Back to Trials
NCT07190209PHASE3Recruiting

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

9/16/2025

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?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Chronic Obstructive Pulmonary Disease

Locations

Chandler Clinical Research Trials- Site Number : 8400025

Chandler, Arizona 85224

United States

Pulmonary Associates - Phoenix - East Bell Road- Site Number : 8400114

Phoenix, Arizona 85032

United States

Epic Medical Research - Surprise- Site Number : 8400096

Surprise, Arizona 85378

United States

IMAX Clinical Trials- Site Number : 8400109

La Palma, California 90623

United States

Long Beach Research Institute- Site Number : 8400027

Long Beach, California 90805

United States

Downtown L.A. Research Center- Site Number : 8400009

Los Angeles, California 90017

United States

Newport Native MD- Site Number : 8400003

Newport Beach, California 92663

United States

Paradigm Research - Redding- Site Number : 8400108

Redding, California 96001

United States

Amicis Research Center - Valencia- Site Number : 8400119

Valencia, California 91355

United States

Helix Biomedics- Site Number : 8400065

Boynton Beach, Florida 33435

United States

Beautiful Minds Clinical Research Center- Site Number : 8400017

Cutler Bay, Florida 33157

United States

Eastern Medical Group Research- Site Number : 8400020

Fort Myers, Florida 33908

United States

Premier Medical Associates- Site Number : 8400012

Lady Lake, Florida 32159

United States

University of Miami Dermatology Clinical Trials Unit- Site Number : 8400078

Miami, Florida 33125

United States

MCR Research- Site Number : 8400004

Miami, Florida 33126

United States

Nuren Medical & Research Center- Site Number : 8400030

Miami, Florida 33144

United States

My Community Research Center- Site Number : 8400164

Miami, Florida 33155

United States

Deluxe Health Center- Site Number : 8400010

Miami Lakes, Florida 33014

United States

Omega Research Consultants - Orlando - Forest City- Site Number : 8400015

Orlando, Florida 32810

United States

Broward Research Center - Pembroke Pines- Site Number : 8400053

Pembroke Pines, Florida 33024

United States

Clinical Research Trials of Florida- Site Number : 8400011

Tampa, Florida 33607

United States

Deluxe Health Center-Tampa- Site Number : 8400056

Tampa, Florida 33607

United States

Private Practice - Dr. David Kavtaradze- Site Number : 8400006

Cordele, Georgia 31015

United States

Primeway Clinical Research- Site Number : 8400121

Fayetteville, Georgia 30214

United States

University of Illinois-Chicago - College of Medicine- Site Number : 8400055

Chicago, Illinois 60612

United States

Avicenna Clinical Research- Site Number : 8400126

Chicago Ridge, Illinois 60415

United States

NorthShore Medical Group - Evanston ( Endeavor Health)- Site Number : 8400073

Evanston, Illinois 60201

United States

Indy Clinical Research- Site Number : 8400071

Indianapolis, Indiana 46268

United States

University of Kansas Medical Center- Site Number : 8400054

Kansas City, Kansas 66160

United States

Southern Clinical Research - Zachary- Site Number : 8400113

Zachary, Louisiana 70791

United States

University of Michigan Health System - Ann Arbor- Site Number : 8400090

Ann Arbor, Michigan 48109

United States

Pulmonary and Medicine Associates- Site Number : 8400007

Warren, Michigan 48088

United States

Mayo Clinic in Rochester - Minnesota- Site Number : 8400005

Rochester, Minnesota 55905

United States

Henderson Clinical Trials- Site Number : 8400026

Henderson, Nevada 89052

United States

Sierra Clinical Research - Las Vegas- Site Number : 8400028

Las Vegas, Nevada 89106

United States

Sanmora Bespoke Clinical Research Solutions- Site Number : 8400144

East Orange, New Jersey 07018

United States

New York Hospital Queens- Site Number : 8400058

Flushing, New York 11355

United States

Advanced Respiratory and Sleep Medicine - Hickory- Site Number : 8400013

Hickory, North Carolina 28601

United States

Atrium Health Wake Forest Baptist Pulmonary, Sleep And Allergy- Site Number : 8400048

