NCT01950312已完成2 期
An Open-label Study of the Effects of Gevokizumab in Corticosteroid-resistant Subjects With Autoimmune Inner Ear Disease
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
- 10
- 试验地点
- 1
- 主要终点
- Improved hearing threshold, as defined by an improvement in either the PTA (Pure Tone Average) of >=5 dB (Decibel), or 12% in the WRS (Word Recognition Score)
研究概览
简要总结
The purpose of this study is to determine if gevokizumab therapy may be an alternate therapy in patients with steroid resistant Autoimmune Inner Ear Disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Autoimmune Inner Ear Disease with active deterioration in at least one ear
- •Failure to respond to a trial of high-dose corticosteroid therapy
- •Contraceptive measures adequate to prevent pregnancy during the study
排除标准
- •Evidence of retrocochlear pathology (vestibular schwannoma) or inner ear malformation (Mondini Malformation or Enlarged Vestibular Aqueduct)
- •History of active or chronic infections
- •Currently receiving, or having received treatment for a malignancy in the past three years
- •Hearing loss that coincides with significant, disabling episodes of vertigo
- •History of allergic or anaphylactic reactions to monoclonal antibodies
- •Female subjects who are pregnant, planning to become pregnant, have recently delivered, or are breast-feeding
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
gevokizumab
Experimental
Solution for subcutaneous injection
干预措施: gevokizumab (Drug)
结局指标
主要结局
Improved hearing threshold, as defined by an improvement in either the PTA (Pure Tone Average) of >=5 dB (Decibel), or 12% in the WRS (Word Recognition Score)
时间窗: Day 28 to Day 84
次要结局
未报告次要终点
研究者
研究点 (1)
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