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 · NCT07190209 · 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 21 US states.
- Chandler Clinical Research Trials- Site Number : 8400025 - Chandler, Arizona, United States
- Pulmonary Associates - Phoenix - East Bell Road- Site Number : 8400114 - Phoenix, Arizona, United States
- Epic Medical Research - Surprise- Site Number : 8400096 - Surprise, Arizona, United States
- IMAX Clinical Trials- Site Number : 8400109 - La Palma, California, United States
- Long Beach Research Institute- Site Number : 8400027 - Long Beach, California, United States
- Downtown L.A. Research Center- Site Number : 8400009 - Los Angeles, California, United States
- Newport Native MD- Site Number : 8400003 - Newport Beach, California, United States
- Paradigm Research - Redding- Site Number : 8400108 - Redding, California, United States
- Amicis Research Center - Valencia- Site Number : 8400119 - Valencia, California, United States
- Helix Biomedics- Site Number : 8400065 - Boynton Beach, Florida, United States
- Beautiful Minds Clinical Research Center- Site Number : 8400017 - Cutler Bay, Florida, United States
- Eastern Medical Group Research- Site Number : 8400020 - Fort Myers, Florida, United States
- Premier Medical Associates- Site Number : 8400012 - Lady Lake, Florida, United States
- University of Miami Dermatology Clinical Trials Unit- Site Number : 8400078 - Miami, Florida, United States
- MCR Research- Site Number : 8400004 - Miami, Florida, United States
- Nuren Medical & Research Center- Site Number : 8400030 - Miami, Florida, United States
- My Community Research Center- Site Number : 8400164 - Miami, Florida, United States
- Deluxe Health Center- Site Number : 8400010 - Miami Lakes, Florida, United States
- Omega Research Consultants - Orlando - Forest City- Site Number : 8400015 - Orlando, Florida, United States
- Broward Research Center - Pembroke Pines- Site Number : 8400053 - Pembroke Pines, Florida, United States
- Clinical Research Trials of Florida- Site Number : 8400011 - Tampa, Florida, United States
- Deluxe Health Center-Tampa- Site Number : 8400056 - Tampa, Florida, United States
- Private Practice - Dr. David Kavtaradze- Site Number : 8400006 - Cordele, Georgia, United States
- Primeway Clinical Research- Site Number : 8400121 - Fayetteville, Georgia, United States
- University of Illinois-Chicago - College of Medicine- Site Number : 8400055 - Chicago, Illinois, United States
- Avicenna Clinical Research- Site Number : 8400126 - Chicago Ridge, Illinois, United States
- NorthShore Medical Group - Evanston ( Endeavor Health)- Site Number : 8400073 - Evanston, Illinois, United States
- Indy Clinical Research- Site Number : 8400071 - Indianapolis, Indiana, United States
- University of Kansas Medical Center- Site Number : 8400054 - Kansas City, Kansas, United States
- Southern Clinical Research - Zachary- Site Number : 8400113 - Zachary, Louisiana, United States
- University of Michigan Health System - Ann Arbor- Site Number : 8400090 - Ann Arbor, Michigan, United States
- Veritas Clinical Research- Site Number : 8400007 - Madison Heights, Michigan, United States
- Mayo Clinic in Rochester - Minnesota- Site Number : 8400005 - Rochester, Minnesota, United States
- Henderson Clinical Trials- Site Number : 8400026 - Henderson, Nevada, United States
- Sierra Clinical Research - Las Vegas- Site Number : 8400028 - Las Vegas, Nevada, United States
- Sanmora Bespoke Clinical Research Solutions- Site Number : 8400144 - East Orange, New Jersey, United States
- New York Hospital Queens- Site Number : 8400058 - Flushing, New York, United States
- Advanced Respiratory and Sleep Medicine - Hickory- Site Number : 8400013 - Hickory, North Carolina, United States
- Atrium Health Wake Forest Baptist Pulmonary, Sleep And Allergy- Site Number : 8400048 - Winston-Salem, North Carolina, United States
- Plains Clinical Research Center- Site Number : 8400140 - Fargo, North Dakota, United States
- Dayton Clinical Research- Site Number : 8400124 - Dayton, Ohio, United States
- Epic Medical Research - Chickasha- Site Number : 8400097 - Chickasha, Oklahoma, United States
- Temple University Hospital - Main Campus- Site Number : 8400059 - Philadelphia, Pennsylvania, United States
- Preferred Primary Care Physicians - Pleasant Hills- Site Number : 8400092 - Pittsburgh, Pennsylvania, United States
- AnMed Oglesby Center- Site Number : 8400074 - Anderson, South Carolina, United States
- MD First Research - Lancaster- Site Number : 8400102 - Lancaster, South Carolina, United States
- REX Clinical Trials - Beaumont- Site Number : 8400014 - Beaumont, Texas, United States
- Novel Research - Bellaire- Site Number : 8400116 - Bellaire, Texas, United States
- South Texas Medical Research Institute - TTS Research- Site Number : 8400018 - Boerne, Texas, United States
- TEN20 Clinical Research - Carrollton- Site Number : 8400141 - Carrollton, Texas, United States
- Corsicana Medical Research- Site Number : 8400134 - Corsicana, Texas, United States
- Syri Research Center- Site Number : 8400069 - Cypress, Texas, United States
- Texas Health Presbyterian Hospital Dallas- Site Number : 8400032 - Dallas, Texas, United States
- Epic Medical Research - De Soto- Site Number : 8400095 - DeSoto, Texas, United States
- Valley Institute of Research- Site Number : 8400118 - Harlingen, Texas, United States
- Trio Clinical Trials- Site Number : 8400106 - Houston, Texas, United States
- HDH Research- Site Number : 8400104 - Houston, Texas, United States
- Baylor College of Medicine- Site Number : 8400076 - Houston, Texas, United States
- Gulf Coast Clinical Research - Houston- Site Number : 8400049 - Houston, Texas, United States
- Lumi Research - Kingwood- Site Number : 8400120 - Kingwood, Texas, United States
Showing 60 of 221 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →