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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
NCT07190222 · Sanofi
In plain English
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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
About this study
All eligible participants will undergo subcutaneous administrations of lunsekimig or matching placebo during a 48-weeks treatment period
Eligibility criteria
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 design
Enrollment target: 942 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2025-09-17
Estimated completion: 2030-01-22
Last updated: 2026-03-23
Interventions
Drug: LunsekimigDrug: Placebo
Primary outcomes
- • Annualized rate of moderate-to-severe chronic obstructive pulmonary disease (COPD) exacerbations (From Baseline up to 48 weeks)
Sponsor
Sanofi · industry
Contacts & investigators
ContactTrial Transparency email recommended (Toll free for US & Canada) · contact · contact-us@sanofi.com · 800-633-1610
All locations (175)
Tucson Clinical Research Institute- Site Number : 8400006Recruiting
Tucson, Arizona, United States
Ark Clinical Research- Site Number : 8400113Recruiting
Long Beach, California, United States
Alliance Clinical - West Hills- Site Number : 8400067Recruiting
Los Angeles, California, United States
California Medical Research Associates - Northridge- Site Number : 8400089Recruiting
Northridge, California, United States
Alpine Clinical Research Center - Boulder - 47th Street- Site Number : 8400005Recruiting
Boulder, Colorado, United States
Critical Care Pulmonary & Sleep Associates- Site Number : 8400081Recruiting
Lakewood, Colorado, United States
Hillcrest Medical Research- Site Number : 8400082Not Yet Recruiting
DeLand, Florida, United States
Finlay Medical Research - Greenacres- Site Number : 8400107Recruiting
Greenacres City, Florida, United States
Direct Helpers Research Center- Site Number : 8400057Recruiting
Hialeah, Florida, United States
Pulmonary Specialists of the Palm Beaches- Site Number : 8400017Recruiting
Loxahatchee Groves, Florida, United States
DL Research Solutions- Site Number : 8400140Recruiting
Miami, Florida, United States
Phoenix Medical Research - Miami - 24th Street- Site Number : 8400027Recruiting
Miami, Florida, United States
Professional Research Center- Site Number : 8400046Recruiting
Miami, Florida, United States
Research Institute of South Florida- Site Number : 8400028Recruiting
Miami, Florida, United States
Innovations Biotech- Site Number : 8400019Recruiting
Miami, Florida, United States
Heuer M.D. Research- Site Number : 8400018Not Yet Recruiting
Orlando, Florida, United States
Florida Institute for Clinical Research- Site Number : 8400001Recruiting
Orlando, Florida, United States
Avanza Medical Research Center- Site Number : 8400015Recruiting
Pensacola, Florida, United States
Hull and Hull Medical Specialists- Site Number : 8400002Recruiting
Plantation, Florida, United States
Appalachian Clinical Research- Site Number : 8400060Recruiting
Adairsville, Georgia, United States
Christie Clinic in Champaign on University- Site Number : 8400023Recruiting
Champaign, Illinois, United States
Sneeze Wheeze & Itch Associates- Site Number : 8400020Recruiting
Normal, Illinois, United States
Asha Clinical Research - Munster- Site Number : 8400115Recruiting
Hammond, Indiana, United States
Care Access - Shreveport - Youree Drive- Site Number : 8400007Recruiting
Shreveport, Louisiana, United States
Lucida Clinical Trials- Site Number : 8400101Recruiting
New Bedford, Massachusetts, United States
Vitalis Clinical Research Center- Site Number : 8400040Recruiting
Allen Park, Michigan, United States
Bolt Clinical Research- Site Number : 8400086Recruiting
