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: NCT07190222
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
2025-09-17
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:s olution 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:s olution 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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Tucson Clinical Research Institute- Site Number : 8400006
Tucson, Arizona, United States
Ark Clinical Research- Site Number : 8400113
Long Beach, California, United States
California Medical Research Associates - Northridge- Site Number : 8400089
Northridge, California, United States
Alpine Clinical Research Center - Boulder - 47th Street- Site Number : 8400005
Boulder, Colorado, United States
Critical Care Pulmonary & Sleep Associates- Site Number : 8400081
Lakewood, Colorado, United States
Finlay Medical Research - Greenacres- Site Number : 8400107
Greenacres City, Florida, United States
Pulmonary Specialists of the Palm Beaches- Site Number : 8400017
Loxahatchee Groves, Florida, United States
Phoenix Medical Research - Miami - 24th Street- Site Number : 8400027
Miami, Florida, United States
Professional Research Center- Site Number : 8400046
Miami, Florida, United States
Research Institute of South Florida- Site Number : 8400028
Miami, Florida, United States
Innovations Biotech- Site Number : 8400019
Miami, Florida, United States
Florida Institute for Clinical Research- Site Number : 8400001
Orlando, Florida, United States
Avanza Medical Research Center- Site Number : 8400015
Pensacola, Florida, United States
Hull and Hull Medical Specialists- Site Number : 8400002
Plantation, Florida, United States
Appalachian Clinical Research- Site Number : 8400060
Adairsville, Georgia, United States
Christie Clinic in Champaign on University- Site Number : 8400023
Champaign, Illinois, United States
Care Access - Shreveport - Youree Drive- Site Number : 8400007
Shreveport, Louisiana, United States
Lucida Clinical Trials- Site Number : 8400101
New Bedford, Massachusetts, United States
Vitalis Clinical Research Center- Site Number : 8400040
Allen Park, Michigan, United States
Bolt Clinical Research- Site Number : 8400086
Brighton, Michigan, United States
Hannibal Regional Healthcare System- Site Number : 8400035
Hannibal, Missouri, United States
Excel Clinical Research - Las Vegas- Site Number : 8400070
Las Vegas, Nevada, United States
AB Clinical Trials- Site Number : 8400075
Las Vegas, Nevada, United States
Bioluminux Clinical Research New Jersey- Site Number : 8400037
Trenton, New Jersey, United States
Mid Hudson Medical Research - New Windsor- Site Number : 8400004
New Windsor, New York, United States
Piedmont Healthcare - Family Medicine- Site Number : 8400022
Statesville, North Carolina, United States
All-Trials Clinical Research- Site Number : 8400008
Winston-Salem, North Carolina, United States
The Oregon Clinic, PC- Site Number : 8400065
Portland, Oregon, United States
MedTrial- Site Number : 8400010
Columbia, South Carolina, United States
Chattanooga Research and Medicine- Site Number : 8400026
Chattanooga, Tennessee, United States
IntraCare- Site Number : 8400034
Dallas, Texas, United States
Premier Pulmonary Critical Care and Sleep- Site Number : 8400111
Denison, Texas, United States
El Paso Pulmonary Association- Site Number : 8400033
El Paso, Texas, United States
Synergy Medical- Site Number : 8400119
Houston, Texas, United States
Axsendo Clinical Research - Houston- Site Number : 8400054
Houston, Texas, United States
Synergy Groups Medical, LLC- Site Number : 8400133
Missouri City, Texas, United States
Medrasa Clinical Research- Site Number : 8400124
Wylie, Texas, United States
Dominion Medical Associates - Richmond - East Leigh Street- Site Number : 8400154
Richmond, Virginia, United States
Rheumatology & Pulmonary Clinic- Site Number : 8400012
Beckley, West Virginia, United States
Investigational Site Number : 0320004
Buenos Aires, , Argentina
Investigational Site Number : 0320002
Buenos Aires, , Argentina
Investigational Site Number : 0320005
Buenos Aires, , Argentina
Investigational Site Number : 0320006
Buenos Aires, , Argentina
Investigational Site Number : 0320001
Buenos Aires, , Argentina
