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 (PERSEPHONE)
June 12, 2026 updated by: Sanofi
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
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
All eligible participants will undergo subcutaneous administrations of lunsekimig or matching placebo during a 48-weeks treatment period
Study Type
Interventional
Enrollment (Estimated)
942
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Trial Transparency email recommended (Toll free for US & Canada)
- Phone Number: option 6 800-633-1610
- Email: contact-us@sanofi.com
Study Locations
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Buenos Aires, Argentina, 1425
- Recruiting
- Investigational Site Number : 0320002
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Buenos Aires, Argentina, 1425
- Recruiting
- Investigational Site Number : 0320001
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Buenos Aires, Argentina, 1122
- Recruiting
- Investigational Site Number : 0320005
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Buenos Aires, Argentina, 1427
- Recruiting
- Investigational Site Number : 0320009
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Buenos Aires, Argentina, 1012
- Recruiting
- Investigational Site Number : 0320011
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Buenos Aires, Argentina, 1128
- Recruiting
- Investigational Site Number : 0320010
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Buenos Aires
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La Plata, Buenos Aires, Argentina, 1900
- Recruiting
- Investigational Site Number : 0320007
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Lobos, Buenos Aires, Argentina, 7240
- Recruiting
- Investigational Site Number : 0320008
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Santa Fe Province
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Rosario, Santa Fe Province, Argentina, 2000
- Recruiting
- Investigational Site Number : 0320004
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Rosario, Santa Fe Province, Argentina, 2000
- Recruiting
- Investigational Site Number : 0320012
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Tucumán Province
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San Miguel de Tucumán, Tucumán Province, Argentina, 4000
- Recruiting
- Investigational Site Number : 0320006
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San Miguel de Tucumán, Tucumán Province, Argentina, T4000
- Recruiting
- Investigational Site Number : 0320003
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Rio de Janeiro, Brazil, 22031-011
- Recruiting
- Hospital Copa D'Or- Site Number : 0760017
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São Paulo, Brazil, 01323-001
- Recruiting
- Hospital Beneficência Portuguesa de São Paulo- Site Number : 0760010
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Federal District
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Brasília, Federal District, Brazil, 72145-450
- Recruiting
- Chronos Pesquisa Clínica- Site Number : 0760012
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Paraná
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Curitiba, Paraná, Brazil, 80030-110
- Recruiting
- Centro de Estudos em Terapias Inovadoras- Site Number : 0760013
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Rio Grande do Norte
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Natal, Rio Grande do Norte, Brazil, 59012-300
- Recruiting
- Hospital Universitário Onofre Lopes- Site Number : 0760016
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
- Recruiting
- Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760001
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Porto Alegre, Rio Grande do Sul, Brazil, 90480-000
- Recruiting
- LMK Servicos Medicos- Site Number : 0760018
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Porto Alegre, Rio Grande do Sul, Brazil, 90480-020
- Recruiting
- Instituto Ceos- Site Number : 0760005
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São Paulo
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São José do Rio Preto, São Paulo, Brazil, 15090-000
- Recruiting
- Fundação Faculdade Regional de Medicina de São José do Rio Preto- Site Number : 0760011
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São José dos Campos, São Paulo, Brazil, 12230-001
- Recruiting
- Centro Internacional de Pesquisa Clínica (CIPES)- Site Number : 0760008
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Alberta
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Calgary, Alberta, Canada, T3R 1W7
- Recruiting
- Investigational Site Number : 1240011
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Ontario
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Ajax, Ontario, Canada, L1S 2J5
- Recruiting
- Investigational Site Number : 1240010
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Guelph, Ontario, Canada, N1h 6j2
- Recruiting
- Investigational Site Number : 1240004
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Ottawa, Ontario, Canada, K1G 6C6
- Recruiting
- Investigational Site Number : 1240012
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Stoney Creek, Ontario, Canada, L8G 2V6
- Recruiting
- Investigational Site Number : 1240009
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Toronto, Ontario, Canada, M5T 3A9
