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Lunsekimig versus placebo for inadequately controlled eosinophilic COPD

A Phase 2b/Phase 3, Randomized, Double-blind, Placebocontrolled, 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 · NCT07190209

This study tests whether regular subcutaneous lunsekimig helps adults aged 40–80 with eosinophilic COPD that remains uncontrolled despite triple inhaled therapy.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment942 (estimated)
Ages40 Years to 80 Years
SexAll
SponsorSanofi Industry-sponsored
Locations183 sites (Chandler, Arizona and 182 other locations)
Trial IDNCT07190209 on ClinicalTrials.gov

What this trial studies

This is a randomized, parallel 3-arm Phase 2b/3 trial comparing subcutaneous lunsekimig to matching placebo over a 48-week treatment period with an additional screening and 8-week follow-up for a total study time up to about 60 weeks. Eligible participants have physician-diagnosed COPD for at least one year, a blood eosinophil count ≥150 cells/µL, persistent symptoms and recent exacerbations despite ICS+LABA+LAMA therapy, and meet standard spirometric criteria. Participants receive scheduled subcutaneous doses of lunsekimig or placebo and are monitored for exacerbations, lung function, symptoms, safety, and tolerability throughout the treatment period. The trial collects safety and efficacy data to determine whether lunsekimig provides clinical benefit in this eosinophilic COPD subgroup.

Who should consider this trial

Good fit: Adults 40 to 80 years old with COPD for ≥1 year, a blood eosinophil count ≥150 cells/µL, persistent symptoms (CAAT ≥10), a history of recent exacerbations, former or current smokers (≥10 pack-years), and on stable triple inhaled therapy are the ideal candidates.

Not a fit: Patients with asthma or asthma-COPD overlap, other significant pulmonary disease, need for high-flow long-term oxygen, eosinophil counts below the entry threshold, or who are well controlled on current therapy are unlikely to benefit from this intervention.

Why it matters

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

How similar studies have performed: Other eosinophil-targeting biologics in COPD have shown modest reductions in exacerbations in selected eosinophilic subgroups, but results across trials have been mixed.

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

Chandler, Arizona and 182 other locations

+133 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.