Chronic Obstructive Pulmonary DiseasePhase 3PERSEPHONENCT07190209
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 25 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 25 countries
- Study dates
- 16 Sep 2025to 22 Jan 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 25 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 25 countries
United States75 sites, 73 recruiting
- Recruiting
Wellness Clinical Research - Allen- Site Number : 8400085
Allen, Texas, 75013
- Recruiting
AnMed Oglesby Center- Site Number : 8400074
Anderson, South Carolina, 29621
- Recruiting
University of Michigan Health System - Ann Arbor- Site Number : 8400090
Ann Arbor, Michigan, 48109
- Recruiting
REX Clinical Trials - Beaumont- Site Number : 8400014
Beaumont, Texas, 77701
- Recruiting
Novel Research - Bellaire- Site Number : 8400116
Bellaire, Texas, 77401
- Recruiting
South Texas Medical Research Institute - TTS Research- Site Number : 8400018
Boerne, Texas, 78006
- Recruiting
Brigham & Women's Hospital- Site Number : 8400148
Boston, Massachusetts, 02115
- Recruiting
Helix Biomedics- Site Number : 8400065
Boynton Beach, Florida, 33435
- Recruiting
TEN20 Clinical Research - Carrollton- Site Number : 8400141
Carrollton, Texas, 75010
- Recruiting
Chandler Clinical Research Trials- Site Number : 8400025
Chandler, Arizona, 85224
- Recruiting
University of Illinois-Chicago - College of Medicine- Site Number : 8400055
Chicago, Illinois, 60612
- Recruiting
Avicenna Clinical Research- Site Number : 8400126
Chicago Ridge, Illinois, 60415
- Recruiting
Epic Medical Research - Chickasha- Site Number : 8400097
Chickasha, Oklahoma, 73018
- Recruiting
Private Practice - Dr. David Kavtaradze- Site Number : 8400006
Cordele, Georgia, 31015
- Recruiting
Corsicana Medical Research- Site Number : 8400134
Corsicana, Texas, 75110
- Recruiting
Beautiful Minds Clinical Research Center- Site Number : 8400017
Cutler Bay, Florida, 33157
- Recruiting
Syri Research Center- Site Number : 8400069
Cypress, Texas, 77065
- Recruiting
Texas Health Presbyterian Hospital Dallas- Site Number : 8400032
Dallas, Texas, 75231
- Recruiting
Dayton Clinical Research- Site Number : 8400124
Dayton, Ohio, 45409
- Recruiting
Epic Medical Research - De Soto- Site Number : 8400095
DeSoto, Texas, 75115
- Completed
Solution Clinical Research- Site Number : 8400039
Doral, Florida, 33178
- Recruiting
Duke Asthma, Allergy and Airway Center- Site Number : 8400047
Durham, North Carolina, 27705
- Recruiting
Sanmora Bespoke Clinical Research Solutions- Site Number : 8400144
East Orange, New Jersey, 07018
- Recruiting
NorthShore Medical Group - Evanston ( Endeavor Health)- Site Number : 8400073
Evanston, Illinois, 60201
- Recruiting
Plains Clinical Research Center- Site Number : 8400140
Fargo, North Dakota, 58104
- Recruiting
Primeway Clinical Research- Site Number : 8400121
Fayetteville, Georgia, 30214
- Recruiting
New York Hospital Queens- Site Number : 8400058
Flushing, New York, 11355
- Recruiting
Eastern Medical Group Research- Site Number : 8400020
Fort Myers, Florida, 33908
- Recruiting
Valley Institute of Research- Site Number : 8400118
Harlingen, Texas, 78550
- Recruiting
Henderson Clinical Trials- Site Number : 8400026
Henderson, Nevada, 89052
- Recruiting
Advanced Respiratory and Sleep Medicine - Hickory- Site Number : 8400013
Hickory, North Carolina, 28601
- Recruiting
Trio Clinical Trials- Site Number : 8400106
Houston, Texas, 77008
- Recruiting
HDH Research, Inc.- Site Number : 8400104
Houston, Texas, 77022
- Recruiting
Baylor College of Medicine- Site Number : 8400076
Houston, Texas, 77030
- Recruiting
Gulf Coast Clinical Research - Houston- Site Number : 8400049
Houston, Texas, 77070
- Recruiting
Indy Clinical Research- Site Number : 8400071
