Home › Trials › NCT06339008

Evaluating lebrikizumab for adults with perennial allergic rhinitis

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lebrikizumab/ LY3650150 in Adult Participants With Perennial Allergic Rhinitis

Phase 3 Interventional Eli Lilly and Company · NCT06339008

This study is testing a new medication called lebrikizumab to see if it can help adults with year-round allergies feel better than current treatments.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment450 (estimated)
Ages18 Years and up
SexAll
SponsorEli Lilly and Company Industry-sponsored
Drugs / interventionslebrikizumab, rituximab, immunotherapy
Locations77 sites (Huntington Beach, California and 76 other locations)
Trial IDNCT06339008 on ClinicalTrials.gov

What this trial studies

This study aims to assess the efficacy and safety of lebrikizumab, an investigational medication, in adults diagnosed with perennial allergic rhinitis (PAR). Participants will receive either lebrikizumab, a placebo, or standard therapy with intranasal corticosteroids over an 18-month period. The study will include individuals with confirmed sensitivity to indoor allergens and will monitor their response to treatment. The goal is to determine if lebrikizumab can provide better relief from symptoms compared to existing therapies.

Who should consider this trial

Good fit: Ideal candidates are adults with physician-diagnosed perennial allergic rhinitis and confirmed sensitivity to indoor allergens.

Not a fit: Patients currently undergoing allergen immunotherapy or those who have previously received lebrikizumab will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from perennial allergic rhinitis.

How similar studies have performed: Other studies have shown promise with similar monoclonal antibody approaches for allergic conditions, suggesting potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion 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 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 this trial is running

Huntington Beach, California and 76 other locations

+27 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Perennial Allergic Rhinitis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.