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
Investigation of Efficacy, Safety, and Tolerability of an Investigational Medication in Adults with Chronic Obstructive Pulmonary Disease (COPD)
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
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Age: 40 years - 80 years
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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 efficacy, safety, and tolerability of an investigational medication given as a subcutaneous injection compared to a placebo in adults with chronic obstructive pulmonary disease (COPD). COPD is a long-term lung disease that causes breathing difficulties. This study focuses on participants who have an eosinophilic phenotype, which means they have higher levels of a type of white blood cell called eosinophils.
Participants in the study will receive subcutaneous administrations of either the investigational medication or a placebo over a 48-week period. A placebo is an inactive substance that looks like the investigational medicine but does not contain any medicine. The study aims to assess how well participants tolerate the treatment and its effects on their COPD symptoms.
- Who can participate: Adults aged 40 to 80 years with a diagnosis of COPD for at least one year can participate. Key criteria include specific lung function, smoking history, and blood eosinophil levels, excluding those with asthma or other significant lung diseases.
- Study details: Participants will receive subcutaneous injections of either the investigational medication or a placebo over a 48-week period.
- Study timelines: The study will last 60 weeks.
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