EUCTR2012-000651-13-PL进行中（未招募）不适用
A Phase 3 Study to Evaluate the Efficacy, Safety, and Effect of Withdrawal and Retreatment With Brodalumab in Subjects With Moderate to Severe PlaquePsoriasis: AMAGINE-1 - AMAGINE-1
Amgen Inc.0 个研究点目标入组 600 人开始时间: 2012年5月18日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 600
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Subject has provided informed consent.
- •- Subject is = 18 and = 75 years of age at time of screening.
- •- Subject has had stable moderate to severe plaque psoriasis for at least 6 months before first dose of IP (eg, no morphology changes or significant flares of disease activity in the opinion of the investigator).
- •- Subject must be considered, in the opinion of the investigator, to be a suitable candidate for treatment with a biologic per regional labeling.
- •- Subject has involved body surface area (BSA) = 10%, PASI = 12, and sPGA = 3 at screening and at baseline.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 570
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •- 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 that, in the opinion of the
- •investigator, could cause this study to be detrimental to the subject.
- •- Subject has used anti-IL-17 biologic therapy ever, or other experimental or commercially available biologic immune modulator(s) within 12 weeks prior to the first IP dose.
- •- Subject currently is enrolled in another investigational device or drug
- •study, or less than 30 days since ending another investigational device or
- •drug study(s), or receiving other investigational agent(s).
- •- Other investigational procedures are excluded.
- •- Subject has known sensitivity to any of the products or components to be
- •administered during dosing.
- •- For women: pregnant or breast feeding, or planning to become pregnant
- •while enrolled in the study and for 8 weeks after the last dose of IP.
研究者
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A Study to Test the Effect and Safety of Brodalumab Compared With Placebo and the Results of Stopping and Restarting Brodalumab Treatment in People with Moderate to Severe Plaque Psoriasis: AMAGINE-1EUCTR2012-000651-13-DEAmgen Inc.600
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