A Randomised, Double-blind, Placebo-controlled, Single and Multiple Dose, Dose-escalation Trial of Anti-IL-20 (109-0012) 100 mg/Vial in Psoriatic Subjects, Followed by an Expansion Phase
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Observed toxicity using the US National Cancer Institute's common terminology criteria for adverse events (CTCAE) - SD phase
研究概览
简要总结
This trial is conducted in the United States of America (USA). The aim of this clinical trial is evaluate the safety and tolerability of anti-IL-20 in patients with psoriasis and to determine the preliminary efficacy in an expansion phase of this trial.
This trial consists of 3 parts: A single dose (SD) dose-escalation phase for 16 weeks, a multiple dose (MD) dose-escalation phase for 22 weeks, and a MD expansion phase for 22 weeks.
Initiation of the MD expansion phase will depend on results from the SD and MD dose-escalation phases and only if an acceptable safety profile is present. Subjects participating in the expansion phase are not allowed to have participated in the previous phases (SD and MD dose-escalation phases) of the trial.
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
- Double (Participant, Investigator)
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
- •Subjects with moderate to severe stable chronic plaque psoriasis for at least 6 months, with or without psoriatic arthritis
- •Affected body surface area (BSA) greater than or equal to 15%
- •Physician's Global Assessment (PGA) score of 3 or more
- •Female subjects of non-childbearing potential or postmenopausal for at least 1 year. Male subjects must agree to use effective method of birth control
- •Body Mass Index (BMI) less than or equal to 38.0 kg/m2
排除标准
- •Concomitant anti-psoriatic treatment
- •Infectious disease requiring systemic anti-infectious treatment within the 2 weeks prior to administration of trial drug
- •Known history of Human Immunodeficiency Virus (HIV)
- •Hepatitis B and/or C (determined by test)
- •Live virus or bacteria vaccines within the last month before drug administration
- •Known active herpes/herpes zoster/cold sores
- •Kidney insufficiency
- •Liver insufficiency
- •Lymphoproliferative disease
- •History or signs of malignancy within the last 5 years
研究组 & 干预措施
Anti-IL-20
干预措施: anti-IL-20 (Drug)
Placebo
干预措施: placebo (Drug)
结局指标
主要结局
Observed toxicity using the US National Cancer Institute's common terminology criteria for adverse events (CTCAE) - SD phase
时间窗: from week 0 until end of trial observation period at week 16
Improvement psoriasis area and severity index score by 75% (PASI75) - MD expansion phase
时间窗: at weeks 1-7, 9-15, 22
Observed toxicity using the US National Cancer Institute's common terminology criteria for adverse events (CTCAE) - MD and MD expansion phases
时间窗: from week 0 until end of trial observation period at week 22
次要结局
- Pharmacokinetics (the rate at which the body eliminates the trial drug) - MD expansion phase(prior to dosing (week 1) and at each dosing visit (week 2-7))
- Pharmacodynamics (the effect of the investigated drug on the body) - SD and MD phases(SD: Prior to dosing (week 1) and through 24 hours and at each visit (week 1-3, 5, 9, 13 and 16). MD: Prior to dosing and at each dosing visit (week 1, 3, 5, 7))
- Observed toxicity using the US National Cancer Institute's common terminology criteria for adverse events (CTCAE) - MD expansion phase(from week 0 until end of trial observation period at week 22)
- Improvement psoriasis area and severity index score by 75% (PASI75) - SD and MD phases(SD: at weeks 1, 3, 9, 13 and 16. MD: at weeks 1, 3, 5, 7, 9, 15, 22)
- Pharmacokinetics (the rate at which the body eliminates the trial drug) - SD and MD phases(SD: Prior to dosing (week 1) and through 24 hours and at each visit (week 1-3, 5, 9, 13 and 16). MD: Prior to dosing and at each dosing visit (week 1, 3, 5, 7))
- Pharmacodynamics (the effect of the investigated drug on the body) - MD expansion phase(prior to dosing (week 1) and at each dosing visit (week 2-7))