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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
Sponsor: Sanofi
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 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.
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
Key Details
Gender
All
Age Range
40 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
942
Start Date
2025-09-16
Completion Date
2030-01-22
Last Updated
2026-10-19
Healthy Volunteers
No
Conditions
Interventions
Lunsekimig
Pharmaceutical form: solution for injection in prefilled syringe. Route of administration: Subcutaneous injection
Placebo
Pharmaceutical form: solution for injection. Route of administration: Subcutaneous injection
Locations (314)
Chandler Clinical Research Trials- Site Number : 8400025
Chandler, Arizona, United States
Pulmonary Associates - Phoenix - East Bell Road- Site Number : 8400114
Phoenix, Arizona, United States
Epic Medical Research - Surprise- Site Number : 8400096
Surprise, Arizona, United States
IMAX Clinical Trials- Site Number : 8400109
La Palma, California, United States
Long Beach Research Institute- Site Number : 8400027
Long Beach, California, United States
Downtown L.A. Research Center- Site Number : 8400009
Los Angeles, California, United States
Newport Native MD- Site Number : 8400003
Newport Beach, California, United States
Paradigm Research - Redding- Site Number : 8400108
Redding, California, United States
Amicis Research Center - Valencia- Site Number : 8400119
Valencia, California, United States
Helix Biomedics- Site Number : 8400065
Boynton Beach, Florida, United States
Beautiful Minds Clinical Research Center- Site Number : 8400017
Cutler Bay, Florida, United States
Solution Clinical Research- Site Number : 8400039
Doral, Florida, United States
Eastern Medical Group Research- Site Number : 8400020
Fort Myers, Florida, United States
Premier Medical Associates- Site Number : 8400012
Lady Lake, Florida, United States
University of Miami Dermatology Clinical Trials Unit- Site Number : 8400078
Miami, Florida, United States
MCR Research- Site Number : 8400004
Miami, Florida, United States
Nuren Medical & Research Center- Site Number : 8400030
Miami, Florida, United States
My Community Research Center- Site Number : 8400164
Miami, Florida, United States
Reed Medical Research Corp- Site Number : 8400167
Miami, Florida, United States
Deluxe Health Center- Site Number : 8400010
Miami Lakes, Florida, United States
Omega Research Consultants - Orlando - Forest City- Site Number : 8400015
Orlando, Florida, United States
Pharmakon Medical Research- Site Number : 8400156
Palm Beach Gardens, Florida, United States
Broward Research Center - Pembroke Pines- Site Number : 8400053
Pembroke Pines, Florida, United States
Clinical Research Trials of Florida- Site Number : 8400011
Tampa, Florida, United States
Deluxe Health Center-Tampa- Site Number : 8400056
Tampa, Florida, United States
Private Practice - Dr. David Kavtaradze- Site Number : 8400006
Cordele, Georgia, United States
Primeway Clinical Research- Site Number : 8400121
Fayetteville, Georgia, United States
University of Illinois-Chicago - College of Medicine- Site Number : 8400055
Chicago, Illinois, United States
Avicenna Clinical Research- Site Number : 8400126
Chicago Ridge, Illinois, United States
NorthShore Medical Group - Evanston ( Endeavor Health)- Site Number : 8400073
Evanston, Illinois, United States
Indy Clinical Research- Site Number : 8400071
Indianapolis, Indiana, United States
University of Kansas Medical Center- Site Number : 8400054
Kansas City, Kansas, United States
Southern Clinical Research - Zachary- Site Number : 8400113
Zachary, Louisiana, United States
Brigham & Women's Hospital- Site Number : 8400148
Boston, Massachusetts, United States
University of Michigan Health System - Ann Arbor- Site Number : 8400090
Ann Arbor, Michigan, United States
Veritas Clinical Research- Site Number : 8400007
Madison Heights, Michigan, United States
Mayo Clinic in Rochester - Minnesota- Site Number : 8400005
Rochester, Minnesota, United States
Henderson Clinical Trials- Site Number : 8400026
Henderson, Nevada, United States
Sanmora Bespoke Clinical Research Solutions- Site Number : 8400144
East Orange, New Jersey, United States
New York Hospital Queens- Site Number : 8400058
Flushing, New York, United States
Duke Asthma, Allergy and Airway Center- Site Number : 8400047
Durham, North Carolina, United States
Advanced Respiratory and Sleep Medicine - Hickory- Site Number : 8400013
Hickory, North Carolina, United States
Science 37, Llc- Site Number : 8400154
Morrisville, North Carolina, United States
