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
Start Date
9/16/2025
Completion Date
1/22/2030
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.
Detailed Description
All eligible participants will undergo subcutaneous administrations of lunsekimig or matching placebo during a 48-weeks treatment period
Eligibility Criteria
Age Range: 40 years to 80 years
Interventions
Lunsekimig
Placebo
Conditions
Locations
Chandler Clinical Research Trials- Site Number : 8400025
Chandler, Arizona 85224
United States
Pulmonary Associates - Phoenix - East Bell Road- Site Number : 8400114
Phoenix, Arizona 85032
United States
Epic Medical Research - Surprise- Site Number : 8400096
Surprise, Arizona 85378
United States
IMAX Clinical Trials- Site Number : 8400109
La Palma, California 90623
United States
Long Beach Research Institute- Site Number : 8400027
Long Beach, California 90805
United States
Downtown L.A. Research Center- Site Number : 8400009
Los Angeles, California 90017
United States
Newport Native MD- Site Number : 8400003
Newport Beach, California 92663
United States
Paradigm Research - Redding- Site Number : 8400108
Redding, California 96001
United States
Amicis Research Center - Valencia- Site Number : 8400119
Valencia, California 91355
United States
Helix Biomedics- Site Number : 8400065
Boynton Beach, Florida 33435
United States
Beautiful Minds Clinical Research Center- Site Number : 8400017
Cutler Bay, Florida 33157
United States
Eastern Medical Group Research- Site Number : 8400020
Fort Myers, Florida 33908
United States
Premier Medical Associates- Site Number : 8400012
Lady Lake, Florida 32159
United States
University of Miami Dermatology Clinical Trials Unit- Site Number : 8400078
Miami, Florida 33125
United States
MCR Research- Site Number : 8400004
Miami, Florida 33126
United States
Nuren Medical & Research Center- Site Number : 8400030
Miami, Florida 33144
United States
My Community Research Center- Site Number : 8400164
Miami, Florida 33155
United States
Deluxe Health Center- Site Number : 8400010
Miami Lakes, Florida 33014
United States
Omega Research Consultants - Orlando - Forest City- Site Number : 8400015
Orlando, Florida 32810
United States
Broward Research Center - Pembroke Pines- Site Number : 8400053
Pembroke Pines, Florida 33024
United States
Clinical Research Trials of Florida- Site Number : 8400011
Tampa, Florida 33607
United States
Deluxe Health Center-Tampa- Site Number : 8400056
Tampa, Florida 33607
United States
Private Practice - Dr. David Kavtaradze- Site Number : 8400006
Cordele, Georgia 31015
United States
Primeway Clinical Research- Site Number : 8400121
Fayetteville, Georgia 30214
United States
University of Illinois-Chicago - College of Medicine- Site Number : 8400055
Chicago, Illinois 60612
United States
Avicenna Clinical Research- Site Number : 8400126
Chicago Ridge, Illinois 60415
United States
NorthShore Medical Group - Evanston ( Endeavor Health)- Site Number : 8400073
Evanston, Illinois 60201
United States
Indy Clinical Research- Site Number : 8400071
Indianapolis, Indiana 46268
United States
University of Kansas Medical Center- Site Number : 8400054
Kansas City, Kansas 66160
United States
Southern Clinical Research - Zachary- Site Number : 8400113
Zachary, Louisiana 70791
United States
University of Michigan Health System - Ann Arbor- Site Number : 8400090
Ann Arbor, Michigan 48109
United States
