NCT05565560进行中（未招募）3 期
A Phase 3, Multicenter, Open-label, Single-arm Study to Assess the Efficacy and Safety of Apremilast (AMG 407) in Japanese Pediatric Subjects From 6 Through 17 Years of Age 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
- 进行中（未招募）
- 发起方
- Amgen
- 入组人数
- 17
- 试验地点
- 50
- 主要终点
- Achievement of a static Physician Global Assessment (sPGA) score of clear (0) or almost clear (1) with at least 2 points reduction from baseline at Week 16
研究概览
简要总结
The primary objective of this study is to evaluate the efficacy of apremilast in children and adolescents (ages 6 through 17 years) with moderate to severe plaque psoriasis.
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
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Japanese participants aged 6 to 17 years at screening
- •Participants must have a weight of ≥ 15 kg
- •Diagnosis of chronic plaque psoriasis for at least 3 months prior to screening
- •Has moderate to severe plaque psoriasis at screening and baseline as defined by:
- •PASI score ≥ 12; and
- •BSA ≥ 10; and
- •sPGA ≥ 3 (moderate to severe)
- •Disease inadequately controlled by or contraindicated for ≥ 1 topical therapy for psoriasis
- •Candidate for systemic therapy or phototherapy
排除标准
- •Psoriasis flare or rebound within 4 weeks prior to screening
- •Evidence of skin conditions, other than psoriasis, that would interfere with clinical assessments
- •Other than psoriasis, history of any clinically significant (as determined by the investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major uncontrolled disease
- •Prior history of suicide attempt at any time in the participant's lifetime prior to screening or baseline in the study, or major psychiatric illness requiring hospitalization within 3 years prior to signing the assent and informed consent
- •Guttate, erythrodermic, or pustular psoriasis at screening and baseline
研究组 & 干预措施
Apremilast
Experimental
Participants with a weight between ≥ 15 kg to < 50 kg will receive apremilast 20 mg twice daily (BID) tablet. Participants weighing ≥ 50 kg will receive apremilast 30 mg BID tablet.
干预措施: Apremilast (Drug)
结局指标
主要结局
Achievement of a static Physician Global Assessment (sPGA) score of clear (0) or almost clear (1) with at least 2 points reduction from baseline at Week 16
时间窗: Week 16
次要结局
- Achievement of at least 75% reduction in Psoriasis Area and Severity Index (PASI) score (PASI-75) from baseline at Week 16(Baseline, Week 16)
- Achievement of at least a 50% reduction in PASI score (PASI-50) from baseline at Week 16(Baseline, Week 16)
- Percent change from baseline in total PASI score at Week 16(Baseline, Week 16)
- Percent change from baseline in affected body surface area (BSA) at Week 16(Baseline, Week 16)
- Achievement of Children Dermatology Life Quality Index (CDLQI) (0/1) at Week 16(Week 16)
- Change from baseline in CDLQI score at Week 16(Baseline, Week 16)
- Number of participants with treatment-emergent adverse events(Approximately 52 weeks)
- Number of participants with clinically significant changes in vital signs(Approximately 62 weeks)
- Number of participants with clinically significant changes in laboratory abnormalities(Approximately 62 weeks)
研究者
研究点 (50)
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