Are you struggling with managing symptoms of Chronic Obstructive Pulmonary Disease (COPD)?
This is a Phase 2/3 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.
Would you like to take part?
As a volunteer in a research study, you’ll receive study-related medical care from the study doctor and regular follow-up of your health to monitor the effectiveness of the care you’ll receive. The results of this research will be used to find out if the investigational medication being studied will be of benefit to others struggling with COPD, and whether it will be made widely available to all Canadians trying to manage this condition. Study volunteers are an important part of moving medical care forward.
You may qualify to participate in this study if you:
- Are between 40 to 80 years of age, inclusive
- Have physician diagnosed chronic obstructive pulmonary disease (COPD) for ≥1 year
- Have 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
- Are a former or current smoker with ≥10 pack-years
- Record a Chronic Airways Assessment Test (CAAT) of ≥10
- Have had ≥2 moderate or ≥1 severe COPD exacerbations in the prior year
- Have been using triple (ICS+LABA+LAMA) COPD therapy ≥12 consecutive weeks
- Test for EOS (blood eosinophil count) ≥ 150 cells/μL
- Have a 18.0 ≤ Body Mass Index ≤ 40.0 kg/m2
You may not qualify to participate if you:
- Have asthma, including pediatric asthma, or ACOS
- Have any significant pulmonary disease other than COPD
- Require long-term oxygen therapy >4.0 L/min or requirement of >2.0 L/minO2 saturation to maintain oxygen saturation >88%
- Have any unstable disorder that can impact participants safety or study outcomes
- Have active or incompletely treated tuberculosis
- Have any current or past malignancies
- Take any 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
There are other eligibility requirements that the study doctor will review. Only the study doctor can finally determine whether you are eligible to participate in the study or not.
