A Phase II/III Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of ICP-332 in Moderate to Severe Chronic Spontaneous Urticaria Subjects Inadequately Controlled by Second Generation H1-antihistamines
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 344
- 试验地点
- 30
- 主要终点
- Phase 2: Change from baseline in Weekly Urticaria Activity Score (UAS7) at Week 4.
研究概览
简要总结
The purpose of this study is to compare the efficacy and safety of ICP-332 in moderate to severe chronic spontaneous urticaria subjects inadequately controlled by second generation H1-antihistamines
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Men and women aged 18 to 75 years.
- •2. Diagnosis of CSU inadequately controlled by second generation H1-antihistamines.
- •3. CSU duration for ≥ 6 months prior to randomization.
- •4. Before initiating any screening or study-specific procedures, the subject must voluntarily sign the informed consent form.
排除标准
- •1. Having the other medical conditions related to CSU or other skin diseases/conditions.
- •2. Potential medical conditions or issues.
- •3. Pregnant female subjects or lactating female subjects.
- •4. The investigator determines that the subject is unsuitable for participating in this study for any reason.
研究组 & 干预措施
ICP-332 dose A（Phase2）
ICP-332 will be administered as tablet
干预措施: ICP-332 Tablets (Drug)
ICP-332 dose B（Phase2）
ICP-332 will be administered as tablet
干预措施: ICP-332 Tablets (Drug)
ICP-332 dose C（Phase2）
ICP-332 will be administered as tablet
干预措施: ICP-332 Tablets (Drug)
Placebo（Phase2）
ICP-332 Placebo will be administered as tablet
干预措施: ICP-332 placebo Tablets (Drug)
ICP-332 dose A or dose B or dose C（Phase3）
ICP-332 will be administered as tablet
干预措施: ICP-332 Tablets (Drug)
Placebo（Phase3）
ICP-332 Placebo will be administered as tablet
干预措施: ICP-332 placebo Tablets (Drug)
结局指标
主要结局
Phase 2: Change from baseline in Weekly Urticaria Activity Score (UAS7) at Week 4.
时间窗: 4 weeks
The Weekly Urticaria Activity Score (UAS7) is a simple scoring system to evaluate urticaria signs and symptoms. It is based on scoring wheals (hive severity score) and itch (itch severity score) separately on a scale of 0 (no signs/symptoms) to 3 (intense signs/symptoms) over 7 days. The final score is calculated by adding together the daily scores, which can range from 0 to 6, for 7 days. This results in a maximum total score of 42 (highest urticaria severity), and a minimum possible score of 0.
Phase 3: Change from baseline in UAS7 at Week 12.
时间窗: 12 weeks
The Weekly Urticaria Activity Score (UAS7) is a simple scoring system to evaluate urticaria signs and symptoms. It is based on scoring wheals (hive severity score) and itch (itch severity score) separately on a scale of 0 (no signs/symptoms) to 3 (intense signs/symptoms) over 7 days. The possible range of the UAS7 score is 0 - 42 (highest hives and itch severity).
Phase 2: Absolute change from baseline in UAS7 at Week 4.
时间窗: 4 weeks
Phase 3: Absolute change from baseline in UAS7 at Week 12
时间窗: 12 weeks
次要结局
未报告次要终点