2025-521379-30-00招募中3 期
J2T-MC-KGBS - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lebrikizumab in Adult and Adolescent Participants With Perennial Allergic Rhinitis
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 5
- 主要终点
- Mean Change from Baseline in Total Nasal Symptom Score (TNSS) [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
- 0 years 至 65+ years（65+ Years, 0-17 Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Physician-diagnosed Perennial Allergic Rhinitis (PAR) Sometimes called “indoor allergies” or “allergies” or “nasal allergies”
- •Participants who have asthma must be stable in the 3 months prior to screening using regular asthma treatment
排除标准
- •Have received a dose of lebrikizumab
- •Has received subcutaneous (known as allergy shots) or sublingual allergen immunotherapy (AIT) any time within the past 3 years before baseline.
- •Have received treatment with any rescue medication during the run-in period
- •Have received treatment with any biologic or systemic immunosuppressants for inflammatory disease or autoimmune disease prior to the baseline visit including biologics for asthma, atopic dermatitis, or other autoimmune diseases.
- •Have a history of seasonal worsening of allergic rhinitis, sometimes called “seasonal allergies” or “hay fever,” and expects worsening anytime during the study.
- •Anticipates significant changes in their daily environmental exposure in the 8 weeks from Week 8 to 16
- •Individual of childbearing potential 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
Mean Change from Baseline in Total Nasal Symptom Score (TNSS) [Time Frame: Baseline, Week 16]
Mean Change from Baseline in Total Nasal Symptom Score (TNSS) [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.
研究点 (5)
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