- Recruiting
- Investigational Site Number : 1240001
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Los Ríos Region
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Valdivia, Los Ríos Region, Chile, 5110683
- Recruiting
- Investigational Site Number : 1520002
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Maule Region
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Talca, Maule Region, Chile, 3465584
- Recruiting
- Investigational Site Number : 1520006
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Reg Metropolitana de Santiago
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Santiago, Reg Metropolitana de Santiago, Chile, 7500692
- Recruiting
- Investigational Site Number : 1520001
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Santiago, Reg Metropolitana de Santiago, Chile, 7500698
- Recruiting
- Investigational Site Number : 1520003
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Santiago, Reg Metropolitana de Santiago, Chile, 7500010
- Recruiting
- Investigational Site Number : 1520004
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Santiago, Reg Metropolitana de Santiago, Chile, 8320325
- Recruiting
- Investigational Site Number : 1520007
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Valparaiso
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Viña del Mar, Valparaiso, Chile, 2531172
- Recruiting
- Investigational Site Number : 1520005
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Beijing, China, 100034
- Recruiting
- Investigational Site Number : 1560035
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Beijing, China, 100144
- Recruiting
- Investigational Site Number : 1560013
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Changchun, China, 130021
- Recruiting
- Investigational Site Number : 1560054
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Changsha, China, 410015
- Recruiting
- Investigational Site Number : 1560032
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Changsha, China, 410011
- Recruiting
- Investigational Site Number : 1560010
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Chengdu, China, 610041
- Recruiting
- Investigational Site Number : 1560018
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Chengdu, China, 610072
- Recruiting
- Investigational Site Number : 1560004
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Chengdu, China, 611130
- Recruiting
- Investigational Site Number : 1560005
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Foshan, China, 528041
- Recruiting
- Investigational Site Number : 1560062
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Guangzhou, China, 510163
- Recruiting
- Investigational Site Number : 1560001
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Guangzhou, China, 510150
- Recruiting
- Investigational Site Number : 1560021
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Hangzhou, China, 310006
- Recruiting
- Investigational Site Number : 1560030
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Harbin, China, 150001
- Recruiting
- Investigational Site Number : 1560024
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Hefei, China, 230032
- Recruiting
- Investigational Site Number : 1560012
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Hefei, China, 231220
- Recruiting
- Investigational Site Number : 1560046
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Hohhot, China, 010050
- Recruiting
- Investigational Site Number : 1560006
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Huizhou, China, 516001
- Recruiting
- Investigational Site Number : 1560044
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Jiaozuo, China, 454001
- Recruiting
- Investigational Site Number : 1560026
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Jinan, China, 250014
- Recruiting
- Investigational Site Number : 1560039
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Jinhua, China, 321000
- Recruiting
- Investigational Site Number : 1560049
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Jining, China, 272011
- Recruiting
- Investigational Site Number : 1560056
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Kunming, China, 650032
- Recruiting
- Investigational Site Number : 1560043
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Langfang, China, 065000
- Recruiting
- Investigational Site Number : 1560023
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Liaocheng, China, 252000
- Recruiting
- Investigational Site Number : 1560047
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Linhai, China, 317000
- Recruiting
- Investigational Site Number : 1560033
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Nanchang, China, 330006
- Recruiting
- Investigational Site Number : 1560002
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Nanchang, China, 330006
- Recruiting
- Investigational Site Number : 1560003
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Nanning, China, 530021
- Recruiting
- Investigational Site Number : 1560051
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Ningbo, China, 315041
- Recruiting
- Investigational Site Number : 1560017
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Pingxiang, China, 337055
- Recruiting
- Investigational Site Number : 1560031
