NCT07838727尚未招募2 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Change from baseline in Urticaria Activity Score over 7 Days (UAS7) at Week 16
研究概览
简要总结
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
- •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 ≥
- •Stable second-generation H1-antihistamine background therapy per protocol.
- •Effective contraception requirements during study and for 6 months after last dose.
排除标准
- •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.
研究组 & 干预措施
Matching placebo SC；4.0 mL at Week 0, then 2.0 mL Q4W，4 doses total.
Placebo Comparator
干预措施: Matching Placebo (Drug)
MG-K10；600 mg SC at Week 0, then 300 mg SC Q4W through Week 12，4 doses total.
Experimental
干预措施: MG-K10 Injection (Drug)
结局指标
主要结局
Change from baseline in Urticaria Activity Score over 7 Days (UAS7) at Week 16
时间窗: 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.
次要结局
- Change from baseline in Itch Severity Score over 7 Days (ISS7) at Week 16(Baseline to Week 16)
- Change from baseline in Hives Severity Score over 7 Days (HSS7) at Week 16(Baseline to Week 16)
研究者
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