Who is eligible for clinical trial NCT07190209?

Participants must meet protocol criteria for Chronic Obstructive Pulmonary Disease. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT07190209 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-06-12

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 (NCT07190209)

🟢 Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: Sanofi

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (9 items) and avoid the listed exclusions (10 items).

Location: Chandler Clinical Research Trials- Site Number : 8400025 — Chandler, Arizona

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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
0 ≤ Body Mass Index ≤ 40.0 kg/m2

Usually NOT eligible if any of the following apply:

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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (215 Sites)

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

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