Lunsekimig for Chronic Obstructive Pulmonary Disease

(THESEUS Trial)

Recruiting at 111 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Sanofi

Must be taking: Triple COPD therapy

Must not be taking: Biologic therapy, Systemic immunosuppressant

Disqualifiers: Asthma, Other pulmonary disease, Malignancies, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 48 weeks

942 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called lunsekimig for people with COPD, a lung disease that makes breathing difficult, who do not respond well to current treatments. The study aims to evaluate the effectiveness and safety of lunsekimig compared to a placebo, a harmless pill with no effect, over about a year. Individuals who have had COPD for at least a year, experience frequent flare-ups, and are on certain medications but still struggle with symptoms might be a good fit. Participants will receive different doses of lunsekimig or a placebo to determine which works best. As a Phase 3 trial, this study represents the final step before potential FDA approval, offering a chance to contribute to advancing COPD treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but it mentions that you cannot have used any biologic therapy or systemic immunosuppressant within 8 weeks before the screening. It also requires that you have been on triple COPD therapy for at least 12 weeks.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that lunsekimig has been tested for safety in conditions like COPD and asthma. In these studies, participants generally tolerated lunsekimig well. Most side effects were mild to moderate, such as headaches or mild reactions at the injection site, while serious side effects were rare.

This clinical trial is in a later stage, indicating more is known about the treatment's safety. Earlier studies have already assessed safety in smaller groups. Although this does not eliminate all risks, it suggests that major safety issues are unlikely. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for COPD?

Most treatments for Chronic Obstructive Pulmonary Disease (COPD), like bronchodilators and corticosteroids, focus on opening airways and reducing inflammation. But Lunsekimig works differently, aiming at a unique pathway to improve lung function and potentially slow disease progression. Researchers are particularly excited because Lunsekimig could offer a new mechanism of action that might complement or even surpass current therapies. This could provide hope for better management of COPD symptoms and improved quality of life for patients.

What evidence suggests that this trial's treatments could be effective for COPD?

Research has shown that lunsekimig may help treat Chronic Obstructive Pulmonary Disease (COPD), particularly in patients with a specific type of cell called an eosinophil. Early findings suggest that lunsekimig can reduce lung inflammation and improve breathing. Studies indicate it may lead to fewer flare-ups and better overall lung function. Although final results are pending, early data from previous studies offer hope for its effectiveness. This trial tests lunsekimig in different dose regimens, labeled as dose regimen A and dose regimen B, to find the best balance between safety and benefits. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

Adults aged 40-80 with poorly controlled COPD and an eosinophilic phenotype can join this study. They must have a history of smoking, specific lung function test results, and at least one severe or two moderate flare-ups in the past year despite triple therapy for COPD.

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

EOS (blood eosinophil count) of at least 150 cells/μL

I have been diagnosed with COPD for at least a year.

Exclusion Criteria

I have or had cancer before.

I need more than 2 liters per minute of oxygen to keep my oxygen levels above 88%.

I do not have any unstable health conditions.

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 people with COPD over three stages: screening up to 4 weeks, treatment for about 48 weeks, and follow-up for roughly 8 weeks. The total study duration is up to 60 weeks.

How Is the Trial Designed?

Group I: Lunsekimig dose regimen B Experimental Treatment 1 Intervention

Participants will receive lunsekimig dose regimen B.

Group II: Lunsekimig dose regimen A Experimental Treatment 1 Intervention

Participants will receive lunsekimig dose regimen A.

Group III: Placebo Placebo Group 1 Intervention

Participants will receive lunsekimig-matching placebo.

Who Is Running the Clinical Trial?

Sanofi

Lead Sponsor

Trials

2,246

Recruited

4,085,000+

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

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07190222

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 ...

2.

sanofi.com

sanofi.com/en/media-room/press-releases/2025/2025-04-15-05-00-00-3061368

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 ...

3.

sanofistudies.com

sanofistudies.com/cwout/CW-V9DEXS//gb/en/listing/313148/efficacy-safety-and-tolerability/

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 ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07190209

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 ...

5.

theglobeandmail.com

theglobeandmail.com/investing/markets/stocks/SNYNF/pressreleases/35470149/sanofis-promising-copd-study-lunsekimigs-potential-impact/

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, ...

6.

mountsinai.org

mountsinai.org/clinical-trials/study-of-lunsekimig-sar443765-compared-with-placebo-in-adults-with-high-risk-asthma

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 ...