NCT01526174

Intratympanic Injection for Autoimmune Inner Ear Disease

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

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: House Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Autoimmune Inner Ear Disease

Interventions

Type	Name	Description
DRUG	Golimumab	Intratympanic injection 0.3ml First Arm: 1 injection Second Arm: 4 injections

Timeline

• Start date: 2012-03-01
• Primary completion: 2013-12-01
• Completion: 2014-04-01
• First posted: 2012-02-03
• Last updated: 2013-10-14