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 (THESEUS)

June 12, 2026 updated by: Sanofi

A Phase 2b/Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study, to Investigate the Efficacy and Safety of Lunsekimig in Adult Participants With Inadequately Controlled Chronic Obstructive Pulmonary Disease (COPD) Characterized by an Eosinophilic Phenotype

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

Chronic Obstructive Pulmonary Disease

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

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

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

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

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lunsekimig dose regimen A Participants will receive lunsekimig dose regimen A.	Drug: Lunsekimig Pharmaceutical form: solution for injection in prefilled syringe. Route of administration: Subcutaneous injection Other Names: SAR443765
Experimental: Lunsekimig dose regimen B Participants will receive lunsekimig dose regimen B.	Drug: Lunsekimig Pharmaceutical form: solution for injection in prefilled syringe. Route of administration: Subcutaneous injection Other Names: SAR443765
Placebo Comparator: Placebo Participants will receive lunsekimig-matching placebo.	Drug: 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

Sanofi

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

EFC18244 Plain Language Results Summary

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 17, 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

EFC18244
2024-518213-25-00 (Ctis: CTIS)
U1111-1308-9980 (Other 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

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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Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Contact

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Publications and helpful links

Helpful Links

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

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