Brighton, Michigan, United States
Hannibal Regional Healthcare System- Site Number : 8400035Recruiting
Hannibal, Missouri, United States
Excel Clinical Research - Las Vegas- Site Number : 8400070Recruiting
Las Vegas, Nevada, United States
AB Clinical Trials- Site Number : 8400075Recruiting
Las Vegas, Nevada, United States
Bioluminux Clinical Research - Hamilton, New Jersey- Site Number : 8400037Recruiting
Hamilton, New Jersey, United States
Mid Hudson Medical Research - New Windsor- Site Number : 8400004Recruiting
New Windsor, New York, United States
East Carolina University- Site Number : 8400102Recruiting
Greenville, North Carolina, United States
Piedmont Healthcare - Family Medicine- Site Number : 8400022Recruiting
Statesville, North Carolina, United States
All-Trials Clinical Research- Site Number : 8400008Recruiting
Winston-Salem, North Carolina, United States
Asthma & Allergy Center - Toledo- Site Number : 8400110Recruiting
Toledo, Ohio, United States
Layrek Clinical Research- Site Number : 8400066Recruiting
Tulsa, Oklahoma, United States
The Oregon Clinic, PC- Site Number : 8400065Recruiting
Portland, Oregon, United States
MedTrial- Site Number : 8400010Recruiting
Columbia, South Carolina, United States
Chattanooga Research and Medicine- Site Number : 8400026Recruiting
Chattanooga, Tennessee, United States
IntraCare- Site Number : 8400034Recruiting
Dallas, Texas, United States
Premier Pulmonary Critical Care and Sleep- Site Number : 8400111Recruiting
Denison, Texas, United States
El Paso Pulmonary Association- Site Number : 8400033Recruiting
El Paso, Texas, United States
Axsendo Clinical Research - Houston- Site Number : 8400054Recruiting
Houston, Texas, United States
SE Houston- Site Number : 8400120Recruiting
Houston, Texas, United States
Synergy Group US - Missouri City- Site Number : 8400119Recruiting
Missouri City, Texas, United States
Synergy Group US - Missouri City- Site Number : 8400133Recruiting
Missouri City, Texas, United States
Elligo Health Care, Hillcroft Medical Clinic Association- Site Number : 8400053Recruiting
Sugar Land, Texas, United States
Medrasa Clinical Research - Wylie- Site Number : 8400124Recruiting
Wylie, Texas, United States
Dominion Medical Associates - Richmond - East Leigh Street- Site Number : 8400154Active Not Recruiting
Richmond, Virginia, United States
Rheumatology & Pulmonary Clinic- Site Number : 8400012Recruiting
Beckley, West Virginia, United States
Investigational Site Number : 0320011Recruiting
Berazategui, Buenos Aires, Argentina
Investigational Site Number : 0320004Recruiting
Buenos Aires, Argentina
Investigational Site Number : 0320002Recruiting
Buenos Aires, Argentina
Investigational Site Number : 0320005Recruiting
Buenos Aires, Argentina
Investigational Site Number : 0320006Recruiting
Buenos Aires, Argentina
Investigational Site Number : 0320001Recruiting
Buenos Aires, Argentina
Investigational Site Number : 0320012Recruiting
Buenos Aires, Argentina
Investigational Site Number : 0320003Recruiting
Buenos Aires, Argentina
Investigational Site Number : 0320009Recruiting
Córdoba, Argentina
Investigational Site Number : 0320007Recruiting
Mendoza, Argentina
Investigational Site Number : 0320008Recruiting
Mendoza, Argentina
Investigational Site Number : 0320010Recruiting
Santa Fe, Argentina
Investigational Site Number : 0360006Recruiting
South Brisbane, Queensland, Australia
Investigational Site Number : 0360002Recruiting
Traralgon, Victoria, Australia
Investigational Site Number : 0360001Recruiting
Osborne Park, Western Australia, Australia
Investigational Site Number : 5540004Recruiting
Dunedin, Australia
Universidade Federal de Goias- Site Number : 0760002Recruiting
Goiânia, Goiás, Brazil
Santa Casa de Misericordia de Belo Horizonte- Site Number : 0760004Recruiting
