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RECRUITING
NCT07190222
PHASE3

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

View on ClinicalTrials.gov

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, 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

Key Details

Gender

All

Age Range

40 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

942

Start Date

2025-09-17

Completion Date

2030-01-22

Last Updated

2026-10-01

Healthy Volunteers

No

Interventions

DRUG

Lunsekimig

Pharmaceutical form: solution for injection in prefilled syringe. Route of administration: Subcutaneous injection

DRUG

Placebo

Pharmaceutical form: solution for injection. Route of administration: Subcutaneous injection

Locations (315)

University of Alabama at Birmingham- Site Number : 8400003

Birmingham, Alabama, United States

Pulmonary Associates - Mobile- Site Number : 8400151

Mobile, Alabama, United States

Tucson Clinical Research Institute- Site Number : 8400006

Tucson, Arizona, United States

Ark Clinical Research- Site Number : 8400113

Long Beach, California, United States

Inglewood Clinical- Site Number : 8400074

Los Angeles, California, United States

Alliance Clinical - West Hills- Site Number : 8400067

Los Angeles, California, United States

California Medical Research Associates - Northridge- Site Number : 8400089

Northridge, California, United States

Acclaim Clinical Research- Site Number : 8400068

San Diego, 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

Howard University Hospital- Site Number : 8400080

Washington D.C., District of Columbia, United States

Meris Clinical Research- Site Number : 8400153

Brandon, Florida, United States

Hillcrest Medical Research- Site Number : 8400082

DeLand, Florida, United States

Finlay Medical Research - Greenacres- Site Number : 8400107

Greenacres City, Florida, United States

Direct Helpers Research Center- Site Number : 8400057

Hialeah, Florida, United States

University of Florida - Jacksonville- Site Number : 8400126

Jacksonville, Florida, United States

Salud Clinical Services- Site Number : 8400109

Lehigh Acres, Florida, United States

Pulmonary Specialists of the Palm Beaches- Site Number : 8400017

Loxahatchee Groves, Florida, United States

Elite Clinical Research - Miami- Site Number : 8400167

Miami, Florida, United States

DL Research Solutions- Site Number : 8400140

Miami, 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

Heuer M.D. Research- Site Number : 8400018

Orlando, 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

Windom Allergy, Asthma and Sinus Specialists- Site Number : 8400041

Sarasota, Florida, United States

Stat Care Pulmonary and Sleep- Site Number : 8400138

St. Petersburg, Florida, United States

Better Life Clinical Research- Site Number : 8400152

Tampa, Florida, United States

Vicis Clinical Research- Site Number : 8400158

Tampa, 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

Sneeze Wheeze & Itch Associates- Site Number : 8400020

Normal, Illinois, United States

Peoria Pulmonary Associates Ltd- Site Number : 8400095

Peoria, Illinois, United States

Asha Clinical Research - Munster- Site Number : 8400115

Hammond, Indiana, United States

Ochsner LSU Health Shreveport - Academic Medical Center- Site Number : 8400083

Shreveport, Louisiana, United States

Care Access - Shreveport - Youree Drive- Site Number : 8400007

Shreveport, Louisiana, United States

Johns Hopkins Bayview Medical Center- Site Number : 8400076

Baltimore, Maryland, 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

Henry Ford Hospital- Site Number : 8400058

Detroit, Michigan, United States

Pulmonary Research Institute of Southeast Michigan - Farmington Hills- Site Number : 8400161

Farmington Hills, Michigan, United States

University of Missouri Health Care - Children's Hospital- Site Number : 8400150

Columbia, Missouri, United States

Hannibal Regional Healthcare System- Site Number : 8400035

Hannibal, Missouri, United States

Washington University- Site Number : 8400144

St Louis, 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 - Hamilton, New Jersey- Site Number : 8400037

Hamilton, New Jersey, United States

Rutgers Institute For Infectious & Inflammatory Diseases (I3d)- Site Number : 8400093

Newark, New Jersey, United States

Trinity Medical, WNY- Site Number : 8400157

Buffalo, New York, United States

Mid Hudson Medical Research - New Windsor- Site Number : 8400004

New Windsor, New York, United States

East Carolina University- Site Number : 8400102

Greenville, North Carolina, 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

