A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Crossover Study to Evaluate the Efficacy and Safety of LY3454738 in Adults With Chronic Spontaneous Urticaria Inadequately Controlled With H1-Antihistamines
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 52
- 试验地点
- 25
- 主要终点
- Mean Change From Baseline in Urticaria Activity Score Over 7 Days (UAS7)
研究概览
简要总结
The reason for this study is to see if the study drug LY3454738 is safe and effective as treatment for participants with hives that are caused by chronic spontaneous urticaria (CSU) and that are not controlled with H1-antihistamines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must agree to use appropriate birth control throughout the study
- •Must have a diagnosis of CSU for at least 6 months
- •Must have CSU symptoms for at least 8 consecutive weeks despite taking anti-histamines
- •Must agree to take an anti-histamine every day during the trial
- •Must be willing to enter information about symptoms in an electronic diary twice a day
排除标准
- •Must not have a cause, other than CSU, for itching, hives, and/or angioedema (swelling beneath the skin)
- •Must not have a current or recent active infection requiring antibiotics
- •Must not have a history of anaphylaxis (severe, life threatening allergic reaction)
- •Must not have asthma requiring medications other than short acting beta agonists (albuterol, etc.)
- •Must not have received prior treatment with omalizumab, ligelizumab, or other experimental biologic for CSU
研究组 & 干预措施
LY3454738
500 milligram (mg) LY3454738 administered intravenously (IV).
干预措施: LY3454738 (Drug)
Placebo
Placebo administered IV.
干预措施: Placebo (Drug)
结局指标
主要结局
Mean Change From Baseline in Urticaria Activity Score Over 7 Days (UAS7)
时间窗: Baseline, Week 12
The UAS7 is the sum of the daily urticaria activity scores (UAS) over a 7-day period and ranges from 0 to 42. The daily UAS is the sum of the daily itch severity score (ISS) and daily number of hives score, and ranges from 0 to 6. The baseline UAS7 is the sum of the daily UAS over the 7 days prior to the first treatment. A higher UAS or higher UAS7 indicates greater urticaria disease activity.The ANCOVA model includes treatment as a factor and baseline UAS7 score in First 12-Week treatment period as covariates. Missing Week 12 scores will be imputed by carrying forward the participants' baseline scores (BOCF).
次要结局
- Mean Change From Baseline in Itch Severity Score Over 7 Days (ISS7)(Baseline, Week 12)
- Percentage of Participants Achieving Urticaria Activity Score Over 7 Days (UAS7) ≤6 (Stratified by Baseline UAS7 (< 28 vs >= 28) Score)(Week 12)
- Mean Change From Baseline in Hives Severity Score Over 7 Days (HSS7)(Baseline, Week 12)
- Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to 336 Hours (AUC [0-336h]) of LY3454738(Before Infusion, after infusion, 1 hour after infusion and 2 hours after infusion on Day 1; Before Infusion on Day 8, 15, 29, 43, 57, 71, 85, 92, 99, 113, 127, 141, 155, 169 and Post-Treatment Follow-up)
- PK: Maximum Concentration (Cmax) of LY3454738(Before Infusion, after infusion, 1 hour after infusion and 2 hours after infusion on Day 1; Before Infusion on Day 8, 15, 29, 43, 57, 71, 85, 92, 99, 113, 127, 141, 155, 169 and Post-Treatment Follow-up)
- Percentage of Participants Achieving Urticaria Activity Score Over 7 Days (UAS7) ≤6 (Stratified by Baseline UAS7 (< Median vs >= Median) Score)(Week 12)