Belo Horizonte, Minas Gerais, Brazil
WM Pesquisas Clínicas em Doenças Respiratórias- Site Number : 0760003Recruiting
Porto Alegre, Rio Grande do Sul, Brazil
Centro Multidisciplinar de Estudos Clínicos- Site Number : 0760001Recruiting
São Bernardo do Campo, São Paulo, Brazil
IBCC - Núcleo de Pesquisa e Ensino- Site Number : 0760005Recruiting
São Paulo, Brazil
Investigational Site Number : 1240051Recruiting
Kelowna, British Columbia, Canada
Investigational Site Number : 1240052Recruiting
West Vancouver, British Columbia, Canada
Investigational Site Number : 1240041Recruiting
Windsor, Ontario, Canada
Investigational Site Number : 1240049Recruiting
Longueuil, Quebec, Canada
Investigational Site Number : 1240047Recruiting
Québec, Quebec, Canada
Investigational Site Number : 1240053Recruiting
Québec, Quebec, Canada
Investigational Site Number : 1240050Recruiting
Saint-Charles-Borromée, Quebec, Canada
Investigational Site Number : 1240054Recruiting
Saint-Charles-Borromée, Quebec, Canada
Investigational Site Number : 1240048Recruiting
Trois-Rivières, Quebec, Canada
Investigational Site Number : 1240042Recruiting
Victoriaville, Quebec, Canada
Investigational Site Number : 1520006Recruiting
Temuco, La Araucanía, Chile
Investigational Site Number : 1520004Recruiting
Recoleta, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520001Recruiting
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520002Recruiting
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520009Recruiting
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520003Recruiting
Viña del Mar, Valparaiso, Chile
Investigational Site Number : 1520007Recruiting
Chillan, Chile
Investigational Site Number : 1560003Recruiting
Baotou, China
Investigational Site Number : 1560022Recruiting
Beijing, China
Investigational Site Number : 1560001Recruiting
Beijing, China
Investigational Site Number : 1560023Recruiting
Beijing, China
Investigational Site Number : 1560005Recruiting
Beijing, China
Investigational Site Number : 1560090Recruiting
Changde, China
Investigational Site Number : 1560057Recruiting
Changsha, China
Investigational Site Number : 1560052Recruiting
Chengdu, China
Investigational Site Number : 1560032Recruiting
Chengdu, China
Investigational Site Number : 1560037Recruiting
Chongqing, China
Investigational Site Number : 1560074Recruiting
Chongqing, China
Investigational Site Number : 1560051Recruiting
Foshan, China
Investigational Site Number : 1560042Recruiting
Ganzhou, China
Investigational Site Number : 1560015Recruiting
Guangzhou, China
Investigational Site Number : 1560034Recruiting
Guangzhou, China
Investigational Site Number : 1560038Recruiting
Guiyang, China
Investigational Site Number : 1560016Recruiting
Haikou, China
Investigational Site Number : 1560009Recruiting
Hangzhou, China
Investigational Site Number : 1560066Recruiting
Hangzhou, China
Investigational Site Number : 1560054Recruiting
Hebei, China
Investigational Site Number : 1560059Recruiting
Hefei, China
Investigational Site Number : 1560007Recruiting
Hohhot, China
Investigational Site Number : 1560050Recruiting
Honghehanizu, China
Investigational Site Number : 1560046Recruiting
Huaian City, China
Investigational Site Number : 1560004Recruiting
Huizhou, China
Investigational Site Number : 1560021Recruiting
Huzhou, China
Investigational Site Number : 1560065Recruiting
Jiangyin, China
Investigational Site Number : 1560055Recruiting
Jinan, China
Investigational Site Number : 1560028Recruiting
Jinan, China
Investigational Site Number : 1560013Recruiting
Jinan, China
Investigational Site Number : 1560079Recruiting
Jingzhou, China
Investigational Site Number : 1560040Recruiting
Jining, China
Investigational Site Number : 1560061Recruiting
