A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of Brodalumab in Subjects With Psoriatic Arthritis: AMVISION-2
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 484
- 试验地点
- 1
- 主要终点
- ACR20 (American College of Rheumatology 20% Improvement) Response Rate Through Week 16
研究概览
简要总结
The primary objective of this study is to evaluate the efficacy of brodalumab, compared to placebo, in subjects with psoriatic arthritis. The key secondary objective is to evaluate the efficacy of brodalumab compared to placebo at week 16. The safety objective of this study is to evaluate the safety profile of brodalumab in subjects with psoriatic arthritis.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects has a diagnosis of psoriatic arthritis (by the Classification of Psoriatic Arthritis criteria (CASPAR), with ≥ 3 tender and ≥ 3 swollen joints (excluding distal interphalangeal joints). Subjects must have at least
- •1 psoriatic skin lesion.
排除标准
- •-Subject has known history of active tuberculosis.
- •Subject has a planned surgical intervention between baseline and the week 52 evaluation.
- •Subject has an active infection or history of infections.
- •Subject has any systemic disease (eg, renal failure, heart failure, hypertension, liver disease, diabetes, anemia) considered by the Investigator to be clinically significant and uncontrolled.
- •Subject has any concurrent medical condition or electrocardiogram (ECG) abnormality that, in the opinion of the investigator, could cause this study to be detrimental to the subject.
- •Subject has severe depression measured by Personal Health Questionnaire Depression Scale (PHQ-8) or suicidal ideation/behavior as measured by and Columbia Suicide Severity Rating Scale (e-CSSRS)
- •Subject has a history or evidence of psychiatric disorder or substance abuse considered by the Investigator to pose a risk to subject safety
研究组 & 干预措施
210 mg brodalumab
Administered via subcutaneous injections.
干预措施: 210 mg brodalumab (Drug)
140 mg brodalumab
Administered via subcutaneous injection.
干预措施: 140 mg brodalumab (Drug)
Placebo
Administered via subcutaneous injection until week 24.
干预措施: Placebo (Drug)
结局指标
主要结局
ACR20 (American College of Rheumatology 20% Improvement) Response Rate Through Week 16
时间窗: Baseline and 16 Weeks
ACR20 is used as a measurement of the proportion of subjects who are reaching a 20% improvement of tender an swollen joint counts. The higher percent of subjects reaching a higher improvement percentage shows greater success.
次要结局
未报告次要终点