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

Study on the Effects of an Investigational Medication on COPD with Eosinophilic Phenotype

Recruiting
40 years - 80 years
All
Phase 3
942 participants needed
10 Locations

Study Overview

This is a parallel, Phase 2/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 40 to 80 years, inclusive) with inadequately controlled Chronic obstructive pulmonary disease (COPD) characterized by an eosinophilic phenotype.

Participation to the study consists of 3 periods:

  • Screening period of up to 4 weeks
  • Randomized intervention period of approximately 48 weeks
  • Follow-up period: Approximately 8 weeks The study duration will be up to 60 weeks.

Study Details

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

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Chronic Obstructive Pulmonary Disease
  • Age: 40 years - 80 years
  • Gender: All

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 ACOS
  • Sgnificant pulmonary disease other than COPD
  • Long-term oxygen therapy >4.0 L/min or requirement of >2.0 L/minO2 saturation to maintain oxygen saturation >88%
  • 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 iPDE-4 unless on stable therapy for >6 months
    • any biologic therapy or systemic immunosuppressant within 8 weeks 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

This study investigates the effects of an investigational medication, administered subcutaneously, in adults with Chronic Obstructive Pulmonary Disease (COPD) characterized by an eosinophilic phenotype. COPD is a chronic lung disease that causes breathing difficulties and is often associated with long-term exposure to harmful substances like cigarette smoke. The study aims to evaluate the efficacy, safety, and tolerability of the investigational medication compared to a placebo, which is an inactive substance that looks like the investigational medicine but does not contain any medicine.

Participants will be randomly assigned to one of three study arms, receiving either the investigational medication or a placebo. The study involves regular subcutaneous administrations over a 48-week period. Participants will be monitored for changes in their COPD symptoms and any side effects that may occur, ensuring a comprehensive assessment of the investigational medication's impact.

  • Who can participate: Adults aged 40 to 80 with a physician-diagnosed COPD for at least one year, characterized by an eosinophilic phenotype, may be eligible. Key criteria include a history of smoking, specific lung function test results, and previous COPD exacerbations.
  • Study details: Participants will receive subcutaneous injections of the investigational medication or a placebo over a 48-week period. The placebo is an inactive substance that resembles the investigational medicine but does not contain any active ingredients.
  • Study timelines: The study will last 60 weeks.
Updated on 14 Oct 2025. Study ID: NCT07190209

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