a Multicenter, Randomized, Open Label Phase II Clinical Study to Evaluate the Safety and Efficacy 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
- 180
- 试验地点
- 26
- 主要终点
- Incidence of adverse events(AE)
研究概览
简要总结
This is a multicenter, randomized, open label phase II clinical study to evaluate the safety and efficacy of AK120 in the treatment of subjects with moderate to severe atopic dermatitis.
详细描述
This is a multicenter, randomized, open label phase II clinical study to evaluate the safety and efficacy of AK120 in the treatment of subjects with moderate to severe atopic dermatitis. The total duration of the study (including screening period) planned for each subject is approximately 29 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
- 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 with a history of an inadequate response or medically inappropriate use of topical drug treatment within 6 months
排除标准
- •Received systemic corticosteroids, immunosuppressive/immunomodulatory drugs, phototherapy within the 4 weeks before randomization.
- •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)
- •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 300mg
AK120 loading dose 600mg, then 300mg subcutaneous injection every 2 weeks thereafter until week 14.
干预措施: AK120 (Drug)
AK120 450mg
AK120 loading dose 600mg, then 450mg subcutaneous injection every 2 weeks thereafter until week 14.
干预措施: AK120 (Drug)
结局指标
主要结局
Incidence of adverse events(AE)
时间窗: week 0 to week 24
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
- Percentage of subjects who achieved (Eczema Area and Severity Index) EASI-75(at week 2/4/8/12/16 /20 and 24)
- Percentage of subjects who achieved (Eczema Area and Severity Index) EASI-50(at week 2/4/8/12/16 /20 and 24)
- Percentage change in (Eczema Area and Severity Index) EASI scores from baseline(at week 2/4/8/12/16 /20 and 24)
- Percentage of subjects who achieved 0/1 in the (Investigator's Global Assessment) IGA(at week 2/4/8/12/16 /20 and 24)
- Percentage of subjects with a (Investigator's Global Assessment) IGA score decrease of ≥ 2 points from baseline(at week 2/4/8/12/16 /20 and 24)
- Percentage change in (affected body surface area) BSA score from baseline(at week 2/4/8/12/16 /20 and 24)