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 and Eosinophilic Phenotype
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
- 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) that is not well controlled and has an eosinophilic phenotype. Participants will be in the study for up to 60 weeks, which includes different periods for screening, treatment, and follow-up. An eosinophilic phenotype means there are higher levels of a type of white blood cell called eosinophils, which can affect breathing.
During the study, participants will receive subcutaneous injections, which are shots given under the skin, of either the investigational medication or a placebo. A placebo is an inactive substance that looks like the investigational medicine but does not contain any medicine. Participants will be observed to see how well the treatment works and if there are any side effects.
- Who can participate: Adults aged 40 to 80 years with COPD for at least one year, specific lung function measurements, and a history of smoking may be eligible. Participants should have recent COPD exacerbations and be on certain COPD therapies.
- Study details: Participants will get regular shots under the skin of either the investigational medicine or a placebo. The study will watch for treatment effects and side effects.
- Study timelines: The study will last up to 60 weeks.
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