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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

2026-10-23

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 (314)

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

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

And 214 more locations on ClinicalTrials.gov