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NCT07190222PHASE3Recruiting

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

Sanofi

Start Date

9/17/2025

Completion Date

1/22/2030

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.

Detailed Description

All eligible participants will undergo subcutaneous administrations of lunsekimig or matching placebo during a 48-weeks treatment period

Eligibility Criteria

Age Range: 40 years to 80 years

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.

Interventions

DRUG

Lunsekimig

DRUG

Placebo

Interested in This Trial?

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Conditions

Chronic Obstructive Pulmonary Disease

Locations

University of Alabama at Birmingham- Site Number : 8400003

Birmingham, Alabama 35233

United States

Tucson Clinical Research Institute- Site Number : 8400006

Tucson, Arizona 85712

United States

Inglewood Clinical- Site Number : 8400074

Inglewood, California 90301

United States

Ark Clinical Research- Site Number : 8400113

Long Beach, California 90815

United States

Alliance Clinical - West Hills- Site Number : 8400067

Los Angeles, California 91307

United States

California Medical Research Associates - Northridge- Site Number : 8400089

Northridge, California 91324

United States

Alpine Clinical Research Center - Boulder - 47th Street- Site Number : 8400005

Boulder, Colorado 80301

United States

Critical Care Pulmonary & Sleep Associates- Site Number : 8400081

Lakewood, Colorado 80228

United States

Howard University Hospital- Site Number : 8400080

Washington D.C., District of Columbia 20060

United States

Finlay Medical Research - Greenacres- Site Number : 8400107

Greenacres City, Florida 33467

United States

Direct Helpers Research Center- Site Number : 8400057

Hialeah, Florida 33012

United States

Pulmonary Specialists of the Palm Beaches- Site Number : 8400017

Loxahatchee Groves, Florida 33470

United States

DL Research Solutions- Site Number : 8400140

Miami, Florida 33155

United States

Phoenix Medical Research - Miami - 24th Street- Site Number : 8400027

Miami, Florida 33165

United States

Professional Research Center- Site Number : 8400046

Miami, Florida 33172

United States

Research Institute of South Florida- Site Number : 8400028

Miami, Florida 33173

United States

Innovations Biotech- Site Number : 8400019

Miami, Florida 33186

United States

Florida Institute for Clinical Research- Site Number : 8400001

Orlando, Florida 32825

United States

Avanza Medical Research Center- Site Number : 8400015

Pensacola, Florida 32503

United States

Hull and Hull Medical Specialists- Site Number : 8400002

Plantation, Florida 33324

United States

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

Sarasota, Florida 34239

United States

Better Life Clinical Research- Site Number : 8400152

Tampa, Florida 33607

United States

Appalachian Clinical Research- Site Number : 8400060

Adairsville, Georgia 30103

United States

Christie Clinic in Champaign on University- Site Number : 8400023

Champaign, Illinois 61820

United States

Sneeze Wheeze & Itch Associates- Site Number : 8400020

Normal, Illinois 61761

United States

Peoria Pulmonary Associates Ltd- Site Number : 8400095

Peoria, Illinois 61603

United States

Asha Clinical Research - Munster- Site Number : 8400115

Hammond, Indiana 46324

United States

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

Shreveport, Louisiana 71105

United States

Lucida Clinical Trials- Site Number : 8400101

New Bedford, Massachusetts 02740

United States

Vitalis Clinical Research Center- Site Number : 8400040

Allen Park, Michigan 48101

United States

Bolt Clinical Research- Site Number : 8400086

Brighton, Michigan 48116

United States

Hannibal Regional Healthcare System- Site Number : 8400035

Hannibal, Missouri 63401

United States

Excel Clinical Research - Las Vegas- Site Number : 8400070

Las Vegas, Nevada 89109

United States

AB Clinical Trials- Site Number : 8400075

Las Vegas, Nevada 89119

United States

Bioluminux Clinical Research - Hamilton, New Jersey- Site Number : 8400037

Hamilton, New Jersey 08690

United States

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

New Windsor, New York 12553

United States

