NCT04614298撤回4 期
A Phase 4 Clinical Study to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy of Brodalumab (KHK4827) in Subjects With Moderate to Severe Plaque Psoriasis
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 25
- 主要终点
- To evaluate the proportion of subjects achieving 75% improvement from baseline in Psoriasis Area and Severity Index (PASI; PASI 75) at Week 12
研究概览
简要总结
The objective of this study is assessing the efficacy and safety of brodalumab in Chinese subjects with moderate to severe plaque psoriasis.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Those who are ≥18 and ≤70 years of age at the time of signing the written informed consent form
- •Those who have involved BSA (the percentage (%) of body surface area involved with lesion) ≥10%, PASI (Psoriasis Area and Severity Index) ≥12 and sPGA (static Physician's global assessment) ≥ 3 at screening and at baseline.
排除标准
- •Those who diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis or medication-induced psoriasis
- •Those who have skin conditions other than psoriasis including eczema at the time of the screening that would interfere with evaluations of the study drug.
研究组 & 干预措施
KHK4827 210 mg SC (Subcutaneous)
Experimental
Single SC administration
干预措施: KHK4827-Active (Drug)
Placebo SC
Placebo Comparator
Single SC administration
干预措施: KHK4827-Placebo (Drug)
结局指标
主要结局
To evaluate the proportion of subjects achieving 75% improvement from baseline in Psoriasis Area and Severity Index (PASI; PASI 75) at Week 12
时间窗: Week 12
次要结局
- To evaluate the proportion of subjects achieving 100% improvement from baseline in PASI (PASI 100) at Week 12(Week 12)
- To evaluate static physician's global assessment (sPGA) of "clear or almost clear (0 or 1)" at Week 12(Week 12)
研究者
研究点 (25)
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