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Monoclonal Antibodies

Lebrikizumab for Rhinosinusitis with Nasal Polyps

Verified Trial
Phase 3
Recruiting
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have you had prior surgery to remove your nasal polyps?
Have you taken systemic corticosteroids in the last 2 years for your nasal polyp symptoms? (oral or injection, ie. prednisone, dexamethasone, triamcinolone, etc.)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 24
Awards & highlights

Summary

This trial will test if lebrikizumab is effective and safe for adults with chronic sinus and nasal polyps who are already using nasal corticosteroids. The study will take around

Who is the study for?
Adults with chronic rhinosinusitis and nasal polyps who are currently being treated with intranasal corticosteroids can join this study. Specific details about who can or cannot participate were not provided, so interested individuals should contact the trial organizers for full eligibility criteria.
What is being tested?
The trial is testing lebrikizumab (LY3650150) to see if it's effective and safe in treating adults with chronic rhinosinusitis and nasal polyps. Participants will either receive lebrikizumab or a placebo alongside standard therapy for an estimated duration of 18 months.
What are the potential side effects?
While specific side effects of lebrikizumab are not listed here, common side effects from similar treatments may include allergic reactions, injection site reactions, headache, fatigue, and possible increased risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 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
Mean CFBL in Endoscopic Nasal Polyp Score (NPS)
Mean Change From Baseline (CFBL) in Participant Reported Nasal Congestion Score (NCS) Severity
Secondary study objectives
Mean CFBL in Postnasal Drip
Mean CFBL in Severity of Loss of Smell
Mean change in Forced Expiratory Volume in 1 Second (FEV1)
+1 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Lebrikizumab every 2 weeks (Q2W)/ every 4 weeks (Q4W)Experimental Treatment2 Interventions
Lebrikizumab will be given as Subcutaneous (SC) injection. Participants will receive background therapy with intranasal corticosteroids (INCS).
Group II: Lebrikizumab Q2W/every 8 weeks (Q8W)Experimental Treatment2 Interventions
Lebrikizumab will be given as SC injection. Participants will receive background therapy with INCS.
Group III: Placebo Q2W/Q4WPlacebo Group2 Interventions
Placebo will be given as SC injection. Participants will receive background therapy with INCS.

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Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,640 Previous Clinical Trials
3,221,134 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,358 Previous Clinical Trials
417,580 Total Patients Enrolled
~340 spots leftby Nov 2025
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