Chronic Obstructive Pulmonary DiseasePhase 3THESEUSNCT07190222
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
A Phase 3 study testing Lunsekimig in people with Chronic Obstructive Pulmonary Disease, run by Sanofi at 314 sites in 26 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Lunsekimig
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 942 participants
- Where
- 314 sitesin 26 countries
- Study dates
- 17 Sep 2025to 22 Jan 2030
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
314 sites in 26 countries. Contact the study team or a site near you to ask about taking part.
Trial Transparency email recommended (Toll free for US & Canada) contact
314 sites in 26 countries
United States75 sites, 71 recruiting
- Recruiting
Appalachian Clinical Research- Site Number : 8400060
Adairsville, Georgia, 30103
- Recruiting
Vitalis Clinical Research Center- Site Number : 8400040
Allen Park, Michigan, 48101
- Recruiting
Solace Clinical Research- Site Number : 8400087
Austin, Texas, 78759
- Recruiting
Johns Hopkins Bayview Medical Center- Site Number : 8400076
Baltimore, Maryland, 21224
- Recruiting
Rheumatology & Pulmonary Clinic- Site Number : 8400012
Beckley, West Virginia, 25801
- Recruiting
University of Alabama at Birmingham- Site Number : 8400003
Birmingham, Alabama, 35233
- Recruiting
Alpine Clinical Research Center - Boulder - 47th Street- Site Number : 8400005
Boulder, Colorado, 80301
- Recruiting
Meris Clinical Research- Site Number : 8400153
Brandon, Florida, 33511
- Recruiting
Bolt Clinical Research- Site Number : 8400086
Brighton, Michigan, 48116
- Recruiting
Trinity Medical, WNY- Site Number : 8400157
Buffalo, New York, 14215
- Recruiting
Christie Clinic in Champaign on University- Site Number : 8400023
Champaign, Illinois, 61820
- Recruiting
Chattanooga Research and Medicine- Site Number : 8400026
Chattanooga, Tennessee, 37404
- Recruiting
MedTrial- Site Number : 8400010
Columbia, South Carolina, 29204
- Recruiting
IntraCare- Site Number : 8400034
Dallas, Texas, 75254
- Recruiting
Hillcrest Medical Research- Site Number : 8400082
DeLand, Florida, 32720
- Recruiting
Premier Pulmonary Critical Care and Sleep- Site Number : 8400111
Denison, Texas, 75020
- Recruiting
Henry Ford Hospital- Site Number : 8400058
Detroit, Michigan, 48202
- Recruiting
El Paso Pulmonary Association- Site Number : 8400033
El Paso, Texas, 79902
- Recruiting
Pulmonary Research Institute of Southeast Michigan - Farmington Hills- Site Number : 8400161
Farmington Hills, Michigan, 48336
- Recruiting
Finlay Medical Research - Greenacres- Site Number : 8400107
Greenacres City, Florida, 33467
- Recruiting
East Carolina University- Site Number : 8400102
Greenville, North Carolina, 27858
- Recruiting
Bioluminux Clinical Research - Hamilton, New Jersey- Site Number : 8400037
Hamilton, New Jersey, 08690
- Recruiting
Asha Clinical Research - Munster- Site Number : 8400115
Hammond, Indiana, 46324
- Recruiting
Hannibal Regional Healthcare System- Site Number : 8400035
Hannibal, Missouri, 63401
- Recruiting
Premier Research Center, Llc- Site Number : 8400146
Hendersonville, Tennessee, 37075
- Recruiting
Direct Helpers Research Center- Site Number : 8400057
Hialeah, Florida, 33012
- Completed
Axsendo Clinical Research - Houston- Site Number : 8400054
Houston, Texas, 77058
- Recruiting
Se Houston- Site Number : 8400120
Houston, Texas, 77061
- Recruiting
Aavon Clinical Trials, Llc- Site Number : 8400166
Houston, Texas, 77074
- Recruiting
University of Florida - Jacksonville- Site Number : 8400126
Jacksonville, Florida, 32209
- Recruiting
Critical Care Pulmonary & Sleep Associates- Site Number : 8400081
Lakewood, Colorado, 80228
- Recruiting
Excel Clinical Research - Las Vegas- Site Number : 8400070
