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
9/17/2025
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
University of Alabama at Birmingham- Site Number : 8400003
Birmingham, Alabama 35233
United States
Tucson Clinical Research Institute- Site Number : 8400006
Tucson, Arizona 85712
United States
Inglewood Clinical- Site Number : 8400074
Inglewood, California 90301
United States
Ark Clinical Research- Site Number : 8400113
Long Beach, California 90815
United States
Alliance Clinical - West Hills- Site Number : 8400067
Los Angeles, California 91307
United States
California Medical Research Associates - Northridge- Site Number : 8400089
Northridge, California 91324
United States
Alpine Clinical Research Center - Boulder - 47th Street- Site Number : 8400005
Boulder, Colorado 80301
United States
Critical Care Pulmonary & Sleep Associates- Site Number : 8400081
Lakewood, Colorado 80228
United States
Howard University Hospital- Site Number : 8400080
Washington D.C., District of Columbia 20060
United States
Finlay Medical Research - Greenacres- Site Number : 8400107
Greenacres City, Florida 33467
United States
Direct Helpers Research Center- Site Number : 8400057
Hialeah, Florida 33012
United States
Pulmonary Specialists of the Palm Beaches- Site Number : 8400017
Loxahatchee Groves, Florida 33470
United States
DL Research Solutions- Site Number : 8400140
Miami, Florida 33155
United States
Phoenix Medical Research - Miami - 24th Street- Site Number : 8400027
Miami, Florida 33165
United States
Professional Research Center- Site Number : 8400046
Miami, Florida 33172
United States
Research Institute of South Florida- Site Number : 8400028
Miami, Florida 33173
United States
Innovations Biotech- Site Number : 8400019
Miami, Florida 33186
United States
Florida Institute for Clinical Research- Site Number : 8400001
Orlando, Florida 32825
United States
Avanza Medical Research Center- Site Number : 8400015
Pensacola, Florida 32503
United States
Hull and Hull Medical Specialists- Site Number : 8400002
Plantation, Florida 33324
United States
Windom Allergy, Asthma and Sinus Specialists- Site Number : 8400041
Sarasota, Florida 34239
United States
Better Life Clinical Research- Site Number : 8400152
Tampa, Florida 33607
United States
Appalachian Clinical Research- Site Number : 8400060
Adairsville, Georgia 30103
United States
Christie Clinic in Champaign on University- Site Number : 8400023
Champaign, Illinois 61820
United States
Sneeze Wheeze & Itch Associates- Site Number : 8400020
Normal, Illinois 61761
United States
Peoria Pulmonary Associates Ltd- Site Number : 8400095
Peoria, Illinois 61603
United States
Asha Clinical Research - Munster- Site Number : 8400115
Hammond, Indiana 46324
United States
Care Access - Shreveport - Youree Drive- Site Number : 8400007
Shreveport, Louisiana 71105
United States
Lucida Clinical Trials- Site Number : 8400101
New Bedford, Massachusetts 02740
United States
Vitalis Clinical Research Center- Site Number : 8400040
Allen Park, Michigan 48101
United States
Bolt Clinical Research- Site Number : 8400086
Brighton, Michigan 48116
United States
Hannibal Regional Healthcare System- Site Number : 8400035
Hannibal, Missouri 63401
United States
Excel Clinical Research - Las Vegas- Site Number : 8400070
Las Vegas, Nevada 89109
United States
AB Clinical Trials- Site Number : 8400075
Las Vegas, Nevada 89119
United States
Bioluminux Clinical Research - Hamilton, New Jersey- Site Number : 8400037
Hamilton, New Jersey 08690
United States
Mid Hudson Medical Research - New Windsor- Site Number : 8400004
New Windsor, New York 12553
United States
East Carolina University- Site Number : 8400102
Greenville, North Carolina 27858
United States
Piedmont Healthcare - Family Medicine- Site Number : 8400022
Statesville, North Carolina 28625
United States
All-Trials Clinical Research- Site Number : 8400008
Winston-Salem, North Carolina 27103
United States
Asthma & Allergy Center - Toledo- Site Number : 8400110
Toledo, Ohio 43617
United States
