A Phase 3, Randomized, Open-Label Study to Assess Efficacy and Safety of Two Different Dose Regimens of Risankizumab Administered Subcutaneously in Japanese Subjects With Generalized Pustular Psoriasis or Erythrodermic Psoriasis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 9
- 主要终点
- Percentage of Participants With Generalized Pustular Psoriasis (GPP) Achieving GPP Clinical Response at Week 16
研究概览
简要总结
The purpose of this study is to investigate the safety and efficacy of two different dose regimens of risankizumab for Japanese subjects with generalized pustular psoriasis (GPP) or erythrodermic psoriasis (EP).
详细描述
Safety and efficacy data through 14 December 2017 are included in the interim analysis, which was conducted after all participants completed the Week 28 visit or discontinued from the study.
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
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a diagnosis of GPP for at least 60 days prior to informed consent based on the diagnostic criteria of the Japanese Dermatological Association (JDA). Subjects not fulfilling one of the diagnostic criteria i.e., "accompanying systemic symptoms including fever or malaise" at the time of screening can be entered.
- •Subjects with an erythema area with pustules accounting for ≥ 10% of the body surface area (BSA), and with a severity assessment criteria score (JDA total score) specified by the JDA of less than
- •Must be candidates for systemic therapy or phototherapy for GPP, as assessed by the investigator.
- •Have a diagnosis of EP prior to informed consent.
- •Subjects with an inflammatory erythema area accounting for ≥ 80% of the BSA at screening and at the time of the first administration of the study drug.
- •Must be candidates for systemic therapy or phototherapy for EP, as assessed by the investigator.
排除标准
- •Previous exposure to risankizumab.
- •Currently enrolled in another investigational study or less than 30 days (from screening) since completing another investigational study (participation in observational studies is permitted).
- •Subjects with active ongoing inflammatory diseases other than GPP that might confound trial evaluations according to investigator's judgment.
- •Subjects with active ongoing inflammatory diseases other than EP that might confound trial evaluations according to investigator's judgment.
- •Subject diagnosed with medication-induced or medication-exacerbated EP.
研究组 & 干预措施
Risankizumab 75 mg
Participants randomized to receive risankizumab 75 mg at Week 0, Week 4, and every 12 weeks up to Week 172.
干预措施: risankizumab (Drug)
Risankizumab 150 mg
Participants randomized to receive risankizumab 150 mg at Week 0, Week 4, and every 12 weeks up to Week 172.
干预措施: risankizumab (Drug)
结局指标
主要结局
Percentage of Participants With Generalized Pustular Psoriasis (GPP) Achieving GPP Clinical Response at Week 16
时间窗: Week 16
GPP Clinical Response defined as at least "Slightly Improved" in the overall improvement rating from baseline according to Japanese Dermatological Association (JDA) total score for GPP. The JDA consists of an assessment of skin symptoms (area of skin with erythema, pustules, and edema) on a scale of 0 (none) to 9 (severe) and a systemic symptoms/assessment of test findings (fever, white blood count \[WBC\], serum C-reactive protein \[CRP\], and serum albumin) on a scale of 0 (none) to 8 (severe). The JDA total score is the sum of the 2 assessments ranging from 0 (mild) to 17 (severe). The overall improvement rating ranges from Markedly improved (decreased by ≥ 3 points) to Worsened (increased by ≥ 1 point); Slightly improved represents no change in points and ≥ 20% and \< 30% reduction of erythema area with pustules compared to baseline, or clinically meaningful improvement in ≥1 other parameters of the severity assessment criteria. Nonresponder imputation (NRI) was used for missing data.
Percentage of Participants With Erythrodermic Psoriasis (EP) Achieving EP Clinical Response at Week 16
时间窗: Week 16
EP Clinical Response, defined as at least "Minimally Improved" in Clinical Global Impression-Global Improvement (CGI-GI) for EP. The CGI-GI is a global assessment by the Investigator of the change in clinical status since the start of treatment. The CGI-GI ratings are as follows: 0 (not assessed), 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse), 7 (very much worse). NRI was used for missing data.
次要结局
- Percentage of Participants With GPP Achieving PASI90 at Week 52(Week 52)
- Percentage of Participants With EP Achieving PASI90 at Week 52(Week 52)
- Percentage of Participants With GPP Achieving GPP Clinical Response at Week 52(Week 52)
- Percentage of Participants With EP Achieving EP Clinical Response at Week 52(Week 52)
- Percentage of Participants With GPP Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16(Week 16)
- Percentage of Participants With EP Achieving PASI90 at Week 16(Week 16)