A 52-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study of Subcutaneous Secukinumab to Demonstrate Efficacy as Assessed by Palmoplantar Pustulosis Psoriasis Area and Severity Index (ppPASI) at 16 Weeks of Treatment, Compared to Placebo, and to Assess Long-term Safety, Tolerability, and Efficacy in Subjects With Moderate to Severe Chronic Palmoplantar Pustular Psoriasis - Amended With an Optional Extension Treatment Period of up to a Total of 148 Weeks
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 237
- 试验地点
- 69
- 主要终点
- Percentage of Participants With ppPASI 75 Response at Week 16 (Period 1)
研究概览
简要总结
A one year study assessing the efficacy and safety of secukinumab compared with placebo in adult patients with moderate to severe palmoplantar pustular psoriasis - amended with an optional extension treatment period of up to a total of 148 weeks
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, Investigator)
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
- •Palmoplantar pustular psoriasis for at least 6 months before Randomization
- •Moderate to severe palmoplantar pustular psoriasis as defined at Baseline by:
- •ppPASI score of ≥ 12 and
- •DLQI ≥ 10
- •Candidate for systemic therapy, defined as having palmoplantar pustular psoriasis inadequately controlled by:
- •Topical treatment, and/or
- •Phototherapy, and/or
- •Previous systemic therapy
排除标准
- •Forms of psoriasis other than chronic plaque psoriasis and pustular palmoplantar psoriasis (e.g., erythrodermic, guttate, or generalized pustular psoriasis)
- •Drug-induced psoriasis (e.g., new onset or current exacerbation from beta-blockers, calcium channel inhibitors, or lithium) or history of proven contact dermatitis
- •Patients not willing to limit UV light exposure (e.g. sunbathing and/or the use of tanning devices) during the course of the study
- •Ongoing use of prohibited psoriasis treatments (e.g., topical or systemic corticosteroids, UV therapy). Washout periods detailed in the protocol have to be adhered to
- •Previous exposure to any biologic drug directly targeting IL-17 or IL-17 Receptor (e.g., secukinumab, ixekizumab, or brodalumab)
- •Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment and for 16 weeks after stopping treatment
- •Active ongoing inflammatory diseases other than psoriasis that might confound the evaluation of the benefit of secukinumab therapy
- •Use of any other investigational drugs within 4 weeks of study drug initiation or within a period of 5 half-lives of the investigational treatment, whichever is longer
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Secukinumab 300mg
Secukinumab 300mg once weekly at Weeks 1, 2 and 3, thereafter at 4-weekly intervals starting Week 4 until Week 48.
In order to maintain the blinding beyond the primary endpoint, placebo was administered at Weeks 17, 18 and 19.
For extension period: Secukinumab 300mg at 4-weekly intervals starting Week 52 up to Week 148.
干预措施: Placebo (Biological)
Secukinumab 150mg
Secukinumab 150mg once weekly at Weeks 1, 2 and 3, thereafter at 4-weekly intervals starting Week 4 until Week 48.
In order to maintain the blinding beyond the primary endpoint, placebo was administered at Weeks 17, 18 and 19.
For extension period: Secukinumab 150mg at 4-weekly intervals starting Week 52 up to Week 148.
干预措施: Placebo (Biological)
Placebo
Placebo once weekly at Weeks 1, 2 and 3, thereafter at 4-weekly intervals starting Week 4 until Week 12. Patients who achieved ppPASI 75 at Week 16 remained on placebo treatment Until week 48 and were not eligible to enter the extension. Patients who did not achieve ppPASI 75 at Week 16 were re-randomized to receive Secukinumab 150mg or Secukinumab 300mg from Week 16 onwards up to Week 148.
干预措施: Placebo (Biological)
Secukinumab 150mg
Secukinumab 150mg once weekly at Weeks 1, 2 and 3, thereafter at 4-weekly intervals starting Week 4 until Week 48.
In order to maintain the blinding beyond the primary endpoint, placebo was administered at Weeks 17, 18 and 19.
For extension period: Secukinumab 150mg at 4-weekly intervals starting Week 52 up to Week 148.
干预措施: Secukinumab 150mg (Biological)
Placebo
Placebo once weekly at Weeks 1, 2 and 3, thereafter at 4-weekly intervals starting Week 4 until Week 12. Patients who achieved ppPASI 75 at Week 16 remained on placebo treatment Until week 48 and were not eligible to enter the extension. Patients who did not achieve ppPASI 75 at Week 16 were re-randomized to receive Secukinumab 150mg or Secukinumab 300mg from Week 16 onwards up to Week 148.
干预措施: Secukinumab 300mg (Biological)
Secukinumab 300mg
Secukinumab 300mg once weekly at Weeks 1, 2 and 3, thereafter at 4-weekly intervals starting Week 4 until Week 48.
In order to maintain the blinding beyond the primary endpoint, placebo was administered at Weeks 17, 18 and 19.
For extension period: Secukinumab 300mg at 4-weekly intervals starting Week 52 up to Week 148.
干预措施: Secukinumab 300mg (Biological)
Placebo
Placebo once weekly at Weeks 1, 2 and 3, thereafter at 4-weekly intervals starting Week 4 until Week 12. Patients who achieved ppPASI 75 at Week 16 remained on placebo treatment Until week 48 and were not eligible to enter the extension. Patients who did not achieve ppPASI 75 at Week 16 were re-randomized to receive Secukinumab 150mg or Secukinumab 300mg from Week 16 onwards up to Week 148.
干预措施: Secukinumab 150mg (Biological)
结局指标
主要结局
Percentage of Participants With ppPASI 75 Response at Week 16 (Period 1)
时间窗: Baseline to Week 16
The primary endpoint was assessed by the palmoplantar pustulosis Psoriasis Area and Severity Index 75 (ppPASI 75). The percentage of subjects who achieved a 75% reduction in ppPASI score from Baseline to Week 16 was measured. The ppPASI is a modification of the PASI score and adjusted for palmoplantar pustular psoriasis by classifying and scoring erythema, scaling (desquamation) and pustules/vesicles. Both palms and both plants are scored from 0 to 4. The extent of involvement of each region of the body is scored from 0 to 6. The total ppPASI score can range from a lower level of 0, corresponding to no signs of psoriasis, up to a maximum of 72.
次要结局
- Percentage of Participants With ppPASI 75 Response Over Time (Period 1)(Baseline to Week 16)
- Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety)(Week 16 to Week 52 (Period 2))
- Percentage of Participants With ppPASI 75 Response Over Time (Extension Period)(Week 52 to Week 148)
- ppPASI: Absolute Change From Baseline to Week 16(Baseline to Week 16)
- Percentage of Participants With ppPASI 75 Response Over Time (Period 2)(Week 16 to Week 52)
- Percentage of Participants With Most Frequent Adverse Events - Period 1 (Patient's Safety)(Baseline to Week 16 (Period 1))
- Percentage of Participants With Most Frequent Adverse Events - Extension Period (Patient's Safety)(Week 52 to Week 148 (extension period))