Pulmonary and Medicine Associates- Site Number : 8400007
Warren, Michigan 48088
United States
Mayo Clinic in Rochester - Minnesota- Site Number : 8400005
Rochester, Minnesota 55905
United States
Henderson Clinical Trials- Site Number : 8400026
Henderson, Nevada 89052
United States
Sierra Clinical Research - Las Vegas- Site Number : 8400028
Las Vegas, Nevada 89106
United States
Sanmora Bespoke Clinical Research Solutions- Site Number : 8400144
East Orange, New Jersey 07018
United States
New York Hospital Queens- Site Number : 8400058
Flushing, New York 11355
United States
Advanced Respiratory and Sleep Medicine - Hickory- Site Number : 8400013
Hickory, North Carolina 28601
United States
Atrium Health Wake Forest Baptist Pulmonary, Sleep And Allergy- Site Number : 8400048
Winston-Salem, North Carolina 27103
United States
Plains Clinical Research Center- Site Number : 8400140
Fargo, North Dakota 58104
United States
Dayton Clinical Research- Site Number : 8400124
Dayton, Ohio 45409
United States
Epic Medical Research - Chickasha- Site Number : 8400097
Chickasha, Oklahoma 73018
United States
Temple University Hospital - Main Campus- Site Number : 8400059
Philadelphia, Pennsylvania 19140-5103
United States
Preferred Primary Care Physicians - Pleasant Hills- Site Number : 8400092
Pittsburgh, Pennsylvania 15236
United States
AnMed Oglesby Center- Site Number : 8400074
Anderson, South Carolina 29621
United States
MD First Research - Lancaster- Site Number : 8400102
Lancaster, South Carolina 29720
United States
REX Clinical Trials - Beaumont- Site Number : 8400014
Beaumont, Texas 77701
United States
Novel Research - Bellaire- Site Number : 8400116
Bellaire, Texas 77401
United States
South Texas Medical Research Institute - TTS Research- Site Number : 8400018
Boerne, Texas 78006
United States
TEN20 Clinical Research - Carrollton- Site Number : 8400141
Carrollton, Texas 75010
United States
Corsicana Medical Research- Site Number : 8400134
Corsicana, Texas 75110
United States
Syri Research Center- Site Number : 8400069
Cypress, Texas 77065
United States
Texas Health Presbyterian Hospital Dallas- Site Number : 8400032
Dallas, Texas 75231
United States
Epic Medical Research - De Soto- Site Number : 8400095
DeSoto, Texas 75115
United States
Valley Institute of Research- Site Number : 8400118
Harlingen, Texas 78550
United States
Trio Clinical Trials- Site Number : 8400106
Houston, Texas 77008
United States
HDH Research- Site Number : 8400104
Houston, Texas 77022
United States
Baylor College of Medicine- Site Number : 8400076
Houston, Texas 77030
United States
Gulf Coast Clinical Research - Houston- Site Number : 8400049
Houston, Texas 77070
United States
Lumi Research - Kingwood- Site Number : 8400120
Kingwood, Texas 77339
United States
Syri Research Center- Site Number : 8400136
Kingwood, Texas 77339
United States
Radiance Clinical Research - Lampasas - West Avenue East- Site Number : 8400063
Lampasas, Texas 76550
United States
Discovery Clinical Trials - San Antonio- Site Number : 8400031
San Antonio, Texas 78229
United States
Bandera Family Health Care - San Antonio- Site Number : 8400021
San Antonio, Texas 78249
United States
Element Research Group- Site Number : 8400115
San Antonio, Texas 78257
United States
Tidewater Physicians Multispecialty Group Clinical Research - Williamsburg- Site Number : 8400081
Williamsburg, Virginia 23188
United States
Investigational Site Number : 0320007