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Shanghai, China, 200240
- Recruiting
- Investigational Site Number : 1560007
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Shanghai, China, 200433
- Recruiting
- Investigational Site Number : 1560008
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Shenyang, China, 110004
- Recruiting
- Investigational Site Number : 1560036
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Shenzhen, China, 518020
- Recruiting
- Investigational Site Number : 1560037
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Shihezi, China, 832008
- Recruiting
- Investigational Site Number : 1560027
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Suining, China, 629000
- Recruiting
- Investigational Site Number : 1560015
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Taiyuan, China, 030001
- Recruiting
- Investigational Site Number : 1560022
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Taizhou, China, 318000
- Recruiting
- Investigational Site Number : 1560034
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Tianjin, China, 300192
- Recruiting
- Investigational Site Number : 1560019
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Wenzhou, China, 325035
- Recruiting
- Investigational Site Number : 1560029
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Wuhan, China, 430030
- Recruiting
- Investigational Site Number : 1560025
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Wuxi, China, 214023
- Recruiting
- Investigational Site Number : 1560050
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Xi'an, China, 710004
- Recruiting
- Investigational Site Number : 1560052
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Xiamen, China, 361004
- Recruiting
- Investigational Site Number : 1560020
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Xiangtan, China, 411100
- Recruiting
- Investigational Site Number : 1560011
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Xianyang, China, 712000
- Recruiting
- Investigational Site Number : 1560055
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Xinxiang, China, 453100
- Recruiting
- Investigational Site Number : 1560058
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Xuzhou, China, 221006
- Recruiting
- Investigational Site Number : 1560040
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Yangzhou, China, 225000
- Recruiting
- Investigational Site Number : 1560041
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Yichang, China, 443003
- Recruiting
- Investigational Site Number : 1560060
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Zhanjiang, China, 524004
- Recruiting
- Investigational Site Number : 1560059
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Zhengzhou, China, 450052
- Recruiting
- Investigational Site Number : 1560057
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Zunyi, China, 563003
- Recruiting
- Investigational Site Number : 1560048
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Ürümqi, China, 830054
- Recruiting
- Investigational Site Number : 1560016
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Kutaisi, Georgia, 4600
- Recruiting
- Investigational Site Number : 2680004
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Tbilisi, Georgia, 0160
- Recruiting
- Investigational Site Number : 2680003
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Tbilisi, Georgia, 0105
- Recruiting
- Investigational Site Number : 2680002
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Tbilisi, Georgia, 0159
- Recruiting
- Investigational Site Number : 2680001
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Tbilisi, Georgia, 0159
- Recruiting
- Investigational Site Number : 2680006
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Chiba, Japan, 260-0852
- Recruiting
- Investigational Site Number : 3920021
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Fukushima, Japan, 960-1295
- Recruiting
- Investigational Site Number : 3920002
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Hiroshima, Japan, 734-8530
- Recruiting
- Investigational Site Number : 3920029
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Kagoshima, Japan, 892-0847
- Recruiting
- Investigational Site Number : 3920039
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Kumamoto, Japan, 862-0909
- Recruiting
- Investigational Site Number : 3920018
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Kumamoto, Japan, 861-4193
- Recruiting
- Investigational Site Number : 3920036
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Kyoto, Japan, 610-0113
- Recruiting
- Investigational Site Number : 3920056
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Osaka, Japan, 545-8586
- Recruiting
- Investigational Site Number : 3920004
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Saga, Japan, 849-0937
- Recruiting
- Investigational Site Number : 3920007
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Tokyo, Japan, 150-8935
- Recruiting
- Investigational Site Number : 3920028
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Tokyo, Japan, 173-8610
- Recruiting
- Investigational Site Number : 3920023
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Tokyo, Japan, 162-8655
- Recruiting
- Investigational Site Number : 3920017
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Aichi-ken
