Recruiting
Phase 3

Lunsekimig

Sponsor:

Sanofi

Code:

NCT07190209

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

NCT07190209

Start date

Sep 16, 2025

Status verified date

Sep, 2026

Completion date

Jan 22, 2030

Anticipated

Primary completion date

Nov 27, 2029

Anticipated

Eligibility Criteria

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)

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

Locations

Chandler Clinical Research Trials- Site Number : 8400025

Recruiting

Chandler, Arizona, United States, 85224

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

Recruiting

Phoenix, Arizona, United States, 85032

Epic Medical Research - Surprise- Site Number : 8400096

Recruiting

Surprise, Arizona, United States, 85378

IMAX Clinical Trials- Site Number : 8400109

Recruiting

La Palma, California, United States, 90623

Long Beach Research Institute- Site Number : 8400027

Recruiting

Long Beach, California, United States, 90805

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

Recruiting

Los Angeles, California, United States, 90017

Newport Native MD- Site Number : 8400003

Recruiting

Newport Beach, California, United States, 92663

Paradigm Research - Redding- Site Number : 8400108

Recruiting

Redding, California, United States, 96001

Amicis Research Center - Valencia- Site Number : 8400119

Recruiting

Valencia, California, United States, 91355

Helix Biomedics- Site Number : 8400065

Recruiting

Boynton Beach, Florida, United States, 33435

Beautiful Minds Clinical Research Center- Site Number : 8400017

Recruiting

Cutler Bay, Florida, United States, 33157

Eastern Medical Group Research- Site Number : 8400020

Recruiting

Fort Myers, Florida, United States, 33908

Premier Medical Associates- Site Number : 8400012

Recruiting

Lady Lake, Florida, United States, 32159

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

Recruiting

Miami, Florida, United States, 33125

MCR Research- Site Number : 8400004

Recruiting

Miami, Florida, United States, 33126

Nuren Medical & Research Center- Site Number : 8400030

Recruiting

Miami, Florida, United States, 33144

My Community Research Center- Site Number : 8400164

Recruiting

Miami, Florida, United States, 33155

Deluxe Health Center- Site Number : 8400010

Recruiting

Miami Lakes, Florida, United States, 33014

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

Recruiting

Orlando, Florida, United States, 32810

Broward Research Center - Pembroke Pines- Site Number : 8400053

Recruiting

Pembroke Pines, Florida, United States, 33024

Clinical Research Trials of Florida- Site Number : 8400011

Recruiting

Tampa, Florida, United States, 33607

Deluxe Health Center-Tampa- Site Number : 8400056

Recruiting

Tampa, Florida, United States, 33607

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

Recruiting

Cordele, Georgia, United States, 31015

Primeway Clinical Research- Site Number : 8400121

Recruiting

Fayetteville, Georgia, United States, 30214

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

Recruiting

Chicago, Illinois, United States, 60612

Avicenna Clinical Research- Site Number : 8400126

Recruiting

Chicago Ridge, Illinois, United States, 60415

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

Recruiting

Evanston, Illinois, United States, 60201

Indy Clinical Research- Site Number : 8400071

Recruiting

Indianapolis, Indiana, United States, 46268

University of Kansas Medical Center- Site Number : 8400054

Recruiting

Kansas City, Kansas, United States, 66160

Southern Clinical Research - Zachary- Site Number : 8400113

Recruiting

Zachary, Louisiana, United States, 70791

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

Recruiting

Ann Arbor, Michigan, United States, 48109

Pulmonary and Medicine Associates- Site Number : 8400007

Recruiting

Warren, Michigan, United States, 48088

Mayo Clinic in Rochester - Minnesota- Site Number : 8400005

Recruiting

Rochester, Minnesota, United States, 55905

Henderson Clinical Trials- Site Number : 8400026

Recruiting

Henderson, Nevada, United States, 89052