Winston-Salem, North Carolina 27103

United States

Plains Clinical Research Center- Site Number : 8400140

Fargo, North Dakota 58104

United States

Dayton Clinical Research- Site Number : 8400124

Dayton, Ohio 45409

United States

Epic Medical Research - Chickasha- Site Number : 8400097

Chickasha, Oklahoma 73018

United States

Temple University Hospital - Main Campus- Site Number : 8400059

Philadelphia, Pennsylvania 19140-5103

United States

Preferred Primary Care Physicians - Pleasant Hills- Site Number : 8400092

Pittsburgh, Pennsylvania 15236

United States

AnMed Oglesby Center- Site Number : 8400074

Anderson, South Carolina 29621

United States

MD First Research - Lancaster- Site Number : 8400102

Lancaster, South Carolina 29720

United States

REX Clinical Trials - Beaumont- Site Number : 8400014

Beaumont, Texas 77701

United States

Novel Research - Bellaire- Site Number : 8400116

Bellaire, Texas 77401

United States

South Texas Medical Research Institute - TTS Research- Site Number : 8400018

Boerne, Texas 78006

United States

TEN20 Clinical Research - Carrollton- Site Number : 8400141

Carrollton, Texas 75010

United States

Corsicana Medical Research- Site Number : 8400134

Corsicana, Texas 75110

United States

Syri Research Center- Site Number : 8400069

Cypress, Texas 77065

United States

Texas Health Presbyterian Hospital Dallas- Site Number : 8400032

Dallas, Texas 75231

United States

Epic Medical Research - De Soto- Site Number : 8400095

DeSoto, Texas 75115

United States

Valley Institute of Research- Site Number : 8400118

Harlingen, Texas 78550

United States

Trio Clinical Trials- Site Number : 8400106

Houston, Texas 77008

United States

HDH Research- Site Number : 8400104

Houston, Texas 77022

United States

Baylor College of Medicine- Site Number : 8400076

Houston, Texas 77030

United States

Gulf Coast Clinical Research - Houston- Site Number : 8400049

Houston, Texas 77070

United States

Lumi Research - Kingwood- Site Number : 8400120

Kingwood, Texas 77339

United States

Syri Research Center- Site Number : 8400136

Kingwood, Texas 77339

United States

Radiance Clinical Research - Lampasas - West Avenue East- Site Number : 8400063

Lampasas, Texas 76550

United States

Discovery Clinical Trials - San Antonio- Site Number : 8400031

San Antonio, Texas 78229

United States

Bandera Family Health Care - San Antonio- Site Number : 8400021

San Antonio, Texas 78249

United States

Element Research Group- Site Number : 8400115

San Antonio, Texas 78257

United States

Tidewater Physicians Multispecialty Group Clinical Research - Williamsburg- Site Number : 8400081

Williamsburg, Virginia 23188

United States

Investigational Site Number : 0320007

La Plata, Buenos Aires 1900

Argentina

Investigational Site Number : 0320008

Lobos, Buenos Aires 7240

Argentina

Investigational Site Number : 0320004

Rosario, Santa Fe Province 2000

Argentina

Investigational Site Number : 0320012

Rosario, Santa Fe Province 2000

Argentina

Investigational Site Number : 0320006

San Miguel de Tucumán, Tucumán Province 4000

Argentina

Investigational Site Number : 0320003

San Miguel de Tucumán, Tucumán Province T4000

Argentina

Investigational Site Number : 0320011

Buenos Aires, 1012

Argentina

Investigational Site Number : 0320005

Buenos Aires, 1122

Argentina

Investigational Site Number : 0320010

Buenos Aires, 1128

Argentina

Investigational Site Number : 0320001

Buenos Aires, 1425

Argentina

Investigational Site Number : 0320002

Buenos Aires, 1425

Argentina

Investigational Site Number : 0320009

Buenos Aires, 1427

Argentina

Chronos Pesquisa Clínica- Site Number : 0760012

Brasília, Federal District 72145-450

Brazil

Centro de Estudos em Terapias Inovadoras- Site Number : 0760013

Curitiba, Paraná 80030-110

Brazil

Hospital Universitário Onofre Lopes- Site Number : 0760016

Natal, Rio Grande do Norte 59012-300

Brazil

LMK Servicos Medicos- Site Number : 0760018

Porto Alegre, Rio Grande do Sul 90480-000

Brazil

Instituto Ceos- Site Number : 0760005

Porto Alegre, Rio Grande do Sul 90480-020

Brazil

Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760001

Porto Alegre, Rio Grande do Sul 90610-000

Brazil

Fundação Faculdade Regional de Medicina de São José do Rio Preto- Site Number : 0760011

