An Open-label Multiple Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Upadacitinib in Pediatric Subjects With Severe Atopic Dermatitis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 18
- 主要终点
- Maximum Plasma Concentration (Cmax)
研究概览
简要总结
The objective of this study is to evaluate the safety, pharmacokinetics and tolerability of multiple doses of upadacitinib in pediatric participants with severe atopic dermatitis and to evaluate palatability of upadacitinib oral solution in pediatric participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with total body weight of 10 kilograms(kg) or higher at Baseline. Beginning with protocol version 6.0, only subjects 3 years of age and older will be enrolled for the remainder of this study.
- •Diagnosed with atopic dermatitis (AD) with onset of symptoms at least 6 months prior to baseline.
- •Meets Hanifin and Rajka criteria for AD.
- •Diagnosed with active severe AD defined by Eczema Area Severity Index (EASI), Validated Investigator's Global Assessment (IGA) and body surface area (BSA).
- •Documented history (within 12 months prior to the Baseline Visit) of inadequate response or intolerance to topical corticosteroids (TCS) and topical calcineurin inhibitor (TCI) OR for whom use of TCS and TCIs is otherwise medically inadvisable.
排除标准
- •Prior exposure to Janus Kinase (JAK) inhibitor.
- •Requirement of prohibited medications during the study.
- •Current use of known moderate or strong inhibitors or inducers of drug metabolizing enzymes within 30 days prior to the first dose of study drug and through the end of Part 1 of the study.
研究组 & 干预措施
Part 1; Cohort 1
Participants, 6 to <12 years of age, will receive low dose of upadacitinib.
干预措施: Upadacitinib (ABT-494) (Drug)
Part 1; Cohort 2
Participants, 6 to <12 years of age, will receive high dose of upadacitinib.
干预措施: Upadacitinib (ABT-494) (Drug)
Part 1; Cohort 3
Participants, 2 to <6 years of age, will receive low dose of upadacitinib.
干预措施: Upadacitinib (ABT-494) (Drug)
Part 1; Cohort 4
Participants, 2 to <6 years of age, will receive high dose of upadacitinib.
干预措施: Upadacitinib (ABT-494) (Drug)
Part 2
Eligible participants who completed Part 1 will receive weight-dependant low dose of upadacitinib.
干预措施: Upadacitinib (ABT-494) (Drug)
结局指标
主要结局
Maximum Plasma Concentration (Cmax)
时间窗: Up to 7 days
It is defined as the maximum observed plasma concentration (Cmax) for upadacitinib.
Time to Maximum Observed Plasma Concentration (Tmax)
时间窗: Up to 7 days
It is defined as the time to maximum plasma concentration (Tmax) of upadacitinib.
Oral Clearance
时间窗: Up to 7 days
Clearance is defined the volume of plasma cleared of the drug per unit time.
Area under the plasma concentration-time curve within a dosing interval (AUCtau)
时间窗: Up to 7 days
The area under the plasma concentration-time curve (AUCtau) is a method of measurement of the total exposure of a drug in plasma.
Number of Participants With Treatment Emergent Adverse Events (TEAE)
时间窗: Up to 2 years
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events (TEAEs) are defined as any event that began or worsened in severity after the first dose of study drug.
次要结局
未报告次要终点