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

NCT07190209

Run by

Sanofi

People needed

942

Starts

2025-09-16

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

• Pulmonary Associates - Phoenix - East Bell Road- Site Number : 8400114 — Phoenix, Arizona, United States (enrolling)
• Epic Medical Research - Surprise- Site Number : 8400096 — Surprise, Arizona, United States (enrolling)
• IMAX Clinical Trials- Site Number : 8400109 — La Palma, California, United States (enrolling)
• Long Beach Research Institute- Site Number : 8400027 — Long Beach, California, United States (enrolling)
• Downtown L.A. Research Center- Site Number : 8400009 — Los Angeles, California, United States (enrolling)
• Newport Native MD- Site Number : 8400003 — Newport Beach, California, United States (enrolling)
• Paradigm Research - Redding- Site Number : 8400108 — Redding, California, United States (enrolling)
• Amicis Research Center - Valencia- Site Number : 8400119 — Valencia, California, United States (enrolling)
• Helix Biomedics- Site Number : 8400065 — Boynton Beach, Florida, United States (enrolling)
• Beautiful Minds Clinical Research Center- Site Number : 8400017 — Cutler Bay, Florida, United States (enrolling)
• Eastern Medical Group Research- Site Number : 8400020 — Fort Myers, Florida, United States (enrolling)
• Premier Medical Associates- Site Number : 8400012 — Lady Lake, Florida, United States (enrolling)
• University of Miami Dermatology Clinical Trials Unit- Site Number : 8400078 — Miami, Florida, United States (enrolling)
• MCR Research- Site Number : 8400004 — Miami, Florida, United States (enrolling)
• Nuren Medical & Research Center- Site Number : 8400030 — Miami, Florida, United States (enrolling)
• My Community Research Center- Site Number : 8400164 — Miami, Florida, United States (enrolling)
• Deluxe Health Center- Site Number : 8400010 — Miami Lakes, Florida, United States (enrolling)
• Omega Research Consultants - Orlando - Forest City- Site Number : 8400015 — Orlando, Florida, United States (enrolling)
• Broward Research Center - Pembroke Pines- Site Number : 8400053 — Pembroke Pines, Florida, United States (enrolling)
• Clinical Research Trials of Florida- Site Number : 8400011 — Tampa, Florida, United States (enrolling)
• Deluxe Health Center-Tampa- Site Number : 8400056 — Tampa, Florida, United States (enrolling)
• Private Practice - Dr. David Kavtaradze- Site Number : 8400006 — Cordele, Georgia, United States (enrolling)
• Primeway Clinical Research- Site Number : 8400121 — Fayetteville, Georgia, United States (enrolling)
• University of Illinois-Chicago - College of Medicine- Site Number : 8400055 — Chicago, Illinois, United States (enrolling)
• Chandler Clinical Research Trials- Site Number : 8400025 — Chandler, Arizona, United States (enrolling)

Full record on ClinicalTrials.gov

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