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Lunsekimig versus placebo for eosinophilic COPD

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

Phase 3 Interventional Sanofi · NCT07190222

This trial tests whether subcutaneous lunsekimig can help adults 40–80 with inadequately controlled COPD who have a high blood eosinophil count.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment942 (estimated)
Ages40 Years to 80 Years
SexAll
SponsorSanofi Industry-sponsored
Locations194 sites (Tucson, Arizona and 193 other locations)
Trial IDNCT07190222 on ClinicalTrials.gov

What this trial studies

This is a randomized, parallel Phase 2b/Phase 3, three-arm trial comparing subcutaneous lunsekimig with matching placebo during a 48-week treatment period followed by an ~8-week follow-up. Eligible participants undergo screening of up to 4 weeks, are randomized to receive study drug or placebo, and continue regular study visits for dosing and safety assessments over about 60 weeks total. The study enrolls adults with an eosinophilic COPD phenotype who remain symptomatic despite triple inhaled therapy, and it measures efficacy, safety, and tolerability outcomes. All participants receive subcutaneous administrations during the intervention period and are monitored for exacerbations, lung function, and adverse events.

Who should consider this trial

Good fit: Adults aged 40–80 with physician-diagnosed COPD for ≥1 year, post-bronchodilator FEV1 20–70% predicted and FEV1/FVC <0.70, ≥2 moderate or ≥1 severe exacerbations in the prior year, on ICS+LABA+LAMA for ≥12 weeks, blood eosinophils ≥150 cells/μL, ≥10 pack-year smoking history, and BMI 18–40 kg/m2.

Not a fit: Patients with asthma or asthma–COPD overlap, other significant pulmonary diseases, long-term high-flow oxygen requirements, or a non-eosinophilic COPD profile are unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, lunsekimig could reduce COPD exacerbations and improve symptom control for patients with an eosinophilic phenotype.

How similar studies have performed: Other biologics that target eosinophils in COPD have shown mixed results, with some trials reporting reduced exacerbations in eosinophilic subgroups but no consistent benefit across all studies.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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 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:

  * 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.

Where this trial is running

Tucson, Arizona and 193 other locations

+144 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Chronic Obstructive Pulmonary Disease
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.