Asthma & Allergy Center - Toledo- Site Number : 8400110

Toledo, Ohio, United States

Layrek Clinical Research- Site Number : 8400066

Tulsa, Oklahoma, United States

The Oregon Clinic - Portland - Northwest 22nd Avenue- Site Number : 8400065

Portland, Oregon, United States

Suburban Research Associates - Media- Site Number : 8400143

Media, Pennsylvania, United States

MedTrial- Site Number : 8400010

Columbia, South Carolina, United States

Chattanooga Research and Medicine- Site Number : 8400026

Chattanooga, Tennessee, United States

Premier Research Center, Llc- Site Number : 8400146

Hendersonville, Tennessee, United States

Solace Clinical Research- Site Number : 8400087

Austin, Texas, 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

Axsendo Clinical Research - Houston- Site Number : 8400054

Houston, Texas, United States

Se Houston- Site Number : 8400120

Houston, Texas, United States

Aavon Clinical Trials, Llc- Site Number : 8400166

Houston, Texas, United States

Synergy Group US - Missouri City- Site Number : 8400119

Missouri City, Texas, United States

Synergy Group US - Missouri City- Site Number : 8400133

Missouri City, Texas, United States

Elligo Health Care, Hillcroft Medical Clinic Association- Site Number : 8400053

Sugar Land, Texas, United States

Medrasa Clinical Research - Wylie- Site Number : 8400124

Wylie, Texas, United States

Rheumatology & Pulmonary Clinic- Site Number : 8400012

Beckley, West Virginia, United States

Investigational Site Number : 0320011

Berazategui, Buenos Aires, Argentina

Investigational Site Number : 0320004

Buenos Aires, Argentina

Investigational Site Number : 0320002

Buenos Aires, Argentina

Investigational Site Number : 0320005

Buenos Aires, Argentina

Investigational Site Number : 0320003

Buenos Aires, Argentina

Investigational Site Number : 0320006

Buenos Aires, Argentina

Investigational Site Number : 0320001

Buenos Aires, Argentina

Investigational Site Number : 0320012

Buenos Aires, Argentina

Investigational Site Number : 0320009

Córdoba, Argentina

Investigational Site Number : 0320007

Mendoza, Argentina

Investigational Site Number : 0320008

Mendoza, Argentina

Investigational Site Number : 0320010

Santa Fe, Argentina

Investigational Site Number : 0360007

Coffs Harbour, New South Wales, Australia

Investigational Site Number : 0360008

Tiwi, Northern Territory, Australia

Investigational Site Number : 0360006

South Brisbane, Queensland, Australia

Investigational Site Number : 0360004

Townsville, Queensland, Australia

Investigational Site Number : 0360002

Traralgon, Victoria, Australia

Investigational Site Number : 0360001

Osborne Park, Western Australia, Australia

Investigational Site Number : 5540004

Dunedin, Australia

Universidade Federal de Goias- Site Number : 0760002

Goiânia, Goiás, Brazil

Santa Casa de Misericordia de Belo Horizonte- Site Number : 0760004

Belo Horizonte, Minas Gerais, Brazil

WM Pesquisas Clínicas em Doenças Respiratórias- Site Number : 0760003

Porto Alegre, Rio Grande do Sul, Brazil

CEMEC - Centro Multidisciplinar de Estudos Clínicos - São Bernardo do Campo- Site Number : 0760001

São Bernardo do Campo, São Paulo, Brazil

IBCC - Núcleo de Pesquisa e Ensino- Site Number : 0760005

São Paulo, Brazil

Investigational Site Number : 1240051

Kelowna, British Columbia, Canada

Investigational Site Number : 1240052

West Vancouver, British Columbia, Canada

Investigational Site Number : 1240045

Niagara Falls, Ontario, Canada

Investigational Site Number : 1240041

Windsor, Ontario, Canada

Investigational Site Number : 1240049

Longueuil, Quebec, Canada

Investigational Site Number : 1240055

Montreal, Quebec, Canada

Investigational Site Number : 1240047

Québec, Quebec, Canada

Investigational Site Number : 1240053

Québec, Quebec, Canada

Investigational Site Number : 1240050

Saint-Charles-Borromée, Quebec, Canada

Investigational Site Number : 1240054

Saint-Charles-Borromée, 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 : 1520004

