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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 taken systemic corticosteroids in the last 2 years for your nasal polyp symptoms? (oral or injection, ie. prednisone, dexamethasone, triamcinolone, etc.)
Has a physician diagnosed you with chronic sinusitis with nasal polyps?
Must not have
Have you had prior surgery to remove your nasal polyps?
Have you ever used steroid nasal sprays for your nasal polyp symptoms? (ie. Flonase, Nasacort, Nasonex, Xhance)
Timeline
Screening 3 days
Treatment 3 days
Follow Up 3 days
Awards & highlights
Pivotal Trial
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 belowExclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Timeline
Screening ~ 3 days1 visit
Treatment ~ 3 days1 visit
Follow Up ~ 3 days1 visit
Screening ~ 3 days
Treatment ~ 3 days
Follow Up ~3 days
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 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Find a Location
Logistics
Travel, including flights, are covered
Your expenses for travel tickets for this trial will be reimbursed.
Other reimbursement is provided
Other forms of reimbursement are provided for this trial.
Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,675 Previous Clinical Trials
3,463,473 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,388 Previous Clinical Trials
426,868 Total Patients Enrolled
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