Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2025-12-26 @ 10:56 AM
NCT ID:
NCT06339008
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.
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06339008
Study Brief:
Protocol Section:
NCT06339008