Recoleta, Reg Metropolitana de Santiago, Chile

Investigational Site Number : 1520001

Santiago, Reg Metropolitana de Santiago, Chile

Investigational Site Number : 1520002

Santiago, Reg Metropolitana de Santiago, Chile

Investigational Site Number : 1520009

Santiago, Reg Metropolitana de Santiago, Chile

Investigational Site Number : 1520003

Viña del Mar, Valparaiso, Chile

Investigational Site Number : 1520007

Chillan, Chile

Investigational Site Number : 1560003

Baotou, China

Investigational Site Number : 1560022

Beijing, China

Investigational Site Number : 1560001

Beijing, China

Investigational Site Number : 1560023

Beijing, China

Investigational Site Number : 1560005

Beijing, China

Investigational Site Number : 1560062

Changchun, China

Investigational Site Number : 1560090

Changde, China

Investigational Site Number : 1560057

Changsha, China

Investigational Site Number : 1560052

Chengdu, China

Investigational Site Number : 1560032

Chengdu, China

Investigational Site Number : 1560037

Chongqing, China

Investigational Site Number : 1560074

Chongqing, China

Investigational Site Number : 1560078

Dalian, China

Investigational Site Number : 1560051

Foshan, China

Investigational Site Number : 1560042

Ganzhou, China

Investigational Site Number : 1560015

Guangzhou, China

Investigational Site Number : 1560034

Guangzhou, China

Investigational Site Number : 1560038

Guiyang, China

Investigational Site Number : 1560016

Haikou, China

Investigational Site Number : 1560009

Hangzhou, China

Investigational Site Number : 1560066

Hangzhou, China

Investigational Site Number : 1560054

Hebei, China

Investigational Site Number : 1560059

Hefei, China

Investigational Site Number : 1560007

Hohhot, China

Investigational Site Number : 1560050

Honghehanizu, China

Investigational Site Number : 1560046

Huai'an, China

Investigational Site Number : 1560004

Huizhou, China

Investigational Site Number : 1560021

Huzhou, China

Investigational Site Number : 1560065

Jiangyin, China

Investigational Site Number : 1560081

Jiaxing, China

Investigational Site Number : 1560055

Jinan, China

Investigational Site Number : 1560028

Jinan, China

Investigational Site Number : 1560013

Jinan, China

Investigational Site Number : 1560079

Jingzhou, China

Investigational Site Number : 1560040

Jining, China

Investigational Site Number : 1560061

Kunming, China

Investigational Site Number : 1560091

Lanzhou, China

Investigational Site Number : 1560077

Luoyang, China

Investigational Site Number : 1560063

Meihekou, China

Investigational Site Number : 1560014

Nanchang, China

Investigational Site Number : 1560087

Nanchang, China

Investigational Site Number : 1560047

Nanjing, China

Investigational Site Number : 1560082

Nanjing, China

Investigational Site Number : 1560027

Nanning, China

Investigational Site Number : 1560018

Nanyang, China

Investigational Site Number : 1560073

Panjin, China

Investigational Site Number : 1560029

Qingdao, China

Investigational Site Number : 1560043

Qingyuan, China

Investigational Site Number : 1560025

Qinhuangdao, China

Investigational Site Number : 1560031

Qiqihar, China

Investigational Site Number : 1560045

Quzhou, China

Investigational Site Number : 1560008

Shanghai, China

Investigational Site Number : 1560017

Shanghai, China

Investigational Site Number : 1560072

Shaoyang, China

Investigational Site Number : 1560035

Shenyang, China

Investigational Site Number : 1560053

Shijiazhuang, China

Investigational Site Number : 1560002

Suzhou, China

Investigational Site Number : 1560024

Taiyuan, China

Investigational Site Number : 1560030

Tianjin, China

Investigational Site Number : 1560075

Ürümqi, China

Investigational Site Number : 1560033

Weifang, China

Investigational Site Number : 1560036

Wenzhou, China

Investigational Site Number : 1560019

Wuhan, China

Investigational Site Number : 1560071

