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 COPD with Eosinophilic Phenotype

Recruiting
40 years - 80 years
All
Phase 3
942 participants needed
44 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
  • Significant 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 safety and effectiveness of an investigational medication compared to a placebo in adults with chronic obstructive pulmonary disease (COPD) characterized by an eosinophilic phenotype. Participants will be involved in the study for up to 60 weeks, which includes different phases like screening, treatment, and follow-up. During this time, participants will receive subcutaneous injections, which means the medicine is given under the skin.

Participants in the study will receive either the investigational medication or a placebo, which is a substance that looks like the medicine but does not contain any active ingredients. The study will involve regular check-ups and assessments to monitor the participants' health and the effects of the treatment. This will help researchers understand how well the treatment works and if there are any side effects.

  • Who can participate: Adults aged 40 to 80 years with COPD diagnosed for at least one year can participate. Key factors include having a certain level of lung function, a history of smoking, and specific blood test results. People with other lung diseases or certain health conditions may not be eligible.
  • Study details: Participants will receive injections under the skin and undergo health assessments during the study. The study will last up to 60 weeks and compare the investigational medication to a placebo, which is an inactive substance that looks like the investigational medicine but does not contain any medicine.
  • Study timelines: The study will last up to 60 weeks.
Updated on 05 Feb 2026. Study ID: NCT07190222

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