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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

NCT07190209 · Sanofi
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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
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: 2025-09-16
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 (153)
Chandler Clinical Research Trials- Site Number : 8400025Recruiting
Chandler, Arizona, United States
Pulmonary Associates - Phoenix - East Bell Road- Site Number : 8400114Recruiting
Phoenix, Arizona, United States
Epic Medical Research - Surprise- Site Number : 8400096Recruiting
Surprise, Arizona, United States
IMAX Clinical Trials- Site Number : 8400109Recruiting
La Palma, California, United States
Long Beach Research Institute- Site Number : 8400027Recruiting
Long Beach, California, United States
Downtown L.A. Research Center- Site Number : 8400009Recruiting
Los Angeles, California, United States
Newport Native MD- Site Number : 8400003Recruiting
Newport Beach, California, United States
Paradigm Research - Redding- Site Number : 8400108Recruiting
Redding, California, United States
Amicis Research Center - Valencia- Site Number : 8400119Recruiting
Valencia, California, United States
Helix Biomedics- Site Number : 8400065Recruiting
Boynton Beach, Florida, United States
Beautiful Minds Clinical Research Center- Site Number : 8400017Recruiting
Cutler Bay, Florida, United States
Eastern Medical Group Research- Site Number : 8400020Recruiting
Fort Myers, Florida, United States
Premier Medical Associates- Site Number : 8400012Recruiting
Lady Lake, Florida, United States
MCR Research- Site Number : 8400004Recruiting
Miami, Florida, United States
Nuren Medical & Research Center- Site Number : 8400030Recruiting
Miami, Florida, United States
Deluxe Health Center- Site Number : 8400010Recruiting
Miami Lakes, Florida, United States
Omega Research Consultants - Orlando - Forest City- Site Number : 8400015Recruiting
Orlando, Florida, United States
Broward Research Center - Pembroke Pines- Site Number : 8400053Recruiting
Pembroke Pines, Florida, United States
Clinical Research Trials of Florida- Site Number : 8400011Recruiting
Tampa, Florida, United States
Deluxe Health Center-Tampa- Site Number : 8400056Recruiting
Tampa, Florida, United States
Private Practice - Dr. David Kavtaradze- Site Number : 8400006Recruiting
Cordele, Georgia, United States
Primeway Clinical Research- Site Number : 8400121Recruiting
Fayetteville, Georgia, United States
Avicenna Clinical Research- Site Number : 8400126Recruiting
Chicago Ridge, Illinois, United States
Indy Clinical Research- Site Number : 8400071Recruiting
Indianapolis, Indiana, United States
University of Kansas Medical Center- Site Number : 8400054Recruiting
Kansas City, Kansas, United States
Southern Clinical Research - Zachary- Site Number : 8400113Recruiting
Zachary, Louisiana, United States
Pulmonary and Medicine Associates- Site Number : 8400007Recruiting
Warren, Michigan, United States
Henderson Clinical Trials- Site Number : 8400026Recruiting
Henderson, Nevada, United States
Sierra Clinical Research - Las Vegas- Site Number : 8400028Recruiting
Las Vegas, Nevada, United States
New York Hospital Queens- Site Number : 8400058Recruiting
Flushing, New York, United States
Advanced Respiratory and Sleep Medicine - Hickory- Site Number : 8400013Recruiting
Hickory, North Carolina, United States
Atrium Health Wake Forest Baptist Pulmonary, Sleep And Allergy- Site Number : 8400048Recruiting
Winston-Salem, North Carolina, United States
Dayton Clinical Research- Site Number : 8400124Recruiting
Dayton, Ohio, United States
Epic Medical Research - Chickasha- Site Number : 8400097Recruiting
Chickasha, Oklahoma, United States
Preferred Primary Care Physicians - Pleasant Hills- Site Number : 8400092Recruiting
Pittsburgh, Pennsylvania, United States
AnMed Oglesby Center- Site Number : 8400074Recruiting
Anderson, South Carolina, United States
REX Clinical Trials - Beaumont- Site Number : 8400014Recruiting
Beaumont, Texas, United States
South Texas Medical Research Institute - TTS Research- Site Number : 8400018Recruiting
Boerne, Texas, United States
Ten20 Clinical Research- Site Number : 8400141Recruiting
Carrollton, Texas, United States
