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)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Amgen
- 入组人数
- 2,621
- 试验地点
- 1,088
- 主要终点
- Number of Participants With Treatment-emergent Adverse Events
研究概览
简要总结
The primary objective of this study is to describe the long-term safety and tolerability of rocatinlimab in participants with moderate-to-severe AD.
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
- Double (Participant, Investigator)
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
- •Completion of an end of treatment duration visit (Week 24 or Week 52 visit for adult or adolescent studies, respectively) in a rocatinlimab parent study (ROCKET-IGNITE, ROCKET-HORIZON, ROCKET-SHUTTLE, ROCKET-ASTRO, ROCKET-ORBIT, OR ROCKET-VOYAGER) within the past 28 days.
- •Participants from the parent study ROCKET-ORBIT must achieve an improvement in EASI score at week 52 of at least 60% compared to parent study baseline (EASI 60).
排除标准
- •Permanent investigational product discontinuation due to safety-related reasons, protocol-defined stopping rules or conditions/reasons unrelated to efficacy during the rocatinlimab parent study (ROCKET-IGNITE, ROCKET-HORIZON, ROCKET-SHUTTLE, ROCKET-ASTRO, ROCKET-ORBIT, OR ROCKET-VOYAGER), or at the time of Screening or Day 1.
研究组 & 干预措施
ARM A: Dose 1 to Dose 1
Participants from parent Rocatinlimab studies ROCKET-Ignite, ROCKET-Horizon, ROCKET-SHUTTLE, or ROCKET-ASTRO who received Dose 1 will be randomized or assigned to receive Dose 1 Every 4 Weeks (Q4W) or Every 8 Weeks (Q8W). Participants from parent Rocatinlimab study ROCKET-VOYAGER who received Dose 1 will be assigned to receive Dose 1 Q4W.
干预措施: Rocatinlimab (Drug)
ARM B: Dose 2 to Dose 2
Participants from parent Rocatinlimab studies ROCKET-Ignite, ROCKET-SHUTTLE, or ROCKET-ASTRO who received Dose 2 will be randomized or assigned to receive Dose 2 Q4W or Q8W.
干预措施: Rocatinlimab (Drug)
ARM E: Dose 1, Dose 2, Placebo, or Open-label (OL) to OL Dose 1
Participants from parent Rocatinlimab studies ROCKET- Ignite, ROCKET-Horizon, ROCKET- SHUTTLE, ROCKET-ASTRO, or ROCKET-VOYAGER who received Dose 1, Dose 2, or placebo will be assigned to receive OL Rocatinlimab Dose 1 Q4W.
Participants who received OL in parent Rocatinlimab study ROCKET- ASTRO will continue to receive OL Rocatinlimab Dose 1 Q4W.
All participants from parent Rocatinlimab study ROCKET-Orbit will continue to receive OL Rocatinlimab Dose 1 Q4W.
干预措施: Rocatinlimab (Drug)
ARM G Group
Participants from Arm F who meet defined criteria will resume OL Rocatinlimab Dose 1 Q4W.
干预措施: Rocatinlimab (Drug)
ARM C: Dose 1 or Dose 2 to Placebo
Participants from parent Rocatinlimab studies ROCKET-Ignite or ROCKET-Horizon who received Dose 1 will be randomized to receive placebo Q4W. Participants from parent Rocatinlimab study ROCKET-Ignite who received Dose 2 will be randomized to receive placebo Q4W.
干预措施: Placebo (Other)
ARM D: Placebo to Placebo
Participants from parent Rocatinlimab studies ROCKET- Ignite, ROCKET-Horizon, ROCKET-SHUTTLE, ROCKET-ASTRO, or ROCKET-VOYAGER who received placebo will be randomized or assigned to receive placebo Q4W.
干预措施: Placebo (Other)
ARM F Group
Participants in Arm E (OL Rocatinlimab Dose 1 Q4W) who meet defined criteria will have Rocatinlimab withdrawn, but will continue all subsequent study visits.
结局指标
主要结局
Number of Participants With Treatment-emergent Adverse Events
时间窗: Up to 116 weeks
次要结局
- Maintaining Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD™) 0/1 Response at Week 32 Among Participants Achieving vIGA-AD™ 0/1 Response at Day 1(Week 32)
- Maintaining a Revised IGA (rIGA™) 0/1 Response at Week 32 Among Participants Achieving rIGA™ 0/1 Response at Day 1(Week 32)
- Maintaining Eczema Area and Severity Index (EASI) 75 Response at Week 32 Among Participants Achieving EASI 75 Response at Day 1(Week 32)
- Maintaining EASI 90 Response at Week 32 Among Participants Achieving EASI 90 Response at Day 1(Week 32)
- Maintaining vIGA-AD™ 0/1 Response and EASI 75 Response at Week 32 Among Participants Achieving vIGA-AD™ 0/1 Response and EASI 75 Response at Day 1(Week 32)
- Maintaining ≥ 4-point Reduction from Parent Study Baseline in Worst Pruritus NRS Score at Week 32 Among Participants Achieving ≥ 4 Point Reduction from Parent Study Baseline in Worst Pruritus NRS Score at Day 1(Week 32)
- Maintaining Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD™) 0/1 Response at Week 32 Among Participants Achieving vIGA-AD™ 0/1 Response at Day 1(Week 32)
- Maintaining Eczema Area and Severity Index (EASI) 75 Response at Week 32 Among Participants Achieving EASI 75 Response at Day 1(Week 32)
- Maintaining vIGA-AD™ 0/1 Response and EASI 75 Response at Week 32 Among Participants Achieving vIGA-AD™ 0/1 Response and EASI 75 Response at Day 1(Week 32)
- Maintaining EASI 90 Response at Week 32 Among Participants Achieving EASI 90 Response at Day 1(Week 32)