Status:
RECRUITING
A Study of Lebrikizumab in Adult Participants With Perennial Allergic Rhinitis (PREPARED-1)
Lead Sponsor:
Eli Lilly and Company
Conditions:
Perennial Allergic Rhinitis (PAR)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
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.
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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.
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Have received treatment with any rescue medication during the run-in period.
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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.
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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.
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Anticipates significant changes in their daily environmental exposure.
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Has a known history of recurrent acute or chronic sinusitis.
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Female participant who is pregnant, breastfeeding or is planning to become pregnant or to breastfeed during the study.
Key Trial Info
Start Date :
April 26 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2028
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT06339008
Start Date
April 26 2024
End Date
October 1 2028
Last Update
March 24 2026
Active Locations (70)
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1
310 Clinical Research
Inglewood, California, United States, 90301
2
Allergy & Asthma Associates of Southern California dba. Southern California Research
Laguna Niguel, California, United States, 92677
3
Allergy and Asthma
San Diego, California, United States, 92123
4
Asthma and Allergy Associates, PC
Colorado Springs, Colorado, United States, 80907-6231