Study to Assess Pharmacodynamics, Clinical Effects, Safety and Pharmacokinetics of TAB08 in Patients With Psoriasis Vulgaris, Not Adequately Controlled With Current Concomitant Therapy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Theramab LLC
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Change of T-lymphocytes subsets in absolute count (number of cells per mL) in peripheral blood at Weeks 2, 3, 4, 8 and 12 comparing to Baseline.
研究概览
简要总结
Study to assess Pharmacodynamics, Safety, Pharmacokinetics and clinical effects of TAB08 during 12 weeks of treatment in patients with Psoriasis Vulgaris, not adequately controlled with current therapy.
详细描述
- To assess dynamics of the T-lymphocytes subpopulations in patients peripheral blood during 12 weeks of TAB08 treatment.
- To assess dynamics of selected cytokines levels in patients peripheral blood during 12 weeks of TAB08 treatment.
- To assess TAB08 concentrations in patients blood during 12 weeks of TAB08 treatment.
- To assess frequency, seriousness and severity of adverse events during 12 weeks of TAB08 treatment.
- To assess changes in PASI, IGA and DLQI during 12 weeks of TAB08 treatment and subsequent 4 weeks follow-up.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of Vulgar Psoriasis
- •Area of Psoriasis skin damage ≥ 10%
- •PASI Score ≥ 12
- •Score on IGA scale ≥ 3
排除标准
- •Other forms of psoriasis in addition to vulgar
- •Prohibited treatment
- •Pregnant or nursing women
- •Concomitant systemic therapy dosage modification (if any) within 4 weeks before randomization
研究组 & 干预措施
Placebo
Placebo to TAB08
干预措施: Placebo (Other)
TAB08 Dose 1
Drug: TAB08 biologic
干预措施: TAB08 (Drug)
结局指标
主要结局
Change of T-lymphocytes subsets in absolute count (number of cells per mL) in peripheral blood at Weeks 2, 3, 4, 8 and 12 comparing to Baseline.
时间窗: 12 weeks
Change of cytokines concentrations (in micrograms/mL) in peripheral blood at Weeks 2, 3, 4, 8 and 12 comparing to Baseline.
时间窗: 12 weeks
Change of cytokines concentrations (in percent) in peripheral blood at Weeks 2, 3, 4, 8 and 12 comparing to Baseline.
时间窗: 12 weeks
Change of T-lymphocytes subsets (in percent) in peripheral blood at Weeks 2, 3, 4, 8 and 12 comparing to Baseline.
时间窗: 12 weeks
次要结局
- TAB08 concentrations in peripheral blood(12 weeks)
- Adverse events frequency, seriousness and severity(16 weeks)
- Psoriasis Area Severity Index (PASI)(16 weeks)
- Investigator Global Assessment (IGA)(16 weeks)
- Patient-reported health outcome assessed by Short Form - Dermatology Quality of Life Index (DLQI)(12 weeks)