Las Vegas, Nevada, 89109
- Completed
AB Clinical Trials- Site Number : 8400075
Las Vegas, Nevada, 89119
- Recruiting
Salud Clinical Services- Site Number : 8400109
Lehigh Acres, Florida, 33936
- Recruiting
Ark Clinical Research- Site Number : 8400113
Long Beach, California, 90815
- Recruiting
Inglewood Clinical- Site Number : 8400074
Los Angeles, California, 90056
- Recruiting
Alliance Clinical - West Hills- Site Number : 8400067
Los Angeles, California, 91307
- Recruiting
Pulmonary Specialists of the Palm Beaches- Site Number : 8400017
Loxahatchee Groves, Florida, 33470
- Recruiting
Suburban Research Associates - Media- Site Number : 8400143
Media, Pennsylvania, 19063
- Recruiting
Elite Clinical Research - Miami- Site Number : 8400167
Miami, Florida, 33144
- Recruiting
DL Research Solutions- Site Number : 8400140
Miami, Florida, 33155
- Recruiting
Phoenix Medical Research - Miami - 24th Street- Site Number : 8400027
Miami, Florida, 33165
- Recruiting
Professional Research Center- Site Number : 8400046
Miami, Florida, 33172
- Recruiting
Research Institute of South Florida- Site Number : 8400028
Miami, Florida, 33173
- Recruiting
Innovations Biotech- Site Number : 8400019
Miami, Florida, 33186
- Recruiting
Synergy Group US - Missouri City- Site Number : 8400119
Missouri City, Texas, 77459
- Recruiting
Synergy Group US - Missouri City- Site Number : 8400133
Missouri City, Texas, 77459
- Recruiting
Pulmonary Associates - Mobile- Site Number : 8400151
Mobile, Alabama, 36608
- Recruiting
Lucida Clinical Trials- Site Number : 8400101
New Bedford, Massachusetts, 02740
- Recruiting
Mid Hudson Medical Research - New Windsor- Site Number : 8400004
New Windsor, New York, 12553
- Recruiting
Rutgers Institute For Infectious & Inflammatory Diseases (I3d)- Site Number : 8400093
Newark, New Jersey, 07103
- Recruiting
Sneeze Wheeze & Itch Associates- Site Number : 8400020
Normal, Illinois, 61761
- Recruiting
California Medical Research Associates - Northridge- Site Number : 8400089
Northridge, California, 91324
- Recruiting
Heuer M.D. Research- Site Number : 8400018
Orlando, Florida, 32819
- Recruiting
Florida Institute for Clinical Research- Site Number : 8400001
Orlando, Florida, 32825
- Recruiting
Avanza Medical Research Center- Site Number : 8400015
Pensacola, Florida, 32503
- Recruiting
Peoria Pulmonary Associates Ltd- Site Number : 8400095
Peoria, Illinois, 61603
- Recruiting
Hull and Hull Medical Specialists- Site Number : 8400002
Plantation, Florida, 33324
- Recruiting
The Oregon Clinic - Portland - Northwest 22nd Avenue- Site Number : 8400065
Portland, Oregon, 97210
- Completed
Acclaim Clinical Research- Site Number : 8400068
San Diego, California, 92120
- Recruiting
Windom Allergy, Asthma and Sinus Specialists- Site Number : 8400041
Sarasota, Florida, 34239
- Recruiting
Ochsner LSU Health Shreveport - Academic Medical Center- Site Number : 8400083
Shreveport, Louisiana, 71103
- Recruiting
Care Access - Shreveport - Youree Drive- Site Number : 8400007
Shreveport, Louisiana, 71105
- Recruiting
Washington University- Site Number : 8400144
St Louis, Missouri, 63110
- Recruiting
Stat Care Pulmonary and Sleep- Site Number : 8400138
St. Petersburg, Florida, 33709
- Completed
Piedmont Healthcare - Family Medicine- Site Number : 8400022
Statesville, North Carolina, 28625
- Recruiting
Elligo Health Care, Hillcroft Medical Clinic Association- Site Number : 8400053
Sugar Land, Texas, 77478
- Recruiting
Better Life Clinical Research- Site Number : 8400152
Tampa, Florida, 33607
- Recruiting
Vicis Clinical Research- Site Number : 8400158
Tampa, Florida, 33615
- Recruiting
Asthma & Allergy Center - Toledo- Site Number : 8400110
Toledo, Ohio, 43617
- Recruiting
Tucson Clinical Research Institute- Site Number : 8400006
Tucson, Arizona, 85712
- Recruiting
Layrek Clinical Research- Site Number : 8400066
Tulsa, Oklahoma, 74133
- Recruiting
Howard University Hospital- Site Number : 8400080
Washington D.C., District of Columbia, 20060
- Recruiting
All-Trials Clinical Research- Site Number : 8400008
Winston-Salem, North Carolina, 27103
- Recruiting
Medrasa Clinical Research - Wylie- Site Number : 8400124
Wylie, Texas, 75098
China75 sites, 75 recruiting
- Recruiting
Investigational Site Number : 1560003
Baotou, 014010
- Recruiting
Investigational Site Number : 1560022
Beijing, 100020
- Recruiting
Investigational Site Number : 1560001
Beijing, 100029
- Recruiting
Investigational Site Number : 1560023
Beijing, 100038
- Recruiting
Investigational Site Number : 1560005
Beijing, 100191
- Recruiting
Investigational Site Number : 1560062
Changchun, 130041
- Recruiting
Investigational Site Number : 1560090
Changde, 415000
- Recruiting
Investigational Site Number : 1560057
Changsha, 410008
- Recruiting
Investigational Site Number : 1560052
Chengdu, 610000
- Recruiting
Investigational Site Number : 1560032
Chengdu, 610081
- Recruiting
Investigational Site Number : 1560037
Chongqing, 400010
- Recruiting
Investigational Site Number : 1560074
Chongqing, NaN
- Recruiting
Investigational Site Number : 1560078
Dalian, 116033
- Recruiting
Investigational Site Number : 1560051
Foshan, 528399
- Recruiting
Investigational Site Number : 1560042
Ganzhou, 341000
- Recruiting
Investigational Site Number : 1560015
Guangzhou, 510180
- Recruiting
Investigational Site Number : 1560034
Guangzhou, 511400
- Recruiting
Investigational Site Number : 1560038
Guiyang, 550004
- Recruiting
Investigational Site Number : 1560016
Haikou, 570216
- Recruiting
Investigational Site Number : 1560009
Hangzhou, 310009
- Recruiting
Investigational Site Number : 1560066
Hangzhou, 310009
- Recruiting
Investigational Site Number : 1560054
Hebei, 050051
- Recruiting
Investigational Site Number : 1560059
Hefei, 230011
- Recruiting
Investigational Site Number : 1560007
Hohhot, 010070
- Recruiting
Investigational Site Number : 1560050
Honghehanizu, 654400
- Recruiting
Investigational Site Number : 1560046
Huai'an, 223300
- Recruiting
Investigational Site Number : 1560004
Huizhou, 516002
- Recruiting
Investigational Site Number : 1560021
Huzhou, 313000
- Recruiting
Investigational Site Number : 1560065
Jiangyin, 214400
- Recruiting
Investigational Site Number : 1560081
Jiaxing, 314001
- Recruiting
Investigational Site Number : 1560055
Jinan, 250001
- Recruiting
Investigational Site Number : 1560028
Jinan, 250013
- Recruiting
Investigational Site Number : 1560013
Jinan, 250014
- Recruiting
Investigational Site Number : 1560079
Jingzhou, 434020
- Recruiting
Investigational Site Number : 1560040
Jining, 272029
- Recruiting
Investigational Site Number : 1560061
Kunming, 650011
- Recruiting
Investigational Site Number : 1560091
Lanzhou, 730000
- Recruiting
Investigational Site Number : 1560077
Luoyang, 471002
- Recruiting
Investigational Site Number : 1560063
Meihekou, 135022
- Recruiting
Investigational Site Number : 1560014
Nanchang, 330006
- Recruiting
Investigational Site Number : 1560087
Nanchang, 330008
- Recruiting
Investigational Site Number : 1560047
Nanjing, 210006
- Recruiting
Investigational Site Number : 1560082
Nanjing, 211100
- Recruiting
Investigational Site Number : 1560027
Nanning, 530021
- Recruiting
Investigational Site Number : 1560018
Nanyang, 473014
- Recruiting
Investigational Site Number : 1560073
Panjin, 422000
- Recruiting
Investigational Site Number : 1560029
Qingdao, 266011
- Recruiting
Investigational Site Number : 1560043
Qingyuan, 511518
- Recruiting
Investigational Site Number : 1560025
