A Phase 3B, Multi Center, Open-label Long-term Extension Study of Apremilast (CC-10004) in Pediatric Subjects from 6 Through 17 Years of Age with Moderate to Severe Plaque Psoriasis
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 53
- 试验地点
- 15
- 主要终点
- Adverse Events: Type, frequency, severity, and relationship to apremilast from Week 0 (Visit 1) through end of Observational Follow-up for the entire study duration
研究概览
简要总结
To evaluate the long-term safety of apremilast in children and adolescents (ages 6 through 17 years) with moderate to severe plaque psoriasis.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Observational Follow-up Phase
- 盲法
- None
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Subject is male or female 6 to 17 years of age, inclusive, at the time the informed consent document is signed by the legal guardian.
- •Subject must have a weight of ≥ 20 kg.
- •Subjects must have an age and sex specific BMI value no lower in range than the 5th percentile on the Centers for Disease Control (CDC) growth chart for children and adolescents (CDC, 2000).
- •Subject must have completed Week 52 (Apremilast Extension Phase) of Study CC-10004-PPSO-
- •Subject is able to sign an assent with a legal guardian/s who understand/s and voluntarily sign/s an informed consent prior to any study-related assessments/procedures being conducted.
排除标准
- •Subject has a condition, including the presence of laboratory abnormalities, or psychiatric illness, that would place the subject at unacceptable risk if he/she were to participate in the study.
- •Subject has a condition that confounds the ability to interpret data from the study.
- •Subject has evidence of skin conditions, other than psoriasis, that would interfere with clinical assessments.
- •Subject is pregnant or breastfeeding.
- •Subject has guttate, erythrodermic, or pustular psoriasis.
结局指标
主要结局
Adverse Events: Type, frequency, severity, and relationship to apremilast from Week 0 (Visit 1) through end of Observational Follow-up for the entire study duration
Adverse Events: Type, frequency, severity, and relationship to apremilast from Week 0 (Visit 1) through end of Observational Follow-up for the entire study duration
Columbia-Suicide Severity Rating Scale (C-SSRS) Questionnaire to monitor depression, suicidal thoughts and behavior for the entire study duration
Columbia-Suicide Severity Rating Scale (C-SSRS) Questionnaire to monitor depression, suicidal thoughts and behavior for the entire study duration
Tanner Staging. Assessment of sexual maturity at Week 0 (Visit 1) and then every 52 weeks. Also early termination visit.
Tanner Staging. Assessment of sexual maturity at Week 0 (Visit 1) and then every 52 weeks. Also early termination visit.
Body weight, height and BMI: Monitor growth - Height and body weight are measured at each visit
Body weight, height and BMI: Monitor growth - Height and body weight are measured at each visit
次要结局
- sPGA - Proportion of subjects with an sPGA score of clear (0) or almost clear (1) with at least a 2-point reduction from baseline
研究者
Wendy Zhang, MD
Scientific
Amgen Inc.