A Phase 2 Study of MG-K10 in Chronic Spontaneous Urticaria
A Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of MG-K10 Humanized Monoclonal Antibody Injection in Subjects With Chronic Spontaneous Urticaria
This Phase 2 study evaluates the efficacy and safety of MG-K10 in participants with chronic spontaneous urticaria inadequately controlled by second-generation H1-antihistamines. Participants are randomized 1:1 to MG-K10 or placebo for 16 weeks, followed by an 8-week follow-up period.
研究概览
研究类型
注册 (估计的)
阶段
- 阶段2
联系人和位置
学习联系方式
- 姓名：Clinical Project Manager
- 电话号码：+86-021-51371305
- 邮箱：xiaofeng.cai@mabgeek.com
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- CSU diagnosed ≥6 months.
- Itch and hives present continuously for >6 weeks despite second-generation H1-antihistamine treatment.
- Before randomization：UAS7 ≥16，ISS7 ≥8，at least one investigator-assessed UAS ≥4.
- Stable second-generation H1-antihistamine background therapy per protocol.
- Effective contraception requirements during study and for 6 months after last dose.
Exclusion Criteria:
- Chronic inducible urticaria or other urticaria/angioedema-mimicking diseases.
- Other chronic pruritic skin disease affecting assessment.
- Active or inadequately treated tuberculosis；acute/subacute infection.
- Clinically significant uncontrolled diabetes，cardiac，renal，hepatic，neurologic，autoimmune，or other severe systemic disease.
- Hypersensitivity to study drug/excipients；severe monoclonal-antibody reaction history.
- Prior MG-K10 trial participation.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：MG-K10；600 mg SC at Week 0, then 300 mg SC Q4W through Week 12，4 doses total.
|
MG-K10 humanized monoclonal antibody injection targeting interleukin-4 receptor alpha (IL-4Rα), administered by subcutaneous injection. |
|
安慰剂比较：Matching placebo SC；4.0 mL at Week 0, then 2.0 mL Q4W，4 doses total.
|
Matching placebo administered by subcutaneous injection, placebo matches MG-K10 in appearance and administration schedule to maintain blinding. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change from baseline in Urticaria Activity Score over 7 Days (UAS7) at Week 16
大体时间：Baseline to Week 16
|
UAS7 is the sum of daily itch severity and hive severity scores over 7 days, with total scores ranging from 0 to 42. The change from baseline at Week 16 will be compared between MG-K10 and placebo. |
Baseline to Week 16
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change from baseline in Itch Severity Score over 7 Days (ISS7) at Week 16
大体时间：Baseline to Week 16
|
The Itch Severity Score over 7 Days (ISS7) is the sum of the daily itch severity scores over 7 consecutive days. Each daily itch severity score ranges from 0 to 3, where 0 indicates no itch and 3 indicates intense itch. The total ISS7 ranges from 0 to 21, where 0 indicates no itch and 21 indicates the most severe itch. Higher ISS7 scores indicate worse itch severity. Change from baseline is calculated as the ISS7 at Week 16 minus the baseline ISS7; a negative change indicates improvement. |
Baseline to Week 16
|
|
Change from baseline in Hives Severity Score over 7 Days (HSS7) at Week 16
大体时间：Baseline to Week 16
|
The Hives Severity Score over 7 Days (HSS7) is the sum of the daily hives severity scores over 7 consecutive days. Each daily hives severity score ranges from 0 to 3, where 0 indicates no hives, 1 indicates fewer than 20 hives per 24 hours, 2 indicates 20 to 50 hives per 24 hours, and 3 indicates more than 50 hives per 24 hours or large confluent areas of hives. The total HSS7 ranges from 0 to 21. Higher HSS7 scores indicate greater hives severity and worse outcome. Change from baseline is calculated as the HSS7 at Week 16 minus the baseline HSS7; a negative change indicates improvement. |
Baseline to Week 16
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
adverse events
大体时间：Baseline to Week 24
|
Adverse events will be assessed from the first administration of study intervention through the protocol-specified follow-up period. The number of participants experiencing at least one adverse event will be summarized by treatment group. |
Baseline to Week 24
|
合作者和调查者
调查人员
- 首席研究员：Jianzhong Zhang, MD、Peking University People's Hospital
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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