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Kōnan, Aichi-ken, Japan, 483-8704
- Recruiting
- Investigational Site Number : 3920042
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Nagoya, Aichi-ken, Japan, 457-8511
- Recruiting
- Investigational Site Number : 3920032
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Toyota, Aichi-ken, Japan, 470-0396
- Recruiting
- Investigational Site Number : 3920057
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Ehime
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Matsuyama, Ehime, Japan, 790-0826
- Recruiting
- Investigational Site Number : 3920047
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Fukuoka
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Fukuoka, Fukuoka, Japan, 819-0055
- Recruiting
- Investigational Site Number : 3920026
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Kurume, Fukuoka, Japan, 830-0011
- Recruiting
- Investigational Site Number : 3920006
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Hiroshima
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Kure, Hiroshima, Japan, 737-0811
- Recruiting
- Investigational Site Number : 3920053
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Hokkaido
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Sapporo, Hokkaido, Japan, 006-0811
- Recruiting
- Investigational Site Number : 3920049
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Hyōgo
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Himeji-Shi, Hyōgo, Japan, 670-0849
- Recruiting
- Investigational Site Number : 3920024
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Kobe, Hyōgo, Japan, 650-0017
- Recruiting
- Investigational Site Number : 3920009
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Kagawa-ken
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Kita, Kagawa-ken, Japan, 761-0701
- Recruiting
- Investigational Site Number : 3920008
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Sakaidechō, Kagawa-ken, Japan, 762-8550
- Recruiting
- Investigational Site Number : 3920030
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Kanagawa
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Kamakura, Kanagawa, Japan, 247-8533
- Recruiting
- Investigational Site Number : 3920040
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Kawasaki, Kanagawa, Japan, 210-0852
- Recruiting
- Investigational Site Number : 3920051
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Yokohama, Kanagawa, Japan, 236-0004
- Recruiting
- Investigational Site Number : 3920015
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Yokohama, Kanagawa, Japan, 221-0855
- Recruiting
- Investigational Site Number : 3920035
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Yokohama, Kanagawa, Japan, 234-0054
- Recruiting
- Investigational Site Number : 3920054
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Mie-ken
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Matsusaka, Mie-ken, Japan, 515-0073
- Recruiting
- Investigational Site Number : 3920045
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Miyagi
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Sendai, Miyagi, Japan, 980-8574
- Recruiting
- Investigational Site Number : 3920005
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Nara
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Kashihara, Nara, Japan, 634-8522
- Recruiting
- Investigational Site Number : 3920001
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Okayama-ken
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Okayama, Okayama-ken, Japan, 701-1192
- Recruiting
- Investigational Site Number : 3920012
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Osaka
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Sakai, Osaka, Japan, 591-8555
- Recruiting
- Investigational Site Number : 3920043
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Saga-ken
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Ureshino-Shi, Saga-ken, Japan, 843-0393
- Recruiting
- Investigational Site Number : 3920020
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Tokyo
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Hachiōji, Tokyo, Japan, 193-0998
- Recruiting
- Investigational Site Number : 3920033
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Yamaguchi
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Ube, Yamaguchi, Japan, 755-8505
- Recruiting
- Investigational Site Number : 3920003
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Jeddah, Saudi Arabia, 23421
- Recruiting
- Investigational Site Number : 6820003
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Riyadh, Saudi Arabia, 12746
- Recruiting
- Investigational Site Number : 6820002
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Riyadh, Saudi Arabia, 11525
- Recruiting
- Investigational Site Number : 6820001
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Adana, Turkey (Türkiye), 01330
- Recruiting
- Investigational Site Number : 7920002
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Ankara, Turkey (Türkiye), 06010
- Recruiting
- Investigational Site Number : 7920006
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Ankara, Turkey (Türkiye), 06620
- Recruiting
- Investigational Site Number : 7920003
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Gaziantep, Turkey (Türkiye), 27310
