A Phase 2, Multi-center, Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Dose-Ranging Study to Evaluate the Efficacy and Safety of AK120 in Adult Subjects With Moderate-to-Severe Atopic Dermatitis
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 79
- 试验地点
- 23
- 主要终点
- Proportion of subjects achieving an Eczema Area and Severity Index (EASI) 75 response
研究概览
简要总结
This is a phase 2, multi-center, randomized, placebo-controlled, double-blind, parallel-group, dose-ranging study, conducted in subjects with moderate-to-severe atopic dermatitis.
详细描述
This phase 2 study is designed to explore the efficacy and safety, as well as pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity of dose-ranging AK120 compared to placebo, which will generate information regarding the selection of dosing regimens with AK120 monotherapy treatment in adult subjects with moderate-to-severe AD.
Primary Objectives:
• To evaluate the efficacy of AK120 in the treatment of adult subjects with moderate-to-severe Atopic Dermatitis (AD).
Secondary Objectives:
- To evaluate the safety of AK120 in the treatment of adult subjects with moderate-to-severe AD.
- To evaluate the Pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity of AK120 in adult subjects with moderate-to-severe AD.
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
Double Blinded
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, over the age of 18
- •Chronic atopic dermatitis (AD) diagnosed at least 1 year.
- •Subject with EASI score ≥16, IGA ≥ 3 (on the 0 to 4 IGA scale, in which 3 is moderate and 4 is severe), ≥ 10% body surface area (BSA) of AD involvement.
- •Subjects with a history of an inadequate response or medically inappropriate use of topical drug treatment within 6 months.
排除标准
- •Inadequate washout period for prior drug therapy (eg. corticosteroids, immunosuppressive/ immunomodulating, biologics, phototherapy, Chinese traditional medicine, anti-infective agents).
- •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 Regimen 1
AK120 Regimen 1- subcutaneous injection every 2 weeks for 30 weeks.
干预措施: AK120 (Drug)
AK120 Regimen 2
AK120 Regimen 2- subcutaneous injection every 2 weeks for 30 weeks.
干预措施: AK120 (Drug)
Placebo to AK120
Placebo subcutaneous injection every 2 weeks, then crossover to AK120 Regimen 1, subcutaneous injection at Week16, after primary endpoint evaluation
干预措施: Placebo (Drug)
Placebo to AK120
Placebo subcutaneous injection every 2 weeks, then crossover to AK120 Regimen 1, subcutaneous injection at Week16, after primary endpoint evaluation
干预措施: AK120 (Drug)
结局指标
主要结局
Proportion of subjects achieving an Eczema Area and Severity Index (EASI) 75 response
时间窗: At week 16
次要结局
- Anti-drug antibodies(ADAs)(Baseline to Week 38)
- Proportion of subjects achieving the Investigator Global Assessment (IGA, on a 5-point scale) for clear (0) or almost clear (1)(At week 16)
- Change in Pruritus-Numerical Rating Scale (P-NRS)(Baseline to Week 38)
- Change in Body Surface Area (BSA) of AD involvement(Baseline to Week 38)
- Adverse events(AEs)/serious adverse events(SAEs)(Baseline to Week 38)
- Individual subject AK120 concentrations in serum at different time points after AK120 administration(Baseline to Week 38)
- Change in Patient Oriented Eczema Measure (POEM)(Baseline to Week 38)
- Change in SCORing Atopic Dermatitis (SCORAD)(Baseline to Week 38)
- Change in pharmacodynamics studies TARC/CCL17 and IgE(Baseline to week 24)