A Phase 3 Study to Evaluate the Efficacy and Safety of Induction and Maintenance Regimens of Brodalumab Compared With Placebo and Ustekinumab in Subjects With Moderate to Severe Plaque Psoriasis: AMAGINE-2
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 1,831
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Psoriasis Area Severity Index (PASI) 100 at Week 12
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy of brodalumab at two different doses
详细描述
.The purpose of this study is to assess the safety and efficacy of brodalumab at two different doses compared with placebo in participants with moderate to severe plaque psoriasis. A second purpose of this study is to assess the safety and efficacy brodalumab at two different doses compared with ustekinumab in participants with moderate to severe plaque psoriasis. A third purpose of this study is to assess the safety and efficacy of 4 maintenance regimens of brodalumab.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has had stable moderate to severe plaque psoriasis for at least 6 months
- •Subject has involved body surface area (BSA) ≥ 10%, PASI ≥ 12, and sPGA ≥ 3 at screening and at baseline
排除标准
- •Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis, or other skin conditions at (eg, eczema) that would interfere with study evaluations
- •Subject has known history of Crohn's disease
- •Subject has any other significant concurrent medical condition or laboratory abnormalities, as defined in the study protocol
- •Subject has not stopped using certain psoriasis therapies as defined in the study protocol
- •Subject has previously used ustekinumab or any anti-IL-17 biologic therapy
- •Subject is pregnant or breastfeeding, or planning to become pregnant while enrolled in the study
- •Female subject is unwilling to use highly effective methods of birth control unless 2 years post-menopausal or surgically sterile
研究组 & 干预措施
210 mg brodalumab
Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.
干预措施: 210 mg brodalumab (Drug)
140 mg brodalumab
Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.
干预措施: 140 mg brodalumab (Drug)
ustekinumab
Administered by subcutaneous (SC) injection per the labeled dosing regimen.
干预措施: ustekinumab (Drug)
Placebo
Administered by subcutaneous (SC) injection until week 12. At week 12 participants are assigned to 210 mg brodalumab.
干预措施: 210 mg brodalumab (Drug)
Placebo
Administered by subcutaneous (SC) injection until week 12. At week 12 participants are assigned to 210 mg brodalumab.
干预措施: placebo (Drug)
结局指标
主要结局
Percentage of Participants With Psoriasis Area Severity Index (PASI) 100 at Week 12
时间窗: 12 Weeks
to evaluate the efficacy of Brodalumab (210mg Q2W) in clearing psoriasis as measured by the proportion of subjects achieving PASI 100 at week 12.
Percentage of Participants With Static Physician Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 12
时间窗: 12 weeks
Measures the physician's impression of the disease at a single point, and a dynamic form in which the physician assesses the global improvement from baseline. Success is defined by a score of 0 or 1 (clear to almost clear).
Percentage of Participants With Psoriasis Area Severity Index (PASI) 75 at Week 12
时间窗: 12 weeks
to evaluate the efficacy of Brodalumab (210mg every 2 weeks, and 140mg every 2 weeks) in subjects with moderate to severe plaque psoriasis, as measured by the proportion of subjects achieving 75% improvement in Psoriasis Area and Severity Index, PASI75 at week 12.
次要结局
未报告次要终点