NCT06088199已完成3 期
A Phase 3, Multi-center, Open-label, Single-arm Study to Assess the Safety of Apremilast (AMG 407) in Pediatric Participants From 6 Through 17 Years of Age With Mild to Moderate 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
- 发起方
- Amgen
- 入组人数
- 51
- 试验地点
- 60
- 主要终点
- Number of Participants With Treatment-emergent Adverse Events
研究概览
简要总结
The primary objective of this post-marketing study is to assess the safety and tolerability of apremilast in pediatric participants (ages 6 through 17 years) with mild to moderate 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
- •Participants must have a weight of ≥ 20 kg.
- •Participant must have an age and sex specific BMI value no lower in range than the fifth percentile on the growth chart for children and adolescents.
- •Participant is able to swallow the study medication tablet.
- •Diagnosis of chronic plaque psoriasis for at least 6 months prior to screening.
- •Has mild to moderate plaque psoriasis at screening and Study Visit 1 as defined by:
- •Psoriasis Area Severity Index score 2-15,
- •Body surface area 2-15%, and
- •Static Physician Global Assessment score of 2-3 (mild to moderate)
- •Disease inadequately controlled by or inappropriate for topical therapy for psoriasis.
排除标准
- •Guttate, erythrodermic, or pustular psoriasis at screening and Study Day
- •Psoriasis flare or rebound within 4 weeks prior to screening.
- •Active tuberculosis (TB) or a history of incompletely treated TB per local guidelines.
- •History of recurrent significant infections.
- •Active infection or infection treated with antibiotic treatment within 14 days of Study Day
- •Any history of or active malignancy or myeloproliferative or lymphoproliferative disease.
- •Current use of the following therapies that may have a possible effect on psoriasis:
- •Conventional systemic therapy for psoriasis within 28 days prior to Study Day 1 (including but not limited to cyclosporine, corticosteroids, methotrexate, oral retinoids, mycophenolate, thioguanine, hydroxyurea, sirolimus, sulfasalazine, azathioprine, and fumaric acid esters).
- •Phototherapy treatment (ie, ultraviolet B [UVB], PUVA) within 28 days prior to Study Day
- •Biologic therapy:
- •Etanercept (or biosimilar) treatment 28 days prior to Study Day 1
- •Adalimumab (or biosimilar) treatment 10 weeks prior to Study Day 1
- •Other TNF or IL-17 blockers (such as infliximab, certolizumab pegol, secukinumab, ixekizumab, brodalumab, or their biosimilars) within 12 weeks prior to Study Day 1
- •Anti-IL-12 or anti-IL-23 treatment (such as ustekinumab, guselkumab, or tildrakizumab) within 24 weeks prior to Study Day
- •Use of tanning booths or other ultraviolet light sources.
- •Answer "Yes" to any question on the Columbia-Suicide Severity Rating Scale during screening or at Study Day
- •Female participant of childbearing potential with a positive pregnancy test assessed at screening and/or Study Day 1 by a serum and/or urine pregnancy test.
研究组 & 干预措施
Apremilast
Experimental
Apremilast will be dosed by participant's body weight and administered twice daily (BID) in the form of oral tablets, approximately 12 hours apart, without restriction of food or drink.
干预措施: Apremilast (Drug)
结局指标
主要结局
Number of Participants With Treatment-emergent Adverse Events
时间窗: Day 1 up to approximately 285 days
次要结局
- Number of Participants With Psoriasis Flare(Up to approximately 285 days)
- Growth and Development as Assessed by Height(Day 1 up to approximately 285 days)
- Tanner Staging of Sexual Maturity(Day 1 and Day 225)
- Number of Participants with Clinically Significant Changes in Vital Signs(Up to approximately 285 days)
- Growth and Development as Assessed by Body Mass Index (BMI)(Day 1 up to approximately 285 days)
- Columbia-Suicide Severity rating Scale (C-SSRS)(Day 1 to Day 225)
- Number of Participants Experiencing Diarrhea Sympotms as Assessed by Stool Diaries(Day 1 to Day 225)
- Number of Participants with Clinically Significant Changes in Laboratory Parameters(Up to approximately 225 days)
- Growth and Development as Assessed by Weight(Day 1 up to approximately 285 days)
- Number of Participants With Psoriasis Rebound(Up to approximately 285 days)
研究者
研究点 (60)
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