942 Participants Needed

Lunsekimig for Chronic Obstructive Pulmonary Disease

(PERSEPHONE Trial)

Recruiting at 22 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Sanofi
Must be taking: Triple COPD therapy
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human 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.12345

Why 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

Post-bronchodilator forced expiratory volume in 1 second (post-BD FEV1) between 20% and 70% of predicted value and FEV1/FVC <0.70
Chronic Airways Assessment Test (CAAT) score of at least 10
Blood eosinophil count (EOS) of at least 150 cells/μL
See 6 more

Exclusion Criteria

I have active or untreated TB.
I have or had cancer before.
I haven't taken any immune system or biologic treatments in the last 8 weeks.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to 4 weeks

Treatment

Participants receive subcutaneous administrations of lunsekimig or matching placebo

48 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Lunsekimig
Trial Overview The trial is testing Lunsekimig against a placebo in adults with poorly controlled COPD marked by an eosinophilic phenotype. It's a parallel study where participants are randomly assigned to receive either the drug or placebo via subcutaneous injection over approximately 48 weeks followed by an 8-week follow-up.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Lunsekimig dose regimen BExperimental Treatment1 Intervention
Group II: Lunsekimig dose regimen AExperimental Treatment1 Intervention
Group III: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Sanofi

Lead Sponsor

Trials
2,246
Recruited
4,085,000+
Paul Hudson profile image

Paul Hudson

Sanofi

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Christopher Corsico profile image

Christopher Corsico

Sanofi

Chief Medical Officer

MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University

Citations

NCT07190222 | Efficacy, Safety, and Tolerability Study of ...This is a parallel, Phase 2/Phase 3, 3-arm study to investigate the efficacy, safety, and tolerability of subcutaneous (SC) treatment with lunsekimig ...
Press Release: Sanofi's respiratory pipeline advances with ...All were mild-to-moderate in severity and all non-serious. Full and final results will be presented at a forthcoming medical meeting. Lunsekimig ...
Efficacy, Safety, and Tolerability Study of Lunsekimig ...This is a parallel, Phase 2/Phase 3, 3-arm study to investigate the efficacy, safety, and tolerability of subcutaneous (SC) treatment with ...
NCT07190209 | Efficacy, Safety, and Tolerability Study of ...This is a parallel, Phase 2/Phase 3, 3-arm study to investigate the efficacy, safety, and tolerability of subcutaneous (SC) treatment with lunsekimig ...
Sanofi's Promising COPD Study: Lunsekimig's Potential ...' The study aims to evaluate the efficacy, safety, and tolerability of Lunsekimig in treating COPD patients with an eosinophilic phenotype, ...
Study of Lunsekimig (SAR443765) Compared With ...The purpose of this study is to assess the efficacy, safety, and tolerability of add-on therapy with SC lunsekimig compared with placebo in male and female ...
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