Atrium Health Wake Forest Baptist Pulmonary, Sleep And Allergy- Site Number : 8400048
Winston-Salem, North Carolina, United States
Plains Clinical Research Center- Site Number : 8400140
Fargo, North Dakota, United States
Dayton Clinical Research- Site Number : 8400124
Dayton, Ohio, United States
Epic Medical Research - Chickasha- Site Number : 8400097
Chickasha, Oklahoma, United States
Oregon Health & Science University (OHSU)- Site Number : 8400155
Portland, Oregon, United States
Temple University Hospital- Site Number : 8400059
Philadelphia, Pennsylvania, United States
Preferred Primary Care Physicians - Pleasant Hills- Site Number : 8400092
Pittsburgh, Pennsylvania, United States
AnMed Oglesby Center- Site Number : 8400074
Anderson, South Carolina, United States
MD First Research - Lancaster- Site Number : 8400102
Lancaster, South Carolina, United States
Circle Clinical Research- Site Number : 8400139
Sioux Falls, South Dakota, United States
Meharry Medical College- Site Number : 8400133
Nashville, Tennessee, United States
Wellness Clinical Research - Allen- Site Number : 8400085
Allen, Texas, United States
REX Clinical Trials - Beaumont- Site Number : 8400014
Beaumont, Texas, United States
Novel Research - Bellaire- Site Number : 8400116
Bellaire, Texas, United States
South Texas Medical Research Institute - TTS Research- Site Number : 8400018
Boerne, Texas, United States
TEN20 Clinical Research - Carrollton- Site Number : 8400141
Carrollton, Texas, United States
Corsicana Medical Research- Site Number : 8400134
Corsicana, Texas, United States
Syri Research Center- Site Number : 8400069
Cypress, Texas, United States
Texas Health Presbyterian Hospital Dallas- Site Number : 8400032
Dallas, Texas, United States
Epic Medical Research - De Soto- Site Number : 8400095
DeSoto, Texas, United States
Valley Institute of Research- Site Number : 8400118
Harlingen, Texas, United States
Trio Clinical Trials- Site Number : 8400106
Houston, Texas, United States
HDH Research, Inc.- Site Number : 8400104
Houston, Texas, United States
Baylor College of Medicine- Site Number : 8400076
Houston, Texas, United States
Gulf Coast Clinical Research - Houston- Site Number : 8400049
Houston, Texas, United States
Lumi Research - Kingwood- Site Number : 8400120
Kingwood, Texas, United States
Syri Research Center- Site Number : 8400136
Kingwood, Texas, United States
Radiance Clinical Research - Lampasas - West Avenue East- Site Number : 8400063
Lampasas, Texas, United States
Discovery Clinical Trials - San Antonio- Site Number : 8400031
San Antonio, Texas, United States
Bandera Family Health Care - San Antonio- Site Number : 8400021
San Antonio, Texas, United States
Element Research Group- Site Number : 8400115
San Antonio, Texas, United States
Tidewater Physicians Multispecialty Group Clinical Research - Williamsburg- Site Number : 8400081
Williamsburg, Virginia, United States
Investigational Site Number : 0320007
La Plata, Buenos Aires, Argentina
Investigational Site Number : 0320008
Lobos, Buenos Aires, Argentina
Investigational Site Number : 0320004
Rosario, Santa Fe Province, Argentina
Investigational Site Number : 0320012
Rosario, Santa Fe Province, Argentina
Investigational Site Number : 0320006
San Miguel de Tucumán, Tucumán Province, Argentina
Investigational Site Number : 0320003
San Miguel de Tucumán, Tucumán Province, Argentina
Investigational Site Number : 0320011
Buenos Aires, Argentina
Investigational Site Number : 0320005
Buenos Aires, Argentina
Investigational Site Number : 0320010
Buenos Aires, Argentina
Investigational Site Number : 0320001
Buenos Aires, Argentina
Investigational Site Number : 0320002
Buenos Aires, Argentina
Investigational Site Number : 0320009
Buenos Aires, Argentina
Investigational Site Number : 0560004
Brussels, Belgium
Investigational Site Number : 0560005
Edegem, Belgium
Investigational Site Number : 0560008
Erpent, Belgium
Investigational Site Number : 0560001
Leuven, Belgium
Investigational Site Number : 0560003
Mechelen, Belgium
Investigational Site Number : 0560007
Yvoir, Belgium
Chronos Pesquisa Clínica- Site Number : 0760012
Brasília, Federal District, Brazil
CETI - Centro de Estudos em Terapias Inovadoras- Site Number : 0760013
Curitiba, Paraná, Brazil
Hospital Universitário Onofre Lopes- Site Number : 0760016
Natal, Rio Grande do Norte, Brazil
Instituto Ceos- Site Number : 0760005
Porto Alegre, Rio Grande do Sul, Brazil
LMK Servicos Medicos- Site Number : 0760018
Porto Alegre, Rio Grande do Sul, Brazil
Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760001
Porto Alegre, Rio Grande do Sul, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto- Site Number : 0760011
São José do Rio Preto, São Paulo, Brazil