Lunsekimig for Chronic Obstructive Pulmonary Disease
(PERSEPHONE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment called lunsekimig for individuals with Chronic Obstructive Pulmonary Disease (COPD) that isn't well-controlled. Researchers aim to assess the effectiveness and safety of this treatment compared to a placebo (a substance with no therapeutic effect). Participants will receive either a placebo or one of two different doses of lunsekimig. The trial seeks individuals who have had COPD for at least a year, experience frequent flare-ups, and have previously smoked. As a Phase 3 trial, this is the final step before FDA approval, offering participants an opportunity to contribute to a potentially groundbreaking treatment for COPD.
Will I have to stop taking my current medications?
The trial does not specify if you must stop taking your current medications, but it does mention that you cannot be on certain therapies like biologic therapy or systemic immunosuppressants within 8 weeks before the screening. It's best to discuss your current medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that lunsekimig is being tested for its safety and effectiveness in treating asthma and COPD, a lung disease that makes breathing difficult. Earlier studies found that lunsekimig is generally well-tolerated, with most people not experiencing serious side effects.
Some side effects were reported, but they were mostly mild. Common ones included redness or swelling at the injection site. These were not serious and could be managed easily.
Lunsekimig is in a late stage of research, indicating existing evidence of its safety for humans. When a treatment reaches this stage, earlier tests have usually shown it to be relatively safe. However, ongoing studies remain important to confirm its safety and effectiveness for COPD.12345Why are researchers excited about this trial's treatments?
Researchers are excited about Lunsekimig for treating Chronic Obstructive Pulmonary Disease (COPD) because it offers a potentially new approach compared to existing treatments like bronchodilators and inhaled corticosteroids. Lunsekimig works by targeting specific pathways in the lungs, which could lead to improved lung function and symptom relief. Additionally, it comes in two different dose regimens, A and B, allowing for potential optimization of effectiveness and patient response. This innovative approach could provide a significant improvement in managing COPD symptoms and enhancing the quality of life for patients.
What evidence suggests that lunsekimig might be an effective treatment for COPD?
Studies have shown that lunsekimig may benefit people with Chronic Obstructive Pulmonary Disease (COPD), particularly those with the eosinophilic phenotype. These patients have higher levels of a specific white blood cell, which lunsekimig targets. Research indicates that the drug reduces lung swelling, potentially improving breathing. Early findings suggest that lunsekimig has shown promise in reducing symptoms and enhancing lung function. While more research is needed, lunsekimig could be a helpful option for COPD patients with this condition. Participants in this trial will receive either lunsekimig in various dose regimens or a placebo to evaluate its effectiveness.12346
Are You a Good Fit for This Trial?
Adults aged 40-80 with COPD for at least a year, specific breathing test scores (FEV1 ≥20% and ≤70%, FEV1/FVC <0.70), blood eosinophil count ≥150 cells/μL, history of smoking (≥10 pack-years), BMI between 18.0-40.0 kg/m2, on triple therapy for COPD for 12 weeks or more, experienced multiple flare-ups in the past year.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive subcutaneous administrations of lunsekimig or matching placebo
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Lunsekimig
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sanofi
Lead Sponsor
Paul Hudson
Sanofi
Chief Executive Officer since 2019
Degree in Economics from Manchester Metropolitan University
Christopher Corsico
Sanofi
Chief Medical Officer
MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University