: A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Dose-ranging Study to Assess the Efficacy and Safety of CDX-0159 in Patients With Chronic Inducible Urticaria
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 196
- 试验地点
- 75
- 主要终点
- Percentage of patients with a negative provocation test at week 12
研究概览
简要总结
The purpose of this study is to assess the clinical effect, the pharmacodynamics, the safety, and the pharmacokinetics of barzolvolimab (CDX-0159) in patients with Chronic Inducible Urticaria who remain symptomatic despite the use of H1-antihistamines.
详细描述
The purpose of this study is to assess the clinical effect, the pharmacodynamics, the safety, and the pharmacokinetics of barzolvolimab in patients with Chronic Inducible Urticaria (Cold Urticaria [ColdU] or Symptomatic Dermographism [SD]) who remain symptomatic despite the use of H1-antihistamines.
There is a screening period of up to 4 weeks, followed by a 20-week treatment period where patients will receive either barzolvolimab 150mg, 300mg or placebo, and then a 24-week follow up period where all patients are observed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
barzolvolimab 150 mg in patients with Symptomatic Dermographism
barzolvolimab 150 mg injection subcutaneous every 4 weeks for 20 weeks
干预措施: barzolvolimab (Biological)
barzolvolimab 300 mg in patients with Symptomatic Dermographism
barzolvolimab 300 mg injection subcutaneous every 8 weeks for 20 weeks
干预措施: barzolvolimab (Biological)
Placebo Comparator in patients with Symptomatic Dermographism
Placebo injection subcutaneous every 4 weeks for 20 weeks
干预措施: Matching Placebo (Drug)
barzolvolimab 150 mg in patients with Chronic Inducible Cold Urticaria
barzolvolimab 150 mg injection subcutaneous every 4 weeks for 20 weeks
干预措施: barzolvolimab (Biological)
barzolvolimab 300 mg in patients with Chronic Inducible Cold Urticaria
barzolvolimab 300 mg injection subcutaneous every 8 weeks for 20 weeks
干预措施: barzolvolimab (Biological)
Placebo Comparator in patients with Chronic Inducible Cold Urticaria
Placebo injection subcutaneous every 4 weeks for 20 weeks
干预措施: Matching Placebo (Drug)
结局指标
主要结局
Percentage of patients with a negative provocation test at week 12
时间窗: From baseline to week 12
Percentage of patients with a negative provocation test for Cold Inducible Urticaria \[ColdU\] or Symptomatic Dermographism \[SD\]) at week 12 * For ColdU patients, a negative provocation test is defined as absence of wheals at the provocation site within 10 min at ≤ 4°C after provocation using TempTest® * For SD patients, a negative provocation test is defined as absence of wheals at the provocation site within 10 min at 0 pins after provocation using the FricTest®
次要结局
- Change in worst itch reported after provocation in both SD and ColdU(From baseline to week 12)
- Change in provocation threshold for SD(From baseline to week 12)
- Change in worst itch reported after provocation for ColdU(From baseline to week 12)
- Change in provocation threshold and itch for ColdU(From baseline to week 12)
- Combined patients with a negative provocation test at week 12(From baseline to week 12)
- Change in worst itch reported after provocation for SD(From baseline to week 12)
- Percentage of patients experiencing adverse events(From baseline to week 20)