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Clinical Trials in the UK / NCT07190222
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

NCT07190222 · tracked via the Priya Life Science UK tracker
Sponsor
Sanofi
Phase
Phase 3
Started
2025-09-17
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 (214)

FacilityCityRegionStatus
University of Alabama at Birmingham- Site Number : 8400003 Birmingham Alabama Recruiting
Tucson Clinical Research Institute- Site Number : 8400006 Tucson Arizona Recruiting
Inglewood Clinical- Site Number : 8400074 Inglewood California Recruiting
Ark Clinical Research- Site Number : 8400113 Long Beach California Recruiting
Alliance Clinical - West Hills- Site Number : 8400067 Los Angeles California Recruiting
California Medical Research Associates - Northridge- Site Number : 8400089 Northridge California Recruiting
Alpine Clinical Research Center - Boulder - 47th Street- Site Number : 8400005 Boulder Colorado Recruiting
Critical Care Pulmonary & Sleep Associates- Site Number : 8400081 Lakewood Colorado Recruiting
Howard University Hospital- Site Number : 8400080 Washington D.C. District of Columbia Recruiting
Finlay Medical Research - Greenacres- Site Number : 8400107 Greenacres City Florida Recruiting
Direct Helpers Research Center- Site Number : 8400057 Hialeah Florida Recruiting
Pulmonary Specialists of the Palm Beaches- Site Number : 8400017 Loxahatchee Groves Florida Recruiting
DL Research Solutions- Site Number : 8400140 Miami Florida Recruiting
Phoenix Medical Research - Miami - 24th Street- Site Number : 8400027 Miami Florida Recruiting
Professional Research Center- Site Number : 8400046 Miami Florida Recruiting
Research Institute of South Florida- Site Number : 8400028 Miami Florida Recruiting
Innovations Biotech- Site Number : 8400019 Miami Florida Recruiting
Florida Institute for Clinical Research- Site Number : 8400001 Orlando Florida Recruiting
Avanza Medical Research Center- Site Number : 8400015 Pensacola Florida Recruiting
Hull and Hull Medical Specialists- Site Number : 8400002 Plantation Florida Recruiting
Windom Allergy, Asthma and Sinus Specialists- Site Number : 8400041 Sarasota Florida Recruiting
Better Life Clinical Research- Site Number : 8400152 Tampa Florida Recruiting
Appalachian Clinical Research- Site Number : 8400060 Adairsville Georgia Recruiting
Christie Clinic in Champaign on University- Site Number : 8400023 Champaign Illinois Recruiting
Sneeze Wheeze & Itch Associates- Site Number : 8400020 Normal Illinois Recruiting
Peoria Pulmonary Associates Ltd- Site Number : 8400095 Peoria Illinois Recruiting
Asha Clinical Research - Munster- Site Number : 8400115 Hammond Indiana Recruiting
Care Access - Shreveport - Youree Drive- Site Number : 8400007 Shreveport Louisiana Recruiting
Lucida Clinical Trials- Site Number : 8400101 New Bedford Massachusetts Recruiting
Vitalis Clinical Research Center- Site Number : 8400040 Allen Park Michigan Recruiting
Bolt Clinical Research- Site Number : 8400086 Brighton Michigan Recruiting
Hannibal Regional Healthcare System- Site Number : 8400035 Hannibal Missouri Recruiting
Excel Clinical Research - Las Vegas- Site Number : 8400070 Las Vegas Nevada Recruiting
AB Clinical Trials- Site Number : 8400075 Las Vegas Nevada Completed
Bioluminux Clinical Research - Hamilton, New Jersey- Site Number : 8400037 Hamilton New Jersey Recruiting
Mid Hudson Medical Research - New Windsor- Site Number : 8400004 New Windsor New York Recruiting
East Carolina University- Site Number : 8400102 Greenville North Carolina Recruiting
Piedmont Healthcare - Family Medicine- Site Number : 8400022 Statesville North Carolina Recruiting
All-Trials Clinical Research- Site Number : 8400008 Winston-Salem North Carolina Recruiting
Asthma & Allergy Center - Toledo- Site Number : 8400110 Toledo Ohio Recruiting

+ 174 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 NCT07190222 on ClinicalTrials.gov ↗ ← All trials in the UK