NCT06339008
A Study of Lebrikizumab in Adult Participants With Perennial Allergic Rhinitis (PREPARED-1)
Active, Not Recruiting
PHASE3Ages 18+InterventionalTreatmentEli Lilly and Company
~450 participants
Updated 2026-08-24 on ClinicalTrials.gov
What's tested:LY3650150PlaceboStandard therapy for INCS
At a glance
Recruiting sites
0 of 74 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Mean Change From Baseline (CFBL) in Total Nasal Symptom Score (TNSS) at Week 16
Measured over Baseline, Week 16
Conditions
Where it's being run
74 sites across 22 statesChina17
Poland11
South Korea8
Germany7
Belgium5
California4
New Jersey3
Florida2
Study leadership
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) · STUDY_DIRECTOR · Eli Lilly and Company
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
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 known) or 8 weeks, whichever is longer.
Systemic immunosuppressants, including JAK inhibitors, within 4 weeks prior to baseline.
Have a history of seasonal worsening of AR and if the seasonal worsening is expected during the 4-week run-in period, the first 16 weeks after randomization, or during the last 8 weeks of the maintenance period.
Anticipates significant changes in their daily environmental exposure.
Has a known history of recurrent acute or chronic sinusitis.
Female participant who is pregnant, breastfeeding or is planning to become pregnant or to breastfeed during the study.
What this trial measures
- Mean Change From Baseline (CFBL) in Total Nasal Symptom Score (TNSS) at Week 16Baseline, Week 16
Total nasal symptom score was a composite of 4 symptoms (rhinorrhea, nasal congestion, nasal itching and sneezing), each symptom was scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total score ranged from 0 to 12. The higher the score was, the more severe the symptoms were.