Status:

RECRUITING

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

Lead Sponsor:

Sanofi

Conditions:

Chronic Obstructive Pulmonary Disease

Eligibility:

All Genders

40-80 years

Phase:

PHASE3

Brief Summary

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...

Detailed Description

All eligible participants will undergo subcutaneous administrations of lunsekimig or matching placebo during a 48-weeks treatment period

Eligibility 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.

Key Trial Info

Start Date :

September 17 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

January 22 2030

Estimated Enrollment :

942 Patients enrolled

Trial Details

Trial ID

NCT07190222

Start Date

September 17 2025

End Date

January 22 2030

Last Update

March 23 2026

Active Locations (175)

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Page 1 of 44 (175 locations)

1

Tucson Clinical Research Institute- Site Number : 8400006

Tucson, Arizona, United States, 85712

2

Ark Clinical Research- Site Number : 8400113

Long Beach, California, United States, 90815

3

Alliance Clinical - West Hills- Site Number : 8400067

Los Angeles, California, United States, 91307

4

California Medical Research Associates - Northridge- Site Number : 8400089

Northridge, California, United States, 91324