NCT07190209
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
PHASE3Ages 40–80InterventionalTreatmentSanofi
~942 participants
Updated 2026-06-15 on ClinicalTrials.gov
What's tested:LunsekimigPlacebo
At a glance
Recruiting sites
215 of 215 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Annualized rate of moderate-to-severe chronic obstructive pulmonary disease (COPD) exacerbations
Measured over From Baseline up to 48 weeks
Conditions
Where it's being run
215 sites across 64 statesChina54
Texas19
Florida13
Japan12
Georgia7
Turkey (Türkiye)7
California6
Argentina6
Who to contact
Trial Transparency email recommended (Toll free for US & Canada)
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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
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
What this trial measures
- Annualized rate of moderate-to-severe chronic obstructive pulmonary disease (COPD) exacerbationsFrom Baseline up to 48 weeks
The annualized moderate or severe COPD exacerbation rate up to 48 weeks treatment period compared to placebo