Indianapolis, Indiana, 46268
- Recruiting
University of Kansas Medical Center- Site Number : 8400054
Kansas City, Kansas, 66160
- Recruiting
Lumi Research - Kingwood- Site Number : 8400120
Kingwood, Texas, 77339
- Recruiting
Syri Research Center- Site Number : 8400136
Kingwood, Texas, 77339
- Recruiting
IMAX Clinical Trials- Site Number : 8400109
La Palma, California, 90623
- Completed
Premier Medical Associates- Site Number : 8400012
Lady Lake, Florida, 32159
- Recruiting
Radiance Clinical Research - Lampasas - West Avenue East- Site Number : 8400063
Lampasas, Texas, 76550
- Recruiting
MD First Research - Lancaster- Site Number : 8400102
Lancaster, South Carolina, 29720
- Recruiting
Long Beach Research Institute- Site Number : 8400027
Long Beach, California, 90805
- Recruiting
Downtown L.A. Research Center- Site Number : 8400009
Los Angeles, California, 90017
- Recruiting
Veritas Clinical Research- Site Number : 8400007
Madison Heights, Michigan, 48071
- Recruiting
University of Miami Dermatology Clinical Trials Unit- Site Number : 8400078
Miami, Florida, 33125
- Recruiting
MCR Research- Site Number : 8400004
Miami, Florida, 33126
- Recruiting
Nuren Medical & Research Center- Site Number : 8400030
Miami, Florida, 33144
- Recruiting
My Community Research Center- Site Number : 8400164
Miami, Florida, 33155
- Recruiting
Reed Medical Research Corp- Site Number : 8400167
Miami, Florida, 33176
- Recruiting
Deluxe Health Center- Site Number : 8400010
Miami Lakes, Florida, 33014
- Recruiting
Science 37, Llc- Site Number : 8400154
Morrisville, North Carolina, 27560
- Recruiting
Meharry Medical College- Site Number : 8400133
Nashville, Tennessee, 37208
- Recruiting
Newport Native MD- Site Number : 8400003
Newport Beach, California, 92663
- Recruiting
Omega Research Consultants - Orlando - Forest City- Site Number : 8400015
Orlando, Florida, 32810
- Recruiting
Pharmakon Medical Research- Site Number : 8400156
Palm Beach Gardens, Florida, 33410
- Recruiting
Broward Research Center - Pembroke Pines- Site Number : 8400053
Pembroke Pines, Florida, 33024
- Recruiting
Temple University Hospital- Site Number : 8400059
Philadelphia, Pennsylvania, 19140
- Recruiting
Pulmonary Associates - Phoenix - East Bell Road- Site Number : 8400114
Phoenix, Arizona, 85032
- Recruiting
Preferred Primary Care Physicians - Pleasant Hills- Site Number : 8400092
Pittsburgh, Pennsylvania, 15236
- Recruiting
Oregon Health & Science University (OHSU)- Site Number : 8400155
Portland, Oregon, 97239
- Recruiting
Paradigm Research - Redding- Site Number : 8400108
Redding, California, 96001
- Recruiting
Mayo Clinic in Rochester - Minnesota- Site Number : 8400005
Rochester, Minnesota, 55905
- Recruiting
Discovery Clinical Trials - San Antonio- Site Number : 8400031
San Antonio, Texas, 78229
- Recruiting
Bandera Family Health Care - San Antonio- Site Number : 8400021
San Antonio, Texas, 78249
- Recruiting
Element Research Group- Site Number : 8400115
San Antonio, Texas, 78257
- Recruiting
Circle Clinical Research- Site Number : 8400139
Sioux Falls, South Dakota, 57104
- Recruiting
Epic Medical Research - Surprise- Site Number : 8400096
Surprise, Arizona, 85378
- Recruiting
Clinical Research Trials of Florida- Site Number : 8400011
Tampa, Florida, 33607
- Recruiting
Deluxe Health Center-Tampa- Site Number : 8400056
Tampa, Florida, 33607
- Recruiting
Amicis Research Center - Valencia- Site Number : 8400119
Valencia, California, 91355
- Recruiting
Tidewater Physicians Multispecialty Group Clinical Research - Williamsburg- Site Number : 8400081
Williamsburg, Virginia, 23188
- Recruiting
Atrium Health Wake Forest Baptist Pulmonary, Sleep And Allergy- Site Number : 8400048
Winston-Salem, North Carolina, 27103
