A Phase II Clinical Study on the Efficacy and Safety of MG-K10 Humanized Monoclonal Antibody Injection in Patients With Moderate to Severe Atopic Dermatitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- The percentage of subjects reaching EASI-75 at 24 weeks of treatment
研究概览
简要总结
This study is a multicenter, randomized, double-blind, parallel controlled phase II study. It is planned to include approximately 60 subjects with moderate to severe atopic dermatitis(AD) to evaluate the efficacy and safety of MG-K10 monotherapy in adult patients with moderate to severe AD, and to observe PK characteristics, PD effects and immunogenicity.
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
- •AD patients diagnosed in accordance with the consensus criteria of the American Academy of Dermatology (2014) had a history of AD or eczema diagnosis of ≥1 year
- •The patient's response to topical medication treatment is insufficient, or it is medically inappropriate to use topical medication for treatment
- •The subjects and their partners agreed to take effective contraceptive measures from signing the Informed Consent Form (ICF) until 6 months after the end of treatment, and had no plans for childbirth, sperm donation or egg donation
排除标准
- •The subject currently has a diagnosis of other active skin diseases (such as psoriasis or lupus erythematosus) that may affect the evaluation of AD
- •Patients with eye diseases that the researchers judged as unsuitable for inclusion
- •Patients with malignant tumors within 5 years
- •There is evidence of active tuberculosis, or there has been evidence of active tuberculosis before and no appropriate documented treatment has been received
- •Confirm active parasitic infection
- •Those with active hepatitis, or positive for hepatitis B surface antigen (HBsAg), or positive for hepatitis B core antibody (HBcAb), or positive for hepatitis C virus (HCV) antibody, or positive for HIV antibody, or positive for (TP-Ab)
- •Women who are breastfeeding or pregnant, or women planning to become pregnant or breastfeed during the study period
- •Those who the researchers consider to have other circumstances that make them unsuitable to participate in the study
结局指标
主要结局
The percentage of subjects reaching EASI-75 at 24 weeks of treatment
时间窗: 24 weeks
The percentage of subjects reaching EASI-75 at 24 weeks of treatment
The percentage of subjects who achieved the IGA score standard at 24 weeks of treatment
时间窗: 24 weeks
The percentage of subjects whose IGA score reached 0 or 1 at 24 weeks of treatment (W24) and decreased by ≥2 points compared with the baseline;
次要结局
未报告次要终点