A Multicenter, Open Label Phase II Clinical Study to Evaluate the Efficacy and Safety of AK120 in the Treatment of Subjects With Moderate to Severe Atopic Dermatitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 450
- 试验地点
- 50
- 主要终点
- Incidence of treatment emergent adverse events (TEAEs)
研究概览
简要总结
This is a multicenter, open label phase II clinical study to evaluate the efficacy and safety of AK120 in the treatment of subjects with moderate to severe atopic dermatitis.
详细描述
This is a multicenter, open label phase II clinical study to evaluate the efficacy and safety of AK120 in the treatment of subjects with moderate to severe atopic dermatitis. The total duration of the study (including screening period, treatment period and follow-up period) planned for each subject is approximately 25 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Male or female subjects aged ≥18≤75 years old.
- •Atopic dermatitis (AD) diagnosed at least half a year before screening.
- •Subject with EASI score ≥16, IGA ≥ 3, BSA ≥ 10% at screening and baseline.
- •Subjects who are suitable for continue using biological treatment assessed by investigator
排除标准
- •Acute onset of AD within 4 weeks before drug administration.
- •The accompany disease have been assessed by the investigators during screening period as unsuitable for participation in this study.
- •Any history or symptoms of malignant tumors in any organ within 5 years prior to screening, regardless of whether treatment has been received and whether there are signs of recurrence or metastasis
- •Have a known or suspected history of immunosuppressive diseases, including a history of invasive infections.
- •Having undergone or planned major surgery within 4 weeks prior to drug administration, or unable to fully recover from surgery prior to drug administration.
- •any medical or psychological condition that puts subjects at risk or may affect the study results assessed by investigators.
研究组 & 干预措施
AK120 300mg Q2W(Double the initial dose)
AK120 600mg (first day) then 300mg Q2W SC until week 14.
干预措施: AK120 300mg Q2W (JAK inhibitor users need to double the initial dose) (Drug)
结局指标
主要结局
Incidence of treatment emergent adverse events (TEAEs)
时间窗: through study completion, an average of 25 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment
次要结局
- Eczema Area and Severity Index (EASI) score(baseline to week 20)
- Investigator's Global Assessment (IGA) 0/1(from baseline to week 20)
- Affected body surface area (BSA) score(from baseline to week 20)
- Area under the curve(AUC) of AK120(before drug administration at week 0/4/8/12/16)
- Anti-drug antibodies (ADA) of AK120(before drug administration at week 0/4/8/16/20)