RecruitingChronic Obstructive Pulmonary Disease

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

Eligible age

40–80 yrs

Accepts

All genders

Locations

21 states

Healthy volunteers

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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.

Sponsor: Sanofi

You may qualify if…

✓ 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

You may not qualify if…

✕ 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: