Safety and Efficacy of Intratympanically Delivered Golimumab for Stabilization of Hearing in Patients With Autoimmune Inner Ear Disease: An Open-label Proof-of-concept Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 16
- 主要终点
- Serious Adverse Events
研究概览
简要总结
The investigators plan to conduct an open-label intratympanic injection proof-of-concept trial of golimumab, a TNF-alpha inhibitor, assessing for hearing loss progression in patients with autoimmune inner ear disease (AIED). This specific aim will be achieved using a two-arm approach. First, the investigators propose to dose 3 individual subjects with a single intratympanic injection of golimumab and follow each for 30 days, closely examining them for adverse events. If there are no serious adverse events, with FDA approval, the investigators propose to dose 14 subjects, each with 4 intratympanic injections of golimumab.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of autoimmune inner ear disease (AIED) by the principal investigator
- •Idiopathic, bilateral sensorineural hearing loss
- •History of, or audiograms showing, rapid progression of hearing loss
- •Bilateral loss of at least 30 dB in one or more frequencies (0.25 - 6 kHz)
- •Hearing responsive on high-dose oral steroids and steroid-dependent, as determined by history and the principal investigator. The subject can be taking oral steroid, at the maintenance level, if enrolled in the First Arm and, if enrolled in the Second Arm, will begin taper after the first injection.
- •Provided written informed consent for participation in the clinical study
排除标准
- •Positive MRI for vestibular schwannoma
- •Positive FTA (syphilis)
- •Significant middle ear disease (e.g., otitis media)
- •Positive blood test for Lyme disease
- •Positive tuberculosis test
- •Concurrent or past treatment or use of medications and/or substances known to cause ototoxicity(for example, aminoglycosides [e.g., gentamicin], cisplatin, loop diuretics, Yorgason et al., 2006)
- •Known adverse reaction to golimumab, adalimumab, etanercept, infliximab, rituximab, ustekinumab, or other biologic immunomodulators
- •Concurrent (within the past 3 months prior to enrollment) live viral intranasal vaccine (flu)
- •Positive test for HIV
- •Positive test for Hepatitis B and C
- •Presence of a demyelinating disease, such as multiple sclerosis
- •Women of childbearing potential only: Positive serum pregnancy test prior to the only/first injection
- •Active infections
研究组 & 干预措施
First Arm
Determine safety of intratympanic injection
干预措施: Golimumab (Drug)
Second Arm
Efficacy evaluation of 4 intratympanic injections
干预措施: Golimumab (Drug)
结局指标
主要结局
Serious Adverse Events
时间窗: 30 days
Serious Adverse Events
Pure-tone threshold change
时间窗: 6 weeks
Change in pure-tone threshold from baseline to 6 week after initiation of treatment
次要结局
未报告次要终点