A Single Arm Multiple Dose Study to Assess the Efficacy and Safety of ANB019 in Subjects With Generalized Pustular Psoriasis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 13
- 主要终点
- Percentage of Participants Achieving Clinical Response on the Clinical Global Impression (CGI) Scale
研究概览
简要总结
The main objectives of this study are to evaluate the efficacy, safety and tolerability of imsidolimab in adults with active GPP.
详细描述
Single arm, multiple-dose study evaluating the use of imsidolimab for the treatment of GPP.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of active GPP
- •Japanese Dermatology Association (JDA) severity index total score of at least 6 and erythema with pustules accounting for at least 10% of body surface area or a moderate severity score on Generalized Pustular Psoriasis Physician's Global Assessment (GPPPGA)
- •Must be candidates for systemic therapy or phototherapy
排除标准
- •Erythrodermic, guttate psoriasis, drug induced GPP
- •Any other ongoing inflammatory disease that interfere with the Investigator's ability to evaluate the subject's response to therapy
- •History of recurrent or chronic infection
- •ongoing use of psoriasis prohibited medication
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Imsidolimab
Participants received imsidolimab 750 mg intravenously (IV) on Day 1 followed by administration of 3 doses of subcutaneous (SC) imsidolimab 100 mg on Days 29, 57, and 85.
干预措施: Imsidolimab (Biological)
结局指标
主要结局
Percentage of Participants Achieving Clinical Response on the Clinical Global Impression (CGI) Scale
时间窗: Week 4 and Week 16
Clinical response was defined as "Very much improved," "Much Improved," or "Minimally Improved" on the CGI scale according to the Modified Japanese Dermatological Association Severity Index (JDA-SI) total score. The JDA-SI includes assessment of skin lesions (area of erythema with pustules, area of erythema total, and area of edema) and fever, white blood cell count, C-reactive protein and serum albumin levels. The total score ranges from 0 to 17 (severe). CGI was assessed based on the JDA-SI according to the following: * Very Much Improved: Reduction in JDA-SI total score by 3 or \> points; * Much improved: Reduction in JDA-SI total score by 1 or 2 points; * Minimally improved: No change in JDA-SI total score and area of erythema with pustules reduced by \<20% or clinically meaningful improvement in at least 1 other component of the modified JDA-SI.
Percent Change From Baseline in Body Surface Area of Erythema With Pustules at Week 1, Week 4, and Week 16
时间窗: Baseline, Week 1, Week 4, and Week 16
Excluding palms and soles from 0% to 100%. The palmar surface of one hand (using the subject's hand and including the fingers) represents 1% of his or her total BSA.
次要结局
- Percent Change From Baseline in Modified Japanese Dermatological Association - Severity Index (mJDA-SI) Total Skin Lesions Score at Week 1, Week 4, and Week 16(Baseline, Week 1, Week 4, and Week 16)
- Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 1, Week 4, and Week 16(Baseline and Week 1, Week 4, and Week 16)
- Percentage of Participants Achieving a Generalized Pustular Psoriasis Physician's Global Assessment (GPPPGA) Score of 0 or 1 at Week 1, Week 4, and Week 16(Week 1, Week 4, and Week 16)