a Randomized Double-blind, Placebo-controlled, Multicenter Phase III Clinical Study to Evaluate the Efficacy and Safety of AK120 in the Treatment of Patients With Moderate to Severe Atopic Dermatitis
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 420
- 试验地点
- 59
- 主要终点
- Percentage of subjects who achieved (Eczema Area and Severity Index) EASI-75
研究概览
简要总结
This is a randomized double-blind, placebo-controlled, multicenter phase III clinical study evaluating the efficacy and safety of AK120 injection in the treatment of patients with moderate to severe atopic dermatitis.
详细描述
This is a randomized double-blind, placebo-controlled, multicenter phase III clinical study evaluating the efficacy and safety of AK120 injection in the treatment of patients with moderate to severe atopic dermatitis. The entire study included a screening period, a double-blind controlled treatment period, a conversion and maintenance treatment period, and a safe 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
- •Male or female subjects aged ≥18≤75 years old.
- •Atopic dermatitis (AD) diagnosed at least 1 year before screening.
- •Subject with eczema area and severity index (EASI) score ≥16, Investigator Global Assessment (IGA) score≥ 3, Body Surface Area (BSA) score ≥ 10% at screening and baseline.
- •Previously received at least 4 weeks of moderate to strong or at least 2 weeks of strong local glucocorticoid (TCS) treatment for AD before screening, with poor efficacy or intolerable
排除标准
- •Acute onset of AD within the first 4 weeks of randomization.
- •Have participated in any clinical research on AK120 in the past
- •Received systemic corticosteroids, immunosuppressive/immunomodulatory drugs, phototherapy within the 4 weeks before randomization.
- •Received treatment with other clinical research drugs (non-biological agents) within the first 4 weeks or 5 half-lives of randomization (whichever is longer)
- •Received or planned to receive live vaccine treatment within the 3 months before randomization or during the study period.
- •Received allergen specific immunotherapy within the 3 months before randomization.
- •Have a history of allergies to any component of AK120 and/or severe allergic reactions to monoclonal antibodies.
研究组 & 干预措施
AK120 600mg/300mg
AK120 600mg(first day) then 300mg Q2W subcutaneous injection thereafter until week 50.
干预措施: AK120 (Drug)
Placebo/AK120 600mg to 300mg
placebo Q2W SC, then AK120 600mg at week 16, thereafter change to AK120 300mg Q2W subcutaneous injection until week 50.
干预措施: AK120 (Drug)
结局指标
主要结局
Percentage of subjects who achieved (Eczema Area and Severity Index) EASI-75
时间窗: at week 16
Percentage of patients in both treatment group and placebo group who achieved EASI 75 at week 16.
次要结局
- Percentage of subjects who achieved 0/1 in the (Investigator's Global Assessment) IGA(at week 16)