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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Perennial Allergic Rhinitis (PAR)

In brief

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.

Key facts

Study ID

NCT06339008

Run by

Eli Lilly and Company

People needed

450

Starts

2024-04-26

Expected to finish

2028-10-01

Last updated by the study team

2026-07-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 310 Clinical Research — Inglewood, California, United States
• Allergy & Asthma Associates of Southern California dba. Southern California Research — Laguna Niguel, California, United States
• Allergy and Asthma — San Diego, California, United States
• Asthma and Allergy Associates, PC — Colorado Springs, Colorado, United States
• Allergy and Asthma Diagnostic Center — Tallahassee, Florida, United States
• University of South Florida — Tampa, Florida, United States
• Northwestern University — Chicago, Illinois, United States
• Asthma Allergy Center of Chicago — River Forest, Illinois, United States
• Bluegrass Allergy Research — Lexington, Kentucky, United States
• Respiratory Medicine Research Institute of Michigan, PLC — Ypsilanti, Michigan, United States
• Clinical Research Institute — Minneapolis, Minnesota, United States
• University of Missouri Hospital — Columbia, Missouri, United States
• Allergy and Asthma Consultants — St Louis, Missouri, United States
• Asthma and Allergy Center — Bellevue, Nebraska, United States
• Circuit Clinical/Hudson-Essex Allergy — Belleville, New Jersey, United States
• Circuit Clinical/Mercer Allergy and Pulmonary Associates — Hamilton, New Jersey, United States
• Dr. Patrick Perin — Teaneck, New Jersey, United States
• Smith Allergy and Asthma — Horseheads, New York, United States
• Allergy Partners — Asheville, North Carolina, United States
• Bernstein Clinical Research Center, LLC — Cincinnati, Ohio, United States
• Northwest Research Center — Portland, Oregon, United States
• Allergy and Clinical Immunology Associates — Pittsburgh, Pennsylvania, United States
• AARA Research Center — Dallas, Texas, United States
• Kerrville Allergy and Asthma Associates — Kerrville, Texas, United States
• Allergy and Asthma Specialists Medical Group — Huntington Beach, California, United States

Full record on ClinicalTrials.gov

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