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Lunsekimig for Nasal Polyps

Phase 2
Recruiting
Research Sponsored by Sanofi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Be older than 18 years old
Must not have
Signs or a CT scan suggestive of Allergic fungal rhinosinusitis
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to week 24

Summary

This trial aims to test a new treatment for Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) in adults who are not responding well to their current nasal corticosteroid treatment

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While the specific side effects of Lunsekimig are not detailed here, common side effects from similar treatments may include reactions at the injection site, headache, fatigue, and potential allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have severe nasal polyps despite using nasal sprays for 2 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have symptoms or a CT scan indicating allergic fungal sinusitis.
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I have not had nasal/sinus surgery in the last 6 months.
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I have an ongoing worm infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to week 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to week 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in bilateral endoscopic nasal polyp score (NPS).
Secondary study objectives
Change in Lund-Mackay CT score
Change in SNOT-22 total score.
Change in University of Pennsylvania Smell Identification Test (UPSIT) score.
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm 2Experimental Treatment1 Intervention
Participant will receive lunsekimig subcutaneous (SC) every 4 weeks and intranasal mometasone furoate nasal spray (MFNS) for 24 weeks.
Group II: Arm 1Placebo Group1 Intervention
Participant will receive placebo subcutaneous (SC) every 4 weeks and intranasal mometasone furoate nasal spray (MFNS) for 24 weeks.

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Who is running the clinical trial?

SanofiLead Sponsor
2,201 Previous Clinical Trials
4,036,346 Total Patients Enrolled
~53 spots leftby Jan 2027
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