The Effects of Gevokizumab in Corticosteroid-resistant Subjects With Autoimmune Inner Ear Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2015-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Autoimmune Inner Ear Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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gevokizumab

Solution for subcutaneous injection

Group Type EXPERIMENTAL

gevokizumab

Intervention Type DRUG

Interventions

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gevokizumab

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No