A Phase 3, Multicenter, Randomized, Open-label, Performance Study With Self-administered Subcutaneous Rocatinlimab (AMG 451) in Adolescent and Adult Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Outpost)
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- Amgen
- 入组人数
- 151
- 试验地点
- 82
- 主要终点
- Proportion of Full-dose Self-administered Rocatinlimab Injections Among Total Attempted Injections up to Week 16
研究概览
简要总结
The primary objective of this study is to assess successful self-administration of rocatinlimab subcutaneously using devices for injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 12 at Day
- •Diagnosis of AD according to American Academy of Dermatology (AAD) Consensus Criteria (2014) that has been present for at least 12 months.
- •History of inadequate response to Topical Corticosteroids (TCS) of medium to higher potency (with or without topical calcineurin inhibitors [TCI]).
- •Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™) score ≥ 3 at screening and pre-randomization.
- •Eczema Area and Severity Index (EASI) score ≥ 16 at initial at screening and pre-randomization.
- •≥ 10% body surface area (BSA) of AD involvement at screening and pre-randomization.
排除标准
- •Treatment with a biological product within 12 weeks or 5 half-lives, whichever is longer, prior to day 1 pre-randomization.
- •Treatment with any of the following medications or therapies within 5 half-lives prior to day 1 pre-randomization:
- •Systemic corticosteroids
- •Non-biologic, non-targeted systemic immunosuppressants
- •Oral or Topical Janus kinase inhibitors
- •Treatment with any of the following medications or therapies within 1 week before day 1 pre-randomization:
- •Topical phosphodiesterase 4 (PDE4) inhibitors
- •Other topical immunosuppressive agents (not including TCS/TCI)
- •Combination topical agents containing any of the above components
研究组 & 干预措施
Rocatinlimab Dose 1 Prefilled Syringe (PFS)
Rocatinlimab will be self-administered subcutaneously using a PFS. Participants will receive rocatinlimab for 52 weeks.
干预措施: Rocatinlimab Prefilled Syringe (Combination Product)
Rocatinlimab Dose 2 PFS
Rocatinlimab will be self-administered subcutaneously using a PFS. Participants will receive rocatinlimab for 52 weeks.
干预措施: Rocatinlimab Prefilled Syringe (Combination Product)
Rocatinlimab Dose 2 Autoinjector (AI)
Rocatinlimab will be self-administered subcutaneously using an AI. Participants will received rocatinlimab for 52 weeks.
干预措施: Rocatinlimab AI (Combination Product)
结局指标
主要结局
Proportion of Full-dose Self-administered Rocatinlimab Injections Among Total Attempted Injections up to Week 16
时间窗: Up to Week 16
次要结局
- Proportion of Devices that Have Been Reported with Product Complaints Related to Function by Participants, Caregivers, or Investigators Among Total Dispensed Devices up to Week 16(Up to Week 16)