A Study of Lebrikizumab in Adult Participants With Perennial Allergic Rhinitis (PREPARED-1) (NCT06339008) | Clinical Trial Compass
RecruitingPhase 3
A Study of Lebrikizumab in Adult Participants With Perennial Allergic Rhinitis (PREPARED-1)
United States450 participantsStarted 2024-04-26
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 randomization are eligible.
* Have received treatment with any rescue medication during the run-in period.
* Have received treatment with any biologic or systemic immunosuppressants, including Janus Kinase inhibitors (JAK) for inflammatory disease or autoimmune disease prior to the baseline visit:
* Any current or prior use of biologics indicated for asthma or AD are prohibited.
* B cell-depleting biologics, including rituximab, within 6 months.
* Other biologics within 5 half-lives (if k…
What they're measuring
1
Mean Change From Baseline (CFBL) in Total Nasal Symptom Score (TNSS) at Week 16
Timeframe: Baseline, Week 16
Trial details
NCT IDNCT06339008
SponsorEli Lilly and Company
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2026-09
Contact for this trial
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or