Sierra Clinical Research - Las Vegas- Site Number : 8400028

Recruiting

Las Vegas, Nevada, United States, 89106

Sanmora Bespoke Clinical Research Solutions- Site Number : 8400144

Recruiting

East Orange, New Jersey, United States, 07018

New York Hospital Queens- Site Number : 8400058

Recruiting

Flushing, New York, United States, 11355

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

Recruiting

Hickory, North Carolina, United States, 28601

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

Recruiting

Winston-Salem, North Carolina, United States, 27103

Plains Clinical Research Center- Site Number : 8400140

Recruiting

Fargo, North Dakota, United States, 58104

Dayton Clinical Research- Site Number : 8400124

Recruiting

Dayton, Ohio, United States, 45409

Epic Medical Research - Chickasha- Site Number : 8400097

Recruiting

Chickasha, Oklahoma, United States, 73018

Temple University Hospital - Main Campus- Site Number : 8400059

Recruiting

Philadelphia, Pennsylvania, United States, 19140-5103

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

Recruiting

Pittsburgh, Pennsylvania, United States, 15236

AnMed Oglesby Center- Site Number : 8400074

Recruiting

Anderson, South Carolina, United States, 29621

MD First Research - Lancaster- Site Number : 8400102

Recruiting

Lancaster, South Carolina, United States, 29720

REX Clinical Trials - Beaumont- Site Number : 8400014

Recruiting

Beaumont, Texas, United States, 77701

Novel Research - Bellaire- Site Number : 8400116

Recruiting

Bellaire, Texas, United States, 77401

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

Recruiting

Boerne, Texas, United States, 78006

TEN20 Clinical Research - Carrollton- Site Number : 8400141

Recruiting

Carrollton, Texas, United States, 75010

Corsicana Medical Research- Site Number : 8400134

Recruiting

Corsicana, Texas, United States, 75110

Syri Research Center- Site Number : 8400069

Recruiting

Cypress, Texas, United States, 77065

Texas Health Presbyterian Hospital Dallas- Site Number : 8400032

Recruiting

Dallas, Texas, United States, 75231

Epic Medical Research - De Soto- Site Number : 8400095

Recruiting

DeSoto, Texas, United States, 75115

Valley Institute of Research- Site Number : 8400118

Recruiting

Harlingen, Texas, United States, 78550

Trio Clinical Trials- Site Number : 8400106

Recruiting

Houston, Texas, United States, 77008

HDH Research- Site Number : 8400104

Recruiting

Houston, Texas, United States, 77022

Baylor College of Medicine- Site Number : 8400076

Recruiting

Houston, Texas, United States, 77030

Gulf Coast Clinical Research - Houston- Site Number : 8400049

Recruiting

Houston, Texas, United States, 77070

Lumi Research - Kingwood- Site Number : 8400120

Recruiting

Kingwood, Texas, United States, 77339

Syri Research Center- Site Number : 8400136

Recruiting

Kingwood, Texas, United States, 77339

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

Recruiting

Lampasas, Texas, United States, 76550

Discovery Clinical Trials - San Antonio- Site Number : 8400031

Recruiting

San Antonio, Texas, United States, 78229

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

Recruiting

San Antonio, Texas, United States, 78249

Element Research Group- Site Number : 8400115

Recruiting

San Antonio, Texas, United States, 78257

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

Recruiting

Williamsburg, Virginia, United States, 23188

Investigational Site Number : 1240011

Recruiting

Calgary, Alberta, Canada, T3R 1W7

Investigational Site Number : 1240010

Recruiting

Ajax, Ontario, Canada, L1S 2J5

Investigational Site Number : 1240004

Recruiting

Guelph, Ontario, Canada, N1h 6j2

Investigational Site Number : 1240012

Recruiting

Ottawa, Ontario, Canada, K1G 6C6

Investigational Site Number : 1240009

Recruiting

Stoney Creek, Ontario, Canada, L8G 2V6

Investigational Site Number : 1240001

Recruiting

Toronto, Ontario, Canada, M5T 3A9

More Information

Sponsor

Sanofi

Last update posted

Sep 2, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Sanofi on 2026-09-02.