NCT02982005已完成3 期
A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study With an Open Label Extension to Evaluate the Efficacy and Safety of 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
- 3 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Psoriasis area and severity index (PASI) 75 response
研究概览
简要总结
The primary objective of this study is to evaluate the efficacy and safety of KHK4827 in subjects with moderate to severe plaque psoriasis randomized in a double-blind manner to receive KHK4827 or placebo for 12 weeks
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has had stable moderate to severe plaque psoriasis for at least 6 months
- •Subject has involved BSA ≧ 10%, PASI ≧ 12, and sPGA ≧ 3 at screening and at baseline
排除标准
- •Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, or a medication-induced psoriasis, or other skin conditions (e.g., eczema) at screening that would interfere with study evaluations
- •Subject scheduled to undergo a surgical intervention during the study period
- •Subject has any active infection or history of infections as defined in the study protocol
- •Subject has known history of Crohn's disease
- •Subject has any other significant concurrent medical condition or laboratory abnormalities, as defined in the study protocol
- •Subject has not stopped using certain psoriasis therapies as defined in the study protocol
- •Subject has previously used any anti-IL-17 biologic therapy
- •Subject is pregnant or breast feeding, or planning to become pregnant while enrolled in the study
- •Women of child-bearing potential or fertile men who do not agree to use effective contraception from the day of providing consent through 12 weeks after the last dose of investigational product.
- •Subject has known history or evidence of suicidal ideation (severity of 4 or 5) or any suicidal behavior based on an assessment with the Columbia-Suicide Severity Rating Scale (C-SSRS) at screening or at baseline
- •Subject has severe depression based on a total score of ≥ 15 on the Patient Health Questionnaire-8 (PHQ-8) at screening or at baseline
- •Subject has known history or evidence of a psychiatric disorder that, in the opinion of the investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
- •Subject has known history of alcohol and/or substance abuse within the last 12 months"
研究组 & 干预措施
KHK4827
Experimental
KHK4827 administered SC
干预措施: KHK4827 (Drug)
Placebo
Placebo Comparator
Placebo administered SC
干预措施: Placebo (Drug)
结局指标
主要结局
Psoriasis area and severity index (PASI) 75 response
时间窗: at week 12
Static physician's global assessment (sPGA) of "0 (clear)" or "1 (almost clear)"
时间窗: at week 12
次要结局
- Body surface area (BSA) involvement of lesion(Baseline to week 64)
- Serum KHK4827 concentration(Baseline, Week 8, Week 10, Week 12, Week 24)
- Psoriasis scalp severity index (PSSI) score (applicable only to subjects who had scalp symptoms at baseline)(Baseline to week 64)
- Laboratory values(Baseline to week 64)
- Vital signs(Baseline to week 64)
- Anti-KHK4827 antibodies(Baseline, Week 12, Week 24, Week 48, Week 64)
- PASI 50/75/90/100 response by visit(Baseline to week 64)
- sPGA of "0 (clear) or 1 (almost clear)" by visit(Baseline to week 64)
- Dermatology life quality index (DLQI)(Baseline to week 64)
- Treatment-emergent adverse events (TEAEs) or drug-related TEAEs(Baseline to week 64)
- Nail psoriasis severity index (NAPSI) score (applicable only to subjects who had nail symptoms at baseline)(Baseline to week 64)
研究者
研究点 (1)
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