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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Chronic Obstructive Pulmonary Disease

In brief

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.

Key facts

Study ID

NCT07190222

Run by

Sanofi

People needed

942

Starts

2025-09-17

Expected to finish

2030-01-22

Last updated by the study team

2026-06-15

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Tucson Clinical Research Institute- Site Number : 8400006 — Tucson, Arizona, United States (enrolling)
• Inglewood Clinical- Site Number : 8400074 — Inglewood, California, United States (enrolling)
• Ark Clinical Research- Site Number : 8400113 — Long Beach, California, United States (enrolling)
• Alliance Clinical - West Hills- Site Number : 8400067 — Los Angeles, California, United States (enrolling)
• California Medical Research Associates - Northridge- Site Number : 8400089 — Northridge, California, United States (enrolling)
• Alpine Clinical Research Center - Boulder - 47th Street- Site Number : 8400005 — Boulder, Colorado, United States (enrolling)
• Critical Care Pulmonary & Sleep Associates- Site Number : 8400081 — Lakewood, Colorado, United States (enrolling)
• Howard University Hospital- Site Number : 8400080 — Washington D.C., District of Columbia, United States (enrolling)
• Finlay Medical Research - Greenacres- Site Number : 8400107 — Greenacres City, Florida, United States (enrolling)
• Direct Helpers Research Center- Site Number : 8400057 — Hialeah, Florida, United States (enrolling)
• Pulmonary Specialists of the Palm Beaches- Site Number : 8400017 — Loxahatchee Groves, Florida, United States (enrolling)
• DL Research Solutions- Site Number : 8400140 — Miami, Florida, United States (enrolling)
• Phoenix Medical Research - Miami - 24th Street- Site Number : 8400027 — Miami, Florida, United States (enrolling)
• Professional Research Center- Site Number : 8400046 — Miami, Florida, United States (enrolling)
• Research Institute of South Florida- Site Number : 8400028 — Miami, Florida, United States (enrolling)
• Innovations Biotech- Site Number : 8400019 — Miami, Florida, United States (enrolling)
• Florida Institute for Clinical Research- Site Number : 8400001 — Orlando, Florida, United States (enrolling)
• Avanza Medical Research Center- Site Number : 8400015 — Pensacola, Florida, United States (enrolling)
• Hull and Hull Medical Specialists- Site Number : 8400002 — Plantation, Florida, United States (enrolling)
• Windom Allergy, Asthma and Sinus Specialists- Site Number : 8400041 — Sarasota, Florida, United States (enrolling)
• Better Life Clinical Research- Site Number : 8400152 — Tampa, Florida, United States (enrolling)
• Appalachian Clinical Research- Site Number : 8400060 — Adairsville, Georgia, United States (enrolling)
• Christie Clinic in Champaign on University- Site Number : 8400023 — Champaign, Illinois, United States (enrolling)
• Sneeze Wheeze & Itch Associates- Site Number : 8400020 — Normal, Illinois, United States (enrolling)
• University of Alabama at Birmingham- Site Number : 8400003 — Birmingham, Alabama, United States (enrolling)

Full record on ClinicalTrials.gov

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