A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Demonstrate the Efficacy of Subcutaneous Secukinumab [300 mg] as Assessed by the Psoriasis Scalp Severity Index (PSSI) at 12 Weeks of Treatment, Compared to Placebo, and to Assess Safety and Tolerability up to 24 Weeks in Adult Subjects With Moderate to Severe Scalp Psoriasis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 17
- 主要终点
- Psoriasis Scalp Severity Index 90 (PSSI 90)
研究概览
简要总结
This study will assess the efficacy and safety of secukinumab compared to placebo in adult patients who have moderate to severe scalp 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
- •Chronic scalp psoriasis for at least the previous six months
- •Moderate to severe scalp psoriasis as defined by a PSSI score of ≥12 and 30% or higher of scalp surface area affected
- •Must be candidates for systemic therapy, which means having scalp psoriasis inadequately controlled by topical treatments (corticosteroids), and/or phototherapy, and/or previous systemic therapy.
排除标准
- •Forms of psoriasis other than chronic plaque
- •Drug-induced psoriasis (e.g., new onset or current exacerbation from β-blockers, calcium channel inhibitors)
- •Ongoing use of prohibited treatments (e.g., topical or systemic corticosteroids, UV therapy)
- •Prior exposure to secukinumab (AIN457) or any other biologic drug directly targeting IL17A or IL-17RA receptors
- •Use of other investigational drugs within 30 days prior to study entry, or within a period of 5 half-lives of the investigational treatment, whichever is longer
- •Active, ongoing inflammatory diseases other than psoriasis that might confound the evaluation of the benefit of secukinumab
- •Active system infections (with the exception of the common cold) during the two weeks prior to starting study treatment
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Secukinumab
Eligible patients will receive secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by monthly dosing starting at Week 8 through Week 20 inclusive
干预措施: Secukinumab 300 mg (Biological)
Placebo
Eligible patients will receive placebo doses once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by a dose after four weeks at Week 8. Prior to taking the Week 12 dose, the patient will be assessed for response to treatment using the Psoriasis Scalp Severity Index (PSSI). If the subject is a responder, the subject will continue on placebo dosing weekly at Weeks 12, 13, 14, 15 and 16 and then after four weeks at Week 20. Subjects who are not responders will be switched to treatment with secukinumab 300 mg and will dose once weekly at Weeks 12, 13, 14, 15 and 16 and then after four weeks at Week 20.
干预措施: Placebo (Biological)
结局指标
主要结局
Psoriasis Scalp Severity Index 90 (PSSI 90)
时间窗: 12 weeks
PSSI 90 response (yes) at Week 12; PSSI 90 response means at least a 90% improvement in scalp psoriasis Percentage of participants with Psoriasis Scalp Severity Index 90 (PSSI 90) response of "yes"
次要结局
- Psoriasis Scalp Severity Index 75 (PSSI 75) Response(12 weeks)
- Psoriasis Scalp Severity Index 100 (PSSI 100) Response(12 weeks)
- Psoriasis Area and Severity Index 90 (PASI 90)(12 weeks)
- Psoriasis Area and Severity Index 100 (PASI 100)(12 weeks)
- Investigator's Global Assessment Model 2011 (GA Mod 2011) Score of 0 or 1 (Entire Body Including Scalp)(12 weeks)
- Secondary: Investigator's Global Assessment Model 2011 (IGA Mod 2011) Score of 0 or 1 (Scalp Only)(12 weeks)
- Change From Baseline in PSSI Score(12 weeks)
- Time to 50% Reduction in PSSI Score up to Week 12(12 weeks)
- Change From Baseline in Subject Assessment of Pain(12 weeks)
- Psoriasis Area and Severity Index 75 (PASI 75)(12 weeks)
- Change From Baseline in Subject Assessment of Itching(12 weeks)
- Change From Baseline in Subject Assessment of Scaling (Scalp Only)(12 weeks)