- Recruiting
Southern Clinical Research - Zachary- Site Number : 8400113
Zachary, Louisiana, 70791
China53 sites, 53 recruiting
- Recruiting
Investigational Site Number : 1560035
Beijing, 100034
- Recruiting
Investigational Site Number : 1560013
Beijing, 100144
- Recruiting
Investigational Site Number : 1560054
Changchun, 130021
- Recruiting
Investigational Site Number : 1560010
Changsha, 410011
- Recruiting
Investigational Site Number : 1560032
Changsha, 410015
- Recruiting
Investigational Site Number : 1560018
Chengdu, 610041
- Recruiting
Investigational Site Number : 1560004
Chengdu, 610072
- Recruiting
Investigational Site Number : 1560005
Chengdu, 611130
- Recruiting
Investigational Site Number : 1560062
Foshan, 528041
- Recruiting
Investigational Site Number : 1560021
Guangzhou, 510150
- Recruiting
Investigational Site Number : 1560001
Guangzhou, 510163
- Recruiting
Investigational Site Number : 1560030
Hangzhou, 310006
- Recruiting
Investigational Site Number : 1560024
Harbin, 150001
- Recruiting
Investigational Site Number : 1560012
Hefei, 230032
- Recruiting
Investigational Site Number : 1560046
Heifei, 230091
- Recruiting
Investigational Site Number : 1560006
Hohhot, 010050
- Recruiting
Investigational Site Number : 1560044
Huizhou, 516001
- Recruiting
Investigational Site Number : 1560026
Jiaozuo, 454001
- Recruiting
Investigational Site Number : 1560039
Jinan, 250014
- Recruiting
Investigational Site Number : 1560049
Jinhua, 321000
- Recruiting
Investigational Site Number : 1560056
Jining, 272011
- Recruiting
Investigational Site Number : 1560043
Kunming, 650032
- Recruiting
Investigational Site Number : 1560023
Langfang, 065000
- Recruiting
Investigational Site Number : 1560047
Liaocheng, 252000
- Recruiting
Investigational Site Number : 1560033
Linhai, 317000
- Recruiting
Investigational Site Number : 1560002
Nanchang, 330006
- Recruiting
Investigational Site Number : 1560003
Nanchang, 330006
- Recruiting
Investigational Site Number : 1560051
Nanning, 530021
- Recruiting
Investigational Site Number : 1560017
Ningbo, 315041
- Recruiting
Investigational Site Number : 1560031
Pingxiang, 337055
- Recruiting
Investigational Site Number : 1560007
Shanghai, 200240
- Recruiting
Investigational Site Number : 1560008
Shanghai, 200433
- Recruiting
Investigational Site Number : 1560036
Shenyang, 110004
- Recruiting
Investigational Site Number : 1560037
Shenzhen, 518020
- Recruiting
Investigational Site Number : 1560027
Shihezi, 832008
- Recruiting
Investigational Site Number : 1560022
Taiyuan, 030001
- Recruiting
Investigational Site Number : 1560034
Taizhou, 318000
- Recruiting
Investigational Site Number : 1560019
Tianjin, 300192
- Recruiting
Investigational Site Number : 1560016
Ürümqi, 830054
- Recruiting
Investigational Site Number : 1560029
Wenzhou, 325035
- Recruiting
Investigational Site Number : 1560025
Wuhan, 430030
- Recruiting
Investigational Site Number : 1560050
Wuxi, 214023
- Recruiting
Investigational Site Number : 1560052
Xi'an, 710004
- Recruiting
Investigational Site Number : 1560020
Xiamen, 361004
- Recruiting
Investigational Site Number : 1560011
Xiangtan, 411100
- Recruiting
Investigational Site Number : 1560058
Xinxiang, 453100
- Recruiting
Investigational Site Number : 1560040
Xuzhou, 221006
- Recruiting
Investigational Site Number : 1560041
Yangzhou, 225000
- Recruiting
Investigational Site Number : 1560060
Yichang, 443003
- Recruiting
Investigational Site Number : 1560053
Yinchuan, 750000
- Recruiting
Investigational Site Number : 1560059
Zhanjiang, 524004
- Recruiting
Investigational Site Number : 1560057
Zhengzhou, 450052
- Recruiting
Investigational Site Number : 1560048
Zunyi, 563003
Japan42 sites, 42 recruiting
- Recruiting