- Recruiting
- Investigational Site Number : 7920004
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Istanbul, Turkey (Türkiye), 34020
- Recruiting
- Investigational Site Number : 7920005
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Izmir, Turkey (Türkiye), 35340
- Recruiting
- Investigational Site Number : 7920007
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Mersin, Turkey (Türkiye), 33070
- Recruiting
- Investigational Site Number : 7920001
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Bradford, United Kingdom, BD9 6RJ
- Recruiting
- Investigational Site Number : 8260002
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Bristol, City of
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Bristol, Bristol, City of, United Kingdom, BS37 4AX
- Recruiting
- Investigational Site Number : 8260014
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Hammersmith and Fulham
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London, Hammersmith and Fulham, United Kingdom, W6 7HY
- Recruiting
- Investigational Site Number : 8260015
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Leicestershire
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Leicester, Leicestershire, United Kingdom, LE1 5WW
- Recruiting
- Investigational Site Number : 8260003
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London, City of
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Harrow, London, City of, United Kingdom, HA1 3UJ
- Recruiting
- Investigational Site Number : 8260009
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London, London, City of, United Kingdom, Se1 7eh
- Recruiting
- Investigational Site Number : 8260031
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Oxfordshire
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Oxford, Oxfordshire, United Kingdom, OX3 9DU
- Recruiting
- Investigational Site Number : 8260034
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West Sussex
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Worthing, West Sussex, United Kingdom, BN11 2DH
- Recruiting
- Investigational Site Number : 8260032
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Arizona
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Chandler, Arizona, United States, 85224
- Recruiting
- Chandler Clinical Research Trials- Site Number : 8400025
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Phoenix, Arizona, United States, 85032
- Recruiting
- Pulmonary Associates - Phoenix - East Bell Road- Site Number : 8400114
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Surprise, Arizona, United States, 85378
- Recruiting
- Epic Medical Research - Surprise- Site Number : 8400096
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California
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La Palma, California, United States, 90623
- Recruiting
- IMAX Clinical Trials- Site Number : 8400109
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Long Beach, California, United States, 90805
- Recruiting
- Long Beach Research Institute- Site Number : 8400027
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Los Angeles, California, United States, 90017
- Recruiting
- Downtown L.A. Research Center- Site Number : 8400009
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Newport Beach, California, United States, 92663
- Recruiting
- Newport Native MD- Site Number : 8400003
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Redding, California, United States, 96001
- Recruiting
- Paradigm Research - Redding- Site Number : 8400108
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Valencia, California, United States, 91355
- Recruiting
- Amicis Research Center - Valencia- Site Number : 8400119
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Florida
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Boynton Beach, Florida, United States, 33435
- Recruiting
- Helix Biomedics- Site Number : 8400065
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Cutler Bay, Florida, United States, 33157
- Recruiting
- Beautiful Minds Clinical Research Center- Site Number : 8400017
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Fort Myers, Florida, United States, 33908
- Recruiting
- Eastern Medical Group Research- Site Number : 8400020
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Lady Lake, Florida, United States, 32159
- Recruiting
- Premier Medical Associates- Site Number : 8400012
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Miami, Florida, United States, 33126
- Recruiting
- MCR Research- Site Number : 8400004
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Miami, Florida, United States, 33144
- Recruiting
- Nuren Medical & Research Center- Site Number : 8400030
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Miami, Florida, United States, 33125
- Recruiting
- University of Miami Dermatology Clinical Trials Unit- Site Number : 8400078
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Miami, Florida, United States, 33155
- Recruiting
- My Community Research Center- Site Number : 8400164
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Miami Lakes, Florida, United States, 33014
- Recruiting
- Deluxe Health Center- Site Number : 8400010
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Orlando, Florida, United States, 32810
- Recruiting
