Lunsekimig for Nasal Polyps

Not currently recruiting at 42 trial locations

Overseen By Trial Transparency email recommended (Toll free for US & Canada)

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Sanofi

Must be taking: Intranasal corticosteroids

Must not be taking: Systemic corticosteroids, Anti-IgE, Monoclonal antibodies

Disqualifiers: Nasal surgery, Allergic fungal rhinosinusitis, HIV, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates whether lunsekimig, an experimental drug, can help people with nasal polyps who haven't found success with nasal sprays. Participants will receive either lunsekimig or a placebo alongside their usual nasal spray to determine if lunsekimig can reduce symptoms like nasal congestion and loss of smell. The trial is suitable for those who have experienced nasal congestion and other symptoms for at least two months, even while using nasal sprays. The goal is to find a more effective way to manage nasal polyps and improve daily life for those affected. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important medical advancements.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop your current medications, but it does exclude those who have recently used certain therapies like systemic corticosteroids or monoclonal antibodies. It's best to discuss your specific medications with the trial team.

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

Research has shown that lunsekimig was well tolerated in past studies. Participants did not report any major safety issues, indicating the treatment was generally safe. Researchers are also testing it for other conditions like asthma, which means its safety has been studied in different groups of people.

These findings suggest that lunsekimig is likely safe for most people. However, as with any treatment, risks or side effects may still exist. Discuss any concerns with the study team or your doctor before deciding to join a trial. ^{1 2 3 4 5}

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

Researchers are excited about Lunsekimig for treating nasal polyps because it offers a new approach that could be more effective than current options like corticosteroid nasal sprays, oral corticosteroids, or surgery. Unlike these treatments, Lunsekimig is a biologic agent administered through subcutaneous injection every four weeks, aiming to directly target the inflammatory processes causing nasal polyps. This targeted mechanism could lead to better symptom control and fewer side effects compared to standard therapies, which often involve broader suppression of the immune system. If successful, Lunsekimig may offer a more convenient and effective solution for patients suffering from this chronic condition.

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

This trial will compare the effects of lunsekimig with a placebo for treating nasal polyps. Studies have shown that lunsekimig targets specific proteins causing inflammation, which can ease symptoms related to breathing problems. In earlier research with asthma patients, lunsekimig greatly improved lung function and reduced inflammation. Early results from other studies suggest it might also be effective for nasal polyps, as it targets similar pathways involved in this condition. Overall, these findings suggest that lunsekimig could benefit people with nasal polyps, especially those who haven't found success with other treatments. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

Adults aged 18-70 with chronic rhinosinusitis and nasal polyps, who still have symptoms like nasal blockage or loss of smell despite using nasal steroids. They must score moderately to severely on a symptom scale and have noticeable polyps in both nostrils.

Inclusion Criteria

I have had severe nasal symptoms including congestion and loss of smell for over 2 months.

I have severe nasal polyps despite using nasal sprays for 2 months.

Exclusion Criteria

I have symptoms or a CT scan indicating allergic fungal sinusitis.

I have not taken steroids, anti-IgE, or monoclonal antibody treatments recently.

I have not had nasal/sinus surgery in the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants receive subcutaneous lunsekimig or placebo every 4 weeks along with intranasal mometasone furoate nasal spray for 24 weeks

24 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Lunsekimig

Trial Overview The trial is testing Lunsekimig, an add-on therapy given by injection, against a placebo. It's for adults whose sinus issues aren't controlled by standard treatments. The study will last about 40 weeks including screening, treatment period, and follow-up.

How Is the Trial Designed?

Group I: Arm 2 Experimental Treatment 1 Intervention

Participant will receive lunsekimig subcutaneous (SC) every 4 weeks and intranasal mometasone furoate nasal spray (MFNS) for 24 weeks.

Group II: Arm 1 Placebo Group 1 Intervention

Participant will receive placebo subcutaneous (SC) every 4 weeks and intranasal mometasone furoate nasal spray (MFNS) for 24 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

Published Research Related to This Trial

In a post hoc analysis of the SINUS-24 and SINUS-52 studies, dupilumab significantly improved patient-reported symptoms and objective measures in patients with chronic rhinosinusitis with nasal polyps (CRSwNP), with responder rates at week 24 showing 64% improvement in nasal congestion compared to 24% in the placebo group.