Texas Health Presbyterian Hospital Dallas- Site Number : 8400032Recruiting
Dallas, Texas, United States
Epic Medical Research - De Soto- Site Number : 8400095Recruiting
DeSoto, Texas, United States
Trio Clinical Trials- Site Number : 8400106Recruiting
Houston, Texas, United States
HDH Research- Site Number : 8400104Recruiting
Houston, Texas, United States
Gulf Coast Clinical Research - Houston- Site Number : 8400049Recruiting
Houston, Texas, United States
Lumi Research - Kingwood- Site Number : 8400120Recruiting
Kingwood, Texas, United States
Radiance Clinical Research - Lampasas - West Avenue East- Site Number : 8400063Recruiting
Lampasas, Texas, United States
Discovery Clinical Trials - San Antonio- Site Number : 8400031Recruiting
San Antonio, Texas, United States
Bandera Family Health Care - San Antonio- Site Number : 8400021Recruiting
San Antonio, Texas, United States
Investigational Site Number : 0320007Recruiting
La Plata, Buenos Aires, Argentina
Investigational Site Number : 0320008Recruiting
Lobos, Buenos Aires, Argentina
Investigational Site Number : 0320004Recruiting
Rosario, Santa Fe Province, Argentina
Investigational Site Number : 0320012Recruiting
Rosario, Santa Fe Province, Argentina
Investigational Site Number : 0320003Recruiting
San Miguel de Tucumán, Tucumán Province, Argentina
Investigational Site Number : 0320006Recruiting
San Miguel de Tucumán, Tucumán Province, Argentina
Investigational Site Number : 0320011Recruiting
Buenos Aires, Argentina
Investigational Site Number : 0320005Recruiting
Buenos Aires, Argentina
Investigational Site Number : 0320010Recruiting
Buenos Aires, Argentina
Investigational Site Number : 0320001Recruiting
Buenos Aires, Argentina
Investigational Site Number : 0320002Recruiting
Buenos Aires, Argentina
Investigational Site Number : 0320009Recruiting
Buenos Aires, Argentina
Chronos Pesquisa Clínica- Site Number : 0760012Recruiting
Brasília, Federal District, Brazil
Centro de Estudos em Terapias Inovadoras- Site Number : 0760013Recruiting
Curitiba, Paraná, Brazil
Hospital Universitário Onofre Lopes- Site Number : 0760016Recruiting
Natal, Rio Grande do Norte, Brazil
LMK Servicos Medicos- Site Number : 0760018Recruiting
Porto Alegre, Rio Grande do Sul, Brazil
Instituto Ceos- Site Number : 0760005Recruiting
Porto Alegre, Rio Grande do Sul, Brazil
Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760001Recruiting
Porto Alegre, Rio Grande do Sul, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto- Site Number : 0760011Recruiting
São José do Rio Preto, São Paulo, Brazil
Centro Internacional de Pesquisa Clínica (CIPES)- Site Number : 0760008Recruiting
São José dos Campos, São Paulo, Brazil
Hospital Beneficência Portuguesa de São Paulo- Site Number : 0760010Recruiting
São Paulo, Brazil
Investigational Site Number : 1240010Recruiting
Ajax, Ontario, Canada
Investigational Site Number : 1240004Recruiting
Guelph, Ontario, Canada
Investigational Site Number : 1240012Recruiting
Ottawa, Ontario, Canada
Investigational Site Number : 1240009Recruiting
Stoney Creek, Ontario, Canada
Investigational Site Number : 1240001Recruiting
Toronto, Ontario, Canada
Investigational Site Number : 1520002Recruiting
Valdivia, Los Ríos Region, Chile
Investigational Site Number : 1520006Recruiting
Talca, Maule Region, Chile
Investigational Site Number : 1520004Recruiting
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520001Recruiting
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520003Recruiting
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520007Recruiting
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520005Recruiting
Viña del Mar, Valparaiso, Chile
Investigational Site Number : 1560054Recruiting
Changchun, China
Investigational Site Number : 1560010Recruiting
Changsha, China
Investigational Site Number : 1560032Recruiting
Changsha, China
Investigational Site Number : 1560018Recruiting
Chengdu, China
Investigational Site Number : 1560004Recruiting
Chengdu, China
Investigational Site Number : 1560005Recruiting
Chengdu, China
Investigational Site Number : 1560062Recruiting
Foshan, China
Investigational Site Number : 1560021Recruiting
Guangzhou, China
Investigational Site Number : 1560001Recruiting
Guangzhou, China
Investigational Site Number : 1560030Recruiting
Hangzhou, China
