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Clinical Trials in the UK / NCT07190209
Recruiting Phase 3

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 · tracked via the Priya Life Science UK tracker
Sponsor
Sanofi
Phase
Phase 3
Started
2025-09-16
Last updated
2026-09-15

Condition(s) studied

Chronic Obstructive Pulmonary Disease

Investigational drug(s) / intervention(s)

LunsekimigPlacebo

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

Study 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.

Eligibility

Sex
ALL
Min age
40 Years
Max age
80 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (221)

FacilityCityRegionStatus
Chandler Clinical Research Trials- Site Number : 8400025 Chandler Arizona Recruiting
Pulmonary Associates - Phoenix - East Bell Road- Site Number : 8400114 Phoenix Arizona Recruiting
Epic Medical Research - Surprise- Site Number : 8400096 Surprise Arizona Recruiting
IMAX Clinical Trials- Site Number : 8400109 La Palma California Recruiting
Long Beach Research Institute- Site Number : 8400027 Long Beach California Recruiting
Downtown L.A. Research Center- Site Number : 8400009 Los Angeles California Recruiting
Newport Native MD- Site Number : 8400003 Newport Beach California Recruiting
Paradigm Research - Redding- Site Number : 8400108 Redding California Recruiting
Amicis Research Center - Valencia- Site Number : 8400119 Valencia California Recruiting
Helix Biomedics- Site Number : 8400065 Boynton Beach Florida Recruiting
Beautiful Minds Clinical Research Center- Site Number : 8400017 Cutler Bay Florida Recruiting
Eastern Medical Group Research- Site Number : 8400020 Fort Myers Florida Recruiting
Premier Medical Associates- Site Number : 8400012 Lady Lake Florida Recruiting
University of Miami Dermatology Clinical Trials Unit- Site Number : 8400078 Miami Florida Recruiting
MCR Research- Site Number : 8400004 Miami Florida Recruiting
Nuren Medical & Research Center- Site Number : 8400030 Miami Florida Recruiting
My Community Research Center- Site Number : 8400164 Miami Florida Recruiting
Deluxe Health Center- Site Number : 8400010 Miami Lakes Florida Recruiting
Omega Research Consultants - Orlando - Forest City- Site Number : 8400015 Orlando Florida Recruiting
Broward Research Center - Pembroke Pines- Site Number : 8400053 Pembroke Pines Florida Recruiting
Clinical Research Trials of Florida- Site Number : 8400011 Tampa Florida Recruiting
Deluxe Health Center-Tampa- Site Number : 8400056 Tampa Florida Recruiting
Private Practice - Dr. David Kavtaradze- Site Number : 8400006 Cordele Georgia Recruiting
Primeway Clinical Research- Site Number : 8400121 Fayetteville Georgia Recruiting
University of Illinois-Chicago - College of Medicine- Site Number : 8400055 Chicago Illinois Recruiting
Avicenna Clinical Research- Site Number : 8400126 Chicago Ridge Illinois Recruiting
NorthShore Medical Group - Evanston ( Endeavor Health)- Site Number : 8400073 Evanston Illinois Recruiting
Indy Clinical Research- Site Number : 8400071 Indianapolis Indiana Recruiting
University of Kansas Medical Center- Site Number : 8400054 Kansas City Kansas Recruiting
Southern Clinical Research - Zachary- Site Number : 8400113 Zachary Louisiana Recruiting
University of Michigan Health System - Ann Arbor- Site Number : 8400090 Ann Arbor Michigan Recruiting
Veritas Clinical Research- Site Number : 8400007 Madison Heights Michigan Recruiting
Mayo Clinic in Rochester - Minnesota- Site Number : 8400005 Rochester Minnesota Recruiting
Henderson Clinical Trials- Site Number : 8400026 Henderson Nevada Recruiting
Sierra Clinical Research - Las Vegas- Site Number : 8400028 Las Vegas Nevada Recruiting
Sanmora Bespoke Clinical Research Solutions- Site Number : 8400144 East Orange New Jersey Recruiting
New York Hospital Queens- Site Number : 8400058 Flushing New York Recruiting
Advanced Respiratory and Sleep Medicine - Hickory- Site Number : 8400013 Hickory North Carolina Recruiting
Atrium Health Wake Forest Baptist Pulmonary, Sleep And Allergy- Site Number : 8400048 Winston-Salem North Carolina Recruiting
Plains Clinical Research Center- Site Number : 8400140 Fargo North Dakota Recruiting

+ 181 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07190209 on ClinicalTrials.gov ↗ ← All trials in the UK