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
Sponsored by Sanofi
About this study
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.
All eligible participants will undergo subcutaneous administrations of lunsekimig or matching placebo during a 48-weeks treatment period
Where this study is enrolling (7)
- Call 602-443-4068
Pulmonary Associates - Phoenix - East Bell Road- Site Number : 8400114
Phoenix, Arizona
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- Call (224) 364-7100
NorthShore Medical Group - Evanston ( Endeavor Health)- Site Number : 8400073
Evanston, Illinois
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Temple University Hospital- Site Number : 8400059
Philadelphia, Pennsylvania
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Trio Clinical Trials- Site Number : 8400106
Houston, Texas
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Baylor College of Medicine- Site Number : 8400076
Houston, Texas
Show all 7 locations
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HDH Research- Site Number : 8400104
Houston, Texas
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Gulf Coast Clinical Research - Houston- Site Number : 8400049
Houston, Texas
Who can participate
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
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Trial data sourced from ClinicalTrials.gov.