La Plata, Buenos Aires 1900
Argentina
Investigational Site Number : 0320008
Lobos, Buenos Aires 7240
Argentina
Investigational Site Number : 0320004
Rosario, Santa Fe Province 2000
Argentina
Investigational Site Number : 0320012
Rosario, Santa Fe Province 2000
Argentina
Investigational Site Number : 0320006
San Miguel de Tucumán, Tucumán Province 4000
Argentina
Investigational Site Number : 0320003
San Miguel de Tucumán, Tucumán Province T4000
Argentina
Investigational Site Number : 0320011
Buenos Aires, 1012
Argentina
Investigational Site Number : 0320005
Buenos Aires, 1122
Argentina
Investigational Site Number : 0320010
Buenos Aires, 1128
Argentina
Investigational Site Number : 0320001
Buenos Aires, 1425
Argentina
Investigational Site Number : 0320002
Buenos Aires, 1425
Argentina
Investigational Site Number : 0320009
Buenos Aires, 1427
Argentina
Chronos Pesquisa Clínica- Site Number : 0760012
Brasília, Federal District 72145-450
Brazil
Centro de Estudos em Terapias Inovadoras- Site Number : 0760013
Curitiba, Paraná 80030-110
Brazil
Hospital Universitário Onofre Lopes- Site Number : 0760016
Natal, Rio Grande do Norte 59012-300
Brazil
LMK Servicos Medicos- Site Number : 0760018
Porto Alegre, Rio Grande do Sul 90480-000
Brazil
Instituto Ceos- Site Number : 0760005
Porto Alegre, Rio Grande do Sul 90480-020
Brazil
Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760001
Porto Alegre, Rio Grande do Sul 90610-000
Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto- Site Number : 0760011
São José do Rio Preto, São Paulo 15090-000
Brazil
Centro Internacional de Pesquisa Clínica (CIPES)- Site Number : 0760008
São José dos Campos, São Paulo 12230-001
Brazil
Hospital Copa D'Or- Site Number : 0760017
Rio de Janeiro, 22031-011
Brazil
Hospital Beneficência Portuguesa de São Paulo- Site Number : 0760010
São Paulo, 01323-001
Brazil
Investigational Site Number : 1240011
Calgary, Alberta T3R 1W7
Canada
Investigational Site Number : 1240010
Ajax, Ontario L1S 2J5
Canada
Investigational Site Number : 1240004
Guelph, Ontario N1h 6j2
Canada
Investigational Site Number : 1240012
Ottawa, Ontario K1G 6C6
Canada
Investigational Site Number : 1240009
Stoney Creek, Ontario L8G 2V6
Canada
Investigational Site Number : 1240001
Toronto, Ontario M5T 3A9
Canada
Investigational Site Number : 1520002
Valdivia, Los Ríos Region 5110683
Chile
Investigational Site Number : 1520006
Talca, Maule Region 3465584
Chile
Investigational Site Number : 1520004
Santiago, Reg Metropolitana de Santiago 7500010
Chile
Investigational Site Number : 1520001
Santiago, Reg Metropolitana de Santiago 7500692
Chile
Investigational Site Number : 1520003
Santiago, Reg Metropolitana de Santiago 7500698
Chile
Investigational Site Number : 1520007
Santiago, Reg Metropolitana de Santiago 8320325
Chile
Investigational Site Number : 1520005
Viña del Mar, Valparaiso 2531172
Chile
Investigational Site Number : 1560035
Beijing, 100034
China
Investigational Site Number : 1560013
Beijing, 100144
China
Investigational Site Number : 1560054
Changchun, 130021
China
Investigational Site Number : 1560010
Changsha, 410011
China
Investigational Site Number : 1560032
Changsha, 410015
China
Investigational Site Number : 1560018
Chengdu, 610041
China
Investigational Site Number : 1560004
Chengdu, 610072
China
Investigational Site Number : 1560005
Chengdu, 611130
China
Investigational Site Number : 1560062
Foshan, 528041
China
Investigational Site Number : 1560021
Guangzhou, 510150
China
Investigational Site Number : 1560001
Guangzhou, 510163
China
Investigational Site Number : 1560030
Hangzhou, 310006
China
Investigational Site Number : 1560024
Harbin, 150001
China
Investigational Site Number : 1560012
Hefei, 230032
China
Investigational Site Number : 1560046
Hefei, 231220
China
Investigational Site Number : 1560006
Hohhot, 010050
China
Investigational Site Number : 1560044
Huizhou, 516001
China
Investigational Site Number : 1560026
Jiaozuo, 454001
China
Investigational Site Number : 1560039
Jinan, 250014
China
Investigational Site Number : 1560049
Jinhua, 321000
China
Investigational Site Number : 1560056
Jining, 272011
China
Investigational Site Number : 1560043
Kunming, 650032
China
Investigational Site Number : 1560023
Langfang, 065000
China
Investigational Site Number : 1560047
Liaocheng, 252000
China
Investigational Site Number : 1560033
Linhai, 317000
China
Investigational Site Number : 1560002
Nanchang, 330006
China
Investigational Site Number : 1560003
Nanchang, 330006
China
Investigational Site Number : 1560051
Nanning, 530021
China
Investigational Site Number : 1560017
Ningbo, 315041
China
Investigational Site Number : 1560031
Pingxiang, 337055
China
Investigational Site Number : 1560007
Shanghai, 200240
China
Investigational Site Number : 1560008
Shanghai, 200433
China
Investigational Site Number : 1560036
Shenyang, 110004
China
Investigational Site Number : 1560037
Shenzhen, 518020
China
Investigational Site Number : 1560027
Shihezi, 832008
China
Investigational Site Number : 1560015
Suining, 629000
China
Investigational Site Number : 1560022
Taiyuan, 030001
China
Investigational Site Number : 1560034
Taizhou, 318000
China
Investigational Site Number : 1560019
Tianjin, 300192
China
Investigational Site Number : 1560016
Ürümqi, 830054
China
Investigational Site Number : 1560029
Wenzhou, 325035
China
Investigational Site Number : 1560025
Wuhan, 430030
China
Investigational Site Number : 1560050
Wuxi, 214023
China
Investigational Site Number : 1560052
Xi'an, 710004
China
Investigational Site Number : 1560020
Xiamen, 361004
China
Investigational Site Number : 1560011
Xiangtan, 411100
China
Investigational Site Number : 1560055
Xianyang, 712000
China
Investigational Site Number : 1560058
Xinxiang, 453100
China
Investigational Site Number : 1560040
Xuzhou, 221006
China
Investigational Site Number : 1560041
Yangzhou, 225000
China
Investigational Site Number : 1560060
Yichang, 443003
China
Investigational Site Number : 1560059
Zhanjiang, 524004
China
Investigational Site Number : 1560057
Zhengzhou, 450052
China
Investigational Site Number : 1560048
Zunyi, 563003
China
Investigational Site Number : 2680004
Kutaisi, 4600
Georgia
Investigational Site Number : 2680002
Tbilisi, 0105
Georgia
Investigational Site Number : 2680001
Tbilisi, 0159
Georgia
Investigational Site Number : 2680006
Tbilisi, 0159
Georgia
Investigational Site Number : 2680003
Tbilisi, 0160
Georgia
Investigational Site Number : 3920042
Kōnan, Aichi-ken 483-8704
Japan
Investigational Site Number : 3920032
Nagoya, Aichi-ken 457-8511
Japan
Investigational Site Number : 3920057
Toyota, Aichi-ken 470-0396
Japan
Investigational Site Number : 3920047
Matsuyama, Ehime 790-0826
Japan
Investigational Site Number : 3920026
Fukuoka, Fukuoka 819-0055
Japan
Investigational Site Number : 3920006
Kurume, Fukuoka 830-0011
Japan
