A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Effect of Secukinumab on Aortic Vascular Inflammation and Cardiometabolic Biomarkers After 12 Weeks of Treatment, Compared to Placebo, and up to 52 Weeks of Treatment With Secukinumab in Adult Subjects With Moderate to Severe Chronic Plaque-type Psoriasis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 1
- 主要终点
- Aortic Vascular Inflammation as Measured by FDG-PET/CT
研究概览
简要总结
This study evaluated the effect of secukinumab compared to placebo on aortic vascular inflammation in adult patients who have moderate to severe plaque psoriasis that is poorly controlled by current psoriasis treatments.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females at least 18 years of age with moderate to severe plaque psoriasis
排除标准
- •Forms of psoriasis other than chronic plaque psoriasis
- •Previous exposure to IL-17A or IL-17 receptor targeting agents.
- •Other active or ongoing disease that may interfere with evaluation of psoriasis or places the patient at unacceptable risk
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Secukinumab
Eligible patients received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by monthly dosing starting at Week 8 through Week 48 inclusive
干预措施: Secukinumab 300 mg (Drug)
Placebo then Secukinumab
Eligible patients received placebo doses once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by a dose after four weeks at Week 8.
Beginning with the Week 12 dose, participants were switched to treatment with secukinumab 300 mg and were dosed once weekly at Weeks 12, 13, 14, 15 and 16 followed by monthly dosing through Week 48 inclusive.
干预措施: Placebo (Biological)
结局指标
主要结局
Aortic Vascular Inflammation as Measured by FDG-PET/CT
时间窗: baseline, 12 weeks
Change from baseline in the target to background ratio from the whole aorta. Effect of secukinumab 300 mg subcutaneous (sc) compared to placebo on aortic vascular inflammation with respect to the change from baseline in the target (arterial vascular uptake) to background (venous blood pool) ratio from the aorta. The primary analysis time point was at Week 12. Increased aortic vascular inflammation as measured by (18F) fluorodeoxyglucose positron emission tomography with computer assisted tomography (FDG-PET/CT)
次要结局
- LDL Size(baseline, 12 weeks)
- Change in Adiponectin Total(baseline, 12 weeks)
- Change in Apolipoprotein B(baseline, 12 weeks)
- Change in Cholesterol(baseline, 12 weeks)
- Change in Ferritin(baseline, 12 weeks)
- Change in Leptin(baseline, 12 weeks)
- LDL Particle Total(baseline, 12 weeks)
- Change VLDL Particle Total(baseline, 12 weeks)
- Change in HDL Cholesterol(baseline, 12 weeks)
- HDL Particle Total(baseline, 12 weeks)
- HOMA-IR(baseline, 12 weeks)
- Change in IL-6(baseline, 12 weeks)
- Change in TNF-α(baseline, 12 weeks)
- Change in CRP(baseline, 12 weeks)
- Change in GlycA(baseline, 12 weeks)
- Change in HDL Function (Cholesterol Efflux)(baseline, 12 weeks)
- HDL Size(baseline, 12 weeks)
- Change in Fetuin A(baseline, 12 weeks)
- Change in IL-18(baseline, 12 weeks)
- Change LDL Cholesterol(baseline, 12 weeks)
- Change in Triglycerides(baseline, 12 weeks)
- Psoriasis Area and Severity Index 100 (PASI100)(week 12)
- Change in IL-2 Receptor A(baseline, 12 weeks)
- Change in Intermediate-Density Lipoprotein (IDL) Particle(baseline, 12 weeks)
- VLDL Size(baseline, 12 weeks)
- Psoriasis Area and Severity Index 90 (PASI 90)(week 12)
- Investigator's Global Assessment Modified 2011 (IGA Mod 2011) Score of 0 or 1(week 12)
- Area and Severity Index 75 (PASI 75)(week 12)
- Dermatology Life Quality Index (DLQI) Total Score(baseline, 12 weeks)