East Carolina University- Site Number : 8400102

Greenville, North Carolina 27858

United States

Piedmont Healthcare - Family Medicine- Site Number : 8400022

Statesville, North Carolina 28625

United States

All-Trials Clinical Research- Site Number : 8400008

Winston-Salem, North Carolina 27103

United States

Asthma & Allergy Center - Toledo- Site Number : 8400110

Toledo, Ohio 43617

United States

Layrek Clinical Research- Site Number : 8400066

Tulsa, Oklahoma 74133

United States

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

Portland, Oregon 97210

United States

MedTrial- Site Number : 8400010

Columbia, South Carolina 29204

United States

Chattanooga Research and Medicine- Site Number : 8400026

Chattanooga, Tennessee 37404

United States

IntraCare- Site Number : 8400034

Dallas, Texas 75254

United States

Premier Pulmonary Critical Care and Sleep- Site Number : 8400111

Denison, Texas 75020

United States

El Paso Pulmonary Association- Site Number : 8400033

El Paso, Texas 79902

United States

Axsendo Clinical Research - Houston- Site Number : 8400054

Houston, Texas 77058

United States

SE Houston- Site Number : 8400120

Houston, Texas 77061

United States

Synergy Group US - Missouri City- Site Number : 8400119

Missouri City, Texas 77459

United States

Synergy Group US - Missouri City- Site Number : 8400133

Missouri City, Texas 77459

United States

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

Sugar Land, Texas 77478

United States

Medrasa Clinical Research - Wylie- Site Number : 8400124

Wylie, Texas 75098

United States

Rheumatology & Pulmonary Clinic- Site Number : 8400012

Beckley, West Virginia 25801

United States

Investigational Site Number : 0320011

Berazategui, Buenos Aires 1886

Argentina

Investigational Site Number : 0320004

Buenos Aires, 1006

Argentina

Investigational Site Number : 0320002

Buenos Aires, 1023

Argentina

Investigational Site Number : 0320005

Buenos Aires, 1121

Argentina

Investigational Site Number : 0320006

Buenos Aires, 1280

Argentina

Investigational Site Number : 0320001

Buenos Aires, 1414

Argentina

Investigational Site Number : 0320012

Buenos Aires, 1638

Argentina

Investigational Site Number : 0320003

Buenos Aires, 1650

Argentina

Investigational Site Number : 0320009

Córdoba, 5003

Argentina

Investigational Site Number : 0320007

Mendoza, 5500

Argentina

Investigational Site Number : 0320008

Mendoza, 5500

Argentina

Investigational Site Number : 0320010

Santa Fe, 3000

Argentina

Investigational Site Number : 0360008

Tiwi, Northern Territory 0810

Australia

Investigational Site Number : 0360006

South Brisbane, Queensland 4101

Australia

Investigational Site Number : 0360004

Townsville, Queensland 4814

Australia

Investigational Site Number : 0360002

Traralgon, Victoria 3844

Australia

Investigational Site Number : 0360001

Osborne Park, Western Australia 6017

Australia

Investigational Site Number : 5540004

Dunedin, 9016

Australia

Universidade Federal de Goias- Site Number : 0760002

Goiânia, Goiás 74605-020

Brazil

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

Belo Horizonte, Minas Gerais 30150-221

Brazil

WM Pesquisas Clínicas em Doenças Respiratórias- Site Number : 0760003

Porto Alegre, Rio Grande do Sul 91010-006

Brazil

Centro Multidisciplinar de Estudos Clínicos- Site Number : 0760001

São Bernardo do Campo, São Paulo 09715-090

Brazil

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

São Paulo, 04014-002

Brazil

Investigational Site Number : 1240051

Kelowna, British Columbia V1Y 4N7

Canada

Investigational Site Number : 1240052

West Vancouver, British Columbia V7T 2Z3

Canada

Investigational Site Number : 1240041

Windsor, Ontario N8X 1T3

Canada

Investigational Site Number : 1240049

Longueuil, Quebec J4K 1C8

Canada

Investigational Site Number : 1240055

Montreal, Quebec H3T 1E2

Canada

Investigational Site Number : 1240047

Québec, Quebec G1V 4G5

Canada

Investigational Site Number : 1240053

Québec, Quebec G2J 0C4

Canada

Investigational Site Number : 1240050

Saint-Charles-Borromée, Quebec J6E 2B4

Canada

Investigational Site Number : 1240054

Saint-Charles-Borromée, Quebec J6E 2B4

Canada

Investigational Site Number : 1240048

Trois-Rivières, Quebec G8T 7A1

Canada

Investigational Site Number : 1240042

Victoriaville, Quebec G6P 3Z8

Canada

Investigational Site Number : 1520006

Temuco, La Araucanía 4810345

Chile

Investigational Site Number : 1520004

Recoleta, Reg Metropolitana de Santiago 8420000

Chile

Investigational Site Number : 1520001

Santiago, Reg Metropolitana de Santiago 7500587

Chile

Investigational Site Number : 1520002

Santiago, Reg Metropolitana de Santiago 7750495

Chile

Investigational Site Number : 1520009

Santiago, Reg Metropolitana de Santiago 8380453

Chile

Investigational Site Number : 1520003

Viña del Mar, Valparaiso 2540364

Chile

Investigational Site Number : 1520007

Chillan, 3800761

Chile

Investigational Site Number : 1560003

Baotou, 014010

China

Investigational Site Number : 1560022

Beijing, 100020

China

Investigational Site Number : 1560001

Beijing, 100029

China

Investigational Site Number : 1560023

Beijing, 100038

China

Investigational Site Number : 1560005

Beijing, 100191

China

Investigational Site Number : 1560090

Changde, 415000

China

Investigational Site Number : 1560057

Changsha, 410008

China

Investigational Site Number : 1560052

Chengdu, 610000

China

Investigational Site Number : 1560032

Chengdu, 610081

China

Investigational Site Number : 1560037

Chongqing, 400010

China

Investigational Site Number : 1560074

Chongqing,

China

Investigational Site Number : 1560078

Dalian, 116033

China

Investigational Site Number : 1560051

Foshan, 528399

China

Investigational Site Number : 1560042

Ganzhou, 341000

China

Investigational Site Number : 1560015

Guangzhou, 510180

China

Investigational Site Number : 1560034

Guangzhou, 511400

China

Investigational Site Number : 1560038

Guiyang, 550004

China

Investigational Site Number : 1560016

Haikou, 570216

China

Investigational Site Number : 1560009

Hangzhou, 310009

China

Investigational Site Number : 1560066

Hangzhou, 310009

China

Investigational Site Number : 1560054

Hebei, 050051

China

Investigational Site Number : 1560059

Hefei, 230011

China

Investigational Site Number : 1560007

Hohhot, 010070

China

Investigational Site Number : 1560050

Honghehanizu, 654400

China

Investigational Site Number : 1560046

Huaian City,

China

Investigational Site Number : 1560004

Huizhou, 516002

China

Investigational Site Number : 1560021

Huzhou, 313000

China

Investigational Site Number : 1560065

Jiangyin, 214400

China

Investigational Site Number : 1560081

Jiaxing, 314001

China

Investigational Site Number : 1560055

Jinan, 250001

China

Investigational Site Number : 1560028

Jinan, 250013

China

Investigational Site Number : 1560013

Jinan, 250014

China

Investigational Site Number : 1560079

Jingzhou, 434020

China

Investigational Site Number : 1560040

Jining, 272029

China

Investigational Site Number : 1560061

Kunming, 650011

China

Investigational Site Number : 1560091

Lanzhou, 730000

China

Investigational Site Number : 1560077

Luoyang, 471002

China

Investigational Site Number : 1560063

Meihekou, 135022

China

Investigational Site Number : 1560014

Nanchang, 330006

China

Investigational Site Number : 1560087

Nanchang, 330008

China

Investigational Site Number : 1560047

Nanjing, 210006

China

Investigational Site Number : 1560082

Nanjing, 211100

China

Investigational Site Number : 1560018

Nanyang, 473014

China

Investigational Site Number : 1560073

Panjin, 422000

China

Investigational Site Number : 1560029

Qingdao, 266011

China

Investigational Site Number : 1560043

Qingyuan, 511518

China

Investigational Site Number : 1560025

Qinhuangdao, 066000

China

Investigational Site Number : 1560031

Qiqihar, 161000

China

Investigational Site Number : 1560045

Quzhou, 324000

China

Investigational Site Number : 1560008

Shanghai, 200025

China

Investigational Site Number : 1560017

Shanghai, 201200

China

Investigational Site Number : 1560072

Shaoyang, 422000

China

Investigational Site Number : 1560035

Shenyang, 110000

China

Investigational Site Number : 1560053

Shijiazhuang, 050031

China

Investigational Site Number : 1560002

Suzhou, 215006

China

Investigational Site Number : 1560024

Taiyuan, 030032

China

Investigational Site Number : 1560030

Tianjin, 300052

China

Investigational Site Number : 1560075

