A Multicenter, Open Label Phase II Clinical Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of AK120 in Adolescents With Moderate-to-severe AD
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 试验地点
- 6
- 主要终点
- Incidence of adverse events(AE)
研究概览
简要总结
This is a A multicenter, open label, phase II clinical study to evaluate the safety, pharmacokinetics (PK), pharmacodynamics(PD), and preliminary efficacy of AK120 in adolescents with moderate-to-severe atopic dermatitis
详细描述
This is a A multicenter, open label, phase II clinical study aimed to evaluate the safety, PK, PD, and preliminary efficacy of AK120 in adolescents with moderate-to-severe AD. The entire study include screening period(week -4 to week 0), treatment and follow-up period(16 weeks). The duration of the study is about 20 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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 at baseline.
- •AD diagnosed at least half a year before screening.
- •Subject with EASI score ≥16, IGA ≥ 3, BSA ≥ 10% at screening and baseline.
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 1 month or 5 half-lives 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 300mg every two weeks (Q2W) subcutaneous injection
Subjects with heavy weight
干预措施: AK120 (Drug)
AK120 300mg every three weeks (Q3W) subcutaneous injection
Subjects with light weight
干预措施: AK120 (Drug)
结局指标
主要结局
Incidence of adverse events(AE)
时间窗: week -4 to week 16
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
- PK evaluation: maximum plasma concentration (Cmax)(Baseline till last follow-up visit ( up to day 113))
- PK evaluation: time to maximum plasma concentration (Tmax)(Baseline till last follow-up visit ( up to day 113))
- PD evaluation: Thymus and activation regulated chemokine (TARC)/CCL17(Baseline till last follow-up visit ( up to day 113))
- Change in Eczema Area and Severity Index (EASI) scores(week 0/2/4/8/12/16)
- Change in affected Body Surface Area (BSA) scores(week 0/2/4/8/12/16)
- Subjects who achieved 0/1 in the Investigator's Global Assessment (IGA)(week 0/2/4/8/12/16)
- Change in Children's Dermatology Life Quality Index (CDLQI) scores(week 0/2/4/8/12/16)
- Change in Patient Oriented Eczema Measure (POEM) scores(week 0/2/4/8/12/16)