Wuhan, China

Investigational Site Number : 1560070

Xi'an, China

Investigational Site Number : 1560020

Xi'an, China

Investigational Site Number : 1560083

Xiangyang, China

Investigational Site Number : 1560006

Xinxiang, China

Investigational Site Number : 1560058

Xuzhou, China

Investigational Site Number : 1560089

Yinchuan, China

Investigational Site Number : 1560076

Yiyang, China

Investigational Site Number : 1560044

Zhangzhou, China

Investigational Site Number : 1560011

Zhengzhou, China

Investigational Site Number : 1560084

Zigong, China

Investigational Site Number : 1560039

Zunyi, China

Investigational Site Number : 2030007

Brandýs nad Labem-Stará Boleslav, Czechia

Investigational Site Number : 2030006

Havlíčkův Brod, Czechia

Investigational Site Number : 2030005

Hradec Králové, Czechia

Investigational Site Number : 2030001

Jindřichův Hradec, Czechia

Investigational Site Number : 2030002

Kralupy nad Vltavou, Czechia

Investigational Site Number : 2030004

Prague, Czechia

Investigational Site Number : 2760005

Bamberg, Germany

Investigational Site Number : 2760006

Berlin, Germany

Investigational Site Number : 2760012

Berlin, Germany

Investigational Site Number : 2760004

Berlin, Germany

Investigational Site Number : 2760003

Berlin, Germany

Investigational Site Number : 2760011

Berlin, Germany

Investigational Site Number : 2760015

Bonn, Germany

Investigational Site Number : 2760016

Landsberg am Lech, Germany

Investigational Site Number : 2760002

Leipzig, Germany

Investigational Site Number : 2760001

Peine, Germany

Investigational Site Number : 2760010

Witten, Germany

Investigational Site Number : 3000007

Athens, Greece

Investigational Site Number : 3000006

Athens, Greece

Investigational Site Number : 3000002

Exochi, Greece

Investigational Site Number : 3000001

Ioannina, Greece

Investigational Site Number : 3000004

Palaió Fáliro, Greece

Investigational Site Number : 3760004

Ashkelon, Israel

Investigational Site Number : 3760007

Beersheba, Israel

Investigational Site Number : 3760010

Haifa, Israel

Investigational Site Number : 3760008

Haifa, Israel

Investigational Site Number : 3760005

Jerusalem, Israel

Investigational Site Number : 3760003

Jerusalem, Israel

Investigational Site Number : 3760002

Petah Tikva, Israel

Investigational Site Number : 3760011

Ramat Gan, Israel

Investigational Site Number : 3760001

Rehovot, Israel

Investigational Site Number : 3760006

Tel Aviv, Israel

Investigational Site Number : 4400001

Kaunas, Lithuania

Investigational Site Number : 4580004

George Town, Malaysia

Investigational Site Number : 4580006

Kajang, Malaysia

Investigational Site Number : 4580003

Kota Bharu, Malaysia

Investigational Site Number : 4580001

Kuala Lumpur, Malaysia

Investigational Site Number : 4580002

Kuala Terengganu, Malaysia

Investigational Site Number : 4580005

Miri, Malaysia

Investigational Site Number : 4580007

Sibu, Malaysia

Investigational Site Number : 4840012

León, Guanajuato, Mexico

Investigational Site Number : 4840002

Guadalajara, Jalisco, Mexico

Investigational Site Number : 4840009

Chihuahua City, Mexico

Investigational Site Number : 4840010

Durango, Mexico

Investigational Site Number : 4840003

Mexico City, Mexico

Investigational Site Number : 4840016

Mexico City, Mexico

Investigational Site Number : 5280002

Arnhem, Netherlands

Investigational Site Number : 5280001

Breda, Netherlands

Investigational Site Number : 5280010

Dordrecht, Netherlands

Investigational Site Number : 5280007

Nijmegen, Netherlands

Investigational Site Number : 5280008

Nijmegen, Netherlands

Investigational Site Number : 5280003

The Hague, Netherlands

Investigational Site Number : 5280009

Zutphen, Netherlands

Investigational Site Number : 5540003

Christchurch, Canterbury, New Zealand

Investigational Site Number : 5540002

Ebdentown, Wellington Region, New Zealand