- Omega Research Consultants - Orlando - Forest City- Site Number : 8400015
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Pembroke Pines, Florida, United States, 33024
- Recruiting
- Broward Research Center - Pembroke Pines- Site Number : 8400053
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Tampa, Florida, United States, 33607
- Recruiting
- Clinical Research Trials of Florida- Site Number : 8400011
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Tampa, Florida, United States, 33607
- Recruiting
- Deluxe Health Center-Tampa- Site Number : 8400056
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Georgia
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Cordele, Georgia, United States, 31015
- Recruiting
- Private Practice - Dr. David Kavtaradze- Site Number : 8400006
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Fayetteville, Georgia, United States, 30214
- Recruiting
- Primeway Clinical Research- Site Number : 8400121
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Illinois
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Chicago, Illinois, United States, 60612
- Recruiting
- University of Illinois-Chicago - College of Medicine- Site Number : 8400055
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Chicago Ridge, Illinois, United States, 60415
- Recruiting
- Avicenna Clinical Research- Site Number : 8400126
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Evanston, Illinois, United States, 60201
- Recruiting
- NorthShore Medical Group - Evanston ( Endeavor Health)- Site Number : 8400073
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Indiana
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Indianapolis, Indiana, United States, 46268
- Recruiting
- Indy Clinical Research- Site Number : 8400071
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Kansas
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Kansas City, Kansas, United States, 66160
- Recruiting
- University of Kansas Medical Center- Site Number : 8400054
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Louisiana
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Zachary, Louisiana, United States, 70791
- Recruiting
- Southern Clinical Research - Zachary- Site Number : 8400113
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Michigan
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Ann Arbor, Michigan, United States, 48109
- Recruiting
- University of Michigan Health System - Ann Arbor- Site Number : 8400090
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Warren, Michigan, United States, 48088
- Recruiting
- Pulmonary and Medicine Associates- Site Number : 8400007
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Minnesota
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Rochester, Minnesota, United States, 55905
- Recruiting
- Mayo Clinic in Rochester - Minnesota- Site Number : 8400005
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Nevada
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Henderson, Nevada, United States, 89052
- Recruiting
- Henderson Clinical Trials- Site Number : 8400026
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Las Vegas, Nevada, United States, 89106
- Recruiting
- Sierra Clinical Research - Las Vegas- Site Number : 8400028
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New Jersey
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East Orange, New Jersey, United States, 07018
- Recruiting
- Sanmora Bespoke Clinical Research Solutions- Site Number : 8400144
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New York
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Flushing, New York, United States, 11355
- Recruiting
- New York Hospital Queens- Site Number : 8400058
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North Carolina
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Hickory, North Carolina, United States, 28601
- Recruiting
- Advanced Respiratory and Sleep Medicine - Hickory- Site Number : 8400013
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Winston-Salem, North Carolina, United States, 27103
- Recruiting
- Atrium Health Wake Forest Baptist Pulmonary, Sleep And Allergy- Site Number : 8400048
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North Dakota
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Fargo, North Dakota, United States, 58104
- Recruiting
- Plains Clinical Research Center- Site Number : 8400140
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Ohio
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Dayton, Ohio, United States, 45409
- Recruiting
- Dayton Clinical Research- Site Number : 8400124
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Oklahoma
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Chickasha, Oklahoma, United States, 73018
- Recruiting
- Epic Medical Research - Chickasha- Site Number : 8400097
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19140-5103
- Recruiting
- Temple University Hospital - Main Campus- Site Number : 8400059
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Pittsburgh, Pennsylvania, United States, 15236
- Recruiting
- Preferred Primary Care Physicians - Pleasant Hills- Site Number : 8400092
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South Carolina
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Anderson, South Carolina, United States, 29621