Qinhuangdao, 066000
- Recruiting
Investigational Site Number : 1560031
Qiqihar
- Recruiting
Investigational Site Number : 1560045
Quzhou, 324000
- Recruiting
Investigational Site Number : 1560008
Shanghai, 200025
- Recruiting
Investigational Site Number : 1560017
Shanghai, 201200
- Recruiting
Investigational Site Number : 1560072
Shaoyang, 422000
- Recruiting
Investigational Site Number : 1560035
Shenyang, 110000
- Recruiting
Investigational Site Number : 1560053
Shijiazhuang, 050031
- Recruiting
Investigational Site Number : 1560002
Suzhou, 215006
- Recruiting
Investigational Site Number : 1560024
Taiyuan, 030032
- Recruiting
Investigational Site Number : 1560030
Tianjin, 300052
- Recruiting
Investigational Site Number : 1560075
Ürümqi, 830001
- Recruiting
Investigational Site Number : 1560033
Weifang, 261041
- Recruiting
Investigational Site Number : 1560036
Wenzhou, 325027
- Recruiting
Investigational Site Number : 1560019
Wuhan, 430014
- Recruiting
Investigational Site Number : 1560071
Wuhan, 430022
- Recruiting
Investigational Site Number : 1560070
Xi'an, 710004
- Recruiting
Investigational Site Number : 1560020
Xi'an, 710126
- Recruiting
Investigational Site Number : 1560083
Xiangyang, 441021
- Recruiting
Investigational Site Number : 1560006
Xinxiang, 45300
- Recruiting
Investigational Site Number : 1560058
Xuzhou, 221018
- Recruiting
Investigational Site Number : 1560089
Yinchuan, 750004
- Recruiting
Investigational Site Number : 1560076
Yiyang, 413000
- Recruiting
Investigational Site Number : 1560044
Zhangzhou, 363000
- Recruiting
Investigational Site Number : 1560011
Zhengzhou, 450003
- Recruiting
Investigational Site Number : 1560084
Zigong, 643000
- Recruiting
Investigational Site Number : 1560039
Zunyi, 563002
South Africa13 sites, 13 recruiting
- Recruiting
Investigational Site Number : 7100011
Benoni, 1500
- Recruiting
Investigational Site Number : 7100009
Boksburg, 1459
- Recruiting
Investigational Site Number : 7100001
Cape Town, 7530
- Recruiting
Investigational Site Number : 7100003
Cape Town, 7764
- Recruiting
Investigational Site Number : 7100002
Durban, 4001
- Recruiting
Investigational Site Number : 7100014
Durban, 4001
- Recruiting
Investigational Site Number : 7100006
Durban, 4092
- Recruiting
Investigational Site Number : 7100004
Durban, 4302
- Recruiting
Investigational Site Number : 7100005
Johannesburg, 2001
- Recruiting
Investigational Site Number : 7100013
Krugersdorp, 1739
- Recruiting
Investigational Site Number : 7100012
Pretoria, 0084
- Recruiting
Investigational Site Number : 7100007
Pretoria, 0157
- Recruiting
Investigational Site Number : 7100010
Welkom, 9459
Argentina12 sites, 12 recruiting
- Recruiting
Investigational Site Number : 0320011
Berazategui, Buenos Aires, 1886
- Recruiting
Investigational Site Number : 0320004
Buenos Aires, 1006
- Recruiting
Investigational Site Number : 0320002
Buenos Aires, 1023
- Recruiting
Investigational Site Number : 0320005
Buenos Aires, 1121
- Recruiting
Investigational Site Number : 0320003
Buenos Aires, 1182
- Recruiting
Investigational Site Number : 0320006
Buenos Aires, 1280
- Recruiting
Investigational Site Number : 0320001
Buenos Aires, 1414
- Recruiting
Investigational Site Number : 0320012
Buenos Aires, 1638
- Recruiting
Investigational Site Number : 0320009
Córdoba, 5003
- Recruiting
Investigational Site Number : 0320007
Mendoza, 5500
- Recruiting
Investigational Site Number : 0320008
Mendoza, 5500
- Recruiting
Investigational Site Number : 0320010
Santa Fe, 3000
Canada12 sites, 12 recruiting
- Recruiting
Investigational Site Number : 1240051
Kelowna, British Columbia, V1Y 4N7
- Recruiting
Investigational Site Number : 1240049
Longueuil, Quebec, J4K 1C8
- Recruiting
