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
NCT ID: NCT07190209
Last Updated: 2026-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
942 participants
INTERVENTIONAL
2025-09-16
2030-01-22
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Lunsekimig dose regimen A
Participants will receive lunsekimig dose regimen A.
Lunsekimig
Pharmaceutical form: solution for injection in prefilled syringe Route of administration: Subcutaneous injection
Lunsekimig dose regimen B
Participants will receive lunsekimig dose regimen B
Lunsekimig
Pharmaceutical form: solution for injection in prefilled syringe Route of administration: Subcutaneous injection
Placebo
Participants will receive lunsekimig-matching placebo
Placebo
Pharmaceutical form: solution for injection Route of administration: Subcutaneous injection
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Asthma, including pediatric asthma, or ACOS
* Sgnificant pulmonary disease other than COPD
* Long-term oxygen therapy \>4.0 L/min or requirement of \>2.0 L/minO2 saturation to maintain oxygen saturation \>88%
* 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 iPDE-4 unless on stable therapy for \>6 months
* any biologic therapy or systemic immunosuppressant within 8 weeks 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
40 Years
80 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Locations
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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
Newport Native MD- Site Number : 8400003
Newport Beach, 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
Premier Medical Associates- Site Number : 8400012
Lady Lake, Florida, United States
MCR Research- Site Number : 8400004
Miami, Florida, United States
Nuren Medical & Research Center- Site Number : 8400030
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
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- Site Number : 8400056
Tampa, Florida, United States
Private Practice - Dr. David Kavtaradze- Site Number : 8400006
Cordele, Georgia, United States
Avicenna Clinical Research- Site Number : 8400126
Chicago Ridge, 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
Pulmonary and Medicine Associates- Site Number : 8400007
Warren, Michigan, United States
Henderson Clinical Trials- Site Number : 8400026
Henderson, Nevada, United States
Sierra Clinical Research - Las Vegas- Site Number : 8400028
Las Vegas, Nevada, United States
New York Hospital Queens- Site Number : 8400058
Flushing, New York, United States
Advanced Respiratory and Sleep Medicine - Hickory- Site Number : 8400013
Hickory, North Carolina, United States
Dayton Clinical Research- Site Number : 8400124
Dayton, Ohio, United States
Epic Medical Research - Chickasha- Site Number : 8400097
Chickasha, Oklahoma, United States
Preferred Primary Care Physicians - Pleasant Hills- Site Number : 8400092
Pittsburgh, Pennsylvania, United States
REX Clinical Trials - Beaumont- Site Number : 8400014
Beaumont, Texas, United States
South Texas Medical Research Institute - TTS Research- Site Number : 8400018
Boerne, Texas, United States
DCT-HCWC, LLC dba Discovery Clinical Trials- Site Number : 8400032
Dallas, Texas, United States
Epic Medical Research - De Soto- Site Number : 8400095
DeSoto, Texas, United States
Trio Clinical Trials, LLC- Site Number : 8400106
Houston, Texas, United States
HDH Research, Inc.- Site Number : 8400104
Houston, Texas, United States
Gulf Coast Clinical Research- Site Number : 8400049
Houston, Texas, United States
Lumi Research - Kingwood- Site Number : 8400120
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
Investigational Site Number : 0320003
San Miguel de Tucumán, Tucumán Province, Argentina
Investigational Site Number : 0320006
San Miguel de Tucumán, Tucumán Province, Argentina
Investigational Site Number : 0320011
Buenos Aires, , Argentina
Investigational Site Number : 0320005
Buenos Aires, , Argentina
Investigational Site Number : 0320001
Buenos Aires, , Argentina
Investigational Site Number : 0320002
Buenos Aires, , Argentina
Investigational Site Number : 0320009
Buenos Aires, , Argentina
Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760001
Porto Alegre, Rio Grande do Sul, Brazil
Investigational Site Number : 1240010
Ajax, Ontario, Canada
Investigational Site Number : 1240004
Guelph, Ontario, Canada
Investigational Site Number : 1240012
Ottawa, Ontario, Canada
Investigational Site Number : 1240009
Stoney Creek, Ontario, Canada
Investigational Site Number : 1520002
Valdivia, Los Ríos Region, Chile
Investigational Site Number : 1520006
Talca, Maule Region, Chile
Investigational Site Number : 1520004
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520001
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520003
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520005
Viña del Mar, Región de Valparaíso, Chile
Investigational Site Number : 1560010
Changsha, , China
Investigational Site Number : 1560032
Changsha, , China
Investigational Site Number : 1560018
Chengdu, , China
Investigational Site Number : 1560004
Chengdu, , China
Investigational Site Number : 1560021
Guangzhou, , China
Investigational Site Number : 1560001
Guangzhou, , China
Investigational Site Number : 1560030
Hangzhou, , China
Investigational Site Number : 1560044
Huizhou, , China
Investigational Site Number : 1560026
Jiaozuo, , China
Investigational Site Number : 1560039
Jinan, , China
Investigational Site Number : 1560049
Jinhua, , China
Investigational Site Number : 1560033
Linhai, , China
Investigational Site Number : 1560002
Nanchang, , China
Investigational Site Number : 1560017
Ningbo, , China
Investigational Site Number : 1560037
Shenzhen, , China
Investigational Site Number : 1560022
Taiyuan, , China
Investigational Site Number : 1560034
Taizhou, , China
Investigational Site Number : 1560029
Wenzhou, , China
Investigational Site Number : 1560025
Wuhan, , China
Investigational Site Number : 1560011
Xiangtan, , China
Investigational Site Number : 1560040
Xuzhou, , China
Investigational Site Number : 1560041
Yangzhou, , China
Investigational Site Number : 3920015
Yokohama, Kanagawa, Japan
Investigational Site Number : 3920026
Fukuoka, , Japan
Investigational Site Number : 8260014
Bristol, Bristol, City of, United Kingdom
Investigational Site Number : 8260031
Glasgow, Glasgow City, United Kingdom
Investigational Site Number : 8260003
Leicester, Leicestershire, United Kingdom
Investigational Site Number : 8260009
Harrow, London, City of, United Kingdom
Investigational Site Number : 8260002
Bradford, , United Kingdom
Investigational Site Number : 8260015
London, , United Kingdom
Investigational Site Number : 8260032
Worthing, , United Kingdom
Countries
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Central Contacts
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Trial Transparency email recommended (Toll free for US & Canada)
Role: CONTACT
Related Links
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EFC18243 Plain Language Results Summary
Other Identifiers
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2024-518016-39-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
EFC18243
Identifier Type: -
Identifier Source: org_study_id
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