Recruiting

Phase 3

LunsekimigEfficacy, 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

Code:

NCT07190222

Conditions

Chronic Obstructive Pulmonary Disease

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Lunsekimig

Placebo

Study Details

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease

Study ID

NCT07190222

Start date

Sep 17, 2025

Status verified date

Oct, 2026

Completion date

Jan 22, 2030

Anticipated

Primary completion date

Nov 27, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

942 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Lunsekimig dose regimen A

Participants will receive lunsekimig dose regimen A.

experimental: Lunsekimig dose regimen B

Participants will receive lunsekimig dose regimen B.

placebo comparator: Placebo

Participants will receive lunsekimig-matching placebo.

Interventions

Lunsekimig

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

Placebo

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

Primary outcome measure

Annualized rate of moderate-to-severe chronic obstructive pulmonary disease (COPD) exacerbations [ Time Frame: From Baseline up to 48 weeks ]

Central Contacts and Locations

Central contacts

Trial Transparency email recommended (Toll free for US & Canada)

800-633-1610 contact-us@sanofi.com

Locations

University of Alabama at Birmingham- Site Number : 8400003

Recruiting

Birmingham, Alabama, United States, 35233

Pulmonary Associates - Mobile- Site Number : 8400151

Recruiting

Mobile, Alabama, United States, 36608

Tucson Clinical Research Institute- Site Number : 8400006

Recruiting

Tucson, Arizona, United States, 85712

Ark Clinical Research- Site Number : 8400113

Recruiting

Long Beach, California, United States, 90815

Inglewood Clinical- Site Number : 8400074

Recruiting

Los Angeles, California, United States, 90056

Alliance Clinical - West Hills- Site Number : 8400067

Recruiting

Los Angeles, California, United States, 91307

California Medical Research Associates - Northridge- Site Number : 8400089

Recruiting

Northridge, California, United States, 91324

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

Recruiting

Boulder, Colorado, United States, 80301

Critical Care Pulmonary & Sleep Associates- Site Number : 8400081

Recruiting

Lakewood, Colorado, United States, 80228

Howard University Hospital- Site Number : 8400080

Recruiting

Washington D.C., District of Columbia, United States, 20060

Meris Clinical Research- Site Number : 8400153

Recruiting

Brandon, Florida, United States, 33511

Hillcrest Medical Research- Site Number : 8400082

Recruiting

DeLand, Florida, United States, 32720

Finlay Medical Research - Greenacres- Site Number : 8400107

Recruiting

Greenacres City, Florida, United States, 33467

Direct Helpers Research Center- Site Number : 8400057

Recruiting

Hialeah, Florida, United States, 33012

University of Florida - Jacksonville- Site Number : 8400126

Recruiting

Jacksonville, Florida, United States, 32209

Salud Clinical Services- Site Number : 8400109

Recruiting

Lehigh Acres, Florida, United States, 33936

Pulmonary Specialists of the Palm Beaches- Site Number : 8400017

Recruiting

Loxahatchee Groves, Florida, United States, 33470

Elite Clinical Research - Miami- Site Number : 8400167

Recruiting

Miami, Florida, United States, 33144

DL Research Solutions- Site Number : 8400140

Recruiting

Miami, Florida, United States, 33155

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

Recruiting

Miami, Florida, United States, 33165

Professional Research Center- Site Number : 8400046

Recruiting

Miami, Florida, United States, 33172

Research Institute of South Florida- Site Number : 8400028

Recruiting

Miami, Florida, United States, 33173

Innovations Biotech- Site Number : 8400019

Recruiting

Miami, Florida, United States, 33186

Heuer M.D. Research- Site Number : 8400018

Recruiting

Orlando, Florida, United States, 32819

Florida Institute for Clinical Research- Site Number : 8400001

Recruiting

Orlando, Florida, United States, 32825

Avanza Medical Research Center- Site Number : 8400015

Recruiting

Pensacola, Florida, United States, 32503

Hull and Hull Medical Specialists- Site Number : 8400002

Recruiting

Plantation, Florida, United States, 33324

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

Recruiting

Sarasota, Florida, United States, 34239

Stat Care Pulmonary and Sleep- Site Number : 8400138

Recruiting

St. Petersburg, Florida, United States, 33709

Better Life Clinical Research- Site Number : 8400152

Recruiting

Tampa, Florida, United States, 33607

Vicis Clinical Research- Site Number : 8400158

Recruiting

Tampa, Florida, United States, 33615

Appalachian Clinical Research- Site Number : 8400060

Recruiting

Adairsville, Georgia, United States, 30103

Christie Clinic in Champaign on University- Site Number : 8400023

Recruiting

Champaign, Illinois, United States, 61820

Sneeze Wheeze & Itch Associates- Site Number : 8400020

Recruiting

Normal, Illinois, United States, 61761

Peoria Pulmonary Associates Ltd- Site Number : 8400095

Recruiting

Peoria, Illinois, United States, 61603