- Recruiting
- AnMed Oglesby Center- Site Number : 8400074
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Lancaster, South Carolina, United States, 29720
- Recruiting
- MD First Research - Lancaster- Site Number : 8400102
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Texas
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Beaumont, Texas, United States, 77701
- Recruiting
- REX Clinical Trials - Beaumont- Site Number : 8400014
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Bellaire, Texas, United States, 77401
- Recruiting
- Novel Research - Bellaire- Site Number : 8400116
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Boerne, Texas, United States, 78006
- Recruiting
- South Texas Medical Research Institute - TTS Research- Site Number : 8400018
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Carrollton, Texas, United States, 75010
- Recruiting
- TEN20 Clinical Research - Carrollton- Site Number : 8400141
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Corsicana, Texas, United States, 75110
- Recruiting
- Corsicana Medical Research- Site Number : 8400134
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Cypress, Texas, United States, 77065
- Recruiting
- Syri Research Center- Site Number : 8400069
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Dallas, Texas, United States, 75231
- Recruiting
- Texas Health Presbyterian Hospital Dallas- Site Number : 8400032
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DeSoto, Texas, United States, 75115
- Recruiting
- Epic Medical Research - De Soto- Site Number : 8400095
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Harlingen, Texas, United States, 78550
- Recruiting
- Valley Institute of Research- Site Number : 8400118
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Houston, Texas, United States, 77008
- Recruiting
- Trio Clinical Trials- Site Number : 8400106
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Houston, Texas, United States, 77022
- Recruiting
- HDH Research- Site Number : 8400104
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Houston, Texas, United States, 77070
- Recruiting
- Gulf Coast Clinical Research - Houston- Site Number : 8400049
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Houston, Texas, United States, 77030
- Recruiting
- Baylor College of Medicine- Site Number : 8400076
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Kingwood, Texas, United States, 77339
- Recruiting
- Lumi Research - Kingwood- Site Number : 8400120
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Kingwood, Texas, United States, 77339
- Recruiting
- Syri Research Center- Site Number : 8400136
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Lampasas, Texas, United States, 76550
- Recruiting
- Radiance Clinical Research - Lampasas - West Avenue East- Site Number : 8400063
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San Antonio, Texas, United States, 78229
- Recruiting
- Discovery Clinical Trials - San Antonio- Site Number : 8400031
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San Antonio, Texas, United States, 78249
- Recruiting
- Bandera Family Health Care - San Antonio- Site Number : 8400021
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San Antonio, Texas, United States, 78257
- Recruiting
- Element Research Group- Site Number : 8400115
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-
Virginia
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Williamsburg, Virginia, United States, 23188
- Recruiting
- Tidewater Physicians Multispecialty Group Clinical Research - Williamsburg- Site Number : 8400081
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Lunsekimig dose regimen A
Participants will receive lunsekimig dose regimen A.
|
Pharmaceutical form: solution for injection in prefilled syringe.
Route of administration: Subcutaneous injection
Other Names:
|
|
Experimental: Lunsekimig dose regimen B
Participants will receive lunsekimig dose regimen B
|
Pharmaceutical form: solution for injection in prefilled syringe.
Route of administration: Subcutaneous injection
Other Names:
|
|
Placebo Comparator: Placebo
Participants will receive lunsekimig-matching placebo
|
Pharmaceutical form: solution for injection.
Route of administration: Subcutaneous injection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Annualized rate of moderate-to-severe chronic obstructive pulmonary disease (COPD) exacerbations
Time Frame: From Baseline up to 48 weeks
|
The annualized moderate or severe COPD exacerbation rate up to 48 weeks treatment period compared to placebo
|
From Baseline up to 48 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline in pre-Bronchodilator Forced Expiratory Volume in 1 second (pre-BD FEV1)
Time Frame: From Baseline up to 48 weeks
|
The pre-Bronchodilator Forced Expiratory Volume in 1 second is defined as the volume of air exhaled from the lungs in the first second of a forced expiration.
|
From Baseline up to 48 weeks
|
|
Change from baseline in the SGRQ-C total score
Time Frame: From Baseline up to 48 weeks
|
The St. George's Respiratory Questionnaire for patients with chronic obstructive pulmonary disease is derived from the St. George's Respiratory Questionnaire (SGRQ) and is designed to measure and quantify health status in adult patients with chronic airflow limitation.
