A Randomized Double-blind, Placebo-controlled, Multicenter Phase III Clinical Study Evaluating the Efficacy and Safety of AK120 in the Treatment of Moderate-to-severe Atopic Dermatitis (AD) in Adolescents
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 198
- 试验地点
- 28
- 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 in the treatment of moderate-to-severe AD in adolescents.
详细描述
This is a randomized double-blind, placebo-controlled, multicenter phase III clinical study to evaluate the safety and efficacy of AK120 in the treatment of moderate-to-severe AD in adolescents. The total duration of the study planned is approximately 57 weeks.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects aged ≥12<18 years old, weight ≥ 30kg.
- •AD diagnosed at least half a year before screening.
- •Subject with EASI score ≥16, IGA ≥ 3, BSA ≥ 10% at screening and baseline
- •Daily peak P-NRS scores (weekly average) at baseline visit ≥ 4.
排除标准
- •Acute onset of AD in 4 weeks prior to enrollment.
- •Undergone or planned surgery during the study period within the 4 weeks prior to enrollment, or unable to fully recover from surgery before enrollment.
- •Previously suffered from vernal keratoconjunctivitis (VKC) or atopic keratoconjunctivitis (AKC).
- •Received systemic traditional Chinese medicine treatment within the 4 weeks before randomization or topical traditional Chinese medicine treatment within 1 week before randomization.
- •Received treatment with other clinical study drugs within 4 weeks or 5 halflives before randomization (whichever is longer).
- •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 every two weeks (Q2W) subcutaneous injection
AK120 600mg at day 1, then 300mg subcutaneous injection Q2W thereafter until week 46.
干预措施: placebo (Drug)
AK120 600mg every three weeks (Q3W) subcutaneous injection
AK120 600mg at day 1, then 300mg subcutaneous injection Q3W thereafter until week 45.
干预措施: placebo (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 18 （day 127)
At week 18, the percentage of subjects who achieved EASI-75 compared to baseline. The EASI score ranges from 0 (no eczema) to 72 (maximum severity).
Percentage of subjects with the Investigator's Global Assessment (IGA) score decrease of ≥ 2 points
时间窗: at week 18 （day 127)
At week 18, the percentage of subjects with the IGA score decrease of ≥ 2 points from baseline. The IGA is a five-point scale ranging from 0 to 4 ( 0 indicates clear, 4 indicates severe).
次要结局
- Percentage change in affected Body Surface Area (BSA)(week 0 to week 52)
- percentage change of Peak Pruritus Numerical Rating Scale (P-NRS) scores(week 0 to week 52)
- Percentage changes in the Children's Dermatology Life Quality Index (CDLQI) score(week 0 to week 52)
- Incidence of Adverse Events (AE)(week 0 to week 52)