Investigational Site Number : 3920021
Chiba, 260-0852
- Recruiting
Investigational Site Number : 3920046
Fujieda, Shizuoka, 426-0077
- Recruiting
Investigational Site Number : 3920026
Fukuoka, Fukuoka, 819-0055
- Recruiting
Investigational Site Number : 3920002
Fukushima, 960-1295
- Recruiting
Investigational Site Number : 3920033
Hachiōji, Tokyo, 193-0998
- Recruiting
Investigational Site Number : 3920024
Himeji-Shi, Hyōgo, 670-0849
- Recruiting
Investigational Site Number : 3920029
Hiroshima, 734-8530
- Recruiting
Investigational Site Number : 3920058
Iizuka, Fukuoka, 820-8505
- Recruiting
Investigational Site Number : 3920039
Kagoshima, 892-0847
- Recruiting
Investigational Site Number : 3920040
Kamakura, Kanagawa, 247-8533
- Recruiting
Investigational Site Number : 3920001
Kashihara, Nara, 634-8522
- Recruiting
Investigational Site Number : 3920051
Kawasaki, Kanagawa, 210-0852
- Recruiting
Investigational Site Number : 3920008
Kita, Kagawa-ken, 761-0701
- Recruiting
Investigational Site Number : 3920059
Kiyose, 204-8522
- Recruiting
Investigational Site Number : 3920009
Kobe, Hyōgo, 650-0017
- Recruiting
Investigational Site Number : 3920042
Kōnan, Aichi-ken, 483-8704
- Recruiting
Investigational Site Number : 3920036
Kumamoto, 861-4193
- Recruiting
Investigational Site Number : 3920018
Kumamoto, 862-0909
- Recruiting
Investigational Site Number : 3920053
Kure, Hiroshima, 737-0811
- Recruiting
Investigational Site Number : 3920006
Kurume, Fukuoka, 830-0011
- Recruiting
Investigational Site Number : 3920056
Kyoto, 610-0113
- Recruiting
Investigational Site Number : 3920045
Matsusaka, Mie-ken, 515-0073
- Recruiting
Investigational Site Number : 3920047
Matsuyama, Ehime, 790-0826
- Recruiting
Investigational Site Number : 3920032
Nagoya, Aichi-ken, 457-8511
- Recruiting
Investigational Site Number : 3920012
Okayama, Okayama-ken, 701-1192
- Recruiting
Investigational Site Number : 3920004
Osaka, 545-8586
- Recruiting
Investigational Site Number : 3920007
Saga, 849-0937
- Recruiting
Investigational Site Number : 3920043
Sakai, Osaka, 591-8555
- Recruiting
Investigational Site Number : 3920030
Sakaidechō, Kagawa-ken, 762-8550
- Recruiting
Investigational Site Number : 3920049
Sapporo, Hokkaido, 006-0811
- Recruiting
Investigational Site Number : 3920005
Sendai, Miyagi, 980-8574
- Recruiting
Investigational Site Number : 3920060
Takamatsu, Kagawa-ken, 761-8073
- Recruiting
Investigational Site Number : 3920028
Tokyo, 150-8935
- Recruiting
Investigational Site Number : 3920017
Tokyo, 162-8655
- Recruiting
Investigational Site Number : 3920023
Tokyo, 173-8610
- Recruiting
Investigational Site Number : 3920057
Toyota, Aichi-ken, 470-0396
- Recruiting
Investigational Site Number : 3920003
Ube, Yamaguchi, 755-8505
- Recruiting
Investigational Site Number : 3920020
Ureshino-Shi, Saga-ken, 843-0393
- Recruiting
Investigational Site Number : 3920035
Yokohama, Kanagawa, 221-0855
- Recruiting
Investigational Site Number : 3920054
Yokohama, Kanagawa, 234-0054
- Recruiting
Investigational Site Number : 3920015
Yokohama, Kanagawa, 236-0004
- Recruiting
Investigational Site Number : 3920062
Yonezawa, Yamagata, 992-0033
Germany14 sites, 14 recruiting
- Recruiting
Investigational Site Number : 2760006
Ahrensburg, 22926
- Recruiting
Investigational Site Number : 2760011
Augsburg, 86150
- Recruiting
Investigational Site Number : 2760002
Bendorf, 56170
- Recruiting
Investigational Site Number : 2760009
Berlin, 10787
- Recruiting
Investigational Site Number : 2760007
Berlin, 12159
- Recruiting
Investigational Site Number : 2760013
Darmstadt, 64283
- Recruiting
Investigational Site Number : 2760004
Frankfurt, 60596
- Recruiting
Investigational Site Number : 2760008
Frankfurt, 60596
- Recruiting