Investigational Site Number : 1240055
Montreal, Quebec, H3T 1E2
- Recruiting
Investigational Site Number : 1240045
Niagara Falls, Ontario, L2H 1H5
- Recruiting
Investigational Site Number : 1240047
Québec, Quebec, G1V 4G5
- Recruiting
Investigational Site Number : 1240053
Québec, Quebec, G2J 0C4
- Recruiting
Investigational Site Number : 1240050
Saint-Charles-Borromée, Quebec, J6E 2B4
- Recruiting
Investigational Site Number : 1240054
Saint-Charles-Borromée, Quebec, J6E 2B4
- Recruiting
Investigational Site Number : 1240048
Trois-Rivières, Quebec, G8T 7A1
- Recruiting
Investigational Site Number : 1240042
Victoriaville, Quebec, G6P 3Z8
- Recruiting
Investigational Site Number : 1240052
West Vancouver, British Columbia, V7T 2Z3
- Recruiting
Investigational Site Number : 1240041
Windsor, Ontario, N8X 1T3
Germany10 sites, 10 recruiting
- Recruiting
Investigational Site Number : 2760005
Bamberg, 96049
- Recruiting
Investigational Site Number : 2760006
Berlin, 10119
- Recruiting
Investigational Site Number : 2760012
Berlin, 10717
- Recruiting
Investigational Site Number : 2760004
Berlin, 10961
- Recruiting
Investigational Site Number : 2760003
Berlin, 12203
- Recruiting
Investigational Site Number : 2760011
Berlin, 13187
- Recruiting
Investigational Site Number : 2760015
Bonn, 53127
- Recruiting
Investigational Site Number : 2760016
Landsberg am Lech, 86899
- Recruiting
Investigational Site Number : 2760001
Peine, 31224
- Recruiting
Investigational Site Number : 2760010
Witten, 58452
Israel10 sites, 10 recruiting
- Recruiting
Investigational Site Number : 3760004
Ashkelon, 7830604
- Recruiting
Investigational Site Number : 3760007
Beersheba, 8457108
- Recruiting
Investigational Site Number : 3760010
Haifa, 3104802
- Recruiting
Investigational Site Number : 3760008
Haifa, 3436212
- Recruiting
Investigational Site Number : 3760005
Jerusalem, 9103102
- Recruiting
Investigational Site Number : 3760003
Jerusalem, 9112001
- Recruiting
Investigational Site Number : 3760002
Petah Tikva, 4941492
- Recruiting
Investigational Site Number : 3760011
Ramat Gan, 5262100
- Recruiting
Investigational Site Number : 3760001
Rehovot, 7610001
- Recruiting
Investigational Site Number : 3760006
Tel Aviv, 6423906
United Kingdom10 sites, 10 recruiting
- Recruiting
Investigational Site Number : 8260013
Chertsey, Surrey, KT16 0PZ
- Recruiting
Investigational Site Number : 8260007
London, England, E11 1NR
- Recruiting
Investigational Site Number : 8260008
London, Hammersmith and Fulham, W6 8RF
- Recruiting
Investigational Site Number : 8260001
London, London, City of, Se1 7eh
- Recruiting
Investigational Site Number : 8260016
London, London, City of, SW1P 2PF
- Recruiting
Investigational Site Number : 8260035
Milton Keynes, Buckinghamshire, MK19 6FG
- Recruiting
Investigational Site Number : 8260005
Reading, RG1 5AN
- Recruiting
Investigational Site Number : 8260017
Rotherham, S61 1AH
- Recruiting
Investigational Site Number : 8260030
Salford, Manchester, M6 8HD
- Recruiting
Investigational Site Number : 8260006
Southampton, Hampshire, SO16 6YD
Spain8 sites, 8 recruiting
- Recruiting
Investigational Site Number : 7240001
Badalona, Barcelona [Barcelona], 08916
- Recruiting
Investigational Site Number : 7240008
Barcelona, Catalunya [Cataluña], 08017
- Recruiting
Investigational Site Number : 7240007
Chamberí, Madrid, Comunidad de, 28010
- Recruiting
Investigational Site Number : 7240006
Madrid, Madrid, Comunidad de, 28046
- Recruiting
Investigational Site Number : 7240002
Madrid, 28003
- Recruiting
Investigational Site Number : 7240005
Madrid, 28040
- Recruiting
Investigational Site Number : 7240004
Santander, Cantabria, 39008
- Recruiting
Investigational Site Number : 7240003
Zaragoza, Aragon, 50009
