LY2525623 (IL-23 Antibody) Multiple-Dose Study in Adults With Plaque Psoriasis
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Percentage of Participants Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Scale by Week 12
研究概览
简要总结
In this study, we will evaluate clinical activity, safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of 5 LY2525623 dosing groups compared to placebo in adults with plaque psoriasis.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
180 mg LY2525623
干预措施: LY2525623 Intravenous (Drug)
Intravenous Placebo
干预措施: Placebo Intravenous (Drug)
Subcutaneous Placebo
干预措施: Placebo Subcutaneous (Drug)
3 mg LY2525623
干预措施: LY2525623 Subcutaneous (Drug)
10 mg LY2525623
干预措施: LY2525623 Subcutaneous (Drug)
30 mg LY2525623
干预措施: LY2525623 Subcutaneous (Drug)
90 mg LY2525623
干预措施: LY2525623 Subcutaneous (Drug)
结局指标
主要结局
Percentage of Participants Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Scale by Week 12
时间窗: Baseline through 12 weeks
PASI combines extent of body-surface involvement assessments in 4 anatomical regions and severity of regional desquamation, erythema, and plaque induration/infiltration. Overall score: 0 (no psoriasis) to 72 (severe disease). Study BDAD was terminated after enrolling only 8 patients. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.
Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Scale at Weeks 12 and 24
时间窗: Baseline, 12 weeks, 24 weeks
PASI combines body-surface assessments and severity of desquamation, erythema, and plaque induration/infiltration. Overall score:0(no psoriasis) to 72(severe disease). Percent(%) improvement=(baseline PASI-observed PASI)/baseline PASI\*100. Study BDAD was terminated after enrolling only 8 patients. Least Squares (LS) Mean Values were adjusted for time, treatment, and baseline. Given small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.
次要结局
- Change From Baseline in Relative Physician's Global Assessment (rPGA) Scale at 12 Weeks and 24 Weeks(Baseline, 12 weeks, 24 weeks)
- Change From Baseline in the Visual Analog Scale (VAS) for Psoriatic Arthritis at 12 Weeks and 24 Weeks(Baseline, 12 weeks, 24 weeks)
- Change From Baseline in the Patient's Global Assessment of Psoriasis Scale at 12 Weeks and 24 Weeks(Baseline, 12 weeks, 24 weeks)
- Change From Baseline in the Dermatology Life Quality Index (DLQI) Score at 12 Weeks(Baseline, 12 weeks)
- Change From Baseline in the 16-Item Quick Inventory for Depressive Symptomatology-Self Report (QIDS16SRTotal) at 12 Weeks(Baseline, 12 weeks)
- Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) at 12 Weeks(Baseline, 12 weeks)
- Pharmacokinetics: Area Under the Time Concentration Curve Through 24 Weeks(Baseline through 24 weeks)
- Number of Participants Who Developed Anti-LY2525623 Antibody Results Through 24 Weeks(Baseline through 24 weeks)