Asha Clinical Research - Munster- Site Number : 8400115

Recruiting

Hammond, Indiana, United States, 46324

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

Recruiting

Shreveport, Louisiana, United States, 71103

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

Recruiting

Shreveport, Louisiana, United States, 71105

Johns Hopkins Bayview Medical Center- Site Number : 8400076

Recruiting

Baltimore, Maryland, United States, 21224

Lucida Clinical Trials- Site Number : 8400101

Recruiting

New Bedford, Massachusetts, United States, 02740

Vitalis Clinical Research Center- Site Number : 8400040

Recruiting

Allen Park, Michigan, United States, 48101

Bolt Clinical Research- Site Number : 8400086

Recruiting

Brighton, Michigan, United States, 48116

Henry Ford Hospital- Site Number : 8400058

Recruiting

Detroit, Michigan, United States, 48202

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

Recruiting

Farmington Hills, Michigan, United States, 48336

Hannibal Regional Healthcare System- Site Number : 8400035

Recruiting

Hannibal, Missouri, United States, 63401

Washington University- Site Number : 8400144

Recruiting

St Louis, Missouri, United States, 63110

Excel Clinical Research - Las Vegas- Site Number : 8400070

Recruiting

Las Vegas, Nevada, United States, 89109

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

Recruiting

Hamilton, New Jersey, United States, 08690

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

Recruiting

Newark, New Jersey, United States, 07103

Trinity Medical, WNY- Site Number : 8400157

Recruiting

Buffalo, New York, United States, 14215

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

Recruiting

New Windsor, New York, United States, 12553

East Carolina University- Site Number : 8400102

Recruiting

Greenville, North Carolina, United States, 27858

All-Trials Clinical Research- Site Number : 8400008

Recruiting

Winston-Salem, North Carolina, United States, 27103

Asthma & Allergy Center - Toledo- Site Number : 8400110

Recruiting

Toledo, Ohio, United States, 43617

Layrek Clinical Research- Site Number : 8400066

Recruiting

Tulsa, Oklahoma, United States, 74133

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

Recruiting

Portland, Oregon, United States, 97210

Suburban Research Associates - Media- Site Number : 8400143

Recruiting

Media, Pennsylvania, United States, 19063

MedTrial- Site Number : 8400010

Recruiting

Columbia, South Carolina, United States, 29204

Chattanooga Research and Medicine- Site Number : 8400026

Recruiting

Chattanooga, Tennessee, United States, 37404

Premier Research Center, Llc- Site Number : 8400146

Recruiting

Hendersonville, Tennessee, United States, 37075

Solace Clinical Research- Site Number : 8400087

Recruiting

Austin, Texas, United States, 78759

IntraCare- Site Number : 8400034

Recruiting

Dallas, Texas, United States, 75254

Premier Pulmonary Critical Care and Sleep- Site Number : 8400111

Recruiting

Denison, Texas, United States, 75020

El Paso Pulmonary Association- Site Number : 8400033

Recruiting

El Paso, Texas, United States, 79902

Se Houston- Site Number : 8400120

Recruiting

Houston, Texas, United States, 77061

Aavon Clinical Trials, Llc- Site Number : 8400166

Recruiting

Houston, Texas, United States, 77074

Synergy Group US - Missouri City- Site Number : 8400119

Recruiting

Missouri City, Texas, United States, 77459

Synergy Group US - Missouri City- Site Number : 8400133

Recruiting

Missouri City, Texas, United States, 77459

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

Recruiting

Sugar Land, Texas, United States, 77478

Medrasa Clinical Research - Wylie- Site Number : 8400124

Recruiting

Wylie, Texas, United States, 75098

Rheumatology & Pulmonary Clinic- Site Number : 8400012

Recruiting

Beckley, West Virginia, United States, 25801

Investigational Site Number : 1240051

Recruiting

Kelowna, British Columbia, Canada, V1Y 4N7

Investigational Site Number : 1240052

Recruiting

West Vancouver, British Columbia, Canada, V7T 2Z3

Investigational Site Number : 1240045

Recruiting

Niagara Falls, Ontario, Canada, L2H 1H5

Investigational Site Number : 1240041

Recruiting

Windsor, Ontario, Canada, N8X 1T3

Investigational Site Number : 1240049

Recruiting

Longueuil, Quebec, Canada, J4K 1C8

Investigational Site Number : 1240055

Recruiting

Montreal, Quebec, Canada, H3T 1E2

Investigational Site Number : 1240047

Recruiting

Québec, Quebec, Canada, G1V 4G5

Investigational Site Number : 1240053

Recruiting

Québec, Quebec, Canada, G2J 0C4

Investigational Site Number : 1240050

Recruiting

Saint-Charles-Borromée, Quebec, Canada, J6E 2B4

Investigational Site Number : 1240054

Recruiting

Saint-Charles-Borromée, Quebec, Canada, J6E 2B4

Investigational Site Number : 1240048

Recruiting

Trois-Rivières, Quebec, Canada, G8T 7A1

Investigational Site Number : 1240042

Recruiting

Victoriaville, Quebec, Canada, G6P 3Z8

More Information

Sponsor

Sanofi

Last update posted

Oct 23, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by Sanofi on 2026-10-23. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.