A Phase 2b/Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study, to Investigate the Efficacy and Safety of Lunsekimig in Adult Participants With Inadequately Controlled Chronic Obstructive Pulmonary Disease (COPD) Characterized by an Eosinophilic Phenotype
A Phase 2b/Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study, to Investigate the Efficacy and Safety of Lunsekimig in Adult Participants With Inadequately Controlled Chronic Obstructive Pulmonary Disease (COPD) Characterized by an Eosinophilic Phenotype
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:
All eligible participants will undergo subcutaneous administrations of lunsekimig or matching placebo during a 48-weeks treatment period
Inclusion Criteria:
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:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
contact-us@sanofi.com800-633-1610 ext. option 6
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