São José do Rio Preto, São Paulo 15090-000

Brazil

Centro Internacional de Pesquisa Clínica (CIPES)- Site Number : 0760008

São José dos Campos, São Paulo 12230-001

Brazil

Hospital Copa D'Or- Site Number : 0760017

Rio de Janeiro, 22031-011

Brazil

Hospital Beneficência Portuguesa de São Paulo- Site Number : 0760010

São Paulo, 01323-001

Brazil

Investigational Site Number : 1240011

Calgary, Alberta T3R 1W7

Canada

Investigational Site Number : 1240010

Ajax, Ontario L1S 2J5

Canada

Investigational Site Number : 1240004

Guelph, Ontario N1h 6j2

Canada

Investigational Site Number : 1240012

Ottawa, Ontario K1G 6C6

Canada

Investigational Site Number : 1240009

Stoney Creek, Ontario L8G 2V6

Canada

Investigational Site Number : 1240001

Toronto, Ontario M5T 3A9

Canada

Investigational Site Number : 1520002

Valdivia, Los Ríos Region 5110683

Chile

Investigational Site Number : 1520006

Talca, Maule Region 3465584

Chile

Investigational Site Number : 1520004

Santiago, Reg Metropolitana de Santiago 7500010

Chile

Investigational Site Number : 1520001

Santiago, Reg Metropolitana de Santiago 7500692

Chile

Investigational Site Number : 1520003

Santiago, Reg Metropolitana de Santiago 7500698

Chile

Investigational Site Number : 1520007

Santiago, Reg Metropolitana de Santiago 8320325

Chile

Investigational Site Number : 1520005

Viña del Mar, Valparaiso 2531172

Chile

Investigational Site Number : 1560035

Beijing, 100034

China

Investigational Site Number : 1560013

Beijing, 100144

China

Investigational Site Number : 1560054

Changchun, 130021

China

Investigational Site Number : 1560010

Changsha, 410011

China

Investigational Site Number : 1560032

Changsha, 410015

China

Investigational Site Number : 1560018

Chengdu, 610041

China

Investigational Site Number : 1560004

Chengdu, 610072

China

Investigational Site Number : 1560005

Chengdu, 611130

China

Investigational Site Number : 1560062

Foshan, 528041

China

Investigational Site Number : 1560021

Guangzhou, 510150

China

Investigational Site Number : 1560001

Guangzhou, 510163

China

Investigational Site Number : 1560030

Hangzhou, 310006

China

Investigational Site Number : 1560024

Harbin, 150001

China

Investigational Site Number : 1560012

Hefei, 230032

China

Investigational Site Number : 1560046

Hefei, 231220

China

Investigational Site Number : 1560006

Hohhot, 010050

China

Investigational Site Number : 1560044

Huizhou, 516001

China

Investigational Site Number : 1560026

Jiaozuo, 454001

China

Investigational Site Number : 1560039

Jinan, 250014

China

Investigational Site Number : 1560049

Jinhua, 321000

China

Investigational Site Number : 1560056

Jining, 272011

China

Investigational Site Number : 1560043

Kunming, 650032

China

Investigational Site Number : 1560023

Langfang, 065000

China

Investigational Site Number : 1560047

Liaocheng, 252000

China

Investigational Site Number : 1560033

Linhai, 317000

China

Investigational Site Number : 1560002

Nanchang, 330006

China

Investigational Site Number : 1560003

Nanchang, 330006

China

Investigational Site Number : 1560051

Nanning, 530021

China

Investigational Site Number : 1560017

Ningbo, 315041

China

Investigational Site Number : 1560031

Pingxiang, 337055

China

Investigational Site Number : 1560007

Shanghai, 200240

China

Investigational Site Number : 1560008

Shanghai, 200433

China

Investigational Site Number : 1560036

Shenyang, 110004

China

Investigational Site Number : 1560037

Shenzhen, 518020

China

Investigational Site Number : 1560027

Shihezi, 832008

China

Investigational Site Number : 1560015

Suining, 629000

China

Investigational Site Number : 1560022

Taiyuan, 030001

China

Investigational Site Number : 1560034

Taizhou, 318000

China

Investigational Site Number : 1560019

Tianjin, 300192

China

Investigational Site Number : 1560016

Ürümqi, 830054

China

Investigational Site Number : 1560029

Wenzhou, 325035

China

Investigational Site Number : 1560025

Wuhan, 430030

China

Investigational Site Number : 1560050

Wuxi, 214023

China

Investigational Site Number : 1560052

Xi'an, 710004

China

Investigational Site Number : 1560020

Xiamen, 361004

China

Investigational Site Number : 1560011

Xiangtan, 411100

China

Investigational Site Number : 1560055

Xianyang, 712000

China

Investigational Site Number : 1560058

Xinxiang, 453100

China

Investigational Site Number : 1560040

Xuzhou, 221006

China

Investigational Site Number : 1560041

Yangzhou, 225000

China

Investigational Site Number : 1560060

Yichang, 443003

China

Investigational Site Number : 1560059

Zhanjiang, 524004

China

Investigational Site Number : 1560057

Zhengzhou, 450052

China

Investigational Site Number : 1560048

Zunyi, 563003

China

Investigational Site Number : 2680004

Kutaisi, 4600

Georgia

Investigational Site Number : 2680002

Tbilisi, 0105

Georgia

Investigational Site Number : 2680001

Tbilisi, 0159

Georgia

Investigational Site Number : 2680006

Tbilisi, 0159

Georgia

Investigational Site Number : 2680003

Tbilisi, 0160

Georgia

Investigational Site Number : 3920042

Kōnan, Aichi-ken 483-8704

Japan

Investigational Site Number : 3920032

Nagoya, Aichi-ken 457-8511

Japan

Investigational Site Number : 3920057

Toyota, Aichi-ken 470-0396

Japan

Investigational Site Number : 3920047

Matsuyama, Ehime 790-0826

Japan

Investigational Site Number : 3920026

Fukuoka, Fukuoka 819-0055

Japan

Investigational Site Number : 3920006

Kurume, Fukuoka 830-0011

Japan

Investigational Site Number : 3920053

Kure, Hiroshima 737-0811

Japan

Investigational Site Number : 3920049

Sapporo, Hokkaido 006-0811

Japan

Investigational Site Number : 3920024

Himeji-Shi, Hyōgo 670-0849

Japan

Investigational Site Number : 3920009

Kobe, Hyōgo 650-0017

Japan

Investigational Site Number : 3920008

Kita, Kagawa-ken 761-0701

Japan

Investigational Site Number : 3920030

Sakaidechō, Kagawa-ken 762-8550

Japan

Investigational Site Number : 3920040

Kamakura, Kanagawa 247-8533

Japan

Investigational Site Number : 3920051

Kawasaki, Kanagawa 210-0852

Japan

Investigational Site Number : 3920035

Yokohama, Kanagawa 221-0855

Japan

Investigational Site Number : 3920054

Yokohama, Kanagawa 234-0054

Japan

Investigational Site Number : 3920015

Yokohama, Kanagawa 236-0004

Japan

Investigational Site Number : 3920045

Matsusaka, Mie-ken 515-0073

Japan

Investigational Site Number : 3920005

Sendai, Miyagi 980-8574

Japan

Investigational Site Number : 3920001

Kashihara, Nara 634-8522

Japan

Investigational Site Number : 3920012

Okayama, Okayama-ken 701-1192

Japan

Investigational Site Number : 3920043

Sakai, Osaka 591-8555

Japan

Investigational Site Number : 3920020

Ureshino-Shi, Saga-ken 843-0393

Japan

Investigational Site Number : 3920033

Hachiōji, Tokyo 193-0998

Japan

Investigational Site Number : 3920003

Ube, Yamaguchi 755-8505

Japan

Investigational Site Number : 3920021

Chiba, 260-0852

Japan

Investigational Site Number : 3920002

Fukushima, 960-1295

Japan

Investigational Site Number : 3920029

Hiroshima, 734-8530

Japan

Investigational Site Number : 3920039

Kagoshima, 892-0847

Japan

Investigational Site Number : 3920036

Kumamoto, 861-4193

Japan

Investigational Site Number : 3920018

Kumamoto, 862-0909

Japan

Investigational Site Number : 3920056

Kyoto, 610-0113

Japan

Investigational Site Number : 3920004

Osaka, 545-8586

Japan

Investigational Site Number : 3920007

Saga, 849-0937

Japan

Investigational Site Number : 3920028

Tokyo, 150-8935

Japan

Investigational Site Number : 3920017

Tokyo, 162-8655

Japan

Investigational Site Number : 3920023

Tokyo, 173-8610

Japan

Investigational Site Number : 6820003

Jeddah, 23421

Saudi Arabia

Investigational Site Number : 6820001

Riyadh, 11525

Saudi Arabia

Investigational Site Number : 6820002

Riyadh, 12746

Saudi Arabia

Investigational Site Number : 7920002

Adana, 01330

Turkey (Türkiye)

Investigational Site Number : 7920006

Ankara, 06010

Turkey (Türkiye)

Investigational Site Number : 7920003

Ankara, 06620

Turkey (Türkiye)

Investigational Site Number : 7920004

Gaziantep, 27310

Turkey (Türkiye)

Investigational Site Number : 7920005

Istanbul, 34020

Turkey (Türkiye)

Investigational Site Number : 7920007

Izmir, 35340

Turkey (Türkiye)

Investigational Site Number : 7920001

Mersin, 33070

Turkey (Türkiye)

Investigational Site Number : 8260014

Bristol, Bristol, City of BS37 4AX

United Kingdom

Investigational Site Number : 8260015

London, Hammersmith and Fulham W6 7HY

United Kingdom

Investigational Site Number : 8260003

Leicester, Leicestershire LE1 5WW

United Kingdom

Investigational Site Number : 8260009

Harrow, London, City of HA1 3UJ

United Kingdom

Investigational Site Number : 8260031

London, London, City of Se1 7eh

United Kingdom

Investigational Site Number : 8260034

Oxford, Oxfordshire OX3 9DU

United Kingdom

Investigational Site Number : 8260032

Worthing, West Sussex BN11 2DH

United Kingdom

Investigational Site Number : 8260002

Bradford, BD9 6RJ

United Kingdom