Lunsekimig for Nasal Polyps

Recruiting at 33 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

80 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the drug Lunsekimig for Nasal Polyps?

Research shows that targeting type 2 inflammatory cytokines (proteins involved in inflammation) like IL-4, IL-5, and IL-13 is effective in treating nasal polyps. Similar drugs, such as dupilumab, which block IL-4 and IL-13, have significantly improved symptoms and reduced the need for surgery in patients with nasal polyps. ^{1 2 3 4 5}

What is the purpose of this trial?

This is a parallel, Phase 2, 2-arm, multicenter, randomized, double-blind, placebo-controlled, proof-of-concept study for treatment of CRSwNP. 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 70 years, inclusive) with CRSwNP who are inadequately controlled on intranasal corticosteroid treatment. Participants with and without co-morbid asthma will be included in the study, and lung function will be assessed in both groups. The study duration will be up to approximately 40 weeks per participant, including 4 weeks of screening run-in period, 24 weeks of intervention period, and 12 weeks of follow-up.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Biologics for the Treatment of Allergic Rhinitis, Chronic Rhinosinusitis, and Nasal Polyposis. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Dupilumab in CRSwNP: Responder Analysis Using Clinically Meaningful Efficacy Outcome Thresholds. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

The Effect of Dupilumab on Intractable Chronic Rhinosinusitis with Nasal Polyps in Japan. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Dupilumab efficacy in patients with chronic rhinosinusitis with nasal polyps with and without allergic rhinitis. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

The Choice of Biologics in Patients with Severe Chronic Rhinosinusitis with Nasal Polyps. [2021]