NCT04061252已完成3 期
A Phase 3, Placebo-Controlled, Double-Blind Comparative Study of KHK4827 With an Open-Label Extension in Subjects With Palmoplantar Pustulosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- Change from baseline in Palmoplantar Pustulosis Area and Severity Index (PPPASI) total score at Week 16
研究概览
简要总结
Evaluation of efficacy and safety of KHK4827 in Subjects with Palmoplantar Pustulosis
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has had a diagnosis of palmoplantar pustulosis for at least 24 weeks as of the time of informed consent.
- •Subject has a PPPASI total score ≥12 and a PPPASI severity score of pustules/vesicles on the palms or soles ≥2 both at the pre-examination and enrollment examination;
- •Subject inadequately responded to any one or combination of the following therapies before informed consent: Topical corticosteroids, Topical vitamin D3, Phototherapy, Etretinate
排除标准
- •Subject has a diagnosis of plaque psoriasis, pustular psoriasis, drug-induced palmoplantar pustulosis, or pompholyx;
- •Subject has an improvement in PPPASI total score of ≥4 points during the screening period;
- •Subject has a history or evidence of psychiatric disorder or alcohol/drug abuse that, in the opinion of the investigator or subinvestigator, may compromise the safety of the subject because of participation in the study or may interfere with assessments and procedures in the study or study completion;
- •Subject has a past or current history of suicidal ideation (severity of 4 or 5) or any suicidal behavior at enrollment, as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS);
- •Subject has severe depression with a PHQ-8 total score of ≥15 at enrollment
研究组 & 干预措施
KHK4827 210mg Q2W SC
Experimental
干预措施: KHK4827 (Drug)
Placebo Q2W SC
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in Palmoplantar Pustulosis Area and Severity Index (PPPASI) total score at Week 16
时间窗: Baseline, Week 16
PPPASI is composed of subscores of erythema (E), pustules/vesicles (P), desquamation/scales (D) on the left (L) and right (R) palm (P) and sole (S) respectively. PPPASI is calculated by the following calculation formula. PPPASI=(E+P+D) Area\*0.2 (RP)+(E+P+D) Area\*0.2 (LP)+ (E+P+D) Area\*0.3 (RS)+(E+P+D) Area\*0.3 (LS).
次要结局
- Change from baseline in Palmoplantar Pustulosis Severity Index (PPP-SI) total score at Week 16(Baseline, Week 16)
- The percentage of participants who achieved at least 50% improvement in PPPASI score from Baseline to Week 16(Week 16)
- The percentage of participants who achieved at least 75% improvement in PPPASI score from Baseline to Week 16(Week 16)
- The percentage of participants who achieved a Physician's Global Assessment(PGA) score of 0 or 1 at Week 16(Week 16)
- Change from baseline in PPPASI total score at each assessment time point(Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68)
- Change from baseline in PPP-SI total score at each assessment time point(Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68)
- Change from baseline in Dermatology Life Quality Index (DLQI) score at each evaluation point(Baseline, Week 8, 16, 24, 32, 44, 56, 68)
研究者
研究点 (2)
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