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 of Investigational Medication for Chronic Obstructive Pulmonary Disease (COPD)

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

Study Overview

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 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 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.

This study investigates Chronic Obstructive Pulmonary Disease (COPD). Participants will be adults with COPD that is not adequately controlled and characterized by an eosinophilic phenotype.

This study evaluates the safety, effectiveness, and tolerability of a subcutaneous treatment compared to a placebo. It focuses on understanding how well the treatment works and how safe it is for participants.

  • Who can participate: Adults aged 40 to 80 years with diagnosed COPD for at least one year, who are former or current smokers with a significant smoking history, may participate. Key factors include specific lung function parameters and a history of COPD exacerbations.
  • Study details: Participants will receive either the investigational medication or a placebo, which is an inactive substance that looks like the investigational medicine but does not contain any medicine. The treatment is given as a subcutaneous injection over a period of 48 weeks.
  • Study timelines: The study will last 60 weeks.
Updated on 24 May 2026. Study ID: NCT07190222

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