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Arm 2 for Chronic Rhinosinusitis

Phase 2
Waitlist Available
Research Sponsored by Sanofi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to end of study (approximately 36 weeks)
Awards & highlights

Summary

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.

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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to end of study (approximately 36 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to end of study (approximately 36 weeks) 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
Anti-drug antibodies (ADA) against lunsekimig
Change in Lund-Mackay CT score
Change in SNOT-22 total score.
+14 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
2,185 Previous Clinical Trials
3,978,645 Total Patients Enrolled
~53 spots leftby Jan 2027
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