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Testing lunsekimig for adults with chronic rhinosinusitis and nasal polyps

A Randomized Phase 2, Double-blind, Placebo-controlled, Parallel-group, 2-arm Study to Assess the Efficacy, Safety, and Tolerability of Subcutaneous Lunsekimig in Adult Participants With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

Phase 2 Interventional Sanofi · NCT06454240

This study is testing if a new treatment called lunsekimig can help adults with chronic sinus issues and nasal polyps who haven't found relief from their current medications.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment80 (estimated)
Ages18 Years to 70 Years
SexAll
SponsorSanofi Industry-sponsored
Locations27 sites (La Jolla, California and 26 other locations)
Trial IDNCT06454240 on ClinicalTrials.gov

What this trial studies

This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy, safety, and tolerability of lunsekimig as an add-on therapy for adults aged 18 to 70 with chronic rhinosinusitis with nasal polyps (CRSwNP) who have not responded adequately to intranasal corticosteroids. Participants will be monitored over a period of approximately 40 weeks, which includes a 4-week screening phase, a 24-week treatment phase, and a 12-week follow-up. The study will also assess lung function in participants with and without co-morbid asthma.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with chronic rhinosinusitis with nasal polyps who have not achieved adequate symptom control with intranasal corticosteroids.

Not a fit: Patients who have recently received systemic corticosteroids or other specific therapies for their condition may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve symptoms and quality of life for patients suffering from chronic rhinosinusitis with nasal polyps.

How similar studies have performed: Other studies have shown promise in treating chronic rhinosinusitis with similar therapeutic approaches, but this specific treatment is being evaluated for the first time.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

- A minimum bilateral nasal polyp score of 5 out of a maximum score of 8 for both nostrils (with at least a score of 2 for each nostril) despite use of intranasal corticosteroid treatment for at least 2 months prior to screening

Ongoing symptoms for at least 2 months prior to screening, including:

* Nasal congestion, blockage, or obstruction with moderate or severe symptom severity at screening (Score 2 or 3 on NC Score) and a weekly average severity score of at least 1 (range 0 to 3) at randomization (NC Score: 0=no symptoms, 1=mild, 2=moderate, and 3=severe).
* At least 1 of the following 2 symptoms: (1) partial loss of smell (hyposmia) or total loss of smell (anosmia); (2) anterior and/or posterior rhinorrhea.

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

* Patient who has received any therapies such as for example systemic corticosteroids, anti-IgE therapy, monoclonal antibody and some others in the specified timeframe(s) prior to the screening visit
* Patients who have undergone any nasal/sinus surgery within 6 months before screening or for whom NPS cannot be determined accurately on endoscopy due to anatomic changes to the nasal cavity from past nasal/sinus surgery
* Patients with conditions/concomitant diseases making them non evaluable for the primary efficacy endpoint
* Signs or a CT scan suggestive of Allergic fungal rhinosinusitis
* Active/chronic helminthic infection
* History of human immunodeficiency virus (HIV) infection or positive HIV screen (Anti-HIV- and HIV-2 antibodies) at screening visit
* Patients with positive or indeterminate hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C antibody at screening visit NOTE: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial

Where this trial is running

La Jolla, California and 26 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Chronic Rhinosinusitis With Nasal Polyps
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.