Investigational Site Number : 5540001

Auckland, New Zealand

Investigational Site Number : 5780004

Arendal, Norway

Investigational Site Number : 5780003

Bergen, Norway

Investigational Site Number : 5780002

Lørenskog, Norway

Investigational Site Number : 5780001

Trondheim, Norway

Investigational Site Number : 6160005

Poznan, Greater Poland Voivodeship, Poland

Investigational Site Number : 6160002

Poznan, Greater Poland Voivodeship, Poland

Investigational Site Number : 6160007

Krakow, Lesser Poland Voivodeship, Poland

Investigational Site Number : 6160004

Lodz, Lódzkie, Poland

Investigational Site Number : 6160003

Bialystok, Podlaskie Voivodeship, Poland

Investigational Site Number : 6160006

Chęciny, Poland

Investigational Site Number : 6160001

Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, Poland

Investigational Site Number : 6420001

Brasov, Romania

Investigational Site Number : 6420003

Cluj-Napoca, Romania

Investigational Site Number : 6420002

Oradea, Romania

Investigational Site Number : 7020002

Singapore, Singapore

Investigational Site Number : 7020001

Singapore, Singapore

Investigational Site Number : 7030002

Humenné, Slovakia

Investigational Site Number : 7030003

Levice, Slovakia

Investigational Site Number : 7030001

Spišská Nová Ves, Slovakia

Investigational Site Number : 7100011

Benoni, South Africa

Investigational Site Number : 7100009

Boksburg, South Africa

Investigational Site Number : 7100001

Cape Town, South Africa

Investigational Site Number : 7100003

Cape Town, South Africa

Investigational Site Number : 7100002

Durban, South Africa

Investigational Site Number : 7100014

Durban, South Africa

Investigational Site Number : 7100006

Durban, South Africa

Investigational Site Number : 7100004

Durban, South Africa

Investigational Site Number : 7100005

Johannesburg, South Africa

Investigational Site Number : 7100013

Krugersdorp, South Africa

Investigational Site Number : 7100012

Pretoria, South Africa

Investigational Site Number : 7100007

Pretoria, South Africa

Investigational Site Number : 7100010

Welkom, 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 : 4100002

Seoul, Seoul-teukbyeolsi, South Korea

Investigational Site Number : 4100001

Seoul, Seoul-teukbyeolsi, South Korea

Investigational Site Number : 4100006

Seoul, Seoul-teukbyeolsi, South Korea

Investigational Site Number : 7240003

Zaragoza, Aragon, Spain

Investigational Site Number : 7240001

Badalona, Barcelona [Barcelona], Spain

Investigational Site Number : 7240004

Santander, Cantabria, Spain

Investigational Site Number : 7240008

Barcelona, Catalunya [Cataluña], Spain

Investigational Site Number : 7240007

Madrid, Madrid, Comunidad de, Spain

Investigational Site Number : 7240006

Madrid, Madrid, Comunidad de, Spain

Investigational Site Number : 7240002

Madrid, Spain

Investigational Site Number : 7240005

Madrid, Spain

Investigational Site Number : 1580007

Changhua, Taiwan

Investigational Site Number : 1580008

Hsinchu, Taiwan

Investigational Site Number : 1580001

Kaohsiung City, Taiwan

Investigational Site Number : 1580004

Taichung, Taiwan

Investigational Site Number : 1580005

Taipei, Taiwan

Investigational Site Number : 1580002

Taipei, Taiwan

Investigational Site Number : 1580003

Taipei, Taiwan

Investigational Site Number : 1580006

Taoyuan City, Taiwan

Investigational Site Number : 8260035

Milton Keynes, Buckinghamshire, United Kingdom

Investigational Site Number : 8260007

London, England, United Kingdom

Investigational Site Number : 8260008

London, Hammersmith and Fulham, United Kingdom

Investigational Site Number : 8260006

Southampton, Hampshire, United Kingdom

Investigational Site Number : 8260001

London, London, City of, United Kingdom

Investigational Site Number : 8260016

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, United Kingdom

Investigational Site Number : 8260017

Rotherham, United Kingdom