Taiwan8 sites, 8 recruiting
- Recruiting
Investigational Site Number : 1580007
Changhua, 500
- Recruiting
Investigational Site Number : 1580008
Hsinchu, 300
- Recruiting
Investigational Site Number : 1580001
Kaohsiung City, 80756
- Recruiting
Investigational Site Number : 1580004
Taichung, 407
- Recruiting
Investigational Site Number : 1580005
Taipei, 100
- Recruiting
Investigational Site Number : 1580002
Taipei, 110
- Recruiting
Investigational Site Number : 1580003
Taipei, 112
- Recruiting
Investigational Site Number : 1580006
Taoyuan City, 333
Australia7 sites, 7 recruiting
- Recruiting
Investigational Site Number : 0360007
Coffs Harbour, New South Wales, 2450
- Recruiting
Investigational Site Number : 5540004
Dunedin, 9016
- Recruiting
Investigational Site Number : 0360001
Osborne Park, Western Australia, 6017
- Recruiting
Investigational Site Number : 0360006
South Brisbane, Queensland, 4101
- Recruiting
Investigational Site Number : 0360008
Tiwi, Northern Territory, 0810
- Recruiting
Investigational Site Number : 0360004
Townsville, Queensland, 4814
- Recruiting
Investigational Site Number : 0360002
Traralgon, Victoria, 3844
Chile7 sites, 7 recruiting
- Recruiting
Investigational Site Number : 1520007
Chillan, 3800761
- Recruiting
Investigational Site Number : 1520004
Recoleta, Reg Metropolitana de Santiago, 8420000
- Recruiting
Investigational Site Number : 1520001
Santiago, Reg Metropolitana de Santiago, 7500587
- Recruiting
Investigational Site Number : 1520002
Santiago, Reg Metropolitana de Santiago, 7750495
- Recruiting
Investigational Site Number : 1520009
Santiago, Reg Metropolitana de Santiago, 8380453
- Recruiting
Investigational Site Number : 1520006
Temuco, La Araucanía, 4810345
- Recruiting
Investigational Site Number : 1520003
Viña del Mar, Valparaiso, 2540364
Malaysia7 sites, 7 recruiting
- Recruiting
Investigational Site Number : 4580004
George Town, 10990
- Recruiting
Investigational Site Number : 4580006
Kajang, 43000
- Recruiting
Investigational Site Number : 4580003
Kota Bharu, 16150
- Recruiting
Investigational Site Number : 4580001
Kuala Lumpur, 59100
- Recruiting
Investigational Site Number : 4580002
Kuala Terengganu, 20400
- Recruiting
Investigational Site Number : 4580005
Miri, 98000
- Recruiting
Investigational Site Number : 4580007
Sibu, 96000
Netherlands7 sites, 7 recruiting
- Recruiting
Investigational Site Number : 5280002
Arnhem, 6815 AD
- Recruiting
Investigational Site Number : 5280001
Breda, 4818 CK
- Recruiting
Investigational Site Number : 5280010
Dordrecht, 3318 AT
- Recruiting
Investigational Site Number : 5280007
Nijmegen, 6525 GA
- Recruiting
Investigational Site Number : 5280008
Nijmegen, 6532 SZ
- Recruiting
Investigational Site Number : 5280003
The Hague, 2545 CH
- Recruiting
Investigational Site Number : 5280009
Zutphen, 7207 AE
Poland7 sites, 7 recruiting
- Recruiting
Investigational Site Number : 6160003
Bialystok, Podlaskie Voivodeship, 15-879
- Recruiting
Investigational Site Number : 6160006
Chęciny, 26-060
- Recruiting
Investigational Site Number : 6160007
Krakow, Lesser Poland Voivodeship, 30-033
- Recruiting
Investigational Site Number : 6160004
Lodz, Lódzkie, 90-302
- Recruiting
Investigational Site Number : 6160001
Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, 27-400
- Recruiting
Investigational Site Number : 6160005
Poznan, Greater Poland Voivodeship, 60-309
- Recruiting
Investigational Site Number : 6160002
Poznan, Greater Poland Voivodeship, 60-693
South Korea7 sites, 7 recruiting
- Recruiting
Investigational Site Number : 4100007
Anyang-si, Gyeonggi-do, 14068
- Recruiting
Investigational Site Number : 4100005
Daegu, Gyeongsangbuk-do, 42415
- Recruiting
Investigational Site Number : 4100003