Investigational Site Number : 2760003
Frankfurt am Main, 60389
- Recruiting
Investigational Site Number : 2760012
Hamburg, 20354
- Recruiting
Investigational Site Number : 2760001
Leipzig, 04347
- Recruiting
Investigational Site Number : 2760010
Lübeck, 23552
- Recruiting
Investigational Site Number : 2760005
Mainz, 55128
- Recruiting
Investigational Site Number : 2760018
Munich, 80539
Argentina12 sites, 12 recruiting
- Recruiting
Investigational Site Number : 0320011
Buenos Aires, 1012
- Recruiting
Investigational Site Number : 0320005
Buenos Aires, 1122
- Recruiting
Investigational Site Number : 0320010
Buenos Aires, 1128
- Recruiting
Investigational Site Number : 0320001
Buenos Aires, 1425
- Recruiting
Investigational Site Number : 0320002
Buenos Aires, 1425
- Recruiting
Investigational Site Number : 0320009
Buenos Aires, 1427
- Recruiting
Investigational Site Number : 0320007
La Plata, Buenos Aires, 1900
- Recruiting
Investigational Site Number : 0320008
Lobos, Buenos Aires, 7240
- Recruiting
Investigational Site Number : 0320004
Rosario, Santa Fe Province, 2000
- Recruiting
Investigational Site Number : 0320012
Rosario, Santa Fe Province, 2000
- Recruiting
Investigational Site Number : 0320006
San Miguel de Tucumán, Tucumán Province, 4000
- Recruiting
Investigational Site Number : 0320003
San Miguel de Tucumán, Tucumán Province, T4000
Brazil10 sites, 10 recruiting
- Recruiting
Chronos Pesquisa Clínica- Site Number : 0760012
Brasília, Federal District, 72145-450
- Recruiting
CETI - Centro de Estudos em Terapias Inovadoras- Site Number : 0760013
Curitiba, Paraná, 80030-110
- Recruiting
Hospital Universitário Onofre Lopes- Site Number : 0760016
Natal, Rio Grande do Norte, 59012-300
- Recruiting
Instituto Ceos- Site Number : 0760005
Porto Alegre, Rio Grande do Sul, 90160-093
- Recruiting
LMK Servicos Medicos- Site Number : 0760018
Porto Alegre, Rio Grande do Sul, 90480-000
- Recruiting
Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760001
Porto Alegre, Rio Grande do Sul, 90610-000
- Recruiting
Hospital Copa D'Or- Site Number : 0760017
Rio de Janeiro, 22031-011
- Recruiting
Fundação Faculdade Regional de Medicina de São José do Rio Preto- Site Number : 0760011
São José do Rio Preto, São Paulo, 15090-000
- Recruiting
Centro Internacional de Pesquisa Clínica (CIPES)- Site Number : 0760008
São José dos Campos, São Paulo, 12230-001
- Recruiting
Hospital Beneficência Portuguesa de São Paulo- Site Number : 0760010
São Paulo, 01323-001
France10 sites, 10 recruiting
- Recruiting
Investigational Site Number : 2500012
Brest, 29200
- Recruiting
Investigational Site Number : 2500008
La Tronche, 38700
- Recruiting
Investigational Site Number : 2500006
Le Mans, 72037
- Recruiting
Investigational Site Number : 2500002
Lyon, 69004
- Recruiting
Investigational Site Number : 2500003
Montpellier, 34090
- Recruiting
Investigational Site Number : 2500004
Pessac, 33604
- Recruiting
Investigational Site Number : 2500001
Pontoise, 95300
- Recruiting
Investigational Site Number : 2500005
Reims, 51092
- Recruiting
Investigational Site Number : 2500009
Suresnes, 92151
- Recruiting
Investigational Site Number : 2500011
Vandœuvre-lès-Nancy, 54511
Canada8 sites, 8 recruiting
- Recruiting
Investigational Site Number : 1240010
Ajax, Ontario, L1S 2J5
- Recruiting
Investigational Site Number : 1240011
Calgary, Alberta, T3R 1W7
- Recruiting
Investigational Site Number : 1240004
Guelph, Ontario, N1h 6j2
- Recruiting
Investigational Site Number : 1240012
Ottawa, Ontario, K1G 6C6
- Recruiting
Investigational Site Number : 1240009
Stoney Creek, Ontario, L8G 2V6
- Recruiting
Investigational Site Number : 1240001
Toronto, Ontario, M5T 3A9
- Recruiting
Investigational Site Number : 1240015
Vancouver, British Columbia, V6Z 1Y6
