2023-503433-21-00招募中3 期
A Phase 3, Multicenter, Open-label, Long-term Extension Study of Apremilast in Children 2 Years of Age or Older With Oral Ulcers Associated With Behçet’s Disease or 5 Years of Age or Older With Juvenile Psoriatic Arthritis
Amgen Inc.12 个研究点 分布在 3 个国家目标入组 25 人开始时间: 2023年3月23日最近更新:
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 25
- 试验地点
- 12
- 主要终点
- Body weight, height, and body mass index (BMI)
研究概览
简要总结
Evaluate the long-term safety of apremilast in subjects 2 years of age or older with oral ulcers associated with Behçets disease or 5 years of age or older with active JPsA that have completed Study 20190530 or Study 20190529
研究设计
- 分配方式
- Non Randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 0 years 至 64 years（0-17 Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Subject’s legally authorized representative has provided informed consent when the subject is legally too young to provide informed consent and the subject has provided written assent based on local regulations and/or guidelines prior to any study-specific activities/procedures being initiated.
- •Subject must be < 18 years of age at the time the informed consent document is signed and have completed week 52 (Apremilast Active TreatmenPhase) of Study 20190529 (from a country without another mechanism for post-trial access to apremilast for JPsA) or Study 20190530, where drug is not approved for the subject’s pediatric therapeutic indication in their country.
- •Subject must have an age and sex specific body mass index (BMI) value no lower in range than the 5th percentile on the Centers for Disease Control (CDC) growth chart (Appendix 11.7) for children and adolescents (CDC, 2000) at enrollment.
- •Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
- •Subject must have acceptable benefit/risk for continued treatment with apremilast.
排除标准
- •Answer “Yes” to any question on the Columbia-Suicide Severity Rating Scale (C-SSRS) at the week 52 visit on Study 20190529 (subjects from France and Turkey sites only) or Study
- •Scheduled surgery or other interventions that would interrupt the subject’s participation in the study.
- •Female subjects of childbearing potential (for the purpose of this study, a female subject is considered of childbearing potential if she is ³ 12 years old or has reached menarche, whichever occurred first) unwilling to use protocol specified method of contraception see Appendix 5 (Section 11.5) during treatment and for an additional 30 days after the last dose of investigational product.
- •Female subjects planning to become pregnant while on study through 30 days after the last dose of investigational product.
- •Female subjects of childbearing potential with a positive pregnancy test assessed at week 0 by a highly sensitive urine or serum pregnancy test.
- •Subject has known sensitivity to any of the products to be administered during dosing.
研究组 & 干预措施
Apremilast, Apremilast, Apremilast
Test
干预措施: Apremilast (Drug)
结局指标
主要结局
Body weight, height, and body mass index (BMI)
Body weight, height, and body mass index (BMI)
Vital signs and laboratory parameters
Vital signs and laboratory parameters
Tanner Staging
Tanner Staging
Adverse events: Type, frequency, severity, and relationship to apremilast
Adverse events: Type, frequency, severity, and relationship to apremilast
Columbia-Suicide Severity rating Scale (C-SSRS)
Columbia-Suicide Severity rating Scale (C-SSRS)
次要结局
未报告次要终点
研究者
Medical Information
Scientific
Amgen Inc.
研究点 (12)
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