A Multi-center, Open Label Study of Subcutaneous Secukinumab in Prefilled Syringes as Mono- or Co-therapy to Assess the Efficacy, Safety and Tolerability in Japanese Subjects With Generalized Pustular Psoriasis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 10
- 主要终点
- Number of Patients With Treatment Success at Week 16 Using Non-responder Imputation (Full Analysis Set)
研究概览
简要总结
The purpose of this study was to assess efficacy and safety data of secukinumab in Japanese subjects with generalized pustular psoriasis (GPP). This study was expected to support the filing of secukinumab in the indication of pustular psoriasis in Japan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •At baseline, presence of GPP classified on the basis of the criteria for diagnosis of GPP by Japanese Dermatological Association (JDA)
- •At baseline, erythema area with pustule ≥ 10%
排除标准
- •Erythrodermic, guttate psoriasis, or subcorneal pustular dermatosis at screening.
- •At baseline, : total score of JDA severity index for GPP ≥ 14
- •Drug-induced psoriasis
- •Ongoing use of prohibited psoriasis treatments.
研究组 & 干预措施
AIN457
All subjects were assigned to receive 150 mg secukinumab (AIN457) by subcutaneous injections. AIN457 was administered at baseline, weeks 1, 2, 3, 4. Prior to receiving the week 8 dose, all subjects were assigned to the following treatment group based on clinical components of their Clinical Global Impression (CGI) evaluation at week 8.
- "No up-titration" group received 1 injection of 150 mg AIN457 at weeks 8, 12, and each visit from week 16 until week 48.
- "Up-titration" group received 2 injections of 150 mg AIN457 at weeks 8, 9, 12 and each visit from week 16 until week 48.
Subjects who received 150 mg AIN457 can be up-titrated to 300 mg AIN 457 at any visit starting at week 16 based on clinical components of their CGI evaluation and investigator's discretion.
干预措施: Secukinumab (Biological)
结局指标
主要结局
Number of Patients With Treatment Success at Week 16 Using Non-responder Imputation (Full Analysis Set)
时间窗: 16 weeks
Treatment success was defined as "Minimally improved", "Much improved" or "Very much improved" in Clinical global impression (CGI). Non-responder imputation assigns a value of nonresponse to missing data points, any patient who drops out is assumed to be a non-responder.
次要结局
- Summary of JDA Total Score Category for GPP by Visit up to End of Trial(up to week 148 (End of Trial))
- Summary of Clinical Global Impression up to End of Trial(up to week 148 (End of Trial))
- Number of Patients With Treatment Success at Week 52 Using Non-responder Imputation (Full Analysis Set)(52 weeks)
- Number of Patients With Treatment Success at End of Trial Using Non-responder Imputation (Full Analysis Set)(week 148)
- The Japanese Dermatological Association (JDA) Component Score for GPP Over Time(up to week 148 (end of trial))
- Change From Baseline in Observed Value of Components of the JDA Severity Index for GPP(up to week 148 (end of trial))
- Number of Patients With GPP-related Systemic and Topical Co-medication Over Time(up to week 52)
- Mean Health-related Quality of Life (The Dermatology Life Quality Index [DLQI] and Short Form Health Survey [SF-36]) Over Time(Up to week 148 (end of treatment))