- Recruiting
Investigational Site Number : 1240002
Waterloo, Ontario, N2J 0C1
Hungary8 sites, 8 recruiting
- Recruiting
Investigational Site Number : 3480006
Debrecen, 4032
- Recruiting
Investigational Site Number : 3480005
Edelény, 3780
- Recruiting
Investigational Site Number : 3480001
Gödöllő, 2100
- Recruiting
Investigational Site Number : 3480011
Gyöngyös, 3200
- Recruiting
Investigational Site Number : 3480004
Hajdúnánás, 4080
- Recruiting
Investigational Site Number : 3480002
Mosonmagyaróvár, 9200
- Recruiting
Investigational Site Number : 3480009
Pécs, 7635
- Recruiting
Investigational Site Number : 3480003
Püspökladány, 4150
Italy8 sites, 8 recruiting
- Recruiting
Investigational Site Number : 3800013
Cona, Ferrara, 44124
- Recruiting
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano Site Number : 3800001
Milan, Lombardy, 20122
Maria Sgarlata, 0039-0255033781, maria.sgarlata@policlinico.mi.it
francesco.blasi@policlinico.mi.it
- Recruiting
Azienda Ospedale Università di Padova Site Number : 3800011
Padova, Veneto, 35128
Dr. Gabriella Guarnieri, 0039-0498217791, gabriella.guarnieri@unipd.it
Gabriella Guarnieri, Dr.
- Recruiting
Investigational Site Number : 3800005
Pavia, 27100
- Recruiting
Investigational Site Number : 3800010
Reggio Emilia, 42100
- Recruiting
Investigational Site Number : 3800007
Rozzano, Milano, 20089
- Recruiting
Investigational Site Number : 3800004
Telese Terme, Benevento, 82037
- Recruiting
Investigational Site Number : 3800008
Tradate (Va), 21049
Spain8 sites, 8 recruiting
- Recruiting
Investigational Site Number : 7240006
Benalmádena, Málaga, 29631
- Recruiting
Investigational Site Number : 7240005
Cáceres, Extremadura, 10003
- Recruiting
Investigational Site Number : 7240008
Jerez de la Frontera, Cádiz, 11407
- Recruiting
Investigational Site Number : 7240007
L'Hospitalet de Llobregat, Catalunya [Cataluña], 08907
- Recruiting
Investigational Site Number : 7240003
Málaga, Andalusia, 29010
- Recruiting
Investigational Site Number : 7240001
Mérida, Badajoz, 06800
- Recruiting
Investigational Site Number : 7240004
Palma, 07120
- Recruiting
Investigational Site Number : 7240002
Seville, 41012
United Kingdom8 sites, 8 recruiting
- Recruiting
Investigational Site Number : 8260002
Bradford, BD9 6DA
- Recruiting
Investigational Site Number : 8260014
Bristol, Bristol, City of, BS37 4AX
- Recruiting
Investigational Site Number : 8260009
Harrow, London, City of, HA1 3UJ
- Recruiting
Investigational Site Number : 8260003
Leicester, Leicestershire, LE1 5WW
- Recruiting
Investigational Site Number : 8260015
London, Hammersmith and Fulham, W6 7HY
- Recruiting
Investigational Site Number : 8260031
London, London, City of, Se1 7eh
- Recruiting
Investigational Site Number : 8260034
Oxford, Oxfordshire, OX3 9DU
- Recruiting
Investigational Site Number : 8260032
Worthing, West Sussex, BN11 2DH
Poland7 sites, 7 recruiting
- Recruiting
Investigational Site Number : 6160001
Bialystok, Podlaskie Voivodeship, 15-044
- Recruiting
Investigational Site Number : 6160010
Elblag, 82-300
- Recruiting
Investigational Site Number : 6160009
Katowice, Silesian Voivodeship, 40-648
- Recruiting
Investigational Site Number : 6160003
Katowice, 40-600
- Recruiting
Investigational Site Number : 6160006
Piaseczno, Masovian Voivodeship, 05-500
- Recruiting
Investigational Site Number : 6160004
Sosnowiec, 41-205
- Recruiting
Investigational Site Number : 6160002
Wroclaw, Lower Silesian Voivodeship, 53-149
Turkey (Türkiye)7 sites, 7 recruiting
- Recruiting
Investigational Site Number : 7920002
Adana, 01330
- Recruiting
Investigational Site Number : 7920006
Ankara, 06010
- Recruiting
Investigational Site Number : 7920003
Ankara, 06620
- Recruiting
