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A Study of Lebrikizumab in Adult Participants With Perennial Allergic Rhinitis
EU CTIS ID: 2023-508817-18-00
What this study is testing
To evaluate the efficacy of lebrikizumab up to Week 16 on total nasal symptoms compared with Placebo
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- • Physician-diagnosed 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).
- • A participant who has a known history of dermatographism or identified during the SPT may participate in this study with a positive 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 likely can't join if
- • Have received a dose of lebrikizumab.
- • Is currently on allergen immunotherapy (AIT). 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 for inflammatory disease or autoimmune disease prior to baseline visit: a. Any current or prior use of biologics indicated for asthma or AD are prohibited. b. B cell-depleting biologics, including rituximab, within 6 months. c. other biologics within 5 half-lives (if known) or 8 weeks, whichever is longer. d. Systemic immunosuppressants, including Janus kinase 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
See the full eligibility criteria
- • Physician-diagnosed 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).
- • A participant who has a known history of dermatographism or identified during the SPT may participate in this study with a positive antigen-specific IgE test.
- • Participants who have concomitant asthma must be stable in the 3 months prior to screening using permitted regular asthma treatment.
- • Have received a dose of lebrikizumab.
- • Is currently on allergen immunotherapy (AIT). 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 for inflammatory disease or autoimmune disease prior to baseline visit: a. Any current or prior use of biologics indicated for asthma or AD are prohibited. b. B cell-depleting biologics, including rituximab, within 6 months. c. other biologics within 5 half-lives (if known) or 8 weeks, whichever is longer. d. Systemic immunosuppressants, including Janus kinase 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.
The study team makes the final eligibility decision.
Where it's taking place
- Korea, Republic of
- United States
- China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Korea, Republic of; United States; China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.