Investigational Site Number : 0320003
Buenos Aires, , Argentina
Investigational Site Number : 0320007
Mendoza, , Argentina
Investigational Site Number : 0320008
Mendoza, , Argentina
Investigational Site Number : 0320010
Santa Fe, , Argentina
Investigational Site Number : 0360006
South Brisbane, Queensland, Australia
Investigational Site Number : 0360002
Traralgon, Victoria, Australia
Investigational Site Number : 0360001
Spearwood, Western Australia, Australia
Centro Multidisciplinar de Estudos Clínicos- Site Number : 0760001
São Bernardo do Campo, São Paulo, Brazil
Investigational Site Number : 1240051
Kelowna, British Columbia, Canada
Investigational Site Number : 1240052
North Vancouver, British Columbia, Canada
Investigational Site Number : 1240041
Windsor, Ontario, Canada
Investigational Site Number : 1240050
Saint-Charles-Borromée, Quebec, Canada
Investigational Site Number : 1240054
Saint-Charles-Borromée, Quebec, Canada
Investigational Site Number : 1240049
Saint-Laurent, Quebec, Canada
Investigational Site Number : 1240048
Trois-Rivières, Quebec, Canada
Investigational Site Number : 1240042
Victoriaville, Quebec, Canada
Investigational Site Number : 1520006
Temuco, La Araucanía, Chile
Investigational Site Number : 1520001
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520002
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520003
Viña del Mar, Región de Valparaíso, Chile
Investigational Site Number : 1520007
Chillán, , Chile
Investigational Site Number : 1560079
Jingzhou, New South Wales, China
Investigational Site Number : 1560001
Beijing, , China
Investigational Site Number : 1560090
Changde, , China
Investigational Site Number : 1560074
Chongqing, , China
Investigational Site Number : 1560051
Foshan, , China
Investigational Site Number : 1560042
Ganzhou, , China
Investigational Site Number : 1560015
Guangzhou, , China
Investigational Site Number : 1560009
Hangzhou, , China
Investigational Site Number : 1560021
Huzhou, , China
Investigational Site Number : 1560028
Jinan, , China
Investigational Site Number : 1560077
Luoyang, , China
Investigational Site Number : 1560018
Nanyang, , China
Investigational Site Number : 1560073
Panjin, , China
Investigational Site Number : 1560045
Quzhou, , China
Investigational Site Number : 1560050
Shanghai, , China
Investigational Site Number : 1560036
Wenzhou, , China
Investigational Site Number : 1560071
Wuhan, , China
Investigational Site Number : 1560006
Xinxiang, , China
Investigational Site Number : 1560076
Yiyang, , China
Investigational Site Number : 1560084
Zigong, , China
Investigational Site Number : 5540001
Takapuna, Auckland, New Zealand
Investigational Site Number : 5540003
Christchurch Central City, , New Zealand
Investigational Site Number : 5540002
Ebdentown, , New Zealand
Investigational Site Number : 7100014
Durban, , South Africa
Investigational Site Number : 4100007
Anyang-si, Gyeonggi-do, South Korea
Investigational Site Number : 4100005
Daegu, Gyeongsangbuk-do, South Korea
Investigational Site Number : 4100003
Jeonju, Jeollabuk-do, South Korea
Investigational Site Number : 4100004
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 4100006
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 1580001
Kaohsiung City, , Taiwan
Investigational Site Number : 8260035
Milton Keynes, Buckinghamshire, United Kingdom
Investigational Site Number : 8260007
London, England, United Kingdom
Investigational Site Number : 8260001
London, London, City of, United Kingdom
Investigational Site Number : 8260030
Salford, Manchester, United Kingdom
Investigational Site Number : 8260013
Chertsey, Surrey, United Kingdom
Investigational Site Number : 8260005
Reading, West Berkshire, United Kingdom
Investigational Site Number : 8260016
London, , United Kingdom
Investigational Site Number : 8260017
Rotherham, , 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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EFC18244 Plain Language Results Summary
Other Identifiers
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2024-518213-25-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
EFC18244
Identifier Type: -
Identifier Source: org_study_id
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