A global score ranges from 0 to 100 with lower scores indicating better quality-of-life.
|
From Baseline up to 48 weeks
|
|
SGRQ responder defined as an improvement of ≥4 points in the SGRQ-C total score
Time Frame: From Baseline up to 48 weeks
|
From Baseline up to 48 weeks
|
|
|
Change from baseline in the Chronic airways assessment Test (CAAT) score
Time Frame: From Baseline up to 48 weeks
|
The CAAT is an 8-item patient-reported outcome (PRO) measure designed to assess the impact of chronic airways diseases, including COPD, on patients' health status.
The CAAT has a scoring range of 0-40, with higher scores indicating a greater impact of the disease on health status.
|
From Baseline up to 48 weeks
|
|
Change from baseline in the E-RS:COPD total score
Time Frame: From Baseline up to 48 weeks
|
The Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary Disease (E-RS:COPD) is an 11-item patient-reported outcome (PRO) measure that evaluates the severity of respiratory symptoms in patients with stable COPD.
The total score ranges from 0 to 40, with higher scores indicating more severe respiratory symptoms.
|
From Baseline up to 48 weeks
|
|
Annualized rate of severe COPD exacerbations
Time Frame: From Baseline up to 48 weeks
|
From Baseline up to 48 weeks
|
|
|
Time to first moderate or severe COPD exacerbation
Time Frame: From Baseline up to 48 weeks
|
Time to first occurrence of moderate to severe COPD exacerbation up to 48 weeks
|
From Baseline up to 48 weeks
|
|
Time to first severe COPD exacerbation
Time Frame: From Baseline up to 48 weeks
|
Time to first occurrence of severe COPD exacerbation up to 48 weeks
|
From Baseline up to 48 weeks
|
|
Incidence of potentially clinically significant laboratory abnormalities
Time Frame: From Baseline up to 56 weeks
|
From Baseline up to 56 weeks
|
|
|
Incidence of participants with TEAEs, including AESIs, and SAEs
Time Frame: From Baseline up to 56 weeks
|
Treatment-Emergent Adverse Events (TEAEs), Adverse events of Special Interest (AESIs), Serious Adverse Events (SAEs)
|
From Baseline up to 56 weeks
|
|
Change from baseline in post-Bronchodilator Forced Expiratory Volume in 1 second (post-BD FEV1)
Time Frame: From Baseline up to 48 weeks
|
The post-Bronchodilator Forced Expiratory Volume in 1 second is defined as the volume of air exhaled from the lungs in the first second of a forced expiration.
|
From Baseline up to 48 weeks
|
|
CAAT responder defined as an improvement of ≥2 points in the CAAT total score
Time Frame: From Baseline up to 48 weeks
|
From Baseline up to 48 weeks
|
|
|
E-RS:COPD responder defined as an improvement of ≥2 points in the E-RS:COPD total score
Time Frame: From Baseline up to 48 weeks
|
From Baseline up to 48 weeks
|
|
|
Serum concentration of lunsekimig
Time Frame: From Baseline up to 48 weeks
|
From Baseline up to 48 weeks
|
|
|
Incidence and titer of antidrug antibodies (ADAs)
Time Frame: From Baseline up to 48 weeks
|
From Baseline up to 48 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 16, 2025
Primary Completion (Estimated)
November 27, 2029
Study Completion (Estimated)
January 22, 2030
Study Registration Dates
First Submitted
September 17, 2025
First Submitted That Met QC Criteria
September 17, 2025
First Posted (Actual)
September 24, 2025
Study Record Updates
Last Update Posted (Actual)
June 15, 2026
Last Update Submitted That Met QC Criteria
June 12, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EFC18243
- 2024-518016-39-00 (Ctis: CTIS)
- U1111-1308-9892 (Registry Identifier: ICTRP)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications.
Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants.
Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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SanofiCompletedAsthmaMexico, United Kingdom, China, South Africa, Canada, India, United States, Argentina, Brazil, Israel, Japan, Turkey (Türkiye), South Korea, Chile
-
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