A Phase 3, Open-label, 52-week Study to Assess the Safety, Tolerability, and Efficacy of Rocatinlimab (AMG 451) in Adolescent Subjects Aged ≥ 12 to < 18 Years With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Orbit)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 187
- 试验地点
- 146
- 主要终点
- Number of Participants With Treatment-emergent Serious Adverse Events
研究概览
简要总结
The primary objective of this study is to describe the safety and tolerability of rocatinlimab in adolescents with moderate-to-severe AD.
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
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 12 to < 18 years at day
- •Participant has a diagnosis of AD (according to American Academy of Dermatology Consensus Criteria [Eichenfield, 2014]) that has been present for at least 12 months before signing of informed consent
- •Prior to informed consent, history of inadequate response to topical corticosteroids (TCS) of medium to higher potency (with or without topical calcineurin inhibitors [TCI] as appropriate) or for whom topical treatments are otherwise medically inadvisable (eg, because of important side effects or safety risks)
- •Eczema Area and Severity Index (EASI) score ≥ 12
- •vIGA-AD score ≥ 3
- •≥ 10% BSA of AD involvement at day 1 pre-enrollment
排除标准
- •Treatment with a biological product within 12 weeks or 5 half-lives, whichever is longer, prior to Day 1
- •Treatment with any of the following medications or therapies within 4 weeks or 5 half-lives, whichever is longer, prior to Day 1:
- •Systemic corticosteroids
- •Systemic immunosuppressants
- •Phototherapy
- •Oral or topical janus kinase inhibitors
- •Treatment with any of the following agents within 1 week before day 1 pre-enrollment:
- •Topical PDE4 inhibitors
- •Other topical immunosuppressive agents (not including TCS/TCI)
- •Combination topical agents containing a high- or super-high potency corticosteroid
研究组 & 干预措施
Rocatinlimab
Rocatinlimab will be administered subcutaneously every 4 weeks (Q4W) for 52 weeks with one additional dose at Week 2.
干预措施: Rocatinlimab (Drug)
结局指标
主要结局
Number of Participants With Treatment-emergent Serious Adverse Events
时间窗: Up to 52 Weeks
Number of Participants Who Experienced Treatment-emergent Serious Adverse Events (TESAEs)
时间窗: From first dose of trial intervention to end of trial; median (min, max) duration was 52.1 (2.0, 70.1) weeks
An adverse event (AE) was any untoward medical occurrence in a clinical trial participant irrespective of a causal relationship with the study treatment. A SAE was defined as any untoward medical occurrence that meets at least 1 of the following serious criteria: resulted in death (fatal), was immediately life-threatening, required in-patient hospitalization or prolonged existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or other medically important serious event. A TESAE was defined as an SAE that occurred on or after the first dose of trial intervention.
次要结局
未报告次要终点