A Phase II, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase II Clinical Study to Evaluate the Efficacy and Safety of AK111 in Subjects With Moderate to Severe Plaque Psoriasis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 251
- 试验地点
- 13
- 主要终点
- Proportion of subjects who achieve Psoriasis Area and Severity Index (PASI) 90 response or higher at week 12
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled, multi-center Phase II clinical study to evaluate the efficacy and safety of AK111 for the treatment of moderate to severe plaque psoriasis.
详细描述
This is a randomized, double-blind, placebo-controlled, multi-center Phase II clinical study to evaluate the efficacy and safety of AK111 in subjects with moderate to severe plaque psoriasis. The study will consist of 4 periods: up to 4 weeks screening period, 12 weeks placebo-controlled period,12 weeks crossover treatment period,44 weeks long-term treatment period.
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)
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, 18 to 75 years of age
- •Moderate to severe plaque-type psoriasis diagnosed for at least 6 months
- •Moderate-to-severe plaque psoriasis as defined at baseline by meeting all three criteria:
- •Clinical diagnosis of stable plaque psoriasis with involvement of ≥ 10% body surface area.
- •Psoriasis area and severity index(PASI) ≥
- •Static Physicians Global Assessment score ≥
- •Subjects with a history of an inadequate response, intolerable or medically inappropriate use of systemic therapy and/or phototherapy.
- •Subjects who are women of childbearing potential must have a negative urine pregnancy test at screening and must be practicing an adequate, medically acceptable method of birth control for at least 8 months after the last study drug administration.
排除标准
- •Forms of psoriasis other than chronic plaque-type psoriasis.
- •History or evidence of active TB, Patients with evidence of latent tuberculosis may enter the trial after sufficient treatment according to protocol.
- •Positive results of confirmatory serology test for hepatitis B, hepatitis C, HIV or syphilis at screening.
- •History of a serious or systemic infection within 2 months before screening.
- •History of malignancy of any organ system within the past 5 years.
- •Inadequate washout period for prior drug therapy.
- •Previous use of secukinumab, ixekizumab or any other drug that targets IL-17 or IL-17 receptor.
- •Any medical conditions, in the opinion of the Investigator or the Sponsor's medical monitor, would place the subject at risk, interfere with study participation or study results interpretation.
研究组 & 干预措施
AK111 Regimen 2
AK111 Regimen 2 - subcutaneous injection every 4 weeks up to 60 weeks
干预措施: AK111/Placebo (Biological)
AK111 Regimen 1
AK111 Regimen 1 - subcutaneous injection every 4 weeks up to 60 weeks
干预措施: AK111/Placebo (Biological)
AK111 Regimen 3
AK111 Regimen 3 - subcutaneous injection every 4 weeks up to 60 weeks
干预措施: AK111/Placebo (Biological)
AK111 Regimen 4
AK111 Regimen 4 - subcutaneous injection every 4 weeks up to 60 weeks
干预措施: AK111/Placebo (Biological)
Placebo to AK111
Placebo to AK111-Placebo subcutaneous injection, then 1:1 randomized to AK111 Regimen 3 or Regimen 4 at week 12
干预措施: AK111/Placebo (Biological)
结局指标
主要结局
Proportion of subjects who achieve Psoriasis Area and Severity Index (PASI) 90 response or higher at week 12
时间窗: At week 12
次要结局
- Proportion of subjects who achieve static Physician Global Assessment (sPGA) 0 or 1 at week 12(At week 12)
- Change in serum IL-17A level (Pharmacodynamics parameter）(Baseline to week 68)
- Number and proportion of subjects who developed anti-drug antibodies (ADAs)(Baseline to week 68)
- Proportion of subjects who achieve PASI 75 response or higher at week 12(At week 12)
- Proportion of subjects who achieve PASI 50, PASI 75, PASI 90 and PASI 100 response up to 68 weeks(Baseline to week 68)
- Adverse events (AEs)/serious adverse events (SAEs)(Baseline to week 68)
- AK111 concentrations in serum at different time points(Baseline to week 68)