Jeonju, Jeollabuk-do, 54907
- Recruiting
Investigational Site Number : 4100004
Seoul, Seoul-teukbyeolsi, 05030
- Recruiting
Investigational Site Number : 4100002
Seoul, Seoul-teukbyeolsi, 05355
- Recruiting
Investigational Site Number : 4100001
Seoul, Seoul-teukbyeolsi, 06591
- Recruiting
Investigational Site Number : 4100006
Seoul, Seoul-teukbyeolsi, 07061
Czechia6 sites, 6 recruiting
- Recruiting
Investigational Site Number : 2030007
Brandýs nad Labem-Stará Boleslav, 250 01
- Recruiting
Investigational Site Number : 2030006
Havlíčkův Brod, 580 01
- Recruiting
Investigational Site Number : 2030005
Hradec Králové, 500 05
- Recruiting
Investigational Site Number : 2030001
Jindřichův Hradec, 377 01
- Recruiting
Investigational Site Number : 2030002
Kralupy nad Vltavou, 278 01
- Recruiting
Investigational Site Number : 2030004
Prague, 190 00
Greece6 sites, 6 recruiting
- Recruiting
Investigational Site Number : 3000003
Alexandroupoli, 681 00
- Recruiting
Investigational Site Number : 3000007
Athens, 115 27
- Recruiting
Investigational Site Number : 3000006
Athens, 124 62
- Recruiting
Investigational Site Number : 3000002
Exochi, 570 10
- Recruiting
Investigational Site Number : 3000001
Ioannina, 455 00
- Recruiting
Investigational Site Number : 3000004
Palaió Fáliro, 175 62
Mexico6 sites, 6 recruiting
- Recruiting
Investigational Site Number : 4840009
Chihuahua City, 31210
- Recruiting
Investigational Site Number : 4840010
Durango, 34060
- Recruiting
Investigational Site Number : 4840002
Guadalajara, Jalisco, 44100
- Recruiting
Investigational Site Number : 4840012
León, Guanajuato, 37160
- Recruiting
Investigational Site Number : 4840003
Mexico City, 06700
- Recruiting
Investigational Site Number : 4840016
Mexico City, 14080
Brazil5 sites, 5 recruiting
- Recruiting
Santa Casa de Misericordia de Belo Horizonte- Site Number : 0760004
Belo Horizonte, Minas Gerais, 30150-221
- Recruiting
Universidade Federal de Goias- Site Number : 0760002
Goiânia, Goiás, 74605-020
- Recruiting
WM Pesquisas Clínicas em Doenças Respiratórias- Site Number : 0760003
Porto Alegre, Rio Grande do Sul, 91010-006
- Recruiting
CEMEC - Centro Multidisciplinar de Estudos Clínicos - São Bernardo do Campo- Site Number : 0760001
São Bernardo do Campo, São Paulo, 09715-090
- Recruiting
IBCC - Núcleo de Pesquisa e Ensino- Site Number : 0760005
São Paulo, 04014-002
Norway4 sites, 4 recruiting
- Recruiting
Investigational Site Number : 5780004
Arendal, 4838
- Recruiting
Investigational Site Number : 5780003
Bergen, 5021
- Recruiting
Investigational Site Number : 5780002
Lørenskog, 1478
- Recruiting
Investigational Site Number : 5780001
Trondheim, 7030
New Zealand3 sites, 3 recruiting
- Recruiting
Investigational Site Number : 5540001
Auckland, 0622
- Recruiting
Investigational Site Number : 5540003
Christchurch, Canterbury, 8011
- Recruiting
Investigational Site Number : 5540002
Ebdentown, Wellington Region, 5018
Romania3 sites, 3 recruiting
- Recruiting
Investigational Site Number : 6420001
Brasov, 500051
- Recruiting
Investigational Site Number : 6420003
Cluj-Napoca
- Recruiting
Investigational Site Number : 6420002
Oradea, 410169
Slovakia3 sites, 3 recruiting
- Recruiting
Investigational Site Number : 7030002
Humenné, 066 01
- Recruiting
Investigational Site Number : 7030003
Levice, 934 01
- Recruiting
Investigational Site Number : 7030001
Spišská Nová Ves, 052 01
Singapore2 sites, 2 recruiting
- Recruiting
Investigational Site Number : 7020002
Singapore, 308433
- Recruiting
Investigational Site Number : 7020001
Singapore, 529889
Lithuania1 site, 1 recruiting
- Recruiting
Investigational Site Number : 4400001
Kaunas, 49449
About this study
Official title: 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.