Investigational Site Number : 7920004
Gaziantep, 27310
- Recruiting
Investigational Site Number : 7920005
Istanbul, 34020
- Recruiting
Investigational Site Number : 7920007
Izmir, 35340
- Recruiting
Investigational Site Number : 7920001
Mersin, 33070
Belgium6 sites, 6 recruiting
- Recruiting
Investigational Site Number : 0560004
Brussels, 1000
- Recruiting
Investigational Site Number : 0560005
Edegem, 2650
- Recruiting
Investigational Site Number : 0560008
Erpent, 5101
- Recruiting
Investigational Site Number : 0560001
Leuven, 3000
- Recruiting
Investigational Site Number : 0560003
Mechelen, 2800
- Recruiting
Investigational Site Number : 0560007
Yvoir, 5530
Chile6 sites, 6 recruiting
- Recruiting
Investigational Site Number : 1520004
Santiago, Reg Metropolitana de Santiago, 7500010
- Recruiting
Investigational Site Number : 1520001
Santiago, Reg Metropolitana de Santiago, 7500692
- Recruiting
Investigational Site Number : 1520003
Santiago, Reg Metropolitana de Santiago, 7500698
- Recruiting
Investigational Site Number : 1520006
Talca, Maule Region, 3465584
- Recruiting
Investigational Site Number : 1520002
Valdivia, Los Ríos Region, 5110683
- Recruiting
Investigational Site Number : 1520005
Viña del Mar, Valparaiso, 2531172
Georgia6 sites, 6 recruiting
- Recruiting
Investigational Site Number : 2680004
Kutaisi, 4600
- Recruiting
Investigational Site Number : 2680002
Tbilisi, 0105
- Recruiting
Investigational Site Number : 2680001
Tbilisi, 0159
- Recruiting
Investigational Site Number : 2680005
Tbilisi, 0159
- Recruiting
Investigational Site Number : 2680006
Tbilisi, 0159
- Recruiting
Investigational Site Number : 2680003
Tbilisi, 0160
Denmark5 sites, 5 recruiting
- Recruiting
Investigational Site Number : 2080005
Aalborg, 9000
- Recruiting
Investigational Site Number : 2080004
Hvidovre, 2650
- Recruiting
Investigational Site Number : 2080001
Næstved, 4700
- Recruiting
Investigational Site Number : 2080002
Odense, 5000
- Recruiting
Investigational Site Number : 2080003
Vejle, 7100
Mexico5 sites, 5 recruiting
- Recruiting
Investigational Site Number : 4840008
Durango, 34000
- Recruiting
Investigational Site Number : 4840004
Mexico City, 04970
- Recruiting
Investigational Site Number : 4840001
Monterrey, Nuevo León, 66465
- Recruiting
Investigational Site Number : 4840009
San Juan del Río, Querétaro, 76800
- Recruiting
Investigational Site Number : 4840003
Veracruz, 91900
Portugal5 sites, 5 recruiting
- Recruiting
Investigational Site Number : 6200002
Almada, 2805-267
- Recruiting
Investigational Site Number : 6200004
Braga, 4710-243
- Recruiting
Investigational Site Number : 6200005
Guimarães, 4800-055
- Recruiting
Investigational Site Number : 6200003
Matosinhos Municipality, 4464-509
- Recruiting
Investigational Site Number : 6200001
Porto, 3814-501
Latvia3 sites, 3 recruiting
- Recruiting
Investigational Site Number : 4280001
Daugavpils, LV-5417
- Recruiting
Investigational Site Number : 4280003
Riga, LV-1001
- Recruiting
Investigational Site Number : 4280002
Riga, LV-1002
Saudi Arabia3 sites, 3 recruiting
- Recruiting
Investigational Site Number : 6820003
Jeddah, 23421
- Recruiting
Investigational Site Number : 6820001
Riyadh, 11525
- Recruiting
Investigational Site Number : 6820002
Riyadh, 12746
Estonia2 sites, 2 recruiting
- Recruiting
Investigational Site Number : 2330003
Tallinn, 10128
- Recruiting
Investigational Site Number : 2330001
Tartu, 50406
Sweden2 sites, 2 recruiting
- Recruiting
Investigational Site Number : 7520002
Solna, 171 64
- Recruiting
Investigational Site Number : 7520004
Umeå, 901 85
Finland1 site, 1 recruiting
- Recruiting
Investigational Site Number : 2460002
Turku, 20521
About this study
Official title: 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.