Ürümqi, 830001

China

Investigational Site Number : 1560033

Weifang, 261041

China

Investigational Site Number : 1560036

Wenzhou, 325027

China

Investigational Site Number : 1560019

Wuhan, 430014

China

Investigational Site Number : 1560071

Wuhan, 430022

China

Investigational Site Number : 1560070

Xi'an, 710004

China

Investigational Site Number : 1560020

Xi'an, 710126

China

Investigational Site Number : 1560083

Xiangyang, 441021

China

Investigational Site Number : 1560006

Xinxiang, 453000

China

Investigational Site Number : 1560058

Xuzhou, 221018

China

Investigational Site Number : 1560089

Yinchuan, 750004

China

Investigational Site Number : 1560076

Yiyang, 413000

China

Investigational Site Number : 1560044

Zhangzhou, 363000

China

Investigational Site Number : 1560084

Zigong, 643000

China

Investigational Site Number : 1560039

Zunyi, 563002

China

Investigational Site Number : 4580004

George Town, 10990

Malaysia

Investigational Site Number : 4580003

Kota Bharu, 16150

Malaysia

Investigational Site Number : 4580001

Kuala Lumpur, 59100

Malaysia

Investigational Site Number : 4580002

Kuala Terengganu, 20400

Malaysia

Investigational Site Number : 4580005

Miri, 98000

Malaysia

Investigational Site Number : 4580007

Sibu, 96000

Malaysia

Investigational Site Number : 5540003

Christchurch, Canterbury 8011

New Zealand

Investigational Site Number : 5540002

Ebdentown, Wellington Region 5018

New Zealand

Investigational Site Number : 5540001

Auckland, 0622

New Zealand

Investigational Site Number : 7020001

Singapore, 529889

Singapore

Investigational Site Number : 7100001

Cape Town, Alberta 7530

South Africa

Investigational Site Number : 7100011

Benoni, 1500

South Africa

Investigational Site Number : 7100009

Boksburg, 1459

South Africa

Investigational Site Number : 7100003

Cape Town, 7764

South Africa

Investigational Site Number : 7100002

Durban, 4001

South Africa

Investigational Site Number : 7100004

Durban, 4302

South Africa

Investigational Site Number : 7100005

Johannesburg, 2001

South Africa

Investigational Site Number : 7100013

Krugersdorp, 1739

South Africa

Investigational Site Number : 7100012

Pretoria, 0084

South Africa

Investigational Site Number : 7100007

Pretoria, 0157

South Africa

Investigational Site Number : 7100010

Welkom, 9459

South Africa

Investigational Site Number : 4100007

Anyang-si, Gyeonggi-do 14068

South Korea

Investigational Site Number : 4100005

Daegu, Gyeongsangbuk-do 42415

South Korea

Investigational Site Number : 4100003

Jeonju, Jeollabuk-do 54907

South Korea

Investigational Site Number : 4100004

Seoul, Seoul-teukbyeolsi 05030

South Korea

Investigational Site Number : 4100002

Seoul, Seoul-teukbyeolsi 05355

South Korea

Investigational Site Number : 4100001

Seoul, Seoul-teukbyeolsi 06591

South Korea

Investigational Site Number : 4100006

Seoul, Seoul-teukbyeolsi 07061

South Korea

Investigational Site Number : 1580007

Changhua, 500

Taiwan

Investigational Site Number : 1580006

Guishan, 333

Taiwan

Investigational Site Number : 1580008

Hsinchu, 300

Taiwan

Investigational Site Number : 1580001

Kaohsiung City, 807

Taiwan

Investigational Site Number : 1580004

Taichung, 407

Taiwan

Investigational Site Number : 1580005

Taipei, 100

Taiwan

Investigational Site Number : 1580002

Taipei, 110

Taiwan

Investigational Site Number : 1580003

Taipei, 112

Taiwan

Investigational Site Number : 8260035

Milton Keynes, Buckinghamshire MK19 6FG

United Kingdom

Investigational Site Number : 8260007

London, England E11 1NR

United Kingdom

Investigational Site Number : 8260008

London, Hammersmith and Fulham W6 8RF

United Kingdom

Investigational Site Number : 8260006

Southampton, Hampshire SO16 6YD

United Kingdom

Investigational Site Number : 8260001

London, London, City of Se1 7eh

United Kingdom

Investigational Site Number : 8260016

London, London, City of SW1P 2PF

United Kingdom

Investigational Site Number : 8260030

Salford, Manchester M6 8HD

United Kingdom

Investigational Site Number : 8260013

Chertsey, Surrey KT16 0PZ

United Kingdom

Investigational Site Number : 8260005

Reading, RG1 5AN

United Kingdom

Investigational Site Number : 8260017

Rotherham, S61 1AH

United Kingdom