Investigational Site Number : 3920053
Kure, Hiroshima 737-0811
Japan
Investigational Site Number : 3920049
Sapporo, Hokkaido 006-0811
Japan
Investigational Site Number : 3920024
Himeji-Shi, Hyōgo 670-0849
Japan
Investigational Site Number : 3920009
Kobe, Hyōgo 650-0017
Japan
Investigational Site Number : 3920008
Kita, Kagawa-ken 761-0701
Japan
Investigational Site Number : 3920030
Sakaidechō, Kagawa-ken 762-8550
Japan
Investigational Site Number : 3920040
Kamakura, Kanagawa 247-8533
Japan
Investigational Site Number : 3920051
Kawasaki, Kanagawa 210-0852
Japan
Investigational Site Number : 3920035
Yokohama, Kanagawa 221-0855
Japan
Investigational Site Number : 3920054
Yokohama, Kanagawa 234-0054
Japan
Investigational Site Number : 3920015
Yokohama, Kanagawa 236-0004
Japan
Investigational Site Number : 3920045
Matsusaka, Mie-ken 515-0073
Japan
Investigational Site Number : 3920005
Sendai, Miyagi 980-8574
Japan
Investigational Site Number : 3920001
Kashihara, Nara 634-8522
Japan
Investigational Site Number : 3920012
Okayama, Okayama-ken 701-1192
Japan
Investigational Site Number : 3920043
Sakai, Osaka 591-8555
Japan
Investigational Site Number : 3920020
Ureshino-Shi, Saga-ken 843-0393
Japan
Investigational Site Number : 3920033
Hachiōji, Tokyo 193-0998
Japan
Investigational Site Number : 3920003
Ube, Yamaguchi 755-8505
Japan
Investigational Site Number : 3920021
Chiba, 260-0852
Japan
Investigational Site Number : 3920002
Fukushima, 960-1295
Japan
Investigational Site Number : 3920029
Hiroshima, 734-8530
Japan
Investigational Site Number : 3920039
Kagoshima, 892-0847
Japan
Investigational Site Number : 3920036
Kumamoto, 861-4193
Japan
Investigational Site Number : 3920018
Kumamoto, 862-0909
Japan
Investigational Site Number : 3920056
Kyoto, 610-0113
Japan
Investigational Site Number : 3920004
Osaka, 545-8586
Japan
Investigational Site Number : 3920007
Saga, 849-0937
Japan
Investigational Site Number : 3920028
Tokyo, 150-8935
Japan
Investigational Site Number : 3920017
Tokyo, 162-8655
Japan
Investigational Site Number : 3920023
Tokyo, 173-8610
Japan
Investigational Site Number : 6820003
Jeddah, 23421
Saudi Arabia
Investigational Site Number : 6820001
Riyadh, 11525
Saudi Arabia
Investigational Site Number : 6820002
Riyadh, 12746
Saudi Arabia
Investigational Site Number : 7920002
Adana, 01330
Turkey (Türkiye)
Investigational Site Number : 7920006
Ankara, 06010
Turkey (Türkiye)
Investigational Site Number : 7920003
Ankara, 06620
Turkey (Türkiye)
Investigational Site Number : 7920004
Gaziantep, 27310
Turkey (Türkiye)
Investigational Site Number : 7920005
Istanbul, 34020
Turkey (Türkiye)
Investigational Site Number : 7920007
Izmir, 35340
Turkey (Türkiye)
Investigational Site Number : 7920001
Mersin, 33070
Turkey (Türkiye)
Investigational Site Number : 8260014
Bristol, Bristol, City of BS37 4AX
United Kingdom
Investigational Site Number : 8260015
London, Hammersmith and Fulham W6 7HY
United Kingdom
Investigational Site Number : 8260003
Leicester, Leicestershire LE1 5WW
United Kingdom
Investigational Site Number : 8260009
Harrow, London, City of HA1 3UJ
United Kingdom
Investigational Site Number : 8260031
London, London, City of Se1 7eh
United Kingdom
Investigational Site Number : 8260034
Oxford, Oxfordshire OX3 9DU
United Kingdom
Investigational Site Number : 8260032
Worthing, West Sussex BN11 2DH
United Kingdom
Investigational Site Number : 8260002
Bradford, BD9 6RJ
United Kingdom