Exploratory Study on the Kinetics of Psoriasis Symptoms, Pruritus Intensity and Lesional Biomarkers in Patients With Moderate to Severe Plaque-type Psoriasis Treated With Subcutaneous Secukinumab (300 mg) During a 16 Week Open-label run-in Phase Followed by a 16 Week Randomized, Double-blind, Placebo-controlled Withdrawal Phase
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 20
- 主要终点
- Pruritus Intensity Visual Analogue Scale Score at Week 32
研究概览
简要总结
The study is designed to explore the kinetics of psoriasis symptoms, pruritus intensity and lesional biomarkers.
详细描述
All subjects will undergo a 16 week run-in phase (open label). At Week 16, an evaluation of the PASI response will be performed. Patients who achieve a PASI reduction of less than 98 percent will complete the study at Week 16 and be referred to routine clinical care for psoriasis by the investigator. Patients who achieve extensive remission (PASI reduction by 98-100 percent) at Week 16 will enter the randomized withdrawal phase (blinded) where they will be randomized to receive either secukinumab or matching placebo and will complete the study at Week 32.
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
- •Chronic moderate to severe plaque type psoriasis as diagnosed by a qualified physician at least 6 months prior to baseline and with a PASI score > 10 at baseline.
- •Psoriasis patients with pruritus intensity of ≥ 30 on a 100-point VAS, with a recall period of 24h as part of the PGA-CP, both, at screening and at baseline.
排除标准
- •Underlying conditions other than psoriasis which in the opinion of the investigator currently cause or influence pruritus of the skin (e.g. drug induced pruritus, renal insufficiency, diabetes).
- •Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic, and guttate) at screening or study start.
- •Ongoing use of prohibited psoriasis and non-psoriasis treatments. Washout periods have to be adhered to. If the use of any of the prohibited treatments is required, then the subject may not be included into the study.
- •Pregnancy, breast feeding or inadequate contraception (if necessary)
研究组 & 干预措施
Placebo
Inactive ingredients administered as a matching placebo at Weeks 16, 20, 24, and 28
干预措施: Placebo (Biological)
Secukinumab
300 mg secukinumab (administered as two injections of 150 mg each) at Weeks 16, 20, 24, and 28
干预措施: Secukinumab (Biological)
结局指标
主要结局
Pruritus Intensity Visual Analogue Scale Score at Week 32
时间窗: Week 32
On a 100-mm horizontal line, the patient placed a mark representing their perception of worst itching (pruritus) within a recall period of 24 hours, where 0 = no pruritus and 100 = most severe pruritus.
次要结局
未报告次要终点