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
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 258
- 试验地点
- 24
- 主要终点
- 1. Mean Change From Baseline (CFBL) in Total Nasal Symptom Score (TNSS) at Week 16 Total nasal symptom score was a composite of 4 symptoms (rhinorrhea, nasal congestion, nasal itching and sneezing), each symptom was scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total score ranged from 0 to 12. The higher the score was, the more severe the symptoms were. [Time Frame: Baseline, Week 16]
研究概览
简要总结
To evaluate the efficacy of lebrikizumab up to Week 16 on total nasal symptoms compared with Placebo
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
1. Mean Change From Baseline (CFBL) in Total Nasal Symptom Score (TNSS) at Week 16 Total nasal symptom score was a composite of 4 symptoms (rhinorrhea, nasal congestion, nasal itching and sneezing), each symptom was scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total score ranged from 0 to 12. The higher the score was, the more severe the symptoms were. [Time Frame: Baseline, Week 16]
1. Mean Change From Baseline (CFBL) in Total Nasal Symptom Score (TNSS) at Week 16 Total nasal symptom score was a composite of 4 symptoms (rhinorrhea, nasal congestion, nasal itching and sneezing), each symptom was scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total score ranged from 0 to 12. The higher the score was, the more severe the symptoms were. [Time Frame: Baseline, Week 16]
次要结局
未报告次要终点
研究者
Lilly Clinical Trials information desk
Scientific
Eli Lilly & Co.