A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lebrikizumab/LY3650150 in Participants With Chronic Rhinosinusitis With Nasal Polyps on Background Intranasal Corticosteroids
Eli Lilly and Company
Summary
The main purpose of this study is to evaluate the efficacy and safety of lebrikizumab in participants with chronic rhinosinusitis and nasal polyps treated with intranasal corticosteroids. The study will last about 18 months.
Eligibility
- Age range
- 12+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Physician-diagnosed chronic rhinosinusitis (CRS) with bilateral nasal polyps (NP). * Prior treatment with systemic corticosteroids (SCS) within the last 2 years (or a medical contraindication or intolerance to SCS), prior surgery for NP, or both. * Endoscopic bilateral NPS score of at least 5 out of 8, with a minimum score of 2 in each nasal cavity performed at screening and baseline. * Ongoing symptoms for at least 8 weeks prior to study entry (screening), including: 1. Nasal congestion with moderate or severe symptom severity (score 2 or 3) at screening and a weekly…
Interventions
- DrugLY3650150
Administered SC.
- DrugPlacebo
Administered SC.
- DrugStandard therapy for INCS
Administered as intranasal spray.
Locations (194)
- AllerVie Clinical ResearchBirmingham, Alabama
- University of Alabama at BirminghamBirmingham, Alabama
- Keck Medicine of USCArcadia, California
- University of California, IrvineIrvine, California
- DaVinci Research LLCRoseville, California
- Breathe Clear InstituteTorrance, California