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Recruiting Phase 3 NCT06339008

A Study of Lebrikizumab in Adult Participants With Perennial Allergic Rhinitis (PREPARED-1)

Trial Parameters

Condition Perennial Allergic Rhinitis (PAR)
Sponsor Eli Lilly and Company
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 450
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-04-26
Completion 2026-09
Interventions
LY3650150PlaceboStandard therapy for INCS

Brief Summary

The main purpose of this study is to evaluate the efficacy and safety of lebrikizumab in adult participants with perennial allergic rhinitis. Participants can expect study participation to last up to 29.5 months.

Eligibility Criteria

Inclusion Criteria: * Physician-diagnosed perennial allergic rhinitis (PAR). * Has a positive skin prick test (SPT) with indoor allergens and/or positive serum antigen-specific immunoglobulin E (IgE) for indoor allergens ≥0.70 kU/L, utilizing a validated assay (central laboratory). * The participant must have clinical symptoms at study entry associated with positive perennial allergen as tested by the SPT or a positive serum antigen-specific IgE test. * A participant who has a known history of dermatographism or identified during the SPT may participate in this study with a positive serum antigen-specific IgE test. * Participants who have concomitant asthma must be stable in the 3 months prior to screening using permitted regular asthma treatment. Exclusion Criteria: * Have received a dose of lebrikizumab. * Is currently on AIT subcutaneous immunotherapy or sublingual immunotherapy. However, individuals who discontinued subcutaneous or sublingual immunotherapy for ≥3 years prior to ran

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