Efficacy and Safety of AbGn-168H in Patients With Active Psoriatic Arthritis: a 24-week, Open-label, Multi-center, Phase II Proof of Principle Trial.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 14
- 主要终点
- Proportion of subject reaching American College of Rheumatology score 20 (ACR20)
研究概览
简要总结
To evaluate efficacy, safety, tolerability, and immunogenicity of AbGn-168H administered intravenously in patients with active psoriatic arthritis.
详细描述
This is an open-label, multi-center, multi-dose phase II proof of principle trial to study the efficacy and safety of AbGn-168H in patients with moderate to severe active psoriatic arthritis. A minimum of 15 patients and a maximum of 20 will be recruited in 1 dosing group. For safety evaluation, the parameters to be assessed include physical examination, vital signs (blood pressure, heart rate, respiratory rate and body temperature), 12-lead ECG, safety laboratory tests, adverse events and tolerability. For efficacy evaluation, patients will be evaluated for proportion of subject reaching American College of Rheumatology 20 (ACR 20) in week 12 and proportion of subjects reaching ACR 20, ACR 50 and ACR 70 at different time points; Disease Activity Score 28 (DAS28) at different time points, as well as Target Lesion Psoriasis Severity Score (TLPSS) and static Physician Global Assessment (sPGA) for subjects with active skin lesions at different time point.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Proportion of subject reaching American College of Rheumatology score 20 (ACR20)
时间窗: at 12-week after the first treatment
次要结局
- Disease Activity Score 28 (DAR28)(up 24 weeks after the first treatment)
- Number of subjects with Adverse Event(up to 24 weeks after the first treatment)
- Immunogenicity(up to 24 weeks after the first treatment)
- Target Lesion Psoriasis Severity Score (TLPSS) for subjects with active skin lesions(up 24 weeks after the first treatment)
- Proportion of subjects reaching American College of Rheumatology score 20, 50 and 70 (ACR 20, ACR 50 and ACR70)(up to 24 weeks after the first treatment)
- static Physician's Global Assessment (sPGA) for subjects with active skin lesions(up to 24 weeks after the first treatment)
- Number of subject with abnormal clinical laboratory parameters(up to 24 weeks after the first treatment)