NCT01498874已完成2 期
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Gevokizumab in Subjects With Moderate to Severe Acne Vulgaris
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 127
- 主要终点
- The mean absolute change from baseline in inflammatory facial lesion count at Day 84
研究概览
简要总结
The purpose of this study is to determine whether gevokizumab is effective in the treatment of moderate to severe acne vulgaris.
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
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of moderate to severe acne vulgaris
- •Acne vulgaris unresponsive to oral antibiotics
- •Willingness to maintain current habits for facial cleaning, shaving, and application of cosmetics through the end of the study
排除标准
- •Use of medications or treatments from specified pre-treatment time periods through the end of the study
- •Beard, moustache, sideburns or other facial hair that may interfere with evaluation
- •Other forms of acne
- •History of malignancy within 5 years
- •History of allergic or anaphylactic reactions to monoclonal antibodies
- •History of tuberculosis
- •History of chronic systemic infections
- •Female subjects who are pregnant, planning to become pregnant
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
low dose gevokizumab
Experimental
干预措施: gevokizumab (Drug)
high dose gevokizumab
Experimental
干预措施: gevokizumab (Drug)
结局指标
主要结局
The mean absolute change from baseline in inflammatory facial lesion count at Day 84
时间窗: Baseline and Day 84
次要结局
- The proportion of subjects with a successful treatment outcome at Day 84(Baseline and Day 84)
研究者
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