Investigational Site Number : 1560012Recruiting
Hefei, China
Investigational Site Number : 1560046Recruiting
Hefei, China
Investigational Site Number : 1560044Recruiting
Huizhou, China
Investigational Site Number : 1560026Recruiting
Jiaozuo, China
Investigational Site Number : 1560039Recruiting
Jinan, China
Investigational Site Number : 1560049Recruiting
Jinhua, China
Investigational Site Number : 1560056Recruiting
Jining, China
Investigational Site Number : 1560023Recruiting
Langfang, China
Investigational Site Number : 1560033Recruiting
Linhai, China
Investigational Site Number : 1560002Recruiting
Nanchang, China
Investigational Site Number : 1560003Recruiting
Nanchang, China
Investigational Site Number : 1560051Recruiting
Nanning, China
Investigational Site Number : 1560017Recruiting
Ningbo, China
Investigational Site Number : 1560031Recruiting
Pingxiang, China
Investigational Site Number : 1560007Recruiting
Shanghai, China
Investigational Site Number : 1560037Recruiting
Shenzhen, China
Investigational Site Number : 1560027Recruiting
Shihezi, China
Investigational Site Number : 1560015Recruiting
Suining, China
Investigational Site Number : 1560022Recruiting
Taiyuan, China
Investigational Site Number : 1560034Recruiting
Taizhou, China
Investigational Site Number : 1560016Recruiting
Ürümqi, China
Investigational Site Number : 1560029Recruiting
Wenzhou, China
Investigational Site Number : 1560025Recruiting
Wuhan, China
Investigational Site Number : 1560050Recruiting
Wuxi, China
Investigational Site Number : 1560052Recruiting
Xi'an, China
Investigational Site Number : 1560020Recruiting
Xiamen, China
Investigational Site Number : 1560011Recruiting
Xiangtan, China
Investigational Site Number : 1560055Recruiting
Xianyang, China
Investigational Site Number : 1560040Recruiting
Xuzhou, China
Investigational Site Number : 1560041Recruiting
Yangzhou, China
Investigational Site Number : 1560060Recruiting
Yichang, China
Investigational Site Number : 1560059Recruiting
Zhanjiang, China
Investigational Site Number : 3920042Recruiting
Kōnan, Aichi-ken, Japan
Investigational Site Number : 3920009Recruiting
Kobe, Hyōgo, Japan
Investigational Site Number : 3920008Recruiting
Kita, Kagawa-ken, Japan
Investigational Site Number : 3920040Recruiting
Kamakura, Kanagawa, Japan
Investigational Site Number : 3920015Recruiting
Yokohama, Kanagawa, Japan
Investigational Site Number : 3920012Recruiting
Okayama, Okayama-ken, Japan
Investigational Site Number : 3920043Recruiting
Sakai, Osaka, Japan
Investigational Site Number : 3920020Recruiting
Ureshino, Saga-ken, Japan
Investigational Site Number : 3920033Recruiting
Hachiōji, Tokyo, Japan
Investigational Site Number : 3920003Recruiting
Ube, Yamaguchi, Japan
Investigational Site Number : 3920021Recruiting
Chiba, Japan
Investigational Site Number : 3920026Recruiting
Fukuoka, Japan
Investigational Site Number : 3920029Recruiting
Hiroshima, Japan
Investigational Site Number : 3920039Recruiting
Kagoshima, Japan
Investigational Site Number : 3920018Recruiting
Kumamoto, Japan
Investigational Site Number : 3920028Recruiting
Tokyo, Japan
Investigational Site Number : 7920002Recruiting
Adana, Turkey (Türkiye)
Investigational Site Number : 7920006Recruiting
Ankara, Turkey (Türkiye)
Investigational Site Number : 7920003Recruiting
Ankara, Turkey (Türkiye)
Investigational Site Number : 7920004Recruiting
Gaziantep, Turkey (Türkiye)
Investigational Site Number : 7920005Recruiting
Istanbul, Turkey (Türkiye)
Investigational Site Number : 7920007Recruiting
Izmir, Turkey (Türkiye)
Investigational Site Number : 7920001Recruiting
Mersin, Turkey (Türkiye)
Investigational Site Number : 8260014Recruiting
Bristol, Bristol, City of, United Kingdom
Investigational Site Number : 8260031Recruiting
Glasgow, Glasgow City, United Kingdom
Investigational Site Number : 8260015Recruiting
London, Hammersmith and Fulham, United Kingdom
Investigational Site Number : 8260003Recruiting
Leicester, Leicestershire, United Kingdom
Investigational Site Number : 8260009Recruiting
Harrow, London, City of, United Kingdom
Investigational Site Number : 8260032Recruiting
Worthing, West Sussex, United Kingdom
Investigational Site Number : 8260002Recruiting
Bradford, United Kingdom
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 · TrialPath