2022-501587-17-00招募中3 期
A Phase 3, Multicenter, Double-blind Maintenance Study to Assess Long-term Safety, Tolerability, and Efficacy of Rocatinlimab in Adult and Adolescent Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-ASCEND)
Amgen Inc.198 个研究点 分布在 10 个国家目标入组 615 人开始时间: 2023年10月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 615
- 试验地点
- 198
- 主要终点
- Treatment-emergent adverse events (including clinically significant changes in laboratory values and vital signs) and serious adverse events
研究概览
简要总结
To describe the long-term safety and tolerability of rocatinlimab in subjects with moderate-to-severe AD
研究设计
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- Double (Subject, Investigator, Analyst, Monitor, Carer)
入排标准
- 年龄范围
- 0 years 至 65+ years（65+ Years, 18-64 Years, 0-17 Years）
- 接受健康志愿者
- 否
入选标准
- •Completion of an end of treatment duration visit in a rocatinlimab parent study.
- •Subjects from the parent study 20210263 must achieve an improvement in EASI score by a certain amount at Week 52.
排除标准
- •Permanent investigational product discontinuation due to safety-related reasons, protocol-defined rules or conditions/reasons unrelated to efficacy during the rocatinlimab parent study, or at the time of screening or day
- •Planning to enroll or has newly enrolled in a non-rocatinlimab protocol with other non-rocatinlimab protocol or other investigational device or product.
研究组 & 干预措施
Rocatinlimab
Test
干预措施: Rocatinlimab (Drug)
Placebo for amg 451
Placebo
干预措施: Placebo for amg 451 (Drug)
结局指标
主要结局
Treatment-emergent adverse events (including clinically significant changes in laboratory values and vital signs) and serious adverse events
Treatment-emergent adverse events (including clinically significant changes in laboratory values and vital signs) and serious adverse events
次要结局
- Maintaining vIGA-AD™ 0/1 response among subjects achieving vIGA-AD 0/1 response at day 1
- Maintaining revised IGA (rIGA™) 0/1 response among subjects achieving rIGA 0/1 response at day one
- Maintaining EASI 75 response among subjects achieving EASI 75 response at day 1
- Maintaining vIGA-AD 0/1 response and EASI 75 response among subjects achieving vIGA-AD 0/1 response and EASI 75 response at day 1
- Maintaining reduction from parent study baseline in worst pruritus NRS score among subjects achieving reduction from parent study baseline in worst pruritus NRS score at day 1
研究者
Medical Information
Scientific
Amgen Inc.
研究点 (198)
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