A Double-blind, Placebo-controlled, Randomized, Parallel-group Study to Evaluate the Activity of Oral AB1010 in Adults Patients With Moderate to Severe Chronic Plaque Psoriasis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 主要终点
- Change from baseline in BSA after 12 weeks of treatment
研究概览
简要总结
A double-blind, placebo-controlled, randomized, parallel-group study to evaluate the activity of oral AB1010 in adults patients with moderate to severe chronic plaque psoriasis
详细描述
To evaluate the activity of oral AB1010, administered at two dose levels during 12 weeks to patients with moderate to severe chronic plaque psoriasis, assessed on :
i)Body Surface Area (BSA), Psoriasis Area and Severity Index (PASI), Overall Lesion Severity (OLS), Physician's Global Assessment (PGA) and Patient's Global Psoriasis Assessment (PGPA) ii)clinical and biological safety parameters iii) pharmacokinetic profile of AB1010
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Male or female outpatients aged 18 to 75 years with chronic plaque psoriasis
- •Plaque psoriasis covering ≥ 10% BSA
- •Disease duration ≥ 6 months
- •PASI ≥ 12.0 at screening
排除标准
- •Guttate, erythrodermic or pustular psoriasis as sole or predominant form of the disease
- •Clinically significant psoriasis flare during screening or at time of enrollment
- •Systemic therapy for psoriasis or systemic immunosuppressive therapy for other indications within 28 days prior to enrollment
- •Topical treatment for psoriasis within 14 days prior to enrollment
- •Use of CYP3A4 moderate and strong inhibitors within 4 weeks prior to randomization
- •Active current bacterial, viral (including hepatitis B and C, HIV, EBV, CMV, herpes zoster, herpes simplex), fungal, mycobacterium, protozoan, or other infection
研究组 & 干预措施
Masitinib (AB1010)
Masitinib (AB1010)
干预措施: Masitinib (Drug)
Placebo mactching masitinib
Placebo matching masitinib
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in BSA after 12 weeks of treatment
时间窗: 12 weeks
次要结局
- Percentage change from baseline in PASI score, proportion of patients reaching a 90%, 75% or 50% improvement in PASI score after 12 weeks of treatment; time to and duration of first occurrence in PASI 50, 75 and 90(12 weeks)
- Proportion of patients achieving an OLS rating of Minimal or Clear after 12 weeks(12 weeks)
- Percentage change from baseline in PGA and PGPA after 12 weeks of treatment(12 weeks)