At both week 24 and week 52, dupilumab-treated patients demonstrated clinically meaningful improvements across various measures, including loss of smell and total symptom scores, indicating its efficacy in managing CRSwNP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dupilumab in CRSwNP: Responder Analysis Using Clinically Meaningful Efficacy Outcome Thresholds. Chuang, CC., Guillemin, I., Bachert, C., et al.[2022]

Biologics targeting type 2 inflammatory cytokines (like IL4, IL5, and IL13) show significant efficacy in reducing nasal polyp scores and improving health status in patients with severe chronic rhinosinusitis with nasal polyps, with dupilumab demonstrating the highest reduction in symptoms (35% in nasal polyp score).

All biologics studied not only improved nasal airway blockage but also decreased the need for additional medical or surgical interventions, highlighting their potential as effective treatments for managing this challenging condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Choice of Biologics in Patients with Severe Chronic Rhinosinusitis with Nasal Polyps. Lipworth, BJ., Chan, R.[2021]

Dupilumab significantly improved symptoms and objective measures of chronic rhinosinusitis with nasal polyps (CRSwNP) in patients, regardless of whether they also had allergic rhinitis, based on a pooled analysis of 724 patients from two phase III studies.

The treatment also reduced the need for systemic corticosteroids and sinonasal surgery, demonstrating its efficacy and safety profile, which was consistent across patients with and without allergic rhinitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dupilumab efficacy in patients with chronic rhinosinusitis with nasal polyps with and without allergic rhinitis. Peters, AT., Wagenmann, M., Bernstein, JA., et al.[2023]

In a study involving 49 patients with chronic rhinosinusitis with nasal polyps (CRSwNP) in Japan, dupilumab significantly reduced nasal polyp size, nasal congestion, and sinus opacification compared to placebo, demonstrating its efficacy in improving symptoms after 24 weeks of treatment.

Dupilumab was well tolerated among participants, with the most common side effect being nasopharyngitis, indicating a favorable safety profile consistent with previous studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Dupilumab on Intractable Chronic Rhinosinusitis with Nasal Polyps in Japan. Fujieda, S., Matsune, S., Takeno, S., et al.[2021]

Biologics like anti-IgE (omalizumab) and IL-5 blockers (mepolizumab, reslizumab, benralizumab) have shown effectiveness in treating allergic rhinitis and nasal polyposis, which are linked to type 2 inflammation.

While these treatments are effective, they are also expensive, highlighting the need for future studies to assess their cost-effectiveness compared to traditional medical and surgical options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biologics for the Treatment of Allergic Rhinitis, Chronic Rhinosinusitis, and Nasal Polyposis. Eschenbacher, W., Straesser, M., Knoeddler, A., et al.[2021]

Citations

1. 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 ... Sanofi's respiratory pipeline advances with new data in asthma and plans for new clinical studies in COPD.

2. 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 ...

3. congress.sanofimedical.com congress.sanofimedical.com/s3fs-public/2023-05/ATS%202023%20NANOBODY%20SAR443765%20Oral%20presentation%20SUBMITTED%2005-08-23%20%281%29.pdf?VersionId=64mgz.FmLyHTdN_Yh0H27qkYOzAclsjn

Targeting of TSLP and IL-13 by the novel NANOBODY ... History of nasal polyps, n (%). 2 (17). 2 (8). 4 (11). Enrolled ... Anti-IL-13 trials. SAR443765. –40.9 ppb. (90% CI: –55.4 to –26.4)†. Phase ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12018761/

A proof-of-mechanism trial in asthma with lunsekimig ... A single dose of lunsekimig was well tolerated, significantly suppressed T2 inflammation and improved lung function in mild-to-moderate asthma.

5. sanofi.com sanofi.com/en/media-room/press-releases/2023/2023-05-05-12-30-00-2662513

Press Release: New late-breaking data at ATS 2023 ... New late-breaking data at ATS 2023 demonstrate significant advancements across Dupixent® and broader respiratory pipeline.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11196376/

A first‐in‐human, single and multiple dose study of ... Lunsekimig, a bispecific anti‐TSLP/anti‐IL‐13 NANOBODY® compound, was well tolerated with an acceptable safety and dose‐proportional, linear ...

7. sanofistudies.com sanofistudies.com/cwout/CW-V9DEXS//gb/en/listing/313061/long-term-safety-and-efficacy-7/

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 ...