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 · NCT07190222 · Interventional (participants receive a specific treatment) · Lead sponsor: Sanofi
View the official record on ClinicalTrials.gov →Interventions studied
LunsekimigPlacebo
What this trial is about
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 take part
Age range
40 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
60 locations listed across 24 US states.
- University of Alabama at Birmingham- Site Number : 8400003 - Birmingham, Alabama, United States
- Tucson Clinical Research Institute- Site Number : 8400006 - Tucson, Arizona, United States
- Inglewood Clinical- Site Number : 8400074 - Inglewood, California, United States
- Ark Clinical Research- Site Number : 8400113 - Long Beach, California, United States
- Alliance Clinical - West Hills- Site Number : 8400067 - Los Angeles, California, United States
- California Medical Research Associates - Northridge- Site Number : 8400089 - Northridge, California, United States
- Alpine Clinical Research Center - Boulder - 47th Street- Site Number : 8400005 - Boulder, Colorado, United States
- Critical Care Pulmonary & Sleep Associates- Site Number : 8400081 - Lakewood, Colorado, United States
- Howard University Hospital- Site Number : 8400080 - Washington D.C., District of Columbia, United States
- Finlay Medical Research - Greenacres- Site Number : 8400107 - Greenacres City, Florida, United States
- Direct Helpers Research Center- Site Number : 8400057 - Hialeah, Florida, United States
- Pulmonary Specialists of the Palm Beaches- Site Number : 8400017 - Loxahatchee Groves, Florida, United States
- DL Research Solutions- Site Number : 8400140 - Miami, Florida, United States
- Phoenix Medical Research - Miami - 24th Street- Site Number : 8400027 - Miami, Florida, United States
- Professional Research Center- Site Number : 8400046 - Miami, Florida, United States
- Research Institute of South Florida- Site Number : 8400028 - Miami, Florida, United States
- Innovations Biotech- Site Number : 8400019 - Miami, Florida, United States
- Florida Institute for Clinical Research- Site Number : 8400001 - Orlando, Florida, United States
- Avanza Medical Research Center- Site Number : 8400015 - Pensacola, Florida, United States
- Hull and Hull Medical Specialists- Site Number : 8400002 - Plantation, Florida, United States
- Windom Allergy, Asthma and Sinus Specialists- Site Number : 8400041 - Sarasota, Florida, United States
- Better Life Clinical Research- Site Number : 8400152 - Tampa, Florida, United States
- Appalachian Clinical Research- Site Number : 8400060 - Adairsville, Georgia, United States
- Christie Clinic in Champaign on University- Site Number : 8400023 - Champaign, Illinois, United States
- Sneeze Wheeze & Itch Associates- Site Number : 8400020 - Normal, Illinois, United States
- Peoria Pulmonary Associates Ltd- Site Number : 8400095 - Peoria, Illinois, United States
- Asha Clinical Research - Munster- Site Number : 8400115 - Hammond, Indiana, United States
- Care Access - Shreveport - Youree Drive- Site Number : 8400007 - Shreveport, Louisiana, United States
- Lucida Clinical Trials- Site Number : 8400101 - New Bedford, Massachusetts, United States
- Vitalis Clinical Research Center- Site Number : 8400040 - Allen Park, Michigan, United States
- Bolt Clinical Research- Site Number : 8400086 - Brighton, Michigan, United States
- Hannibal Regional Healthcare System- Site Number : 8400035 - Hannibal, Missouri, United States
- Excel Clinical Research - Las Vegas- Site Number : 8400070 - Las Vegas, Nevada, United States
- AB Clinical Trials- Site Number : 8400075 - Las Vegas, Nevada, United States
- Bioluminux Clinical Research - Hamilton, New Jersey- Site Number : 8400037 - Hamilton, New Jersey, United States
- Mid Hudson Medical Research - New Windsor- Site Number : 8400004 - New Windsor, New York, United States
- East Carolina University- Site Number : 8400102 - Greenville, North Carolina, United States
- Piedmont Healthcare - Family Medicine- Site Number : 8400022 - Statesville, North Carolina, United States
- All-Trials Clinical Research- Site Number : 8400008 - Winston-Salem, North Carolina, United States
- Asthma & Allergy Center - Toledo- Site Number : 8400110 - Toledo, Ohio, United States
- Layrek Clinical Research- Site Number : 8400066 - Tulsa, Oklahoma, United States
- The Oregon Clinic - Portland - Northwest 22nd Avenue- Site Number : 8400065 - Portland, Oregon, United States
- MedTrial- Site Number : 8400010 - Columbia, South Carolina, United States
- Chattanooga Research and Medicine- Site Number : 8400026 - Chattanooga, Tennessee, United States
- IntraCare- Site Number : 8400034 - Dallas, Texas, United States
- Premier Pulmonary Critical Care and Sleep- Site Number : 8400111 - Denison, Texas, United States
- El Paso Pulmonary Association- Site Number : 8400033 - El Paso, Texas, United States
- Axsendo Clinical Research - Houston- Site Number : 8400054 - Houston, Texas, United States
- SE Houston- Site Number : 8400120 - Houston, Texas, United States
- Synergy Group US - Missouri City- Site Number : 8400119 - Missouri City, Texas, United States
- Synergy Group US - Missouri City- Site Number : 8400133 - Missouri City, Texas, United States
- Elligo Health Care, Hillcroft Medical Clinic Association- Site Number : 8400053 - Sugar Land, Texas, United States
- Medrasa Clinical Research - Wylie- Site Number : 8400124 - Wylie, Texas, United States
- Rheumatology & Pulmonary Clinic- Site Number : 8400012 - Beckley, West Virginia, United States
- Investigational Site Number : 3000007 - Athens, Greece
- Investigational Site Number : 5540001 - Auckland, New Zealand
- Investigational Site Number : 1560003 - Baotou, China
- Investigational Site Number : 1560022 - Beijing, China
- Investigational Site Number : 1560001 - Beijing, China
- Investigational Site Number : 1560023 - Beijing, China
Showing 60 of 214 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →