Lunsekimig for Sinusitis with Polyps

Recruiting at 8 trial locations

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: Sanofi

Must be taking: Intranasal steroids

Disqualifiers: Hypersensitivity, Concurrent study, Adverse events, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Compensation: Varies

Number of Visits: 13

Duration: 52 weeks

64 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called lunsekimig for individuals with chronic sinusitis with nasal polyps (CRSwNP) who haven't found relief from other treatments. The goal is to assess the safety and effectiveness of lunsekimig over a long period. Participants will receive lunsekimig shots every four weeks and use a nasal spray daily for a year. This trial suits those who have completed an earlier lunsekimig study and are currently using the nasal spray treatment. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

The trial requires participants to continue using intranasal mometasone furoate nasal spray. The protocol does not specify if you need to stop other medications, so it's best to discuss this with the study team.

Is there any evidence suggesting that lunsekimig is likely to be safe for humans?

Research shows that lunsekimig is under evaluation for its safety and effectiveness in treating chronic rhinosinusitis with nasal polyps (CRSwNP). Early results from other studies suggest that lunsekimig is generally safe for patients. Some participants experienced mild side effects, but no serious safety issues have emerged so far. This is a Phase 2 trial, indicating that the treatment demonstrated some safety in earlier studies, but researchers continue to assess its long-term safety and patient tolerance. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for sinusitis with polyps?

Unlike the standard treatments for sinusitis with polyps, which often include corticosteroids and surgery, Lunsekimig offers a unique approach. Researchers are excited about Lunsekimig because it is administered subcutaneously every four weeks, complementing the daily use of an intranasal mometasone furoate nasal spray. This combination may provide a more sustained and targeted anti-inflammatory effect, potentially reducing polyp size and improving symptoms more effectively than current options. The convenience of a monthly injection, combined with the daily nasal spray, could also improve patient adherence and overall outcomes.

What evidence suggests that lunsekimig might be an effective treatment for sinusitis with polyps?

Research has shown that lunsekimig may help treat chronic rhinosinusitis with nasal polyps (CRSwNP). Participants in this trial will receive lunsekimig along with intranasal mometasone furoate nasal spray as part of their treatment regimen. Patients who used lunsekimig with their regular treatment experienced symptom relief. Studies suggest it can reduce the size and number of nasal polyps, which are growths in the nose that can block breathing. This treatment targets inflammation, a major cause of CRSwNP. Early results indicate that lunsekimig is safe and effective for long-term use in managing this condition. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for adults with chronic rhinosinusitis and nasal polyps who finished a previous study on Lunsekimig. They must be using Mometasone furoate nasal spray and willing to comply with the study requirements for about 56 weeks.

Inclusion Criteria

I am currently using a nasal spray medication called mometasone.

Participants who have completed the treatment period and the follow up period in CRSwNP lunsekimig parent study, including EOS visit, as per protocol

I am willing and able to follow the study's schedule and procedures.

Exclusion Criteria

I am not allergic to lunsekimig or its ingredients.

Concurrent participation in any clinical study other than the parent study, including non-interventional studies

Participants who, during their participation in the parent study, developed an adverse event (AE) or a serious adverse event (SAE) deemed related to lunsekimig, which in the opinion of the Investigator could indicate that continued treatment with lunsekimig may present an unreasonable risk for the participant

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive lunsekimig subcutaneous injections every 4 weeks and intranasal mometasone furoate nasal spray daily for 52 weeks

52 weeks

13 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Lunsekimig

Trial Overview The trial is testing the long-term safety and effectiveness of Lunsekimig in participants from an earlier study. It's a single-arm extension, meaning everyone gets Lunsekimig, without comparison to another drug or placebo.

How Is the Trial Designed?

Group I: Lunsekimig Experimental Treatment 2 Interventions

Participant will receive lunsekimig subcutaneous (SC) every 4 weeks and intranasal mometasone furoate nasal spray (MFNS) daily for 52 weeks.

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/NCT06914908

Long-term Safety and Efficacy Evaluation of Lunsekimig in ... This is a single-arm extension study to investigate the long-term safety, tolerability, and efficacy of lunsekimig in adult participants with inadequately ...

2. clinicaltrials.eu clinicaltrials.eu/trial/study-on-long-term-safety-and-efficacy-of-lunsekimig-for-adults-with-chronic-rhinosinusitis-with-nasal-polyps/

Study on Long-Term Safety and Efficacy of Lunsekimig for ... This study investigates the long-term safety and efficacy of Lunsekimig, a treatment being tested for adults with chronic rhinosinusitis ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06454240

NCT06454240 | A Proof-of-concept Study of Lunsekimig ... The purpose of this study is to assess the efficacy, safety, and tolerability of add-on therapy with subcutaneous lunsekimig in adult participants (aged 18 to ...

4. sanofistudies.com sanofistudies.com/cwout/CW-V9DEXS//us/en/listing/312934/a-proof-of-concept-study-of/

Investigation of an Add-on Therapy for CRSwNP This study investigates a treatment for chronic rhinosinusitis with nasal polyps (CRSwNP), a condition where growths called polyps form in ...

5. 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 ... Lunsekimig now targeting chronic rhinosinusitis and COPD in addition to asthma; Itepekimab expanding into chronic rhinosinusitis along with ...

6. go.drugbank.com go.drugbank.com/drugs/DB19009/clinical_trials?conditions=DBCOND0121724&phase=2&purpose=treatment&status=recruiting

Lunsekimig Recruiting Phase 2 Trials for Chronic ... Long-term Safety and Efficacy Evaluation of Lunsekimig in Adult Participants With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) Who Completed a Previous ...