Kunming, China
Investigational Site Number : 1560077Recruiting
Luoyang, China
Investigational Site Number : 1560063Recruiting
Meihekou, China
Investigational Site Number : 1560014Recruiting
Nanchang, China
Investigational Site Number : 1560047Recruiting
Nanjing, China
Investigational Site Number : 1560082Recruiting
Nanjing, China
Investigational Site Number : 1560018Recruiting
Nanyang, China
Investigational Site Number : 1560073Recruiting
Panjin, China
Investigational Site Number : 1560031Recruiting
Qiqihar, China
Investigational Site Number : 1560045Recruiting
Quzhou, China
Investigational Site Number : 1560008Recruiting
Shanghai, China
Investigational Site Number : 1560017Recruiting
Shanghai, China
Investigational Site Number : 1560072Recruiting
Shaoyang, China
Investigational Site Number : 1560035Recruiting
Shenyang, China
Investigational Site Number : 1560053Recruiting
Shijiazhuang, China
Investigational Site Number : 1560002Recruiting
Suzhou, China
Investigational Site Number : 1560024Recruiting
Taiyuan, China
Investigational Site Number : 1560075Recruiting
Ürümqi, China
Investigational Site Number : 1560033Recruiting
Weifang, China
Investigational Site Number : 1560036Recruiting
Wenzhou, China
Investigational Site Number : 1560019Recruiting
Wuhan, China
Investigational Site Number : 1560071Recruiting
Wuhan, China
Investigational Site Number : 1560020Recruiting
Xi'an, China
Investigational Site Number : 1560006Recruiting
Xinxiang, China
Investigational Site Number : 1560089Recruiting
Yinchuan, China
Investigational Site Number : 1560076Recruiting
Yiyang, China
Investigational Site Number : 1560044Recruiting
Zhangzhou, China
Investigational Site Number : 1560084Recruiting
Zigong, China
Investigational Site Number : 1560039Recruiting
Zunyi, China
Investigational Site Number : 5540003Recruiting
Christchurch, Canterbury, New Zealand
Investigational Site Number : 5540002Recruiting
Ebdentown, Wellington Region, New Zealand
Investigational Site Number : 5540001Recruiting
Auckland, New Zealand
Investigational Site Number : 7100014Active Not Recruiting
Durban, South Africa
Investigational Site Number : 4100007Recruiting
Anyang-si, Gyeonggi-do, South Korea
Investigational Site Number : 4100005Recruiting
Daegu, Gyeongsangbuk-do, South Korea
Investigational Site Number : 4100003Recruiting
Jeonju, Jeollabuk-do, South Korea
Investigational Site Number : 4100004Recruiting
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 4100002Recruiting
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 4100001Recruiting
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 4100006Recruiting
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 1580008Recruiting
Hsinchu, Taiwan
Investigational Site Number : 1580001Recruiting
Kaohsiung City, Taiwan
Investigational Site Number : 1580005Recruiting
Taipei, Taiwan
Investigational Site Number : 1580002Recruiting
Taipei, Taiwan
Investigational Site Number : 1580003Recruiting
Taipei, Taiwan
Investigational Site Number : 8260035Recruiting
Milton Keynes, Buckinghamshire, United Kingdom
Investigational Site Number : 8260007Recruiting
London, England, United Kingdom
Investigational Site Number : 8260008Recruiting
London, Hammersmith and Fulham, United Kingdom
Investigational Site Number : 8260006Recruiting
Southampton, Hampshire, United Kingdom
Investigational Site Number : 8260016Recruiting
London, London, City of, United Kingdom
Investigational Site Number : 8260030Recruiting
Salford, Manchester, United Kingdom
Investigational Site Number : 8260013Recruiting
Chertsey, Surrey, United Kingdom
Investigational Site Number : 8260005Recruiting
Reading, United Kingdom
Investigational Site Number : 8260017Recruiting
Rotherham, United Kingdom