A Randomized, Double-blind, Placebo-controlled, Multicenter Phase Ib/II Clinical Study to Evaluate the Safety, Pharmacokinetics and Efficacy of AK120 in the Treatment of Subjects With Moderate to Severe Atopic Dermatitis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 427
- 试验地点
- 39
- 主要终点
- Phase Ib
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled, multicenter phase Ib/II clinical study to evaluate the safety, pharmacokinetics and efficacy of AK120 in the treatment of subjects with moderate to severe atopic dermatitis.
详细描述
This is a randomized, double-blind, placebo-controlled, multicenter phase Ib/II clinical study to evaluate the safety, pharmacokinetics and efficacy of AK120 in subjects with moderate to severe atopic dermatitis.
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)
盲法说明
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 with age 18 - 75 years (inclusive).
- •Atopic dermatitis (AD) diagnosed at least half an 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
- •Suffering from other inflammatory diseases that may affect efficacy outcomes (such as rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, scleroderma, inflammatory myopathy, mixed connective tissue disease, overlap syndrome, etc.).
- •History of exposure to active TB, and/or history or current evidence of TB infection.
- •Positive serology results at Screening for hepatitis B, hepatitis C or HIV.
- •Any history of vernal keratoconjunctivitis (VKC) or atopic keratoconjunctivitis (AKC) within 6 months before the baseline visit.
- •History of clinical parasite infection, recent or planned travel to an area with endemic parasite infection within 6 months before the Screening visit
- •Any medical or psychiatric condition, laboratory, or ECG parameter which, in the opinion of the Investigator or the Sponsor's medical monitor, would place the subject at risk, interfere with participation in the study, or interfere with the interpretation of study results.
研究组 & 干预措施
AK120 150 mg in phase Ib
subcutaneous injection once a week for 4 weeks.
干预措施: AK120 (Drug)
AK120 300mg in phase Ib
subcutaneous injection once a week for 4 weeks.
干预措施: AK120 (Drug)
Placebo Comparator: Placebo in phase Ib
subcutaneous injection once a week for 4 weeks.
干预措施: Placebo (Drug)
AK120 150mg in phase II
subcutaneous injection every 2 weeks for 50 weeks.
干预措施: AK120 (Drug)
AK120 300mg in phase II
subcutaneous injection every 2 weeks for 50 weeks.
干预措施: AK120 (Drug)
AK120 450mg in phase II
subcutaneous injection every 2 weeks for 50 weeks.
干预措施: AK120 (Drug)
Placebo Comparator: Placebo in phase II
subcutaneous injection every 2 weeks, then crossover to AK120 Regimen 4 and Regimen 5, subcutaneous injection at week 16, after primary endpoint evaluation.
干预措施: Placebo (Drug)
AK120 150mg in phase II extension
subcutaneous injection every 2 weeks for 14 weeks.
干预措施: AK120 (Drug)
AK120 300mg in phase II extension
subcutaneous injection every 2 weeks for 14 weeks.
干预措施: AK120 (Drug)
AK120 450mg in phase II extension
subcutaneous injection every 2 weeks for 14 weeks.
干预措施: AK120 (Drug)
结局指标
主要结局
Phase Ib
时间窗: Baseline to week 12
Tmax of AK120. Assessment of Time to peak(Tmax) of AK120
Phase II
时间窗: at week 16
Percentage of subjects who achieved (Eczema Area and Severity Index)EASI-75
Phase II Extension Study
时间窗: Baseline to week 24
Incidence of treatment emergent AE . 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
- Phase II Extension Study(Baseline to week 24)
- Phase Ib(Baseline to week 12)
- Phase II(Baseline to week 58)