A Phase 3, 24-week, Randomized, Placebo-controlled, Double-blind Study to Assess the Effect of Rocatinlimab on Vaccine Antibody Response in Adult Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET - VOYAGER)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 221
- 试验地点
- 170
- 主要终点
- Number of Participants with a Positive Anti-tetanus Response
研究概览
简要总结
The primary objectives of this study are to:
- estimate vaccine response in rocatinlimab group vs placebo group, assessed using antibody anti-tetanus response at Week 24
- estimate vaccine response in rocatinlimab group vs placebo group, assessed using antibody anti-meningococcal response at Week 24
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 54 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years to 54 years with a diagnosis of AD according to the American Academy of Dermatology (AAD) Consensus Criteria (2014) present for at least 12 months
- •History of inadequate response to topical corticosteroids (TCS) of medium, high, or higher potency (with or without topical calcineurin inhibitors)
- •Subjects with previous systemic treatment for AD are also considered as inadequate responders to topical treatments and are potentially eligible to be included in the study after appropriate washout.
- •Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) score ≥ 3
排除标准
- •Treatment with a biologic 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
- •Janus kinase inhibitors
- •Treatment with any of the following medications or therapies within 1 week, prior to Day 1:
- •TCS of any potency
- •Topical calcineurin inhibitors (TCI)
- •Topical Phosphodiesterase-4 inhibitors (PDE4)
- •Other topical immunosuppressive agents
- •Combination topical agents containing a corticosteroid or calcineurin inhibiting component, PDE4 inhibitors, or other topical immunosuppressive agents
- •Treatment with live virus including live attenuated vaccination 12 weeks prior to day 1 pre-randomization.
- •Treatment with any meningococcal vaccine within 1 year prior to screening, or treatment with any tetanus-, diphtheria-, or pertussis containing vaccine within 5 years prior to screening
研究组 & 干预措施
Rocatinlimab
Rocatinlimab every 4 weeks (Q4W) for 24 weeks with a loading dose at Week 2.
干预措施: Rocatinlimab (Drug)
Placebo
Placebo every 4 weeks (Q4W) for 24 weeks with a loading dose at Week 2.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants with a Positive Anti-tetanus Response
时间窗: Week 20 to week 24
Number of Participants with a Positive Anti-meningococcal Response
时间窗: Week 20 to week 24
Percentage of Participants With a Positive Anti-tetanus Response at Week 24
时间窗: Week 20 to Week 24
Participants received 1 dose of a tetanus vaccine at Week 20. The antibody response to the tetanus vaccine was assessed by measuring serum anti-tetanus immunoglobulin G (IgG) by an immunoassay.
Percentage of Participants With a Positive Anti-meningococcal Response at Week 24
时间窗: Week 20 to Week 24
Participants received 1 dose of a meningococcal vaccine at Week 20. The antibody response to the meningococcal vaccine was assessed by measuring serum anti-meningococcal IgG by an immunoassay.
次要结局
未报告次要终点