Layrek Clinical Research- Site Number : 8400066
Tulsa, Oklahoma 74133
United States
The Oregon Clinic - Portland - Northwest 22nd Avenue- Site Number : 8400065
Portland, Oregon 97210
United States
MedTrial- Site Number : 8400010
Columbia, South Carolina 29204
United States
Chattanooga Research and Medicine- Site Number : 8400026
Chattanooga, Tennessee 37404
United States
IntraCare- Site Number : 8400034
Dallas, Texas 75254
United States
Premier Pulmonary Critical Care and Sleep- Site Number : 8400111
Denison, Texas 75020
United States
El Paso Pulmonary Association- Site Number : 8400033
El Paso, Texas 79902
United States
Axsendo Clinical Research - Houston- Site Number : 8400054
Houston, Texas 77058
United States
SE Houston- Site Number : 8400120
Houston, Texas 77061
United States
Synergy Group US - Missouri City- Site Number : 8400119
Missouri City, Texas 77459
United States
Synergy Group US - Missouri City- Site Number : 8400133
Missouri City, Texas 77459
United States
Elligo Health Care, Hillcroft Medical Clinic Association- Site Number : 8400053
Sugar Land, Texas 77478
United States
Medrasa Clinical Research - Wylie- Site Number : 8400124
Wylie, Texas 75098
United States
Rheumatology & Pulmonary Clinic- Site Number : 8400012
Beckley, West Virginia 25801
United States
Investigational Site Number : 0320011
Berazategui, Buenos Aires 1886
Argentina
Investigational Site Number : 0320004
Buenos Aires, 1006
Argentina
Investigational Site Number : 0320002
Buenos Aires, 1023
Argentina
Investigational Site Number : 0320005
Buenos Aires, 1121
Argentina
Investigational Site Number : 0320006
Buenos Aires, 1280
Argentina
Investigational Site Number : 0320001
Buenos Aires, 1414
Argentina
Investigational Site Number : 0320012
Buenos Aires, 1638
Argentina
Investigational Site Number : 0320003
Buenos Aires, 1650
Argentina
Investigational Site Number : 0320009
Córdoba, 5003
Argentina
Investigational Site Number : 0320007
Mendoza, 5500
Argentina
Investigational Site Number : 0320008
Mendoza, 5500
Argentina
Investigational Site Number : 0320010
Santa Fe, 3000
Argentina
Investigational Site Number : 0360008
Tiwi, Northern Territory 0810
Australia
Investigational Site Number : 0360006
South Brisbane, Queensland 4101
Australia
Investigational Site Number : 0360004
Townsville, Queensland 4814
Australia
Investigational Site Number : 0360002
Traralgon, Victoria 3844
Australia
Investigational Site Number : 0360001
Osborne Park, Western Australia 6017
Australia
Investigational Site Number : 5540004
Dunedin, 9016
Australia
Universidade Federal de Goias- Site Number : 0760002
Goiânia, Goiás 74605-020
Brazil
Santa Casa de Misericordia de Belo Horizonte- Site Number : 0760004
Belo Horizonte, Minas Gerais 30150-221
Brazil
WM Pesquisas Clínicas em Doenças Respiratórias- Site Number : 0760003
Porto Alegre, Rio Grande do Sul 91010-006
Brazil
Centro Multidisciplinar de Estudos Clínicos- Site Number : 0760001
São Bernardo do Campo, São Paulo 09715-090
Brazil
IBCC - Núcleo de Pesquisa e Ensino- Site Number : 0760005
São Paulo, 04014-002
Brazil
Investigational Site Number : 1240051
Kelowna, British Columbia V1Y 4N7
Canada
Investigational Site Number : 1240052
West Vancouver, British Columbia V7T 2Z3
Canada
Investigational Site Number : 1240041
Windsor, Ontario N8X 1T3
Canada
Investigational Site Number : 1240049
Longueuil, Quebec J4K 1C8
Canada
Investigational Site Number : 1240055
Montreal, Quebec H3T 1E2
Canada
Investigational Site Number : 1240047
Québec, Quebec G1V 4G5
Canada
Investigational Site Number : 1240053
Québec, Quebec G2J 0C4
Canada
Investigational Site Number : 1240050
Saint-Charles-Borromée, Quebec J6E 2B4
Canada
Investigational Site Number : 1240054
Saint-Charles-Borromée, Quebec J6E 2B4
Canada
Investigational Site Number : 1240048
Trois-Rivières, Quebec G8T 7A1
Canada
Investigational Site Number : 1240042
Victoriaville, Quebec G6P 3Z8
Canada
Investigational Site Number : 1520006
Temuco, La Araucanía 4810345
Chile
Investigational Site Number : 1520004
