States
IMAX Clinical Trials- Site Number : 8400109
La Palma, California, United States
Long Beach Research Institute- Site Number : 8400027
Long Beach, California, United States
Downtown L.A. Research Center- Site Number : 8400009
Los Angeles, California, United States
Newport Native MD- Site Number : 8400003
Newport Beach, California, United States
Paradigm Research - Redding- Site Number : 8400108
Redding, California, United States
Amicis Research Center - Valencia- Site Number : 8400119
Valencia, California, United States
Helix Biomedics- Site Number : 8400065
Boynton Beach, Florida, United States
Beautiful Minds Clinical Research Center- Site Number : 8400017
Cutler Bay, Florida, United States
Eastern Medical Group Research- Site Number : 8400020
Fort Myers, Florida, United States
Premier Medical Associates- Site Number : 8400012
Lady Lake, Florida, United States
MCR Research- Site Number : 8400004
Miami, Florida, United States
Nuren Medical & Research Center- Site Number : 8400030
Miami, Florida, United States
Deluxe Health Center- Site Number : 8400010
Miami Lakes, Florida, United States
Omega Research Consultants - Orlando - Forest City- Site Number : 8400015
Orlando, Florida, United States
Broward Research Center - Pembroke Pines- Site Number : 8400053
Pembroke Pines, Florida, United States
Clinical Research Trials of Florida- Site Number : 8400011
Tampa, Florida, United States
Deluxe Health Center-Tampa- Site Number : 8400056
Tampa, Florida, United States
Private Practice - Dr. David Kavtaradze- Site Number : 8400006
Cordele, Georgia, United States
Primeway Clinical Research- Site Number : 8400121
Fayetteville, Georgia, United States
Avicenna Clinical Research- Site Number : 8400126
Chicago Ridge, Illinois, United States
Indy Clinical Research- Site Number : 8400071
Indianapolis, Indiana, United States
University of Kansas Medical Center- Site Number : 8400054
Kansas City, Kansas, United States
Southern Clinical Research - Zachary- Site Number : 8400113
Zachary, Louisiana, United States
Pulmonary and Medicine Associates- Site Number : 8400007
Warren, Michigan, United States
Henderson Clinical Trials- Site Number : 8400026
Henderson, Nevada, United States
Sierra Clinical Research - Las Vegas- Site Number : 8400028
Las Vegas, Nevada, United States
New York Hospital Queens- Site Number : 8400058
Flushing, New York, United States
Advanced Respiratory and Sleep Medicine - Hickory- Site Number : 8400013
Hickory, North Carolina, United States
Atrium Health Wake Forest Baptist Pulmonary, Sleep And Allergy- Site Number : 8400048
Winston-Salem, North Carolina, United States
Dayton Clinical Research- Site Number : 8400124
Dayton, Ohio, United States
Epic Medical Research - Chickasha- Site Number : 8400097
Chickasha, Oklahoma, United States
Preferred Primary Care Physicians - Pleasant Hills- Site Number : 8400092
Pittsburgh, Pennsylvania, United States
AnMed Oglesby Center- Site Number : 8400074
Anderson, South Carolina, United States
REX Clinical Trials - Beaumont- Site Number : 8400014
Beaumont, Texas, United States
South Texas Medical Research Institute - TTS Research- Site Number : 8400018
Boerne, Texas, United States
Ten20 Clinical Research- Site Number : 8400141
Carrollton, Texas, United States
Texas Health Presbyterian Hospital Dallas- Site Number : 8400032
Dallas, Texas, United States
Epic Medical Research - De Soto- Site Number : 8400095
DeSoto, Texas, United States
Trio Clinical Trials- Site Number : 8400106
Houston, Texas, United States
HDH Research- Site Number : 8400104
Houston, Texas, United States
Gulf Coast Clinical Research - Houston- Site Number : 8400049
Houston, Texas, United States
Lumi Research - Kingwood- Site Number : 8400120
Kingwood, Texas, United States
Radiance Clinical Research - Lampasas - West Avenue East- Site Number : 8400063
Lampasas, Texas, United States
Discovery Clinical Trials - San Antonio- Site Number : 8400031
San Antonio, Texas, United States
Bandera Family Health Care - San Antonio- Site Number : 8400021
San Antonio, Texas, United States
Investigational Site Number : 0320007
La Plata, Buenos Aires, Argentina
Investigational Site Number : 0320008
Lobos, Buenos Aires, Argentina
Investigational Site Number : 0320004
Rosario, Santa Fe Province, Argentina
Investigational Site Number : 0320012
Rosario, Santa Fe Province, Argentina
Investigational Site Number : 0320003
San Miguel de Tucumán, Tucumán Province, Argentina
Investigational Site Number : 0320006
San Miguel de Tucumán, Tucumán Province, Argentina
Investigational Site Number : 0320011
Buenos Aires, Argentina
Investigational Site Number : 0320005
Buenos Aires, Argentina
Investigational Site Number : 0320010
Buenos Aires, Argentina
Investigational Site Number : 0320001
Buenos Aires, Argentina
Investigational Site Number : 0320002
Buenos Aires, Argentina
Investigational Site Number : 0320009
Buenos Aires, Argentina
Chronos Pesquisa Clínica- Site Number : 0760012
Brasília, Federal District, Brazil
Centro de Estudos em Terapias Inovadoras- Site Number : 0760013
Curitiba, Paraná, Brazil
Hospital Universitário Onofre Lopes- Site Number : 0760016
Natal, Rio Grande do Norte, Brazil
LMK Servicos Medicos- Site Number : 0760018
Porto Alegre, Rio Grande do Sul, Brazil
Instituto Ceos- Site Number : 0760005
Porto Alegre, Rio Grande do Sul, Brazil
Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760001
Porto Alegre, Rio Grande do Sul, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto- Site Number : 0760011
São José do Rio Preto, São Paulo, Brazil
Centro Internacional de Pesquisa Clínica (CIPES)- Site Number : 0760008
São José dos Campos, São Paulo, Brazil
Hospital Beneficência Portuguesa de São Paulo- Site Number : 0760010
São Paulo, Brazil
Investigational Site Number : 1240010
Ajax, Ontario, Canada
Investigational Site Number : 1240004
Guelph, Ontario, Canada
Investigational Site Number : 1240012
Ottawa, Ontario, Canada
Investigational Site Number : 1240009
Stoney Creek, Ontario, Canada
Investigational Site Number : 1240001
Toronto, Ontario, Canada
Investigational Site Number : 1520002
Valdivia, Los Ríos Region, Chile
Investigational Site Number : 1520006
Talca, Maule Region, Chile
Investigational Site Number : 1520004
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520001
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520003
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520007
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520005
Viña del Mar, Región de Valparaíso, Chile
Investigational Site Number : 1560054
Changchun, China
Investigational Site Number : 1560010
Changsha, China
Investigational Site Number : 1560032
Changsha, China
Investigational Site Number : 1560018
Chengdu, China
Investigational Site Number : 1560004
Chengdu, China
Investigational Site Number : 1560005
Chengdu, China
Investigational Site Number : 1560062
Foshan, China
Investigational Site Number : 1560021
Guangzhou, China
Investigational Site Number : 1560001
Guangzhou, China
Investigational Site Number : 1560030
Hangzhou, China
Investigational Site Number : 1560012
Hefei, China
Investigational Site Number : 1560046
Hefei, China
Investigational Site Number : 1560044
Huizhou, China
Investigational Site Number : 1560026
Jiaozuo, China
Investigational Site Number : 1560039
Jinan, China
Investigational Site Number : 1560049
Jinhua, China
Investigational Site Number : 1560056
Jining, China
Investigational Site Number : 1560023
Langfang, China
Investigational Site Number : 1560033
Linhai, China
Investigational Site Number : 1560002
Nanchang, China
Investigational Site Number : 1560003
Nanchang, China
Investigational Site Number : 1560051
Nanning, China
Investigational Site Number : 1560017
Ningbo, China
Investigational Site Number : 1560031
Pingxiang, China
Investigational Site Number : 1560007
Shanghai, China
Investigational Site Number : 1560037
Shenzhen, China
Investigational Site Number : 1560027
Shihezi, China
Investigational Site Number : 1560015
Suining, China
Investigational Site Number : 1560022
Taiyuan, China
Investigational Site Number : 1560034
Taizhou, China
Investigational Site Number : 1560016
Ürümqi, China
Investigational Site Number : 1560029
Wenzhou, China
Investigational Site Number : 1560025
Wuhan, China
Investigational Site Number : 1560050
Wuxi, China
Investigational Site Number : 1560052
Xi'an, China
Investigational Site Number : 1560020
Xiamen, China
Investigational Site Number : 1560011
Xiangtan, China
Investigational Site Number : 1560055
Xianyang, China
Investigational Site Number : 1560040
Xuzhou, China
Investigational Site Number : 1560041
Yangzhou, China
Investigational Site Number : 1560060
Yichang, China
Investigational Site Number : 1560059
Zhanjiang, China
Investigational Site Number : 3920042
Kōnan, Aichi-ken, Japan
Investigational Site Number : 3920009
Kobe, Hyōgo, Japan
Investigational Site Number : 3920008
Kita, Kagawa-ken, Japan
Investigational Site Number : 3920040
Kamakura, Kanagawa, Japan
Investigational Site Number : 3920015
Yokohama, Kanagawa, Japan
Investigational Site Number : 3920012
Okayama, Okayama-ken, Japan
Investigational Site Number : 3920043
Sakai, Osaka, Japan
Investigational Site Number : 3920020
Ureshino, Saga-ken, Japan
Investigational Site Number : 3920033
Hachiōji, Tokyo, Japan
Investigational Site Number : 3920003
Ube, Yamaguchi, Japan
Investigational Site Number : 3920021
Chiba, Japan
Investigational Site Number : 3920026
Fukuoka, Japan
Investigational Site Number : 3920029
Hiroshima, Japan
Investigational Site Number : 3920039
Kagoshima, Japan
Investigational Site Number : 3920018
Kumamoto, Japan
Investigational Site Number : 3920028
Tokyo, Japan
Investigational Site Number : 7920002
Adana, Turkey (Türkiye)
Investigational Site Number : 7920006
Ankara, Turkey (Türkiye)
Investigational Site Number : 7920003
Ankara, Turkey (Türkiye)
Investigational Site Number : 7920004
Gaziantep, Turkey (Türkiye)
Investigational Site Number : 7920005
Istanbul, Turkey (Türkiye)
Investigational Site Number : 7920007
Izmir, Turkey (Türkiye)
Investigational Site Number : 7920001
Mersin, Turkey (Türkiye)
Investigational Site Number : 8260014
Bristol, Bristol, City of, United Kingdom
Investigational Site Number : 8260031
Glasgow, Glasgow City, United Kingdom
Investigational Site Number : 8260015
London, Hammersmith and Fulham, United Kingdom
Investigational Site Number : 8260003
Leicester, Leicestershire, United Kingdom
Investigational Site Number : 8260009
Harrow, London, City of, United Kingdom
Investigational Site Number : 8260032
Worthing, West Sussex, United Kingdom
Investigational Site Number : 8260002
Bradford, United Kingdom