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 start16 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
- NCT07190209
- Sponsor's protocol ID
- EFC18243
- Other IDs
- 2024-518016-39-00, U1111-1308-9892
- Acronym
- PERSEPHONE
- Status last verified
- Oct 2026
- First submitted
- 17 Sep 2025
- Last updated
- 19 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
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07190209
- Acronym / sponsor ID
- PERSEPHONE / EFC18243
- Conditions
- Chronic Obstructive Pulmonary Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 942 participants (estimated)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 16 Sep 2025 (actual)
- Primary completion
- 27 Nov 2029 (estimated)
- Study completion
- 22 Jan 2030 (estimated)
- First posted
- 24 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a parallel, Phase 2b/Phase 3, 3-arm study to investigate the efficacy, safety, and tolerability of subcutaneous (SC) treatment with lunsekimig compared with placebo in adult participants (aged 40 to 80 years, inclusive) with inadequately controlled Chronic obstructive pulmonary disease (COPD) characterized by an eosinophilic phenotype.
Participation to the study consists of 3 periods:
- Screening period of up to 4 weeks
- Randomized intervention period of approximately 48 weeks
- Follow-up period: Approximately 8 weeks The study duration will be up to 60 weeks.
Detailed description
All eligible participants will undergo subcutaneous administrations of lunsekimig or matching placebo during a 48-weeks treatment period
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lunsekimig dose regimen A | Experimental | Drug: LunsekimigParticipants will receive lunsekimig dose regimen A. |
| Lunsekimig dose regimen B | Experimental | Drug: LunsekimigParticipants will receive lunsekimig dose regimen B |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive lunsekimig-matching placebo |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LunsekimigAlso: SAR443765Pharmaceutical form: solution for injection in prefilled syringe. Route of administration: Subcutaneous injection | Drug | Lunsekimig dose regimen A, Lunsekimig dose regimen B |
| PlaceboPharmaceutical form: solution for injection. Route of administration: Subcutaneous injection | Drug | Placebo |
Primary outcome
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
15 secondary outcomes
Change from baseline in post-Bronchodilator Forced Expiratory Volume in 1 second (post-BD FEV1)
Time frame: From Baseline up to 48 weeks
Change from baseline in pre-Bronchodilator Forced Expiratory Volume in 1 second (pre-BD FEV1)
Time frame: From Baseline up to 48 weeks
Change from baseline in the SGRQ-C total score
Time frame: 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
Change from baseline in the Chronic airways assessment Test (CAAT) score
Time frame: 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
Change from baseline in the E-RS:COPD total score
Time frame: 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
Annualized rate of severe COPD exacerbations
Time frame: 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 severe COPD exacerbation
Time frame: From Baseline up to 48 weeks
Incidence of participants with TEAEs, including AESIs, and SAEs
Time frame: From Baseline up to 56 weeks
Incidence of potentially clinically significant laboratory abnormalities
Time frame: From Baseline up to 56 weeks
Serum concentration of lunsekimig
Time frame: From Baseline up to 48 weeks
Incidence and titer of antidrug antibodies (ADAs)
Time frame: From Baseline up to 48 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- EFC18243 Plain Language Results SummaryLink provided by the sponsor.
- For EU sites click here and navigate to 'Locations and contact points'Link provided by the sponsor.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Trial Transparency email recommended (Toll free for US & Canada) contact
314 sites in 25 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lunsekimig in people with Chronic Obstructive Pulmonary Disease, run by Sanofi at 314 sites in 25 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 314 sites in United States, China, Japan, Germany, Argentina and 20 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trial Transparency email recommended (Toll free for US & Canada) (800-633-1610 ext. option 6, contact-us@sanofi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Annualized rate of moderate-to-severe chronic obstructive pulmonary disease (COPD) exacerbations (time frame: From Baseline up to 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.