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

Korábbi kezelés

• Long-term oxygen therapy >4.0 L/min or requirement of >2.0 L/min to maintain oxygen saturation >88% at rest
• 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.

Más betegség

• Asthma, including pediatric asthma, or asthma-COPD overlap syndrome (ACOS)
• Significant pulmonary disease other than COPD
• Unstable disorder that can impact participants safety or study outcomes
• Active or incompletely treated tuberculosis
• Current or past malignancies

Egyéb

• Participants are excluded from the study if any of the following criteria apply:

• 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