Recoleta, Reg Metropolitana de Santiago 8420000
Chile
Investigational Site Number : 1520001
Santiago, Reg Metropolitana de Santiago 7500587
Chile
Investigational Site Number : 1520002
Santiago, Reg Metropolitana de Santiago 7750495
Chile
Investigational Site Number : 1520009
Santiago, Reg Metropolitana de Santiago 8380453
Chile
Investigational Site Number : 1520003
Viña del Mar, Valparaiso 2540364
Chile
Investigational Site Number : 1520007
Chillan, 3800761
Chile
Investigational Site Number : 1560003
Baotou, 014010
China
Investigational Site Number : 1560022
Beijing, 100020
China
Investigational Site Number : 1560001
Beijing, 100029
China
Investigational Site Number : 1560023
Beijing, 100038
China
Investigational Site Number : 1560005
Beijing, 100191
China
Investigational Site Number : 1560090
Changde, 415000
China
Investigational Site Number : 1560057
Changsha, 410008
China
Investigational Site Number : 1560052
Chengdu, 610000
China
Investigational Site Number : 1560032
Chengdu, 610081
China
Investigational Site Number : 1560037
Chongqing, 400010
China
Investigational Site Number : 1560074
Chongqing,
China
Investigational Site Number : 1560078
Dalian, 116033
China
Investigational Site Number : 1560051
Foshan, 528399
China
Investigational Site Number : 1560042
Ganzhou, 341000
China
Investigational Site Number : 1560015
Guangzhou, 510180
China
Investigational Site Number : 1560034
Guangzhou, 511400
China
Investigational Site Number : 1560038
Guiyang, 550004
China
Investigational Site Number : 1560016
Haikou, 570216
China
Investigational Site Number : 1560009
Hangzhou, 310009
China
Investigational Site Number : 1560066
Hangzhou, 310009
China
Investigational Site Number : 1560054
Hebei, 050051
China
Investigational Site Number : 1560059
Hefei, 230011
China
Investigational Site Number : 1560007
Hohhot, 010070
China
Investigational Site Number : 1560050
Honghehanizu, 654400
China
Investigational Site Number : 1560046
Huaian City,
China
Investigational Site Number : 1560004
Huizhou, 516002
China
Investigational Site Number : 1560021
Huzhou, 313000
China
Investigational Site Number : 1560065
Jiangyin, 214400
China
Investigational Site Number : 1560081
Jiaxing, 314001
China
Investigational Site Number : 1560055
Jinan, 250001
China
Investigational Site Number : 1560028
Jinan, 250013
China
Investigational Site Number : 1560013
Jinan, 250014
China
Investigational Site Number : 1560079
Jingzhou, 434020
China
Investigational Site Number : 1560040
Jining, 272029
China
Investigational Site Number : 1560061
Kunming, 650011
China
Investigational Site Number : 1560091
Lanzhou, 730000
China
Investigational Site Number : 1560077
Luoyang, 471002
China
Investigational Site Number : 1560063
Meihekou, 135022
China
Investigational Site Number : 1560014
Nanchang, 330006
China
Investigational Site Number : 1560087
Nanchang, 330008
China
Investigational Site Number : 1560047
Nanjing, 210006
China
Investigational Site Number : 1560082
Nanjing, 211100
China
Investigational Site Number : 1560018
Nanyang, 473014
China
Investigational Site Number : 1560073
Panjin, 422000
China
Investigational Site Number : 1560029
Qingdao, 266011
China
Investigational Site Number : 1560043
Qingyuan, 511518
China
Investigational Site Number : 1560025
Qinhuangdao, 066000
China
Investigational Site Number : 1560031
Qiqihar, 161000
China
Investigational Site Number : 1560045
Quzhou, 324000
China
Investigational Site Number : 1560008
Shanghai, 200025
China
Investigational Site Number : 1560017
Shanghai, 201200
China
Investigational Site Number : 1560072
Shaoyang, 422000
China
Investigational Site Number : 1560035
Shenyang, 110000
China
Investigational Site Number : 1560053
Shijiazhuang, 050031
China
Investigational Site Number : 1560002
Suzhou, 215006
China
Investigational Site Number : 1560024
Taiyuan, 030032
China
Investigational Site Number : 1560030
Tianjin, 300052
China
Investigational Site Number : 1560075
Ürümqi, 830001
China
Investigational Site Number : 1560033
Weifang, 261041
China
Investigational Site Number : 1560036
Wenzhou, 325027
China
Investigational Site Number : 1560019
Wuhan, 430014
China
Investigational Site Number : 1560071
Wuhan, 430022
China
Investigational Site Number : 1560070
Xi'an, 710004
China
Investigational Site Number : 1560020
Xi'an, 710126
China
Investigational Site Number : 1560083
Xiangyang, 441021
China
Investigational Site Number : 1560006
Xinxiang, 453000
China
Investigational Site Number : 1560058
Xuzhou, 221018
China
Investigational Site Number : 1560089
Yinchuan, 750004
China
Investigational Site Number : 1560076
Yiyang, 413000
China
Investigational Site Number : 1560044
Zhangzhou, 363000
China
Investigational Site Number : 1560084
Zigong, 643000
China
Investigational Site Number : 1560039
Zunyi, 563002
China
Investigational Site Number : 4580004
George Town, 10990
Malaysia
Investigational Site Number : 4580003
Kota Bharu, 16150
Malaysia
Investigational Site Number : 4580001
Kuala Lumpur, 59100
Malaysia
Investigational Site Number : 4580002
Kuala Terengganu, 20400
Malaysia
Investigational Site Number : 4580005
Miri, 98000
Malaysia
Investigational Site Number : 4580007
Sibu, 96000
Malaysia
Investigational Site Number : 5540003
Christchurch, Canterbury 8011
New Zealand
Investigational Site Number : 5540002
Ebdentown, Wellington Region 5018
New Zealand
Investigational Site Number : 5540001
Auckland, 0622
New Zealand
Investigational Site Number : 7020001
Singapore, 529889
Singapore
Investigational Site Number : 7100001
Cape Town, Alberta 7530
South Africa
Investigational Site Number : 7100011
Benoni, 1500
South Africa
Investigational Site Number : 7100009
Boksburg, 1459
South Africa
Investigational Site Number : 7100003
Cape Town, 7764
South Africa
Investigational Site Number : 7100002
Durban, 4001
South Africa
Investigational Site Number : 7100004
Durban, 4302
South Africa
Investigational Site Number : 7100005
Johannesburg, 2001
South Africa
Investigational Site Number : 7100013
Krugersdorp, 1739
South Africa
Investigational Site Number : 7100012
Pretoria, 0084
South Africa
Investigational Site Number : 7100007
Pretoria, 0157
South Africa
Investigational Site Number : 7100010
Welkom, 9459
South Africa
Investigational Site Number : 4100007
Anyang-si, Gyeonggi-do 14068
South Korea
Investigational Site Number : 4100005
Daegu, Gyeongsangbuk-do 42415
South Korea
Investigational Site Number : 4100003
Jeonju, Jeollabuk-do 54907
South Korea
Investigational Site Number : 4100004
Seoul, Seoul-teukbyeolsi 05030
South Korea
Investigational Site Number : 4100002
Seoul, Seoul-teukbyeolsi 05355
South Korea
Investigational Site Number : 4100001
Seoul, Seoul-teukbyeolsi 06591
South Korea
Investigational Site Number : 4100006
Seoul, Seoul-teukbyeolsi 07061
South Korea
Investigational Site Number : 1580007
Changhua, 500
Taiwan
Investigational Site Number : 1580006
Guishan, 333
Taiwan
Investigational Site Number : 1580008
Hsinchu, 300
Taiwan
Investigational Site Number : 1580001
Kaohsiung City, 807
Taiwan
Investigational Site Number : 1580004
Taichung, 407
Taiwan
Investigational Site Number : 1580005
Taipei, 100
Taiwan
Investigational Site Number : 1580002
Taipei, 110
Taiwan
Investigational Site Number : 1580003
Taipei, 112
Taiwan
Investigational Site Number : 8260035
Milton Keynes, Buckinghamshire MK19 6FG
United Kingdom
Investigational Site Number : 8260007
London, England E11 1NR
United Kingdom
Investigational Site Number : 8260008
London, Hammersmith and Fulham W6 8RF
United Kingdom
Investigational Site Number : 8260006
Southampton, Hampshire SO16 6YD
United Kingdom
Investigational Site Number : 8260001
London, London, City of Se1 7eh
United Kingdom
Investigational Site Number : 8260016
London, London, City of SW1P 2PF
United Kingdom
Investigational Site Number : 8260030
Salford, Manchester M6 8HD
United Kingdom
Investigational Site Number : 8260013
Chertsey, Surrey KT16 0PZ
United Kingdom
Investigational Site Number : 8260005
Reading, RG1 5AN
United Kingdom
Investigational Site Number : 8260017
Rotherham, S61 1AH
United Kingdom