Read the detailed description
All eligible participants will undergo subcutaneous administrations of lunsekimig or matching placebo during a 48-weeks treatment period
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Lunsekimig, Placebo
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LunsekimigDrug
Also called SAR443765
Pharmaceutical form: solution for injection in prefilled syringe. Route of administration: Subcutaneous injection
PlaceboDrug
Pharmaceutical form: solution for injection. Route of administration: Subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Lunsekimig dose regimen A | Experimental | Participants will receive lunsekimig dose regimen A. Receives: Drug: Lunsekimig |
| Lunsekimig dose regimen B | Experimental | Participants will receive lunsekimig dose regimen B. Receives: Drug: Lunsekimig |
| Placebo | Placebo comparator | Participants will receive lunsekimig-matching placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annualized rate of moderate-to-severe chronic obstructive pulmonary disease (COPD) exacerbations
The annualized moderate or severe COPD exacerbation rate up to 48 weeks treatment period compared to placebo
Measured: From Baseline up to 48 weeks
Secondary outcomes (15)
Change from baseline in post-Bronchodilator Forced Expiratory Volume in 1 second (post-BD FEV1)
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.
Measured: From Baseline up to 48 weeks
Change from baseline in pre-Bronchodilator Forced Expiratory Volume in 1 second (pre-BD FEV1)
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.
Measured: From Baseline up to 48 weeks
Change from baseline in the SGRQ-C total score
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.
Measured: From Baseline up to 48 weeks
SGRQ responder defined as an improvement of ≥4 points in the SGRQ-C total score
Measured: From Baseline up to 48 weeks
Change from baseline in the Chronic airways assessment Test (CAAT) score
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.
Measured: From Baseline up to 48 weeks
CAAT responder defined as an improvement of ≥2 points in the CAAT total score
Measured: From Baseline up to 48 weeks
Change from baseline in the E-RS:COPD total score
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.
Measured: From Baseline up to 48 weeks
E-RS:COPD responder defined as an improvement of ≥2 points in the E-RS:COPD total score
Measured: From Baseline up to 48 weeks
Annualized rate of severe COPD exacerbations
Measured: From Baseline up to 48 weeks
Time to first moderate or severe COPD exacerbation
Time to first occurrence of moderate to severe COPD exacerbation up to 48 weeks
Measured: From Baseline up to 48 weeks
Time to first severe COPD exacerbation
Time to first occurrence of severe COPD exacerbation up to 48 weeks
Measured: From Baseline up to 48 weeks
Incidence of participants with TEAEs, including AESIs, and SAEs
Treatment-Emergent Adverse Events (TEAEs), Adverse events of Special Interest (AESIs), Serious Adverse Events (SAEs)
Measured: From Baseline up to 56 weeks
Incidence of potentially clinically significant laboratory abnormalities
Measured: From Baseline up to 56 weeks
Serum concentration of lunsekimig
Measured: From Baseline up to 48 weeks
Incidence and titer of antidrug antibodies (ADAs)
Measured: From Baseline up to 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2025
- Study start17 Sep 2025
- Primary completion27 Nov 2029 (estimated)
- Study completion22 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 942 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07190222
- Sponsor's protocol ID
- EFC18244
- Other IDs
- 2024-518213-25-00, U1111-1308-9980
- Acronym
- THESEUS
- Status last verified
- Oct 2026
- First submitted
- 17 Sep 2025
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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