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Lunsekimig for COPD with Eosinophilic Phenotype

This study is testing a drug called Lunsekimig against a placebo (an inactive substance) in adults aged 40 to 80 who have chronic obstructive pulmonary disease (COPD) that isn't well-controlled and is characterized by an "eosinophilic phenotype" (a specific type of inflammation). Researchers want to see if Lunsekimig can reduce the number of moderate-to-severe COPD flare-ups over 48 weeks, and if it is safe and well-tolerated. To join, you must have a COPD diagnosis for at least one year and specific lung function test results. The study is currently recruiting about 942 participants, but its exact status is unclear.

Study design
This is a parallel, Phase 2b/Phase 3 study involving about 942 participants. Participants will be randomly assigned to receive either Lunsekimig or a placebo.
What's involved
You would participate in a screening period of up to 4 weeks, followed by a treatment period of about 48 weeks where you would receive subcutaneous injections. There will also be an 8-week follow-up period, making the total study duration up to 60 weeks.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for approximately 8 weeks after the 48-week treatment period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07190222

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 40–80InterventionalTreatment
Sanofi
~942 participants
Updated 2026-06-15 on ClinicalTrials.gov
What's tested:LunsekimigPlacebo

At a glance

Recruiting sites
211 of 213 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

Chronic Obstructive Pulmonary Disease

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Where it's being run

213 sites across 64 states
China72
Florida13
Argentina11
South Africa10
Texas9
Quebec8
Taiwan8
Malaysia6

Who to contact

Trial Transparency email recommended (Toll free for US & Canada)
[email protected]
800-633-1610 · ext. option 6
Email the study team

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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